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BHI Weekly News Archives

493rd Edition, February 1, 2022

By BHI Weekly News Archives

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Februaryย 01, 2022

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BioHealth Innovation Announces Updates to its Board of Directors

Board of Directors Elects New Chair, Vice-Chair, and Two New Members

ROCKVILLE, MARYLAND, January 31, 2021ย โ€“ย The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Peter S. Briskamn, Executive Managing Director and Mid-Atlantic Life Sciences Practice Co-Lead for JLL, and Christine Dingivan, M.D., President and Chief Executive Officer for Emmes as the new Chair and Vice-Chair in 2022. In addition, Ronald C. Kurz, Senior Director/GM for Canon Virginia, Inc. (CVI), and Dr. Tyrell Rivers, Executive Director of Corporate Development & Ventures at AstraZeneca, will be joining the Board as new members.

BioHealth Innovation and its Board of Directors would also like to thank outgoing Chair Jarrod Borkat for his leadership as he will remain with the Board. The Board would also like to thank Rebecca Farkas, Ph.D., for her contributions as she departs GSK and moves into a new role with CEPI.

ย “We are proud to announce Pete and Christine as our new Chair and Vice-Chair on the BHI Board of Directors,” said Richard Bendis, BHI President and CEO. “Their experience and industry knowledge, plus the additions of Ron and Tyrell are important pieces to not just BHI, but the continued growth of the BioHealth Capital Region.”

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Immediate Job Opportunity: Entrepreneur-In-Residence Role with BioHealth Innovation, Inc. and NIH

POSITION DESCRIPTION โ€“ 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).

Learn more

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BHIโ€™s next EIR Feedback Day is February 16th

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If youโ€™re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please followย this link.

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Entrepreneurial Development | Seed

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

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement expertsโ€ฏmeet with innovators focused on topics including:

  • Optimizing formulation or manufacturingโ€ฏoperationsย 
  • Establishingโ€ฏan advisoryโ€ฏboardโ€ฏย 
  • Layeringโ€ฏintellectual property protectionย 
  • Preparingโ€ฏfor regulatory interactionsย 
  • Gathering evidence to support reimbursement valueย 
  • Engaging withโ€ฏinvestors or strategic partners

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Cartesian Therapeutics Doses Patient with First Allogeneic RNA Cell Therapy for Multiple Myeloma – Cartesian

Gaithersburg, Md., January 25, 2022 โ€“ Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, today announced that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma.ย  To the companyโ€™s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the companyโ€™s fifth FDA Investigational New Drug (IND) allowance in five years.ย  Descartes-25 is produced at Cartesianโ€™s wholly owned cGMP manufacturing facility with the companyโ€™s proprietary RNA Armoryยฎ cell manufacturing platform.ย  This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

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QIAGEN Completes U.S. Federal Contract to Equip Local Public Health Authorities with QIAcuity Digital PCR System for COVID-19 Surveillance | BioSpace

HILDEN, Germany, & GERMANTOWN, Md.–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has completed a U.S. government contract to equip public health laboratories across the country with the QIAcuity digital PCR system to monitor the spread of the COVID-19 pandemic by testing wastewater for the presence of SARS-CoV-2 pathogens.

QIAGEN has shipped more than 35 QIAcuity systems to state and local health laboratories as part of a multi-million-dollar contract with the U.S. National Institutes of Health (NIH) to supply COVID-19 instruments and consumables through the end of 2021.

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Pandemic Preparedness: The next best time to act is now โ€“ Emergent BioSolutions

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 Americaโ€™s pandemic preparedness commensurate with the challenges we face. The bill adds to the important public policy conversation ongoing in Washington, which includes President Bidenโ€™s ambitious $65 billion initiative for preparedness.

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Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

ย 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/ —ย Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announcedย 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.”

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Novavax and Israel Announce Advance Purchase Agreement for Supply of COVID-19 Vaccine

The Novavax vaccine would be the first protein-based alternative available in Israel

GAITHERSBURG, Md., Jan. 28, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Israel’s Ministry of Health today announced an agreement for the purchase of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-Mโ„ข adjuvant.

“Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the Israeli Ministry of Health for their commitment to providing a protein-based COVID-19 vaccine option, based on well-understood technology, to the people of Israel.” ย ย 

Under the advance purchase agreement, Novavax will provide an initial 5 million doses of its protein-based vaccine with an option for Israel to purchase an additional 5 million doses. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval.

