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Jan 31 2022

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

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(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).

Jan 31 2022

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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

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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.

Jan 31 2022

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Businessman hand connecting jigsaw puzzle 2021 08 31 17 18 53 utc

Trends in Talent Acquisition, COVID Edition · BioBuzz

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Businessman hand connecting jigsaw puzzle 2021 08 31 17 18 53 utc

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.

Jan 31 2022

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Cursor and Chancellors Message January 2022 pdf

Looking Back with Pride—and Forward with Purpose

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Cursor and Chancellors Message January 2022 pdf

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.

Jan 31 2022

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Entrepreneurial Development | Seed

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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

Jan 31 2022

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

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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.

Jan 25 2022

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492nd Edition, January 25, 2022

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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.

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.

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.

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.

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)

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.

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.

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.

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.

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.”

Jan 25 2022

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491st Edition, January 18, 2022

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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/

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

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

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.”

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.

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.

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."

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

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.

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

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.

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.

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

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.

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

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.

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.

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,

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

Jan 25 2022

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490th Edition, January 11, 2022

By admin BHI Weekly Newsletter Archives

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January 11, 2022

FOUNDING MEMBER OF

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.

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

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.”

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.”

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.

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.

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.

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.

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.

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.

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.

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.

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).

Jan 25 2022

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489th Edition, January 4, 2022

By admin BHI Weekly Newsletter Archives

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January 04, 2022

FOUNDING MEMBER OF

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.

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.

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.

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: