BHI Weekly Newsletter Archives Archives - Page 29 of 67

Jul 06 2020

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413th Edition – July 6, 2020

By admin BHI Weekly Newsletter Archives

<!doctype html> BioHealth Innovation

July 6, 2020

FOUNDING MEMBER OF

Prestigious annual pediatric medical device competition reveals 10 finalists including BHI client Innara

WASHINGTON, June 29, 2020 /PRNewswire/ — Ten finalists have been named in the prestigious annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in cardiovascular, orthopaedic and spine, and neonatal intensive care unit (NICU) medical devices, finalists were selected from a field of 30 semi-finalists who competed in March 2020. The ten innovators now have access to a new pediatric accelerator program and will compete for FDA-funded grants of up to $50,000 each in the final virtual pitch event on Oct. 7 as part of the 8th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

BHI Client Gentian awarded up to NOK 8.0 million funding to develop a novel high-throughput COVID-19 antibody test

Gentian Diagnostics AS is pleased to announce that the Research Council of Norway (Norges Forskningsråd) has awarded Gentian up to NOK 8.0 million of funding to support the development of a high-throughput COVID-19 antibody test. Gentian has in cooperation with Professor Ørjan Olsvik and Dr. Vegard Skogen at the University of Tromsø, The Arctic University of Norway performed explorative test work that supports an idea of developing a COVID-19 antibody test based on Gentian’s proprietary technology. The assay, if successfully developed, will be designed for use on clinical analysers already available in major laboratories around the world.

Baltimore biotech company PathSensors will be acquired – Technical.ly Baltimore

Inner Harbor-based biotech company PathSensors will be acquired by global security screening and threat detection company Smiths Detection, the companies announced this week.

With the deal, PathSensors will become part of a London-based company with 2,200 employees and a U.S. headquarters in Edgewood.

Image: PathSensors is headquartered at Columbus Center. (Photo by Wikimedia Commons user Smash the Iron Cage, used under Creative Commons license)

Emergent BioSolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing for Johnson & Johnson’s Lead COVID-19 Vaccine Candidate | Emergent BioSolutions Inc.

GAITHERSBURG, Md., July 06, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac® technology. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years.

Fueling an Innovation Ecosystem for Startups to Thrive (Bendis to Moderate)

BHI’s own Rich Bendis will Moderate.

Join us for a lively discussion between our region’s top innovators and connectors to hear about their efforts to help grow the innovation ecosystem and the pipeline of successful startups across the BioHealth Capital Region.

On this webinar, you will learn how you can take advantage of the many resources available throughout the region that will help your company go to market AND increase the opportunity to find success in the process.

Fueling an Innovation Ecosystem for Startups to Thrive

Click here for more information and to register.

Former MedImmune Employees Leading In the BioHealth Capital Region and Beyond · BioBuzz

In a recent conversation someone shared the quote “You can’t throw a stone in the BioHealth Capital Region and not hit somebody who worked at MedImmune”. This statement emphasizes how important the company was in seeding the growth of the biotech industry in Maryland. Founded by Wayne T. Hockmeyer in 1988 as Molecular Vaccines, Inc., MedImmune became one of the cornerstone Biotech companies in what eventually was named the BioHealth Capital Region.

Novavax hires new manufacturing chief to take COVID-19, flu vaccine hopefuls across the finish line | FiercePharma

With its COVID-19 vaccine hopeful cycling through clinical trials, shot maker Novavax is working to flesh out its executive team to help lead the company to the commercial stage. But you can’t get regulatory approval without a sturdy manufacturing operation—and now Novavax has hired an exec to get that operation in order.

Novavax tapped Ben Machielse as its executive vice president of chemistry, manufacturing and controls (CMC) as the vaccine maker works to take its COVID-19 and four-strain flu hopefuls across the finish line, the company said Monday.

Image: Novavax’s newest manufacturing head will join newly hired Chief Medical Officer Filip Dubovsky. (Novavax)

QIAGEN Shareholders Approve All Agenda Items Related to Acquisition by Thermo Fisher Scientific at Annual General Meeting | Business Wire

VENLO, The Netherlands–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that its shareholders today approved all agenda items at the Company’s Annual General Meeting related to the proposed voluntary public takeover offer for the acquisition of all ordinary shares in QIAGEN by Quebec B.V., a wholly-owned subsidiary of Thermo Fisher Scientific Inc. (NYSE: TMO) for EUR 39 per share in cash (the “Offer”).

Protaryx Medical Announces $8.3M in Funding for First-in-Class Technology for Left Atrial Access in Transcatheter Cardiac Procedures | Business Wire

BALTIMORE–(BUSINESS WIRE)–Protaryx™ Medical, a company committed to reimagining access to the left atrium for transcatheter cardiac procedures, today announced that it has raised $8.3 million in funding to develop the company’s first-in-class device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures. The company’s funding includes non-dilutive grants and a seed round totaling $3.2 million and the recently closed $5.1M Series A financing led by Ajax Health, with participation from University of Maryland (UM) Ventures, a returning investor.

ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – BioHealth Capital Region

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

Avantor® Expands Life Sciences Innovation Center to Address Bioprocessing Needs in Protein Science, Monoclonal Antibodies (mAbs), Cell and Gene Therapy | BioSpace

RADNOR, Pa., June 30, 2020 /PRNewswire/ — Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, today announced the expansion of the company’s Bridgewater, N.J. (USA) innovation center. Located close to biotech companies, the site now has nearly double the laboratory and support space.

Bioprocessing efficiency that doesn’t compromise quality continues to be a top priority for the biopharma industry. At the same time, it’s critical to meet increasingly stringent global regulatory standards.

Alexandria LaunchLabs – AgTech, the Premier Platform Accelerating the Growth of Early-Stage AgTech and FoodTech Companies, Announces Winner of Its Inaugural $100,000 AgTech Innovation Prize

PASADENA, Calif. and DURHAM, N.C., June 30, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, today announced the winner of its inaugural $100,000 AgTech Innovation Prize that called on innovators with demonstrated novel approaches to agriculture-, food- and nutrition-related challenges, which are key to advancing human health. The prize was awarded to TerMir Inc., a North Carolina–based agtech company pioneering an innovative and environmentally safe treatment for citrus greening disease—one of the most devastating citrus diseases in the world. Citrus greening disease has resulted in a drop in citrus production and harvesting while driving up costs and job losses. In response to this presently incurable agricultural, environmental and economic challenge, TerMir has developed a cutting-edge and effective solution for breaking the greening cycle with the potential to eradicate the disease.

Innara Health joins MedTech Innovator accelerator – Kansas City Business Journal

Olathe-based Innara Health is setting its sights on international expansion, and its acceptance into a national accelerator program could help that goal come to fruition.

Image: Innara Health’s NTrainer System helps infants born prematurely transition to oral feeding. INNARA HEALTH

Six Veteran-Owned Life Science Companies to Know in the BioHealth Capital Region · BioBuzz

Across Maryland and the BioHealth Capital Region (BHCR), state-level support for veteran-owned and operated life science businesses is strong.

This is evidenced by the rich and diverse tapestry of veteran led life science organizations in the region that spans a number of disciplines, including genomics, regenerative medicine, lab equipment and support, testing and biorisk management services.

Here are BHCR veteran-owned life science companies to keep an eye on as we move deeper into 2020.

Image: https://biobuzz.io

Five BioHealth Capital Region Companies Make List of Largest COVID-19 Government Contracts · BioBuzz

At BioBuzz, we’ve been chronicling the BioHealth Capital Region’s contributions to the battle against the coronavirus pandemic. We’ve covered BHCR companies developing vaccine candidates and creating diagnostic and serological COVID-19; we’ve also written about companies across the region that have delivered essential materials for the fight against COVID-19 and pivoted their business models to help the region navigate this public health crises.

Image: https://biobuzz.io

Mark your calendars now! 5th Annual Women Building Bio (Interactive Virtual Conference)

September 12, 2020

Special Guests Including:

Dr. Michele McMurry-Hearth

President and CEO,

Biotechnology Innovation Organization (BIO)

The Life Sciences Report: Summer 2020 | Wilson Sonsini Goodrich & Rosati – JDSupra

The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm’s chief client corporate development officer, who has broad management experience in the life sciences sector; a piece authored by Paul Grand and Kathryn Zavala of MedTech Innovator outlining 10 reasons why health care start-ups fail; an interview with Ryan Phelan, co-founder and executive director of Revive & Restore, a 501(c)(3) foundation using 21st century biotechnology to address urgent conservation challenges; and an article by Paul P. Campbell of W. L. Gore & Associates on life sciences innovation culture and deconstruction. In addition, the publication includes articles covering life sciences venture financings in which firm clients participated during 2019, the FDA’s recent issuance of a MAPP on the conversion of ANDA approval to tentative approval, and a sampling of COVID-19-related client activity in which the firm has been involved, as well as a summary of other select recent life sciences client highlights.

Image: https://www.jdsupra.com

Johns Hopkins Medicine CEO: Predictive analytics, precision medicine and AI are the future of medicine

Paul Rothman, MD, CEO of Baltimore-based Johns Hopkins Medicine and dean of the medical faculty at Johns Hopkins University, discussed the health system’s COVID-19 data platform and the potential for artificial intelligence to make a difference in how health systems approach treatment in the future in an interview with The Media Line.

Since the pandemic began, Johns Hopkins has gathered COVID-19 data and reported it on a public dashboard for cases and deaths in the U.S. and across the world. Dr. Rothman said the health system is using artificial intelligence and machine learning in its platform and aims to collaborate with others to incorporate data in the future.

Next in Naturals QuickFire Challenge on Immune-Support – Challenge | JLABS

Families often turn to dietary supplements inspired by nature with ingredients such as Elderberry, Vitamin C, and Zinc with the aim to help safely support their immune systems. A heightened awareness for the need to support your immune system throughout the year has resulted in an increased demand for products with immune-supporting and wholesome ingredients.*

To that end, we’re launching the Next in Naturals QuickFire Challenge on Immune-Support, calling on innovators to submit potential solutions inspired by nature that aim to support healthy immune systems in babies, children, or adults.

The innovator(s) with the best idea(s) will receive up to $50,000 in grant funding, one year of residency at an available JLABS, and the opportunity to engage with leadership from Johnson & Johnson Innovation.

Reopening in an Era of COVID-19 – YouTube

https://www.youtube.com/watch?v=qnR9Cmt7am0

COVID-19 Drug & Vaccine Candidate Tracker | GEN

Welcome to GEN’s COVID-19 DRUG & VACCINE CANDIDATE TRACKER website.

Total Drug & Vaccine Candidates: 237 (as of June 8)

The goal of this resource is to provide a comprehensive collection of news, milestones, and updates on drug and vaccine candidates currently being developed for the COVID-19 pandemic.

This resource is based on the reporting of GEN senior news editor Alex Philippidis, who began compiling information on drug and vaccine candidates in the early weeks of the pandemic. The numbers of verified candidates ballooned rapidly from 35 in February 2020, to 60 in March, to 160 in April.

NYC Builds Bio | The City’s Premier Organization for Real Estate.

Across the country today, not just in Boston and San Francisco, in leading and emerging life science clusters, life sciences institutions and innovative companies are working on cell and gene therapies, corona virus vaccines and drugs, and new bioengineering technologies that have the potential to change the way we feed, fuel and heal the world.

The biotech IPO boom is becoming ‘historic’ as four more throw their hats in – Endpoints News

Four more US biotechs filed to go pub lic Fri day as yet more com pa nies clam ber to get through a yawn ing IPO win dow and on to a mar ket that’s sig naled its will ing ness to re ward near ly any new drug mak er.

The new en trants are led by ALX On col o gy and the bi o log i cal an a lyt ics biotech Berke ley Lights, each of whom filed to raise $100 mil lion. The au toim mune com pa ny Pan dion Ther a peu tics al so filed for $75 mil lion, and Kiromic Bio phar ma, a tiny im muno-on col o gy start up based in San An to nio, filed for $25 mil lion.

Baltimore firm Protaryx making medical devices for heart surgery raises $8M – Baltimore Business Journal

The UMB-born startup was co-founded by cardiac surgery chief Dr. James Gammie, who was previously involved with another company that was acquired in 2017 for up to $250 million.

Emergent Bio inks five-year deal with J&J for manufacture of COVID-19 vaccine (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) has closed a five-year agreement with Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for large-scale drug substance manufacturing for J&J’s SARS-CoV-2 vaccine, Ad26.COV2-S.

EBS will provide contract development and manufacturing services over the contract term valued at ~$480M for the first two years. Volume manufacturing will start in 2021 at its Baltimore Bayview facility subsequent to technology transfer.

The company will release updated 2020 guidance when it reports Q2 results.

JNJ is up 2% premarket and EBS up 1%, both on light volume.

Biobuzz Directory – Altimmune Receives Award From U.S. Department of Defense to Fund Phase 1/2 Clinical Trial of T-COVID™ in Outpatients With Early COVID-19

GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.

Jun 29 2020

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412th Edition – June 29, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 29, 2020

FOUNDING MEMBER OF

Alex Philippidis, Genetic Engineering and Biotechnology News Senior News Editor, Guests on BioTalk

Alex Philippidis joins Rich Bendis on BioTalk to discuss the BioHealth Capital Region from a National viewpoint, other Hubs, and how the industry has adapted in the age of COVID-19.

Alex specializes in biopharma business news and industry issues for GEN. He joined GEN in 2011 after four years at GenomeWeb, where he covered research institutes and spent three years following biotech economic development as editor of the weekly newsletter BioRegion News. Alex reports a variety of news stories for GEN and Clinical OMICs and compiles the popular A-Lists series.

Novavax charges ahead with $200M, David Mott appointed to board – Washington Business Journal

Novavax Inc. plans to advance its Covid-19 vaccine candidate with new additions to the company and about $200 million in new funds from selling convertible preferred stock — the latest cash infusion for the Gaithersburg vaccine maker.

The preferred private placement with a Boston-based RA Capital Management investment fund, in a deal that closed June 16, came fewer than two weeks after Novavax (NASDAQ: NVAX) won a Department of Defense contract worth up to $60 million to help manufacture its coronavirus vaccine candidate. It also builds upon $388 million Novavax landed from the Norway-based Coalition for Epidemic Preparedness Innovations for the same program. And it follows the company’s preparations to sell up to $250 million in common stock, a move that sent its stock soaring toward the end of May.

AsclepiX Therapeutics Announces $35 Million Series A Financing | AsclepiX Therapeutics

BALTIMORE, MD, June 24, 2020 – AsclepiX Therapeutics, Inc., a biopharmaceutical company that uses computational biology to identify potent peptide regulators of vascular homeostasis for the treatment of retinal and other important diseases, today announced that it has closed a $35 million Series A financing led by Perceptive Xontogeny Venture Fund (“PXV Fund”) with participation from the Perceptive Life Sciences Fund, both funds managed by Perceptive Advisors, and existing investors Rapha Capital Management and Barer & Son Capital.

Children’s National, NCC-PDI hold medical device competition for COVID-19 innovations – Today’s Medical Developments

In response to medical data highlighting the serious impact of COVID-19 on children’s health, Children’s National is partnering with the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) on a special pitch competition focused on COVID-19 related pediatric medical devices. “Make your Medical Device Pitch for Kids! – COVID-19 edition” is seeking devices that support home health monitoring and telehealth and improve sustainability, resiliency, and readiness in diagnosing and treating children during a pandemic.

