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475th Edition, September 29, 2021

By BHI Weekly Newsletter Archives





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September 29, 2021

FOUNDING MEMBER OF

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BIOTtalk: From the 7th Annual BioHealth Capital Region Forum – Dr. Tara Schwetz, Assistant Director for Biomedical Science Initiatives, White House Office of Science and Technology Policy (OSTP)

Listen now via Google https://bit.ly/3EWtTtJ, Apple https://apple.co/3ocpP2w, Spotify https://spoti.fi/3EUALYu, and TuneIn https://bit.ly/3CGZ8Ho.

The session from the BioHealth Capital Region Forum focuses on a vision for a new science entity, the Advanced Research Projects Agency for Health (ARPA-H). This new NIH Institute would accelerate biomedical innovation and adoption of technologies and approaches to revolutionize healthcare and medicine. Tara A. Schwetz, Ph.D. is the Assistant Director for Biomedical Science Initiatives in the White House Office of Science and Technology Policy (OSTP). She is currently on detail to OSTP from her role as Associate Deputy Director (ADEPD), National Institutes of Health (NIH). During her tenure as ADEPD, Dr. Schwetz also served as the acting Director of the National Institute of Nursing Research (NINR). Prior to assuming these roles, she was the Chief of the Strategic Planning and Evaluation Branch in the Office of the Director at the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Schwetz led several efforts while at NIAID, including conducting an evaluation of the Centers of Excellence for Influenza Research and Surveillance to facilitate evidence-based decision-making and developing the NIAID Strategic Plan for Tuberculosis Research. Previously, Dr. Schwetz served as the Senior Advisor to the Principal Deputy Director of NIH (DEPD), where she coordinated efforts such as Reimagine HHS, the NIH rigor and reproducibility activities, and the first NIH-Wide Strategic Plan. Dr. Schwetz also served in the dual role of the NIH Environmental influences on Child Health Outcomes (ECHO) Interim Associate Program Director and the Special Assistant to the DEPD. Prior to these roles, she was a Health Science Policy Analyst at the National Institute of Neurological Disorders and Stroke, where she helped develop the National Pain Strategy. Dr. Schwetz started her career at NIH as an AAAS Science and Technology Policy Fellow at NINR. She received a BS in biochemistry with honors from Florida State University and a PhD in biophysics from the University of South Florida, followed by a postdoctoral fellowship at Vanderbilt University.

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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.

KOSME is a Korean-government funded non-profit created over forty years ago to support small and medium enterprises in Korea.  In 2001, KOSME opened the Northern Virginia-based KBDC as an outpost to support Korean companies interested in joining the US marketplace.   

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Philophos Seeks – Business Development & Relationship Manager

Philophos, Inc. is an innovative Med Tech device company headquartered near Seoul in South Korea.  We develop and manufacture quality, portable and value priced optical coherence tomography (OCT) devices for retina imaging.  We have a functional prototype that is in pilot testing, and we are in the process of securing medical device approval in both Korea and the U.S.  We seek a key management hire who can focus on accelerating sales, marketing and relationship development efforts for the U.S. market.

We are seeking a full-time, Business Development & Relationship Manager to represent Philophos, Inc. in the U.S..  Duties will include identifying, developing, and maintaining vital relationships as the primary role.  Duties will also include supporting a variety of activities associated with launching our operations in the U.S. Our culture is a fast-paced environment that requires the ability to independently support multiple activities and manage deadlines with great coordination and communication skills with our headquarters team. Preferred traits are someone who is organized, adaptable, high-energy, a self-starter and good critical thinker who can overcome challenges.  The candidate must possess excellent presentation skills including both oral and written communication abilities.  

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Maryland wants to ease US entry for South Korean startups – Technical.ly Baltimore

On Monday, Maryland First Lady Yumi Hogan signed a memorandum of understanding with Hakdo Kim, president of the Korea SMEs and Startups Agency (KOSME).

Through this agreement, the two entities will work together to support Korean tech and environmentally focused small and medium-sized businesses, as well as startups, as they enter the American market. That could bring potential for the companies to join the Maryland Department of Commerce’s soft landing program, which connects companies looking to explore the U.S. with offices and resources at local startup spaces.

Image: Officials including Maryland First Lady Yumi Hogan sign an MOU on Sept. 20. (Photo courtesy of Maryland Department of Commerce)

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South Korea cracks world's top 5 innovators while China edges Japan – Nikkei Asia

PARIS/NEW YORK — South Korea has placed among the top five technological innovators for the first time, according to the latest global ranking, as other Asian economic powers moved up the hierarchy.

South Korea jumped from 10th place to fifth in this year's Global Innovation Index, the World Intellectual Property Organization reported Monday. The East Asian country was bested only by Switzerland, Sweden, the U.S. and the U.K.

The WIPO rankings grade 132 economies based on multiple categories. Elsewhere in Asia, Singapore stood in eighth place, unchanged from last year, while China rose two ranks to 12th.

Image: An ice carving robot at a bar in Seoul: South Korea was the highest-ranking Asian country in the World Intellectual Property Organization's Global Innovation Index this year. © Reuters

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DC welcomes the Children’s National Research & Innovation Campus | WTOP

The Children’s National Research & Innovation Campus was officially welcomed to the former Walter Reed Army Medical Center campus on Wednesday with a visit from D.C.’s mayor and city council chair.

The partnership of Children’s National Hospital, Virginia Tech and Johnson & Johnson Innovation – JLABS @ Washington, DC will host biomedical research already underway and support entrepreneurs in early-stage companies that will work to find answers to health problems plaguing children.

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Novavax EVP: It's up to policymakers to decide use of COVID-19 vaccine | Devex

A senior official for American biotech company Novavax said the company is committed to equitable COVID-19 vaccine allocation and has made a “great effort” to manufacture its vaccine in different sites across the globe. However, whether its vaccine will be used as booster shots or prioritized in countries struggling with supply will be up to policymakers, he said.  

Speaking at a Devex event held on the sidelines of the 76th United Nations General Assembly, John Trizzino, executive vice president at Novavax, said policymakers are responsible for determining how the COVID-19 doses will be used.

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George Mason University: Mason Researchers Use Scent Analysis For COVID Diagnostics | Fairfax City, VA Patch

With COVID-19 continuing to spread throughout the world, there is a demand for rapid, noninvasive diagnostics. George Mason University researchers Robin Couch and Allyson Dailey, members of the College of Science and the Institute of Biohealth Innovation, are working to answer that call with their research on volatile organic compounds (VOCs) for infectious disease detection. VOCs are gases that emanate from a variety of sources, including from humans. Much like a sommelier can smell wine and determine the composition of it, Couch and Dailey have been looking at the scent prints of bacteria. They have been able to successfully diagnose mice infected with biothreat agents using this method, and were able to differentiate standard bacteria strains from antibiotic-resistant strains, as seen in Nature Scientific Reports. Mason holds a patent around the technology on the extraction and analysis of gases through the VOC extraction chamber. When the news of COVID struck the world in March 2020, the researchers embraced it as an opportunity to further test their approach on viruses.

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Expand Your Horizons at Frederick’s Premiere Biopharma Lab / Manufacturing Building
  • Multiple Move-in Ready Spec Suites at the end of Q2 2021 
  • Building delivering Q2 2021 
  • Up to 75,000 SF Available Frederick, 
  • Located In Federal Opportunity Zone

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Capital Region Emerges as Undisputed Leader in War on Infectious Diseases · BioBuzz

Since 1900, there have been eight different pandemics that concerned public health across the globe, such as Zika, MERS, Ebola, Swine Flu, and others, which have led to the loss of millions of people and billions of dollars in economic losses. That’s one reason for the establishment of the Global Pandemic Prevention and Biodefense Center in Montgomery County, Maryland. When COVID broke last year, a task force urged for the formation of an organization that could peer past the current crisis and put on its prognostication hat to prepare for future threats. With its long history of thought leadership in infectious diseases and vaccines development, as well as its proximity to federal health and regulatory agencies, the BioHealth Capital Region was the perfect fit for the biodefense center.

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President Biden Announces Members of President’s Council of Advisors on Science and Technology | The White House

WASHINGTON – Today, President Biden announced 30 of America’s most distinguished leaders in science and technology as members of his President’s Council of Advisors on Science and Technology (PCAST). A direct descendant of the scientific advisory committee established by President Eisenhower in 1957 in the weeks after the launch of Sputnik, PCAST is the sole body of external advisors charged with making science, technology, and innovation policy recommendations to the President and the White House.

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Women Building Bio 2021 | VirginiaBio

Join us on September 30th for the 6th year of the Women Building Bio conference. Don’t miss an event where women converge to advance the industry with all stakeholders, men and women, front and center joining forces.

Our half-day hybrid conference will offer full virtual attendance or the option for in-person viewing at one of 5 regional locations across our state. In-person requires pre-registration at a specific location and space is limited, so do not delay!

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474th Edition, September 22, 2021

By BHI Weekly Newsletter Archives





September 22, 2021

FOUNDING MEMBER OF

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BioTalk: From the 7th Annual BioHealth Capital Region Forum – Dr. Anthony Fauci

Listen to the audio as Rich Bendis, President and CEO of BioHealth Innovation conducts a fireside chat with Dr. Anthony Fauci, Director of the National Institute for Allergy and Infectious Disease (NIAID) since 1984. Dr. Fauci oversees an annual budget of over $6 Billion and has advised 7 President’s on many domestic and global health issues. He has an extensive portfolio of basic and applied research to prevent, diagnose and treat many existing and emerging infectious diseases.

Listen now via Apple https://apple.co/3nNlHWH, Google https://bit.ly/3Ar0uoZ, and Spotify, https://spoti.fi/3ExxAWH

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7th Annual Virtual BioHealth Capital Region Forum Recap

The 7th Annual Virtual BioHealth Capital Region Forum might be over, but that doesn’t mean you can’t access it again. Go to https://eventmobi.com/bhcrforum2021 now to watch or re-watch  every panel, keynote speaker, and bio byte video. Sessions include Fireside Chats with both Dr. Anthony Fauci, Director, U.S. National Institute of Allergy and Infectious Diseases, Joel Marcus, Executive Chairman and Founder, Alexandria Real Estate Equities, Inc./Alexandria Venture Investments, and Dr. Tara Schwetz, Assistant Director for Biomedical Science Initiatives, White House Office of Science and Technology Policy (OSTP). Panels covering our forum theme of Big Bio….Big Data…. Converging range from Federal Funding, Real Estate, Developing Talent, and more.

