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488th Edition, December 28, 2021

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December 28, 2021

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Emmes Acquires Institut Dr. Schauerte, Entering Real World Evidence Market

Company's Third Major Acquisition Expands European Presence in Germany; Adds New Electronic Data Capture Tool to Enhance Real World Evidence Research

ROCKVILLE, Md., Dec. 21, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Institut Dr. Schauerte, a CRO headquartered in Munich, Germany.  Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies.  It has conducted more than 400 studies across a range of therapeutic areas. 

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Ellume COVID-19 Home Test to Allow Users to Send Results Directly to Healthcare Providers

By Holden Wilen – Reporter December 23, 2021, 01:35pm EST Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.  

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.  

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

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Automation Solutions Streamline Pharmacy Workflow, Help Alleviate Challenges

Pharmacy Times interviewed Ronald T. Piervincenzi, PhD, the CEO of US Pharmacopeia (USP), on reflections from 2021 and predictions for 2022.

The discussion is the seventh in a video series collaboration between Pharmacy Times and USP that highlights USP’s work to support the pharmacist and discussed USP’s perspective on timely and topical issues in the field.

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American Gene Technologies’ HIV Clinical Trial Generates Promising Efficacy Data Markers

ROCKVILLE, MD. (PRWEB) DECEMBER 21, 2021 Data from the First Three Patients Shows Critical Efficacy Markers of the HIV Cure Cell Therapy: Engraftment, Persistence, and Maintained HIV-clearing Functionality of Infused Cells

American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached two important milestones for its HIV cure program.  

All three patients achieved engraftment of the genetically modified cell product, AGT103-T, and avoided rejection of the infused cells. In addition, patient samples were challenged to determine if their HIV-specific response remained active. All three products demonstrated an active response. These two studies confirm that the patients retained an appropriate concentration of the product and indicate AGT103-T should be able to create an effective immune response against HIV in the absence of antiretroviral treatment (ART).  

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"There’s Gold in Them Thar Hills!" – VC Funding Floods BioHealth Capital Region in 2021 · BioBuzz

Since the beginning of the global pandemic, capital has flowed into the BioCapital Health Region. Billions of dollars from Operation Warp Speed, as well as private venture firms, have poured in to support startups, as well as companies focused on pandemic responses.

Image: Image / Pixabay  

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Three from Hopkins named to National Academy of Inventors | Hub

Three Johns Hopkins faculty members are among 164 creators or co-developers elected as fellows of the National Academy of Inventors, a distinction that recognizes the people behind the outstanding inventions that have made a difference for society. They join the more than 4,000 current fellows of the academy, which features members of more than 250 institutions worldwide.

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Horseshoe crabs are in danger because everyone wants their blood – The Verge

Conservationists fear that horseshoe crabs, a 450-million-year-old living fossil, will be pushed to the brink of extinction because of the value of their blood to the pharmaceutical industry. Horseshoe crab blood provides a natural source of limulus amebocyte lysate (LAL) which is used to test vaccines, drugs, and medical devices to ensure that they aren’t contaminated with dangerous bacterial toxins called endotoxins. With hundreds of thousands of horseshoe crabs captured and bled of their milky-blue blood each year, conservation groups are now stepping up their advocacy efforts and taking legal action to help save horseshoe crabs and the other species that rely on them.

Image: Horseshoe crabs are bled at the Charles River Laboratory in South Carolina. Timothy Fadek

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Alexandria Center for Life Sciences at Shady Grove | Rockville's Newest Premier Life Science Opportunity

Located in the heart of Maryland’s Shady Grove Life Sciences Center, 9603 Medical Center Drive has efficient access to all points in Montgomery County via Route 355 and I-270 and is minutes to the Intercounty Connector (Route 200), which connects I-270 to I-95.

Click here for more information.

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Only one antibody treatment works against omicron — and it's running out | TheHill

As the omicron variant became the dominant strain in the U.S. this week, health care providers are left with fewer options to treat positive COVID-19 patients as most of the existing treatments have been found to be less effective in fighting off the new variant.

Up until recently, the U.S. Department of Health and Human Services (HHS) had been distributing three types of COVID-19 antibody treatments, Regeneron monoclonal antibodies, Eli Lilly’s antibody treatments and GlaxoSmithKline’s sotrovimab monoclonal antibody.

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California Life Sciences Announcment (Kwame – BHI/NIH EIR)

Please join us in welcoming our two newest members of the CLS Board of Directors!

• Vasiliki Anest,Ph.D: serves as Chief Innovation Officer for USC Norris Comprehensive Cancer Center

• Kwame Ulmer: is a venture partner at Wavemaker Three-Sixty Health

Their experience and backgrounds will be invaluable in supporting CLS’s goals to empower the life sciences ecosystem.

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Maryland Inno – Baltimore biotech getting acquired in deal that could pay up to $575 million

Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.

Image: Personal Genome Diagnostics, or PGDx, which is based in Canton, is getting bought by life sciences giant Labcorp. Carley Milligan

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487th Edition, December 21, 2021

By BHI Weekly Newsletter Archives





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December 21, 2021

FOUNDING MEMBER OF

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WBJ: Exclusive: D.C. startup and Crab Trap winner Nanochon raises millions to upend knee-replacement surgeries

D.C.’s Nanochon LLC just got a step closer in its quest to get a 3D-printed implant to market — thanks to $2 million in fresh funding and the potential to raise more.

The company’s seed round, led by University of Virginia Licensing & Ventures Group’s seed fund, closed at $2 million in September, Nanochon co-founder and CEO Ben Holmes said in an interview. And it’s oversubscribed, now in the process of raising more before a second close.

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Ellume COVID-19 Home Test to Allow Users to Send Results Directly to Healthcare Providers

FREDERICK, Md. and BRISBANE, Australia, Dec. 13, 2021 /PRNewswire/ — In anticipation of the U.S. Food & Drug Administration's (FDA) granting emergency use authorization to two new antiviral treatments for COVID-19, digital diagnostics company Ellume today announced that its COVID-19 Home Test (ECHT) will soon allow users to connect directly with telemedicine providers, which builds on the test's existing capability to share their result directly to healthcare providers. This direct, digital connection to telemedicine providers, currently in development, will help ensure patients have quick access to the new antiviral treatments, which typically must be taken shortly after infection to be most effective. 

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Emergent BioSolutions Announces Initiation of Phase 1 Study Evaluating Its Universal Influenza Vaccine Candidate

GAITHERSBURG, Md., Dec. 16, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced the first participant dosed in its phase 1 study, EBS-UFV-001, evaluating the safety, tolerability, and immunogenicity of the company’s investigational universal influenza vaccine candidate. This current version of Emergent’s universal influenza vaccine candidate contains multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses.  

“Emergent remains focused on investing in our diverse portfolio of R&D programs targeting infectious disease and other public health threats,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “Initiating this phase 1 study demonstrates our commitment to advancing our pipeline and our research and development team’s scientific prowess to adopt an innovative technology and investigate a potential vaccine candidate for a disease that affects millions every year.”  

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

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Montgomery County Racing To Keep Pace With Booming Life Sciences Market

Maryland's Interstate 270 corridor has been a burgeoning life sciences hub for several years, but with the federal government pumping billions into the region during the coronavirus pandemic and more established research tenants beginning to reach maturity, the D.C.-Baltimore region has rocketed to become the third-fastest-growing life sciences market in the country, according to a recent CBRE report.

Image: Bisnow/Jacob Wallace Equilibrium's Jason Rifkin, Scheer Partners' Matthew Brady, the Montgomery County Planning Board's Tina Patterson, GlenLine Investments' Scott Nudelman and JLL Mid-Atlantic's Peter Briskman

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Novavax COVID-19 Vaccine Found to be Safe and Effective in Phase 3 Trial Conducted by UM School of Medicine Researchers

Research Shows Vaccine Has 90 Percent Efficacy at Preventing Infections; Moderate to Severe Disease Occurred Only in Placebo Recipients

An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published today in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol.

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Zalgen Relocates Headquarters to Life Sciences Epicenter in Frederick, Maryland

Frederick, MD, December 16, 2021 – One of the leading biotechnology and diagnostics companies in the field of neglected viral diseases with pandemic potential now calls a prime biotechnology and life sciences community its home, as Zalgen Labs LLC today announced its headquarters has relocated to Frederick, Maryland.  

Preparedness is Zalgen’s mantra. Founded on the concept of developing solutions to emerging viral threats in neglected regions of the world, Zalgen is dedicated to making a meaningful difference in developing and deploying medical countermeasures against neglected tropical diseases. The company is currently supplying antibody testing kits to the Coalition for Epidemic Preparedness Innovations (CEPI) for the largest ever Lassa Fever study in West Africa.  

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VT Corporate Research Center Receives GO Virginia Grant to Expand Lab Facilities and Resources | VT Corporate Research Center

New collaboration with Johnson & Johnson Innovation announced with the aim to accelerate life science sector growth in the New River and Roanoke Valleys by providing access to expert mentors, programming, and commercialization resources for startup companies

Image: https://www.vtcrc.com

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Senior Operations Manager, JLABS @ Washington, DC in Washington, District of Columbia | Non Operating Companies

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

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$1.1M Grant from GO Virginia Coalition Advancing Biotech at the Virginia Tech Corporate Research Center (VTCRC)

BLACKSBURG, Va. (WDBJ) – “Just watch, we’ve got some great things coming,” Virginia Tech Corporate Research Center President and CEO, Brett Malone said as he closed the gathering on Wednesday afternoon.