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CoapTech Awarded Seed Fund Grant from Pennsylvania Pediatric Device Consortium

BALTIMORE,ย Jan. 27, 2022ย /PRNewswire/ย — CoapTech, Inc,ย a medical device company focused onย delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded aย $50,000ย grant by the Children’s Hospital ofย Philadelphia-based Pennsylvania Pediatric Medical Device Consortium (“PPDC”) for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.

The PUMA Systemโ„ขย is a new category of minimally invasive devices, enabling ultrasound procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The PUMA-G Peds System is being developed to allow ultrasound-based placement of gastrostomy tubes in pediatric patients as an alternative to traditional endoscopic or fluoroscopic procedures. Endoscopic procedures cannot “see through” tissue which can result in organ damage or other complications. Fluoroscopic procedures require the use of ionizing radiation which presents long term risk of cancer. The PUMA-G Peds System uses ultrasound to visualize tissue and organs in real time without ionizing radiation. It is designed to operate like the currently available adult PUMA-G System, with modifications to accommodate the pediatric patient population.ย 

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Immunocore announces FDA approval of KIMMTRAKยฎ (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma :: Immunocore PLC

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (โ€œImmunocoreโ€ or the โ€œCompanyโ€), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAKยฎ (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

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Looking Back with Prideโ€”and Forward with Purpose

At the University System of Maryland, January brings with it the chance to reflect on a year of accomplishment and anticipate a year of impact. Because, despite the challenges of the past several months, weโ€™re still doing the work we were built to do. Our students are excelling. Our scholarship is making change. Our research is solving problems. Our service is improving lives.

This is a direct credit to the people of the USM. As COVID upended our academic enterprise and administrative operations, our people kept working harder, with a clarity of purpose and a devotion to mission that is, to me, breathtaking. The achievements and ambitions I share here honor their dedication.

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Maryland life science & digital health companies drive record VC investment. | Maryland Business News

In 2021, venture capitalists invested $2.27 billion in Maryland companies, according to the initial figures from the PitchBook-NVCA Venture Monitor Report. VC investment in 2021 shattered the record set in 2020 of $1.24 billion, and marks the third consecutive year of record-setting investment in Maryland companies.ย 

Given the high concentration of life sciences and digital health companies located in Maryland, itโ€™s no surprise that investors turned their eyes, and their dollars, here last year.ย Significant local investments are fueling innovation across nearly every field, from cancer research to healthcare analytics. Below are some themes from Marylandโ€™s banner year in venture capital.ย 

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Trends in Talent Acquisition, COVID Edition ยท BioBuzz

The pandemic, now approaching year three in full force, has impacted nearly every facet of the life sciencesโ€™ job market. A talent shortage existed pre-pandemic and has only accelerated since then. For life sciences employers, finding and securing talent will continue to be a major challenge throughout 2022.ย 

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5 Cities Emerging As Future Hubs For Life Sciences Development

The current boom in life sciences development mirrors the tech industry, especially geographically; there is an incredible concentration of jobs and investmentย in the top markets, in this case Boston, San Diego and the Bay Area and challenges finding support and funding anywhere else.

Image: Courtesy of Bill Timmerman A lab at 850 PBC, a Wexford lab development in downtown Phoenix.

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Vaccitech CEO Bill Enright Joins Rich Bendis on First BioTalk of 2022

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All Rights Reserved.

492nd Edition, January 25, 2022

By BHI Weekly News Archives





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January 25, 2022

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Vaccitech CEO Bill Enright Joins Rich Bendis on First BioTalk of 2022

Bill visits BioTalk to talk about being a serial entrepreneur, biotech executive, and their recent acquisition of Avidea Technologies.

Listen now via Apple https://apple.co/3fTySQM, Google https://bit.ly/3KDPMkh, Spotify https://spoti.fi/3rI7UB3, Amazon https://amzn.to/33DwOtH, or TuneIn https://bit.ly/3fS8C9f.

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Orgenesis and Johns Hopkins University expand POCare in Maryland through creation of the Maryland Center for Cell Therapy Manufacturing

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.

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University of Maryland Ranks in Top 10 in Research Funds – UMB News

The University of Maryland has again ranked among the top 10 research institutions in the National Science Foundation’s (NSF) Higher Education Research and Development (HERD) Survey, placing 10th among public institutions in research and development (R&D) spending and 16th overall nationally for Fiscal Year 2020.

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Univercells Technologies Partners with Frederick's RoosterBio to Advance Scalable and Continuous Exosomes Manufacture

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.  