Click here for the recap.

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Viewpoint: Ready for an HQ2 redux? It's time to come together for new regional tech collaboration.

Remember the frenzy in 2017 when over 200 cities and towns across the U.S. bid to house the second headquarters for Amazon? Northern Virginia in the D.C. region won that bid ultimately.

But cities, states and regions might want to dust off those bids to enter a new $1 billion competition by the U.S. Economic Development Administration (EDA) that promises more winners across the country in applied science areas to help make the U.S. more technologically competitive and inclusive. Thankfully, this competition will look more like the Olympics with many gold, silver and bronze winners compared with the winner-take-all approach of Amazon HQ2. 

EDA will grant $500,000 in technical assistance to 50 to 60 regional coalitions to develop and support three to eight projects to support a regional growth cluster this fall. Next year, EDA will award 20 to 30 regional coalitions $25 million to $100 million to implement those projects from among those that were successful in Phase One.

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American Gene Technologies Appoints Dr. Robert R. Redfield as Special Advisor to the CEO | American Gene Technologies

American Gene Technologies (AGT) announces the appointment of Dr. Robert R. Redfield, former director of the Centers for Disease Control and Prevention (CDC) and co-founder of the Institute for Human Virology, as special advisor to AGT CEO Jeff Galvin.

Dr. Redfield is well known for his decades of dedicated work in virology, immunology and clinical research. He has helped lead collaborative research into HIV/AIDS since the beginning of the epidemic during his years as a U.S. Army physician and at the University of Maryland School of Medicine. Dr. Redfield has held multiple advisory positions, including with the President's Advisory Council on HIV/AIDS, the National Institutes of Health and the U.S. Food and Drug Administration. He was the CDC director from March 2018 to January 2021, leading the agency through a period of historic challenges, including the onset of the COVID-19 pandemic.

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BHI EIR Feedback Day September 22nd. 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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Patient-Centric Approach to Clinical Trials Improves Outcomes for All Stakeholders

According to researchers at the MIT Sloan School of Management, the probability of FDA approval of an industry-sponsored drug entering Phase One of the clinical trial process is 13.8%(1). A major factor in a trial’s success or failure, notes Dr. Harsha Rajasimha, founder and CEO of Jeeva(TM) Informatics, is the trial sponsor’s ability to recruit and retain patients. Current statistics show that 85% of all clinical trials are delayed during patient recruitment, and 30% are terminated early due to failure to recruit enough patients. Those small proportion of trials that do enroll the required subjects experience 30% dropout rate on an average.(2) “This is bad news,” says Dr. Rajasimha, “not just for the sponsors of these trials and the participants, but for a world in serious need of new and better tools to fight disease.”

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Opinion: President Biden: Don't misuse Bayh-Dole march-in rights-Med-stat.info

In a misguided attempt to control drug costs, some Congressional leaders are urging the Biden administration to misapply a 40-year-old law that supports 6 million jobs, helped launch 15,000 start-up companies, and contributed $1.7 trillion to U.S economic output. The lawmakers — Senators Elizabeth Warren (D-Mass.) and Amy Klobuchar (D-Minn.) and Representative Lloyd Doggett (D-Tex.) — want the Department of Health and Human Services, as well as the Department of Defense, to misuse the march-in provision of the Bayh-Dole Act to set the price of federally-funded medicines — something the provision does not authorize. Such an action would undermine the intention of Bayh-Dole, while inflicting devastating damage on the U.S.

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Visualizing the World's Biggest Pharmaceutical Companies

If the response to the COVID-19 pandemic has taught us anything, it is that in building a patient-centered future, the pharmaceutical industry plays a key role. It has to constantly find new ways to customize medicines while researching and developing new tools and drugs.

By embracing disruptive technologies like 3D printed drugs, artificial intelligence guided therapies, and preventive medicine while working with regulatory agencies, the pharmaceutical companies will benefit from having a digital revolution.

Image: https://www.visualcapitalist.com

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VCs make record bets on quantum computing | PitchBook

Scientists and engineers are still toiling in labs in a race to develop quantum computers that would significantly outperform traditional computers.

But that isn't holding venture capitalists back. They're pouring record-high funding into work on computing power that is still considered years away from being ready.

Investors have invested $1.02 billion into quantum computing companies so far this year. That's more than was funneled into the industry during the previous three years combined, according to PitchBook data.

Image: https://pitchbook.com

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Is a variant worse than Delta on the way? Viral evolution offers clues.

Somewhere in India last October, a person—likely immunocompromised, perhaps taking drugs for rheumatoid arthritis or with an advanced case of HIV/AIDS—developed COVID-19.

Their case might have been mild, but because of their body’s inability to clear the coronavirus it lingered and multiplied. As the virus replicated and moved from one cell to another, parts of the genetic material copied itself incorrectly. Maybe the person lived in a crowded home or went out to buy food in a busy market, but wherever it happened, the altered virus was spread to others. Experts believe this singular situation in one individual is likely how the Delta variant now wreaking havoc in the U.S. and around the world was born.

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Copyright AA(C) BioHealth Innovation 2021
All Rights Reserved.


473rd Edition, September 15, 2021

By BHI Weekly Newsletter Archives
 
 

September 15, 2021

FOUNDING MEMBER OF

 

Summary Graphic

7th Annual Virtual BioHealth Capital Region Forum Recap
 

The 7th Annual Virtual BioHealth Capital Region Forum might be over, but that doesn’t mean you can’t access it again. Go to https://eventmobi.com/bhcrforum2021 now to watch or re-watch  every panel, keynote speaker, and bio byte video. Sessions include Fireside Chats with both Dr. Anthony Fauci, Director, U.S. National Institute of Allergy and Infectious Diseases, Joel Marcus, Executive Chairman and Founder, Alexandria Real Estate Equities, Inc./Alexandria Venture Investments, and Dr. Tara Schwetz, Assistant Director for Biomedical Science Initiatives, White House Office of Science and Technology Policy (OSTP). Panels covering our forum theme of Big Bio….Big Data…. Converging range from Federal Funding, Real Estate, Developing Talent, and more.

Click here for the recap.

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BioBuzz: BioHealth Capital Region Retains Strong Grip on No. 4 Spot of Top 10 U.S. Biopharma Hubs – Eyes Third Spot by 2023
 

 

As a life sciences cluster, the BioHealth Capital Region is poised to become a top-three cluster in the Genetic Engineering & Biotechnology News (GEN) Top 10 Biopharma Clusters ranking on the strengths of early-stage companies becoming commercial successes and the construction of millions of square feet of new wet lab space.

For 2021, the BHCR held onto the fourth-place position behind New York/ New Jersey, San Francisco Bay Area, and the greater Boston area. The latest ranking was revealed at the seventh annual BioHealth Innovation Forum. The region held onto the coveted spot for multiple reasons, including significant funding from the National Institutes of Health, available wet lab space, and patent strength protecting intellectual property.

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Everyone Need Access to At-Home COVID Tests | by John Whyte, MD | Sep, 2021 | Medium
 

“Anyone who wants a COVID test can get one.” When that proclamation was made back in May 2020, it wasn’t true. There was a scarcity of testing supplies and limited sites, and it could take weeks to get back the results — making many of them essentially useless in clinical decision-making. The initial rapid tests on the market were a wild west of different companies who failed to ensure accuracy of their tests — -resulting in significant error rates.

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Emergent to manufacture Providence Therapeutics COVID-19 mRNA vaccine candidate | Seeking Alpha
 
  • Emergent BioSolutions (NYSE:EBS) will manufacture doses of Providence Therapeutics’ PTX-COVID19-B COVID-19 mRNA drug candidate under a five-year agreement. 
  • The agreement is valued at $90M, and covers manufacturing services, studies to support global supply chain activities, and facility and equipment investments. 
  • Next year, Emergent will manufacture tens of millions of doses of PTX-COVID19-B, as well as batches of PTX-COVID19-B formulated bulk drug substance that can yield hundreds of millions more doses.

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BHI EIR Feedback Day September 22nd. 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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Joel S. Marcus, Executive Chairman and Founder of Alexandria Real Estate Equities, Inc./Alexandria Venture Investments, Honored by the 9/11 Memorial & Museum for Distinction in Civic Engagement and Renewal
 

PASADENA, Calif., Sept. 10, 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 its executive chairman and founder, Joel S. Marcus, was honored last evening for Distinction in Civic Engagement and Renewal by the National September 11 Memorial & Museum during its Benefit Broadcast commemorating 20 years since 9/11. This prestigious recognition highlights Mr. Marcus’s many meaningful contributions to the Memorial & Museum and his unwavering support of its mission to commemorate those who lost their lives in the terrorist attacks of September 11, 2001 and February 26, 1993; educate the public and a new generation about their ongoing global impact; and inspire Americans and people around the world to value courage, public service, hope, empathy and resilience in the face of adversity.

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Top 11 Best Selling COVID-19 Vaccines and Drugs of H1 2021
 

The debate over whether and how broadly to approve additional “booster” doses of COVID-19  vaccines is expected to play out this month. This much is certain: The FDA’s Vaccines and Related Biological Products Advisory Committee will discuss whether to recommend booster doses for the Pfizer/BioNTech COVID-19 vaccine (COMIRNATY®, BNT162b2) meets on September 17.

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Gain Therapeutics, Inc. Announces Positive Topline Data in
 

BETHESDA, Md., Sept. 08, 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 topline 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 – GT-02287 and GT-02329 – for the treatment of Gaucher and GBA1 Parkinson’s Disease, demonstrated positive effects on all tested phenotypes.