More than 50 Leaders and residents from the Roanoke Valley and New River Valley gathered as the Virginia Tech Corporate Research Center announced a new “GO Virginia” Grant, that will help advance life science research across the region. The grant is for $599,000 and will cover the majority of the $1.1 million project, with partners helping to cover the rest.

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Meet Your 2021 BioBuzz Award Winners · BioBuzz

Last year we had nearly 2,000 votes for our inaugural 2020 awards – this year we not only surpassed that number but smashed it with over 4,500 votes total. The outpouring of support across networks and social media was truly incredible and is a testament to the strength of our community in the Biohealth Capital Region. From all of us at BioBuzz, thank you for being such an important part of our regional community.

The award categories include:

And now, cue the drumroll – here are your 2021 BioBuzz Award winners! Congrats to all of this year’s winners as well as our amazing finalists and nominees.

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How Quantum Computing Will Change Everything (with Chad Rigetti

Quantum computing won’t be an incremental improvement – it will be a step-change in the power of the technology that underpins a huge part of our economy. Exponentially faster computing won’t just help us solve problems more quickly, but it will also allow us to tackle problems that have been impossible to answer and find answers to questions we did not know to ask.

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$1B Build Back Better Regional Challenge Finalists | U.S. Economic Development Administration

The $1 billionโ€ฏBuild Back Better Regional Challengeโ€ฏis the marquee of EDA’s American Rescue Plan programs that aims to boost economic recovery from the pandemic and rebuild American communities, including those grappling with decades of disinvestment.

The Challenge provides transformational investments to develop and strengthen regional industry clusters across the country, all while embracing equitable economic growth, creating good-paying jobs, and enhancing U.S. global competitiveness. As part of the $300 millionโ€ฏCoal Communities Commitment, EDA will allocate at least $100 million of the Build Back Better Regional Challenge funding to support coal communities.

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Vaccitech acquires Avidea Technologies to expand product

OXFORD, United Kingdom, and BALTIMORE, Dec. 13, 2021 (GLOBE NEWSWIRE) — Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapies and vaccines, today announced that it has acquired US-based Avidea Technologies, Inc. (“Avidea”).

The consideration to Avidea’s existing shareholders is $40 million (comprised of approximately $12.5 million in cash and $27.5 million in Vaccitech American Depository Shares) in addition to potential future payments that are conditioned upon the achievement of certain development milestones.

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Copyright AA(C) BioHealth Innovation 2021
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486th Edition, December 14, 2021

By BHI Weekly Newsletter Archives





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December 14, 2021

FOUNDING MEMBER OF

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Life Sciences Business Strategist – Open Position!

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

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Vaccitech acquires Avidea Technologies to expand product

OXFORD, United Kingdom, and BALTIMORE, Dec. 13, 2021 (GLOBE NEWSWIRE) — Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapies and vaccines, today announced that it has acquired US-based Avidea Technologies, Inc. (“Avidea”).

The consideration to Avidea’s existing shareholders is $40 million (comprised of approximately $12.5 million in cash and $27.5 million in Vaccitech American Depository Shares) in addition to potential future payments that are conditioned upon the achievement of certain development milestones.

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Global pandemic center will be in Rockville medical office building

A global center focusing on pandemic prevention and biodefense work will be in Rockville, county officials and partners in the project said Wednesday.

Connected DMV, a nonprofit that focuses on initiatives with government, private industry academia and community partners, will launch the center.

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Prestigious annual pediatric medical device competition takes aim at congenital heart disease with five innovators sharing $150K in NCC-PDI grants · BioBuzz

Washington D.C., Dec. 10, 2021 (GLOBE NEWSWIRE) — The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. In an unprecedented decision, the competition judges determined that all five finalists were deserving of a grant award and recognition for the potential patient benefit and commercial viability of their innovations. 

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Montgomery County, MD Chosen for Global Pandemic Prevention and Biodefense Center Headquarters — MCEDC

Rockville, Md. — Montgomery County is home to the new Global Pandemic Prevention and Biodefense Center launched by Connected DMV. The Center will be co-located in Rockville at the US Pharmacopeia offices at 12601 Twinbrook Pkwy, Rockville, MD 20852. 

Connected DMV, a leading Greater Washington organization that seeks to help solve complex regional challenges, spearheaded efforts to establish the Global Pandemic Prevention and Biodefense Center in response to the COVID-19 pandemic. The Center’s goal is to help prevent future outbreaks from becoming pandemics by developing a stockpile of human monoclonal antibodies in advance for emerging infectious diseases and by integrating antibody distribution and delivery across the global health and pandemic prevention ecosystem. Montgomery County is uniquely positioned to be the host location for the Center, which aims to harness the rich talent and critical health research, biotech, defense, and government assets required to deliver a full-scale response.

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The Maryland Stem Cell Research Fund (MSCRF) Grant Programs Now Accepting Applications

The Maryland Stem Cell Research Fund (MSCRF) offers six grant programs to accelerate human stem cell-based research, commercialization, and cures. The six programs are designed to support scientists at universities/research institutes or companies based in MD as well as any US-based company with a clinical trial site in MD.  

All programs are now accepting applications. Learn more and apply by January 13, 2022: https://www.mscrf.org/funding-opportunities

Research funded by the MSCRF has led to breakthroughs in stem cell technologies. Discover how MSCRF is accelerating cures – https://www.mscrf.org/our-impact

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Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19

AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

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WBJ – Novavax’s Campus Expansion Plans Earn Green Light in Gaithersburg

Novavax Inc. (NASDAQ: NVAX) just earned a critical approval to expand its Gaithersburg campus, paving the way for the homegrown biotech to exponentially grow its local footprint and stand up facilities to support research, development and manufacturing for years to come.

The Gaithersburg city council unanimously approved Novavax’s development plan on Monday, marking the end of the approval process and giving the company the green light to advance the project — which could extend up to 605,000 square feet.

“Novavax is pleased with this next step in our continued progress, and we appreciate the support from Mayor [Jud] Ashman and the City Council as we expand our important work in the Maryland biotech ecosystem,” Silvia Taylor, Novavax’s senior vice president of global corporate affairs and investor relations, said in an email Tuesday.

The project stands to swell the company’s Montgomery County footprint, which today comprises 79,000 square feet. It’s slated to include two seven-story buildings, a parking garage and green space in the center of the campus. The 180,000-square-foot facility would include laboratory, office and manufacturing space. It may also include up to 5,000 square feet of retail space.

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Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

ROCKVILLE, Md., Dec. 08, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s Disease (PD).

Following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in November 2020 indicating that the NDA was not sufficiently complete to permit a substantive review. The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021

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NexImmune Announces Preliminary Phase 1/2 NEXI-002 Results in Patients with Multiple Myeloma
  • Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition 
  • Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

GAITHERSBURG, Md., Dec. 12, 2021 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.

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CCP's largest project awarded $204 million extension through July 2025 | Hub

The United States Agency for International Development has awarded a $204 million extension to the Johns Hopkins Center for Communication Programs to continue Breakthrough ACTION, its flagship global social and behavior change project, through July 2025.

Started as a five-year, $300 million project in July 2017, Breakthrough ACTION has now worked in 42 countries in Africa, Asia, and Latin America to forge, test, and scale up new and hybrid approaches to social and behavior change. The project uses state-of-the-art, evidence-based tools and collaborations to encourage people to adopt healthy behaviors such as using modern contraceptive methods, sleeping under bed nets, or being tested for HIV. Breakthrough ACTION harnesses the power of communication to inspire long-lasting change and incorporates behavioral science approaches such as behavioral economics and human-centered design to improve programs.

Image: CENTER FOR COMMUNICATION PROGRAMS

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IonQ Leads Charge for Quantum Commercialization at Q2B 2021

COLLEGE PARK, Md., December 07, 2021–(BUSINESS WIRE)–IonQ, Inc. ("IonQ") (NYSE: IONQ), a leader in trapped-ion quantum computing, today announced its participation at the fifth Q2B Practical Quantum Computing Conference (Q2B 2021). On the heels of multiple recent milestones, the IonQ team will discuss strategies and tactics for a successful enterprise partnership approach, as well as practical machine learning applications as the team paves the way for quantum computing commercialization.

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Seed Funds | TEDCO

We work alongside our entrepreneurs as partners to drive the next wave of startups. We leverage our diverse operating and investing experience to uncover opportunities to add value throughout the life cycle of our portfolio companies. Our goal is to meaningfully contribute to the greatest shared outcomes.

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Innoforce Pharmaceuticals

Innoforce (“INF”), a biopharmaceutical manufacturing & development company, announced today the completion of a 1 billion CNY ($156.6M) Series A financing, with the closing of an additional 375M CNY ($58.7M) following the first tranche of 625M CNY ($96M) completed in March 2021.

The Series A financing round was co-led by Yanchuang Capital and South China Venture Capital (SCVC) with additional investment from existing investor Quan Capital Management. In the most recent tranche, Yanchuang Capital increased its investment and additional investors joined, including Advantech Capital, Triwise Capital, CICC Capital, Highrun Capital, Euland Venture, S&G CAPITAL and others.

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Baltimore should be investing more in ‘wet labs’ | READER COMMENTARY

The critical shortage of “wet lab” space in Baltimore is an indictment of a city economic development strategy more concerned with real estate development than with job development (”Baltimore officials hoping to address shortage of ‘wet lab’ space to retain more innovators,” Nov. 15). Colin Tarbert, head of the Baltimore Development Corporation, warned that the shortage jeopardizes the city’s ability to retain existing life science companies, let alone attract new ones.

