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

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

When scientists in South Africa noticed an uptick in Covid-19 cases in the Gauteng Province last November, they began investigating the source. These researchers and others in Botswana quickly discovered the Omicron variant and heroically shared their discovery with the rest of the world. And yet it was still too late — Omicron was already rapidly infecting people across the globe.

Navigating the pandemic has been an all-encompassing, once-in-a-lifetime challenge. Globally, life sciences companies responded with leadership and are emerging stronger. How will life sciences companies continue to respond and what areas can they build resiliency going forward?

The life sciences sector has played a pivotal role amid the COVID-19 pandemic. To cope with the global crisis, traditional competitors partnered to accelerate research and develop the fastest novel vaccine in the history. Governments, health systems, payers, retail pharmacies, and nonprofits are now working collaboratively with the sector to provide widespread distribution and administration.

January 31, 2022 at 7:00 AM EST

Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022

GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

“This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.”

BETHESDA, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”), a biotechnology company transforming the drug discovery paradigm with structurally targeted allosteric regulators identified with its proprietary computational discovery platform, today announced additional details on its R&D Day being held virtually on Friday, February 4, 2022 from 10:00 am – 12:00 pm Eastern Time.

The R&D Day Event, entitled “Neuroscience and Beyond: Harnessing Computational Technology and Allosteric Modulators to Drug the Undruggable” will feature presentations from several Key Opinion Leaders (KOLs):

Zoe Cournia, PhD (Biomedical Research Foundation Academy of Athens) will discuss the role of supercomputing in novel allosteric target discovery. Samuel Broder, MD (former Director of the National Cancer Institute and Scientific Advisor of Gain Therapeutics) will discuss the role of allosteric drug discovery in targeting undruggable proteins in Oncology. Tiago Fleming Outeiro, PhD (University Medical Center Göttingen) will discuss protein misfolding in neurodegenerative diseases. Ricardo A. Feldman, PhD (University of Maryland School of Medicine) will present recent data generated in patient-derived iPSCs with Gain Therapeutics’ structurally targeted allosteric regulators for the treatment of GBA1-associated neurodegeneration in Parkinson’s and Gaucher Disease. Joanne Taylor, PhD (former Director of Neuroscience at Eisai and Scientific Advisor of Gain Therapeutics) will serve as moderator. The Gain Therapeutics management team will present on the following topics:

Intima Bioscience to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its solid tumor cell-therapy candidates NEW YORK and GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

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

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

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These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’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 follow this link.

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’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 follow this link.

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

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

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

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

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

ROCKVILLE, MARYLAND, January 31, 2021 – 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.

 "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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The current boom in life sciences development mirrors the tech industry, especially geographically; there is an incredible concentration of jobs and investment 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.

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

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

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-M™ 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."   

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.

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. 

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

BALTIMORE, Jan. 27, 2022 /PRNewswire/ -- CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children's Hospital of 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 System™ 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. 

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), 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 KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

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.

The pandemic, now approaching year three in full force, has impacted nearly every facet of the life sciences’ 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. 

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, we’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.

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

Regulatory & Business Development Consultations

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

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

Gaithersburg, Md., January 25, 2022 – 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.  To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years.  Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory® cell manufacturing platform.  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.

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.

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.

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. 

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.

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.  

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.”

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)

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.

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.

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.

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.

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,