BHI Weekly Newsletter Archives

SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that it is teaming up with the National Kidney Foundation (NKF) to support National Kidney Month initiatives aimed at improving outcomes for kidney transplant recipients and those suffering from kidney failure.

This marks the seventh consecutive year that CareDx is supporting NKF’s Kidney Patient Summit on Capitol Hill, which is taking place virtually this year on March 2, 2022. Patient representatives will be advocating for more research funding to accelerate the early detection of chronic kidney disease, which could help physicians reverse or delay the need for transplantation.

March 2, 2022 — The U.S. Centers for Medicare and Medicaid Services (CMS) will offer reimbursement for software from Medimaps Group that performs osteoporosis risk fracture assessment via trabecular bone scores (TBS).

The agency assigned the Current Procedural Terminology (CPT) code 77089 for Medimaps' TBS iNsight, which provides a trabecular bone score for x-ray and dual-energy x-ray absorptiometry. It was effective January 2022.

Image: https://www.auntminnie.com

WHAT YOU'LL LEARN

• As new markets are embracing the Life Science industry, why are users feeling bullish in investing and developing in the Mid-Atlantic area? How is our region competing with different markets? 
• Strategic Design & Development: How are investors and developers meeting the latest demands when it comes to design and amenities? What is being implemented to ensure purpose-built life science facilities? 
• How are developers and tenants finding more space as demand for facilities continues to rise? Are we seeing more vacant buildings being converted into labs and other biotech facilities to meet the high demand? 
• With the rise in market opportunity, where is the public and private funding coming from for life science real estate? 
• I-270 Corridor Update: What are the newest projects and investments in the development pipeline? What is expected for this life science & biotech corridor in terms of tenants, investments and development in 2022? How are DC & NoVa competing against this corridor and securing their spot in the asset class?

“I never had been in an ecosystem that had more potential, more assets, that was more disconnected, than this region was at that time.” -Rich Bendis of BioHealth Innovation, Inc. on why Maryland was a great place to grow the BioHealth Capital Region.

Watch: https://bit.ly/3trKMYm

Maryland is home to one of the largest life science clusters in the nation. According to the Maryland Department of Commerce, the State has nearly 2,300 life science companies and 476 private research and development biotechnology firms (NAICS 541714), which represents 5.3% of this U.S. industry.

Some of the nation’s most important research occurs within Maryland at National Institute of Health (NIH), Food & Drug Administration (FDA), federal laboratories, Johns Hopkins, and the University of Maryland. In fiscal year 2018, Maryland received $1.5 billion from NIH for biomedical research, behind four other states (NIH 2018 report):

Image: https://www.americangene.com

With the Bisciotti Foundation Translational Fund, John Hopkins University School of Medicine is bringing seed funding to three teams of researchers creating innovative medical devices.

Each of these devices, which are being developed by Hopkins professors and fellows, aim to dramatically decrease costs on hospitals and improve patient care by taking anesthesia out of the equation. Recipients were awarded between $25,000 and $100,000 to conduct their work during a period of up to nine months.

Image: (L to R) Therese Canares, Mathias Unberath, Clifford Weiss and Ethan Tumarkin. (Courtesy image)

Robert Gourdie, a trailblazing cardiovascular scientist at the Fralin Biomedical Research Institute at VTC, is the first Virginia Tech researcher to receive an Outstanding Investigator Award from the National Institutes of Health (NIH).

The seven-year, $6.4 million grant is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH. Known as an R35, the grant provides Gourdie with increased freedom to carry out inventive research concepts that aren’t tethered to specific, finite projects.

Image: Robert Gourdie, the Commonwealth Research Commercialization Fund Eminent Scholar in Heart Reparative Medicine Research and director of the Fralin Biomedical Research Institute’s Center for Vascular and Heart Research, is Virginia Tech’s first recipient of a National Institutes of Health Outstanding Investigator Award. Photo by Clayton Metz for Virginia Tech.

Foresite Capital, a firm that invests in early-stage healthcare and life sciences companies, today launched a $173 million fund designed to further finance startups launched by its Foresite Labs entrepreneurial innovation hub.