Image: https://www.baltimoresun.com/opinion/readers-respond/bs-ed-rr-wet-labs-letter-20211206-dgtyymlxqrbgnijb4xg277gpje-story.html

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Accellix Raises $10 Million From BroadOak Capital Partners

SAN JOSE, Calif. & BETHESDA, Md.–(BUSINESS WIRE)–Accellix Inc., which provides quick and accurate flow cytometry results in a compact and easy-to-use platform designed for use by cell therapy companies on the manufacturing floor and at the point-of-need, today announced that it has raised $10 million from BroadOak Capital Partners.

BroadOak is known for its flexible growth capital and M&A advice for life sciences tools and services companies. The investment is part of BroadOak’s fifth fund and marks the firm’s third investment in the last six months in the rapidly growing market of tools and services for cell and gene therapy development and manufacturing. BroadOak previously invested in Accellix as part of a prior fund.

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Harnessing the power of monoclonal antibodies in virology

Monoclonal antibodies have become one of humanity’s most powerful, multi-use tools in biology and medicine. Once the field of immunology established that they could be produced to bind very specifically to almost any suitable substance, science has had a means of detecting and/or purifying those substances or, in the case of viruses, identifying the antibodies that will serve as effective treatments. And in these times of pandemic, tools to detect viruses such as SARS-CoV-2 at the point of care and produce novel vaccines are more important than ever. 

Image: Dr. James Crowe, Vanderbilt University Medical Center, Nashville, Tennessee

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NexImmune Announces Preliminary Phase 1/2 NEXI-002 Results in Patients with Multiple Myeloma
  • Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition 
  • Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

GAITHERSBURG, Md., Dec. 12, 2021 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.

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Time of day matters when getting COVID vaccine – Harvard Gazette

Our internal 24-hour circadian clock regulates many aspects of physiology, including the response to infectious disease and vaccination. A new study published in the Journal of Biological Rhythms demonstrates that antibody levels are higher when people receive the SARS-CoV-2 vaccine in the afternoon versus the morning.

Image: https://news.harvard.edu/

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Where New Medical Devices Come From | by John G Younger | Bioeconomy.XYZ | Nov, 2021 | Medium

The transition from Angel to institutional funding is a key step (but not quite an absolute requirement) in the evolution of a start-up bringing a new device to market. Broadening investments accompany deepening organizational sophistication, as start-ups more and more take on the business and regulatory trappings of larger device companies. However, even the best medical devices proposed by the best founding teams must cross the most critical governing threshold before reaching the market.

Image: https://medium.com

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BD finalizes name and leadership for its billion-dollar diabetes spinoff | FierceBiotech

BD has settled on a new name for its new company, the independent spinout that will house its billion-dollar diabetes care business. 

Embecta is set to launch as its own, publicly traded brand in the second quarter of 2022 after almost a century of supplying a portfolio of insulin pens and syringes under the BD banner. The diabetes division contributed about 6% of the company’s revenues in the 2020 fiscal year, or nearly $1.1 billion, by serving about 30 million users worldwide.

Image: Carrying over the “bect” in its logo as a nod to Becton, Dickinson and Company, embecta will maintain international manufacturing sites that previously produced around 8 billion injection devices annually. (BD)

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HHS Secretary Becerra Names Dr. Lawrence Tabak Acting Director of NIH | HHS.gov

Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.  

Earlier this year, current NIH director Francis S. Collins, M.D., Ph.D., announced his decision to end his tenure as the NIH director by the end of the year, and his last day as director will be December 19, 2021.  Dr. Collins is the longest-serving, presidentially-appointed NIH director, having served three U.S. presidents over more than 12 years.

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485th Edition, December 7, 2021

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December 07, 2021

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Novavax tailoring Covid-19 vaccine to Omicron variant while advancing campus expansion plans – Washington Business Journal

The company said Thursday it’s implementing “a two-pronged variant strategy” for the variant.

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United Therapeutics Named by Newsweek as One of America’s Most Responsible Companies 2022 | BioSpace

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2022. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The awards list was announced on December 2, 2021, available on Newsweek’s website, recognizes the top 500 most responsible companies in the United States, spanning 14 industries.

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Life Sciences Business Strategist – Open Position!

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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PharmaShots Interview: Cartesian Therapeutics’s Dr. Murat Kalayoglu Shares Insight on RNA Cell Therapy for an Autoimmune Disease

In an interview with PharmaShots, Dr. Murat Kalayoglu, MD, Ph.D., President, and Chief Executive Officer at Cartesian Therapeutics shared his insights on the P-I/IIa study of Descartes-08 for the treatment of the chronic autoimmune disorder generalized myasthenia gravis (gMG)

Shots:

  • Descartes-08 is an autologous T-cell product that is engineered with RNA to encode for CAR 
  • The company focuses to use RNA instead of DNA to engineer the cell target that helps to target antigen without increasing the risk of these cells proliferating out of control and causing the typical CAR-T cell toxicities 
  • Cartesian has currently three RNA cell therapies i.e., Descartes-08 & Descartes-11 which are being developed for multiple myeloma, high-risk patients, newly diagnosed multiple myeloma while Descartes-30 is an off-the-shelf, RNA engineered cell therapy. The company is expected to complete the P-II studies in 2022 and registration studies in 2024

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Baltimore Startup Rasio Therapeutics Raises $1.5M for Software to Develop Drugs

A Baltimore startup that uses computer software to develop cancer drugs has raised $1.5 million in new funding, according to a recent filing.

Rasio Therapeutics is part of Early Charm Ventures, a Baltimore company focused on running and growing startups. The $1.5 million investment comes from BlueDot Bio, a relatively new investment company, said Ken Malone, managing director of Early Charm Ventures.

Click here to read more via Bizjournals (subscription required)

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Possible Life Sciences and Biotechnology Office Building Coming to Pike & Rose in Location Currently Occupied by Bark Social – The MoCo Show

Possible Life Sciences and Biotechnology Office Building Coming to Pike & Rose in Location Currently Occupied by Bark Social

We recently learned of plans for a potential new office building that could be constructed at 935 Prose Street in Pike & Rose, the current site of Bark Social. 

The plans, authored by Scheer Partners, state that the new building will be a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. The architectural plans show lab space, office space, a fitness center, outdoor green terrace, conference facility, and more. 

Image: https://mocoshow.com

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Francis Collins

About a decade before becoming NIH Director—a position from which he will step down at year’s end—Francis S. Collins, M.D., Ph.D., was at the center of one of the hottest debates in the nascent days of genomics: How many protein-coding sequences comprise the human genome?

Image: Francis Collins

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CoSolve challenges

CoSolve is a biannual, global Open Innovation programme seeking collaborators with innovative solutions to real research challenges. These challenges lie within our R&D research focus areas and require solutions that are immediately translatable. We are looking for collaborators from start-ups and early stage biotechs with expertise in these specialised areas, who can bring innovative ideas that can be rapidly translated into tangible solutions. Working together, your ideas could help shape the development and delivery of new therapies and bring them to patients sooner.

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Biohealth Startup to Establish $5M HQ in Loudoun – Loudoun Now

Athari Biosciences has selected Loudoun County for its new corporate headquarters.

The project includes a wet lab, a tech lab, research and development and office space and is expected to open in early 2022. The project is expected to create 50 jobs with a total investment of $5 million, according to the county’s Department of Economic Development.

The Board of Supervisors will consider a cash incentive of $120,000 to support the completion of the lab space at its Dec. 7 meeting. The incentive has been proposed by the economic development department, which worked with Athari’s leadership team in the search for the firm’s long-term home in the region.

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484th Edition, November 30, 2021

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November 30, 2021

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BioHealth Capital Region Spotlight: Creative Bio-Peptides Awarded $5.78 from NIH to Develop Breakthrough Treatments for Neuroinflammatory/Neurodegenerative Indications

Creative Bio-Peptides, Inc., an emerging drug development company focused on the development of leading-edge multi-chemokine antagonist therapeutic peptides for neuroinflammatory/neurodegenerative conditions, has been awarded $5.8M in non-dilutive funding from three NIH agencies.

“BHI congratulates Creative Bio-Peptides on this significant accomplishment and recognition by the National Institutes of Health,” said Rich Bendis, President & CEO, BioHealth Innovation. “We are proud of our partnership with Creative Bio-Peptides and how both teams worked together in successfully submitting multiple proposals which were funded in this extremely competitive SBIR process.”

Two of the three grants each represent multi-million-dollar funding over a 2-year period as part of the NIH’s HEAL Initiative, committed to providing safe non-opioid pain treatments for the 50 million Americans living with daily chronic pain as well as the 2 million Americans living with dependency or addiction to opioids.

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Supernus Pharmaceuticals Completes Acquisition of Adamas Pharmaceuticals

Acquisition strengthens Parkinson’s disease portfolio and diversifies revenue and cash flow

ROCKVILLE, Md., Nov. 24, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) today announced that it has successfully completed its previously announced acquisition of Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS).

“Adamas fits squarely within our corporate development strategy, adding a late-stage commercial product with significant revenue,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “In addition, the acquisition adds a new growth catalyst, diversifies our revenue base and cash flow, and is expected to be significantly accretive in 2022.”