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Inside DC's $5B year: Here's why local venture capitalists say the VC boom is here to stay – Technical.ly

So, you just had a $5 billion venture capital year. Now what? With the final numbers for Q4 finally in, we can say with certainty that DC had a record-breaking year for investment across the board. To the tune of $4.9 billion, venture capital sang in 2021, with deals growing larger as the year went on.

For some scale, note that the DMV raised just under $2 billion in all of 2020, meaning it more than doubled its dollars in a year. It’s not alone in the bump, though. Nearby Baltimore had its best (albeit much smaller) year in recent history at $768 million and Philadelphia did, too, with a casual $8 billion raised.

Image: (Photo by Flickr user, used via a Creative Commons license)

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United Therapeutics Corporation Announces Historic Achievements in its Xenotransplantation Programs

UKidney™ procedure data published in the American Journal of Transplantation; the first such data published in a peer-reviewed journal

UHeart™ recipient patient reaches a two-week milestone post-transplant

UThymoKidney™ procedure represents a historic first preclinical human model study

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (UT) (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, announced today that the world's first recipient of an investigational genetically-modified xenotransplanted organ, UT’s UHeart™, reached a two-week milestone. University of Maryland School of Medicine (UMSOM) surgeons report continued post-operative cardiovascular improvement in the patient with normal organ function. In addition, the first peer-reviewed publication of a similarly gene-edited investigational xenograft, UT’s UKidney™, in a human preclinical model at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine (UAB) was published yesterday in the American Journal of Transplantation.

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UMBC continues to advance Maryland’s biotech workforce through $900K biomanufacturing grant – UMBC NEWS

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.

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Why Hasn't The Life Sciences Boom Come To Downtown Bethesda?

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.

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BIO Report Outlines Economic Impact of Booming Life Sciences Industry | BioSpace

The Biotechnology Innovation Organization (BIO) provides a glimpse of economic development in the biosciences ecosystem at the state and regional levels. The report, which was developed in partnership with the Council of State Bioscience Associations (CSBA), was released as an industry analysis in the wake of the COVID-19 pandemic and its impact on the overall economy. 

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Launching an Advanced Manufacturing Institute in SPACE | ITIF

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.”

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All Rights Reserved.


491st Edition, January 18, 2022

By BHI Weekly News Archives





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January 19, 2022

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BHI Client Avidea Merger with Vaccitech Provides New Opportunities for SNAPvax Platform · BioBuzz

One month after being acquired in a $40 million deal by U.K.-based Vaccitech plc, the team that was formerly part of Avidea Technologies continues to advance its SNAPvax platform into the crucible of clinical trials in about one year.

Privately-held Avidea is developing next-generation T cell immunotherapies for the treatment of cancer and autoimmune diseases. The company’s immunotherapies are driven by its polymer-drug conjugate technology platform, SNAPvax, which is designed to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition.

Image: https://biobuzz.io/

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First pig-to-human heart transplant: what can scientists learn?

The first person to receive a transplanted heart from a genetically modified pig is doing well after the procedure last week in Baltimore, Maryland. Transplant surgeons hope the advance will enable them to give more people animal organs, but many ethical and technical hurdles remain.

“It’s been a long road to get to this point, and it’s very exciting we are at a point where a group was ready to try this,” says Megan Sykes, a surgeon and immunologist at Columbia University in New York City. “I think there’s going to be a lot of interesting things to be learned.”

Image: Surgeons at the University of Maryland Medical Center transplanted a genetically altered pig heart into David Bennett.Credit: University of Maryland School of Medicine

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One Of America’s Richest Self-Made Women, Martine Rothblatt, Played Key Role In Week’s Historic Heart Transplant

When the University of Maryland Medical Center announced the first successful transplant of a heart that was grown in a genetically altered pig earlier this week, it notched a big win for one of America’s wealthiest self-made women.

Revivicor, a subsidiary of United Therapeutics–founded and led by Martine Rothblatt – supplied the heart that made the surgery possible. A former communications satellite lawyer who went on to cofound Sirius Satellite Radio, Rothblatt, 67,  has  been on a long journey to biotechnology success.  

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

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Founder and Executive Chairman of Emergent BioSolutions Announces Retirement

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.”

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Institute for Bioscience and Biotechnology Research Receives $16.8M Investment from the National Institute of Standards and Technolog

Fri, Jan 14, 2022  

New Cooperative Agreement to Aid in the Development of Therapeutics and Vaccines, Improve Access to Medication  

The Institute for Bioscience and Biotechnology Research (IBBR) announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology (NIST) headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino (NIST). This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges.  

IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines.  This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers.  

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BioSpace: Cartesian Aims to Propel RNA Cell Therapy with Combinations

Cartesian Therapeutics is developing non-permanent cell therapies that can be used soon after diagnosis and address a wide range of diseases beyond cancer. The biotech’s approach to cell engineering relies upon RNA rather than DNA to effect changes within the cells.  

The benefit, Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D. told BioSpace, is that “our RNA approach, compared to a traditional DNA modification, offers an order of magnitude greater control over the therapeutic product and what happens when those cells are in the body.” A high level of control is important if cell therapy is to be used in the treatment of either front-line cancer or in indications where the choice isn’t between life and death.  

“RNA has a measurable half-life,” Kalayoglu explained, so cell therapies driven by RNA aren’t permanent. “The cells can’t proliferate out of control.” Consequently, Cartesian can develop cell therapy for newly diagnosed populations and for autoimmune, respiratory and inflammatory diseases, for example.  

Click here to read more via BioSpace.

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South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine – Jan 12, 2022

— 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."

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Orgenesis and Johns Hopkins University expand POCare in Maryland through creation of the Maryland Center for Cell Therapy Manufacturing

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.

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Chain Drug Review Pharmacy Outlook: Ronald Piervincenzi, USP

January 10, 2022 by Ronald Piervincenzi  

The COVID-19 pandemic made the last year both an extraordinary and challenging time to work in health care. Development, distribution and administration of new vaccines, treatments and preventatives moved at a pace never before experienced. Pharmacists and other health care practitioners were called to the front lines of a mass vaccination effort, working to balance safety, speed and a plethora of daily demands in caring for patients and working to save countless lives. Manufacturers, regulators, pharmacists and other care providers demonstrated how cross-sector collaboration could rapidly transform cutting-edge innovation into the new standard of care, including an expanding scope of practice for many pharmacists.  

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Stem Cell Therapy for NEC – Dr. David Hackam | Maryland Stem Cell Research Fund – YouTube

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

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NIH Technology Accelerator Challenge (NTAC) | National Institute of Biomedical Imaging and Bioengineering

Prize Competition for Maternal Health

NIBIB launched the NIH Technology Accelerator Challenge (NTAC) series of prize competitions to stimulate the design of new diagnostic technologies to transform public and global health and to accelerate the full development of those products for use in low-resource settings. This iteration of NTAC intends to award cash prizes for innovative diagnostic technologies to help improve maternal health by diagnosing conditions related to maternal morbidity and mortality. Pregnancy and childbirth complications are a major global health problem resulting in the deaths of more than 800 women and 7,000 newborns each day. Contributing to the high rates of maternal morbidity and mortality in low-resource settings is the lack of low-cost diagnostics that operate at the point-of-care and are capable of detecting and differentiating common conditions during antenatal and intrapartum periods of pregnancy. Therefore, the intended purpose of NTAC: Maternal Health is to spur and reward the development of low-cost, point-of-care molecular, cellular, and/or metabolic sensing and diagnostic technologies integrated with a digital platform to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality.

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JHU revises COVID-19 safety protocols ahead of spring semester | Hub

ohns Hopkins University is revising its safety protocols ahead of the start of the spring semester as it prepares to resume a broad range of in-person academic, research, and other activities as safely as possible amid the surge in COVID-19 cases caused by the omicron variant, university leaders said Friday.

The most noticeable change is to the university's masking requirement: JHU will now require the use of N95s, KN95s, or a combination of a cloth mask with a surgical mask. In other words, a cloth mask alone or a surgical mask alone will no longer meet the university's mask requirement, wrote Stephen Gange, professor and executive vice provost for academic affairs; Jon Links, professor, vice provost, and chief risk officer; and Kevin Shollenberger, vice provost for student health and well-being and interim vice provost for student affairs in a message to the JHU community on Jan. 14.

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Decentralized Clinical Trials Raise Concerns About Informed Consent

Under pressure of the COVID-19 pandemic, multitudes of clinical trials of new medications and treatments have moved to a decentralized model, bringing them to the patients rather than having patients come to a central trial site such as an urban medical center.(1) At the same time, recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.(2) “This,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “is not an acceptable situation. The extent to which patients comprehend the consent they grant is essential to the ethical conduct of medical research.”

