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430th Edition, November 3, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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November 3, 2020












FOUNDING MEMBER OF



Strengths of Our Region: Combating Infectious Diseases Forum Roundup · BioBuzz

Over the past nine months, more than $7 billion in federal money has poured into the BioHealth Capital Region in support of therapies, diagnostics, and vaccines against COVID-19. In that short time, the region has shown its importance in halting the spread of the ongoing pandemic.

At the 6th Annual BioHealth Capital Region Forum, COVID-19 was a central focus of attendees and panelists. One panel, Strength of Our Region: Combating Infectious Diseases, included representatives from four companies in the region that provided an overview of the region’s role in combating the novel coronavirus as well as other infectious threats. Company representatives from Novavax, Emergent BioSolutions, BioFactura, and Aperiomics pointed to the work conducted by their organizations in COVID, as well as other infectious diseases, including Ebola, influenza, RSV, and SARS. The panel was moderated by Karen Smith, chief medical officer of Emergent BioSolutions, who said she was struck early on in the pandemic that companies in the BioHealth Capital region battling the pandemic are “all in the same storm, just in slightly different boats.” She said they are all trying to figure out a solution to this pandemic but in different manners due to their areas of expertise.

 

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Glocal Innovation Life Sciences Meet-up (Bendis to Speak)- UK/Europe meets East Coast Tickets, Wed 4 Nov 2020 at 11:00 – 13:30 EST | Eventbrite

The Glocal Innovation Life Sciences Meet-Up is run by the UK/Europe based #coffeebuddies online Thought-Leadership community. This is headed by Prof Tony Sedgwick and Graham Combe, and has an Agile Leaders Advisory Board of 18 life science innovation leaders and investors.

This Meet-Up has been inspired by huge advances in technology that allow us to connect, engage, inspire and entertain life science professionals from around the world. There are no boundaries for our abilities to connect and network with other global Thought-Leaders. We started with connecting our #coffeebuddies community with networks in Australia and NZ which is a phenomenal success. This event is the first in the series where we connect with the East Coast of the Americas.

 

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JHU Spinout Thrive Earlier Detection Lands up to $2.15 Billion in Acquisition by Exact Sciences · BioBuzz

MADISON, Wis. and CAMBRIDGE, Mass., Oct. 27, 2020 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) and Thrive Earlier Detection Corp. (“Thrive”), a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, today announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion. The transaction was unanimously approved by both companies’ Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions.

Combining Thrive’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences’ best-in-class scientific platform, clinical organization, and commercial infrastructure will establish Exact Sciences as a leading competitor in blood-based, multi-cancer screening. Thrive, with an early version of CancerSEEK, has conducted a first-of-its-kind 10,000-patient, prospective, interventional study in a real-world clinical setting. In this landmark study, using its mutation and protein biomarker approach, CancerSEEK achieved promising results detecting 10 different types of cancer, including seven with no recommended screening guidelines, with very few false positives. Bringing together highly complementary scientific approaches and the strengths of both organizations, Exact Sciences expects to develop a more accurate test and accelerate the widespread adoption of this potentially life-saving advancement.https://d-1827656436805240469.ampproject.net/2010132225002/frame.htmlAd

Image: https://biobuzz.io

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Novavax Announces Facility Expansion to Support Global Vaccine Development | Novavax Inc. – IR Site

GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company’s immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

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REGENXBIO to Receive $80.0 Million Milestone Payment from Novartis AG | REGENXBIO Inc.

ROCKVILLE, Md., Oct. 27, 2020 /PRNewswire/ — 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 announced that it will receive a milestone payment of $80.0 million from Novartis AG based upon the achievement of $1.0 billion in cumulative net sales of Zolgensma. REGENXBIO expects to recognize this revenue in the third quarter of 2020.

“Zolgensma is a transformative, one-time gene therapy for the treatment of pediatric patients with SMA, a debilitating and potentially deadly disease, and the first approved gene therapy based on REGENXBIO’s NAV Technology. We believe that this achievement provides further validation of the broad potential of NAV Technology to improve the lives of patients in need,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are pleased to have contributed to a therapy that has impacted the lives of over 700 patients with SMA and their families around the world.”

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Neuraly Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 2B Trial of NLY01 for Patients with Alzheimer’s Disease | Business Wire

GAITHERSBURG, Md.–(BUSINESS WIRE)–Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

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Rexahn Pharmaceuticals Announces Stockholder Approval of All Proposals Required for Merger with Ocuphire Pharma :: Rexahn Pharmaceuticals, Inc. (REXN)

ROCKVILLE, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) (“Rexahn”) announced today that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (“Ocuphire”) and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from “Rexahn Pharmaceuticals, Inc.” to “Ocuphire Pharma, Inc.”; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing.

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Emmes Selected as Corporate Achievement Award Winner by the Montgomery County Chamber of Commerce

ROCKVILLE, Md., Oct. 29, 2020 /PRNewswire/ — Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award. Dr. Anne Lindblad, who recently retired as the company’s president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.

According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank’s group vice president for the Greater Washington Market, “Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way.”

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What Floreo’s expansion into ADHD means for the autism-focused virtual reality startup – Washington Business Journal

Through a partnership with NIH, D.C. virtual reality startup Floreo is expanding from autism spectrum disorder to attention deficit hyperactivity disorder.

Image: Floreo’s platform allows kids to practice skills such as pointing or eye contact, with a linked tablet for parents to follow along. COURTESY FLOREO

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Your Health in the “New Normal” of the Pandemic – An Industry Revolutionizing Healthcare As We Know It | Economic Alliance of Greater Baltimore

Greater Baltimore is one of few regions ideally suited to pioneer the future of digital health, an industry that will revolutionize healthcare as we know it. Companies in Greater Baltimore benefit from a rich ecosystem of healthcare assets that collectively provide every component necessary for digital health innovation: transformative research, specialized business incubation, access to funding, a talented workforce, and easily-accessible local and federal clients. The growing list of successes among Greater Baltimore’s digital health companies and groundbreaking partnerships showcase tremendous potential for this industry to play a defining role in the Region and influence healthcare throughout the nation for decades to come. The pandemic has accelerated the development of digital health technologies.

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U.S. Army Awards $599M in Contracts for AstraZeneca Vaccine, Lilly Antibody vs. COVID-19

The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZeneca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555).

The U.S. Department of Defense (DoD) disclosed yesterday that the Army this week awarded firm-fixed-price contracts of $312.5 million with Lilly (W911QY-21-C-0016) on Tuesday, and more than $286.9 million with AstraZeneca (W15QKN-21-C-0003) on Wednesday. The contracts, awarded by U.S. Army Contracting Command, cover an unspecified quantity of bamlanivimab to be made at a Lilly production site in Indianapolis; and 200 million doses of AZD1222 to be produced at AstraZeneca sites in West Chester Township, OH, and Albuquerque, NM.

Image: Spc. Selena M. Castillo prepares to administer a flu vaccination on Fort Sill, Okla., Nov. 15, 2019. Spc. Castillo is a medic for 3rd Battalion, 2nd Air Defense Artillery Regiment, 31st Air Defense Artillery Brigade. The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZenca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555). (Photo By: Army Sgt. Amanda Hunt, U.S. Department of Defense)

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Fina Biosolutions has been issued European patent No. 3099800

Fina Biosolutions has been issued European patent No. 3099800, Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains. The patent covers expression of the conjugate vaccine carrier protein CRM197 in our E. coli strain engineered to have an oxidative cytoplasm. FinaBio markets the E. coli expressed CRM197 under the name EcoCRM®.

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Innovation Pharmaceuticals and George Mason University Announce Public Release of Laboratory Testing Results Demonstrating Brilacidin’s COVID-19 Treatment Potential | BioSpace

WAKEFIELD, Mass. and FAIRFAX, Va., Oct. 30, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.

Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.

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Jaan Biotherapeutics Awarded NIH Grant to Advance Cardiac Muscle Regeneration Therapy – MarketWatch

Sep 05, 2020 (IssueWire via COMTEX) — San Diego, Sep 5, 2020 (Issuewire.com) – Jaan Biotherapeutics (“JBT”), announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health under Award Number R43HL154884. Under the Phase I grant, JBT intends to advance its lead cardiac muscle regeneration viral delivered drug, JBT-miR2 through preclinical testing in large animals. The first indication of JBT-miR2 is for the treatment of Ischemic Heart Disease (IHD), the single largest cause of death of both men and women in the Western World.

JBT-miR2 is a first in class viral delivered microRNA inhibitor that reprograms cardiac muscle cells to divide within the damaged heart, and repair the heart muscle after permanent heart muscle injury, for example following a heart attack.

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Seven Ways the Election Will Shape the Future of Science, Health and the Environment – Scientific American

When all the votes are cast and counted in this year’s momentous November 3 election, the results will have deep and potentially long-lasting impacts on numerous areas of society, including science. President Donald Trump and his challenger, former vice president Joe Biden, have presented vastly different visions for handling crucial issues—ranging from the deadly coronavirus pandemic to the damaging impacts of climate change and immigration policies.

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AstraZeneca’s vaccine candidate could mark a new era for the company — Quartz

Have you heard of a little thing called Covid-19? So has Big Pharma, and the race to develop a vaccine is on. It’s high-stakes geopolitical chess and every country and company involved badly wants to win, including Anglo-Swedish drugmaker AstraZeneca.

When Oxford’s Jenner Institute partnered with AstraZeneca on its vaccine candidate, ChAdOx1 nCoV-19, analysts scratched their heads. AstraZeneca is not a leader in vaccines, unlike its major UK competitor GlaxoSmithKline. It’s relatively small and has a tumultuous history. But if you look, the signs are there that AstraZeneca is building a blueprint to thrive as a 21st century pharma company.

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Emmes Employees Co-Author COVID-19 Vaccine Report for the New England Journal of Medicine | BioSpace

Three Emmes employees were among the co-authors of the recent report, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.” The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis.

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New Johns Hopkins Center Will Research COVID-19 Immunity – CBS Baltimore

ANNAPOLIS (WJZ) — A NIH initiative will fund a new Johns Hopkins center to research COVID-19 immunity as the pandemic continues to affect people of all ages.

The five-year grant will fund more than $2 million a year to the new Johns Hopkins Excellence in Pathogen to support the studies, to start immediately, the immune elements that determine whether people get mild or severe coronavirus after being exposed.

Image: https://baltimore.cbslocal.com – From Video

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Angel Funders Report 2020

Leverage the only verified source of angel investment data to anticipate future trends with the Angel Funders Report 2020!

The Angel Funders Report 2020 is the only source of verified data provided directly by active angel investing groups. The report is based on information collected from a variety of ACA member groups, including some of the most active investing communities. It analyzes angel capital investments made during 2019, and features profiles and insights from leading angel investors and startup company executives. The Angel Funders Report 2020 also includes initial perspectives regarding the impact of the COVID-19 pandemic on the investing ecosystem.

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



429th Edition, October 28, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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October 28, 2020












FOUNDING MEMBER OF



NexImmune CEO Scott Carmer joins Rich Bendis on BioTalk

Scott Carmer, CEO of NexImmune, joins BioTalk to discuss his career in the BioHealth Capital Region, recent Milestones, and his Long-Term Vision for the company

Listen now via Apple https://apple.co/3kxdC3J, Google https://bit.ly/31FlUPB, Spotify https://spoti.fi/3kuVszD, or TuneIN https://bit.ly/2TqqD3f

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BrainScope Wins BioHealth Capital Region 5th Annual Crab Trap Competition

– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

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Sirnaomics nabs a major $105M funding round for next stage of its RNA work | FierceBiotech

After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

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TruGenomix receives $100K from Google

What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

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Autonomous Therapeutics Press Release — MCEDC

Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

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New Emmes CEO talks expansion plans and Covid’s impact on R&D – Washington Business Journal

She said the Rockville research company is set to grow and details Covid’s larger impact on research.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

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Children’s National Hospital receives $5M from Boeing for Walter Reed campus – Washington Business Journal

It will support pediatric research at the health system.

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First Patient Dosed in Monalizumab Phase 3 Clinical Trial Triggers $50M Payment From AstraZeneca | BioSpace

MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

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BARDA Industry Day 2020

What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year, BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

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COVID-19 vaccine biotech Vaccitech nabs Pfizer, Kite vet as full-time CMO | FierceBiotech

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech’s headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

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Otolith Labs raising Series A to get medical device for vertigo to Food and Drug Administration – Washington Business Journal

The startup is now looking for a lead investor for its Series A round to fund the company’s go-to market roadmap.

Image: Sam Owen is founder and CEO of D.C.-based Otolith Labs ALEXANDRA WHITNEY PHOTOGRAPHY

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The Innovation Impact of U.S. Universities | Bush Center

America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

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On the Horizon: New Communities of Innovation; Billions of Dollars of New Investment

By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

Download the PDF

 

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The Global Startup Ecosystem Report – GSER 2020

A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

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Digital Health Report – Q4 2020 | Wilson Sonsini Goodrich & Rosati – JDSupra

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

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Is Alexandria Real Estate Equities a Millionaire-Maker REIT? | Millionacres

Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500’s 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.