Image: https://www.todaysmedicaldevelopments.com

HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia

Charlottesville, Va., June 24, 2020 – HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA). MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids. The diseases result in the rapid buildup of life-threatening metabolites that can lead to severe organ damage, seizures, developmental deficits, and premature death.

Altimmune Receives Award from U.S. Department of Defense to Fund Phase 1/2 Clinical Trial of T-COVID™ in Outpatients with Early COVID-19 | BioSpace

AstraZeneca leading the Covid-19 vaccine race; may get results quite early: WHO – The Hindu BusinessLine

The World Health Organization said on Friday that AstraZeneca’s experimental Covid-19 vaccine is the world’s leading candidate and reached the final stage in terms of development, Reuters reported.

AstraZeneca, a potential vaccine for coronavirus which is being developed by the researchers at the University of Oxford, has entered in large-scale, mid-stage human trials of the vaccine. This week, AstraZeneca signed its tenth supply-and-manufacturing deal.

Image: https://www.thehindubusinessline.com

Replicate Bioscience and Immunomic Therapeutics Form Collaboration to Combat Infectious Diseases and Cancers | Business Wire

ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Replicate Bioscience, Inc. (“Replicate”), a privately-held biopharmaceutical company creating novel treatments to prevent drug resistance in cancers, and Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that the companies have entered into a research and licensing option agreement to combine their platform technologies to combat infectious diseases and cancers.

NIIMBL Announces Nine Project Recipients of $8.9M in Pandemic Response Efforts

NEWARK, Del., June 24, 2020 /PRNewswire/ — Today, the National Institute for Innovation in Manufacturing Biopharmacueticals (NIIMBL) announces that they have identified nine projects to allocate approximately $8.9 million from the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) award received in May 2020 towards the support the nation’s response to the COVID-19 pandemic.

VC fund focused on biotechnology startups spins out of Camden Partners – Baltimore Business Journal

George Petrocheilos and R. Jacob Vogelstein have left Camden Partners to continue to lead the newly independent fund as its managing partners.

Image: George Petrocheilos and R. Jacob Vogelstein are the managing partners of venture investment fund Catalio Capital Management LP. MARK DENNIS

Scientific Engagement Lead JLABS @ Washington, DC in Washington, District of Columbia | Non Operating Companies

Johnson & Johnson Innovation is recruiting a Scientific Engagement Lead of Johnson & Johnson Innovation JLABS. The goal of Johnson & Johnson Innovation is to advance transformative healthcare solutions that improve the lives of people around the world and, in so doing, to deliver value to Johnson & Johnson (“J&J”). JJI accomplishes this by catalyzing new science and technology through collaboration and exchange of ideas. This growing team is looking for a colleague inspired to help build and innovate new ways of fostering a productive life-science ecosystem.

Scott Plank’s newest venture is in the world of organ transplantation – Baltimore Business Journal

Scott Plank’s latest investment is in a company that aims to solve logistical challenges within the organ transplant industry.

MediGO offers a hardware and software platform for organ transplantation logistics, designed to make it easier to track donated organs as they are delivered to their recipients.

Image: https://www.bizjournals.com – JONATHAN MUNSHAM

Summer, is that you?

Dear Innovator,

Happy Pride Month! It’s hard to believe it’s almost July. While we’re facing many challenges here in both Washington, DC and in the U.S., the team and I continued to stay busy while working from home over these past few months.

I wanted to take some time to update you on JLABS @ Washington, DC and our activity. Recently I visited the site and was encouraged to see the progress. The construction team has been hard at work even during these tough times and I am very thankful for those working on the front lines, to include our construction workers, during COVID.

Center for Innovative Technology names this year’s grant recipients – The Virginian-Pilot – Inside Business

A drug company trying to save infants’ lives, a university center protecting hospitals from hackers, a tech company building extreme drones: three groups in the region are getting a cash boost from a fund that spurs innovation in Virginia.

Of the 26 tech companies and four universities receiving grants this year from the Center for Innovative Technology’s Commonwealth Research Commercialization Fund, three are from this region: ReAlta Life Sciences, Old Dominion University and Sentinel Robotic Solutions.

Image: https://www.pilotonline.com

The race to find a COVID-19 vaccine – CBS News

It’s not an understatement to say that the entire nation’s hopes are focused on what’s happening in a Maryland laboratory – step one in manufacturing a potential coronavirus vaccine.

Sean Kirk, executive vice president of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the ingredients needed in the development and testing of a vaccine for clinical trials already underway in Australia. “This is where it begins, to produce the hundreds of millions of doses,” he said.

Image: https://www.cbsnews.com

BioHealth Capital Region M&A Roundup First Half of 2020 · BioBuzz

It has been a tumultuous 2020 for venture capital and mergers and acquisitions due to the market uncertainty sparked by the onset of the coronavirus pandemic. Companies seeking acquisitions and venture capital firms alike continue to find their footing, as do the life science companies progressing toward important milestones during a global public health crisis.

Image: https://biobuzz.io

With cell and gene therapy boom coming, experts at Novartis, Kite trumpet need for capacity | FiercePharma

Cell and gene therapy has evolved into one of the biopharma industry’s hottest markets, with a major splash of investment and a run of approvals anticipated in the coming years. To meet what’s likely to be massive demand for manufacturing capacity, industry experts are calling for “forward-looking” investments—but as one pointed out, those checks aren’t easy to write.

Image: As many as 10 to 20 new cell and gene therapies could be approved each year through 2025. (Gilead)

Novavax Expands Executive Leadership and Announces Key Promotions | Novavax Inc. – IR Site

GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Ben Machielse as Executive Vice President, CMC, with responsibility for overseeing Novavax’ manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions:

Update on New JLABS Incubator in Washington, DC – Blog Post | JLABS

Our newest Johnson & Johnson Innovation JLABS location, JLABS @ Washington, DC, continues to move closer to opening later this year. We recently caught up with Sally Allain, Regional Head of JLABS @ Washington, DC to get the latest updates on construction, how the team has adjusted in response to COVID measures, and what we can expect for the remainder of 2020.

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials | FDA

The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.

Image: https://www.linkedin.com/posts/astrazeneca_today-the-fdas-oncology-center-of-excellence-activity-6681307663625728000-S01t/

How telemedicine can help close the maternal health gap | Healthcare IT News

In 2012, there were fewer than 1,400 maternal-fetal medicine specialists in the United States, and 98% resided inmetropolitan areas.

This left pregnant patients in rural areas without the ability to access care, especially if travel was not an option.

Today, telehealth can be used to fill that gap – but providers still may face challenges in ensuring patients get the services they need.

Virtual PitchRounds – BioPharma and MedTech Innovation

Southeast Life Sciences, the organization behind 400 presentations, 790 funding transactions, and $5.2B in investments from 500 distinct investors is going virtual for a special edition of PitchRounds.

SE PitchRounds is Southeast Life Sciences presentation program. This special PitchRounds event is intended for companies in the southeast United States that are working on products, services, etc. that are addressing a need related to Covid-19. If you have any questions about eligibility, please contact Jason Rupp at jrupp@southeastlifesciences.org

MedTech Innovator Announces Top 50 Medtech Startups Selected for Annual Showcase and Accelerator | Business Wire

LOS ANGELES–(BUSINESS WIRE)–MedTech Innovator, the premier nonprofit accelerator in the medical technology industry, today announced the 50 companies selected to participate in the organization’s flagship four-month Showcase and Accelerator program, featuring the industry’s most transformative device, diagnostic, and digital health technologies from around the globe. These up and coming startups will receive unparalleled visibility and access to leading manufacturers, providers, investors, and other industry stakeholders. As part of its Accelerator program, MedTech Innovator will award up to $500,000 in cash and in-kind prizes during its final competition at The MedTech Conference, powered by AdvaMed.

Apr 27 2020

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403rdEdition – April 28, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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April 28, 2020

FOUNDING MEMBER OF

Innara Health and BHI Partner to Accelerate Company Growth

FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology. Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely. “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia. “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

Immunomic Therapeutics Announces Close of $61.3M Financing – Bloomberg

Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

Gentian AS Seeking Collaborator to Test BioMarker Performance in Severe COVID-19 Cases

Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

LifeSprout, Inc. Closes $28.5 Million Series A Financing

BALTIMORE, Md., April 27, 2020 /PRNewswire/ — LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

“We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. “The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible.”

Baltimore Company Will Produce COVID-19 Vaccine Under New Agreement With Johnson & Johnson | WBFF

A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

“We’ll be providing the drug substance manufacturing which is essentially the vaccine itself,” says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.

Personal Genome Diagnostics Receives FDA Clearance for PGDx elio™ tissue complete, the First Comprehensive Genomic Profiling Diagnostic Kit for Oncology | Business Wire

BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD | REGENXBIO Inc.

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

“I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections,” said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.

Hard to Find Small Lab Space – Only Two Spaces Left! – Alexandria LaunchLabs™

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

Governor Hogan Introduces Safe, Gradual, and Effective ‘Maryland Strong: Roadmap to Recovery’

ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

Five takeaways from Gov. Larry Hogan’s plan to reopen Maryland – Baltimore Sun

Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

Emergex Signs Agreement with GEORGE MASON UNIVERSITY for Highly Pathogenic RNA Virus Studies

Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

AGT CEO Jeff Galvin on the Future of the Gene and Cell Therapy Industry | BioSpace

The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Image: https://www.biospace.com

J&J to partner with Emergent Bio on coronavirus vaccine candidate (NYSE:JNJ) | Seeking Alpha

Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.

J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.

What Is Contact Tracing? How It Will Be Used for COVID-19 | Time

In the coronavirus era, a host of epidemiological terms have entered common public use. There’s the now-ubiquitous “social distancing,” and the newly politicized “flatten the curve.” And as states and local governments seek a way out of lockdowns that have brought their economies to a near-standstill, “contact tracing” has made its way into everyday conversation as well.

Image: Public health nurse Lee Cherie Booth conducts a test for COVID-19 outside of the Salt Lake City Public Health Center on April 10, 2020, accompanied by Salt Lake County infectious disease nurse Travis Langston. When a swab test comes back positive, contact tracing starts. Scott G Winterton—The Deseret News via AP

JLABS @ Washington, DC Children’s QuickFire Challenge

When a child gets seriously sick, it’s up to us to fight for the world that they believe in. Johnson & Johnson Innovation is at the forefront of that fight. Helping to build a better future for the next child battling cancer, fighting the flu or facing the need for surgery.

The JLABS @ Washington, DC Children’s QuickFire Challenge invites innovators to submit game changing ideas, technologies, and solutions that have the potential to impact pediatric oncology, pediatric surgery and influenza. The innovator(s) with the best idea(s) will be awarded up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies

Maryland’s venture capital funding was on the rise in Q1 2020. Then the pandemic arrived – Technical.ly Baltimore

Maryland tech companies started the year bringing in a surge of venture capital funding, and three of the state’s top 10 deals were in Baltimore, according to data from the latest PwC/CB Insights MoneyTree report. But a downturn in the last two weeks as the COVID-19 pandemic-caused slowdown took hold is leaving reason to keep celebrations on lockdown for now.

The $227 million that 21 companies raised from investors was a 44% uptick from the $115 million in the fourth quarter of 2019.

Image: The Huntress team. (Courtesy photo)

What to do after receiving a Paycheck Protection Program loan – Philadelphia Business Journal

Just over three weeks ago the CARES Act, a massive piece of legislation designed to combat the economic havoc being wrought by the coronavirus pandemic, was enacted.

One significant piece of that legislation is the Paycheck Protection Program (PPP), which allows small businesses to borrow funds from the Small Business Administration and affiliated lenders roughly equivalent to 2.5 months of payroll costs. The use of borrowed funds is restricted to “payroll costs” (employee compensation, group health benefits, retirement benefits, state unemployment taxes), rent, mortgage interest, interest on other loans and utilities.

Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis.

Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis. We are dealing with substantial decreases in revenue as well as increased expenses directly tied to addressing this global pandemic. Children’s National Hospital is losing $1 million a day. I had a chance to share our challenges with NBC News Reporter Josh Lederman and to spotlight some potential solutions. #covid19 #pediatrics #finances #federalfunding #healthcare #childrenshospital

This physician-founder is making a device to protect medical staff during intubation procedures – Technical.ly Baltimore

Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

How to reopen the US, according to Johns Hopkins and Harvard – Business Insider

Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.

Though staying inside is certainly keeping more infections at bay right now, it’s not without its costs.

Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is “hemorrhaging $100 billion to $350 billion a month,” according to the new Harvard analysis, which was released on Monday.

Image: A worker wears a protective face mask in a factory of roll-forming machine maker Gasparini, in Mirano. Reuters

Dr. Anthony Fauci ‘Not Overly Confident’ With US COVID-19 Testing | TIME

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.

Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.

5 trends in venture capital (beyond the pandemic) | MIT Sloan

Even prior to COVID-19, change was afoot in the venture capital industry. Machine learning and algorithms were emerging as new ways to spot winners, and cities like Boston staked out turf as VC hot spots, proving that not all innovation takes place in Silicon Valley.

Performance of calprotectin and cystatin C in prediction of severe events in COVID-19 patients

We at Gentian AS believe it is the duty of all companies in the health industry to help combat the ongoing pandemic of COVID-19/Corona virus. High mortality and long hospitalisation are the consequences of the severe cases with COVID-19 pneumonia. Hence, it is important to identify biomarkers that early could aid in rapid and effective identification of the severely affected patients. In the Gentian test portfolio, the two biomarkers, cystatin C and plasma calprotectin, could be useful for the early detection of the severely affected COVID-19 patients. To do our part we are reaching out to research/hospital institutions who want to run a trial to assess whether these biomarkers can make a contribution in the detection of severe COVID-19 cases.

Colleges make plans for bringing students back 2020 – The Washington Post

In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.

But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.

Xconomy: Life Science a VC Bright Spot in Q1, But Startups May Soon Struggle

Even as the novel coronavirus has derailed daily life and business operations, the life sciences sector continues to see companies make public debuts and ink both financing and partnership deals.

In venture capital, US deal activity in the first quarter tallied 2,300 financings totaling $34.2 billion, according to the latest report by the National Venture Capital Association, which uses data from PitchBook. That’s roughly on track to match the total raised in the past two years, both record-setters in one way or another. But the likelihood of that pace continuing is slim, according to the report.

Image: Sarah de Crescenzo

Apr 27 2020

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409th Edition – June 9, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 9, 2020

FOUNDING MEMBER OF

Anthony D. Saleh, Ph.D., CEO of miRecule, joins Rich Bendis on BioTalk

miRecule CEO Anthony D. Saleh, Ph.D. guests on BioTalk to discuss his company, his many roles in startup companies, and being an Entrepreneur in Residence with BHI

BioHealth Innovation Leading Five Digital RESI Conference Virtual Panels

With the LSN Digital RESI Conference approaching quickly, Event Gold Sponsor, BioHealth Innovation (BHI), is stepping up to help lead five panels with some heavy hitters from the BioHealth Capital Region (BHCR) on June 8-10, 2020.

Great Investment Opportunities in the BioHealth Capital Region

While we adjust to a COVID-19 world, there continue to be great investment opportunities in the BioHealth Capital Region. Join BHCR CEOs as they make short introductions about themselves and companies. Join CEOs from American Gene Technologies International Inc., miRecule, Adaptive Phage, Healion Bio, KaloCyte, Emocha, Tailored Therapeutics, Inc., DEKA, and Ashvattha Therapeutics, Inc.