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Maryland Today | IonQ, UMD to Establish First-of-its-Kind Facility to…
 

IonQ, the leading developer of quantum computing devices, and the University of Maryland, an international powerhouse in quantum research and applications, today announced a partnership to create the National Quantum Lab at Maryland, or Q-Lab. It will be the nation’s first user facility that enables the scientific community to pursue world-leading research through hands-on access to a commercial-grade quantum computer. UMD-affiliated students, faculty, researchers, staff and partners across the country will have an unprecedented opportunity to gain experience with IonQ’s industry-leading trapped-ion quantum computer hardware and collaborate with IonQ scientists and engineers.

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USP launches an Office of Organizational Culture, Equity and Inclusion Excellence headed by Chief Equity Officer and Senior Advisor Debra Joy Pérez, Ph.D. 
 

Rockville, MD, September 13, 2021 – The U.S. Pharmacopeia (USP) announces the launch of a new department, the Office of Organizational Culture, Equity and Inclusive Excellence (Equity Office). Headed by Chief Equity Officer (CEqO) and Senior Advisor to the CEO, Debra Joy Pérez, Ph.D. (she/her/ella), the Equity Office will shape and implement all diversity, equity, inclusion and belonging (DEIB) programs and initiatives. 

“Our DEIB work should always be about seeing diverse perspectives and how to approach complex problems from different viewpoints. DEIB is all about culture building, it is a way of looking at the work and the world that fosters the best workplace for our people,” said Debra Joy Pérez, Ph.D, USP CEqO and Senior Advisor to the CEO. “Evidence shows that when more diverse perspectives are included, there is more innovation, creative thinking and better problem solving—three critical drivers in applying our science to fulfill our public health mission. Our fundamental belief at USP is that equity equals excellence – excellence in our staff and excellence in our science. Only when we fully embrace the practice of equity can we benefit from the richness and talents of our staff.”  

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Robert E. Fischell Institute for Biomedical Devices Director William Bentley was named the recipient of the 2021 Society for Biological Engineering D.I.C. Wang Award for Excellence in Biochemical Engineering. 
 

Robert E. Fischell Institute for Biomedical Devices Director William Bentley was named the recipient of the 2021 Society for Biological Engineering D.I.C. Wang Award for Excellence in Biochemical Engineering. This annual award recognizes individuals for their contributions to the field and to the practice of biochemical engineering through their position in industry or academia as exemplified by Professor Daniel I.C. Wang of MIT. 

Wang made tremendous contributions to the biochemical engineering profession and biotechnology community, both in this country and internationally. He was a pivotal leader in developing the biotechnology industry and in shaping biochemical engineering education and training over the past five decades.

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Most Detailed #Visualization of Human Cell Ever Created
 

Most Detailed #Visualization of Human Cell Ever Created – this 3D model of a eukaryotic cell is created using X-ray, nuclear magnetic resonance (NMR), and cryo-electron microscopy datasets. It is an attempt to visualize the many pathways involved in cellular processes (i.e. signal transduction, protein synthesis, endocytosis, vesicular transport, cell-cell adhesion, apoptosis) as well as the great complexity & beauty of the cell’s molecular machinery.

Image: https://www.linkedin.com

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Could VC Investment Spike In Life Sciences Become Too Much Of A Good Thing?
 

At first blush, things are looking great in the life sciences real estate market. In particular, venture capital funding is exploding, supporting new companies or expansion from existing ones that should keep demand high for properties and continue to support larger rents. But this could lead to some overheating in the property market and to a shift in the way life sciences investors want to handle real estate.

Image: Unsplash – Life sciences lab space rents are soaring as biotech VC investment in the U.S. hits record levels.

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Scott Mortensen on COVID-19 Patients
 

his is how I see it…

We all have a choice. We all take in information. We use that information to make daily and life decisions. Some decisions affect only us, but most decisions affect us AND others.

We’ve learned throughout this pandemic that our decisions affect many others. I invite you to consider your decisions (vaccination, wearing masks when necessary, etc) and how you can help yourself AND even more importantly others. Consider it your service to others. Set aside political views and issues and serve others.

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5 Questions with Bill Snider, Partner, BroadOak Capital Partners · BioBuzz
 

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This week we welcome Bill Snider, Partner, BroadOak Capital Partners.

Bill Snider is a Partner at BroadOak and leads the firm’s growth capital investing activities. Mr. Snider has more than 25 years of institutional investment experience. Prior to BroadOak, he was a general partner and co-founder of Emerging Technology Partners (ETP), LLC, a life sciences-focused venture capital firm. Before ETP, Bill was a vice president and portfolio manager at T. Rowe Price, where his responsibilities included managing $2 billion of mutual fund and institutional client portfolios. He currently serves on the boards of Codex DNA, Halo Labs, Science and Medicine Group, and the MdBio Foundation. He has made more than 50 growth capital investments while at BroadOak and looks forward to making 50 more.

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472nd Edition, September 8, 2021

By BHI Weekly Newsletter Archives
If you are having trouble viewing this email, please click here
 

September 8, 2021

FOUNDING MEMBER OF

 

Dr. Xavier Barril, Gain Therapeutics, and Hartaj Singh, Oppenheimer & Co. Inc. Join Rich Bendis on BioTalk
 

Dr. Xavier Barril, Chief Scientific Officer, Gain Therapeutics, and Hartaj Singh, Managing Director and Senior Analyst, Oppenheimer & Co. Inc., Join BioTalk to discuss Artificial Intelligence and Machine Learning in Drug Discovery Wall StreetAcaacs Views on this Exciting Science.

Listen Now via Apple https://apple.co/3z1rdqN, Google https://bit.ly/2X2pNPu, Spotify https://spoti.fi/2Vn2Ohx, and TuneIn https://bit.ly/38PJn41.

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Less than 1 week until the VIRTUAL & FREE 7th Annual BioHealth Capital Region Forum
 

 

Last Week to Register!

Key speakers are to the right. (Tara Schwetz, Joel Marcus, Chris Monroe)

The BioHealth Capital Region Forum is free Virtual 2 Half-Day event for executive-level biotech leaders. The theme of the forum this year is “Big Data…Big Data…Converging” with panels on Big Data in Biotech, Infectious Diseases, Developing Talent, Regional Real Estate, IP Analysis and Protection, Funding, and a Fire Side Chat with Dr. Anthony Fauci, NIAID Director.

The 7th Annual BioHealth capital Region Forum is organized by event partners – Association of University Research Parks, AstraZeneca, BioHealth Innovation, BRAINBox Solutions, Inc, Children’s National Hospital, Emergent BioSolutions, George Mason University, Johnson & Johnson Innovation – JLABS @ Washington, DC, Maryland Department of Commerce, and Virginia Bio. Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Please join us for our 7th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow. We hope you’re able to join us!

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2021 CrabTrap – Last Week to Register
 

Last week to register!

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Discover how the Maryland Stem Cell Research Fund is Accelerating Cures
 

New Launch-MSCRF’s YouTube Channel Highlighting Stem Cell Research in Maryland

The Maryland Stem Cell Research Fund (MSCRF) is focused on identifying and fostering cutting-edge research and innovation in the field of regenerative medicine in MD. Their Accelerating Cures initiative comprises programs that help transition human stem cell-based technologies from the bench to the bedside as well as mechanisms to build and grow stem cell companies in Maryland. MSCRF is committed to accelerating stem cell research, cures and commercialization, in addition to building a collaborative stem cell community in our region.

The Maryland Stem Cell Research Fund was established by the State of Maryland under the Maryland Stem Cell Research Act of 2006 to promote State-funded stem cell research and cures through grants and loans to public and private entities in the State.

Click Here to visit the new channel.

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How FauciAcaacs Moonshot For Future Pandemics Could Build Out A Vaccine Assembly Line
 

Lucky is the last word that comes to mind when thinking about Covid-19, a worldwide pandemic that has killed millions, locked down entire nations and rattled world markets. But Dr. Barney Graham, a researcher responsible for key research that helped create the coronavirus vaccine,AA believes that luck played a big role in the creation of the therapeutic.

AcaAIf it was a bunyavirus or an arenavirus, we would have been lost for months or a year or two just trying to get the right thing made,AcaA he said, referencing two of the many virus families that could still spark a global outbreak.

Image: Courtesy NIAID Dr. Anthony Fauci receiving a shot of the Moderna vaccine in December 2020.

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Researchers develop a machine learning-based screening tool for genetic syndromes in children
 

With an average accuracy of 88%, a deep learning technology offers rapid genetic screening that could accelerate the diagnosis of genetic syndromes, recommending further investigation or referral to a specialist in seconds, according to a study published in The Lancet Digital Health. Trained with data from 2,800 pediatric patients from 28 countries, the technology also considers the face variability related to sex, age, racial and ethnic background, according to the study led by Children’s National Hospital researchers.

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Maryland Today | $25M NSF Award Funds New UMD-led Institute forAcaA|
 

The University of Maryland has been tapped to lead a multi-institutional effort supported by the National Science Foundation (NSF) to develop quantum simulation devices that can understand and exploit the unique behavior of complex quantum systems while speeding the introduction of general-use quantum computers.

Image: UMD Computer Science Professor Andrew Childs (second from left) is principal investigator in the new NSF Quantum Leap Challenge Institute for Robust Quantum Simulation. Photo by John T. Consoli

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OneQuantum Startups – News, Ideas, and Resources – by Bijan DaBell – OneQuantum | Startup Chapter
 

My name is Julie Lenzer, and IAcaacm currently the chief innovation officer at the University of Maryland and also the Founding Director of the Quantum Startup Foundry. Although I am one semester away from my Masters in Machine Learning, my background is not in academia Acaa� IAcaacm actually a recovering entrepreneur and active angel investor. IAcaacve also spent the last 10 years building ecosystems for entrepreneurs through various roles, including 2 AA1/2 years in the Obama Administration as the Director for the Office of Innovation and Entrepreneurship. IAcaacve also trained entrepreneurs and spoken around the world through various programs and my own nonprofit aimed at helping women start technology-based companies. And yes, I sleep.