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Johns Hopkins No. 10 in ‘U.S. News’ Best Global University rankings | Hub

Johns Hopkins moved up a spot to No. 10 in the annual U.S. News & World Report Best Global University Rankings released today, a year after moving up to No. 11 from No. 12 in the 2020 rankings.

Johns Hopkins also ranks among the top 10 universities in the world in 15 subject areas and among the top 20 in 19 subject areas. Ten new subject area rankings were added to the list this year, bringing the total to 38.

Image: https://hub.jhu.edu

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Venture Capital Giant NEA Is Said to Explore Minority Stake Sale – Bloomberg

New Enterprise Associates Inc., one of the world’s largest venture capital firms, is in talks to sell a minority stake in itself, according to people with knowledge of the matter.

The Silicon Valley firm has held discussions with several potential investors, said the people, who requested anonymity because the talks are private. No deal has been reached, and it’s possible one won’t materialize. Representatives for NEA didn’t immediately respond to requests for comment.

Image: NEA’s Scott Sandell Photographer: David Paul Morris/Bloomberg

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FDA Coronavirus Meeting Focuses on Vaccine Safety | Barron’s

In a long-awaited meeting on America’s crash program to deliver vaccines against the Covid-19 coronavirus, leaders of the program reviewed the measures they have taken to assure the effectiveness and safety of the vaccines. The U.S. Food and Drug Administration convened a panel of independent vaccine experts to ask questions during the Thursday online session. The meeting was designed to reassure the public on the integrity and transparency of the FDA’s vaccine oversight, as the agency has wrestled with political pressure and pockets of public vaccine hesitancy.

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Brexit White Paper

Introduction

The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law.

From 1st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.

Negotiations between the EU and UK are still ongoing to define the future relationship and with only a matter of months left before the end of the transition period there has been no formal agreement. For the pharmaceutical industry this presents numerous challenges as companies prepare to continue supply of medicines that comply with new legislation. The preferred outcome for many within the industry will be to implement a mutual recognition agreement for areas such as GMP certification, batch testing, etc. between the UK and EU. It is unclear at this stage if an encompassing mutual recognition agreement is achievable so all involved parties should be preparing for a ‘no deal’ scenario and review existing guidance to understand risk exposure and mitigating actions.

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DOD Announces $87.5 Million for New Bioindustrial Manufacturing USA Institute – ASME

Last week, the Department of Defense (DOD) announced a seven-year award of $87 million for a new Manufacturing USA institute: BioMADE. The BioIndustrial Manufacturing and Design Ecosystem (BioMADE) institute joins a network of 8 other DOD institutes, making for a total of 16 institutes supported across the federal government in the Manufacturing USA program. ASME has been a long-time supporter and advocate of the Manufacturing USA program.

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The 2020 State New Economy Index | ITIF

Different geographies and jurisdictions play different roles in the global economy. Some specialize in what economists call “seedbed” functions—generating new products and firms, often through cutting-edge innovation. Others specialize in corporate functions by offering attractive environments for company headquarters or other management activities. Still others specialize in more routine production functions for goods or services, handling aspects of the work that involve less innovation and have lower skill requirements. Finally, some regions specialize in resource production tied to geographical endowments, such as minerals, arable land, or lumber.

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TBJ Plus: Blueprint for economic recovery beyond Raleigh, Durham; Film crews return to NC; Wait times for voting in Wake County – Triangle Business Journal

BLUEPRINT FOR ECONOMIC RECOVERY BEYOND THE TRIANGLE: Most experts agree Raleigh and Durham are well positioned for a strong recovery from the pandemic, but what about the areas well beyond the Triangle’s core?

A new report released Wednesday from RTI International is meant to address that very question. The Innovation Corridor Blueprintincludes 12 areas of focus for leaders and stakeholders to tackle in a 100-mile radius around the Triangle. Topics range from digital infrastructure and affordable housing to biohealth technology and addressing systemic racism.

Image: An illustration of the Raleigh-Durham skylines. SEANPAVONEPHOTO

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



428th Edition, October 21, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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October 21, 2020












FOUNDING MEMBER OF



6th Annual “Virtual” BioHealth Capital Region Forum Recap

Recordings of Keynotes, Panels and the Fireside Chat Available Online

The 6th Annual BioHealth Capital Region (BHCR) Forum like many events in 2020, went virtual this year with over 1,200 online registrants and 59 speakers coming together. The Forum, which has been held at AstraZeneca (Formerly MedImmune) since 2014 in Gaithersburg, MD, brought together the BioHealth Industry with a full slate featuring leaders of industry, academia, and government. The common message throughout the entire agenda was how this region has continued to operate and innovate while working to help the world solve the COVID-19 Pandemic.

The 2020 Crab Trap Competition, typically held during the Forum, will take place at Noon on October 21st. The Crab Trap focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and BioHealth cyber security. This years’ finalists include BrainScope, CARRTECH, Creative Bio-Peptides, innara HEALTH, and KaloCyte.

The entire 6th Annual BioHealth Capital Region is currently available by visiting https://eventmobi.com/biohealth2020.

NOTE: If you haven’t already registered, please enter your information for immediate access. Click on the “Agenda” line to browser all the videos now available.

 

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Annual BioHealth Capital Region Forum Showcases Robust Growth Across 4th Largest Biopharma Cluster · BioBuzz

The Sixth Annual BioHealth Capital Region Forum brought together industry leaders from across the region who discussed the accomplishments and strengths of the region as its member companies continue to innovate new therapies and medicines in one of the strongest bio-hub regions in the United States.

The forum, which drew more than 1,100 registrants and included 59 world-class speakers and panelists, had a different look this year due to the ongoing COVID-19 pandemic. Instead of gathering together in the heart of the BioHealth Capital Region at AstraZeneca’s Gaithersburg facility, the forum was held virtually. The event offered multiple panels and keynotes that highlighted advancements made in the region across several areas, including cell and gene therapies, the use of artificial intelligence and the ongoing battle against COVID-19.

Image: https://biobuzz.io

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BioHealth Innovation Appoints Sally Allain, Joseph F. Sanchez, PhD, and Robert Silverman to Board of Directors

New Members Continue BHI’s Commitment and Mission in the BioHealth Capital Region

ROCKVILLE, MARYLAND, October 20, 2020 The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of three new board members, Sally Allain, Head of JLABS @ Washington, DC, Joseph F. Sanchez, PhD, Director, Science Engagement, R&D North America, AstraZeneca, and Robert Silverman, Chief Business Officer, Alloy Therapeutics, Inc. BHI’s leadership also thanked outgoing Board of Director member Tracey Vetterick, formally of AstraZeneca for her contributions to the organization and support of many years.

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Montgomery County Executive Marc Elrich joins Rich Bendis on BioTalk

Montgomery County Executive Marc Elrich joins BioTalk to discuss his Career Path, the BioHealth Industry and plans to support the Industry in MoCo.

Listen now on Apple https://apple.co/37dYS5Z, Google https://bit.ly/2IC4eOp, Spotify https://spoti.fi/2IDpN11, TuneIn https://bit.ly/31cjHuZ, and YouTube (Audio) https://bit.ly/31bsiho.

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Justin Yang, Biomedical Advanced Research and Development Authority (BARDA) Director of the DRIVe Catalyst Office, Joins Rich Bendis on BioTalk

BARDA Director of the DRIVe Catalyst Office, Justin Yang, Joins BioTalk to share how BARDA collaborates with the BioHealth Industry, partners with Incubators, and helps fund innovation.

Listen now via Apple https://apple.co/3dqDyLH, Google https://bit.ly/3jZyeRU, Spotify https://spoti.fi/34YL9xg, and TuneIn https://bit.ly/3k1uM9x.

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Maryland companies raked in $256 million in venture capital in 3Q – Baltimore Business Journal

Maryland is on pace to see its second-largest funding year ever.

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AstraZeneca receives $486M in U.S. funding to advance Covid-19 antibody treatment – Philadelphia Business Journal

The U.S. government is providing roughly $486 million to AstraZeneca to accelerate the Big Pharma company’s experimental Covid-19 therapy.

The funds will be used to advance AstraZeneca’s antibody combination, AZD7442, into two phase-III clinical trials. The last-stage studies, expected to begin later this month or early next month, will involve more than 6,000 study participants at sites in and outside the United States. (Phase-III clinical trials are typically the last hurdle a pharmaceutical company must successfully clear before seeking approval for a new drug candidate.)

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Adaptive Phage Therapeutics gets FDA green light to advance superbug therapy, as COVID-19 ‘underscores the critical need’ – Washington Business Journal

Adaptive Phage Therapeutics can take its therapy for superbugs to human trials.

Image: Dr. Carl Merril, third from right, with his son Greg, CEO and co-founder of Adaptive Phage Therapeutics, and other members of the team. ADAPTIVE PHAGE THERAPEUTICS INC.

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Paula Sorrell leads George Mason University entrepreneurship – Washington Business Journal

She aims to have a big presence in the local business community.

Image: Paula Sorrell is the new associate vice president of innovation and economic development at George Mason University. GEORGE MASON UNIVERSITY

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FDA Veteran Outlines Plans to Increase Diversity in Medtech Industry

What is MedTech Color?

MedTech Color is a non-profit organization focused on ensuring people of color enter, remain, and flourish in the medtech industry. There is immense untapped potential from people of color, and we’re committed to providing and promoting opportunities for them to make a meaningful contribution to the industry.

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FDA Commissioner Says Panel Must Review COVID Vaccine

JOHN WHYTE: You’re watching “Coronavirus in Context.” I’m Dr. John Whyte, chief medical officer at WebMD. Today I’m joined by Dr. Stephen Hahn. He’s the commissioner of the US Food and Drug Administration. Dr. Hahn, thanks for joining me.

STEPHEN M HAHN: John, thank you. Really appreciate the opportunity, and it’s great to be part of this webcast.

Image: Stephen M. Hahn M.D.

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VC investment shows no signs of a pandemic slowdown – Technical.ly Baltimore

VC investment dollars hit a seven-quarter high in the U.S. in the third quarter of 2020: A total of $36.5 billion was invested in U.S. tech and healthcare companies, according to data from the MoneyTree Report by PwC/CB Insights. That’s up 30% from the second quarter. The total number of deals rose to 1,461 investments in companies, up 1% over the prior quarter.

It’s the second straight quarter of growth, indicating that a slowdown toward the end of March as the pandemic set in didn’t become the norm.

“Things are still going gangbusters,” said Brad Phillips, a director in PwC’s Emerging Company Services practice. “It’s been a relief for a lot of people that were in the market and just didn’t know what was going to happen.”

Image: Whitebox’s Baltimore team inside its Curtis Bay HQ. (Courtesy photo)

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5 Questions with Martha Schoonmaker, Executive Director, Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC) · BioBuzz

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions Martha Schoonmaker, Executive Director, Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC).

Martha Schoonmaker is the first Executive Director for the PIC MC Foundation, the entity that develops, manages, and markets the Germantown campus on behalf of Montgomery College for company locations. PIC MC is an integrated academic, business, and research campus and is the only community college with a hospital, Holy Cross Germantown Hospital, located as the anchor resident partner.

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Investor leaves TEDCO to launch RareBreed, a Baltimore-based early-stage venture fund – Baltimore Business Journal

Mac Conwell hopes to raise an initial fund worth about $10 million for his new investment firm RareBreed Ventures.

Image: McKeever “Mac” Conwell, a local entrepreneur and investor, has launched his own venture fund called RareBreed Ventures. KAITLIN NEWMAN FOR BBJ

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2020 BHCR Forum – BioHealth Capital Region

This event is free for biotech leaders is presented by BioHealth Innovation, VirginiaBio, Children’s National Health System, Deloitte, JLABS @ Washington D.C., Johns Hopkins University, Maryland Department of Commerce, Quality Biologics, George Mason University, University System of Maryland and AstraZeneca. Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Please join us for our Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

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Palo Alto office shopping spree tops $850 million

PALO ALTO — A big Southern California real estate and investment firm has gobbled up its latest in a string of Palo Alto office property purchases, a deal that extends a buying spree in the Silicon Valley tech hub that now tops $850 million.

Alexandria Real Estate, acting through an affiliate, has bought two Palo Alto office buildings on Hillview Avenue near Arastradero Road, acquiring a site that’s in the famed Stanford Research Park.

The deal suggests investors still seek to collect commercial properties in choice and prestigious locations despite the economic uncertainties that the coronavirus has triggered.

Image: https://www.mercurynews.com

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2020 BioHealth Capital Region Virtual Forum & Crab Trap Competition Registration, Mon, Oct 19, 2020 at 8:00 AM | Eventbrite

Thank you for your interest in the 6th Annual BioHealth Capital Region Forum on Monday, October 19, 2020 that will highlight the accomplishments of today and chart our successes of tomorrow.