Image: http://www.prweb.com

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Detection of SARS-CoV-2 and other RNA Virus Using a Novel Improved RT-qPCR Method that Increases Sensitivity & Improves Safety

DNA or RNA-based diagnostic tests for infectious diseases are critical in modern medicine. The current gold standard for COVID-19 detection is testing SARS-CoV-2 viral RNA by quantitative reverse transcription Polymerase Chain Reaction (RT-qPCR). This method involves patient sample collection with a nasopharyngeal swab, storage of the swab in a universal transport medium during transport to a testing site, RNA extraction, and analysis of the extracted RNA sample. Collected patient samples, in addition to the possible presence of SARS-CoV-2, also contain inhibitors for downstream enzymatic reactions, RNA degrading enzymes (e.g., RNase), and magnesium and calcium ions that are required for RNase activity. Active RNase in the patient sample can reduce the amount of SARS-CoV-2 RNA in the sample; so, the RNA needs to be extracted for analysis.

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Structural Biology Illuminates Molecular Determinants of Broad Ebolavirus Neutralization by Human Antibodies for Pan-Ebolavirus Therapeutic Development | Immunology | Frontiers

Monoclonal antibodies (mAbs) have proven effective for the treatment of ebolavirus infection in humans, with two mAb-based drugs Inmazeb™ and Ebanga™ receiving FDA approval in 2020. While these drugs represent a major advance in the field of filoviral therapeutics, they are composed of antibodies with single-species specificity for Zaire ebolavirus. The Ebolavirus genus includes five additional species, two of which, Bundibugyo ebolavirus and Sudan ebolavirus, have caused severe disease and significant outbreaks in the past. There are several recently identified broadly neutralizing ebolavirus antibodies, including some in the clinical development pipeline, that have demonstrated broad protection in preclinical studies.

Image: https://www.frontiersin.org

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Unblock research bottlenecks with non-profit start-ups

It takes more than a great idea to accomplish a great project. Our research and experience have convinced us that many worthy projects wither or are never launched because neither academic laboratories, start-up firms nor government facilities can support them.

This applies particularly to projects that would produce public goods, such as data sets or tools, that could make research faster and easier. Few research-enabling projects will be commercially viable enough to attract venture capital.

Image: Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

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MEDA Education Session: "Primer on selling to hospitals"

Wednesday, February 02, 2022, 12:00pm – 01:30pm

Winning over a hospital Value Analysis Committee or “VAC” is a must for companies targeting hospital customers.

What does it take?

Who makes up VACs?

Case studies, lecture format + Q/A time.

Wednesday, February 2, 2022 12pm – 1:30pm EST

via webinar

To learn more click here.

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Let’s Discuss the "still" Soaring Healthcare Investments in 2021 and beyond

Jonny’s back! Despite the continuation of COVID -19 through 2021, 2021 was a spectacular year for venture fundraising.  Investment in every healthcare sector set records, and most experienced record IPO activity as well. 

With pullback in both investments and public market performance in late 2021, what will 2022 have in store? Jon will provide his unique insights into 2021s market performance and his crystal ball predictions for 2022,

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Age-Tech & Digital Health Solutions: Fundamentals of Longevity Economy Market (Audio Descriptions) – YouTube

The Developing and Accelerating Age-Tech and Digital Health Solutions webinar series, hosted by NIA’s Small Business Program, offers research entrepreneurs and biotech small business owners insights and best practices for digital health and age-tech solutions. The Understanding the Fundamentals of the Longevity Economy Market session provides guidance on developing and positioning your solutions, defining customer market segments, understanding reimbursement pathways, and creating a profitable and impactful business model.

https://www.youtube.com/watch?v=IcbPXa0_NOY

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490th Edition, January 11, 2022

By BHI Weekly News Archives





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January 11, 2022

FOUNDING MEMBER OF

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Horizon Therapeutics plc Announces Significant Expansion of East Coast Research and Development and Technical Operations Capability | Horizon Therapeutics plc

DUBLIN–(BUSINESS WIRE)–Jan. 6, 2022– Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. to be the first tenant at the Alexandria Center® at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will serve as the company’s primary East Coast research and development and technical operations hub. Construction at the 192,000-square-foot site is underway and Horizon expects to start work on interior improvements in 2023. Additional terms of the agreement were not disclosed.

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MIMETAS opens Phenotypic Screening Center

Leiden, May 27, 2021 – MIMETAS, the global leader in human-relevant organ-on-a-chip models, has just opened their Phenotypic Screening Center. The center facilitates large-scale screening campaigns on Organ-on-a-Chip models, a powerful technology that improves the human physiological relevance of cultured tissues by utilizing microfluidic techniques. In contrast to other Organ-on-a-Chip platforms, the MIMETAS OrganoPlate® technology offers the scalability and the throughput needed for drug discovery studies.