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National Cancer Institute (NCI) Awards Isoprene Pharmaceuticals, Inc. a Two-Year $2 Million Small Business Innovation Research (SBIR) Grant
 

BALTIMORE, Sept. 7, 2021 /PRNewswire/ — Isoprene Pharmaceuticals, Inc., an early-stage small molecule oncology company developing oral therapeutics for triple negative breast cancer (TNBC) and other cancers, today announced that the National Institute of Health’s (NIH) NCI has awarded the company a two-year $2 millionAA Small Business Innovation Research (SBIR) Direct-to-Phase II grant. This grant will support ongoing advanced pre-clinical studies intended to lead to the filing of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA), as a prelude to Phase I clinical trials. Vidya P. Ramamurthy, PhD, Isoprene’s chief scientific officer, and Vincent C. O. Njar, PhD, co-founder and chief executive officer of Isoprene and Professor at the University of Maryland School of Medicine (UMSOM), are the principal investigators for the program.

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Dr. Jean Bennett and George Migausky Join REGENXBIO Board of Directors
 

REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jean Bennett, M.D., Ph.D., and George Migausky to its Board of Directors, effective September 3, 2021. Dr. Bennett, a leading molecular genetics researcher, is the F.M. Kirby Emeritus Professor of Ophthalmology at the Perelman School of Medicine and previously served as director of the Center for Advanced Retinal and Ocular Therapeutics (CAROT) at the University of Pennsylvania. She will serve as a member of REGENXBIO’s Nominating and Corporate Governance Committee. Mr. Migausky brings more than 30 years of public company leadership and senior financial management experience. He will serve as a member of REGENXBIO’s Audit Committee.

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Children’s National, Cerner name 5 winners of pediatric digital health innovation accelerator
 

Washington, D.C.-based Children’s National Hospital and Cerner unveiled the five winners of their first annual Bear Institute Pediatric Accelerator Challenge for Kids, the organizations recently announced.AA

Children’s National and Cerner launched the Bear Institute in 2013 to support pediatric healthcare technology and innovation. The organizations kicked off the accelerator in June as a way to increase technology innovation and treatments for pediatric healthcare.AA

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Join JLABS @ Washington, DC: Providing a Best in Class Experience for Biotech Companies
 

At Johnson & Johnson Innovation Acaa� JLABS (AcaAJLABSAcaA), we value great ideas and are passionate about removing obstacles to success. We help innovators unleash the potential of their early scientific discoveries, by:

  • Providing you with state-of-the-art infrastructure (lab and offices) if neededAA
  • Assigning you a mentor to help you on your journey and connect you to our network of professionalsAA
  • Giving you access to our investor communityAA
  • Offering you the training and skills you need Part of the Johnson & Johnson Innovation family

JLABS is part of the largerAA Johnson & Johnson InnovationAA family of companies, which includes ourAA deal teamsAA and therapeutic experts for early-stage development, our establishedAA venture capital arm,AA ourAA business development groupAA focusing on later-stage development.AA

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Women Building Bio 2021 | VirginiaBio
 

Join us on September 30th for the 6th year of the Women Building Bio conference. DonAcaact miss an event where women converge to advance the industry with all stakeholders, men and women, front and center joining forces.

Our half-day hybrid conference will offer full virtual attendance or the option for in-person viewing at one of 5 regional locations across our state. In-person requires pre-registration at a specific location and space is limited, so do not delay!

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Pediatric COVID-19 Data Challenge | Challenge.gov
 

While most children with COVID-19 are asymptomatic or have mild symptoms, healthcare providers have difficulty determining which of their pediatric patients will progress to moderate or severe COVID-19 early in the progression. Some of these patients develop multisystem inflammatory syndrome in children (MIS-C), a life-threatening inflammation of organs and tissues. Methods to distinguish children at risk for severe COVID-19 complications, including conditions such as MIS-C are needed for earlier interventions to improve pediatric patient outcomes.

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BARDA seeks partners to develop agnostic diagnostic assays
 

On August 23, 2021, BARDA’s Division of Research, Innovation, and Ventures (DRIVe) opened a new area of interest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) solicitation to expand the capabilities of existing next-generation sequencing diagnostics to agnostically detect any pathogenic respiratory RNA virus including new, emerging and existing viruses.

Next-generation sequencing diagnostics have been established for oncology and some genetic disorders, and such technology also is needed for infectious diseases due to growing health security challenges and threats. In a viral outbreak or pandemic, having agnostic tests Acaa� especially those which can detect any respiratory RNA virus and can be implemented rapidly without the need for additional regulatory approvals Acaa� is crucial.

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World University Rankings 2022 | Times Higher Education (THE)
 

The Times Higher Education World University Rankings 2022 include more than 1,600 universities across 99 countries and territories, making them the largest and most diverse university rankings to date.

The table is based on 13 carefully calibrated performance indicators that measure an institutionAcaacs performance across four areas: teaching, research, knowledge transfer and international outlook.

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Can European biotechs achieve greater scale in a fragmented landscape? | McKinsey
 

EuropeAcaacs biotech industry continues on a trajectory of growth fueled by innovations from cell and gene therapies to antisense, messenger RNA (mRNA), and chimeric antigen receptor T-cell therapy (CAR-T), with more emerging technologies and techniques on the horizon. The industry has made considerable progress in improving access to capital and talent gaps in the past few years. However, its future growth will depend on whether it can continue to scale up innovation and keep up with the pace of change in other regions. Biotechs, investors, and other stakeholders will need to play their part in the industryAcaacs next act if the promise of a golden age of biotech is to become a reality.

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Machine learning tool detects genetic syndrome risk | Children’s National
 

With an average accuracy of 88%, a deep learning technology offers rapid genetic screening that could accelerate the diagnosis of genetic syndromes, recommending further investigation or referral to a specialist in seconds, according to a study published in The Lancet Digital Health. Trained with data from 2,800 pediatric patients from 28 countries, the technology also considers the face variability related to sex, age, racial and ethnic background, according to the study led by ChildrenAcaacs National Hospital researchers.

Read More

 
A Pandemic CanAcaact Stop Bayh-DoleAcaa�But Politicians Might
 

What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently donAcaact agree.

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2021 BPI Readers’ Choice Awards – Downstream Nominees
 

Regardless of molecule, the goal of biopharmaceutical downstream processing is to reduce process- and product-related impurities while maintaining the highest possible process yield. However, emerging modalities such as those based on gene-edited human cells, transgenes carried by viral vectors, and proteins transferred by exosomes all are pointing out limitations in current downstream strategies, which by and large have been developed around purification of monoclonal antibodies (MAbs). This year’s nominees in the BPI Readers’ Choice downstream category highlight technologies and processing strategies that biopharmaceutical developers and manufacturing organizations are developing to address the separation and purification demands raised by innovative therapies.

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471st Edition, August 31, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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August 31, 2021












FOUNDING MEMBER OF



Maryland State Delegate, Lily Qi, Returns to BioTalk with Rich Bendis

Lily Qi, Representative for the 15th legislative district in the Maryland House of Delegates. Joins BioTalk to discuss her career, Biotech in Montgomery County, and being a supporter of the BioHealth Capital Region

Listen now on Google https://bit.ly/3sW3iHE, Apple https://apple.co/3yvdkR4,  Spotify https://spoti.fi/3yxKRdw, TuneIn https://bit.ly/3zz8gww

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NIA Fellow Daniela Lecca Joins BHI as New Postdoc Fellow

Daniela Lecca completed her education in Italy, where she received her Ph.D. in Toxicology from the University of Cagliari for her research on the neuroprotective and immunomodulatory actions of a PPAR-γ agonist in MPTP mouse models of Parkinson’s disease. During her Ph.D. program, she spent a short-term period as a visiting Ph.D. student at the Dept of Neuroscience of the Karolinska Institutet in Stockholm, Sweden. She carried out a project on non-motor symptoms onset in a MPTP chronic model of Parkinson’s disease. After completing her Ph.D., she won a fellowship from her University that allowed her to join as a special volunteer the Synaptic Plasticity section of the National Institute on Drug Abuse in Baltimore, Maryland; here, she worked on a research project on the role of L-DOPA-mediated neuroinflammation in the non-motor symptoms of Parkinson’s disease, by a 6-OHDA mouse model.

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2021 BioHealth Capital Region Mon, Sep 13, 2021

ONLY TWO WEEKS LEFT TO REGISTER

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Join us for the 7th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

 

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BioNTech selects Maryland for U.S. manufacturing facility | Maryland Business News

German-based BioNTech has announced that they will soon be joining Montgomery County, Maryland’s growing list of world-renowned international companies in the “Immunology Capital Next to the Nation’s Capital.” BioNTech is acquiring a Gaithersburg manufacturing facility and cell therapy R&D platform from Kite, a unit of Gilead Sciences, to support the development of BioNTech’s expanding pipeline of novel cell therapies.

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University of Maryland | NSF Awards UMD $15M to Lead Mid-Atlantic…

The National Science Foundation (NSF) has selected the University of Maryland to lead one of five multi-institutional hubs that will provide entrepreneurial training to academic researchers in science and engineering in order to foster and maintain U.S. global leadership in innovation.

The $15 million I-Corps Hubs, funded over five years, will extend the foundation’s Innovation Corps, or I-Corps, program that helps researchers commercialize their technologies and translate the impact of their work to the broader public. Each regional hub will include at least eight universities.

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Maryland-based Emergent BioSolutions begins trials of its plasma-derived therapy for COVID

Emergent BioSolutions Inc. is conducting phase clinical 3 trials of its plasma-derived therapy for outpatient treatment of COVID-19, the company announced this week.

The randomized clinical trial will assign participants to receive infusions of either a placebo or the plasma treatment. Emergent is one of two companies providing hyperimmune globulin products for the trial, which plans to enroll 820 patients across the U.S. and abroad.

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Health Tech: Harsha Rajasimha On How JEEVA’s Technology Can Make An Important Impact In Our Overall Wellness | by Dave Philistin, CEO of Candor | Authority Magazine | Aug, 2021 | Medium

Thank you so much for joining us in this interview series. Before we dive in, our readers would love to learn a bit more about you. Can you tell us a bit about your childhood backstory and how you grew up?

I had an introverted childhood growing up in an orthodox Hindu family with my caring parents, two brothers, and paternal grandparents. My father was a bank officer all his life and has been my major inspiration. He had his master’s in mathematics and was a child prodigy at it. He could do 6-digit multiplication and division faster than I could crunch the numbers in a calculator.