We are thrilled to welcome executive-level biohealth industry leaders from across the country and overseas. To make the best use of your time and enable you to network with our 1000+ registrants and learn from the 58+ industry speakers, please use the instructions below to join our virtual event platform, https://eventmobi.com/biohealth2020

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QuickFire Challenge Awardees Recognized at HLTH VRTL 2020 – News | JLABS

October 14, 2020 – Johnson & Johnson Innovation announced today at the virtual 2020 HLTH conference the awardees for the JLABS @ Washington, DC Children’s, Maternal Health, and Diversity in Innovation QuickFire Challenges, which respectively aimed to catalyze pediatric innovation, improve maternal health in the United States, and support diverse innovators. These challenges embody Johnson & Johnson Innovation’s commitment to catalyzing potential solutions to today’s greatest healthcare challenges.

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Eight Innovative, Virginia Life Science Startups to Know · BioBuzz

At BioBuzz, we’re dedicated to bringing you interesting and important stories that emerge from the thriving life sciences ecosystem that is the BioHealth Capital Region (BHCR).

The heart of the BHCR biohealth cluster is Maryland, with its vast network of government research agencies, the strong university system, and a deep network of established, emerging, and startup life science companies across a wide range of fields, including cell and gene therapy, advanced biomanufacturing, phage therapy, medical devices and more traditional biotech and pharma organizations. That’s not even to mention the remarkable efforts of myriad Maryland vaccine companies to develop the first approved, safe, and efficacious SARS-CoV-2 vaccine.

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The Washington Post Announces Top Workplace Rankings | Emmes

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, and the process is based on a scientific survey of employees who rate their workplace culture.

The Post’s annual survey honored 200 organizations as Top Workplaces. Emmes was selected in the large company category, which included organizations with between 500 and 999 employees. More than 3,600 area companies were invited to have their employees take the survey.

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citybizlist : Washington DC : Need Startup Funding? Here Are 65 Venture Capital Firms in the Baltimore-DC Region

If you’re located in New York City or the Silicon Valley, venture capital firms are abundant and well covered by the media — you can’t escape them. But entrepreneurs in the Baltimore-D.C. region don’t need to go so far to find a firm that could propel their startup to growth.

The local venture capital community is robust, with dozens of firms that invest in all sorts of industries, from healthcare to fintech to cybersecurity. And it’s part of the reason that in 2016, approximately $1.09 billion was invested in local high-tech startups by VC firms, placing the region in the top 10 funded clusters in the U.S.

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Trump Administration Expands Collaboration With AstraZeneca to Develop and Manufacture an Investigational Monoclonal Antibody to Prevent COVID-19 > U.S. DEPARTMENT OF DEFENSE > Release

To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) today announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent infection with SARS-CoV-2, the coronavirus that causes COVID-19.

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Can culture and community drive success? – Research & Development World

Not every research project succeeds. And not every company survives. However, the ones that align with the culture of winning and sign up and adopt the community charter are opting in for a much higher chance of disrupting their industry and changing the rules of the game.

So, you are probably thinking it’s not important, right?

But it is… At the Virginia Tech Corporate Research Center, we have the unique ability to witness effective project teams daily. With over 200 companies creating breakthroughs from nanomaterials to self-driving vehicles, we have a ready-made ‘team laboratory’ to understand what works and how to scale.

Image: Brett Malone, Ph.D., President & CEO Virginia Tech Corporate Research Center

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



427th Edition, October 13, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


October 12, 2020












FOUNDING MEMBER OF



MCEDC President and CEO Benjamin Wu joins BioTalk to discuss all things Montgomery County, Economic Development, and the BioHealth Industry

Montgomery County Economic Development Corporation (MCEDC)  President and CEO  Benjamin Wu Chats with Rich Bendis on BioTalk.

Listen now Apple https://apple.co/2SJB2a5, Google https://bit.ly/2SMLbmd, Spotify https://spoti.fi/34SWcrIhttps://bit.ly/2SMde5j, and YouTube Audio https://bit.ly/2GSHXeu

As the President and Chief Executive Officer of MCEDC, Ben Wu leads the public-private economic development of Maryland’s largest jurisdiction which comprises 25% of the state’s economy with a GDP greater than 13 states. A Montgomery County native, Ben is an accomplished executive with over three decades of professional experience leading operations at the highest levels of our nation and state.

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6th Annual BioHealth Capital Region Forum (Oct 19th, 2020) (REGISTER NOW!)

Join fellow biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of more than 55 BioHealth Capital Region industry leaders to this virtual event!

 

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Life Sciences Go Viral in Maryland

When Maryland Gov. Larry Hogan visited Novavax recently, President and CEO Stanley C. Erck shared some welcome news for the governor publicly: Novavax had more than doubled its workforce so far this year, adding 116 people to the 100 that it employed at the start of 2020.

“The plan is to double that again, to add another 200 in the coming six months just in the U.S.,” Erck said, part of an expansion plan by Novavax to grow its workforce to 1,000 people worldwide. Novavax recently expanded into a third building at its Gaithersburg, MD, headquarters, and is also in talks for an additional 200,000 square feet of lab space locally.

Image: Maryland Gov. Larry Hogan (2d from left) chats with Gale Smith, PhD, Novavax Discovery and Preclinical Research and Chief Scientist, during a tour of the company’s Gaithersburg, MD, facilities. (Office of Governor Larry Hogan)

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First Patient Dosed in NexImmune Phase 1/2 Clinical Trial of NEXI-002 in Multiple Myeloma

GAITHERSBURG, MD — October 6, 2020 – NexImmune, a clinical-stage biotechnology company developing a portfolio of unique non-genetically-engineered T cell immunotherapies, announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology.

“While the primary objective in this trial with NEXI-002 is to demonstrate safety and tolerability, we also hope to see initial signs of immunological and clinical activity,” said Han Myint, MD, Chief Medical Officer at NexImmune. “The AIM technology gives us the unique ability to direct populations of natural T cells against a powerful combination of cell surface and endogenous anti-tumor targets specific to multiple myeloma. We believe this approach has potential to address primary tumor escape mechanisms, and provide deep and durable clinical responses.”

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FDA Grants GlycoMimetics Rare Pediatric Disease Designation for Rivipansel for Treatment of Sickle Cell Disease – BioHealth Capital Region

ROCKVILLE, Md.–(BUSINESS WIRE)–Oct. 5, 2020– GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.

“The FDA’s designation recognizes the morbidity and mortality burdens of sickle cell disease as well as its significant impact during childhood with life-long implications. With this designation, the agency acknowledges the urgent need for improved treatment of children living with sickle cell disease,” stated Helen Thackray, Chief Medical Officer of GlycoMimetics.

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Pipeline – Immunomic Therapeutics

Our allergy assets remain an underpinning of Immunomic Therapeutics’ success, and have enabled our pivot to focus on oncology.

In addition to our canine atopic dermatitis vaccine concept, our vaccines using ITI’s lysosomal targeting technology have already been tested in several clinical studies in both allergy and oncology.

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Baltimore venture capital firm Catalio Capital Management closes $100M fund – Baltimore Business Journal

Catalio’s portfolio includes many notable local biotech companies, including Personal Genome Diagnostics Inc. and Thrive Earlier Detection Corp.

Image: George Petrocheilos (right) and R. Jacob Vogelstein are the managing partners of venture investment fund Catalio Capital Management LP. MARK DENNIS – https://www.bizjournals.com

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Qiagen to Complement COVID-19 Testing Portfolio with Novel Kit That Simplifies and Accelerates PCR Analysis for Research – COVID-19 – Hospimedica.com

QIAGEN N.V. (Venlo, Netherlands) plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.

QIAGEN’s innovative QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. The kit, which uses the most common transport media such as Universal Transport Media (UTMTM) as the starting material, includes both sample extraction components and optimized PCR reagents for only one procedure.

Image: QIAprep& Viral RNA UM Kit (Photo courtesy of QIAGEN N.V.)

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How This Med Tech Startup Pivoted to Fight the Pandemic

Across the world in 2019, UNICEF reports that over 2.4 million infants died in their first month of life, the vast majority in the developing world. 

The situation in sub-Saharan Africa is particularly dire: an infant born in that region is 10 times more likely to die during its first month of life than a child born in a high-income country. Most of these deaths are preventable. 

It was statistics like these that inspired biomedical engineers Sona Shah and Teresa Cauvel to found Neopenda in 2015.

Neopenda, a Cisco social entrepreneurship prize winner, is a social enterprise that develops innovative technologies for health systems in underserved populations. 

 

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Children’s National Hospital earns 2020 CHIME Digital Health Most Wired recognition | Children’s National Hospital

Children’s National Hospital has received 2020 Digital Health Most Wired recognition by The College of Healthcare Information Management Executives (CHIME) as a certified level eight. The CHIME Digital Health Most Wired program conducts an annual survey to assess how effectively health care organizations apply core and advanced technologies into their clinical and business programs to improve health and care in their communities.

“Children’s National is honored to receive the Most Wired recognition for our inpatient and ambulatory venues,” said Matt MacVey, vice president and chief information officer at Children’s National. “We have made substantial investments in technology in support of our mission to provide a high-quality experience and optimal health outcomes for children regionally, nationally and internationally.”

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The unsung mapmakers | Hub

In the early days of managing the Johns Hopkins COVID-19 dashboard, experts at the university and those at Esri, the company providing the mapping software for the real-time pandemic tracker, had a friendly rivalry.

“They would tell us, ‘Oh, your COVID map is big, but not as big as our Pokémon Go map,’ which was their most in demand,” says Reina Murray, an application administrator at JHU’s Sheridan Libraries.

By March, the volume of web traffic to the Hopkins map effectively shut down that conversation—the Hopkins dashboard now holds the record as Esri’s highest-used service of all time, drawing hundreds of millions of feature requests every day. At a peak in March, the dashboard saw 4.56 billion feature requests.

Image: https://hub.jhu.edu/

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This Maryland program will pair cyber researchers and entrepreneurial grad students to form startups – Technical.ly Baltimore

Maryland universities are home to lots of cyber researchers and technologists working on new ways to secure our increasingly technology-reliant society. Those higher education institutions are also home to graduate students looking for an entrepreneurial leap.

A new program is looking to connect the two, and form new startups in the process.

The Maryland New Venture Fellowship for Cybersecurity, created by University of Maryland, Baltimore County incubator bwtech@UMBC and the University System of Maryland, is launching this fall to support 10 early-stage teams. The program was recently awarded $594,000 in federal funds from the Economic Development Administration of the United States Department of Commerce. With matching funds from Baltimore County, the total funding reaches about $1.3 million.

Image: Welcome to bwtech@UMBC. – Courtesy Photo

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Propelling TRADE AND INNOVATION BETWEEN QUÉBEC AND MARYLAND in life sciences and public health (October 15, 2020 – 2:30 p.m.)

You are invited to continue strengthening the Québec-Maryland collaboration!

Objectives of this webinar

  • Highlight the signing of the cooperation agreement between Québec and Maryland in the field of life sciences and public health and launch the work of the advisory committee.
  • Share the government’s vision for life sciences and public health, particularly in the context of a health emergency.
  • Create links, strengthen cooperation and mutually inspire each other with the most innovative expertise and initiatives aimed at establishing joint alliances in a sector of excellence.

Introductory remarks

Québec Delegate General in New York, Catherine Loubier

Schedule

The importance of the life sciences sector for Québec and the State of Maryland

Minister of International Relations and La Francophonie, and Minister of Immigration, Francization and Integration, Nadine Girault

Secretary of Commerce for the State of Maryland, Kelly Schulz

Québec-Maryland collaboration agreement in life sciences and public health

Montréal’s life sciences ecosystem

CEO of Montréal In Vivo, Frank Béraud

Québec City’s life sciences ecosystem

CEO of Québec International, Carl Viel

Maryland’s life sciences and public health ecosystem

Director of BioHealth and Life Sciences, Maryland Department of Commerce, Ulyana Desiderio

Q&A with the panelists

Register here

https://us02web.zoom.us/webinar/register/WN_ozdJpKpXSMC9n0Esrqo-rA

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Covid-19 drives historic demand for life sciences real estate

All the fundamentals are aligning for the life sciences industry, as Covid-19 accelerates already growing demand for real estate in the sector.

Rents are rising for lab space, vacancies are plunging and research and development, and employment and new development are expanding further, thanks to strong venture capital investment.

In the top life sciences markets there’s currently about 13.9 million square feet of space under construction, but active tenant demand is outpacing that, running at about 14.7 million square feet, according to a new report from CBRE. Lab-space vacancy is historically low at less than 8% percent in most top life sciences markets, pushing rents higher.

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Amytrx Enrolling Clinical Trial of AMTX-100 in Patients with Atopic Dermatitis

08 October 2020

Germantown, MD, USA (October 08, 2020) – Amarex Clinical Research, LLC, an NSF International company client, Amytrx Therapeutics (“Amytrx”), recently initiated clinical testing of their anti-inflammatory therapeutic product AMTX-100 for dermatological diseases and conditions with the enrollment of patients in a first-in-man Phase 1/2b study for treatment of mild to moderate atopic dermatitis. Amarex wrote and submitted the IND application for Amytrx and is now managing the clinical trial.

Preclinical safety studies in the IND cover several other inflammatory skin conditions including psoriasis, rosacea, acne, herpes type 1 and 2, and shingles.