Image: https://www.mimetas.com

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NexImmune Announces Formation of Autoimmune and Infectious Diseases Scientific Advisory Board

GAITHERSBURG, Md., Jan. 05, 2022 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced the formation of its Autoimmune and Infectious Disease Scientific Advisory Board (AI & ID SAB). The AI & ID SAB is comprised of distinguished academic and industry leaders in the fields of autoimmune and infectious diseases, translational research, immunology and T cell biology.

“As we continue to advance our AIM nanotechnology platform, we are grateful to have the input and guidance of these established experts,” said Jerry Zeldis, NexImmune’s EVP of R&D. “Their combined experience in autoimmune and infectious diseases, translational science and clinical development will help make informed decisions as we expand our pipeline and explore new therapeutic areas.”

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South Duvall Takes Next Step to Bring 45,000 Square Feet of Lab Space to Rockville

ROCKVILLE, Maryland – January 6, 2022 South Duvall today announced that it has submitted construction plans for permit to bring 45,000 square feet of lab space to 1450 Research Boulevard in Rockville, MD. South Duvall will renovate the façade, create new building amenities and common areas, and install brand-new mechanical, electrical, and plumbing systems. Three move-in ready lab spec suites ranging from 2,800 square feet to 3,700 square feet range are expected to deliver by the fourth quarter of 2022 with two full floors of roughly 15,000 square feet available for tenant fit out now. Leasing will be handled by Scheer Partners. “The submission of construction plans for our lab conversion of 1450 Research Boulevard begins our timeline to deliver much needed lab space to the I-270 corridor in 2022,” said Matthew Brown, director of acquisitions, South Duvall. “Our design team took lessons we have learned from other similar projects and developed an exciting plan to deliver a unique, best-in-class lab building.”  

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BHI Recruiting a Senior Analyst, Immediate Opening.

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.

Download the Full Job Description.

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BioBuzz: Charlottesville’s Molecular Biologicals is Changing the Game in Wound Care BioBuzz: Charlottesville’s Molecular Biologicals is Changing the Game in Wound C

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

Click here to read more via BioBuzz.

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Zalgen Labs’ move to Frederick is another sign of the BioHealth Capital Region’s strengths

Maryland biotech company Zalgen Labs has moved to Frederick, illustrating the magnetism of the biotech hub for leaders like its own Dr. Luis Branco who want to capitalize on the new sense of collaboration the pandemic has brought about in life sciences companies in the region.

The move to Frederick puts Zalgen closer to the epicenter of what’s known as BioHealth Capital Region (BHCR) that encompasses Maryland, Virginia and DC. Frederick alone is home to over 80 biotech companies, according to the county’s Office of Economic Development.

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REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystroph

ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ —

  • Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector 
  • Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose 
  • cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202
  • REGENXBIO expects to initiate trial in the first half of 2022

REGENXBIO Inc. (Nasdaq: RGNX) today announced the clearance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to evaluate RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne) in a first-in-human clinical trial. RGX-202 is designed to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector. REGENXBIO plans to initiate the trial in the first half of 2022.

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A regional economic development strategy and why commercial real estate should care

The U.S. Economic Development Administration announced last month the winners of $500,000 planning grants to 60 jurisdictions across the country for the $1 billion Build Back Better Regional Challenge. Winners of Phase 2 Build Back Better will be eligible for federal grants of up to $100M to create new science and technology parks and districts, accelerators, and other technology infrastructure across the country.

Funding for the technology infrastructure must go to a nonprofit, such as a university, but the nonprofit will need the commercial real estate industry to design, build and manage this technology infrastructure.

The District of Columbia/Maryland/Virginia (DMV) region submitted some very good bids, including ones in quantum technology, biotechnology, advanced manufacturing, and other topics but only Howard County for cyber security, Richmond, Virginia in bio manufacturing, and rural Southwest Virginia in transportation logistics won planning grants.

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Dr. James Crowe, Director of the Vanderbilt Vaccine Center Visits Bloomberg Markets: America, and CNBC’s Squawk Box

On this snowy start to 2022, I wanted to share with you two interviews with AHEAD100 Chief Scientist Dr. James Crowe that occurred over the last week on CNBC and Bloomberg TV. Each piece is a powerful continuation of our work to build awareness and support for the work of the Global Pandemic Prevention and Biodefense Center and lead initiative, AHEAD100 — and together, they garnered more than 100 million impressions, representing more than $1 million in advertising value equivalent.