The new fund will be one source of capital for Foresite Labs startups, which will continue to be funded through the $969 million raised last year by Foresite Capital—consisting of the $775-million Fund V and a $193.75 million fund for selectively making additional investments in their highest conviction Fund V portfolio companies, called the Opportunity Fund.

Image: Vikram (Vik) Bajaj, PhD, a managing partner with Foresite Capital and the Co-Founder and CEO of the firm’s Foresite Labs entrepreneurial innovation hub.

POSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

Johns Hopkins University led all U.S. institutions in total National Institutes of Health (NIH) funding for federal fiscal year 2021, with more than $820 million in awards, $824,856,274 to be exact. The rest of the top ten institutions were:

After struggling through COVID-19 vaccine production woes in 2021, Emergent BioSolutions has another surprise for its investors in early 2022. 

Last month, Emergent projected revenues of $1.4 billion to $1.5 billion for this year. Now, the company has dropped the figure to $1.3 to $1.4 billion. 

Why the adjustment?

In its quarterly report, Emergent credited its decision to undergo maintenance on its troubled Baltimore Bayview facility “earlier than anticipated,” and to expand the project to set the facility up for “future non-pandemic work.”

USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster   Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.

To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.

In a bid to keep and grow its flagship biohealth sector, Montgomery County is dramatically streamlining its regulatory review process for industry players who want to build or expand big lab facilities.

A new zoning text amendment, which the County Council unanimously approved Tuesday, will slash the lab entitlement process time from nearly two years to six months in an effort to “roll out the red carpet” for biotech industry leaders, said Councilman Andrew Friedson, D-District 1, who spearheaded the legislation.

Image: Montgomery County Councilman Andrew Friedson, D-District 1, speaks at a county event to unveil a new zoning process change. The Wednesday gathering was held outside of biotech United Therapeutics' Silver Spring campus. DAN BRENDEL

In this issue of Cell Host and Microbe, Haslwanter et al., 2022 present a comprehensive investigation into the molecular and functional basis of 17D vaccine responses and into differences between antibody neutralization of the 17D and related African lineage strains to contemporary Central/South American strains, including the emergent YFV ES-504 strain.

Image: https://www.cell.com

WILMINGTON, Del.–(BUSINESS WIRE)–Amalgam Rx, Inc., a leader in connecting healthcare providers, payers, and life sciences companies through a SaaS-enabled digital marketplace and product platform, and Privia Health Group, Inc., a national physician enablement company, announced a collaboration for multiple EHR-integrated services.

Leveraging Amalgam’s real-time, point-of-care decision support engine, the companies are working together to simplify and enhance the way providers practice value-based care, recruit for clinical trials, and ensure medication safety. Privia Health selected several offerings from Amalgam’s marketplace including:

Image: https://www.businesswire.com

The University of Maryland named Dr. Dean Chang as its new interim chief innovation officer and associate vice president for innovation and economic development of the research division, according to an email Monday from the interim and incoming vice presidents for research.

Chang served as founding associate vice president for innovation and entrepreneurship for this university’s Academy for Innovation and Entrepreneurship over the last nine years. In the position, he worked with more than 41,000 students in all 12 of the university’s colleges and schools in innovation, the email said.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs of the National Institutes of Health (NIH) supported the development of 99 drugs from 1996-2020 — a total that includes 16 percent of all such treatments that made a “significant” advance over available medicines. This finding is just one of the impacts that the National Academies of Sciences, Engineering and Medicine (NASEM) attributes to the program in a new report.

The University of Maryland Baltimore County has joined the highest ranks of research universities in the country, a milestone for the young school with a reputation for producing scientists and engineers of color.

The 55-year-old university in suburban Baltimore reached Research 1, or R1, status, a distinction for universities with very high research activity.

Image: Trevor Shepard, a chemistry major, works on a viscosity experiment at the University of Maryland Baltimore County in October 2020. (Michael Robinson Chavez/The Washington Post)

The Universities at Shady Grove (USG) – with nine partner universities offering a wide range of life-changing academic programs on one convenient campus in Montgomery County – has been an innovative model for higher education delivery since its inception in 2000.