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VIRTUAL INVESTORS’ CONFERENCE ON BIOHEALTH (November 18, 2020)

IMN’s Virtual Investors’ Conference on BioHealth, taking place November 18, will provide a platform to understand the intersection of securitization across the biotech and healthcare sector, helping educate investors, borrowers and industry participants on the hottest new asset class in equity capital markets. This one-day virtual conference will focus on both on European and U.S. opportunities and challenges, as regulatory challenges will be forefront on both sides of the globe. 

BioHealth issuance in 2020 has now surpassed $60 billion globally, spurring this asset class to become the second most popular equity capital markets sector, with momentum driven by huge secondary moves and companies benefitting from a greater focus on healthcare investing that Covid-19 has generated.  

Join this must-attend gathering to engage with hedge funds, institutional investors, and more, to discover exciting new investment opportunities as this sector expands to comply with policy, market demand and changing consumer needs.

 

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2020
All Rights Reserved.



426th Edition, October 6, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


October 6, 2020












FOUNDING MEMBER OF



Jeff Galvin, CEO and Founder of American Gene Technologies (AGT), Returns to BioTalk with Rich Bendis

American Gene Technologies International Inc. (AGT) CEO and Founder, Jeff Galvin returns to update us of their Phase 1 Clinical Trial of their lead #HIV Program, their expansion in a new facility, and what’s next!

Listen now on Apple https://apple.co/2Gi2GIF, Google https://bit.ly/2GizVvu, Spotify https://spoti.fi/2GxROGd, and TuneIn https://bit.ly/3l9HK56.

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BHCR takes 4th Place out of 29 teams at its first time at the FRAXA Biotech Games

The BioHealth Capital Region was represented for the first time at the FRAXA Biotech Games and took home FOURTH PLACE! This national competition is hosted annually by the FRAXA Research Foundation to raise funds and awareness for Fragile X research. Fragile X is the most common inherited cause of autism and intellectual disabilities. The BioHealth Capital Region was represented by BioHealth Innovation team members Ashwin Kulkarni, Rini Pek, Salman Hasan, and Delphine Lissa. BHI’s CEO Rich Bendis proudly stated “The BioHealth Capital Region cluster ranks 4th in Genetic Engineering News and now in the FRAXA games thanks to our crack team of analysts. Going forward, we’re looking to move up in both ranking!.”

 

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6th Annual BioHealth Capital Region Forum (Oct 19th, 2020) (REGISTER NOW!)

Join fellow biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

 

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BioHealth Capital Region Investor Forum (Virtual on October 20th and 21st.)

The BioHealth Capital Region Investor Forum is going Virtual on October 20th and 21st. Contact BHI at BHI@BioHealthInnovation.org to apply to be a Company or Investor at this invite-only event.

 

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SBIR Virtual Office Hours

Are you and early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Learn more about whether or not federal or state non-dilutive funding makes sense for you. Discuss potential strategies for success. Sign up for a free 1:1 advice and feedback regarding non-dilutive funding strategy and applications with BHI staff who have helped companies secured SBIR, STTR and other awards—at twice the national average win rate.   This program is open to anyone, though scheduling priority is given to Montgomery County companies, courtesy support from MCEDC.

Click here to schedule a time.

 

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Aziyo Biologics sets IPO terms, taps new execs and board members – Washington Business Journal

The Silver Spring company first filed in mid-September to trade on the Nasdaq stock exchange.

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Timing ‘couldn’t be better’ for scaling Innara Health’s solution for preemies, CEO says

One of Kansas City’s most under the radar startups is scaling up amid COVID-19 — thanks in part to a share of $250 thousand in non-dilutive funding from a Los Angeles-based accelerator and FDA sponsored pediatric device consortia.

“When COVID hit, one of the things I took from that was, ‘When you’re not selling, your process better be impeccable,’” said Chris Mathia, CEO of Innara Health, the healthtech startup behind the NTrainer — the only FDA approved solution for improving oral coordination in premature babies. 

Image: Chris Mathia, Innara Health

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Prestigious national pediatric medical device competition announces six winners to share in $250K NCC-PDI grant funding

WASHINGTON, Sept. 30, 2020 /PRNewswire/ — The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces six awardees chosen in its annual “Make Your Medical Device Pitch for Kids!” competition to share in $250,000 in grants funded by the Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. The competition, powered by NCC-PDI partner MedTech Innovator, focused on cardiovascular, NICU, and orthopaedic and spine devices, which are areas of critical need where innovation can significantly improve children’s healthcare. The virtual event aired today as part of the 8th Annual Pediatric Device Innovation Symposium presented by Children’s National Hospital in conjunction with The MedTech Conference, powered by AdvaMed.

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Vaccine Work Boosts Montgomery County Life Sciences Demand, Outpacing Available Space

The vaccine-related activity is creating more demand for lab space in an already tight market, further reducing vacancy rates and driving up rents. This dynamic is leading developers to consider breaking ground on spec and converting vacant office buildings to lab space, multiple experts said Thursday on Bisnow’s Life Science Surge webinar.

Image: Courtesy of HFF The GSK Global Vaccine Center in Rockville

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10 International Vaccine Influencers Who Exemplify Maryland’s Leading Role in Public Health · BioBuzz

The state of Maryland is the global epicenter of vaccine research and development. This has never been more evident than right now as scores of Maryland companies have risen to the global challenge of developing the first approved vaccine for SARS-CoV-2.

We’ve written extensively about the region’s push to develop a viable, effective and safe COVID-19 vaccine. Companies like Novavax, Emergent BioSolutions and Altimmune are on the leading edge with some of the most promising COVID-19 Vaccine candidates progressing through clinicals. While Maryland as a global vaccine R&D juggernaut might be news to those outside of the region, Maryland’s life science ecosystem has been a leading vaccine R&D hub for years.

Image: https://biobuzz-io.cdn.ampproject.org

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5 Questions with Amy Adams, Executive Director of the Institute for Biohealth Innovation at George Mason University · BioBuzz

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Amy Adams, Executive Director of the Institute for Biohealth Innovation at George Mason University.

As Executive Director of the Institute for Biohealth Innovation at George Mason University, Amy Adams is responsible for nurturing and advancing biohealth research and innovation interests of more than 250 faculty and thousands of students who represent a broad range of academic disciplines. Her role includes fostering partnerships with industry, healthcare, government, and academic partners.

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Shape Theranostics Releases Initial Data Showing Potentially More Effective Method to ID and Inactivate COVID-19

Drug- and vaccine-based methods of attacking the SARS-CoV-2 virus rely on chemical properties to identify the virus (for example surface antigens). These chemical properties can change when the virus mutates, rendering those therapies ineffective. An alternative method for identifying the virus would be to use the physical properties (size, shape, rigidity) of the viral capsule (capsid). These capsid properties make the virus easy to recognize with a microscope. Without an intact capsid, the virus cannot survive in the body. Shape Theranostics is trying to use microscopic iron devices that will take advantage of the unique physical properties of the viral capsid to identify and inactivate the virus.

In a newly published work supported by the U.S. National Institute for Aging, Shape Theranostics scientists (working with investigators at Georgetown University) showed that the micro-devices can change MRI signals in a way that depends on viral load. These signals enabled quantitative measurement of the SARS-CoV-2 in physiological solutions. The amount of iron in these investigational products would be less than for off-the-shelf oral iron supplements. Initial preclinical studies demonstrated no toxicity from the micro-devices. The publication (IEEE Engineering in Medicine and Biology) can be downloaded from www.ShapeTheranostics.com.

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NIST Announces New Round of SBIR Efforts; Mojdeh Bahar Quoted – Executive Gov

The National Institute of Standards and Technology (NIST) has selected 19 small businesses to develop new technologies through grants totaling over $4.4 million in value. The awardees will address various technology needs under phases one and two of the agency’s Small Business Innovation Research (SBIR) program, NIST said Thursday.

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NCATS Awards Palantir Technologies Inc. $36M Contract to Support its Secure Scientific Platforms Environment | Business Wire

DENVER–(BUSINESS WIRE)–Palantir Technologies Inc. (NYSE:PLTR) announced today that it was awarded a $36m one-year indefinite delivery, indefinite quantity (IDIQ) contract with the National Center for Advancing Translational Sciences (NCATS) for enterprise data integration and data management to support the NCATS Secure Scientific Platforms Environment.

Palantir’s Foundry software will be provided in various configurations to the NCATS Secure Scientific Platforms Environment, which supports several critical health missions through the integration, management, security, and analysis of any kind of scientific data, and provides controlled access to internal and external collaborators.

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Alexandria Real Estate Equities, Inc. Achieves the First-Ever Fitwel Viral Response Certification With Distinction and Announces Strategic Partnership With Fitwel to Elevate Health, Wellness and Safety in Laboratory Buildings

PASADENA, Calif., Oct. 1, 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 that it has been recognized by the Center for Active Design (CfAD), the operator of Fitwel®, as the first-ever company to achieve a Fitwel Viral Response Certification with Distinction, the highest certification level within the Fitwel Viral Response module. Alexandria’s comprehensive and industry-leading COVID-19 prevention guidelines and practices, which expand upon its existing rigorous health and safety standards for its tenants, employees, visitors, service providers and key industry stakeholders, contributed to this highly impactful and tremendous accomplishment.

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Johns Hopkins receives grant to study COVID-19, transgender persons | State | heraldmailmedia.com

BALTIMORE — Johns Hopkins University is getting a $1.44 million federal grant to study potential COVID-19 testing gaps and disparities for transgender persons.

The grant is from the National Institute of Allergy and Infectious Diseases. The COVID, transgender research funding was announced by U.S. Sens. Ben Cardin and Chris Van Hollen and U.S. Reps. Dutch Ruppersberger, John Sarbanes and Kweisi Mfume. They are all Maryland Democrats.

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USM Maryland Momentum Fund invests $300,000 in N5 Sensors – USM

Baltimore, Md. (Sept. 30, 2020)—The Maryland Momentum Fund has invested $300,000 in Rockville-based N5 Sensors Inc., a company developing smart, microscale, wearable sensors to detect gas, chemicals and additional environmental conditions for a variety of applications, fund officials announced today.

The investment completes a financing round of more than $1 million for the company and includes funding from Blu Venture Investors.

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Family Ties Run Deep at These Five Life Science Companies · BioBuzz

Whether it’s “Mom and Pop” retail storefronts, family-run services companies or life science companies developing innovative, life saving products, family owned-and-operated businesses are the lifeblood of the global economy.

According to Cornell University’s SC Johnson School of Business, “There are 5.5 million family businesses in the US. (FEUSA, 2011) Family-owned businesses contribute 57% of the U.S. GDP (that’s $8.3 trillion), employ 63% of the workforce (FEUSA, 2011), and are responsible for 78% of all new job creation. (Astrachan & Shanker, 2003) 35% of Fortune 500 companies are family-controlled. (Businessweek.com, 2006).”

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MD BioManufacturing Companies Appy Now to Receive Up to $20K in Engineering Services

Marylad biomanufacturing companies can receive up to $20,000 in free energy engineering services, potentially saving hundreds of thousands of dollars a result while increasing productivity and workplace safety and comfort. These services are provided thru a grant program managed by the Maryland Regional Manufacturing Institute’s (RMI) Energy Edge Program. Companies should email Stacey@RMIofMaryland.com for an application and more information.

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Nurse Innovators: Submit ideas to improve COVID-19 patient care

The power of nurse-led innovation and know-how is more critical than ever when developing potential solutions amid a global crisis. With extensive patient experience, nurses’ ideas have the potential to profoundly improve human health.

Time is running out for nurses to submit ideas that aim to profoundly transform COVID-19 patient care in the Johnson & Johnson Nurses Innovate QuickFire Challenge: COVID-19 Patient Care in partnership with the American Organization for Nursing Leadership (AONL) and the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders (SONSIEL).

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Hopkins introduces SMILE, a new platform for finding remote and in-person jobs and internships | Hub

Johns Hopkins has consolidated the university’s job and internship postings onto a single website, SMILE, a new platform for finding remote and in-person experiential learning opportunities across all JHU divisions.

All positions posted on SMILE are non-credit bearing, compensated via JHU payroll, and part time. Students will continue to use the existing Handshake platform for off-campus internships and full-time positions.

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Post-Doc in Systems Immunology and/or Bioinformatics

Charlottesville-based AMPEL BioSolutions currently has an opening in its rigorous two-year postdoctoral program that trains PhD to be competitive applicants for Scientist positions in Pharma/Biotech, the NIH and universities. PostDoc positions are located in: Systems Immunology, Bioinformatics, Machine Learning or a combination of these fields. Publication and grant writing are essential components of the training period. AMPEL has a hybrid environment of remote and in-office personnel. High-caliber work suitable for presentation at scientific meetings and/or publication in the peer-reviewed literature is expected. Successful applicants will possess excellent organizational skills, the ability to think critically, prowess in written and oral communication, and the initiative to work proactively in a collaborative environment. The company has successfully implemented this program during the past few years with several postdocs successfully gaining industry and publication experience. Please send your send CV, 3 references, research interests & relevant skills/experience to the COO at AMPEL.