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 6/24, 7/22, 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

Emergent BioSolutions will produce COVID-19 vaccines in Baltimore, Rockville under $628 million federal contract – Baltimore Sun

Emergent BioSolutions Inc. will help produce COVID-19 vaccines in Baltimore and Rockville under a federal contract.

Gaithersburg-based Emergent said Tuesday it will manufacture vaccines under an existing contract with a division of U.S. Department of Health & Human Services, assisting government efforts to fast-track the vaccine. Emergent has long worked with the federal health agency’s Biomedical Advanced Research and Development Authority.

Novavax awarded $60M Department of Defense contract for Covid-19 vaccine – Washington Business Journal

Novavax Inc. just scored even more support for its coronavirus vaccine program.

The Gaithersburg company said late Thursday it won a Department of Defense contract worth up to $60 million to help manufacture its Covid-19 vaccine candidate, NVX‑CoV2373. The funding, from the Defense Health Program, would back the production of multiple pieces of the vaccine, to be manufactured in the U.S., according to Novavax’s (NASDAQ: NVAX) announcement.

Virginia Based AMPEL BioSolutions’ Technology Predicts Severity of Illness in COVID19 Patients and Identifies Treatments

Charlottesville, Virginia. June 9, 2020. AMPEL BioSolutions announces genomic analysis and findings that could improve treatment of COVID19 patients with approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint, the study reveals a gene-based test that will be able to determine those patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL’s CovGENE approach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a “whole body” understanding of the effects of SARS-CoV2 virus.

AstraZeneca lays out plans to produce 2 billion doses of Covid-19 vaccine

The drug giant AstraZeneca said Thursday that it has found partners to manufacture and distribute 2 billion doses of the experimental Covid-19 vaccine created by Oxford University, inking a series of deals with non-government organizations and another manufacturer.

Image: RAPHAEL LAFARGUE/ABACA/SIPA USA VIA AP

AstraZeneca Approaches Gilead About Potential Merger

AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record.

The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said, asking not to be identified because the details are private. AstraZeneca didn’t specify terms for any transaction, they said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren’t in formal talks, the people added.

Image: Photographer: David Paul Morris/Bloomberg

Altimmune Launches Clinical Trial for COVID-19 Vaccine for the Treatment of Patients with Early SARS-CoV-2 infection – Biobuzz Directory

GAITHERSBURG, MD, June 1, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020.

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls.

COVID-19 Vaccine Progress from 14 BioHealth Capital Region Organizations – BioHealth Capital Region – BioBuzz

Editor’s Note: This post was originally published on April 7, 2020. As updates are discovered and advancements are announced regarding the work below, details will be published for accuracy.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

U.S. gives AstraZeneca $1 billion for COVID-19 vaccine candidate – UPI.com

May 21 (UPI) — European pharmaceutical company AstraZeneca said Thursday it has received more than $1 billion from the U.S. government to develop its coronavirus vaccine candidate.

The drugmaker has partnered with the University of Oxford on its “AZD1222” vaccine, one of several candidates worldwide in clinical trials.

The funding came from the the Biomedical Advanced Research and Development Authority, a branch of the Department of Health and Human Services.

Image: AstraZeneca plans at least 400 million doses and has lined up manufacturing capacity for one billion doses with first deliveries set for September. File Photo by Drago Prvulovic/EPA

AstraZeneca Ranked Most Inventive, Roche Most Innovative

AstraZeneca (AZN) was ranked the most the most inventive pharmaceutical company for the second year in a row by IDEA Pharma’s Invention and Innovation Index for 2020. Meanwhile, Roche (RHHBY) jumped seven places from its 2019 ranking to capture the top spot in the list of most innovative pharma firms.

IDEA is an international consulting firm that works with pharma companies to position their products in the early phase to maximize market success and consult on innovation. The firm bases its Innovation Index on the answer to the following question: “If two companies had the same molecule, who would be more successful with it?” It also considers their ability to bring products from phases 1 and 2 to market and commercialize them successfully, according to CEO Mike Rea.

CEOs, Academics Step Out to Fill National Leadership Void – Maryland Matters

Amid a wrenching series of crises that have riven the nation, particularly over matters of race and law enforcement, corporate leaders throughout Maryland have voiced support for the social justice movement that has become more urgent and grown after the death of George Floyd.

Over the last few days, corporate CEO’s, university leaders and others have acknowledged the pain that Americans of all stripes are experiencing, and have pledged to be part of the solution.

NodThera Announces Close of $55 Million Series B Financing

Financing round led by Novo Ventures and includes new investors Cowen Healthcare Investments and Sanofi Ventures, as well as existing investors 5AM Ventures, F-Prime Capital, Sofinnova Partners and founding investor Epidarex Capital

Proceeds to support advancement of pipeline of small molecule NLRP3 inflammasome inhibitors, including continued progression of NT-0167 through clinical development

CAMBRIDGE, UK, BOSTON & SEATTLE – June 3, 2020 – NodThera, a clinical stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat diseases driven by chronic inflammation, today announced that it has secured $55 million (£44 million) in a Series B financing. NodThera’s lead candidate, NT-0167, is being evaluated in a Phase 1 clinical trial in healthy volunteers.

Pfizer Establishes New Program to Support Continued Biotechnology Innovation | Business | oleantimesherald.com

Pfizer Inc. (NYSE: PFE) today announced the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.

“There has never been a more important moment to pursue new collaborations in our industry,” said John Young, Pfizer’s Chief Business Officer. “The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”

Global Deaths Due to Various Causes and COVID-19

Always good to see a new relational perspective. #perspective #thinking #reflection #designthinking #innovationculture

VCs Cautious of “COVID-19 Contortionists” and Telemedicine “Gold Rush” · BioBuzz

COVID-19 is fundamentally changing how we live, how we do business, and how we approach and deliver our healthcare. In the past 14 weeks, there has been unprecedented growth for a segment of companies who were positioned to meet these rapidly sweeping changes to our lives, while so many others have had to close their doors or are fighting to stay in business. COVID-19 has sparked millions of job losses.

Image: https://biobuzz.io

SARS-CoV-2 Infection Mapped through Respiratory Tract

SARS-CoV-2 is known to infect cells of the respiratory tract. A deeper understanding of which cells support the infection, and to what extent, could lead to insights into disease progression and severity. Scientists at the UNC School of Medicine sought to understand which cells in the airway the virus infects, and how it gets into the lungs in the patients who develop pneumonia. To this end, they have characterized some of the ways in which SARS-CoV-2 infects the nasal cavity and infects and replicates progressively less well in cells lower down the respiratory tract—including the lungs.

Image: SARS-CoV-2 (red) infected ciliated cells in the COVID-19 patient’s bronchi. (Takanori Asakura, PhD, UNC School of Medicine)

Novavax Awarded Department of Defense Contract for COVID-19 Vaccine Nasdaq:NVAX

GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

Apr 27 2020

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410th Edition – June 16, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 16, 2020

FOUNDING MEMBER OF

Fina Biosolutions Receives SBIR Matching Grant from Montgomery County, MD

Fina Biosolutions recently received a $25,000 Montgomery County SBIR/STTR Phase I matching grant to support its NIH SBIR grant focused on “Genetically detoxified tetanus toxin for use in vaccines.” The grant comes from a subprogram of the Montgomery County Economic Development Fund. Andrew Lees, Fina Biosolutions’ Scientific Director said, “we are very grateful for the County’s support for our research. We intend to use the funds to hire a part-time employee who we expect will transition to full-time. We also are appreciative of the assistance we received from BioHealth Innovation in guiding us through the County grant process”. Fina Biosolutions is developing the genetically detoxified tetanus toxin as a carrier protein for peptide and glycan conjugate vaccines. Montgomery County, Maryland is the first county in the U.S. to offer matching grants to NIH SBIR/STTR awardees to further leverage the public and private investment in their R&D and job growth activities.

Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Nasdaq:VIE

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of all patients with NMOSD test positive for anti-AQP4 antibodies.

Glyscend Therapeutics Completes $20.5M Financing Round to Advance Novel Oral Polymer Therapy for Type 2 Diabetes

BALTIMORE, June 11, 2020 (GLOBE NEWSWIRE) — Glyscend Therapeutics, a privately held biopharmaceutical company developing novel treatments for type 2 diabetes (T2D) and related metabolic conditions, today announced the closing of a $20.5 million Series A financing round. Healthcare investors Brandon Capital Partners, through its Medical Research Commercialisation Fund (MRCF), and Santé Ventures led the round of funding, which will be used to support the development of the company’s novel oral polymer therapy for patients with T2D and other metabolic diseases. Breakout Labs (a fund in the Thiel Foundation) provided seed funding in 2019.

AstraZeneca taps Emergent as U.S. partner for potential COVID-19 vaccine – Reuters

AstraZeneca has inked manufacturing deals globally to meet its target of making 2 billion doses of the vaccine, including with two Bill Gates-backed ventures and a $1.2 billion agreement with the U.S. government.

The company’s vaccine is among the first to move into mid-stage trials and the first indication of its effectiveness would likely be available in June or July. There are no approved vaccines or treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus.

2020 AURP BIO HEALTH CAUCUS – Supporting the Growth of Bio Health Innovation Districts Worldwide – RECAP

At AURP’s BIO Health Caucus, we explored trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important.

Click here to download the PDF

KaloCyte raises $300K from Maryland Momentum Fund – Technical.ly Baltimore

Less than a year after relocating its headquarters to Baltimore, biotech company KaloCyte has raised new funding from Maryland-based investors and expanded its local team.

On Monday, the company announced that it raised $300,000 from the Maryland Momentum Fund, which is a venture fund created by the University System of Maryland that invests in affiliated companies. It is part of a larger funding round for the preclinical-stage company, which is developing an artificial red blood cell substitute. Called ErythroMer, it can be used in situations where stored red blood cells are not available, such as treating trauma when patients have a need for blood.

Image: Baltimore’s BioPark is part of the University System of Maryland. (Courtesy photo)

Sirnaomics to spin off RNAimmune to develop novel mRNA therapeutics and vaccines – Maryland Daily Record

Sirnaomics Inc., a Gaithersburg-based biopharmaceutical company engaged in the discovery and development of RNAi therapeutics, Friday announced a corporate technology spinoff establishing an independent biopharmaceutical company, RNAimmune Inc. This new entity is focusing on and specializing in messenger RNA (mRNA) based therapeutics and vaccine development, with exclusively licensed Polypeptide-Lipid Nanoparticle (PLNP) delivery technology and large scale …

BRIEF-Novo Nordisk To Acquire Corvidia Therapeutics – Reuters – congrats to Ram Aiyar former BHI EIR

* NOVO NORDISK TO ACQUIRE CORVIDIA THERAPEUTICS AND EXPAND PRESENCE IN CARDIOVASCULAR DISEASE

* UNDER TERMS OF AGREEMENT, NOVO NORDISK WILL ACQUIRE ALL OUTSTANDING SHARES OF CORVIDIA THERAPEUTICS FOR AN UPFRONT PAYMENT OF 725 MILLION US DOLLARS IN CASH

Emmes Announces Its Work on a Phase 3 Clinical Trial for Breakthrough Therapy Designation Product | BioSpace

ROCKVILLE, Md., June 15, 2020 /PRNewswire/ — Emmes Group today announced that it provided the Phase 3 clinical trial support for a new investigational cell therapy that offers a promising treatment opportunity for patients who need an allogeneic bone marrow transplant. Emmes’ work for Gamida Cell Ltd., an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, involved full scope clinical trial support for this study that was conducted at more than 50 centers in the United States, Latin America, Europe and Asia. Emmes also supported the early development Phase 1 and 2 trials that began in 2010.

Charlottesville company develops test to predict most severe cases of COVID-19

CHARLOTTESVILLE, Va. (WVIR) – The COVID-19 pandemic has presented many complex challenges to those in the medical field. One Charlottesville-based company stepped up to the plate to come up with a solution beyond just testing for the virus.

AMPEL BioSolutions typically does personalized medicine for Lupus patients, but when the pandemic struck scientists switched gears: They went beyond just developing a “positive or negative” coronavirus test. Scientists with AMPEL say they have developed technology to predict whether a patient will have mild or severe symptoms, which could be life-saving.

Image: (FILE) (Source: MGN Image) – https://www.nbc29.com

2020 Life Science Venture Capital Funding Roundup for Q1/Q2 in the BioHealth Capital Region · BioBuzz

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C. and Maryland.

FSIF COVID BIOSCIENCE APPLIES FOR PATENT ON INNOVATIVE NEW COVID-19 TEST

<p>Cambridge, MD, June 15 — FSIF COVID BioScience, a biotechnology company focused on harnessing the power of the human immune system to diagnosis and treat Covid-19, announced today that it just filed a new patent for the Company’s innovative FSIF(FullSpectrumInterferonFingerprint)COVID-19test. While thetechnology behind thisnewly filed patent will serve as an accurate diagnostic for COVID-19, its real value is the ability stratify patients into degrees of disease severity as noted in the grid below:

Maryland Stem Cell Research Commission Announces over $7 Million in awards to Accelerate Cures | MSCRF

COLUMBIA, Md. (June 5, 2020)— The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2020 recipients for a total of $ 7,053,759. The Commission has also issued a Request for Applications (RFAs) for its first round of funding for fiscal year 2021 and is looking to continue accelerating cutting-edge research and cures through the Maryland Stem Cell Research Fund (MSCRF).

PathSensors Inc. Announced the Completion of Phase I of a SBIR

PathSensors Inc., a Baltimore biotechnology company, announced today the completion of Phase I of a Small Business Innovation Research (SBIR) program funded by the National Institute of Food and Agriculture (NIFA) entitled “Food Safety in the 21st Century: Rapid Toxin Detection in the Field”. The project’s goal was to engineer and develop a field-deployable instrument for portable pathogen and toxin detection.

SilcsBio and Dalriada Drug Discovery Launch Partnership to Create a Rapid Drug Discovery Service Suite | Press Release | I95 Business

June 11, 2020, Baltimore, MD and Toronto, ON – SilcsBio, a technology company that develops innovative software and provides services for structure-based drug design, and Dalriada Drug Discovery, a full service small molecule drug discovery contract research organization supporting global innovators through its TURN-KEY™ model, today announced the launch of a formal partnership to enable enhanced support for their clients’ programs.

Under the new partnership, SilcsBio’s expertise in computer-aided drug design (CADD) will be vertically integrated with Dalriada’s world-class wet-lab drug discovery capabilities accelerating clients’ target-directed programs. Through close work between the two expert scientific teams and integration of CADD, medicinal chemistry, target screening, and ADME, clients can expect accelerated hit identification, lead generation, and lead optimization cycles.

Immunomic Therapeutics to Present at AACR Virtual Annual Meeting II – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice. UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the AACR Virtual Annual Meeting II, June 22-24, 2020.

FDA Grant and Gift from Entrepreneur Provide $250K in Awards for Pediatric Medical Device Competition Focused on COVID-19 Innovations | Benzinga

WASHINGTON, June 11, 2020 /PRNewswire/ — As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

The Top Biotech Companies That are Hiring – June 2020 · BioBuzz

Despite the uncertainty created by the COVID-19 pandemic, companies across the BioHealth Capital Region (BHCR) continue to hunt for talented life science professionals to advance their technologies, produce their commercial products for the patients that need them, and for many they are also supporting COVID-19 vaccine and diagnostic efforts that the whole world is counting on.