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REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subre…

ROCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ —

  • ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada
  • Pivotal trials expected to support BLA submission for RGX-314 in 2024

REGENXBIO Inc. (Nasdaq: RGNX) today announced the initiation of ASCENTTM, the second of two Phase III pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD). ASCENT, the first trial to be initiated by REGENXBIO under the eye care collaboration with AbbVie, is currently active and screening patients. RGX-314 is being investigated as a potential  one-time gene therapy for the treatment of wet AMD.

A Biologics License Application (BLA) is expected to be submitted to the United States Food and Drug Administration (FDA) in 2024 based on two pivotal trials, ASCENT and the ongoing ATMOSPHERE trial.

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Hibiscus BioVentures Partners with the Barbara Ann Karmanos Cancer Institute to Advance Translational Cancer Research

– Partnership aims to drive innovation and clinical development of novel therapeutics for cancer treatment –

ROCKVILLE, Md.–(BUSINESS WIRE)–Hibiscus BioVentures, a firm committed to building patient-focused companies around transformative technologies, today announced it has entered into a partnership agreement with the Detroit-based Barbara Ann Karmanos Cancer Institute (Karmanos). This partnership between Hibiscus’ venture studio, Hibiscus BioTechnology, and Karmanos seeks to leverage the combined resources of the two organizations to develop innovative therapeutics for the treatment of cancer. Karmanos is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country.

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Dr. James Crowe, Director of the Vanderbilt Vaccine Center Visits Bloomberg Markets: America, and CNBC’s Squawk Box

Isaac Newton apocryphally discovered his second law – the one about gravity – after an apple fell on his head. Much experimentation and data analysis later, he realised there was a fundamental relationship between force, mass and acceleration. He formulated a theory to describe that relationship – one that could be expressed as an equation, F=ma – and used it to predict the behaviour of objects other than apples. His predictions turned out to be right (if not always precise enough for those who came later).

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489th Edition, January 4, 2022

By BHI Weekly News Archives





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January 04, 2022

FOUNDING MEMBER OF

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

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

POSITION DESCRIPTION – Senior Analyst, Ph.D.

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

Download the Full Job Description.

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Johns Hopkins Again Heads List Of Top American Universities Based On R And D Spending

Total research and development (R and D) expenditures at American colleges and universities topped $86 billion in Fiscal Year 2020, according to the most recent Higher Education Research and Development (HERD) Survey, released by the National Science Foundation (NSF) on Monday. The total represents an increase of $2.7 billion (3.3%) over FY 2019.

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Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies

Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against

Omicron (B.1.1.529) and other variants

Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose

Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January

Company to host investor conference call today from 4:30 – 5:00 pm ET

GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.

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THE ECONOMIC IMPACT OF THE UNIVERSITY SYSTEM OF MARYLAND

The University System of Maryland (USM) retained the Jacob France Institute of the University of Baltimore to prepare this update of the prior 2012 The Economic Impact of the University System of Maryland: A Fiscal Perspective FY2011 report. This analysis uses the Human Capital Approach to assess the system’s economic impact and State of Maryland’s return on its investment by assessing the incremental earnings impacts associated with four cohorts of USM graduates and the current impacts of out-of-state spending attracted to Maryland by the USM. The key findings of this analysis are as follows:

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Governor Hogan Announces New MDTA, MTA and Dept. of Commerce leaders | WBFF

On Thursday, Governor Larry Hogan announced three key appointments in Maryland.

Former Maryland Secretary of Commerce Mike Gill has been named secretary of the Maryland Department of Commerce, succeeding Secretary Kelly Schulz.

Gill is chairman of Columbia-based Evergreen Advisors, which was his role prior to serving as Maryland’s secretary of commerce from 2015 to 2019. He has four decades of experience in business, which includes founding Hoyt Capital, an investment and advisory firm serving startups and growth companies. He served as a member of the University System of Maryland Board of Regents from 2004 to 2009.

Image: Photo of Maryland flag at Annapolis State House (WBFF)

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The Most Active Biotech Venture Investors in 2021 – Crunchbase News

Investment into biotech and health care boomed during the pandemic as thousands of venture capital firms turned their attention to breakthrough artificial intelligence, cancer-detection technology, mental health treatments, digital doctor visits, diagnostics and more. 