Visit the Ample Biosolutions Website.

Download the PDF

 

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Copyright © BioHealth Innovation 2020
All Rights Reserved.



425th Edition, September 29, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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September 29, 2020












FOUNDING MEMBER OF



6th Annual BioHealth Capital Region Forum (Oct 19th, 2020) (REGISTER NOW!) (2)

This invitation-only event is free for executive level biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

*Please note that attendees’ name might be recorded if participating in the chat function during the event.

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Novavax Executive Vice President, Chief Business Officer and Chief Financial Officer, John Trizzino, Guests on BioTalk with Rich Bendis

John Trizzino, Novavax Executive Vice President, Chief Business Officer and Chief Financial Officer Joins BioTalk to Discuss the Company’s History, COVID-19 Vaccine Development, and Collaboration in the BioHealth Capital Region

Listen now on Apple https://apple.co/2EJ4ucS, Google https://bit.ly/36eBQLS, Spotify, https://spoti.fi/2HDE9hr, TuneIn https://bit.ly/3kS20Z1, and Youtube (audio) https://bit.ly/3kYlHyb.

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3rd Annual BioHealth Capital Region Investor Forum (Oct 20-21st, 2020)

The BioHealth Capital Region Investor Forum is going Virtual on October 20th and 21st. To apply as an investor seeking biohealth opportunities, or as a biohealth company seeking to have your opportunity reviewed by investors, email BHI@BioHealthInnovation.org with Investment Conference in the subject line.

 

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International Biomedical Research Alliance Award sponsored by BioHealth Innovation

First awarded in 2016, the International Biomedical Research Alliance’s Innovation Award recognizes novel solutions in biology or medicine and acknowledges discoveries of unusual importance, application, or magnitude that make use of new or unusual methods, paradigms, or approaches to solve important problems in biology or medicine. This year, the Innovation Award was graciously sponsored by BioHealth Innovation Inc. and presented to Michael Metrick. A graduate of James Madison University, Michael is working toward completion of his PhD in the NIH Oxford-Cambridge Scholars Program. The Scholars Program is a novel, dual-mentored, and international collaboration between the National Institutes of Health (NIH) in Bethesda, Maryland and the Universities of Oxford and Cambridge, respectively, in the United Kingdom.  The Scholars Program’s elite students conduct their own biomedical research project in an average completion time of 4.2 years.  Michael is in the MD/PhD track and his MD is in progress at the University of Illinois at Chicago.  Michael is mentored by Prof. Byron Caughey at the NIH’s National Heart Lung and Blood Institute (NHLBI) Rocky Mountain Laboratory in Hamilton, Montana and Prof. Michele Vendruscolo at the University of Cambridge.

Image: Michael Metrick

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Open Innovation CoSolve | AstraZeneca Open Innovation

CoSolve is a new global, virtual, Open Innovation challenge at AstraZeneca, seeking to find new collaborators – those with the boldest innovations and solutions that will help us create the next wave of medicines to help transform patients’ lives.

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Dr. Christine Dingivan Joins Emmes as President and CEO | BioSpace

ROCKVILLE, Md., Sept. 23, 2020 /PRNewswire/ — Emmes today announced that Dr. Christine Dingivan has joined the company as its new president and chief executive officer.  She is succeeding Dr. Anne Lindblad, who is retiring after 38 years at the company.  Dr. Dingivan will be Emmes’ fourth chief executive since the company was founded in 1977.

Image: https://www.biospace.com

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Anne Khademian on new role at the Universities at Shady Grove – Washington Business Journal

Her entrance comes just as Montgomery County leaders are examining what role USG can play in bringing in more business.

Image: Anne Khademian starts as the executive director of the Universities at Shady Grove in October. THE UNIVERSITIES AT SHADY GROVE

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MONTGOMERY COUNTY, MARYLAND TOPS THE STATE IN 2020 INC. MAGAZINE’S ANNUAL RANKING OF 5000 NATION’S FASTEST-GROWING COMPANIES

ROCKVILLE, Md. — A broad range of 49 Montgomery County, Maryland companies made the list in this year’s annual Inc. 5000 list of the fastest-growing privately-owned companies in the United States. The recognized companies span industries that include software, IT system development, health, biotech, consumer products, advertising & marketing, construction, government services and financial services.

Among the Montgomery County companies, there is a prevalence in software, healthcare/bio and government services—a natural fit with access to one of the country’s most highly educated workforces and local proximity to world-class federal research institutions in science, health, medicine and cybersecurity such as NIST, NIH, FDA and NCCOE.

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Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom | Novavax Inc. – IR Site

GAITHERSBURG, Md., Sept. 24, 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 initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

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Children’s National – NIAID Partnership | CTSI-CN

A one day symposium bringing together investigators, researchers, and clinicians from National Institute of Allergy and Infectious Diseases (NIAID) and Children’s National Hospital as well as other interested participants from outside institutions, to discuss the creation, progress, and evolution of this first-of-its-kind collaboration between the NIAID at the National Institutes of Health and Children’s National, a pediatric academic medical center. This year, the event will highlight the current COVID-19 and MIS-C pandemic, with a specific focus on the pediatric population. Dr. Anthony Fauci, Director of NIAID, will provide an overview on the infectious disease, and leading experts from Children’s National, NIAID, and other institutions will share the novel research and science being done to address this worldwide issue.

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Graybug Vision Inc. (GRAY) IPO Opens 19% Higher

Today’s IPO for Graybug Vision Inc. (NASDAQ: GRAY) opened for trading at $19 after pricing 5,625,000 shares of common stock at a public offering price of $16.00 per share.

In addition, Graybug has granted the underwriters a 30-day option to purchase up to an additional 843,750 shares of common stock at the initial public offering price, less underwriting discounts and commissions

SVB Leerink and Piper Sandler are acting as joint bookrunning managers for the offering. Needham & Company and Wedbush PacGrow are acting as passive bookrunners for the offering.

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AstraZeneca, Samsung reach $331M biologics manufacturing deal amid Korean CMO’s expansion push | FiercePharma

Unlike some other manufacturers, Samsung Biologics has enjoyed a revenue boost from the novel coronavirus pandemic, and it’s accelerating its expansion plans to match. With a $2 billion “super plant” in the offing, Samsung now has a new Big Pharma supply deal in place to keep driving growth.

AstraZeneca tapped Samsung Biologics for a $331 million supply pact to produce bulk drug substance and “drug product to support AstraZeneca’s biologics therapeutics” at the CMO’s Plant 3 facility in Incheon, South Korea, the partners said Tuesday.

Image: Samsung Biologics’ expansion plans include a $2 billion “super plant” at the CMO’s Incheon complex. (Samsung)

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Virtual DC Startup Showcase @ GW Registration, Tue, Sep 29, 2020 at 2:00 PM | Eventbrite

The George Washington University (GW) Technology Commercialization Office is pleased to host the inaugural DC Startup Showcase.

DC Startup Showcase will present companies developing disruptive healthcare innovations.

Log on to our live YouTube channel to see pitches from entrepreneurs seeking funding to bring the fruits of high-impact research to market.

Then join our Zoom rooms to follow up with specific startups, ask questions of our legal sponsors, and/or mix and mingle with DC’s best entrepreneurs, investors, and business leaders.

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TIME Names Johns Hopkins University COVID-19 Map Creator To 100 Most Influential People List For 2020 – CBS Baltimore

BALTIMORE (WJZ) — TIME recently named a Johns Hopkins University professor to its 2020 list of the 100 most influential people in the world for developing a free and open website for the public to track the COVID-19 pandemic in near-real-time.

Lauren Gardner, a civil and systems engineering professor in the Whiting School of Engineering, led the team that built the COVID-19 Dashboard in late January.

Image: https://coronavirus.jhu.edu/map.html

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Coronavirus vaccine could come thanks to horseshoe crab blood

GREENVILLE, S.C. – Allen Burgenson had a job, his father explained as they stood on the sand.

This was Allen’s first fishing trip, but he wasn’t going to take anything from the bay. He was to return the water’s gifts to the deep, where they’d belonged for hundreds of millions of years.

If he spotted a horseshoe crab on its back, his father said as he held Allen’s hand, that meant it was in trouble and needed Allen’s help to get home. Allen just had to flip it over. Its 10 legs could make it the rest of the way back to the crashing waves.

Image: https://www.usatoday.com

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Top 50 NIH-Funded Institutions of 2020

A new federal fiscal year (FY) begins October 1, but lawmakers at deadline haven’t even agreed on stopgap funding needed to keep Washington fully functioning next month, let alone come to terms on a new budget for FY 2021.

As a result, nobody yet knows how much funding the NIH will have net fiscal year. President Donald Trump began the budget process in February, weeks before COVID-19 led to shutdowns nationwide, by proposing a record $4.9 trillion spending plan that would have cut the NIH’s budget by 7%, from $41.7 billion to $38.4 billion.

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Alumnus’ VCU journey leads to new corporation — and a chance to fix America’s drug shortage problem

Wednesday, Sept. 23, 2020

Earlier this year, the federal Department of Health and Human Services announced a four-year contract worth $354 million for Richmond-based Phlow Corp. to manufacture medication components and drugs in the United States that could treat COVID-19 and other diseases.

If extended to the maximum 10 years, the contract could be worth $812 million. Phlow is a new company, co-founded and formally launched this year by Virginia Commonwealth University College of Engineering professor and alumnus B. Frank Gupton, Ph.D., and three-time VCU alumnus Eric S. Edwards. Edwards earned his B.S. in biology from the College of Humanities andSciences in 2002, his Ph.D. from the School of Pharmacy in 2011 and his M.D. from the School of Medicine in 2013.

Image: Phlow co-founder Eric Edwards, an alumnus of VCU’s College of Humanities and Sciences, School of Pharmacy and School of Medicine, speaks at a School of Pharmacy Graduate Advisory Board meeting in 2019. (Danny Tiet, School of Pharmacy)

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WhyWeVax™ Announces Expansion of Board of Directors with Eight New Members

SAN FRANCISCO, Sept. 25, 2020 /PRNewswire/ — Why We Vaccinate, Inc., a 501(3)(c) educational organization dedicated to provide a credible and trusted source for honest and factual information on vaccines, their efficacy, safety and importance to public health, announced today the appointment of eight new board members. These additions to the organization’s leadership further its efforts to develop educational programs and facts-based messages. Our goals are to put forward information on the science and safety of vaccines, educating the population on the value of all vaccines and immunization programs.

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Gov. Hogan tours Gaithersburg lab working on COVID-19 vaccine

GAITHERSBURG, Md. — Governor Larry Hogan on Thursday visited a Gaithersburg laboratory, that’s in the process of developing a possible COVID-19 vaccine.

Novavax Inc., was awarded $1.6 billion through the Federal Government’s Operation Warp Speed to produce large-scale manufacturing, and delivery of 100 million vaccine doses as early as late 2020.

The company is just one of several in Montgomery County and Baltimore, helping to find a vaccine.

Image: Photo by: Gov. Hogan’s Office Gov. Hogan visits Novavax Inc.

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ClearMask works to remove communication barriers during COVID-19 | Maryland Business News

In an effort to improve communication among children, hard-of-hearing, and Deaf individuals, ClearMask is working to provide accessibility to everyone during the COVID-19 pandemic.

ClearMask teamed up with Montgomery County-based business Xometry, the largest on-demand manufacturing platform, to produce the PPE design for its fully transparent surgical mask. Xometry has one of the largest 3D printing plants in the Mid Atlantic region.

Image: https://open.maryland.gov

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new FNIH awards website is a celebration of science

I am writing to share the exciting news that the Foundation for the NIH has just launched a dynamic new website to salute the incredible accomplishments of the recipients of 2020 FNIH honors:

  • Dr. Aviv Regev, winner of the Lurie Prize in Biomedical Sciences

  • Dr. Anthony Fauci, winner of the Charles A. Sanders, M.D., Partnership Award

  • Dr. Michael Wilson, winner of Trailblazer Prize for Clinician-Scientists

The new site features in-depth interviews, engaging interactive content, and more in a celebration of scientific achievement. To check out the site, visit awards.fnih.org.

We think your community will be interested in learning more about the FNIH prizes and these esteemed recipients! We are hoping that you might be willing to share the site.

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Cellphire President G. Michael Fitzpatrick Awarded Armed Services Program Lifetime Achievement Award | Nachricht | finanzen.net

ROCKVILLE, Md., Sept. 23, 2020 /PRNewswire/ — Cellphire, the global leader in long-term stabilization and storage of platelets, is proud to announce that the Armed Services Blood Program (ASBP) has awarded Cellphire President G. Michael Fitzpatrick, PhD, with the 2020 ASBP Lifetime Achievement Award for his service and significant contributions to ASBP and the warfighter.

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USAJOBS – Job Announcement

CRCHD seeks motivated scientists to serve as Program Directors in its Diversity Training Branch (DTB) and Integrated Networks Branch (INB). These Program Directors will manage and develop a portfolio of innovative grant-supported diversity training (DTB) and network-based initiatives (INB), and identify scientific opportunities to generate new knowledge supporting the NCI mission. The successful candidates will hold a Ph.D., M.D. or equivalent degree.