Image: https://medium.com

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JLL assists in Montgomery County’s real estate transformation

Home to the National Institutes of Health and operations of nearly every leading biopharmaceutical company, Montgomery County, Maryland, has been on the frontlines of coronavirus vaccine research and other life-saving developments. Its thriving life sciences sector is among the diverse industries that had brought steady population growth to the County. Over the past decade, demand for housing and retail services—as well as land prices—had grown dramatically. In response to growing constituent needs, Montgomery County set out to transform its real estate management.

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New biomanufacturing lab space to be built in Frederick | Maryland Business News

State-of-the-art biomanufacturing-ready office space is coming to Frederick County.

Matan Companies recently broke ground on the new Progress Labs at Riverside I in Frederick. Located in Riverside Research Park, the 215,000 square-foot project is adjacent to the National Cancer Institute’s Frederick National Laboratory and just four miles from Fort Detrick.

This project is a significant addition to Maryland’s biohealth cluster, which is home to numerous leading companies and federal agencies and where office and laboratory space for bio companies remains in high demand.

Image: https://open.maryland.gov

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Machine learning in cardiovascular trials

Automating adjudication of events in cardiovascular trials Clinical trials for cardiovascular (CV) disease are time consuming and expensive to run, often requiring large patient populations to meet the statistical requirements needed to demonstrate efficacy.1 These trials require robust data packages to achieve market approvals and registrations in order to get essential new medicines to patients.

Image: https://www.astrazeneca.com

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COVID-19 Research: Studying SARS CoV-2 Variants of Concern

Since its emergence in December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide, causing a global pandemic (coronavirus disease-19 or COVID-19) with more than 188 million confirmed infections and more than 4 million fatalities (as of July 19, 2021) (https://covid19.who.int). While the majority of the infections are asymptomatic or manifest in mild to moderate forms, a small percentage of people develop severe respiratory illness with a fatal outcome.

Image: Figure 1 Key mutations in the spike protein of SARS-CoV Variants of Concern (VoC) (B.1.1.7, B.1.351, B.1.1.248, and B.1.617.2) and Variants of Interest (B.1.526, B.1.427, and B.1.429). Mutations occur on all spike protein subunits. Mutations in other areas of the genome have been identified and are currently under investigation.  

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NCATS Small Business Funding: Resources and Tips to Commercialize Your Translational Science Innovation

Join the National Center for Advancing Translational Sciences (NCATS) in collaboration with the Biotechnology Innovation Organization (BIO) on Wednesday, August 25th, 2021, for a webinar to learn about the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs for researchers and entrepreneurs in translational science.

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NIH Applicant Assistance Program – Eva Garland ConsultingEva Garland Consulting

The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses with an interest in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application to any of the following Institutes and Centers:

  • The National Cancer Institute (NCI SBIR)
  • The National Institute on Aging (NIA SBIR)
  • The National Heart, Lung, and Blood Institute (NHLBI SBIR)
  • The National Institute of Neurological Disease and Stroke (NINDS SBIR)
  • The National Institute of Nursing Research (NINR SBIR)
  • The National Center for Complementary and Integrative Health (NCCIH SBIR)
  • The National Center for Advancing Translational Sciences (NCATS SBIR)
  • The National Institute of Environmental Health Sciences (NIEHS SBIR)
  • New this cycle! The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD SBIR)
  • New this cycle! The National Institute on Alcohol Abuse and Alcoholism (NIAAA SBIR)

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A public-private partnership is needed to develop new antivirals – STAT

The U.S. government’s announcement that it is investing $3 billion into research on antiviral medicines for Covid-19 is a step in the right direction and comes at a critical moment in the pandemic — though earlier, of course, would have been better.

But based on my experience with drug development, in particular with antivirals, in both government and the private sector, I know that the process takes longer and is more expensive than anyone ever anticipates. I believe that $3 billion in federal funds is not nearly enough, and that at least $10 billion in clinical research funding is needed to discover and develop the new antiviral medicines that patients desperately need and that physicians have been asking for since the start of the pandemic.

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BioHealth Innovation Adds Diane Ignar, Ph.D. and Dr. Loleta Robinson as NIH New Entrepreneurs-in-Residence · BioBuzz

ROCKVILLE, MARYLAND, August 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Diane Ignar, Ph.D., and Dr. Loleta Robinson to the expanding Entrepreneurs-in-Residence (EIR) team. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources. Diane will work with NIH’s National Institute on Aging, and Loleta will work with their Office of Extramural Research.

Image: https://biobuzz.io

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JCI Insight – Human antibody recognition of H7N9 influenza virus hemagglutinin following natural infection

Avian H7N9 influenza viruses cause sporadic outbreaks of human infections and threaten to cause a major pandemic. The breadth of B cell responses to natural infection and the dominant antigenic sites recognized during first exposure to H7 HA following infection are incompletely understood. Here, we studied the B cell response to H7 HA of two individuals who had recovered from natural H7N9 virus infection. We used competition-binding, hydrogen-deuterium mass spectrometry, and single-particle negative stain electron microscopy to identify the patterns of molecular recognition of the antibody responses to H7 hemagglutinin.

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AURP 2021 – Innovation Elevated

Ranked among the top US states for thriving business climates for over six years, according to Forbes, Utah’s tech prowess, unicorn startups and public-private development makes the University of Utah Research Park the key location to begin the new decade. The University of Utah Research Park, dubbed Bionic Valley in the 1980’s, residing in the region identified as Silicon Slopes, is a sleeping giant housing more than 48 companies alongside 81 academic departments and employs a workforce of more than 14,000 has a staggering annual impact to the regional economy. In addition, the Milken Institute’s 2018 State Technology and Science Index ranked the state of Utah fifth in the US for its “capabilities and broader commercialization ecosystems that contribute to firm expansion, high-skills job creation and broad economic growth”.

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The Secret’s Out: Mason is an economic driver | George Mason University

George Mason University boosts the Washington, D.C., metropolitan region economy by supplying an educated, skilled, and multifaceted workforce, by partnering with key employers, and through the Mason-based Virginia Small Business Development Center.

In 2020, the Small Business Development Center network assisted 9,500 businesses, resulting in $86 million in new capital received and 1,167 loans obtained.

Mason incubated and supported or accelerated more than 1,600 Virginia companies in fiscal year 2019.

Investing in our local economy means cultivating Mason’s existing private and public partnerships—and forging new ones—to drive innovation.

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QIAGEN receives FDA authorization for rapid portable test

QIAGEN has announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach® SARS CoV-2 Antigen Test, which is designed for environments that require a high volume of fast and accurate test results.

The rapid portable test can detect SARS-CoV-2 antigen in people with active infections in 2 to 15 minutes and can process an average of around 30 swab samples per hour, providing digital test results that do not require subjective interpretation. Clinical studies have shown the test to have a sensitivity of at least 80% and a specificity of 98.0%.

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9603 MEDICAL CENTER DRIVE Alexandria Center® for Life Science at Shady Grove

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

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Discover Frederick Maryland

In April of 2019, Kite, a Gilead Company, announced their decision to locate to Frederick County, MD and open a new manufacturing facility on a 20-acre site located at the Urbana Corporate Center. A lot of progress has happened since then; Kite finished their brand new 279,000 SF biologics manufacturing facility in April 2021. To learn more, Solash Aviles and Jodie Bollinger from the Frederick County Office of Economic Development met with Chris McDonald, Senior Vice President, Global Head of Manufacturing at Kite and Jim Jackson, Vice President, Manufacturing Operations and Site Head at Kite.

Image: http://www.discoverfrederickmd.com

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Qiagen N.V. – QIAGEN reaches milestone with its kits used to process more than three billion biological samples to date

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the number of biological samples processed with consumables kits has passed the three billion mark – a record that underlines its leadership in enabling molecular laboratories to gain valuable insights in research, combatting diseases and forensics.

This milestone particularly underscores QIAGEN’s standout position in sample preparation, the most crucial stage of molecular testing at which DNA, RNA or proteins are extracted from human samples. QIAGEN’s sample prep kits have become the gold standard in sample extraction and earned over 200,000 references in academic studies. With more than 500 consumable kits and automated systems such as QIAsymphony, QIAcube Connect, QIAcube HT and EZ1, QIAGEN is the most trusted brand in sample preparation.

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Cartesian Therapeutics Announces Clinical Responses in First Cohort of Phase 1b/2a Trial in Myasthenia Gravis | Cartesian

Gaithersburg, MD, August 24, 2021 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company pioneering RNA cell therapy in and beyond oncology, today announced clinical data from the first cohort of an ongoing Phase 1/2a clinical trial of Descartes-08 in patients with generalized Myasthenia Gravis (gMG). Descartes-08 is an mRNA-modified, autologous CAR T-cell product directed against B-Cell Maturation Antigen (BCMA).

The cohort was intended to test safety and tolerability. Descartes-08 was well tolerated, with no cytokine release syndrome (CRS) or other serious product-related adverse events. Of note, all patients experienced at least a full class improvement on the MGFA Clinical Classification. Patients also showed marked improvement on the Myasthenia Gravis Composite (MGC) scale, a standard measure of overall disease severity. About three months after Descartes-08 administration, mean improvement in MGC scale was over 50%.

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470th Edition, August 24, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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August 24, 2021












FOUNDING MEMBER OF



BioHealth Innovation Adds Diane Ignar, Ph.D. and Dr. Loleta Robinson as NIH New Entrepreneurs-in-Residence

Biohealth and Entrepreneur Experts Joins Robust Entrepreneurs-in-Residence (EIR) Team

ROCKVILLE, MARYLAND, August 23, 2021 BioHealth Innovation Inc. (BHI) announces the addition of Diane Ignar, Ph.D., and Dr. Loleta Robinson to the expanding Entrepreneurs-in-Residence (EIR) team. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources. Diane will work with NIH’s National Institute on Aging, and Loleta will work with their Office of Extramural Research.