But two of those investment firms have emerged as major leaders, not only in the number of biotech funding rounds led, but also in overall dollars invested into the industry. Boston-based RA Capital Management and New York-based OrbiMed ranked first and second, respectively, on the two lists compiled using Crunchbase data. 

Image: https://news.crunchbase.com

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Wanted to be sure you saw this on CNBC and Bloomberg!

On this snowy start to 2022, I wanted to share with you two interviews with AHEAD100 Chief Scientist Dr. James Crowe that occurred over the last week on CNBC and Bloomberg TV. Each piece is a powerful continuation of our work to build awareness and support for the work of the Global Pandemic Prevention and Biodefense Center and lead initiative, AHEAD100 — and together, they garnered more than 100 million impressions, representing more than $1 million in advertising value equivalent.

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488th Edition, December 28, 2021

By BHI Weekly News Archives





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December 28, 2021

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

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

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

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

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

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

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

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

POSITION DESCRIPTION – Senior Analyst, Ph.D.

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

Download the Full Job Description.

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Automation Solutions Streamline Pharmacy Workflow, Help Alleviate Challenges

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

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

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

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

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

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

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

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

Image: Image / Pixabay  

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Three from Hopkins named to National Academy of Inventors | Hub

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

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

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

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

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

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

Click here for more information.

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

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

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

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

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

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

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

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

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

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

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

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

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487th Edition, December 21, 2021

By BHI Weekly News Archives





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December 21, 2021

FOUNDING MEMBER OF

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

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

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

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

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

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

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

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

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BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

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

POSITION DESCRIPTION – Senior Analyst, Ph.D.

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

Download the Full Job Description.

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Montgomery County Racing To Keep Pace With Booming Life Sciences Market

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

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

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

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

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

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Zalgen Relocates Headquarters to Life Sciences Epicenter in Frederick, Maryland

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

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

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

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

Image: https://www.vtcrc.com

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

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

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

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

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

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Meet Your 2021 BioBuzz Award Winners · BioBuzz

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

The award categories include:

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

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How Quantum Computing Will Change Everything (with Chad Rigetti

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

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

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

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

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Vaccitech acquires Avidea Technologies to expand product

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

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

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486th Edition, December 14, 2021

By BHI Weekly News Archives





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December 14, 2021

FOUNDING MEMBER OF

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Life Sciences Business Strategist – Open Position!

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

POSITION DESCRIPTION – Senior Analyst, Ph.D.

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

Download the Full Job Description.

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Vaccitech acquires Avidea Technologies to expand product

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

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

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Global pandemic center will be in Rockville medical office building

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

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

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

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

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

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

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

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

Image: CENTER FOR COMMUNICATION PROGRAMS

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IonQ Leads Charge for Quantum Commercialization at Q2B 2021

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

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Seed Funds | TEDCO

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

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Innoforce Pharmaceuticals

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

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

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

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

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

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Accellix Raises $10 Million From BroadOak Capital Partners

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

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

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Harnessing the power of monoclonal antibodies in virology

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

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

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

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

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Time of day matters when getting COVID vaccine – Harvard Gazette

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

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

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

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

Image: https://medium.com

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

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

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

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

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

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

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

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485th Edition, December 7, 2021

By BHI Weekly News Archives





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December 07, 2021

FOUNDING MEMBER OF

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

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

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

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

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Life Sciences Business Strategist – Open Position!

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

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

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

Click here for more details.

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

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

Shots:

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

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

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

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

Click here to read more via Bizjournals (subscription required)

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

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

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

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

Image: https://mocoshow.com

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Francis Collins

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

Image: Francis Collins

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CoSolve challenges

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

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

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

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

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

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484th Edition, November 30, 2021

By BHI Weekly News Archives





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November 30, 2021

FOUNDING MEMBER OF

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

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

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

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

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Supernus Pharmaceuticals Completes Acquisition of Adamas Pharmaceuticals

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

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

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

Compelling Strategic Rationale

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

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Life Sciences Business Strategist – Open Position!

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

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

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

Click here for more details.

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

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

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

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Immunomic Therapeutics Announces Collaboration With iOncologi

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

November 23, 2021 06:41 PM Eastern Standard Time

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

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

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

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

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

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

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

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

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LifeSprout, Inc. Appoints Michael Kranda as CEO and Director

Industry veteran to lead regenerative cell therapy products company

November 18, 2021

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

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

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

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

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

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

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

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

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

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Health Canada announces results of Emergent BioSolutions facility inspection | BioSpace

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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The Healthtech Index

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

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

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

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