After two decades of growth, evolution and success, it’s time for the USG community to now build on the solid foundation it has established by charting a solid course for “USG 2.0.” It’s time for us to develop our first-ever Strategic Plan, to help shape the future direction of a unique University System of Maryland institution that is the largest and most comprehensive of the state’s regional higher education centers.

Image: https://shadygrove.umd.edu/about-usg/leadership-governance/office-of-the-executive-director/usg-2.0

New zoning measure spearheaded by Friedson will accelerate and streamline the regulatory process to develop and spur expansion of biohealth facilities in Montgomery County

On Wednesday, February 16 at 10:30 a.m. Councilmember Andrew Friedson and Montgomery County biohealth and economic development leaders will hold a press conference to reinforce Montgomery County’s commitment to innovation and the biohealth sector at United Therapeutics Corp. in Silver Spring.

Looking to make connections and identify partners in the life sciences industry? Use the Maryland Life Sciences Directory, a free tool for exploring more than 1,000 profiles of companies active in Maryland’s robust life science markets, including biotechnology, medical technology, pharmaceuticals, digital health, manufacturing, regulatory services, and related subsectors. Explore company profiles for an overview of business activities, products, and services, and to connect with potential partners.  

FREDERICK, Md. and BRISBANE, Australia, Jan. 10, 2022 /PRNewswire/ — Digital diagnostics company Ellume today announced that the QIAreach QuantiFERON-TB test (QIAreach QFT), developed with Ellume technology, and designed to advance the control of tuberculosis (TB) in areas with limited infrastructure, has been approved by the Global Fund’s Expert Review Panel for Diagnostics.  Approval of QIAGEN N.V.’s battery-operated QIAreach QFT means the product will now be available to public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as through the Stop TB Partnership’s Global Drug Facility (GDF). This development comes after the QIAreach QFT product was launched in October 2021, following CE marking.

On Saturday, January 29, the World Health Organization (WHO) Executive Board approved the renewal of official relations with the United States Pharmacopeial Convention (USP) through 2023. As an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, USP is honored to continue our longstanding partnership with the WHO and contribute our expertise to shape and advance policies and strategies to improve the health and wellbeing of people around the world.

Image: https://www.linkedin.com/

The University of Maryland, Baltimore County has received a Carnegie Classification, the nation’s highest designation for research universities.

Two other universities in Maryland – Johns Hopkins University and the University of Maryland – share the classification.

The Carnegie Classification of Institutions of Higher Education ranked UMBC in the R1 category, which signifies “very high research activity.”

UMBC is one of only 146 R1 institutes nationally, including 107 public universities and 39 private universities.

“This is an amazing accomplishment by faculty, staff, and administrative leaders who have built a research culture that nurtures undergraduate and graduate students,” said UMBC president Freeman Hrabowski in a news release.

Image: Photo via the University of Maryland, Baltimore County

The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation’s potential. Learn about the aspects of product development beyond the science of the awards. 

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

• Optimizing formulation or manufacturing operations 
• Establishing an advisory board  
• Layering intellectual property protection 
• Preparing for regulatory interactions 
• Gathering evidence to support reimbursement value 
• Engaging with investors or strategic partners

Global public health is at a critical inflection point. Do we learn the lessons of this pandemic and build a modern public health infrastructure to prepare us for the next one? Or do we repeat the mistakes of the current and past pandemics?

This week, Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr released a bipartisan draft bill aimed at evolving America’s pandemic preparedness commensurate with the challenges we face. The bill adds to the important public policy conversation ongoing in Washington, which includes President Biden’s ambitious $65 billion initiative for preparedness.

 NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant strains

GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

“We’re extremely proud of the work of our teams and we look forward to FDA’s review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “I’d like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today’s milestone of EUA request submission.”

Proof-of-concept of exosomes manufacturing in scale-X™ bioreactor to demonstrate advantages of intensified and integrated platforms. RoosterBio to leverage scalable, continuous bioprocessing technologies to deliver regenerative therapies at reduced timelines and costs, improving access for patients.  