Compelling Strategic Rationale

  • Strengthens Parkinson’s disease portfolio with GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy and Osmolex ER® (amantadine) extended release tablets, approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.
  • Diversifies and increases revenue base and cash flow, and combined with the acquisition of US WorldMeds CNS products in 2020, significantly reduces the reliance on net sales of Trokendi XR®.
  • Potential synergies of $60 million to $80 million in year one due to strong overlap with existing infrastructure.
  • The acquisition is expected to be significantly accretive in 2022.

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Life Sciences Business Strategist – Open Position!

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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QIAGEN reaffirms effectiveness of its SARS-CoV-2 PCR tests in light of the new coronavirus variant B.1.1.529

HILDEN, Germany & GERMANTOWN, Maryland–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections in light of the emergence of a new variant of concern detected in South Africa.

QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against the genetic mutations of the variant, which is known by its scientific name, B.1.1.529. The assessment was made against data available in the GISAID and GenBank public databases.

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Immunomic Therapeutics Announces Collaboration With iOncologi

– Potential to bring in-house cell-based therapies that potentiate checkpoint inhibitors

November 23, 2021 06:41 PM Eastern Standard Time

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”) a privately held clinical-stage biotechnology company focused on advancing its proprietary nucleic acid immunotherapy platform, announced today an exclusive option to license or acquire a series of innovative technologies in the immuno-oncology space from iOncologi, Inc., (“iOi”).

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Montgomery County Hires State House Vet to Coordinate White Flint BioHub Proposal

Montgomery County failed in its bid lure Amazon, the e-commerce giant that opted to build its second headquarters in Arlington, Va.

But top county officials have an alternate vision for the area surrounding the White Flint Metro station — a “life sciences hub” that exploits the presence of the close-by National Institutes of Health and Food and Drug Administration.

“My goal is to produce a signature project that restates Montgomery County’s case as the leading life sciences center in the country,” said Montgomery County Executive Marc B. Elrich (D) in an interview. “(White Flint) is sitting on the Metro. It’s right down from the Beltway, and there’s a ton of under-developed property there.”

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Emmes Announces Completion of Third ACTT Clinical Trial for COVID-19

ROCKVILLE, Md., Nov. 29, 2021 /PRNewswire/ — Emmes today announced that it conducted the data and statistical analysis for the third iteration of the Adaptive COVID-19 Treatment Trial (ACTT-3), using its proprietary Advantage eClinical system.  The ACTT-3 trial assessed the efficacy and safety of interferon beta-1a plus remdesivir compared to remdesivir alone in hospitalized adults with COVID-19.

Preliminary data from prior small studies had suggested a potential benefit of interferon beta-1a, a natural antiviral component of the immune system, for COVID-19 patients.  The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored a randomized, double-blind, placebo-controlled clinical trial that included 969 participants at 63 hospitals in five countries, including the U.S. to evaluate the combination of interferon beta-1a and remdesivir.

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LifeSprout, Inc. Appoints Michael Kranda as CEO and Director

Industry veteran to lead regenerative cell therapy products company

November 18, 2021

BALTIMORE–(BUSINESS WIRE)–LifeSprout, Inc., a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced the appointment of Michael Kranda as CEO and member of the board of directors.

“We’re pleased to have attracted an executive of Michael’s caliber to lead LifeSprout at this pivotal time for the company as we proceed to leverage the full potential of our regenerative cell therapy platform,” said Sashank Reddy, M.D., Ph.D., co-founder of LifeSprout.

“I welcome the opportunity to lead the LifeSprout team, and collaborate with the thought leaders in tissue engineering, nano biotechnology, and materials science from Johns Hopkins to establish a new standard of bio stimulatory products for cell therapy applications,” said Kranda, LifeSprout, Inc. CEO.

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Bank of antibodies against nasty viruses that’s proposed for Maryland aims to prevent next pandemic.

As the world continues to grapple with the coronavirus pandemic that has claimed more than 5 million lives, a group of researchers is working to get ahead of the next killer pathogen.

They aim to identify and establish a bank of warrior antibodies in Maryland, close to the National Institutes of Health in Bethesda. The antibodies would be derived from a who’s who of viruses most likely to wreak havoc, such as coronaviruses, influenzas, and flaviviruses that cause Zika and debilitating conditions such as encephalitis.

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Richmond Inno – The Center for Innovative Technology has a new name. Here’s how it aims to impact Virginia's innovation ecosystem

The Center for Innovative Technology is now known as the Virginia Innovation Partnership Corporation. But it’s more than just a name change.

The rebranding is seen as a vital step in helping to propel Virginia forward as a nationwide leader in innovation, startups and technology, said Bob Stolle, president and CEO of VIPC

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Health Canada announces results of Emergent BioSolutions facility inspection | BioSpace

OTTAWA, ON, Nov. 24, 2021 /CNW Telbec/ – Health Canada

Health Canada has completed its onsite inspection of the Emergent BioSolutions   facility in Baltimore, Maryland. The European Medicines Agency and South African Health Products Regulatory Authority also participated in this inspection remotely. All three regulators found the facility to be compliant with Good Manufacturing Practices (GMPs).

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TEDCO's Maryland Innovation Initiative Advances Innovative Technologies From Lab to Market

COLUMBIA, Md., Nov. 22, 2021 /PRNewswire/ — TEDCO, Maryland's economic engine for technology companies, announced its recent round of funding, including investments in 12 start-up companies and funding to 36 university projects through the Maryland Innovation Initiative (MII). 

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park. The program's mission is to accelerate promising technologies with significant commercial potential to market while leveraging each partner University's strengths.

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Report: Baltimore leaders have 150 recommendations to grow an 'equitech' city – Technical.ly Baltimore

Baltimore leaders are coalescing around a big vision to build a more inclusive tech economy over the next decade, but there will be many small steps required to get there.

It means involving the whole community. That’s why ecosystem-building org UpSurge Baltimore rallied more than 200 partners this year to center Baltimore’s growth as a tech hub through the lens of equitech. UpSurge launched in April with equitech as a framework for prioritizing startups and companies with diverse leadership, teams and products that address societal barriers. It also partnered with Techstars to bring an accelerator to Baltimore focused around that vision. Around the same time, it also launched UpSurge Teams to convene.

Image: Photo by Flickr user Sue, used under a Creative Commons license

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Collaborative Minds: Big Solutions – Hosted by the NOVA BioHub (Dec 2)

December 2nd, 12:00 P.M. – 1:15 P.M.
Location: George Mason University SciTech Campus (Manassas, VA)

The event will also be offered virtually
Please click here to RSVP

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Red Cell Forms Zephyr AI to Revolutionize Drug Discovery and Precision Medicine

TYSONS, Va.–(BUSINESS WIRE)–Red Cell Partners (“Red Cell”), an investment and incubation firm that backs, builds, and scales technology-led companies in healthcare and defense, today announced the formation of Zephyr AI, Inc. (“Zephyr AI”).

Zephyr AI’s mission is to transform drug discovery, redefine personalized medicine, and empower healthcare systems to achieve better patient outcomes at lower cost. Zephyr AI integrates artificial intelligence with extensive datasets to upend traditional “guess and test” drug development and personalized medicine processes to unearth novel therapeutics, new applications for existing therapeutics, and advanced biomarkers for individualized treatments.

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The Healthtech Index

Study uses data to reveal the cities with the most developed healthtech ecosystems in the world, and identify the cities that are leading the technological advancement of different healthcare sectors, including telemedicine and mental health.

  • Out of the 85 best cities for healthtech in the world, Boston ranks #1.
  • Boston is the highest ranking city in the index and the global capital of biometric data gathering, hearing aids, cardiovascular and gynaecology. New York and San Francisco rank second and third.
  • Taipei leads the index for R&D funding levels in healthtech, followed by Beijing and Boston.
  • Boston has the highest number of healthtech startups, ahead of San Francisco and Singapore. 
  • Healthtech employees in Zurich receive the highest salaries, followed by Basel and San Jose (USA). Employees in Beijing receive the lowest salaries for the same job roles.

Berlin, Germany, November 2021 – software development company Moove-It.com has released a study that analyzes the healthtech capabilities of 85 global cities. As a company that helps organizations use technology for positive impact in multiple industries including healthcare, Moove It decided to conduct a study to identify which global locations have the most developed healthtech ecosystems. To do this, they assessed each city against a range of factors related to investment, corporate infrastructure, human capital, and their healthtech credentials in different sectors. The resulting index gives insight into which cities have the most robust healthtech ecosystems, and which are the global capitals of healthtech in different healthcare sectors.

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483rd Edition, November 23, 2021

By BHI Weekly Newsletter Archives





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November 23, 2021

FOUNDING MEMBER OF

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Happy Thanksgiving!

Happy Thanksgiving from the BHI Team!

Deka Biosciences Raises USD 20 Million in Series A Financing

GERMANTOWN, Md., Nov. 16, 2021 /PRNewswire/ — Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

Deka Biosciences 2021 Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines™ – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine™ structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine™ to patients that will benefit the most.

Read More

Life Sciences Business Strategist – Open Position!

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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Study aiming to define acute traumatic encephalopathy (ATE) published by leading neurology journal | VirginiaBio

BrainBox HeadSmart II Study Investigators Aim to Provide Clinicians with First-Ever Biomarkers and other Functional measurements for Acute Traumatic Encephalopathy (ATE.) A clinical trial of multi-modal diagnostic/prognostic test, already underway, is published in Frontiers in Neurology/NeuroTrauma.