We shouldn’t care who wins the vaccine ‘race’ – The Washington Post

Regarding the June 4 front-page article “Cold War echoes in race for vaccine,” about the “race” among nations, notably the United States, China, and Russia and other European nations for development of a vaccine against the novel coronavirus:

When communicating about vaccines and dates, leaders should be careful to note that this means candidate vaccines. We actually have a vaccine only after it is proved effective and safe over a long period, requiring time (years, not months), durability (e.g., the measles vaccine lasts a lifetime whereas some others are much shorter), a formula that covers all or most strains (especially those recurring seasonally) and feasibility (cost, global availability, etc.).

Covid-19 vaccine price controls would scare off developers, Fauci says at BIO – MedCity News

As multiple companies work to develop vaccines against the virus that causes Covid-19, it will be important for them to work with the federal government toward an understanding with regard to fair pricing, but outright price controls could risk scaring companies away, a doctor helping lead efforts to develop drugs and vaccines for the disease told biotech industry executives Tuesday.

Image: https://medcitynews.com

Johns Hopkins to resume on-campus lab research next week | Hub

Johns Hopkins University researchers will be permitted to resume on-site laboratory activities beginning next week, the first steps of a gradual resumption of on-campus activities envisioned in the weeks and months ahead as the university emerges from a monthslong period of distancing prompted by the COVID-19 pandemic.

Covid-19 roundup: Fauci talks pricing, disparate impact and the virus’s enduring mysteries; China to offer experimental vaccines to overseas workers – Endpoints News

Multiple vaccines will ultimately be approved for Covid-19, NIAID chief Anthony Fauci told BIO yesterday, and the companies that make them should be allowed to profit, “as long as it’s not in an outrageous way.” Sitting down for a rare extended interview with new BIO chief Michelle McMurry-Heath,

Image: NIAID chief Anthony Fauci (AP Images)Image: https://endpts.com

The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life | BIO

This ninth biennial TEConomy/BIO report focuses on the economic footprint of the industry geographically including the latest trends in the bioscience industry for the nation, states, and metropolitan areas. Check out state-by-state information on the performance of the bioscience economy.

Congratulations to Our Digital RESI June Innovation Challenge Winners! | Next Phase Newsletter

Our 3-day Digital RESI June conference came to an end yesterday, and we are very excited to announce the Top 3 Winners of the Innovation Challenge. Each participating finalist company had a dedicated page where you could view their virtual poster, short pitch, and other supplementary materials that the companies made available for viewing.

Producing Enough Vaccine For The Coronavirus Means Companies Have To Start Now : Shots – Health News : NPR

Once upon a time, developing a new vaccine was a step-by-step process that went from concept, to design, to tests in humans, to regulatory approval, to manufacturing.

It was a process that could take a decade or more.

But the urgent need for a COVID-19 vaccine has radically changed all that. Now, the hope is the entire process can be completed in a year or less.

Image: Cell culture operators prepare a 2000-liter single-use bioreactor to produce proteins used to make vaccines. Philip Taciak/Emergent Biosolutions

NIH announces $1 million prize competition to target global disease diagnostics

The National Institutes of Health has launched a $1 million Technology Accelerator Challenge (TAC) to spur the design and development of non-invasive, handheld, digital technologies to detect, diagnose and guide therapies for diseases with high global and public health impact. The Challenge is focused on sickle cell disease, malaria and anemia and is led by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The Bill & Melinda Gates Foundation is cooperating with NIH to help accelerate the transformation of design concepts into products for low-resource settings.

Can you catch Covid-19 from someone without symptoms? — Quartz

On Monday, June 8, an official at the World Health Organization (WHO) made a surprising statement. People who have Covid-19 but are asymptomatic—meaning they never develop symptoms like fever, coughing, or gastrointestinal distress—very rarely gave it to others, stated Maria Van Kerkhove, the WHO’s technical lead on the Covid-19 pandemic, at a regularly-scheduled press briefing.

The very next day, the organization took it back. Some might have taken WHO’s original statement to mean that “stealth transmission” of Covid-19 is unlikely—that if a person isn’t actively coughing and sneezing, you don’t need to worry about getting infected. But that’s not necessarily the case. On June 9, WHO clarified that while most transmission seems to come from people showing symptoms, it’s too soon to know exactly how the virus spreads.

Image: AP PHOTO/PETROS KARADJIAS – https://qz.com/

BioHealth Capital Region Spotlighted at RESI

The BioHealth Capital Region featured at last week’s Redefining Early Stage Investments Conference (RESI) where speakers from the region discussed a range of topics of interest to early stage companies including:

For more information, check out the RESI Conference site or contact BHI.

Creatv Announces Ability to Predict Immunotherapy Treatment Response for Non-Small Cell Lung Cancer (NSCLC) using a Simple Blood Test | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv Microtech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with stage II-III NSCLC treated with chemoradiation therapy (CRT) and consolidated immunotherapy. Clinical data presented at the ASCO 2020 virtual annual meeting shows the ability to predict which NSCLC patients will benefit from anti-PD-L1/PD-1 immunotherapies. “We are delighted to present a method to stratify patients responding to immunotherapy by a single tube of blood collected after completion of CRT,” said Dr. Cha-Mei Tang, CEO of Creatv. “Early identification of patients that do not respond to immunotherapy will reduce unnecessary patient suffering from ineffective and costly treatment, allowing patients to proceed to alternative therapies.” Currently, no other blood test can predict immunotherapy treatment response for lung cancer.

AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine | FiercePharma

AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.

Image: AstraZeneca agreed to dole out $750 million last week to boost its COVID-19 shot capacity to more than 2 billion doses. (AstraZeneca)

Apr 27 2020

Love0

411th Edition – June 23, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 23, 2020

FOUNDING MEMBER OF

Charles Andres and Christian Barrow join BioTalk to discuss investing, growth and the BioHealth Capital Region during COVID-19

Charles Andres, Ph.D., RAC, Associate at Wilson Sonsini Goodrich & Rosati, and Christian Barrow, Executive Director, Life Sciences Banking at JP Morgan, join Rich Bendis for a Virtual BioTalk

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

The BioHealth Capital Region Featured at Digital RESI LSN Global Conference

The Life Science Network’s Digital Redefining Early State Investments (RESI) took place online June 8-10, 2020, and featured some of the most knowledgeable voices from the BioHealth Capital Region. The region was well represented across four panels titled:

AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant | FiercePharma

British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine. To reach that lofty goal, AstraZeneca has reached a deal with New Jersey-based Catalent to help with the final stages of the shot’s manufacturing.

Catalent will be tasked with finishing and packaging duties for AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate, AZD1222, at its 305,000-square-foot manufacturing facility in Anagni, Italy, the CDMO said Monday.

Image: Catalent will be tasked with helping finish and package AstraZeneca’s COVID-19 vaccine candidate. (Catalent)

Emergent Bio to invest $75M in Canton site (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) will invest $75M in its Canton, Massachusetts facility, focused on the development and manufacturing of drug substance for live viral vaccines and plans to expand into viral vector and gene therapy.

The investment will include a state-of-the-art, multi-suite operation up to 1000L scale.

Rexahn and Ocuphire Enter into Definitive Merger Agreement :: Rexahn Pharmaceuticals, Inc. (REXN)

ROCKVILLE, Md. and FARMINGTON HILLS, Mich., June 17, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN) and Ocuphire Pharma, Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of eye disorders, today announced the companies have entered into a definitive merger agreement under which Ocuphire will merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction. Following closing, which is expected to occur in the second half of 2020, the combined company will change its name to Ocuphire Pharma, Inc. and is expected to trade on the Nasdaq Capital Market under the ticker symbol “OCUP.” The combined company will focus on the advancement of its pipeline of ophthalmic drug candidates.

Emmes Chosen as a Top Area Workplace

ROCKVILLE, Md., June 17, 2020 /PRNewswire/ — Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post’s 2020 Top Workplaces list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees.

The Washington Post partnered with employee research and consulting firm Energage, LLC, to conduct the survey, and the highest ranked workplaces were chosen based on employee responses about their own company. There were 3,500 area companies invited to participate, and 406 were surveyed. This is the seventh year the survey has been conducted.

Sirnaomics and Precision NanoSystems Have Formed a Partnership | BioSpace

Developing and Manufacturing Novel RNAi drug Candidates Using Precision NanoSystems’ NxGen™ Platform

GAITHERSBURG, MD and VANCOUVER, BC, June 17, 2020 /PRNewswire/ – Sirnaomics Inc. (Sirnaomics) and Precision NanoSystems Inc. (PNI) jointly announced a partnership on the development and manufacture of Sirnaomics polypeptide nanoparticle-based RNAi therapeutic product. This strategic joint effort includes the execution of a NanoAssemblr® platform license and supply agreement, plus successful production of multiple batches of Sirnaomics drug product candidates, STP705 and STP707, for ongoing IND enabling safety and toxicity studies, as well as several clinical studies.

ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – Immunomic Therapeutics

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

WASHINGTON, June 16, 2020 /PRNewswire/ — Children’s National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children’s Hospitals annual rankings. This marks the fourth straight year Children’s National has made the list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fourth year in a row.

The Children’s National Hospital neonatology program, which provides newborn intensive care, ranked No.1 in the nation by U.S. News for the fourth year in a row.

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B | BioSpace

GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

Preclinical Data for PRGN-3005 UltraCAR-T® Demonstrate Superior Expansion and Persistence of UltraCAR-T Compared to Traditional CAR-T | BioSpace

GERMANTOWN, Md., June 22, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T® in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and is accessible on the AACR e-poster website.

Emergent to add gene therapy capacity – Bioprocess InsiderBioProcess International

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector.

The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts.

At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000.

CrazyCap helps Martine Rothblatt Cheer On Her Team Through Crisis! – PharmiWeb.com

MIAMI, June 22, 2020 /PRNewswire/ — Esteemed lawyer, author, and entrepreneur, Martine Rothblatt, Ph.D., found a thoughtful and practical way to thank her employees at United Therapeutics, who have been going above and beyond during this time of the coronavirus crisis. The team at United Therapeutics, a biopharmaceutical company, has always been dedicated to working hard on life-saving biotech innovations. During the global coronavirus pandemic, United Therapeutics has recognized the dire need to develop treatments for COVID-19 patients and has responded quickly by initiating three projects intended to help with COVID-19, including an artificial lung technology that could help avoid the need for the use of ventilators.

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

GMU selects three finalists for $250M Institute for Digital InnovAtion | Virginia Business

George Mason University on Monday announced three development and property management firms as finalists to build and operate its proposed $250 million Institute for Digital InnovAtion (IDIA), set to open in September 2025 on its Arlington campus. The university released a request for proposals in February, to which 105 developers responded.

Image: Concept rendering of George Mason University’s Institute for Digital InnovAtion (IDIA) in Arlington – https://www.virginiabusiness.com

AstraZeneca agrees to make Covid-19 vaccine for Europe | BreakingNews.ie

Pharmaceutical giant AstraZeneca has struck a deal with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of an experimental Covid-19 vaccine, as efforts to boost manufacturing capacity continue at pace.

The alliance, which was forged by Germany, France, Italy and the Netherlands to speed up production of a vaccine, is set to take delivery of the material being tested by the University of Oxford by the end of 2020.

University of Maryland Medical System awarded $18.7 million federal grant to fight coronavirus – Baltimore Sun

The University of Maryland Medical System will receive more than $18.7 million in funding from the Federal Emergency Management Agency (FEMA) in the ongoing effort to combat the coronavirus, the arm of the U.S. Department of Homeland Security announced Monday.

GSK gets FDA approval for HIV drug for children – MarketWatch

Shares of GlaxoSmithKline GSK, +0.36% were down 0.05% in premarket trading on Monday after the Food and Drug Administration late on Friday approved its HIV drug Tivicay as a treatment for infants and children. Tivicay is the company’s second-best selling drug in its HIV portfolio. About 2,200 children in the U.S. had been diagnosed with HIV in 2016, according to statistics provided by the Centers for Disease Control and Prevention. GSK’s stock has gained 14.9% since the start of the year. The S&P 500 SPX, -0.56% is down 5.8% year-to-date. The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.

Novavax Appoints Biotechnology Veteran David Mott to Board of Directors | Novavax Inc. – IR Site

GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

Advisory Board | Johns Hopkins Technology Ventures

The IDEA Board champions innovation and entrepreneurship across the Johns Hopkins University, providing the vision and strategy by which Johns Hopkins will bring the next generation of discoveries to market. This group of stakeholders from industry, academia, startups, and the broader ecosystem is also helping to catalyze new economic activity and partnerships that will build a better Baltimore.

GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance – Xconomy

GlaxoSmithKline got its first taste of synthetically lethal cancer therapies via an acquisition. Now it’s trying for a bigger bite of this emerging drug class through a research alliance with Ideaya Biosciences that spans three of the biotech’s programs, all slated to reach clinical trials in the next three years.

Emergent BioSolutions Adding Approximately 300 Jobs After New COVID-19 Vaccine Contracts

Business is booming for Emergent BioSolutions as it has assisted in the country’s push to create COVID-19 treatments and vaccines. Emergent is developing two plasma-based treatments for COVID-19 and has partnered with four companies on vaccine candidates. It is additionally partnering with the Federal Government to develop and manufacture COVID-19 vaccines. As a result of this wave of new business, the company is hiring approximately 300 new employees in Baltimore and Rockville.

Emergent BioSolutions Enters Viral Vector And Gene Therapy Arena – Contract Pharma

Emergent BioSolutions has unveiled plans to strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, MA facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

Lockheed’s ventures arm backs quantum computing and training tech firms — Washington Technology

Lockheed Martin Ventures — the defense company’s technology startup investment arm — has backed two companies through separate avenues announced this week.

In a release Tuesday, quantum computing company IonQ said it grew its total fundraising amount to $84 million through a new Series B round that represents its second significant round of investments since the 2015 founding with $2 million in seed money.

Image: https://washingtontechnology.com

Royalty Pharma, drug firm that doesn’t develop drugs, shatters IPO record

Royalty Pharma, a business built on investing in other people’s medicines, raised $2.2 billion in a record IPO on Tuesday, and the early hours of trading boosted its valuation to more than $25 billion.

The company, founded in 1996, priced about 78 million shares at $28 each. Royalty Pharma opened trading at $44, an instant 57% increase, suggesting the company’s bankers left a fair amount of money on the table.

BIA | EPIDAREX CAPITAL CLOSES NEW £102 MILLION UK VENTURE FUND TO BUILD SUCCESSFUL LIFE SCIENCE COMPANIES

Edinburgh, UK, 22 June 2020 – Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, announces that it has closed Epidarex Capital III UK LP (the “Fund”) at £102.1 million. The Fund will build new life science companies based on world-class research and innovation from emerging hubs across the UK, including spinouts from highly regarded universities. Typical initial investments will range from £2 million to £5 million.

Apr 20 2020

Love0

402nd Edition – April 21, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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April 20, 2020

FOUNDING MEMBER OF

Biohealth Innovation – COVID-19 Resources

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19. Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia

Maryland

Governor’s Update – https://governor.maryland.gov/coronavirus/
General Update – https://coronavirus.maryland.gov/
Business Resources – https://govstatus.egov.com/md-coronavirus-business

Montgomery County, MD

Virginia

US Small Business Administration

Volunteers

Entrepreneur-in-Residence Feedback Session

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? There are a couple openings remaining for tomorrow (Wednesday) ‘s EIR session. Schedule your feedback session with BHI EIRs by videoconference here by 2 p.m. today, Tuesday and forward your power point deck to BHI at that time. Next month’s session is scheduled for May 27th.