 “BHI is pleased to welcome Diane and Loleta to our growing group of EIRs working with the National Institutes of Health,” said Richard Bendis, BHI President, and CEO. “Their backgrounds in healthcare, venture capital, and helping early-stage businesses are key to our mission for the program nationally, and regionally.”

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GlycoMimetics CEO Rachel King steps down, successor named – Washington Business Journal

The exec has been at the helm of the company for 18 years.

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Alexandria Chairman Joel Marcus On Emerging Cities, Megacampuses And ‘Hucksters’

When Joel Marcus, a trained accountant and biotech industry lawyer, started lab real estate giant Alexandria Real Estate Equities in the 1990s, the sure bet many see in biotech wasn’t visible to many. The company’s first leases in San Francisco charged lab tenants just $6 per SF. Now, the REIT’s average tenant pays just shy of $70.

Image: Courtesy of Alexandria Real Estate Equities Alexandria Real Estate Equities Chairman Joel Marcus

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50 Over 50 2021: Vision

Armed with brilliant ideas, experience and a determination to disrupt, these 50 women are making an impact on society and culture through healthcare, robotics, music, dance, and so much more. It’s the third chapter of our 50 Over 50 project, launched in June and produced in partnership with Mika Brzezinski’s Know Your Value initiative.

 

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Gain Therapeutics: A True Revolution In Drug Development (NASDAQ:GANX) | Seeking Alpha

With so many new public biotechnology companies minted in the last 18 months, it has become more difficult to sift out the winners from the losers. During 2020, the biotech industry gave birth to an unprecedented 89 new public companies, and 2021 is on pace to beat this record-setting year. Of all the strong-performing IPOs and biotech companies out there, companies focused on precision medicine, or compounds that directly affect disease-causing genes or proteins, continue to be the subsector getting significant attention, with high valuations being assigned to early- and mid-stage companies.

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Empower Therapeutics Inc. Granted Exclusive License to Develop Digital Therapeutics Platform for Neuromodulation of Pain Sensitivity

BALTIMORE, Aug. 19, 2021 /PRNewswire/ — Empower Therapeutics Inc., a Baltimore-based startup, has secured worldwide, exclusive rights to a simple, reliable brainwave biomarker for pain sensitivity. Empower plans to leverage the technology, which is jointly owned by the University of Maryland, Baltimore (UMB) and the University of Birmingham, U.K., to develop a cutting-edge digital therapeutics platform to determine and modify pain sensitivity for chronic pain therapy.

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Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO Dr Murat Kalayoglu

A key factor in the success of a developing drug or therapy is the success of early clinical trials. A focus on Good Manufacturing Practice (GMP) standards for phase 1, first-in-human trials is critical to maximize the chances of success from a project’s start. For cell therapy development, where even small errors can make a big difference, it’s even more important.

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Johns Hopkins Tech Ventures startups saw $1B in investment in fiscal 2021 – Baltimore Business Journal

Startups with ties to Johns Hopkins ties have contributed significantly to the highest-ever amounts of capital being raked in across Maryland and beyond. For example, three spinout companies raised mega-deals in fiscal 2021, or venture deals worth $100 million or more.

Image: Johns Hopkins Technology Ventures operates several FastForward startup accelerator programs for student-led ventures and other growing spinout companies. KAITLIN NEWMAN

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Johns Hopkins Technology Ventures – Fiscal Year 2021 Annual Report

I’m pleased to share with you JHTV’s annual report for Fiscal Year 2021. The pandemic made FY21 an unusual one, but the JHTV team made it an extraordinary one, as the report demonstrates. We took full advantage of the momentum that had been building prior to the pandemic and used our digital connectivity to continue bringing the benefits of academic discovery to the world. Among our FY21 achievements:

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BXP Life Sciences Expands with Montgomery County, Maryland Acquisition – BioHealth Capital Region

BOSTON – July 27, 2021 – Boston Properties, Inc. (NYSE: BXP), the largest publicly traded developer, owner, and manager of Class A office properties in the United States, announced today that it has agreed to purchase the Shady Grove Bio+Tech Campus in Rockville, Maryland. The property includes seven existing buildings comprising approximately 435,000 square feet across 31 acres in the Shady Grove life sciences cluster, a highly desirable location for leading and emerging companies in the biotechnology sector.

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Sonosa Medical Spins Out of the MDC Studio

The MDC Studio is pleased to announce the spin-out of the company, Sonosa Medical, Inc., as an independent entity. Founded in 2019, Sonosa Medical is developing next-generation devices poised to transform the diagnosis and treatment of obstructive sleep apnea (OSA). The company is led by Dr. Stephen Restaino as Chief Executive Officer, Dr. Jeffrey Wolf as Medical Advisor, and Dr. Gil Blankenship as Chairman of the Board. Dr. Restaino and his team have been developing novel technology for the detection and treatment of OSA using a wearable device. Their work has been funded by a $3.35 million Phase II Small Business Innovation Research (SBIR) award from the Defense Advanced Research Projects Agency (DARPA).

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Gain Therapeutics – Protein Misfolding

Since the precise 3D structure of a protein is essential for its function, misfolding can result in significant downstream consequences. If this misfolding occurs to an enzyme, oftentimes the catalytic reaction can no longer take place, leading to substrate accumulation to toxic levels and subsequent cellular dysfunction.

There are many reasons why enzymes misfold. The most obvious is a genetic mutation in which a change to the amino acid sequence leads to an incorrect folding pattern. However, there are other causes of misfolding that can affect even wildtype enzymes, including states that increase cellular stress such as aging and inflammation.

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Novavax taps new execs in windup to Covid-19 vaccine launch – Washington Business Journal

The appointments are just the latest in a series of additions the company has made throughout the pandemic.

Image: Stanley Erck is president and CEO of Novavax.

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BHI’s Rich Bendis Interviewed by Anne Khademian on “This is USG” Video Podcast

“This is USG” is a video podcast series launched by the Universities at Shady Grove (USG) in October 2020. The series features Dr. Anne Khademian, USG’s Executive Director, interviewing guests who are closely connected to USG and the greater community. Guests include students; alumni; staff; faculty; members of the USG Board of Advisors; business, community and university leaders; and others.

https://youtu.be/0pe8g47_f-o

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469th Edition, August 17, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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August 17, 2021












FOUNDING MEMBER OF



Connected DMV Formally Launches Global Pandemic Prevention and Biodefense Center and will be headquartered in Montgomery County, Maryland

August 11, 2021 (Washington, D.C.) – A bold new public-private partnership to prevent future viral outbreaks from becoming pandemics has moved one step closer to realization, as the Greater Washington cross-sector nonprofit, Connected DMV, has announced the formal launch of a Global Pandemic Prevention and Biodefense Center (GPPBC). The Center will serve as a vehicle to foster greater collaboration among pandemic prevention stakeholders to deliver on strategic projects needed to advance pandemic preparedness and avoidance. The signature initiative of the Center accelerates the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks.

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Dr. Anne Khademian ,Executive Director, The Universities at Shady Grove, Welcomes Rich Bendis to #ThisIsUSG Podcast”

In this episode of #ThisIsUSG, BioHealth Innovation President and CEO Rich Bendis joins Dr. Anne Khademian for a discussion about BioHealth Innovation’s role in advancing the biotechnology/life sciences industry in Montgomery County and the capital region as a whole.

https://www.youtube.com/watch?v=0pe8g47_f-o

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Medcura raises $7.4 Million to Expand FDA-Approved Line of Hemostatic and Wound Treatment Products

RIVERDALE, Md., Aug. 12, 2021 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, today announced it has raised $7.4 million in private equity to support its growing product line and development of its lead surgical candidate for clinical evaluation. The financing includes the sale of Series A Preferred stock as well as common stock based, in part, from certain investors benefitting from a Maryland Investment Incentive Program.

“Medcura has reached a pivotal point in our growth,” said Larry Tiffany, CEO of Medcura. “Our products are positively impacting the lives of patients and our community. With these funds we can accelerate product development, expand our commercial footprint and bring the company’s potentially lifesaving technology to operating rooms and battlefields worldwide.”

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EMA Endorses Track-and-Trace Recommendations

On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.

However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.

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QIAGEN and OncXerna Therapeutics Sign Licensing and Master Companion Diagnostic Agreements | Business Wire

HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.–(BUSINESS WIRE)–QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.

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Life Sciences Employee Return to Office Survey Results | August 2021 · BioBuzz

One of the top questions that employers in the Life Sciences community within the Capital Region are asking is how companies are approaching bringing employees back to the office. That’s why we asked nearly 30 top employers in the area to share their strategies in a recent survey conducted by BioBuzz Media.

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BHI EIR Feedback Day August 18th. 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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How A Disconnected Biohealth Ecosystem Became The Next Big Thing – YouTube

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

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

Brand new office / lab suites. Flexible suites that can be combined for larger uses. Full third floor available for customization.

Approximately 47,000 BRSF.

Click here to download a brochure.

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2021 Technology Showcase | NCI Technology Transfer Center | TTC The 2021 Technology Showcase will highlight technologies under development at the National Cancer Institute and the Frederick National Laboratory to encourage technology licensing and collabo

OVERVIEW:

  • Free, half-day virtual event.
  • Hear from inventors from the National Cancer Institute and the Frederick National Laboratory about technologies primed for commercialization and/or collaboration; great opportunity for biotech stakeholders and companies of all sizes, including start-ups.
  • Panel sessions focused on technology commercialization.
  • Lightning Pitch & Poster Session highlighting additional NIH technologies available for licensing and collaborative development presented by the NCI Technology Transfer Ambassadors Program.

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UMBC graduates more Black students who go on to earn doctorates in natural sciences and engineering than any other U.S. college – UMBC NEWS

As a trifecta of crises upended life in 2020, the need for a diverse scientific and medical community grew ever more clear. George Floyd’s murder elicited worldwide protests against racial injustice. COVID-19 affected all of our lives and had an outsize impact on Black and brown communities. And COVID-19’s economic fallout only exacerbated extreme wealth inequality.

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How these 50 innovators on our DC Inno on Fire list are heating up the startup universe – Washington Business Journal

We’re taking a closer look at each of the 50 winners of our 2021 Inno on Fire honorees.

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FDA new drug applications to cost more than $3M in 2022

Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.