Investigators in a major clinical trial of patients with mild traumatic brain injury (mTBI or concussion) describe for the first time objective diagnostic criteria, based on blood biomarkers and neurologic testing, for acute traumatic encephalopathy (ATE), the immediate physiologic consequence the injury.

Acute Traumatic Encephalopathy (ATE) represents the condition of an objective measure of TBI associated symptoms or dysfunction that occur as long as 90 days following an acute head injury, according to the investigators. It may be manifest by neuropsychiatric dysfunction, imaging pathology, or biomarker abnormalities in a patient presenting with a history consistent with TBI. Objective criteria for ATE have the potential to advance the understanding of mild TBI and significantly improve its subsequent clinical management.

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Health IT Panel Focuses on Leveling the Playing Field for Women in Healthcare Leadership – Children's National

Although women account for nearly half of entry-level jobs in the healthcare industry, female clinician-scientist executives continue to be sparse among healthcare leadership ranks. Less than a third of C-suite roles – approximately 26 percent – are filled by women and tend to focus on human resources or marketing, according to a recent analysis by Becker’s Hospital Review.

Image: Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital, spoke on gender gaps in healthcare leadership during the 6th annual Health IT + Revenue Cycle Conference hosted by Becker’s Healthcare.

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REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

ROCKVILLE, Md., Nov. 22, 2021 /PRNewswire/ —

  • Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector
  • Commercial-scale cGMP material to be used in clinical development
  • Company on track to submit IND by end of 2021

REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal domain and a muscle specific promoter to support targeted therapy for improved resistance to muscle damage associated with Duchenne. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector. 

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Montgomery Establishes Small Business Accelerator Program with M&T Bank – Conduit Street

Montgomery County announced that it has collaborated with M&T Bank to establish a Small Business Accelerator Program to aid minority business owners.

The Montgomery County Office of Human Rights and M&T Bank announced this week that they will partner to host a new 10-week business accelerator program to small businesses based in the county.

The program, set to begin January 11, 2022, will be free for participants and will feature business mentors, coaches and subject matter experts.

Image: https://conduitstreet.mdcounties.org – From Tweet

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These 12 startups are entering the Baltimore-based Techstars Equitech Accelerator – Technical.ly Baltimore

The first cohort of the Techstars Equitech Accelerator is bringing global startups to Baltimore, and supporting companies already growing from a base in the city.

On Thursday, the accelerator announced the first 12-company cohort for the Baltimore-based program, kicking off the programming phase for one of the key initatives aimed at making the city a top-tier tech hub through the lens of equitech. This framework, coined and championed by UpSurge Baltimore, prioritizes supporting companies that are led by underrepresented founders, building diverse teams and developing solutions that aim to address systemic societal challenges.

Image: The Baltimore skyline. (Photo by Flicker user Phil! Gold)

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Emmes and MedGenome Launch Genomics Strategic Partnership Focused on Advancing Rare Disease Research

ROCKVILLE, Md., Nov. 15, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients.

"This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treatments to patients around the world who are suffering from rare diseases and desperately awaiting new therapies," said Emmes Chief Executive Officer Dr. Christine Dingivan.

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TEDCO Generates $2.3 Billion in Economic Benefits to the State of Maryland and Supports 10,433 Maryland Jobs, According to New Independent Study

COLUMBIA, Md., Nov. 17, 2021 /PRNewswire/ — TEDCO, Maryland's economic engine for technology companies, announced today the findings of an independent study detailing the impact of TEDCO's six core programs to the state of Maryland.

Conducted by the University of Baltimore's Jacob France Institute, the study found that TEDCO provides significant value to the state's start-up community, supporting 10,433 Maryland jobs and more than $2.3 billion in statewide economic activity as of 2021.

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Maryland Today | UMD Ranks Among Top 10 Schools for Entrepreneurship…

The University of Maryland secured its place among the nation’s top schools for entrepreneurship in new rankings that reflect its commitment to innovation education during the height of virtual learning amid the pandemic.

In the 2022 edition of the annual rankings, announced today by The Princeton Review and Entrepreneur magazine, UMD placed No. 10 for undergraduate entrepreneurship education across all institutions—its seventh consecutive year in the top 10 and 10th straight year in the top 25—and No. 4 among public universities. It was also listed at No. 24 for graduate entrepreneurship education. New this year, The Princeton Review ranked schools regionally, and UMD came in at No. 2 in the Northeast.

Image: MFA in performance alum Rob Jansen leads a workshop, "The Art of Presence: How to Warm Up for a Presentation," at the Startup UMD Suite in the Diamondback Garage. UMD's efforts to support entrepreneurs and innovators were recognized yesterday by The Princeton Review and Entrepreneur magazine. Photo by Emma Howells

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Alexandria Real Estate Equities, Inc. Is Leading the Integration of Mission-Critical R&D and Next-Gen Manufacturing for Companies in Research Triangle That Are Developing Targeted Gene and Cell Therapies and Other Complex Medicines

PASADENA, Calif. and DURHAM, N.C., Nov. 16, 2021 /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, agtech and technology campuses in AAA innovation cluster locations, today announced that it is advancing the revolution for complex integrated R&D and next-gen manufacturing in Research Triangle, N.C. through its strategic partnerships with top-tier emerging biotechnology companies, along with its acquisition of purpose-focused development sites in the region, to enable their increased control over the quality of their medicines, patient access, supply chains, and their intellectual property, critical processes and talent.  

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Top 10 RNA-Based Biopharmas

In institutions and companies, investigators spent some two decades working on RNA-based drugs and vaccines before COVID-19 afforded many of them an opportunity to apply all that research into patients, with support from governments and regulators eager to fight the pandemic.

For two once obscure companies—Moderna, which went public in 2018, and BioNTech, which followed a year later—that opportunity has translated into multiple billions of dollars in new revenues. Not surprisingly as a result, both companies far outpace the other public companies ranked by GEN this year among top RNA-based biopharma companies.

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482nd Edition, November 16, 2021

By BHI Weekly Newsletter Archives
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November 16, 2021

FOUNDING MEMBER OF

 

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Deka Biosciences Raises USD 20 Million in Series A Financing
 

GERMANTOWN, Md., Nov. 16, 2021 /PRNewswire/ — Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

Deka Biosciences 2021 Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakinesโ„ข โ€“ intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakineโ„ข structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakineโ„ข to patients that will benefit the most.

 

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BioTalk Rewind, John Mumm, CEO of Deka BioSciences, Virtually Chats with Rich Bendis on BioTalk
 

Deka BioSciences CEO, John Mumm, CEO of Deka BioSciences, virtually guests on BioTalk to discuss his history in the BioHealth Capital Region, Precision Medicine, and Funding Strategies.

Listen now via Apple http://apple.co/3aIy6Ew, Google http://bit.ly/3sfEysd, Spotify http://spoti.fi/3aJq8ei, and Tunein http://bit.ly/2Me25ut.

John has spent 24 years researching and developing various technologies associated with IL-10. His work experience included various leadership roles at Anergen, Introgen Therapeutics, Bacterial BarCodes, Schering-Plough, Merck, Targenics, ARMO BioSciences, ACIR BioSciences, and MedImmune/AstraZeneca. Johnโ€™s primary focus has been on discovery research at the interface between cancer biology and the adaptive immune response. Visit https://www.dekabiosciences.com/ to learn more about them today.

Click here to view the transcript.

 

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Life Sciences Business Strategist – Open Position!
 

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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BHI EIR Feedback Day November 17th. Register Now!
 

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

 

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Emmes and MedGenome Launch Genomics Strategic Partnership Focused on Advancing Rare Disease Research
 

ROCKVILLE, Md., Nov. 15, 2021 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients.

“This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treatments to patients around the world who are suffering from rare diseases and desperately awaiting new therapies,” said Emmes Chief Executive Officer Dr. Christine Dingivan.

 

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Making The Impossible Possible: A Conversation With Martine Rothblatt
 

In this riveting Whatโ€™s Ahead conversation youโ€™ll hear how Martine Rothblatt, creator of SiriusXM, left the communications field entirely to hunt for a cure for a rare, mortal disease with which her daughter was diagnosed. The pressure was intense, as patients usually died within two to three years of diagnosis. After immense effortโ€”and setbacksโ€”Rothblatt and her team came up with an effective treatment, which saved her daughter and thousands of others.

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Maryland’s Gain Therapeutics, Inc. Announces Breakthrough Pre-Clinical Data of Novel Small Molecules for the Treatment of Parkinson’s Disease and Gaucher Disease
 

Study results demonstrate first small molecule approach to significantly reduce phosphorylated and aggregated -synuclein and increase GCase protein levels with transport to the lysosomes in iPSC dopaminergic neurons

Results presented at Michael J. Fox Foundation’s Therapeutic Development Webinar

BETHESDA, Md, Nov. 10, 2021 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company directly addressing the urgent need for effective neurodegenerative therapies, today announced data from the Company’s study conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds โ€“ GT-02287 and GT-02329 โ€“ for the treatment of Gaucher and GBA1 Parkinson’s Disease, demonstrated highly statistically significant effects on all tested phenotypes representing a key breakthrough in the potential to treat neurodegenerative disorders characterized by misfolded proteins including Parkinson’s Disease, Alzheimer’s, Gaucher’s Disease and Lewy Body Dementia. Study results were presented at The Michael J. Fox Foundation for Parkinson’s Research’s Innovating from Drug Discover to the Clinic: Novel Approaches to PD Therapeutic Development webinar.