Click here to schedule a time with us and send your slide deck to: bhi(at)biohealthinnovation.org.

Contact Judy Costello for more information.

E: jcostello(at)BioHealthInnovation.org

P: 301.637.8854P: 301.637.8854

AstraZeneca Donates 3 Million Surgical Masks to Direct Relief for Covid-19 Supply Needs in the U.S.

Direct Relief today announced a donation from AstraZeneca of 3 million surgical masks for US healthcare workers battling Covid-19.

“For the dedicated and courageous healthcare workers across this country treating Covid-19 and non-Covid19 patients, working without an adequate supply of face masks and other protective equipment is like going into battle without body armor,” said Direct Relief CEO Thomas Tighe. “This generous and timely donation from AstraZeneca will make a substantial difference in keeping these vital workers safe and able to continue providing care for us all.”

Image: Pallets of surgical masks, donated by AstraZeneca, are prepared at Direct Relief’s global distribution facility in California for delivery via FedEx to health workers battling Covid-19 across the United States. (Photo: Direct Relief)

JLABS @ Washington D.C.: A Healthcare Incubator With a Focus on Pandemics | Johnson & Johnson

It was a year ago this month that Johnson & Johnson Innovation first unveiled plans to launch a healthcare innovation facility in Washington, D.C., in collaboration with BARDA—also known as the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

BARDA’s mission: the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures—vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products—needed to protect us from chemical, biological, radiological and nuclear (CBRN) health security threats, as well as pandemic influenza and emerging infectious diseases.

Image: Photo courtesy of Children’s National Hospital

Aledade raises $64M in Series C, supports doctors with COVID supplies – Washington Business Journal

Bethesda’s Aledade Inc. has done it again.

The fast-growing health tech startup, which helps physician practices cut costs and build accountable care organizations, has raked in a whopping $64 million in Series C financing, after kicking of 2019 with $56 million in then-new investments — and all in a moment of general investor restraint.

The funding will enable Aledade to continue expanding its national network of doctor-led ACOs, the company said Monday. It will also support the addition of more value-based contracts with Medicare, Medicaid and commercial health plans. It comes as Aledade sees annual revenue grow 60% and projects it will surpass $150 million within the next year, it said in an email to the WBJ.

Image: Farzad Mostashari is the CEO and founder of Aledade. JOANNE S. LAWTON

200 Investors for Tech Hubs

RESI is planning its first ever, dedicated, digital partnering event on April 29-30th with over 200 investors participating! We’re offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times. If you are able to promote this event among your constituents, we would like to offer them the possibility to register at a 50% discount, good until April 17th. That means the registration for 2 full days of partnering will cost less than $300!

Special 50% Discount Offer for Tech Hub Constituents (2-Day registration only, ends April 17th) Registration price $595 = $297.50

Medcura moves into New Corporate HQ

RIVERDALE, Md., April 17, 2020 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, announced today that it has moved into a new purpose-built facility in Riverdale, Maryland that will support the manufacture and commercialization of its growing product line.

Medcura chose the Discovery District, a growing center for technology and innovation, where high-tech companies can build businesses that develop, manufacture and commercialize disruptive new products. The Company worked with Terrapin Development and St. John Properties to design and deliver a facility that can house product development, manufacturing and leadership functions that will support commercialization of consumer, clinical, surgical and military applications of its proprietary platform. The Company intends to manufacture core cGMP compliant hemostatic and wound treatment materials at a scale necessary for commercial launch and in support of the clinical development of implantable devices.

Image: PRNewsfoto/Medcura, Inc.

QIAGEN Launches Assay for Cancer Patients Following FDA’s Nod

QIAGEN N.V. QGEN announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.

Precigen Announces Clearance of IND to Initiate Phase I/II Study for First-in-Class PRGN-2009 AdenoVerse™ Immunotherapy to Treat HPV-positive (HPV+) Solid Tumors | BioSpace

GERMANTOWN, Md., April 20, 2020 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors. HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

LABORATORY SPACE Available in Rockville – MD

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Access to Route 28, Route 355, I-270, and Route 200/ICC
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Emergency generator
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Click here for more information.

GSK CEO: Coronavirus vaccine with Sanofi is ‘unprecedented collaboration’

GlaxoSmithKline CEO Emma Walmsley on Tuesday told CNBC’s Jim Cramer that her company’s newly announced partnership with industry peer Sanofi is an “unprecedented collaboration” between competitors.

The European pharmaceutical giants are combining their resources to develop a Covid-19 vaccine and aim to produce a batch within the next 20 months.

Image: https://www.cnbc.com

Bayh-Dole 40 | Event (Thursday, April 23, 2020 – 12:30 PM TO 1:45 PM EDT)

The world is anxiously awaiting effective treatments for Covid-19, which is ravaging most countries. Fortunately, some of the best minds in our public and private sectors are putting everything they have into developing effective vaccines, drugs, and tests that are so desperately needed. Because of the Bayh-Dole Act, which allows academic institutions and federal laboratories to effectively license their discoveries so they can make the leap from being laboratory concepts into useful products, these partnerships are proceeding at full speed. Unfortunately, some want to undo this model at the very time we need it the most.

EXCLUSIVE: AstraZeneca’s Calquence Shows Early Promise For COVID-19 Patients

British drug giant AstraZeneca is rushing forward a big clinical trial for its blood cancer drug Calquence because it has shown early promising results in later-stage COVID-19 patients—those in intensive care units and on ventilators. Calquence and top-selling leukemia drug Imbruvica are the latest hopes in getting coronavirus patients off ventilators, where there is a 50% mortality rate.

Meet the Johns Hopkins team developing a 3D-printed device allowing COVID-19 patients to share ventilators – Technical.ly Baltimore

The COVID-19 crisis brought a shortage of ventilators that can help people battling the lung condition caused by the disease and led to a dire puzzle that leaders in the government and healthcare system are working to solve: how to acquire enough ventilators so that doctors don’t have to face the choice of refusing the machine to someone who needs it.

Image: The ventilator splitter prototype. (Photo courtesy of Johns Hopkins/Will Kirk)

US Venture Capital Investment Has Strong Showing in Q1 2020, with Economic Downturn Brought on by COVID-19 Primed to Slow Activity | State | chinookobserver.com

SEATTLE, April 14, 2020 /PRNewswire/ — After elevated venture capital (VC) investment in the past few years, deal activity maintained momentum in the first quarter of 2020 amid the impending economic downturn due to the COVID-19 pandemic, which will slow activity through the rest of the year, according to the PitchBook-NVCA Venture Monitor, the authoritative quarterly report on venture capital activity in the entrepreneurial ecosystem jointly produced by PitchBook and the National Venture Capital Association (NVCA), with support from Silicon Valley Bank and Carta.

Virginia Governor Orders Residents to Stay Home Until June 10

Virginia Governor Ralph Northam on Monday issued an order to residents stay at home until June 10, part of expanded efforts to curtail the coronavirus pandemic that continues to spread across the country.

“I want to be clear: Do not go out unless you need to go out. This is very different than wanting to go out,” the Democratic governor said in announcing the order.

Northam noted that “some of our beaches and other recreational areas were literally packed” over the weekend, and warned that, “everyone who is gathering in a crowd is putting themselves and others at risk.”

Abbott Launches Third COVID-19 Test, a Laboratory-Based Antibody Blood Test That Will Ship in the U.S. Starting Tomorrow – Apr 15, 2020

ABBOTT PARK, Ill., April 15, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.

This antibody test adds to Abbott’s existing COVID-19 tests that are already being used, including its m2000™ molecular laboratory system and its ID NOW™ molecular point-of-care device.

HHS collaborates with non-government organizations to further COVID-19 immunotherapies – Homeland Preparedness News

The push for convalescent plasma and hyperimmune globulin immunotherapies to use against COVID-19 continues at the federal level, with the U.S. Department of Health and Human Services (HHS) touting collaboration with non-governmental entities to see it done.

New Hopkins coronavirus maps looks at individual counties in US – Maryland Daily Record

Johns Hopkins University, whose global count of COVID-19 cases and deaths has become one of the most popular sources for information about the disease, has unveiled a new United States map that dives into the pandemic on a county level.

The U.S. map provides information about counties’ health infrastructure, population and policies and cases related to COVID-19, the disease caused by the coronavirus.

Image: Johns Hopkins University’s map tracking the COVID-19 has added county data, including snapshot infographics, like this one of Prince George’s County, for every county in the country. (Johns Hopkins University)

Undetected COVID-19 Cases Counted by NIH

Current COVID-19 tests detect the presence of the SARS-CoV-2 viral RNA genome in patients’ samples through RT-PCR. They are designed to identify who has the virus in their system, at the time of testing. But, testing in the United States has been inadequate on multiple levels. There are not enough tests, leaving some patients waiting in long lines outside of the hospital and others sleeping overnight in their cars, waiting to be tested. Also, the tests’ levels of sensitivity (identifying those with the disease correctly) and specificity (identifying those without the disease) have been called into question.

Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development

While President Trump continues to promote antimalarial drugs such as hydroxychloroquine sulfate and azithromycin to treat COVID-19—“What do you have to lose?” he exclaimed during the April 4 Coronavirus Task Force Briefing—the global community of drug discovery researchers and biopharmas is developing a much broader menu of therapeutic options.

Blinking Red: 25 Missed Pandemic Warning Signs

“Nobody knew there’d be a pandemic” … “Nobody has ever seen anything like this before” … “Nobody would have ever thought a thing like this could have happened.”

Those were President Trump’s words in March about the COVID-19 pandemic. Trump’s repeated protestations were questioned by, among others, Trump himself, who told the White House press corps on March 17 that, “I felt it was a pandemic long before it was called a pandemic.”

COVID-19: ‘Cough chamber’ shows six-feet not far enough – Neuroscience News

Summary: Droplets from a cough travel at a speed of 1.2 meters per second at peak velocity. Findings reveal that there is no logical reason to suggest 6 foot of physical distance is substantial at reducing coronavirus transmission.

Source: Western University

A recent Western-led study says two meters might not be far enough away if someone lets an uncovered cough loose in your direction – meaning sneeze and cough etiquette is more than a simple social nicety, but a key to stopping the spread of diseases like COVID-19.

Image: Western Engineering’s cough chamber is a two-metre enclosed cube with an opening and chin rest in the front, which is used as an access point for study participants to cough. Within the cube, a camera and a laser are used to determine the velocity of the expelled droplets from the cough. The image is credited to Frank Neufeld.

Fed Steps Up to Provide More Help to Small and Mid-Sized Businesses, Including PPP Borrowers | Insights | Venable LLP

On Thursday morning, the Board of Governors of the Federal Reserve System (Board) released the highly anticipated details of its massive $600 billion Main Street Lending program (Program) to support small and mid-sized businesses with up to 10,000 employees. The Program is particularly welcomed by businesses that are too large to be eligible for loans under for the Paycheck Protection Program (PPP).

Iceland’s Aggressive COVID-19 Testing Helped Curb Outbreak

Iceland has 364,000 inhabitants. Currently, roughly 10% of them are aware of whether or not they have COVID-19. This is due to a massive undertaking by Kári Stefánsson, MD, Dr. Med., the co-founder, president, and CEO of deCODE genetics—a population genetics powerhouse that has routinely produced new discoveries in fields such as genomic architecture, cancer genetics, and mental illness. Now, deCODE has combined the most intensive targeted testing and general screening of any population to date for SARS-CoV-2.

GSK joins Sanofi effort to make coronavirus vaccine

Sanofi and GSK, two of the biggest names in vaccine development, are joining forces on creating a coronavirus vaccine, the companies announced Tuesday.

Sanofi launched the project in February; what’s new is GSK’s contribution of an adjuvant — a substance that is added to a vaccine to enhance people’s immune responses.

Image: JOSEPH N. DISTEFANO

Apr 20 2020

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401st Edition – April 14, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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April 14, 2020

FOUNDING MEMBER OF

2020 BioHealth Capital Region Forum Planning Committee Update

We hope you and your families are well. This is a reminder that due to COVID19 the BioHealth Capital Region Forum, originally scheduled to take place this week, April 14th and 15th at AstraZeneca, has been postponed.

We are looking into combining the BioHealth Capital Region Forum with the BioHealth Capital Region Investment Conference which tentatively will be held between October 19th and 21st, 2020. We will advise you of our future direction on these events as soon as we develop our path forward. Please save these dates until we finalize the details as we hope to have an in-person event at that time. Thank you for your patience and understanding during these challenging times.

– BioHealth Capital Region Forum Planning Committee

Montgomery County wants to spur medical manufacturing to fight coronavirus – Washington Business Journal

The coronavirus outbreak has required all manner of businesses and government agencies to turn on a dime and think creatively — and the Montgomery County Economic Development Corp. is no exception with its new effort to spur medical manufacturing.

In normal times, the EDC focuses primarily on attracting and retaining businesses in the Maryland suburb. But as a global pandemic roils the economy, many companies are simply struggling to survive, not eyeing new office space or a splashy relocation.

Image: Ben Wu, president and CEO of the Montgomery County Economic Development Corporation, is leading an effort to create a new “manufacturing ecosystem” for medical equipment in the county. EMAN MOHAMMED

MARYLAND Business Relief Wizard

There are numerous local and national programs for businesses in need of emergency support, but understanding which options are relevant for your organization can be a challenge.

The Maryland Business Relief Wizard is a tool that helps connect businesses with the resources and programming for which they’re eligible, streamlining the process of finding support.

Biotech Beach Emergent BioSolutions Aims to Fight COVID-19 | BioSpace

Biopharma companies are attacking the COVID-19 pandemic from many fronts. Emergent BioSolutions is among those leading the fight. The company has a proven track record, partners and extensive networks to advance vaccines or therapeutics quickly toward trials.

Emergent BioSolutions supplies the Strategic National Stockpile with vaccines against anthrax and smallpox, and treatments against anthrax, botulism and smallpox vaccine complications. Its pipeline includes vaccines against Chikungunya and anthrax (again), treatments targeting Zika and Influenza A, and now, COVID-19.

Image: https://www.biospace.com

The COVID-19 vaccine development landscape

The genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19, was published on 11 January 2020, triggering intense global R&D activity to develop a vaccine against the disease. The scale of the humanitarian and economic impact of the COVID-19 pandemic is driving evaluation of next-generation vaccine technology platforms through novel paradigms to accelerate development, and the first COVID-19 vaccine candidate entered human clinical testing with unprecedented rapidity on 16 March 2020.

Dr. Fauci: ‘We need to put our foot on the accelerator’ to see an end to COVID-19 pandemic | fox8.com

WASHINGTON (NEXSTAR) ─ Even though he says the worst is yet to come, Dr. Anthony Fauci, the nation’s top infectious-disease expert, has seen signs of progress in the country’s fight against the coronavirus.

“The next week we’re going to see a spike in deaths throughout the country, particularly in the hot spot areas like New York, but simultaneously with that, we’re starting to see some cautiously optimistic type signs,” Fauci said.

Image: https://fox8.com

Daniels to Johns Hopkins community: ‘Our work continues’ | Hub

Johns Hopkins President Ronald J. Daniels shared a message with the university community today. The full text of the message is below.