The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.

Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.

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FZata Announces First-in-Class “Live Biologics In A Pill” Platform Entering Manufacturing Phase · BioBuzz

FZata, Inc. is developing our ground-breaking “Live Biologics In A Pill” platform for oral delivery of live biologics. Live Biologics In A Pill will open up a new route of oral administration for innovative live biologic therapeutics. FZata is pleased to announce that our lead drug, FZ002, has advanced to manufacturing stage and IND-enabling studies. FZ002 is a first-in-class live biotherapeutic product (LBP) yeast for the treatment of Clostridioides difficile (C. diff) infection. C. diff bacteria can cause life-threatening diarrhea. Infections occur most often in people who have taken antibiotics for other conditions. It is the most common healthcare-associated infection and the CDC has labeled it at the highest urgent threat level.

Image: https://biobuzz.io

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NCI Technology Transfer Center (TTC) Communications for Industry Partners

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0642). Do not return the completed form to this address.

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Join United Therapeutics Corporation…..

This is what it is ALL about – the largest 3D printed hydrogel. This lung model can be perfused and ventilated and this blueprint replicates the entire conducting airway and large vasculature of the lung. Blueprint by Gregory Hurst. BioInk Formulation by Aman Kaur. Huge #DreamTeam Effort!

Looking to be on one of UT’s dream teams? Look no further: https://bit.ly/2QIqx6m

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468th Edition, August 10, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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August 10, 2021












FOUNDING MEMBER OF



Reverse BioTalk – Jeff Galvin, CEO of American Gene Technologies Interviews Rich Bendis, CEO and President of BioHealth Innovation, Inc.

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

You can also listen to the audio only version via Apple https://apple.co/37wc6Kk, Google https://bit.ly/2XbLe0v, Spotify https://spoti.fi/3yCWhxE, and TuneIn https://bit.ly/3AqYkoR.

Click here to view the video interview between Jeff and Rich.

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GlycoMimetics Names Harout Semerjian as New Chief Executive Officer to Succeed Retiring CEO Rachel King – GlycoMimetics, Inc.

ROCKVILLE, Md.–(BUSINESS WIRE)–Aug. 4, 2021– GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

 

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Paul Rennie OBE and Professor Jason Snape Join Rich Bendis on BioTalk (2)

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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BHI EIR Feedback Day August 18th. Register Now! (2)

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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Sands Capital Closes $560 Million Life Sciences Fund

ARLINGTON, Va., Aug. 9, 2021 /PRNewswire/ — Sands Capital held a first and final closing of its second life sciences dedicated fund, Sands Capital Life Sciences Pulse Fund II, L.P. (“Pulse II”), raising $560 million. This close increases total Pulse Strategy assets under management to more than $950 million, including Sands Capital Life Sciences Pulse Fund, L.P. (“Pulse I”) and related vehicles. The team will continue investing with the same emphasis on private therapeutics, diagnostics, and life sciences tools businesses. The strategy’s mission is to help transform how diseases are defined, diagnosed, and treated.

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Emergent BioSolutions to Resume Manufacturing Covid-19 Vaccine at Bayview Facility · BioBuzz

GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.

“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Emergent chief executive officer, Robert Kramer. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19.”

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EY named founding member of the University of Maryland Quantum Startup Foundry

COLLEGE PARK, Md. – The Quantum Startup Foundry (QSF) at the University of Maryland (UMD) today announced that Ernst & Young LLP (EY US) is a founding member of the QSF and will help the foundry advance its mission of accelerating leading-edge quantum technologies and driving the second quantum revolution.

EY is the first professional services firm and overall organization to work with the foundry on programs that connect the virtual and physical resources needed to support quantum entrepreneurs and startups. Additionally, EY will provide insight, mentorship, customer and investor introductions, and other services to companies cultivated through the QSF.

 

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Is Maryland Becoming a Hub for Bacteriophage Technologies? · BioBuzz

The Bacteriophage (Phage) Therapy (PT) market is growing rapidly in the U.S. The rise of antibiotic resistant bacteria and multidrug-resistant bacteria (MDRs) across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What’s more, the phage modality is a great fit for targeted personalized medicine approaches.

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8 hospitals, health systems piloting digital transformation programs

Hospitals and health systems across the U.S. are pushing forward digital transformation efforts by creating new tools and launching innovative programs. 

Here are the organizations that announced pilots of new innovation programs or expansions to existing programs during June and July, as reported by Becker’s Hospital Review.

1. Worcester, Mass.-based UMass Memorial Health expanded care beyond hospital walls with the recent rollout of its tech-powered hospital-at-home program. 

 

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Advanced Studies in Technology Transfer | Course Catalog and Student Handbook 2021-2022

The FAES Academic Programs at NIH offers a unique Advanced Studies in Technology Transfer to persons with a Bachelor’s degree in science or engineering or a related field. Courses are offered in the evenings, making it convenient for working professionals and postgraduate Fellows to gain expertise and experience in patenting, licensing, collaborative agreements, and other fundamental intellectual property transactions. The technology transfer profession field employs more than 10,000 professionals in the U.S., with many practicing their trade in the greater Washington, D.C. metro area.The course instructors are leading practitioners in the field, so students can simultaneously gain the necessary knowledge and build professional networks.

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Pharmaceutical industry must fix broken supply chain: Phlow

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques. People both inside the pharmaceutical industry and outside share many common concerns about the state of the pharma supply chain. Interruptions caused by the COVID-19 pandemic, global unrest, severe weather catastrophes, and other events stand to disrupt the supply of essential ingredients and products; these challenges have pharma professionals, government leaders, and others looking for ways to shore up the supply chain and avoid interruptions.

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License with Sana Biotechnology | MaxCyte Inc

GAITHERSBURG, MD, 9 August 2021 – MaxCyte, Inc. (Nasdaq: MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the signing of a clinical and commercial license with Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on creating and delivering engineered cells as medicines.

Under the terms of the agreement, Sana Biotechnology obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

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467th Edition, August 3, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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August 3, 2021












FOUNDING MEMBER OF



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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AstraZeneca chief calls for global cooperation in the fight against COVID-19 and climate change – I by IMD

The chief executive of AstraZeneca has underscored the importance of multilateral cooperation in the fight against COVID-19 as well as other systemic global challenges such as climate change, calling global warming “the biggest threat to humanity”.

In a wide-ranging and exclusive interview, Pascal Soriot expressed unease over what he saw as an excessive focus on Western nations in the context of vaccinations. He told IMD’s President Jean-François Manzoni: “The whole discussion is about [the] US and Europe, but there are 7 billion people outside of those two regions.”

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MaxCyte Announces Pricing of Upsized Offering and Approval to List on the Nasdaq Global Select Market

GAITHERSBURG, Md., July 29, 2021 /PRNewswire/ — MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the “Offering”).

MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

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Emergent BioSolutions to restart COVID-19 vaccine manufacturing in Baltimore – Technical.ly Baltimore

Maryland biotech company Emergent BioSolutions said on Thursday that it was approved by the U.S. Food and Drug Administration (FDA) to resume manufacturing of Johnson & Johnson’s COVID-19 vaccine at its Bayview plant in East Baltimore. The Gaithersburg-based company, which serves as a contract manufacturer for pharma companies, has an agreement with J&J to provide doses of its one-shot vaccine.

Image: Emergent Biosolutions’ Bayview facility. (Courtesy photo)

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The Storied 25 Year History Behind the Baltimore Biotech Manufacturing Facility Producing COVID-19 Vaccines · BioBuzz

Emergent Biosolutions’ vaccine manufacturing plant in Baltimore has been the subject of many headlines this past year for its’ role in producing several COVID-19 Vaccines. However, the history of this facility goes back more than two decades.

For the past 25 years, this Baltimore biopharmaceutical facility has played a significant role in Maryland’s life sciences ecosystem. Over the course of its life, the building has gone from being home to vaccine and small molecule manufacturing to the development of countermeasures for biologic threats, including COVID-19.

Image: https://biobuzz.io

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BHI EIR Feedback Day August 18th. 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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Immunomic Therapeutics Expands Board of Directors with Appointments of Two New Members – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it has appointed Steve Sang Young Park and Robert V. Ahlgren as new members to its Board of Directors, expanding the board to eight members.

“We are pleased to welcome Steve and Robert to Immunomic’s Board. Our scientific platform, financial acumen and growth strategies are strengthened by their wealth of knowledge and leadership experience,” commented Dr. William Hearl, CEO of ITI. “Each brings deep and diverse expertise across global financial markets and large healthcare companies that will be meaningful to us as we advance our immunotherapy pipeline and strategic vision.”

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Mason’s Michael Buschmann and team at start-up AexeRNA Therapeutics Inc. pursue patents for improved COVID-19 vaccines

George Mason University bioengineering professor Michael Buschmann and a team of scientific collaborators have devised improved lipid nanoparticle technologies to deliver mRNA that could make mRNA vaccines such as the COVID-19 vaccines less costly, with fewer side-effects and more available worldwide.

Image: Michael Buschmann (seated) and his team that includes (l to r) Aarthi Narayanan, Mikell Paige and Caroline Hoemann have developed improved technology that could help make COVID-19 vaccines better and more readily available. Not pictured: Pat Gillevet. Photo by Evan Cantwell/Creative Services

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New Collaboration Aims to Improve Measurement of Viral Vectors Used in Cutting-Edge Gene Therapies

A large interlaboratory study of adeno-associated virus (AAV), an important tool in gene therapy, will be led by USP and NIST in collaboration with NIIMBL.

Rockville, MD, July 27, 2021 —The United States Pharmacopeia (USP), the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies.

AAVs are particularly useful for gene therapies because they are not known to cause human disease and cannot replicate on their own. AAV-based therapies are currently used to treat a type of inherited retinal dystrophy that causes blindness and spinal muscular atrophy in children, and treatments for many more diseases are currently being developed. However, to use AAVs most effectively, scientists need to accurately measure attributes related to their quality. These attributes include the purity of the AAV product and the relative number of virus particles that contain the full genetic payload.