 

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TwinLabs in Rockville Fills Up With Four New Tenants โ€“ Commercial Observer
 

The first phase of TwinLabs, a life sciences complex in Rockville, Md., has been fully pre-leased, with four companies taking the entire 25,000 square feet of space, according to JLL, which is handling leasing for the property.

A joint venture between Bethesda, Md.-based GlenLine Investments and Singerman Real Estate of Chicago is redeveloping two buildings adjacent to the National Institute of Allergy and Infectious Diseases HQ into Class A lab space, after making major capital improvements. The duo acquired the 74,500-square-foot asset in 2020. 

Image: TWINLABS AT 5640 FISHERS LANE. PHOTO: JLL

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REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie
 

ROCKVILLE, Md., Nov. 9, 2021 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. As previously announced on September 13, 2021, under the terms of the agreement, REGENXBIO will receive an upfront payment from AbbVie of $370 million with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones.

Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO will participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

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South Duvall and Sagamore Ventures to Bring Life Science to City Garage
 

BALTIMORE, Nov. 10, 2021 /PRNewswire/ — South Duvall and Sagamore Ventures have announced a partnership to bring more than 100,000 square feet of biotech laboratory space to City Garage in Port Covington, Baltimore, over the next 10 years, with approximately 75,000 square feet being delivered in the next year, announced Scheer Partners, which brokered the transaction.

“Baltimore is home to many world class institutions, but there’s been a true need for space built for research and development,” said Matthew Brown, Director of Acquisitions, South Duvall. “City Garage and Port Covington will be the perfect place for the innovative life science community to grow in Baltimore.”

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935 Prose – The Next Evolution in Innovation.
 

935 Prose is a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. It is positioned to recruit and retain the best-and-brightest scientific talent and will set a new standard for life science facilities. Located in the heart of North Bethesdaโ€™s nationally-acclaimed, metro-accessible, Pike & Rose mixed-use neighborhood.

Image: From PDF

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481st Edition, November 9, 2021

By BHI Weekly Newsletter Archives





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November 9, 2021

FOUNDING MEMBER OF

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BioTalk Welcomes Ellington West, CEO & Co-founder of Sonavi Labs

Ellington West, CEO & Co-founder of Sonavi Labs, joins BioTalk to discuss their building the startup, their medical device, and raising funds in the BioHealth Capital Region.

Listen via Apple https://apple.co/3H25FPN, Google https://bit.ly/3kfXaXH, Spotify https://spoti.fi/3kgBLxI, and TuneIn https://bit.ly/3H43oU6.

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Life Sciences Business Strategist – Open Position!

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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BHI EIR Feedback Day November 17th. Register Now!

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Gaitherburg's Adaptive Phage Therapeutics Announces Strategic Agreement with ARLG to Support Phase 1b/2 Cystic Fibrosis Study

GAITHERSBURG, MD, November 2, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has entered into an agreement with the Antibacterial Resistance Leadership Group (ARLG) to support a multi-center Phase 1b/2, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. 

ARLG consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. Created in 2013, ARLG is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. It is facilitated by the Duke Clinical Research Institute and works under the leadership of an executive committee, four component centers, and two Principal Investigators: Vance Fowler, MD, of Duke University, and Henry "Chip" Chambers, MD, of University of California, San Francisco. The NIAID is the Sponsor of this study.

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Record Funding Invested in Montgomery County, Maryland Companies in 2021 Q1-Q3 — MCEDC

Rockville, Md. — Thus far in 2021, a record pace for initial public offerings (IPO), private investment and venture capital deals has been set in Montgomery County. Over $18 billion of investment across 76 companies and 87 separate transactions have been made in the first three quarters of the year from January 1 through September 30. The companies receiving funding span major industries from life sciences and health tech to quantum and media.

Image: https://thinkmoco.com

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Strategies in uncertainty: How best to expand our licensed nurse aide workforce – Guest columns – McKnight's Long-Term Care News

The U.S. Department of Health and Human Services declared a Public Health Emergency (PHE) in response to the COVID-19 pandemic on January 31, 2020.

The Centers for Medicare & Medicaid Services followed by issuing waivers covering certain requirements that directly impact nurse aide training.  Legislators and regulators reacted by approving individual state waivers aligned with CMS’ guidance that aimed to ease the challenges of increasing the number of certified nurse aide caregivers. Some of the most significant challenges include the closure of or limited access to nurse aide testing facilities, a shortage of qualified nurse instructors and mandated quarantine protocols.   

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Deka Biosciences Announces Scientific Advisory Board Members — DEKA BioSciences

Germantown, MD (November 4, 2021) – Deka Biosciences is pleased to announce the appointment of six new members to its Scientific Advisory Board: Aurélien Marabelle, MD, PhD (Gustave Roussy), Aung Naing, MD, FACP (MD Anderson Cancer Center), Abhishek Tripathi, MD (OU Health Stephenson Cancer Center), Khusru Asadullah, MD (The Charité – Universitätsmedizin Berlin, Dermatological Practice in Potsdam), Hans-Dieter Volk, MD (The Charité – Universitätsmedizin Berlin), and Florin Selaru, MD (John’s Hopkins University). 

“It is my honor to welcome such a highly esteemed group of world leaders and experts in regulation of the immune system to the company’s Scientific Advisory Board” said Dr. John Mumm, CEO, Deka Biosciences. “Each member will be invaluable to Deka as we continue to develop our Diakines into the next generation targeted cytokine platform that drive cures in both cancer and in patients suffering from autoinflammatory disease.”

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Virginia Catalyst Awards $1.9 Million in Grants to Support Life Sciences in the Commonwealth | VirginiaBio

The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC),  announced that it has awarded $1.9 million in grants to three life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 12 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

“We are excited to continue our mission of supporting collaborations and fostering economic growth in Virginia’s life sciences, enabling the Commonwealth to compete on a national and global scale,” said Mike Grisham, CEO, Virginia Catalyst. “The critical mass achieved by these collaborations provides Virginia with competitive advantages over other states and has resulted in significant outside capital being invested to finance the commercialization of Virginia’s innovations and create significant high-paying jobs for the Commonwealth.”

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'I see amazing momentum.' Efforts to find HIV cure are speeding up in Maryland | WJLA

The efforts to find a functional cure for HIV are speeding up for one Maryland company after the Data Safety and Monitoring Board found no serious, adverse events with the third patient, as was the case for the previous two, American Gene Technologies announced.

"One patient can be lucky. Two can be very lucky. Three is a trend, and so actually the Data Safety and Monitoring Board has decided that they will meet quarterly from now on. We don't need to check in with them between each patient, so that means we can greatly accelerate the clinical trial," said CEO and Founder of American Gene Technologies Jeff Galvin.

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CIT GAP Funds Invests in Cerillo to Illuminate Scientific Research Possibilities with Innovative Technologies

Richmond, VA, Oct. 13, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) today announced that CIT GAP Funds, the direct investment program of the Virginia Innovation Partnership Authority (VIPA) has invested in Charlottesville, Va.-based Cerillo. Cerillo designs innovative laboratory technologies that allow scientists to collect data more efficiently and researchers to amplify their impact on the world. Cerillo will use CIT’s funding to expand sales and marketing efforts and to continue expanding its business operations and product development teams, which will position the company for rapid growth.

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Early Charm Announces Doubling of Production and Development Space at Baltimore’s 1100 Wicomico

November 2, 2021, Baltimore, MD – In a move to accommodate its continued fast growth, Early Charm – a company that creates, owns and operates ventures that convert science to revenue – announced today it is more than doubling its production and lab space at Baltimore's 1100 Wicomico building.

This significant expansion will occur adjacent to Early Charm's 3,200 square feet of current production and development space, bringing total production and development space to just under 7,000 square feet.

Image: https://www.earlycharm.com/

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Maryland on track to surpass $2B in VC funding this year

By Giacomo Bologna

November 03, 2021, Maryland is on track to top $2 billion worth of venture capital deals in 2021, its highest ever total.

The state had 34 deals totaling almost $400 million in the third quarter of the year, according to the most recent PitchBook-NVCA Venture Monitor report, which is released quarterly with support from Silicon Valley Bank and Affinity.

Through three quarters of 2021, Maryland has had 134 deals worth about $1.6 billion, the report said. This surpasses the entire amount of venture capital raised in 2020, when companies in Maryland raised about $1.26 billion.

PitchBook-NVCA Venture Monitor revised some figures it released earlier this year, but Greater Baltimore still appears headed for a record-breaking year. The area had 13 deals totaling $72 million in Q3, pushing its year-to-date total past $500 million. That's just shy of 2020's $524 million VC total for the entire year.

Click here to read more from the Business Journals. Subscription may be required.

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Six Up-and-Coming COVID-19 Vaccines

Since the start of the COVID-19 pandemic, the response from public health agencies, regulators, researchers, and industry has been dominated by the development of vaccines. As of October 14, McGill University’s McGill COVID19 Vaccine Tracker listed 153 vaccines in clinical development, of which 23 had been approved or authorized for emergency use in at least one country.

In the United States, the FDA has approved one COVID-19 vaccine (Pfizer/BioNTech’s Comirnaty) and authorized for emergency use two others (Moderna’s Moderna COVID-19 Vaccine and Johnson & Johnson’s Janssen COVID-19 Vaccine). Beyond the United States, most approvals and authorizations have been granted to those vaccines and others developed by AstraZeneca/University of Oxford (122 countries), Sinopharm (65), Sinovac Biotech (40), Russia’s Gamaleya Research Institute (16), and CanSino Biologics (9).