Dear Johns Hopkins Faculty, Students, and Staff:

It has been a long and nerve-wracking month since we began to fully prepare for, and mitigate the impact of, the extraordinary challenges posed by COVID-19. Our colleagues from the Bloomberg School of Public Health remind us that we are still likely a few weeks from the peak of the pandemic in Maryland. For the foreseeable future, we will remain under significant strain as we respond in ways that run counter to our normal course of action and to our community’s innate desire to connect in person with each other.

Image: https://president.jhu.edu/

emocha Expanding Remote Monitoring Service for COVID-19 Exposed Healthcare Professionals – emocha Mobile Health Inc.

In response to the COVID-19 crisis, emocha Mobile Health has implemented a remote monitoring service powered by human engagement to support health systems including Johns Hopkins Medicine and LifeBridge Health-affiliated hospitals. emocha uses short, asynchronous video check-ins to identify, track, and manage symptoms of healthcare professionals who have been exposed to COVID-19.

Healthcare workers are on the front lines of the COVID-19 (coronavirus) pandemic, and ensuring their safety and availability is critical. The virus is spreading rapidly across the globe with more than 35,350 confirmed cases in the United States as of March 23. As a result, this highly infectious and novel disease requires strategies to protect the public’s health and to slow the rate of transmission.

PathSensors, Inc. Announced the Development of a SARS-CoV-2 Biosensor – PathSensors

BALTIMORE, MD March 24, 2020 – PathSensors Inc, a Baltimore biotechnology company, announced today that they are developing a CANARY ™ biosensor to detect the Novel SARS Coronavirus (SARS-CoV-2), the causal agent for the coronavirus disease COVID–19. The biosensor will be available for research purposes in May 2020 and validation data on the new SARS-CoV-2 product will be available June 2020.

CANARY ™ technology provides a unique opportunity to reduce the impending public health impact of COVID-19 with rapid results and high specificity. The initial application for this PathSensors product will be for testing of environmental swabs and air monitoring in sensitive spaces such as hospitals, offices, food services, etc. PathSensors will continue to advance the assay’s capabilities as the novel virus is further characterized. As the SARS-CoV-2 biosensor is commercialized, PathSensors expects new uses to emerge, such as rapid specimen screening.

Aphena Pharma Solutions | Maryland Department of Commerce

BALTIMORE, MD (April 13, 2020) – Aphena Pharma Solutions, an industry leading organization that provides packaging and manufacturing solutions for the medical industry, is planning to expand its pharmaceutical manufacturing operations in the Town of Easton. The company, which currently operates within a 110,000 square foot facility at 7978 Industrial Park Road, is purchasing an additional 54,000 square foot facility adjacent to its existing location. Building renovations and the installation of new equipment is expected to begin this year, with an estimated completion time of December 2020. Aphena currently employs 150 full-time workers and plans to add an additional 100 jobs in Talbot County over the next two years.

ITI Forms Collaboration with EpiVax & PharmaJet to Develop Novel Vaccine Candidate Against COVID-19 Using Its Investigational UNITE Platform – Immunomic Therapeutics

ROCKVILLE, Md. & PROVIDENCE, R.I. & GOLDEN, Colo.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it is developing a nucleic acid vaccine candidate against COVID-19 leveraging its investigational UNITE platform for prevention of the novel coronavirus disease caused by SARS-Cov-2 coronavirus. Immunomic will work with leaders from EpiVax and PharmaJet, who have a wealth of immunology and vaccine delivery expertise, to rapidly develop its COVID-19 vaccine. Immunomic’s UNITE platform has been widely applied to create vaccine candidates for rabies, yellow fever, dengue fever, hepatitis C and SARS, a relative to the SARS-Cov-2 coronavirus.

Epidemic Modeling 102: All CoVID-19 models are wrong, but some are useful

This is the second post of the “Epidemic Modeling” series. We will be building up on our discussion from the first post, “Epidemic Modeling 101: Or why your CoVID-19 exponential fits are wrong”, so you might want to start reading there. You can find the notebooks I wrote to implement the models and generate the figures over at the GitHub repository I made specifically for this series:

Image: https://medium.com

Children’s National Hospital Prepares to Admit Adults for First Time Due to Coronavirus | National News | US News

CHILDREN’S NATIONAL Hospital, one of the country’s leading pediatric medical centers, is prepared to accept adult patients after expanding its admission criteria for the first time in history to bolster the D.C. region’s hospital capacity during the coronavirus crisis.

In the event that regional hospitals see a surge of adult patients, Children’s National will accept patients under 30 years old who are showing respiratory symptoms and who may or may not have tested positive for COVID-19, a spokesperson tells U.S. News. The pediatric hospital, which opened in 1870, will also admit patients in their 20s with cancer or sickle cell disease if other area hospitals become concerned about capacity during a surge.

Alexandria Real Estate Equities offering life science companies ‘Room to Grow’

Alexandria Real Estate Equities, Inc. (NYSE:ARE), an S&P 500® urban office REIT, is the first and longest-tenured owner, operator, and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, including Greater Boston, San Francisco, New York City, San Diego, Seattle, Maryland, and Research Triangle. Alexandria has a longstanding and proven track record of developing Class A properties clustered in life science, technology, and agtech campuses that provide our innovative tenants with highly dynamic and collaborative environments that enhance their ability to successfully recruit and retain world-class talent and inspire productivity, efficiency, creativity, and success. For more information, please visit www.are.com.

How long do coronaviruses live on surfaces?

One of the most common questions that people search about hashtag#coronavirus is how long it lives on surface. Part of the hashtag#healthcommunication and hashtag#healthliteracy is presenting complicated information in different ways. Kudos to my WebMD colleagues for this inforgraphic

David Rubenstein Interviews Economic Experts on COVID-19 – YouTube

The Economic Club of Washington, D.C. hosted its fifth virtual event on April 8, 2020. Club President David Rubenstein interviewed economic experts on the state of the economy and the financial forecast. In addition, they discussed the current U.S. and global economy, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Federal Reserve’s response to the pandemic, and the way forward post COVID-19. Additionally, Dr. Kurt Newman provided a medical update on the evolving virus. The interview took place in three segments.

3 lessons from Children’s National Hospital on rapidly setting up drive-thru COVID-19 testing | FierceHealthcare

Just as many schools around the nation began shuttering for the year last month due to the pandemic, top officials at Children’s National Hospital were quickly mounting their own response to address COVID-19 concerns among kids.

“We heard from our pediatricians in late February, early March that they were very worried about what they were seeing in the community,” said Children’s National Chief Operating Officer Kathleen Gorman during a virtual roundtable with FierceHealthcare this week.

Image: Here’s a look at the advice Children’s National had to offer other hospitals about lessons learned from standing up a drive-thru specimen collection site within one week. (Children’s National Health System)

Women’s Venture Competition – AIM-HI

The AIM-HI Accelerator Fund’s Women’s Venture Competition is a high-profile initiative among women-led oncology start-up companies or venture teams aspiring to soon establish such firms, in which all participants are offered access to intensive accelerator boot-camp programming by one of the world’s most renowned women entrepreneur accelerator and business training service providers, Springboard Enterprises, and—subject to due diligence and negotiation—the winning business will receive up to $300,000 in AIM-HI investment.

Pediatric Medical Device Pitch Competition Pivots to Virtual Format Amid COVID-19 Crisis · BioBuzz

COVID-19 wasn’t about to stop the important work being done to meet the large unmet need for pediatric medical devices among patients younger than 18. NCC-PDI’s annual “Make Your Medical Device Pitch for Kids!” pitch competition moved to a 100% virtual event format to keep pediatric medical device innovation moving forward while complying with social distancing recommendations that will help to flatten the curve.

In late March, 30 outstanding companies pitched their pediatric device innovations in cardiovascular, orthopedic, spine and Neonatal Intensive Care Unit (NICU) devices — areas where the need is greatest — to judges in a virtual meeting room setting.

Image: https://biobuzz.io

Will JPM21 be safe to attend? Plus: Layoffs at Sage and a deal brokered over Zoom

Just three months ago, thousands of biotech types blotted out the streets of San Francisco for the J.P. Morgan Healthcare Conference, four days of crowded rooms, overstuffed bars, and double-booked meetings. Today, with the coronavirus forcing the industry to interact via videoconference, that kind of physical proximity is difficult to imagine. And it might still be unsafe by the time JPM 2021 rolls around.

The DMV region’s life sciences sector jumped into the fight against COVID-19. Here’s why it could move quickly – Technical.ly Baltimore

A new coronavirus was spreading in the U.S., and with social distancing orders going into place, talk immediately turned to finding a treatment that could stop the spread. In Maryland, companies jumped into action. Work began on a vaccine at Gaithersburg-based Novavax, and the company partnered with Emergent Biosolutions on initial development and manufacturing. Gaithersburg’s Altimmune is also developing a vaccine, and announced plans last week for a preclinical testing collaboration with the University of Alabama Birmingham.

MD National Capital Region Economic Development Alliance Press Release — MCEDC

Rockville, Md. — In a greater effort to ensure that the Maryland National Capital Region can emerge as quickly as possible from the expected economic hardships of the COVID-19 coronavirus, the Montgomery County Economic Development Corporation (MCEDC) announced today that it has joined with its state peers in the Greater Washington metropolitan area to form a regional alliance to support an economic recovery.

A Joint Statement of collaboration formalizing the Maryland National Capital Region Economic Development Alliance (MNCREDA) was signed virtually by the leaders of the economic development organizations representing six counties. The Joint Statement document and a photo of its virtual signing are attached.

Image: https://thinkmoco.com

Coronavirus updates: Nursing homes surge in deaths, Italy daily death toll

Nobel-prize winning economist Robert Shiller warns a pandemic of fear could tip the economy into an undeserved depression.

Shiller, an expert in how our emotions drive financial decisions, finds the sheer volume of chatter surrounding depression risks due to the coronavirus could severely hurt the economy.

Image: https://www.cnbc.com

These 8 maps show the massive drop in smog caused by the coronavirus

As streets have emptied of traffic during the coronavirus crisis and airlines have cut flights, the changes have temporarily helped another public health crisis—air pollution. In the Northeastern U.S., nitrogen dioxide pollution (the air pollution caused by internal combustion engines burning fossil fuels) fell 30% in March as lockdowns began. Los Angeles’s usual smog has nearly disappeared. The same pattern happened earlier in China and Italy as mobility slowed, factories shut down, and hazy skies cleared.

Image: These maps show the air pollution levels in late March 2019 and the late March 2020. Map: courtesy Descartes Labs

The 6-feet office is designed for work after COVID-19

It’s hard to imagine now—as most of us are reading this in quarantine, with our feet propped on Costco boxes of spaghetti noodles—but we will one day have to go back to our offices. COVID-19 won’t be eradicated, and not everyone will be immune. But we’ll still be expected to sit at a desk and work. So how will work…work?

Image: courtesy Cushman & Wakefield

‘We need an army’: Hiring of coronavirus trackers is likely set to soar

K.J. Seung is surprised to be hiring and training new workers in Boston.

His public health nonprofit, Partners in Health, specializes in helping the poorest people in developing nations — tracking down contacts of Ebola patients in Liberia and Sierra Leone; running child health and HIV clinics in Haiti; and operating tuberculosis control programs in Peru. But now it is advertising for 500 people to help do what’s known as contact tracing to try to control Covid-19 in Massachusetts.

Image: Riders on the New York City subway last week wear personal protective equipment. JOHN MINCHILLO/AP

The “Newest Normal”: The Six Pivots for Economic, Skills, Investment-Resilient Strategies | LinkedIn

First went the energy sector, second the stock-market, then the health-pandemic outbreak, soon flood and storm season return. These persistent shock waves of challenges and disasters do not allow for economies, companies, institutions nor individuals to absorb much less pause operationally, financially, nor emotionally. The “New Normal” is survival – not of the fittest but of those able to pivot their strategies and visions the fastest. Here are six economic, skill, and investment resilient strategies for the 21st Century Pivot. (And yes, you and your team have little time to conduct the typical whiteboard session, report preparation, spreadsheet development because The Pivot is now!)

VA 30 Day Fund – Home

The COVID-19 crisis has put millions of small business jobs at risk. These small businesses are experiencing a near-fatal cash crunch as they struggle to keep their doors open and jobs intact. These next few critical weeks will impact millions of jobs.

The non-profit Virginia 30 Day Fund provides forgivable loans for Virginia-based small businesses. The forgivable loan is intended to provide immediate financial assistance (within maximum three days) to meet payroll, preserve healthcare coverage for employees and save jobs while they await recently approved federal funding.

The Virginia 30 Day Fund is designed to be quick, easy, and free of red tape, as small business owners work to keep employees on board in the near term. All we ask in return: if you can, pay it forward.

Danaher raises $825M to pay down debts, days after closing acquisition of GE’s biopharma business – Washington Business Journal

Danaher Corp. (NYSE: DHR), the massive D.C. conglomerate of industrial and commercial manufacturers, said Wednesday it has raised $753.7 million euros, or the equivalent of $825.3 million, through the issuance of new shares and will use proceeds to pay off debts, according to a Securities and Exchange commission filing.

The raise was disclosed just days after Danaher finally closed its $21.4 billion acquisition of the biopharma business of General Electric Co.’s life sciences division. Danaher announced its intent to purchase the business in February 2019, and the deal necessitated regulatory approvals in several countries and a substantial stock sale to finance the acquisition.

Image: Danaher Corp. closed its $21.4 billion acquisition of GE’s biopharma business March 31. IGOR GOLOVNIOV

NIH begins study to quantify undetected cases of coronavirus infection | National Institutes of Health (NIH)

A new study has begun recruiting at the National Institutes of Health in Bethesda, Maryland, to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have antibodies to the virus. The presence of antibodies in the blood indicates a prior infection. In this “serosurvey,” researchers will collect and analyze blood samples from as many as 10,000 volunteers to provide critical data for epidemiological models. The results will help illuminate the extent to which the novel coronavirus has spread undetected in the United States and provide insights into which communities and populations are most affected.

Image: Colorized scanning electron micrograph of an apoptotic cell (blue) infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. NIAID

6 Ways To Doom Your Startup Despite A Great Solution – Startup Professionals Musings

As an entrepreneur mentor and startup investor, I see with sadness the 50 to 90 percent that fail. If you ask them for a reason, most will insist that they couldn’t get funding, or they ran out of money too early. But I’m not convinced that it’s as simple as that. Many are just not facing the reality that their passion had a critical business flaw.

Image: https://blog.startupprofessionals.com

8 Tips for Running a Startup Like a True Leader

Everybody thinks they’re a leader, but most are far from it. Successful startups, at all levels, depend on leadership and the ability of a few to organize both day-to-day and long-term goals. On the face of it, this sounds simple, but the reality is that not everyone is cut out to lead and to run a successful startup. It requires a certain mindset and armory of skills. These eight tips can help you lead your team.

Good Time to Invest in Health Care in China: Qiming Venture Partners – Bloomberg

Gary Rieschel, founding managing partner at Qiming Venture Partners, one of China’s most prominent venture capital firms, discusses the opportunities he sees in the market. Qiming has closed a new $1.1 billion fund, even as uncertainties around Covid-19 depress startup funding. Rieschel speaks with Selina Wang and Rishaad Salamat on “Bloomberg Markets: China Open.” (Source: Bloomberg)

Image: https://www.bloomberg.com

We Need Imagination Now More Than Ever

The idea of “crisis management” requires no explanation right now. Something unexpected and significant happens, and our first instincts are to defend against — and later to understand and manage — the disturbance to the status quo. The crisis is an unpredictable enemy to be tamed for the purpose of restoring normality.