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Kraton (BHI Client) Seeking Approval for BIAXAMTM as a Self-Sterilizing Sulfonated Polymer (2)

HOUSTON, Sept. 9, 2020 /PRNewswire/ — Kraton Corporation (NYSE: KRA), a leading global producer of specialty polymers and high-value biobased products derived from pine wood pulping co-products, is seeking regulatory approval for BIAXAM, a novel sulfonated polymer technology with long-lasting self-disinfecting properties that has been demonstrated in studies to quickly inactivate up to 99.99% of SARS-CoV-2 (virus that causes COVID-19) and other microbes.

Read More



Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2020
All Rights Reserved.



424th Edition, September 22, 2020

By BHI Weekly Newsletter Archives

 

 
 

 

September 22, 2020

FOUNDING MEMBER OF

 

 

Dr. Sally Mossman, Head of U.S. R&D for GSK Vaccines, Joins BioTalk to discuss their Rockville location, the BioHealth Capital Region, and the development of a COVID-19 Vaccine
 

Listen now via Apple https://apple.co/2RMiuoY, Google https://bit.ly/3iUXZCw, Spotify https://spoti.fi/32R5ll4, TuneIn https://bit.ly/33QE1m0, YouTube (Audio) https://bit.ly/367Ux47.

Dr. Mossman obtained her Ph.D. in herpes virology from the University of Liverpool, UK. Thereafter she conducted two postdoctoral fellowships in HIV vaccine research in the USA, first at Colorado State University, Fort Collins, and then at the University of Washington, Seattle. She spent 8 years within Corixa Corporation, a biotechnology company focusing on developing novel approaches to vaccines, including adjuvants, delivery strategies, and proprietary antigen candidates for infectious disease and cancer vaccines.  She joined GlaxoSmithKline Vaccines in 2006 and spent 10 years in Rixensart Belgium in the early development of infectious disease vaccines. More recently, she relocated to Maryland as part of the founding leadership team for the USA R&D headquarters for GSK Vaccines in Rockville, where she was initially heading up the Discovery effort. She is now Head of the Rockville R&D site and oversees a portfolio of vaccine candidates at all stages of development as well as driving key vaccine technologies, including mRNA and Adenovirus platforms. 

Read More

 

 

 

5th Annual BioHealth Capital Region (BHCR) Crab Trap Competition (REGiSTER NOW!)
 

Don’t miss your chance to be named the BioHealth Startup with the Most Commercial Potential at the BHCR Forum, win $10,000 and more!

 

Applications due: 9/30

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

Read More

 

 

 

6th Annual BioHealth Capital Region Forum (Oct 19th, 2020) (REGISTER NOW!)
 

This invitation-only event is free for executive level biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

*Please note that attendees’ name might be recorded if participating in the chat function during the event.

Read More

 

 

 

Kraton (BHI Client) Seeking Approval for BIAXAMTM as a Self-Sterilizing Sulfonated Polymer
 

HOUSTON, Sept. 9, 2020 /PRNewswire/ — Kraton Corporation (NYSE: KRA), a leading global producer of specialty polymers and high-value biobased products derived from pine wood pulping co-products, is seeking regulatory approval for BIAXAM, a novel sulfonated polymer technology with long-lasting self-disinfecting properties that has been demonstrated in studies to quickly inactivate up to 99.99% of SARS-CoV-2 (virus that causes COVID-19) and other microbes.

Read More

 

 

 

Emergent Biosolutions pumps $75m into Canton facility – News – Canton Journal – Canton, MA
 

Emergent BioSolutions will further strengthen its contract development and manufacturing capabilities by expanding into viral vector and gene therapy by investing $75 million in its Canton facility.

The facility is focused on the development and manufacturing of drug substances for live viral vaccines, including the company’s smallpox vaccine.

“Emergent’s expansion into advanced therapy CDMO services is based on our biologics expertise and a strong understanding of our customers’ current and future needs,” said Sean Kirk, executive vice president, manufacturing and technical operations at Emergent BioSolutions. “We are investing in our people, plants and products to meet the growing demand for precision treatments and to help get these therapies to patients.”

 

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Qiagen completes takeover of PCR automation player NeuMoDx for $248M | MedTech Dive
 

Qiagen signed up to distribute the mid- and high-throughput versions of NeuMoDx’s PCR automation systems in major markets outside the U.S. in 2018. The agreement saw Qiagen take a 20% stake in its new partner and secure an option to buy the remaining 80% for $234 million, plus adjustments for cash, indebtedness and transaction costs. Since then, Qiagen and NeuMoDx have worked to expand the test menu, most recently in response to COVID-19.

Read More

 

 

 

Venture Summit Virtual Connect
 

BioHealthInnovation invites you to join over 120 leading VCs, Corp VCs, Angel Investors and over 100Top Innovators online at Venture Summit Virtual Connect being held on November 17th – 19 th 2020.One-on-One (zoom) investor meetings, 2 days of content including timely panel discussions, workshopsand an inspiring keynotes. Register now to confirm your spot: https://bit.ly/2DMyzYx & get an extra20% off the Early Bird Rates with Discount Code: BIOHEALTHVIP .

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Bio and Pharma Manufacturing Renaissance – YouTube
 

Bio and Pharma Manufacturing Renaissance

 

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Aurinia Pharmaceuticals Prepares for Commercial Launch from New Maryland Site on the Heels of 2020 Hiring Spree · BioBuzz
 

Aurinia Pharmaceuticals (Aurinia) is a late-stage clinical biopharmaceutical company (Toronto Stock Exchange (TSX:AUP); NASDAQ (NASDAQ:AUPH) focused on commercializing therapies for rare autoimmune and inflammatory conditions. Headquartered in Vancouver, British Columbia, the company announced in March 2020 that it had established its U.S. commercial center of operations in Rockville, Maryland, which is actively staffing up with key personnel. Among the key leaders, Aurinia attracted were two veteran industry executives with deep ties to the region: former top MedImmune executives Peter Greenleaf and Max Donley are the company’s CEO and EVP, Internal Operations and Strategy, respectively. They both joined Aurinia’s leadership team in 2019

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Graybug Vision files for $86 Million IPO on NASDAQ · BioBuzz
 

Graybug Vision, an Ocular disease biotech, filed with the SEC on September 4, 2020 for an $86 million IPO on the Nasdaq Global Market under the ticker symbol GRAY. SVB Leerink, Piper Sandler, Needham & Co. and Wedbush PacGrow are the joint underwriters on the offering, for which pricing terms were not disclosed.

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GlycoT Therapeutics Grants Sublicense of Glycoengineering Technology to Daiichi Sankyo | Maryland | curated.tncontentexchange.com
 

BALTIMORE, Sept. 14, 2020 /PRNewswire/ — GlycoT Therapeutics LLC, a UM Ventures start-up company based on intellectual property (IP) developed at the University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP), has executed a sublicense agreement for its glycoengineering technology with Daiichi Sankyo Company, Limited (Daiichi Sankyo; www.daiichisankyo.com). The agreement grants Daiichi Sankyo worldwide and non-exclusive rights to IP that GlycoT currently licenses from UMB and UMCP, and includes an undisclosed upfront payment, annual fees, and adequate royalties of sales to GlycoT.

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Emergex Vaccines and George Mason University Identify T-Cell Epitopes Presented by SARS-Cov-2 Infected Cells
 

Doylestown PA, USA and Abingdon, Oxon, UK, 15 September 2020 – Emergex Vaccines Holding Limited (‘Emergex’), a company tackling major global infectious disease threats through the development of synthetic ‘set point’ vaccines which prime the T-Cell immune response, today announces the determination of a Class I MHC expression library, or ligandome, for SARS-Cov-2 infected cells, in collaboration with George Mason University (‘GMU’), National Center for Biodefense and Infectious Diseases, Virginia, USA.

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EU pays $384 million for Sanofi-GSK COVID vaccine as WHO scheme deadline looms | Reuters
 

BRUSSELS/PARIS (Reuters) – The European Union has agreed to buy a potential COVID-19 vaccine from Sanofi SASY.PA and GSK GSK.L in its second such deal to secure supplies, as a deadline for joining the World Health Organization’s (WHO) vaccine purchase programme looms.

 

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Roche receives U.S. emergency approval for coronavirus vs. flu test | Reuters
 

ZURICH (Reuters) – Drugmaker Roche on Friday said it had received Emergency Use Authorization from the U.S. Food and Drug Administration for a test to quickly detect whether a patient has SARS-CoV-2 or one of two forms of influenza

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21 Emerging Life Science Companies Fueling Maryland’s Biohealth Ecosystem · BioBuzz
 

Maryland is the epicenter of biotech and life science innovation in the BioHealth Capital Region (BHCR). The state is home to a burgeoning life science ecosystem, including a rapidly growing cell and gene therapy industry, a robust and growing advanced biomanufacturing environment, and a deep network of leading research universities and critical government life science research entities.

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5 Questions with Tammi Thomas, Vice President, Marketing & Communications at TEDCO · BioBuzz
 

“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Tammi Thomas, Vice President, Marketing & Communications at TEDCO.

Image: https://biobuzz.io

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1500 EAST GUDE DRIVE ROCKVILLE, MARYLAND – AVAILABLE NOW 21,400 RSF OF LABORATORY/OFFICE SPACE (Alexandria)
 

TENANT AMENITIES • Up to 21,400 RSF of office/lab suite available

• Divisible to 9,529 RSF and 11,871 RSF

• Conveniently located between Route 28 and Route 355 in Rockville, MD

• Proximate to other life science companies

• The proposed plans (attached) include heavily improved laboratory space • Emergency back-up power

• Ample surface parking

• Close proximity to Rockville Town Square, containing restaurants, retail, and more

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Biotech-focused investor SR One is looking to raise $400m for its new fund | AltAssets Private Equity News
 

SR One, a venture capital firm focused on the biotech space, is looking to raised up to $400m for its new fund.

The firm has yet to register any capital for SR One Capital Fund I, according to the latest US Securities and Exchange Commission filing.

It is unclear whether the $400m figure on the document is just a target or will also be a hardcap for the fundraise.

Read More

 

 

 

AURP: Changemakers: Leading Communities of Innovation in Uncertainty
 

Interactive remarks with the world’s top leaders in innovation and inspiration Plan for up-to-the-moment discussions on global issues including projected outcomes from the U.S. 2020 Presidential election.

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423rd Edition, September 15, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


September 15, 2020












FOUNDING MEMBER OF



5th Annual BioHealth Capital Region (BHCR) Crab Trap Competition

Don’t miss your change to be named the BioHealth Startup with the Most Commectial Potential at the BHCR Forum, win $10,000 and more!

 

Applications due: 9/24

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

Read More




Previous BioHealth Capital Region Crab Trap Winners from Sonavex, Galen Robotics, and Floreo Join Rich Bendis on BioTalk

A special BioTalk with former Crab Trap winners from the BioHealth Capital Region Forum. David Narrow, CEO of Sonavex, Bruce Lichorowic, President & CEO, Dave Saunders, CTO & Co-Founder of Galen Robotics, and Vijay Ravindran, Co-Founder & CEO of Floreo, Inc. give updates on their companies since winning the Crab Trap competition in previous years.

Listen now via Apple https://apple.co/3iHuNPv, Google https://bit.ly/2DXClOI, Spotify https://spoti.fi/3bXhgAx, TuneIn https://bit.ly/3iuENvc, or YouTube Audio https://bit.ly/33smGzz

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SBIR Virtual Office Hours

Are you and early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Learn more about whether or not federal or state non-dilutive funding makes sense for you. Discuss potential strategies for success. Sign up for a free 1:1 advice and feedback regarding non-dilutive funding strategy and applications with BHI staff who have helped companies secured SBIR, STTR and other awards—at twice the national average win rate. This program is open to anyone, though scheduling priority is given to Montgomery County companies, courtesy support from MCEDC.

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Md. Labs Developing Vaccines and Therapeutics, Attracting Federal Dollars – Maryland Matters

A 2016 decision to link the research labs at the University of Maryland College Park with those at the University of Maryland at Baltimore is paying dividends in the competition for federal COVID-19 research dollars, a top education official told a science advisory panel on Wednesday.

The decision was a spinoff of the University of Maryland Strategic Partnership Act, said Laurie Ellen Locasio, vice president for research at the two institutions.

Read More




Sign Up Now – September 23rd EIR Feedback Session

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: 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

 

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Governor Hogan Announces Acquisition of 250,000 Rapid Antigen Tests from Becton Dickinson | thebaynet.com | TheBayNet.com | Articles

ANNAPOLIS, Md. – Governor Larry Hogan today announced the acquisition of 250,000 rapid point-of-care antigen tests, which will be deployed to nursing homes, assisted-living facilities, and correctional and juvenile detention centers across the state. The purchase makes Maryland, the founding member of the bipartisan interstate testing compact with the Rockefeller Foundation, the first state in the compact to move forward with an order for rapid antigen tests.