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These Countries Have The Most Startup Investment For Their Size – Crunchbase News

Among the world’s largest nations, the U.S. has by far the highest rate of startup investment relative to population. Over the past year, venture investors put nearly $270 billion to work—averaging out to around $800 for every person in the country. 

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But among all countries, the U.S. ranks fourth in per capita startup investment. The No. 1 and No. 2 slots go to Singapore and Israel, two smaller countries that punch well above their weight class for tech-driven entrepreneurship.

Image: https://news.crunchbase.com

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480th Edition, November 2, 2021

By BHI Weekly Newsletter Archives





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November 2, 2021

FOUNDING MEMBER OF

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BioTalk Welcomes Amritha Jaishankar, PhD, Executive Director, Maryland Stem Cell Research Fund (MSCRF)

Amritha Jaishankar, PhD, Executive Director, Maryland Stem Cell Research Fund (MSCRF), joins BioTalk to discuss her career, investing in Maryland, and accelerating cures.

Listen via Apple https://apple.co/3ED5uIy, Google https://bit.ly/3EudFqG, Spotify https://spoti.fi/3EudHii, and TuneIn https://bit.ly/3bs9a3u.

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Paul Rennie OBE and Professor Jason Snape Join Rich Bendis on BioTalk

Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 – UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

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A US – UK Discussion: How to Conduct Clinical Trials as Seth Toback, Vice President, Clinical Development at Novavax and Divya Chadha Manek, Director of Business Development at the National Institute for Health Research (NIHR) join Rich Bendis on BioTalk.

Listen now via Apple https://apple.co/3BSIFjn, Google https://bit.ly/3j7YyLt, Spotify https://spoti.fi/2Z474Ec, and TuneIn https://bit.ly/3DUweUz.

Divya Chadha Manek was appointed as the NIHR CRN’s Head of Commercial Business Development in 2015 then in 2020, Divya was seconded to the UK Vaccines Taskforce (VTF) which was set up in response to the COVID-19 pandemic to lead the UK’s search for a safe and effective vaccine. Divya was responsible for supporting global pharmaceutical companies to rapidly generate the evidence required for marketing authorisation of COVID-19 vaccines. Divya also played a pivotal role in conceptualising and developing the NHS Vaccine Research Registry.

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Ellume team for takies the Accenture Australia Award for Product Innovation

Congrats to Dr Sean Parsons and the Ellume team for taking out the Accenture Australia Award for Product Innovation at the Lord Mayor’s Business Awards.

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Catalent’s Investment in Expanding its State-of-the-Art Gene Therapy Commercial Manufacturing Campus in Harmans, Maryland, Increases to $360M

SOMERSET, N.J. – October 26, 2021 — Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced a $230 million expansion project to add three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene therapy campus in Harmans, Maryland, to meet growing customer demand.

The Harmans campus, located close to Baltimore Washington International Airport (BWI), includes a now fully operational, state-of-the-art U.S. FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. A second facility is under construction following an initial $130 million investment by Catalent in 2020, which will add five new manufacturing suites that are expected to be operational mid-2022. This latest investment will include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for just-in-time inventory space, ultra-low temperature freezers, and its water-for-injection infrastructure. When complete at the end of 2022, the campus will house a total of 18 CGMP viral vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000-liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance.

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JuneBrain Moves to UM BioPark for Next Growth Phase | UM BioPark

BALTIMORE, MD, OCT. 29, 2021 – The University of Maryland BioPark (UM BioPark) today announced that JuneBrain Inc., a telehealth device company that empowers ophthalmology and neurology communities, joined the UM BioPark as its newest tenant. JuneBrain, a Maryland-based company, is located in the BioPark’s innovation space in the Lion Brothers Building on Hollins Street.

“We are delighted to welcome JuneBrain to our tenant community,” said Jane Shaab, executive director of the UM BioPark. “The BioPark is an ideal fit for emerging technology companies seeking pre-built space to grow. By fostering unique opportunities and connections, we provide a supportive environment that helps companies thrive at any stage in their development.”

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BHI EIR Feedback Day November 17th. Register Now!

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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Maryland Commerce Launches Maryland Innovation Investment Tax Credit – The Southern Maryland Chronicle

BALTIMORE, MD (October 26, 2021) — The Maryland Department of Commerce has launched the Maryland Innovation Investment Tax Credit, which will help foster the growth of the state’s technology sectors by incentivizing investment in early-stage companies. The program, which has $2 million in funding for FY 2022, will also help increase overall investments in current and emerging tech sectors, and boost the number of individual investors in Maryland tech companies.

Applications from potential qualified Maryland technology companies are now being accepted. To submit an application, click here. To be eligible, a company must have 50 employees or less; an aggregate capitalization of at least $100,000; and be in a qualifying tech sector, which includes advanced manufacturing, aerospace, agriculture, artificial intelligence, blue technology, cybersecurity, education, energy and sustainability, financial, life sciences, quantum, and sensors and robotics. 

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Noble Life Sciences Welcomes Rigoberto Sanchez, Associate Director, Quality Assurance.

Noble Life Sciences is delighted to welcome Rigoberto Sanchez, Associate Director, Quality Assurance (QA).

Dr. Sanchez will be responsible for Quality Assurance and regulatory compliance with Title 21 of the US Code of Federal Regulations (CFR), Part 58, for studies conducted in accordance with Good Laboratory Practices; animal welfare regulations provided by the Guide for the Care and Use of Laboratory Animals and the Office of Laboratory Animal Welfare (OLAW); the Institutional Animal Care and Use Committee (IACUC); standards provided by the Association for Assessment and Accreditation for Laboratory Animal Care (AAALAC) and additional local, state, federal and international regulations.

Image: https://content.noblelifesci.com

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MaxCyte Signs Strategic Platform License with Nkarta, Inc. to Advance Natural Killer Cell Therapy Programs

Nkarta to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its oncology cell-therapy candidates

SOUTH SAN FRANCISCO and GAITHERSBURG, Md., Oct. 28, 2021 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Nkarta, Inc., a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer.

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Novavax files for authorization of Covid-19 vaccine in UK – Washington Business Journal

Novavax Inc. (NASDAQ: NVAX) has filed for regulatory approval of its Covid-19 vaccine candidate in the U.K. — a major step toward seeking approval in more countries, including the U.S.

The Gaithersburg biotech said Wednesday it has completed all of the requirements for its submission to the U.K.’s regulatory agency, after kicking off a rolling review process earlier this year. It’s a big step for the company, which has faced numerous manufacturing challenges that have prolonged its ability to get its protein-based vaccine across the finish line in multiple markets.

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Women in Bio Celebrates 20 years and Foundational Roots in the DC area

October 2021, A 2020 survey conducted by BIO found that in the 100 biotech companies surveyed, women made up nearly half of total employees, but accounted for only 31% of executives and 23% of CEOs. Women’s representation suffers a steep decline in leadership positions across the life sciences, and the gap only widens for women of color.

When Lynn Johnson Langer and Debra Bowes, started their careers in the life sciences they both knew that gender diversity was rare, and even scarcer as women entrepreneurs. “Networking events I attended were mainly comprised of men. There were no opportunities to talk with women about their experiences and career opportunities,” said Johnson Langer.

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Four Ways Quantum Computing Could Change The World

Organizations and governments around the world are pouring billions of dollars into quantum research and development, with the likes of Google, Microsoft and Intel racing to reach quantum supremacy. 

The stakes are high, and with so many major players, the arrival of full-scale quantum computers could be around the corner. 

In order to prepare, it’s vital that we as technology leaders educate ourselves on the reality of these machines, and the impacts they could have around the world. Unfortunately, it’s not all positive. 

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10 from Johns Hopkins elected to National Academy of Medicine | Hub

Ten Johns Hopkins University faculty members have been elected to the National Academy of Medicine, an independent organization of leading professionals from diverse fields, including health, medicine, and the natural, social, and behavioral sciences. It serves alongside the National Academy of Sciences and the National Academy of Engineering as adviser for the nation and the international community.

Through its domestic and global initiatives, the academy works to address critical issues in health, medicine and related policy. Membership is considered one of the highest honors in health and medicine.

Image: https://hub.jhu.edu

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5 Ways Emotional Intelligence Will Make You a Better Leader

In today's world, successful entrepreneurs know that effective leadership requires development through diligent, intentional practice; and the best leaders among us invest in building their skill sets to improve their performance over time. 

Many of us still focus on strengthening the traditional skills associated with leadership, such as effective decision-making, strategic thinking and managing others. But one of the most vital skill sets a leader can have is often the least understood: emotional intelligence.

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How To Be Successful When You Are A Multi-Passionate Entrepreneur

As creators, we are frequently told to find our passion and begin building our portfolio and network as early as possible. After all, the more time we can dedicate to something, the better the outcome will be. Inherently, entrepreneurs are creative which can lead to being multi-passionate, meaning a lot of different ideas excite us at once. Radmila Lolly, a musician and fashion designer, says being an artist isn’t a one-size-fits-all endeavor. In fact, finding success as an artist is all about not having limits.