But we may not be able to return to our familiar pre-crisis reality. Pandemics, wars, and other social crises often create new attitudes, needs, and behaviors, which need to be managed. We believe imagination — the capacity to create, evolve, and exploit mental models of things or situations that don’t yet exist — is the crucial factor in seizing and creating new opportunities, and finding new paths to growth.

Image: Illustration by Kirsten Ulve

We should stop categorizing careers as academic vs. nonacademic (opinion)

About a year ago, I made a career transition into professional and academic development support for graduate students and postdoctoral scholars. I have found the work immensely fulfilling, and as with any other new position, I spent quite a bit of time in my first several months trying to catch myself up to speed on the lingo of the profession.

Apr 20 2020

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400th Edition – April 7, 2020

By admin BHI Weekly Newsletter Archives

<!doctype html> BioHealth Innovation

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April 7, 2020

FOUNDING MEMBER OF

BHI and DLA Piper Host Webinar on Navigating the CARES Act for Life Sciences Companies in the BioHealth Capital Region

On April 3rd, 2020, DLA Piper and BioHealth Innovation, Inc. (BHI) presented an overview of the key provisions for BioHealth Capital Region Life Sciences companies in the $2 trillion Coronavirus Aid, Relief, and Economic Security Act stimulus package via webinar.

The hour-long review and discussion was recorded and is NOW AVAILABLE to access online.

BioHealth Innovation Appoints Rebecca Farkas, PhD and Sara Nayeem, M.D. to Board of Directors

New Members Continue GSK and NEA’s commitment to the BHI mission and the BioHealth Capital Region

ROCKVILLE, MARYLAND, April 6, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of two new board members, Rebecca Farkas, PhD, Director, External R&D, Scientific Collaborations at GSK, and Sara Nayeem, M.D., Partner at New Enterprise Associates (NEA). BHI’s leadership also thanked outgoing Board of Directors members Rip Ballou of GSK and David Mott of NEA for their contributions to the organization and friendship of many years.

“I am honored to welcome both Rebecca and Sara to our Board of Directors,” said Richard Bendis, BHI President and CEO. “They both bring a combination of experience and fresh vision to our already robust collection of industry leaders. We are excited to to work with them to help grow the BioHealth Capital Region industry cluster.”

Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk Guests on BioTalk

Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond

Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.

Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

BioHealth Innovation Entrepreneur-in-Residence Feedback (April 22nd)

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs through video conference on one of the following dates: 4/22, 5/20. (45 minute blocks of time beginning at 9:00 in the morning.)

Pre-registration is required; sign up here:

For questions/more information, contact BHI.

Immunomic Therapeutics builds coronavirus vaccine, plots IPO – Washington Business Journal

Immunomic Therapeutics Inc. is pivoting, as many are, in this new era to work on a vaccine for the novel coronavirus. But it’s also pursuing goals that would be considered ambitious even before the world changed: It’s closing in on a $50 million raise, advancing its brain cancer program — and positioning itself for an initial public offering.

The Rockville vaccine maker secured the first $10 million of this latest fundraising round at the end of January from Korean investment group HLB, and it expects to close on another $40 million-plus in the next couple of weeks, said Bill Hearl, founder and CEO of ITI. That capital would support the immuno-oncology company’s therapy for glioblastoma, an aggressive brain cancer, now heading into a phase 2 clinical trial after a successful phase 1 study that extended the typical 14- to 16-month median survival rate to 41 months.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

BioHealth Capital Region COVID-19 Resources

BioHealth Capital Region COVID19 Resources:

District of Columbia

Maryland

Governor’s Update – https://governor.maryland.gov/coronavirus/
General Update – https://coronavirus.maryland.gov/
Business Resources – https://govstatus.egov.com/md-coronavirus-business\

Montgomery County, MD

Virginia

US Small Business Administration

Volunteers

URGENT: Providers Needed | COVID-19, Maryland

Like many states across the nation, Maryland is preparing for a possible surge of COVID-19 patients.  Johns Hopkins is working with the state and the University of Maryland to erect an Alternate Care Site at the Baltimore Convention Center (ACS BCC). The ACS BCC is planned to open by mid-April and is intended to be used as a post-acute treatment facility.

Johns Hopkins is working on the recruitment, contracting, and credentialing of temporary Physicians and Advanced Practitioners. Compensation will be provided. We are reaching out to you, as a leader within your organization, in hopes that you might forward this to interested parties who may be willing to temporarily assist in treating patients recovering from COVID-19. Please see the attached job posting for details.

Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding | grants.nih.gov

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

You’ve Never Heard of BARDA, the Agency That May Rescue You From Coronavirus

One of America’s biggest companies has teamed up with one of the country’s least-known federal agencies to make doses of a coronavirus vaccine. Lots of them.

The deal underscores the important role that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, plays behind the scenes in protecting Americans—and everyone, really—from pandemics.

Emergent BioSolutions gets $14.5M in federal funding to expedite COVID-19 plasma therapy development | TechCrunch

Last week, we spoke to the head of Emergent BioSolutions’ Therapeutics Business Unit Dr. Laura Saward about her company’s work developing plasma-based potential treatments for COVID-19. Now, the company announced that it has received $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS), to speed the development of one of its treatment candidates.

Johns Hopkins gets FDA approval to test blood plasma therapy to treat COVID-19 patients | Hub

The U.S. Food and Drug Administration approved a clinical trial Friday that will allow Johns Hopkins University researchers to test a therapy for COVID-19 that uses plasma from recovering patients.

Arturo Casadevall, a Johns Hopkins infectious disease expert, proposed the use of convalescent plasma to treat critically ill COVID-19 patients and to boost the immune systems of health care providers and first responders. He assembled a team of physicians and scientists from around the United States to establish a network of hospitals and blood banks that can collect, isolate, and process blood plasma from COVID-19 survivors

QIAGEN Receives US FDA EUA for First and Only Syndromic Coronavirus Test – COVID-19 – Hospimedica.com

QIAGEN (Hilden, Germany) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The EUA approval status comes after QIAGEN recently began shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.

Image: QIAstat-Dx Respiratory SARS-CoV-2 Panel test (Photo courtesy of QIAGEN)

How to Obtain an SBA Coronavirus PPP Loan and Have It Forgiven

The number-one pressure on small-business owners right now is payroll. Whether you’re a sole proprietor one-person-show or a company with 500 employees, you’ve certainly felt the pressure. Maybe you’ve already stopped paying yourself, have laid off workers or cut hours. Well, you can thank your federal government for the best aid program recently offered for small business, the Paycheck Protection Program loan (aka Coronavirus Stimulus Loan, or PPP Loan).

GSK, AstraZeneca in talks for joint U.K. COVID-19 diagnostics project: Bloomberg | FierceBiotech

GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

Image: Global supplies of testing reagents and other materials, including swabs, have been faced with overwhelming demand in recent weeks. (NIAID – Rocky Mountain Laboratories)

When working remotely, constant communication is key to more action – Washington Business Journal

Not long ago, working from home was an option for some of us.

Today, it’s the norm for nearly all of us.

Unless your job absolutely requires you to be on the front lines, the coronavirus pandemic has caused us all to set up home offices and social distance ourselves from coworkers and clients alike.

That shift has likely carried some stumbling blocks, something even the most seasoned remote worker can attest to.

Image: https://www.bizjournals.com

Potential COVID-19 Treatments and Vaccines in Research Pipeline

We’re currently tracking 95 potential treatments and 52 potential vaccines in the pipeline to combat hashtag#COVID19.

There are thousands of researchers all over the world racing to get a treatment or vaccine to market.

Three Long-Time Emmes Employees Are Named VPs

ROCKVILLE, Md., April 6, 2020 /PRNewswire/ — Emmes today announced that Heather Hill, Dr. Adam Mendizabal and Dr. Nilay Shah have been promoted to vice president. According to Dr. Anne Lindblad, president and chief executive officer, “These promotions reflect their talent and value to the organization. Heather, Adam and Nilay demonstrate our commitment to developing staff and promoting from within. They will strengthen and add great value to our leadership team and will support our plans to grow both internally and externally.”

Heather Hill

Dr. Adam Mendizabal

Dr. Nilay Shah

Washington Business Journal’s Sara Gilgore to anchor DC Inno

A few weeks ago, I was in New Orleans for a jam-packed wedding weekend, complete with a crawfish boil, second line parade, Hawaii-themed 30th birthday luau for the bride-to-be, and more gumbo and jambalaya than we could eat (and guys, we’re talking authentic Louisiana Creole, which was just delicious.)

Image: Image via the Business Journals

Accelerator Series / Maryland SBDC

COVID-19 Notice for Maryland SBDC Clients, Stakeholders, and Partners

We are committed to serving our clients during the COVID-19 (Coronavirus) health emergency.

Consulting Services – New clients already in business can request COVID consulting assistance by clicking on the “I’M IN BUSINESS- GET CONSULTING” on our home page. The link is right below this notice towards the right side of the page. Continuing clients may continue to contact their consultant by phone, web conference, or email.

Training – All in-person training scheduled during the month of April has been canceled, postponed or offered online. If a paid training class is canceled or postponed, participants may request a refund or apply the funds to another class. If the class will be offered online, registered participants will receive an email with instructions for participating in the online class.

Emergency Assistance Package for Covid-19

Information regarding the hashtag#montgomerycountymd Public Health Emergency Grant Program passed by County Council yesterday. The County Executive’s staff is preparing regulations and plans to implement the program as quickly as possible. Businesses may submit questions about the program to: BizinfoCovid19@montgomerycountymd.gov. More info to come! hashtag#covid19response hashtag#moco

Image: https://www.linkedin.com

SBA loans: Answers on interest rates, application process and CARES Act from Mid-Atlantic boss – Philadelphia Business Journal

Steve Bulger has heard all the complaints.

The acting director for the U.S. Small Business Administration’s Mid-Atlantic region knows about the technical issues that applicants for the agency’s Economic Injury Disaster Loans (EIDL) faced last week.

He’s received questions about why those loans come with interest rates well above the Federal Reserve’s current standard rate.

Image: Steve Bulger, acting director for the U.S. Small Business Administration’s Mid-Atlantic region, has been dealing with an overflow of loan applications from small businesses struggling amid the COVID-19 crisis. U.S. SMALL BUSINESS ADMINISTRATION

FDA launches push to speed up Covid-19 drug development efforts – MedCity News

The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.

The Food and Drug Administration hopes to expedite development of treatments for Covid-19 under a new program that the agency announced Tuesday.

The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.

Image: https://medcitynews.com

Sagamore Spirit and Johns Hopkins collaborate to make hand sanitizer | Hub

In the middle of a hand-sanitizer shortage caused by the coronavirus pandemic, Johns Hopkins and Baltimore distillery Sagamore Spirit are working together to manufacture the disinfectant for use by the Johns Hopkins Health System.

The collaboration came together in less than 10 days, with Sagamore Spirit converting 100% of its distillation processes from rye whiskey mash bills to corn ethanol in support of the effort.

Image: IMAGE CREDIT: WILL KIRK / JOHNS HOPKINS UNIVERSITY

7 BioHealth Capital Region Diagnostics Companies Leading the Fight Against COVID-19 · BioBuzz

Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing.

Image: https://biobuzz.io

COVID-19 Tip Sheet: Story Ideas from Johns Hopkins

Newswise — When T.C. Wu, M.D., Ph.D., M.P.H., and Chien-Fu Hung, Ph.D., heard earlier this year about a new coronavirus that was spreading in China, their pathology labs immediately started developing a vaccine. That’s because nearly 20 years ago, Wu and Hung worked on a vaccine for another coronavirus that originated in China — severe acute respiratory syndrome, or SARS. So far, Wu and Hung have observed that the new coronavirus is “smarter” and “sneakier” than SARS, and they are concerned it will not go away like SARS did. Wu and Hung can discuss how their lab administered the new coronavirus vaccine to mice, and that preliminary results should be back by the end of the month. Watch this video and read this story about their efforts.

Anthony Fauci Shows Us the Right Way to Be an Expert – Scientific American Blog Network

Anthony Fauci has been an extraordinary presence during the COVID-19 crisis: calm yet urgent, informative yet plain-spoken. Along the way, he’s doing something even more difficult than explaining COVID-19. He’s providing insight about the role of the scientific expert in a liberal democracy.

Image: https://en.wikipedia.org/wiki/Anthony_Fauci

Children’s National Hospital coronavirus testing kids | wusa9.com

WASHINGTON — Nearly 300 children have now been tested in the District’s first drive-thru COVID-19 coronavirus test site, with no kids in the nation’s capital needing life-saving ventilators as the virus wreaks havoc on older populations.

But after the first American infant died of coronavirus in Chicago on Saturday, a new focus on testing children has entered the national conversation – with treatment for the youngest coronavirus patients potentially playing a key role in fighting the outbreak.

Image: https://www.wusa9.com

How Biotech Player You Haven’t Heard of Is Racing Gilead, Moderna to Coronavirus Treatment – TheStreet

Emergent BioSolutions (EBS) – Get Report may be a small company up against the heavy hitters, but it has a plan for a coronavirus treatment, one indication that many players are taking their shot at a vaccine, as the world eagerly waits a solution.

Monday, Johnson & Johnson (JNJ) – Get Report said it will start human testing of a vaccine for the Coronavirus as early as September. The company joins Gilead Sciences (GILD) – Get Report, which the World Health Organization says is a front-runner in making a viable drug, in finding a solution to Covid-19.

Image: https://www.thestreet.com

Amid concerns that startups could be left out of COVID-19 bailout, investors step up lobbying | TechCrunch

The massive bailout package that the U.S. government passed last week to stave off an economic collapse from measures put in place to mitigate the spread of the COVID-19 epidemic is giving out billions to American small businesses. But startups that received venture capital money could be left out.

Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19 NYSE:EBS

GAITHERSBURG, Md., April 02, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

Emergent BioSolutions Signs Agreement with Novavax to Manufacture NanoFlu™

GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (EBS) today announced an agreement with Novavax, Inc. (NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

Coronavirus Patients May Carry Virus for a Week after Symptoms Have Resolved

A small study reported by researchers in Beijing and the United States found that 50% of patients treated for COVID-19 infection still carried the virus for up to eight days after their symptoms had disappeared. The authors, reporting their results in American Journal of Respiratory and Critical Care Medicine, say they don’t yet know whether the virus might still be capable of transmission at the late stages of disease. However, the results indicate that quarantine periods might need to be lengthened in some recovered patients.

Image: NIAID

venBio Closes $394 Million Life Sciences Venture Capital Fund | BioSpace

SAN FRANCISCO–(BUSINESS WIRE)– venBio Partners LLC today announced the closing of venBio Global Strategic Fund III (“venBio Fund III”), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

Emergent Announces Partnership with the U.S. Government

We’re proud to announce a partnership with the U.S. Government on a comprehensive response to expedite development of our plasma-derived therapy to address hashtag#COVID19. https://lnkd.in/eHGC5F6

hashtag#toprotectandenhance hashtag#emergentbiosolutions hashtag#COVID19 hashtag#coronavirus

Image: https://www.linkedin.com

Solicitations | SBIR.gov

Solicitations play an important role in making the general public aware of funding opportunities available to the small businesses of the nation. Participating Federal Agencies post these funding opportunities on a regular periodic basis throughout the year associated to SBIR/STTR.