Image: https://www.thebaynet.com

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Immunomic Therapeutics Inc. Expands into South Korea – Immunomic Therapeutics

Seoul Office Will Be Opening to Develop Immunomic Therapeutics Investigational Cell Therapy for Brain Cancer

September 10, 2020 08:00 AM Eastern Daylight Time SEOUL–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, originating in the United States recently opened its first office in South Korea. This continues to build on ITI’s overall strategy to be the partner-of-choice for innovative biotechnology companies in emerging centers of excellence worldwide.

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In Conversation with Troy LeMaile-Stovall, TEDCO’s New CEO and Executive Director · BioBuzz

The Maryland Technology Development Corporation (TEDCO) announced in July 2020 that it had completed the executive search for a new leader with the hiring of Troy LeMaile-Stovall, a seasoned leader with deep ties to the BioHealth Capital Region (BCHR).

LeMaile-Stovall just recently officially took the helm of TEDCO and we thought it a great time to catch up with him for a wide-ranging and insightful conversation about his background and vision for TEDCO and the BHCR biotech and life science ecosystem.

Image: https://biobuzz.io

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The Center for Innovative Technology Announces Bob Stolle as Chief Executive Officer and President

Richmond, VA, Sept. 11, 2020 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) Board of Directors today announced Bob Stolle as the organization’s Chief Executive Officer and President of CIT. Stolle previously served as CIT’s Senior Vice President of Policy and Regional Initiatives as well as the head of CIT’s Entrepreneurial Ecosystems Division.

“Virginia’s entrepreneurship community has grown tremendously during Ed Albrigo’s tenure at CIT, and we are grateful for his dedicated service to our Commonwealth,” said Governor Ralph Northam. “I am pleased to welcome Bob Stolle to lead the agency and its efforts to advance our innovation economy.”

Image: The Center for Innovative Technology Announces Bob Stolle as Chief Executive Officer and President – https://www.globenewswire.com

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6th Annual BioHealth Capital Region Forum (Oct 19th, 2020)

This invitation-only event is free for executive level biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

*Please note that attendees’ name might be recorded if participating in the chat function during the event.

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Venture Summit Virtual Connect – youngStartup Ventures

We’re dedicated to helping cutting-edge innovators and leading investors connect. VSVC3 will be an engaging and immersive [live] interactive virtual summit providing startups the opportunity to gain the visibility they need and investors access to vetted deal flow.

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Top 5 TED Talks on Gene Technology that Every Biotech Leader Must Watch | American Gene Technology

TED Talks began in 1984 as a conference originating in Silicon Valley where powerful voices in Technology, Entertainment, and Design came together to spread potent ideas with broad relevance. Today there are thousands of talks of 18 minutes or less, in more than 100 languages, covering topics ranging from science to global issues. Despite this diversity, all TED talks share a devotion to Ideas Worth Spreading.

Image: https://www.americangene.com

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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists – The New York Times

The morning after the world learned that a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms.

Image: Pascal Soriot, chief executive of the drug company AstraZeneca, in Washington in February.Credit…Erin Schaff/The New York Times

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When Will There Be a Coronavirus Vaccine? | Time

The cleverest of enemies thrive on surprise attacks. Viruses—and coronaviruses in particular—know this well. Remaining hidden in animal hosts for decades, they mutate steadily, sometimes serendipitously morphing into more effective and efficient infectious agents. When a strain with just the right combination of genetic codes that spell trouble for people makes the leap from animal to human, the ambush begins.

Image: Illustration by Peter Greenwood for TIME – https://time.com

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NIH continues to boost national COVID-19 testing capacity | National Institutes of Health (NIH)

The National Institutes of Health today announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31, 2020.

Image: MatMaCorp’s Solas 8 portable detection system for SARS-CoV-2 is designed to improve on-site testing capabilities of CLIA labs in rural communities.MatMaCorp

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Virginia Tech Research Sees Continued Growth – The Roanoke Star News

Virginia Tech’s research expenditures are up, in addition to an increase in sponsored awards by 15 percent, building upon the last fiscal year’s expenditure total of $542 million, despite the impact of COVID-19 felt nationally by higher education institutes, according to preliminary fiscal year end reports.

Image: Researchers Nisha Duggal (left) and James Weger-Lucarelli from the Fralin Life Sciences Institute and Virginia-Maryland College of Veterinary Medicine are establishing a reverse genetics system for SARS-CoV-2 that will serve as the basis for vaccine design. Photo: Ray Meese, Virginia Tech. – https://theroanokestar.com

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California Developer Plans 169,812 Sq. Ft. Lab and Office Building in Port Covington

Pasadena, California-based Alexandria Real Estate Equities, Inc. is planning a six-story, 169,812 sq. ft. lab and office building in Port Covington. The project is a collaboration between Alexandria and The Port Covington Development Team.

This building is proposed for lot E8 on the Chapter 1B Master Plan of the Port Covington project. This lot fronts a newly-aligned Cromwell St. and is adjacent to the northeast of the Rye Street Market complex. Rye Street Market is three connected buildings that make up 275,000 sq. ft. with 185,000 sq. ft. of office space, a 13,000 sq. ft. open-air market and food hall, 50,000 sq. ft. of pedestrian-oriented retail, a 12,000 sq. ft. meeting facility, and a 15,000 sq. ft. rooftop event space.

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Fearless – Accelerate your business apply for hutch 2021

2020 has shown us the demands that are made on tech to keep our society running. Whether it’s teams pivoting from in-office meetings to 100+ person Zoom chats or state governments having trouble processing unemployment because of overloaded systems, good tech, especially good civic tech is needed now more than ever.

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Dr. Anne Khademian Named Executive Director of Universities at Shady Grove – USM

Baltimore, Md. (Sept. 15, 2020) – Dr. Anne Khademian, a Presidential Fellow and professor at Virginia Tech, has been appointed executive director of the Universities at Shady Grove, the University System of Maryland (USM) regional higher education center offering undergraduate and graduate degree programs from nine USM institutions at its campus in Rockville, Md.

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All Rights Reserved.



422nd Edition, September 9, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


September 9, 2020












FOUNDING MEMBER OF



Head of JLABS @ Washington, D.C., Sally Allain, MSc., MBA, Guests on BioTalk

Sally Allain, MSc., MBA, Head of JLABS @ Washington, D.C. joins Rich Bendis on BioTalk to discuss her career, the decision to open a BioHealth Capital Region location, and their new BLUE KNIGHT™ collaboration.

Listen now via Apple https://apple.co/35ivWc3, Google https://bit.ly/3k0vOlA, Spotify https://spoti.fi/2R84fuh, TuneIn https://bit.ly/2F0a0rN, and YouTube Audio https://www.youtube.com/watch?v=efHvb42ohtc.

Read More




Biotech leaders call for Covid-19 data transparency, FDA independence

WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments.

Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal regulators make it clear to the public that any vaccines or treatments will be approved strictly based on science.

Image: Colorized scanning electron micrograph of a cell (purple) infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. NIAID

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Alexandria Venture Investments Recognized as #1 Most Active Biopharma Investor for Third Consecutive Year

PASADENA, Calif., Sept. 4, 2020 /PRNewswire/ — Alexandria Venture Investments, the strategic venture capital platform of 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, was recognized by Silicon Valley Bank in its “Mid-Year 2020 Healthcare Investments and Exits Report” as the #1 most active biopharma investor by new deal volume from 2019 to 1H20. As a testament to Alexandria’s position at the heart of the life science ecosystem, this marks the third consecutive year the company’s venture capital platform has earned this distinguished and impactful recognition. Since its founding in 1996, Alexandria Venture Investments has strategically invested in some of the most disruptive and promising seed-, early- and growth-stage technologies and companies, and it stands today as an integral component of the company’s uniquely differentiated and multifaceted business strategy.

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California developer Alexandria Real Estate proposes office, lab building at Baltimore’s Port Covington – Baltimore Business Journal

The 170,000-square-foot building would be located near Rye Street Tavern.

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Unique Team-Building and Promotion for your BioHealth Company: FRAXA Biotech Games™ for Research – Register Now. Games Begin This Thursday Sept. 10th

Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

 

 

Read More




Sanofi, GSK start human trial of their COVID-19 vaccine

Pharmaceutical giants Sanofi and Glaxo Smith Kline (GSK) on Thursday started a clinical trial for their jointly developed COVID-19 vaccine candidate.

A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US, the two drugmakers said.

The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s pandemic adjuvant technology.

The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the COVID-19 vaccine candidate.

 

Read More




AstraZeneca Launches 30,000-Patient Phase III U.S. Trial of COVID-19 Vaccine

AstraZeneca said today it has launched a 30,000-patient Phase III trial in the U.S. of AZD1222, the COVID-19 vaccine it is co-developing with the University of Oxford and a spinout—a study that will account for most of the 50,000 participants on which the company intends to assess the vaccine.

The Phase III D8110C00001 trial (NCT04516746) is intended to evaluate the safety, efficacy, and immunogenicity of AZD1222 (formerly ChadOx1 nCoV-19) for the prevention of COVID-19. Participants will be randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.

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Johnson & Johnson Innovation and BARDA Select a Surge Force of Companies with the Aim to Combat the COVID-19 Pandemic as Part of Its BLUE KNIGHT™ Collaboration – News | JLABS

WASHINGTON, D.C., August 27, 2020 – Johnson & Johnson Innovation LLC today announced the first companies to be part of its medical countermeasure innovation collaboration called Blue Knight, a joint initiative dedicated to anticipating potential health security threats, activating the global innovation community, and amplifying scientific and technological advancements with the aim to prepare for and respond to our rapidly evolving global health environment. Blue Knight has been developed in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, and Johnson & Johnson Innovation – JLABS (JLABS), a global network of life science incubators empowering and enabling innovators to deliver potential life-enhancing health and wellness solutions to people around the globe.

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Ceres Nanosciences Receives $6.5M NIH Award

MANASSAS, Va. — September 2, 2020 — Ceres Nanosciences, a privately held company that makes innovative products to improve diagnostic testing, announced it has been awarded a contract from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative. The contract, for $6.5 million, will support an expansion to increase the manufacturing capacity of Ceres’ Nanotrap® Virus Particles for COVID-19 tests.

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Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19 – Cartesian

Gaithersburg, MD, September 1, 2020 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe ARDS, including that caused by COVID-19. Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

Read More




NIH Awards MicroGEM up to $40.9M to Fast-Track Rapid, No-Lab COVID-19 Saliva Test

CHARLOTTESVILLE, Va., Sept. 2, 2020 /PRNewswire/ — MicroGEM today announced it has been awarded up to $40.9 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company’s molecular diagnostic test that provides rapid, sensitive and specific identification of SARS-CoV-2 and influenza types A and B at the point-of-need.

MicroGEM’s COVID-19 saliva test provides laboratory-quality results in 15 minutes, allowing non-medical personnel to obtain rapid, on-site detection of COVID-19 without a laboratory. The system detects SARS-CoV-2 in saliva, simultaneously with influenza types A and B, using real-time reverse transcriptase RT-PCR. Based on patented enzymatic RNA extraction technology, the system is a simple approach to quickly detecting and managing infectious disease.

Read More




American Gene Technologies Gets Go-Ahead to Test Possible HIV Cure | BioSpace

HIV therapies, typically cocktails of antiviral drugs, have proven to be very successful in controlling HIV/AIDS. However, they are not a “cure,” which is a very lofty goal. American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

Read More




Emergent BioSolutions Teams Up with Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and MAPDA to Highlight Importance of Overdose Reversal Medicines on International Overdose Awareness Day | BioSpace

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that it is teaming up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and Mothers Against Prescription Drug Abuse (MAPDA) to highlight the importance of potentially lifesaving overdose reversal medicines on International Overdose Awareness Day 2020. International Overdose Awareness Day is a global event held on August 31 each year that aims to raise awareness of overdose and reduce the stigma of drug-related deaths. Emergent, in collaboration with these teams and MAPDA, will address the importance of accessing overdose reversal medicines through special announcements, videos, and stadium presentations.

Read More




J&J, BARDA pick 7 startups to back in fight against COVID-19—and beyond | FierceBiotech

As the world scrambles to develop diagnostics, treatments and vaccines for COVID-19, one big question looms: How will we face the next pandemic? Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) are teaming up once again to answer that.

Through a joint effort dubbed Blue Knight, the duo aims to boost innovation and “amplify” scientific and technological advancements to prepare for potential health threats—starting with COVID-19. They’ve picked seven startups from J&J’s global JLABS network to participate. The startups will receive up to $500,000 in support, as well as mentorship from BARDA and J&J to help them navigate R&D challenges and regulatory pathways and get medicines and tools to patients and healthcare workers as soon as possible.

Image: Startups chosen for the program may participate at JLABS locations in Washington, D.C., New York, San Diego or Toronto. If they don’t need a physical location or lab space, they may participate virtually. (Johnson & Johnson)

Read More




GSK is hiring in Richmond.