FREDERICK, MD. (PRWEB) JANUARY 20, 2022

Univercells Technologies, a leading provider of novel biomanufacturing technologies for flexible and scalable viral production, announces today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and hMSC bioprocess systems. This partnership will optimize manufacturing of extracellular vesicles (EVs) using scalable and continuous bioprocessing technologies to propel the commercialization of regenerative therapies at affordable costs.  

UMBC has received a $900,000 grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop and implement a new, short-term biomanufacturing training program. Four universities, all classified as minority-serving institutions (MSIs), received funding for similar programs, designed to meet critical national workforce needs. 

Image: Charmaine Hipolito ’20, and Titina Sirak ’20, right, alumni of UMBC’s TLST program at The Universities at Shady Grove, speak with visitors at a celebration for the opening of USG’s new Biomedical Sciences and Engineering Building in November 2019. Photo by Marlayna Demond ’11 for UMBC.

A life sciences building in downtown Bethesda seemed like a slam dunk when StonebridgeCarras and Donohoe Cos. first proposed it in 2018. The site at 8280 Wisconsin Ave. was located close to the National Institutes of Health, the largest source of life sciences funding in the country, and in an urbanized core primed to attract a vibrant millennial workforce.

Image: Bisnow/Jon Banister A view looking down Wisconsin Avenue in Bethesda with Carr’s The Wilson and The Elm development in the background.

Time for a Concerted Effort to Explore Manufacturing in Microgravity Environments

Space is emerging as the next frontier for advanced manufacturing. The market alone for biomanufacturing in space is expected to reach nearly $3 billion by the mid-2030s. Similar microgravity markets exist in other engineering and technology areas.

Accordingly, the administration and Congress need a coordinated effort to take advantage of the incredible opportunity of manufacturing at scale in the microgravity environment. As a recent gathering of corporations, federal agencies, scientists, and engineers examining biomanufacturing in space noted: “The formation of a public-private consortium is needed to further prioritize opportunities, de-risk space-based research and development (R&D) and guide the translation of results into commercial applications on Earth.”

GAITHERSBURG, Md., Jan. 14, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that Fuad El-Hibri, founder and executive chairman, has decided to retire effective April 1, 2022.

“Creating and leading Emergent has been the honor of my life, and it would not have been possible without the help of our incredible team,” said El-Hibri. “I want to thank everyone at Emergent, past and present, for helping advance our inspiring mission over the past two decades. I could never have imagined the number of lives we would impact, and I will forever be proud of our accomplishments. Emergent is on track to achieving its 2024 strategic plan goals and I have utmost confidence in the executive team under the leadership of Bob Kramer and the oversight of our highly experienced and capable board. While I have been looking forward to retirement after 23 years of service, I will be rooting from the sidelines as a fan, friend, and shareholder.”

— Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine granted approval in South Korea

GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, today announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.

"Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine."

Center will expand Orgenesis’ Point of Care (POCare) Platform Capabilities in Maryland GERMANTOWN, Md., Jan. 18, 2022 (GLOBE NEWSWIRE) — Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and The Johns Hopkins University, today announce the next phase of their collaboration. This new phase involves construction of a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins which is planned to start in Q2 2022 and is expected to be operational in Q2 of 2023.

Construction of the new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been funded in part by a $5 million grant from the State of Maryland. The new state-of-the-art 7,000-square-foot facility has been designed to meet U.S. Food and Drug Administration standards and provides Johns Hopkins clinicians and researchers with a more streamlined path to treat patients and take promising and novel treatments from the lab to patient trials. This path will enable local capacity for processing of clinical therapeutics at the point of care, rather than having to outsource clinical trial cell and gene therapy manufacturing to third parties.

Dr. David Hackam and his lab are utilizing human stem cell technologies to tackle the leading cause of death and disability in premature infants, necrotizing enterocolitis (NEC), as well as other chronic intestinal conditions that affect children and adults. As the Chief of Pediatric Surgery at Johns Hopkins University and Surgeon-in-Chief of Johns Hopkins Children's Center, Dr. Hackam knows firsthand the complicated neonatal surgery and the devastating long-term effects that result from NEC.

https://www.youtube.com/watch?v=c5jVLDWrV4g