To become involved with the Small Business Innovation Research (SBIR) or the Small Business Technology Transfer (STTR) program, small businesses can compete by submitting solicited proposals to these agencies. A winner in the competitive solicitation process is awarded a grant or contract. The SBIR/STTR program does not fund unsolicited proposals (proposals that do not refer to and address a specific topic in a current agency SBIR/STTR solicitation).

Mar 24 2020

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398th Edition – March 24, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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March 24, 2020

FOUNDING MEMBER OF

BioHealth Capital Region Resources for Businesses Impacted by COVID-19

Here are some resources you might find useful if you’re impacted by COVID-19

Volunteers

Urgent Need for Healthcare Workers

As our community responds to COVID-19, Adventist HealthCare hospitals are caring for those most impacted by the virus in our community. Their need for health care professionals will grow more urgent as the number of local cases increase. As part of its preparedness planning, Adventist HealthCare is asking the research community to help. They are looking for physicians, nurses or technicians who could assist with testing, registration and patient care. If you would be willing to serve Adventist HealthCare during this unprecedented time, please contact Yasmin Nasser at (ynasser@adventisthealthcare.com/301-315-3220) to be added to a list of reserve employees. Whether you are social distancing and practicing good hygiene, or choose to serve in a more direct way, we applaud everyone’s efforts to stop the spread of COVID-19 in our community.

BHI portfolio company MockV Solutions led by David Cetlin acquired by Maravai LifeSciences

SAN DIEGO (March 17, 2020) – Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech partners, announced today that it has acquired MockV Solutions. MockV plays an important role in helping biopharma customers develop manufacturing processes that are free of viral contamination, leading to the production of safe biotherapeutics. The MockV acquisition, coupled with Maravai’s previous acquisition of Cygnus Technologies, expands Maravai’s leadership position in bioprocess impurity testing. Impurity testing is a critical step in the development and manufacture of biotherapeutic products.

QIAGEN dramatically ramping up global production capacity for RNA extraction kits for use in detection of SARS-CoV-2 coronavirus

Hilden, Germany, and Germantown, Maryland, March 17, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19.

QIAGEN has historically allocated global production capacity to manufacture RNA nucleic extraction reagents to supply about 1.5 million patient tests on a monthly basis. Now QIAGEN is ramping up production capacity for these reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020. A significant capacity expansion project is underway at sites in Europe and the United States to reach more than 20 million patient tests on a monthly basis by the end of 2020 to support the response to this global public health crisis.

For Maryland, medical worker shortage may be top concern as coronavirus spreads | WTOP

There have been concerns about possible shortages of hospital beds and protective gear during the COVID-19 pandemic, but the biggest concern in Maryland may be not having enough medical workers.

“Staffing might be more of a constraint than beds and supportive equipment,” said Bob Atlas, president and CEO of the Maryland Hospital Association. The group represents all of the state’s hospitals.

Emergent Biosolutions will manufacture Vaxart’s experimental coronavirus vaccine in Baltimore – Technical.ly Baltimore

Gaithersburg-based Emergent Biosolutions on Wednesday said it signed a second agreement in a week that will bring manufacturing of a coronavirus vaccine candidate to Baltimore.

The new agreement is with Vaxart, a San Francisco-based biotechnology company that is developing an experimental oral vaccine candidate that would be administered by tablet.

Image: https://technical.ly – Courtesy photo

COVID-19 Resources for Applicants and Recipients of NIH Funding | NIH Extramural Nexus

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. This is a rapidly evolving situation, and we are aware that many institutions are taking a variety of “social distancing” measures, including switching to telework and cancelling or postponing classes and non-essential meetings.

In Conversation: Sean Kirk, Emergent BioSolutions · BioBuzz

Following up on the recent article Two Maryland Biotechs Partner to Bring Coronavirus/COVID-19 Vaccine Candidate into Clinical Trials, BioBuzz had the opportunity to speak with Emergent BioSolutions Executive Vice President, Manufacturing and Technical Operations, Sean Kirk.

Let’s start by having you provide a brief background on your role at Emergent.

I have been with the company for nearly 17 years, and have had the good fortune of working in and being responsible for many key parts of the business including manufacturing operations, quality assurance, regulatory affairs, product development, U.S. government program management, global operational excellence, global supply chain, medical and clinical affairs. In these roles I have spent a lot of time across Emergent’s sites and have been based in Lansing, Mich. – where I started – Gaithersburg, Md, and Winnipeg, Manitoba.

Emergent BioSolutions Signs Development and Manufacturing Agreement with Vaxart for their Experimental Oral Vaccine Candidate for Coronavirus Disease – BioHealth Capital Region

GAITHERSBURG, Md., March 18, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST™ platform.

Critical Conversations with Rich Bendis

Rich speaks with VIVA Creative • Business Development & Strategic Partnerships. Image:

http://vivacreative.vzaar.me – From Video

http://vivacreative.vzaar.me/21376036

Maryland company swamped with applicants to help assemble coronavirus test kits | wusa9.com

GERMANTOWN, Md. — German company Qiagen is racing to assemble new COVID-19 test kits. Already approved for use in Europe, Qiagen’s new kits are now getting assembled in their North American headquarters in Germantown, Maryland.

Image: Qiagen’s North American headquarters in Germantown, Maryland Nathan Baca

Catching Up to Coronavirus: Top 60 Treatments in Development

Anthony Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), offered hope to the thousands of people with confirmed cases of COVID-19, and the millions around the world whose lives have been disrupted by the pandemic caused by SARS-CoV-2, when he expressed to a congressional panel last week his hope that the first patients would be dosed with vaccines in development for the novel coronavirus “in a few weeks.”

Md. biotech companies are working on new COVID-19 vaccines, tests – Baltimore Business Journal

Novavax and Emergent Biosolutions are not the only Maryland companies developing COVID-19 countermeasures. More than 15 local companies will meet virtually Friday to share their efforts.

Image: Maryland biotechs are coming together to build vaccines and diagnostic tests for COVID-19. CENTERS FOR DISEASE CONTROL AND PREVENTION

Pathogen-testing company Aperiomics has launched a COVID-19 test – Technical.ly DC

Sterling, Virginia-based biotech company Aperiomics has launched a new test that can detect COVID-19.

Founded in 2014, the company uses genomic analysis and machine learning to detect known pathogens from a sample of any nature in just one test. Aperiomics reports that its Xplore-PATHO tech can accurately identify nearly 40,000 microorganisms including over 12,000 clinically relevant pathogens.

Image: An Xplore-COVID-19 testing kit from Aperiomics – Courtesy Photo

FDA Just Approved a Rapid Coronavirus Test That Can Diagnose COVID-19 in 45 Minutes

The US Food and Drug Administration has approved a coronavirus test that can deliver a COVID-19 diagnosis in 45 minutes.

The test, made by California-based Cepheid, got emergency clearance on Saturday, eight days after the agency gave fast-track approval for a test by Roche, which can diagnose the novel coronavirus within three hours.

These 17 Maryland biotech companies are collaborating in the fight against COVID-19 – Technical.ly Baltimore

As more cases of COVID-19 are being reported and leaders seek tests and treatments, biotech companies are stepping up efforts to develop new tests and treatments.

That includes Maryland, where life sciences companies are working on vaccines, therapeutics and diagnostics. They’re also seeking to share what they’re working on and offer up resources: On Friday, Maryland Life Sciences is putting together a call with more than 15 companies where they’ll look to connect and share needs.

COVID-19 Reinfection Not a Concern, Monkey Study Suggests

Concerns about SARS-CoV-2 infection have reached an all-time high in the United States and around the globe. With increasing numbers of COVID-19 cases, hospitalizations, and deaths—and “social distancing” now a household word—the possibility of being infected is on everyone’s mind.

As if that weren’t enough to worry about, the surfacing of multiple personal accounts—primarily out of China and Japan—of patients who recovered after infection only to fall ill a second time, have some worried about the possibility of reinfection.

Lung Bioengineering in Silver Spring evaluates donated lungs to determine if they are suitable for transplant

Heather Phillips was supposed to be getting ready to join her extended family at its annual pumpkin carving celebration in Clarksburg, but instead she was still at work at Lung Bioengineering in downtown Silver Spring. It was late on a Saturday morning in October, and she’d been working all night. Now she stood inside the loading dock of the two-story building awaiting, for the third time in 12 hours, the delivery of an insulated cardboard box filled with ice and a pair of human lungs.

Image: Specialists Sam Popa (left) and Erin Larrabee prepare a set of lungs in a Lung Bioengineering operating room. Photo by Lisa Helfert

Aurinia Pharmaceuticals, helmed by Peter Greenleaf, expands into Rockville – Washington Business Journal

A Canadian pharmaceutical company is expanding into Rockville about a year after an executive with a long history in Maryland’s bioscience industry took the helm.

Aurinia Pharmaceuticals Inc. of Victoria, British Columbia, announced plans to open a new office in the city of Rockville on Tuesday, bringing about 100 employees to 30,000 square feet. The company could someday expand to employ as many as 500 people and occupy up to 120,000 square feet in Rockville during the next seven years, depending on its success in securing federal approvals for one of its drugs.

Image: Peter Greenleaf, a biotech executive with lots of history locally, is bringing his latest company to Rockville. JOANNE S. LAWTON

Biobuzz Directory – Immunomic Therapeutics Announces Completion of Pre-IND Meeting With US FDA for ITI-1001, a Vaccine for the Treatment of GBM

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

Biobuzz Directory – Aurinia Pharmaceuticals to Bring 500 New Jobs to Maryland at New Commercial Operations Center in Rockville

VICTORIA, British Columbia–(BUSINESS WIRE)–

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia’s plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

Why Investment And IP Clustering Is Key To An Innovative Future Across The Globe, With Joel Marcus

Joel S. Marcus is the Executive Chairman and Founder of Alexandria Real Estate Equities, Inc. (NYSE:ARE), an urban office REIT and the first and longest-tenured owner, operator and developer uniquely focused on collaborative life science, technology and ag-tech campuses in AAA innovation cluster locations. Mr. Marcus co-founded Alexandria in 1994 as a garage startup with $19 million in Series A capital. As CEO from March 1997 to April 2018, he led its growth into an investment-grade-rated S&P 500 company.

Image: https://www.forbes.com

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

INDIANAPOLIS, March 16, 2020 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test for COVID-19 (coronavirus) to a network of hospital and reference laboratories across the U.S. to enable automated, high-volume patient testing. Shipping of the initial 400,000 test kits began Friday, March 13, and will be completed this week. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

Startups developing tech to combat COVID-19 urged to apply for fast-track EU funding | TechCrunch

The European Commission put out a call Friday for startups and small businesses which are developing technologies that could help combat the COVID-19 outbreak to apply for fast-track EU funding.

The push is related to a €164M pot of money that’s being made available for R&D via the European Innovation Council (EIC) — a European Union funding vehicle which supports the commercialization of high risk, high impact technologies.

GeneDx Celebrates 20 Year History as Pioneer In Genetic Sequencing and Testing · BioBuzz

GeneDx, a global leader in genomics and patient testing, is celebrating its remarkable 20th anniversary throughout the month of March.

The Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BioHealth Capital Region as a global biohealth cluster. GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The company’s whole exome sequencing program and comprehensive testing capabilities are world-renowned.

Image: https://biobuzz.io

Study Shows How Mild Coronavirus Infection is Beaten by Immune Response

Researchers at the Peter Doherty Institute for Infection and Immunity in Australia have mapped immune responses in a patient in response to COVID-19 infection, demonstrating the body’s ability to fight the virus and recover from the infection. The team tested blood samples taken from one of Australia’s first cases of COVID-19, at four different time points during the infection. “We looked at the whole breadth of the immune response in this patient using the knowledge we have built over many years of looking at immune responses in patients hospitalized with influenza,” said Oanh Nguyen, PhD, co-author of the researchers report, which is published in Nature Medicine.

Image: Outbreak response in action: Centers for Disease Control and Prevention (CDC) staff support the COVID-19 response in the CDC’s Emergency Operations Center (EOC). (CDC; photo credit James Gathany)

GSK, AstraZeneca, Genentech, and Novartis Identified as the Top Companies Driving Therapeutic Innovation in Asthma

MORRISTOWN, N.J., March 18, 2020 /PRNewswire/ — In an ongoing series of research conducted by KMK Consulting, Inc. covering Innovation & Customer Value, GSK was ranked as the top company delivering superior customer value and sales force engagement, as well as delivering therapeutic innovation in the asthma market according to pulmonary disease specialists. The research was conducted in February 2020, using KMK’s Rapid Pulse Survey platform. AstraZeneca, Genentech, and Novartis rounded out the top organizations driving innovation and customer value in this space.

Trials to begin on Covid-19 vaccine in UK next month | Health | The Guardian

A massive effort is under way to develop a UK vaccine for coronavirus within months and make it available to save lives before the end of the year, the Guardian has learned.

Researchers at Oxford University, led by Prof Sarah Gilbert, are planning a safety trial on humans of what is expected to be the UK’s first coronavirus vaccine next month. Provided that it goes smoothly, they will move directly into a larger trial to assess how effective the vaccine is at protecting against the infection.

Council Post: How Digitizing Healthcare Can Transform Patient Care

The biopharma industry spent $90 billion on R&D in 2016, a figure that represents about 20% of total sales. Despite this significant financial investment by the industry and splashy media headlines, how much, or little, is healthcare really digitizing?

During the 2020 JP Morgan Healthcare Conference, a panel of senior executives, including Brent Saunders, chairman, president and CEO of Allergan, Tariq Shaukat, president of industry product and solutions for Google Cloud, and Sara Nayeem, MD, partner at New Enterprise Associates, joined me to share their perspectives and insights on how biopharma and medtech companies are driving digital health.

Maryland Industrial Partnerships (MIPS) – SPRING 2020 UPDATE

Despite the serious impacts of the coronavirus, MIPS is continuing its normal business activities, although we have moved many of our operations online. Our upcoming round of proposals are due May 1 at 5 p.m. We continue to work with the Maryland business and academic communities to support your efforts to develop technology products and services. Now is an excellent time to develop new products in order to have them ready for market when the U.S. economy begins to recover in the not-too-distant future.

Thermo Fisher Scientific Continues Investments to Accelerate Biopharma Commercialization

NEEDHAM, Mass., March 23, 2020 /PRNewswire/ — For biopharma companies faced with increasing demand for new biologics, cell and gene therapies, and drug products, Thermo Fisher Scientific is investing more than $475 million in new capabilities and capacity in 2020. This investment, in addition to those made in 2019, brings the total investment over two years to approximately $800 million across the company’s pharma services business.

“We’ve invested strategically to ensure that lack of capabilities, capacity or supply is never a reason medicines are delayed in reaching patients,” said Mike Shafer, president, Thermo Fisher’s pharma services business. “Our offering can provide solutions at all points along the pathway to commercialization, whether it’s an emerging biotech working on vaccine for a novel virus or a high-volume pharmaceutical manufacturer delivering necessary drugs at scale.”

The Zidd and Fizz Show

Keeping angels and startups company while working from home! Great guests and great topics! The ZIDDANDFIZZ Show: Angels Talk Ziad Henry Moukheiber Faz Bashi hashtag#podcasting hashtag#podcasts

Cellphire Begins Phase 2 Trial of Thrombosomes® in Bleeding Thrombocytopenic Patients

ROCKVILLE, Md., March 18, 2020 /PRNewswire/ — Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.

In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.

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