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479th Edition, October 26, 2021

By BHI Weekly Newsletter Archives





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October 26, 2021

FOUNDING MEMBER OF

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BioTalk Welcomes Mr. Hakdo Kim, President, Korea SMEs & Startups Agency KOSME)

Mr. Hakdo Kim, President, Korea SMEs & Startups Agency KOSME), joins Rich Bendis from the BHI Offices to discuss their biotech mission, their relationship with Maryland, and opportunities to expand in the United States

Listen now on Apple https://apple.co/2XGxg7i, Google https://bit.ly/3bbuDxz, Spotify https://spoti.fi/2XI5h7n, and TuneIn https://bit.ly/2XGwYNJ.

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Dr. Kim and the delegation for KOSME visit BHI

On September 20th,  BioHealth Innovation, Inc. (BHI) hosted a delegation from KOSME, the Korea SMEs and Startups Agency.  Leading the overseas team was KOSME’s President, Dr. Hakdo Kim, who met with BHI board members, Entrepreneurs in Residence, and recorded a “BioTalk with Rich Bendis” podcast episode in which Dr. Kim discussed a new partnership with BHI and a Memorandum of Understanding KOSME signed with the State of Maryland.  

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Life Sciences Business Strategist – Open Position! Apply Now

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Life Sciences Business Strategist to join its team in Rockville, Maryland. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

Click here for more details.

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New EMPWR Fund of Fund launched with BioHealth Capital Fund in it

Andrea Alms, Co-Fund Manager & Partner, BioHealth Capital Fund, recently joined a panel on “Impact Firms Take the Lead: Private Equity & Private Credit” with Emerge Capital Management on October 11th. Emerge’s EMPWR Program has a talented roster of sub-advisors that features a special focus on women private fund leaders. During this special webinar panel, we will be focusing on EMPWR’s private equity and private debt sleeve. We will have three private fund managers join us and present how their private, impact funds can improve the quality of life around the world.

Click here to watch the recording.

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SoftSpotTM by PediaMetrix becomes the first smartphone app to receive FDA clearance for cranial measurements

OCT 06, 2025 08:30 EST

PediaMetrix received 510(k) clearance from the US Food and Drug Administration (FDA) for SoftSpotTM, a cross platform software solution for infant cranial evaluation at the point of care. The FDA clearance demonstrates SoftSpot’s safety and efficacy for infant cranial measurements using a smartphone.

“This is an important milestone for PediaMetrix and we see great potential in now bringing this innovative technology to pediatricians in the US and around the world”, said Fereshteh Aalamifar, PhD, President & CEO of PediaMetrix. Currently, pediatricians are not equipped with any tool for quantitative measurement of cranial shape and only perform visual assessment. They refer parents of children at risk to specialists for quantitative measurements, which can cause delays in the early detection and intervention. SoftSpot brings the power of a specialist to a pediatric office using a smartphone.

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BHI EIR Feedback Day October 27th. Register Now!

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

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BHI Board Member Alexandria Venture Investments Maintains Recognition as #1 Most Active Early-Stage Life Science Investor

PASADENA, Calif., Oct. 18, 2021 /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, agtech and technology campuses in AAA innovation cluster locations, was recognized by Silicon Valley Bank in its Healthcare Investments and Exits: Mid-Year 2021 Report as the #1 most active biopharma corporate investor by new deal volume from 2020 to 1H21 for the fourth consecutive year and the #1 most active new Series A investor in biopharma by new deal volume from 2020 to 1H21. These most recent leadership rankings are a testament to Alexandria's position at the vanguard and heart of the life science ecosystem. In addition to its leadership in early-stage life science venture capital investing, Alexandria Venture Investments was listed as one of the five most active U.S. investors in agrifoodtech in the 2021 AgFunder AgriFoodTech Investment Report earlier this year. Alexandria Venture Investments has for more than 25 years strategically invested in some of the most disruptive life science, agrifoodtech and technology companies advancing transformative new modalities and platforms to meaningfully improve human health. Fully integrated into Alexandria's differentiated and multifaceted business, the highly successful mission-critical Alexandria Venture Investments platform provides the company with strategic insight into these industries, strengthens relationships with key entrepreneurs and investors and enables the curation of the highest-quality tenant base.

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A US – UK Discussion: How to Conduct Clinical Trials as Seth Toback, Vice President, Clinical Development at Novavax and Divya Chadha Manek, Director of Business Development at the National Institute for Health Research (NIHR) join Rich Bendis on BioTalk.

Listen now via Apple https://apple.co/3BSIFjn, Google https://bit.ly/3j7YyLt, Spotify https://spoti.fi/2Z474Ec, and TuneIn https://bit.ly/3DUweUz.

Divya Chadha Manek was appointed as the NIHR CRN’s Head of Commercial Business Development in 2015 then in 2020, Divya was seconded to the UK Vaccines Taskforce (VTF) which was set up in response to the COVID-19 pandemic to lead the UK’s search for a safe and effective vaccine. Divya was responsible for supporting global pharmaceutical companies to rapidly generate the evidence required for marketing authorisation of COVID-19 vaccines. Divya also played a pivotal role in conceptualising and developing the NHS Vaccine Research Registry.

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935 Prose – The Next Evolution of Innovaiton

935 Prose is a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. It is positioned to recruit and retain the best-and-brightest scientific talent and will set a new standard for life science facilities.

Click here for the brochure

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Phlow Included in BARDA Contract Development and Manufacturing Organization Network to Provide Domestic API Capability for Essential Medicines and Medical Countermeasures

Phlow is strategically working with the U.S. government to ensure preparedness for future national health crises  

October 20, 2021 09:00 AM Eastern Daylight Time

RICHMOND, Va.–(BUSINESS WIRE)–Phlow Corp., a U.S.-based essential medicines impact company, today announced that it has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) contract development and manufacturing organization (CDMO) network. The network is part of a comprehensive effort by the U.S. government to provide a domestically integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools to address public health emergencies.  

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Gain Therapeutics – Gain Therapeutics Appoints Matthias Alder as Chief Operating Officer

BETHESDA, Md., Oct. 19, 2021 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced the appointment of Matthias Alder as Chief Operating Officer to advance the Company’s strategic and operational objectives, including the establishment of additional industry partnerships and the transition of the Company’s lead program in Gaucher and Parkinson’s Disease into clinical trials, which is expected to occur in 2022.

“I am delighted to welcome Matthias to Gain’s growing team as we methodically scale our platform and build our internal clinical trial capabilities and operations,” said Eric Richman, Chief Executive Officer of Gain. “He brings extensive experience in the pharma and biotech industries and is a seasoned executive who will complement our current executive team at a pivotal time for Gain as we grow the organization and prepare to advance our lead program into clinical trials.”

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Milken Institute Report Highlights How Maryland is Growing one of the Nation’s Strongest Life Science Ecosystems · BioBuzz

Home to an array of renowned universities, federal labs, and government resources, it’s no surprise that the globally renowned Milken Institute found that Maryland “has one of the nation’s strongest life sciences industries,” according to its recent report.

It’s clear that Maryland’s efforts to grow its recognition as a life sciences/biotech hub have paid off. However, there is still more work to be done in order for Maryland’s R&D growth trajectory to keep up with other leading hubs such as Massachusetts and North Carolina.

Image: https://biobuzz.io

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FORBES Magazine Insert – Maryland: A Magnet For Innovation by State of Maryland – issuu

This Forbes special section showcases how the state continues to step up its game to keep businesses thriving. Maryland's dynamic and ever-growing aerospace, cybersecurity, energy, financial services, life sciences, manufacturing, and real estate industries are all showcased throughout the publication.

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America on Edge: Settling for Second Place?

The United States is on edge in ways the nation has rarely experienced throughout its young history. The country’s global leadership is being challenged in a rapidly changing and increasingly competitive world. Meanwhile, the nation’s sustained complacency in dealing with long-festering domestic needs has weakened our institutions from within and placed in grave danger our leadership in the critical fields of science and technology—on which so much of our economy and security is based. America is at a tipping point, in short, and Americans are justifiably unsettled.

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Maryland E-Nnovation Grant Supports Medical Research

October 20, 2021    |   By Deborah Kotz

University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, announced today that UMSOM has been awarded $1.25 million in matching funds from the Maryland E-Nnovation Initiative Fund (MEIF), administered by the Maryland Department of Commerce. The funds, totaling $2.5 million when combined with private philanthropy, will enable the establishment of a new Center for Pathogen Research. They will also enable UMSOM to support research professorships in the Department of Microbiology and Immunology and the Department of Neurology.

The Alicia and Yaya Foundation made a $750,000 philanthropic commitment to establish the Alicia and Yaya Foundation Professorship in Pathogen Research in the Department of Microbiology and Immunology. Matching state funds bring the total to $1.5 million, which will establish an endowed professorship for Matthew Frieman, PhD, associate professor of Microbiology and Immunology at UMSOM. He will also serve as the director of a new Center for Pathogen Research.

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Danae Partners with Materic, Receives Follow-on Investment from Conscious Venture Partners

Danae expands its 3-D Print manufacturing capacity, adds access to unique 3D printing technologies from Materic

October 21, 2021, Baltimore, MD – Danae, Inc., a Baltimore-based 3-D Printing design and manufacturing company, today announced it has partnered with Materic, LLC and received investment from Conscious Venture Partners through their Conscious Venture Fund II.

Located at Baltimore’s 1100 Wicomico, Danae has used this investment to install eight new printers to meet its rapidly growing customer demand. The new machines extend Danae’s capabilities allowing them to manufacture parts using Selective Laser Sintering (SLS) or Stereolithography (SLA) technologies. SLS uses a laser to transform powder into a 3D model whereas SLA uses a laser to cure liquid resin into hardened plastic.

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