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Shuttle Pharma Awarded a New Patent for Selective Inhibitors for Cancer Treatment

ROCKVILLE, Md., July 29, 2021 /PRNewswire/ — Shuttle Pharmaceuticals Holdings, Inc (Shuttle Pharma), a Maryland-based developer of new drugs for cancer treatment, was awarded US Patent No.: 11,034,667 B2 for “Selective Histone Deacetylase Inhibitors for the treatment of Human Disease.” These non-cytotoxic, highly selective inhibitors target the histone deacetylase 6 (HDAC6) enzyme to stimulate the immune system for applications in the treatment of cancers, neurological diseases and immunological disorders.

Lead inventor Scott Grindrod, PhD describes histone deacetylase (HDAC) inhibitors as “a novel class of drugs that target enzymes involved in regulation of critical cellular functions that can inhibit cancer growth and activate cellular immunity. These are key target functions to improve cancer treatment. HDAC6 regulates the innate immune system and will be tested to activate an anti-cancer immune response to increase the effectiveness of chemotherapy and radiation therapy. The molecules in this patent enhance Shuttle Pharma’s platform technology of selective inhibitor discovery for cancer treatment.”

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Cerecor Announces Positive Initial Phase 1b Results for CERC-002 in Moderate to Severe Crohn’s Disease Patients

ROCKVILLE, Md. and CHESTERBROOK, Pa., July 26, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunologic, immuno-oncologic and rare genetic disorders, today announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate to severe Crohn’s disease (CD). Crohn’s disease is a disorder affecting as many as 780,000 people in the United States.

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Check-out JLABS quarterly portfolio update

Each quarter we bring you an update from our Johnson & Johnson Innovation – JLABS Portfolio of ompanies across our 13 sites, from San Diego to Shanghai. Beyond news of our companies milestones, we also report on the diversity of our JLABS Portfolio leadership as we seek to reflect the patients we serve.

This past quarter JLABS @ Washington, DC opened its doors and welcomed the inaugural class of residents with areas of focus ranging from health equity to broad-spectrum antivirals. Housed at the new Children’s National Research & Innovation Campus, JLABS @ Washington, DC also serves as the BLUE KNIGHT™ hub in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). You can read more about our newest site in Fierce Biotech and you can always find our latest stats and companies via our JLABS Portfolio Navigator. Finally, don’t forget to register to virtually join the JLABS @ Washington, DC Grand Opening celebration on September 22!

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Boston Properties to Acquire Maryland Biotech Campus for $117M – Commercial Observer

Boston Properties (BXP) is set to acquire the Shady Grove Bio+Tech Campus, a seven-building, 435,000-square-foot office park in Rockville, Md., for $116.5 million, from Lantian, the company announced.

The deal is expected to close in the third quarter of this year.

The 31-acre property, located at 9600 Gudelsky Drive, is situated within the Shady Grove life sciences cluster, home to a host of companies in the biotechnology sector. It is also currently home to the Universities at Shady Grove, a biomedical and tech-focused university that is part of the University System of Maryland.

Image: PETE OTTENI. PHOTO: BY BXP

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The Delta Variant: How Companies Should Respond

The rapidly spreading Delta variant is forcing employers to rethink their strategies for handling the pandemic. Policies they should reconsider include encouraging or requiring employees to be vaccinated, whether to hold off on having remote workers return to company facilities, rules for social distancing and wearing masks at job sites, ventilation, testing, travel restrictions, communicating exposures, and support for mental health care. This article offers advice on how to think through these issues.close

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Why is the delta variant of Covid-19 more transmissible? — Quartz India

The delta variant spreads much faster than other Covid-19 strains—and scientists may now know why.

People infected with the delta variant have more than 1,260 times the viral load—the concentration of viral particles in the body—than those with the original strain found in China, a group of scientists has reported in a preprint paper. A higher viral load can have many implications such as more severe disease. Its most significant contribution is to a virus’s higher transmissibility.

Image: https://qz.com

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466th Edition, July 27, 2021

By BHI Weekly Newsletter Archives




BioHealth Innovation


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July 27, 2021












FOUNDING MEMBER OF



Jeff Boyle, President of Ellume USA, joins Rich Bendis on BioTalk

Jeff Boyle, President of Ellume USA, joins Rich Bendis on BioTalk to chat about his history, their Flagship U.S. Manufacturing Facility in Frederick, MD, and why BioHealth Capital Region is a right fit for their company goals.

Listen now on Google https://bit.ly/3i0XFUO, Apple https://apple.co/2TDD1kg, Spotify https://spoti.fi/3kWwP1P, and TuneIn https://bit.ly/3BGPDrP

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MaxCyte Announces Launch of Offering and Application to List on the Nasdaq Global Market

GAITHERSBURG, Md., July 26, 2021 /PRNewswire/ — MaxCyte, Inc., (LSE: MXCT) (LSE: MXCN), a leading provider of platform technologies for cell engineering, today announced the commencement of an underwritten offering of 12,000,000 shares of common stock (the “Offering”) at an expected offering price between $11.50 and $13.50 per share. All shares to be sold in the Offering will be offered by MaxCyte. In addition, MaxCyte intends to grant the underwriters a 30-day option to purchase up to 1,800,000 additional shares of common stock.

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Emergent BioSolutions wins extension on smallpox vaccine deal – Baltimore Business Journal

The extension follows a tumultuous time for the Gaithersburg company, making it unclear if the government would proceed with deals as normal.

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Montgomery County Updates: County Welcomes BioNTech to Gaithersburg for U.S. Manufacturing Facility

German-based BioNTech has announced that it will soon be joining Montgomery County’s growing list of world-renowned international companies in the “Immunology Capital Next to the Nation’s Capital.” BioNTech is acquiring a Gaithersburg manufacturing facility and cell therapy research and development platform from Kite, a unit of Gilead Sciences, to support the development of BioNTech’s expanding pipeline of novel cell therapies.

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BioNTech to Acquire Kite’s Neoantigen TCR Cell Therapy R&D Platform and Manufacturing Facility in Gaithersburg, MD · BioBuzz

MAINZ, Germany & SANTA MONICA, Calif.–(BUSINESS WIRE)–BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Kite, a Gilead Company (Nasdaq: GILD, “Kite”) today announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD. The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

Image: https://biobuzz.io

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Alexandria Plans 200K SF Lab Building To Kick Off Huge Rockville Project

Montgomery County is set to consider plans for the first phase of a five-building life sciences project in Rockville.

An affiliate of life sciences giant Alexandria Real Estate Equities filed plans for a 200K SF research and development building as part of an 18-acre project on Darnestown Road. The Montgomery County Planning Board is scheduled to hear the plans on July 29.

Image: Montgomery County Planning Department A rendering of the 200K SF lab building on Darnestown Road in Rockville.

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Matan Companies breaks ground on Progress Labs at Riverside

Matan Companies breaks ground on Progress Labs at Riverside I The City-based project will feature 215,000 square feet of biomanufacturing-ready space — including a 96,000 square foot existing building, which is available for immediate occupancy, as well as a 118,000 square foot expansion building, which will be delivered in June 2022.

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Game Changers | VT Corporate Research Center

Come join the Virginia Tech Corporate Research Center for Game Changer Week! Game Changer Week, set for August 23-27, 2021 will bring together industry disruptors, entrepreneurs, innovators, and researchers for a variety of online and in-person events. Events include webinars, happy hours, start-up mentoring, special guests, open houses, and more!

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Preparing for the Endless Frontier: What Universities, States and Regions Should Do Now While Congress Finalizes Its Plans?

The Endless Frontier bill, now incorporated into the U.S. Innovation and Competition Act, made progress in the U.S. Senate while parallel legislation in the House also advanced to create a Technology Directorate in the NSF. Congress and the Administration also advanced through the budget process and other Congressionally authorization bills billions of dollars to create new tech hubs, advanced manufacturing, increased tech transfer, test beds, and applied research. Collectively this is one of the largest investments in applied research and tech based economic development undertaken by the federal government.

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HIV Cure Program Releases Initial Clinical Trial Data | American Gene Technologies

ROCKVILLE, MD, July 15, 2021 /Globe Newswire/ — American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient’s immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment.

Image: https://www.americangene.com

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Immunomic’s Academic Collaborator Dr. John Sampson Recognized as “World Expert” in Glioblastoma as Part of Glioblastoma Awareness Day | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields. The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as “World Expert”. Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

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Science Magazine: ARPA-H: Accelerating biomedical breakthroughs | The White House

The biomedical research ecosystem has delivered advances that not long ago would have been inconceivable, exemplified by highly effective COVID-19 vaccines developed by global partners and approved in less than a year. The United States stands at a moment of unprecedented scientific promise and is challenged to ask: What more can we do to accelerate the pace of break-throughs to transform medicine and health? Toward that end, President Biden recently proposed to create a new entity, the Advanced Research Projects Agency for Health (ARPA-H), within the National Institutes of Health (NIH) “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” requesting $6.5 billion in the fiscal year 2022 budget.

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The NIH’s Investment in Biotech Ecosystems | Bioeconomy.XYZ

The US National Institutes of Health (NIH) are the largest public supporter of basic life science in the world.

With an FY2020 budget of $42 billion, most of their expenditures are university grants supporting either new discoveries or early-state clinical studies of promising treatments and diagnostic tests.

Since 1982, Congress has mandated that a fraction of the total annual NIH budget be put to work via grants or contracts to small life science and biotech companies rather than academic institutions.

Image: Photo by National Cancer Institute on Unsplash

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Sponsored | The essential guide to drug commercialization: A manufacturer’s handbook for selecting solutions and partners | BioSpace

You have invested the time, expertise, and financial resources to develop a therapy that changes patient lives for the better. After all of your hard work and dedication, how can you ensure your product reaches patients? What are the key commercialization considerations for healthcare innovators, large and small? Learn how to unlock product potential in this step-by-step guide to making the most of your commercialization investments.

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Covid vaccine maker BioNTech buys Gaithersburg manufacturing facility – Washington Business Journal

The German firm hopes to expand its cancer treatments with the purchase.

Image: BioNTech is buying a Gaithersburg manufacturing facility on Clopper Road from Kite Pharma. GOOGLE STREET VIEW

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