Microbiology Team Leader – https://jobs.gsk.com/en-gb/jobs/241125?lang=it-it (we also have a video of the line manager talking about the role, if you can add it to the newsletter)

New Product Development Director – Voltaren – https://jobs.gsk.com/en-gb/jobs/251039?lang=en-us&previousLocale=en-GB (we also have a line manager’s video)

Senior Process Engineer – https://jobs.gsk.com/en-gb/jobs/258078?lang=en-us&previousLocale=en-GB

Read More




Development of COVID-19 vaccine AZD1222 expands into US Phase III clinical trial across all adult age groups – Vaccitech

Vaccitech Ltd, a clinical-stage biopharmaceutical company developing immunotherapies to treat and prevent infectious diseases and cancer, announces that the development of AstraZeneca’s AZD1222 vaccine has expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. AZD1222 was co-invented by Vaccitech and Oxford University’s Jenner Institute.

The US Phase III trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

Read More




Skincare of the Future QuickFire Challenge – Challenge | JLABS

Advances in science and technology can drive the next generation of skincare innovations. Today, cutting edge dermatological research and technologies hold the potential to revolutionize pore minimizing and anti-aging solutions.

To that end, Johnson & Johnson Innovation, Johnson & Johnson Consumer Inc., and Alibaba’s TMALL announce the Skincare of the Future QuickFire Challenge, calling on innovators to submit products, services and technologies aiming to help consumers tackle the world’s toughest skincare challenges, with a specific focus on pore minimizing and anti-aging solution.

Read More




TruGenomix, a Veteran-Led Biotech Instrumental in Early Identification & Awareness of PTSD, Raises $1.8 Million Seed Round, Led by Sanford Health & Viking Global

TruGenomix recently announced $1.8 million in financing in a seed round led by Sanford Health. The startup, a graduate of the Illumina Accelerator program and a Veteran Founder Initiative company, also announced matching funding from Viking Global, a partner of the Illumina Accelerator.

As a veteran-owned business, TruGenomix’s founding mission of improving the lives of U.S. military service members and veterans remains at its roots. With a vision of bringing behavioral health into the 21st century, TruGenomix is advancing the diagnosis of post-traumatic stress disorder (PTSD) through leveraging genomic and machine learning technologies.

Image: https://fi.co

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Nobelpharma Press Release — MCEDC

ROCKVILLE, Md. — Recognizing the benefits of proximity to leading U.S. researchers, regulators and advocacy groups, Nobelpharma America, LLC has chosen Montgomery County, Maryland as the location for its first overseas subsidiary of Nobelpharma Co. Ltd., a company headquartered in Tokyo, Japan. Nobelpharma’s company mission is to contribute to society by providing critical but neglected pharmaceuticals and medical devices.

Nobelpharma meets an essential patient need: it develops curative drugs and medical devices for diseases that often go overlooked because of the small number of patients. Examples include patients suffering from tuberous sclerosis complex (TSC) and adductor spasmodic dysphonia.

Read More




5th Annual BioHealth Capital Region (BHCR) Crab Trap Competition

Don’t miss your change to be named the BioHealth Startup with the Most Commectial Potential at the BHCR Forum, win $10,000 and more!

 

Applications due: 9/24

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

Read More




Vaccitech Awarded U.K. Grant for COVID Vaccine Research

Vaccitech officials say the company received a U.K. government grant to support research with its next-generation technology platform to protect against COVID-19. The grant is part of the UKRI-NIHR COVID-19 rapid response rolling call for proposals with potential to deliver public health impacts within 12 months.

Preclinical data indicate Vaccitech’s new platform induces antibody and cell-mediated immune responses when compared with the adenoviral platforms currently in vaccine trials for COVID-19, according to Bill Enright, Vaccitech CEO. The preclinical data informed the decision of UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR), and other funders, including the World Health Organization (WHO), to support Vaccitech’s research efforts, he added.

Read More




Jonathan DeCarlo Named Chief Financial Officer at Emmes

ROCKVILLE, Md., Sept. 1, 2020 /PRNewswire/ — Emmes today announced that Jonathan DeCarlo has been promoted to chief financial officer. DeCarlo, who has served as vice president and controller, is replacing Brian Hochheimer, who is retiring after 15 years at Emmes.

Dr. Anne Lindblad, president and chief executive officer, said, “Jon has been a key player in Emmes’ growth and success. His technical skills, high levels of integrity and honesty, and vision, have earned the trust and respect from all those with whom he works. We are thrilled to have him as our new chief financial officer. I am extremely confident Emmes will be in excellent hands under Jon’s leadership.”

Read More




ITI Announces Publication of Results from 3 ATTAC Studies of CMV-Specific Dendritic Cell Vaccines for the Treatment of GBM – Immunomic Therapeutics

ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that results from multiple ATTAC clinical studies of dendritic cell vaccines have been published online by American Association for Cancer Research (AACR) in an article titled, “Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.”

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma (GBM), with leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells.

Read More




Johns Hopkins University Giving Wellness Kits To Undergrads To Protect Against COVID-19 – CBS Baltimore

BALTIMORE (WJZ) — As the fall semester begins, Johns Hopkins University wants to make sure its students are protected.

They are giving out wellness kits to undergraduates to help protect both students and the nearby community.

Read More



Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



421st Edition – September 1, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


September 1, 2020












FOUNDING MEMBER OF



Unique Team-Building and Promotion for your BioHealth Company: FRAXA Biotech Games™ for Research

Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

 

 

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Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, Joins Rich Bendis on BioTalk

Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, joins BioTalk to discuss her career, the economic development environment in Baltimore, and how to create a greater sense of partnership between perceived competing regions.

Listen now via Apple https://apple.co/2DikZfg, Google https://bit.ly/2Exq5oD , Spotify https://spoti.fi/31GmIUV, TuneIn https://bit.ly/32FjGQ5, and YouTube Audio https://bit.ly/31IwGFl.

Michele L. Whelley, President & CEO, is an economic development professional who is well-known throughout the region’s business community, Whelley brings new energy and focus to marketing the region, ensuring that EAGB will continue to strengthen its marketing platform as a critical component of fostering and supporting a vibrant and growing economy throughout the Greater Baltimore region.   

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5th Annual BioHealth Capital Region (BHCR) Crab Trap Competition

Don’t miss your chance to be named the BioHealth Startup with the Most Commercial Potential at the BHCR Forum, win $10,000 and more!

CONSIDERATIONS:

  • Technical Feasibility and IP
  • Commercialization and Marketing Strategy
  • Leadership Team and Collaborations
  • Funding to Date and Financial Projections

CRITERIA:

  • Demonstrated Proof of Concept/MVP
  • Have received funding (dilutive/nondilutive)
  • Understand regulatory and reimbursement hurdles
  • A clear path to market and scalable

PREVIOUS WINNERS:

Sonavex

LifeSprout

Galen Robotics

Floreo

Applications due: 9/15

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

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OS Therapies to develop BlinkBio next-generation Antibody Drug Conjugate (ADC) technology; BlinkBio CEO Colin Goddard joins OS Therapies Board | BioSpace

CAMBRIDGE, Md. and LONDON, Aug. 26, 2020 (GLOBE NEWSWIRE) — OS Therapies, and late-stage clinical research biotechnology company focused on Osteosarcoma and other solid tumors today announced the co-exclusive licensing of BlinkBio’s novel Si-Linker and Cassette Payload technologies, and exclusive licensing of the BlinkBio technology to target Folate Receptor Alpha (FRα) for tumors and other targeted diseases.

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Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine | Novavax Inc. – IR Site

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

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Arcellx Announces EvansMDS Grant Awarded for Collaboration with Johns Hopkins and University of Colorado Researchers to Support Development of Arcellx ARC-sparX Platform Candidate ACLX-002

GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) — Arcellx today announced the award of an EvansMDS Discovery Research Grant to Johns Hopkins University to support development of an Arcellx ARC-sparX therapy in the treatment of high-risk myelodysplastic syndromes (MDS). The collaborative effort, led by Amy E. DeZern, M.D., at the Johns Hopkins University School of Medicine, aims to advance development of ACLX-002, an immune cell therapy candidate directed at the therapeutic target CD123. The collaboration includes research to be conducted by Craig Jordan, Ph.D., of the University of Colorado School of Medicine, and materials and expertise to be contributed by Arcellx.

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REGENXBIO Announces FDA Clearance of IND for Phase II Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery | BioSpace

ROCKVILLE, Md., Aug. 25, 2020 /PRNewswire/ — 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 announced the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR). The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE, in the second half of 2020.

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Catalent to make drug substance for AstraZeneca’s COVID-19 vaccine candidate – Reuters

(Reuters) – Catalent Inc said on Monday its Maryland facility would make the drug substance used in the COVID-19 vaccine being developed by AstraZeneca Plc and the University of Oxford, starting “late in the third quarter” this year.

The New Jersey-based company said the drug substance will be made at its commercial gene therapy manufacturing facility in Harmans.

Catalent would supply the so-called viral vector, which is a genetically modified harmless virus designed to trick the human body into producing certain parts of the coronavirus. These proteins, in turn, prompt the immune system to develop an arsenal for any real COVID-19 infections.

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Alexandria Real Estate Equities pays $590.4 million for huge portion of Parmer RTP – Triangle Business Journal

A huge portion of a campus in Research Triangle Park has been sold in a deal that tops $590 million.

 

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Qiagen to launch digital, portable test for COVID-19 antibodies, preordering 900K for U.S. | FierceBiotech

Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes.

With a small digital hub and interchangeable testing stick system, the eHub was developed for use against the novel coronavirus in collaboration with Australian diagnostic developer Ellume. The device can process up to eight samples simultaneously, or up to 32 tests per hour, to detect the presence of IgA, IgM or IgG antibodies in plasma or serum.

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Emergent BioSolutions Announces Appointment of Marvin White to the Company’s Board of Directors NYSE:EBS

GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

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Catalent Expands Manufacturing Support for COVID-19 Vaccine AZD1222

SOMERSET, N.J. – Aug 24, 2020 — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.

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Hampton Roads accelerator program goes virtual amid pandemic – The Virginian-Pilot – Inside Business

Imagine being able to use science to choose the right music for an advertising campaign or being able to order food and groceries on a military base from a veteran-owned small business.

Hampton Roads startups are bringing these ideas and more to this year’s 757 Accelerate program. In the midst of a global pandemic, the region’s startup accelerator is moving its entire program online and implementing a new abridged program for three more area startups.

Image: From left, Secret Chord Laboratories founders Scott Miles, David Rosen and Robert Abelow will be participating in the third 757 Accelerate startup program. Due to the coronavirus pandemic, the program will be switching to operating virtually this year. (Courtesy photo)

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Crisis innovators: How 5 local companies are addressing the pandemic head-on – DC Inno

Coronavirus made 2020 the year of the pivot.

But the D.C.-area ventures having real, direct impact on the Covid-19 crisis have done more than tweak their business models; they’re innovating, persevering and committing to getting us through the pandemic in one piece.

They’re laying groundwork and executing on plans to tackle the disease. They’re developing resources and launching initiatives to serve our communities, as we grapple with dangerous and disruptive ripple effects born from the public health emergency. They’re conducting research, donating dollars and delivering on their promises, all with one goal: to push through this period and make life easier in the interim, and thereafter.

Image: Coronavirus has challenged the region’s businesses to step up. fpm – https://www.bizjournals.com

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J.P. Morgan on the state of life sciences and strategies to fuel innovation – MedCity News

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector.

Image: Peter Meath – https://medcitynews.com

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Genomic Analysis Suggests Some Endangered Species May Be at High Risk of SARS-CoV-2

Humans are not the only species facing a potential threat from SARS-CoV-2, according to the results of a study by an international scientific team headed by researchers at the University of California, Davis (UC Davis). Using genomic analysis to compare the amino acids of a key part of the ACE2 protein that is used by SARS-CoV-2 to gain entry into human cells, with those of the ACE2 protein in more than 400 other animals, the team found it feasible that many different species, including some, like the Western lowland gorilla, which are highly endangered, could potentially be infected by the virus.

Image: Western lowland gorilla (Trisha Shears/FreeImages)

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United States establishes a dozen AI and quantum information science research centers | Science | AAAS

The United States aims to invest $765 million over the next 5 years in a dozen scientific centers dedicated to the study of artificial intelligence (AI) and quantum information science (QIS), such as quantum computing, the White House announced today. Numerous private tech companies such as IBM, Google, and Intel will also contribute to the twin pushes, which call for a total of more than $1 billion in research investment.

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NIH programmes funded $1.2b in 2019 for early stage drug development

The US National Institutes of Health (NIH) is one of the largest early stage life sciences investors, and funds over $1B in awards each year through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programmes, according to NIH representatives who spoke at the “Key Role of NIH in the Product Development Pipeline” panel session at the Biotechnology Innovation Organization (BIO) Digital International Convention on 9 June.

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OxiWear rushes to get wearable oxygen monitor to Covid-19 patients – Washington Business Journal

OxiWear’s own founder is a user herself of its oxygen monitor for patients with severe pulmonary hypertension.

Image: Shavini Fernando is founder and CEO of OxiWear. LESLIE E. KOSSOFF/GEORGETOWN UNIVERSITY

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