Catalyze Preclinical Services Program

The Preclinical Services Program expands the support available to innovators with a heart, lung, blood, or sleep to include preclinical development activities from end-stage proof-of-concept through preclinical development and US regulatory submissions. Preclinical services are tailored to the development needs of each product. Applicants can request specific services required to advance their technology to the clinic or regulatory submission. Once a project is selected for support, the level of support and services provided are negotiated between the Principal Investigator and NHLBI.

GAITHERSBURG, MD / ACCESSWIRE / February 23, 2023 / BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("Bullfrog AI" or the "Company"), a digital technology company using machine learning to usher in a new era of precision medicine, today announced a co-development arrangement with the J. Craig Venter Institute (JCVI), a world-leading institution in genomics research and innovation, for the design and validation of a synthetic HSV-1 (herpes simplex type 1) virus particle targeting colorectal cancer.

Exciting News: #AGT CEO, Jeff Galvin, won “the most prestigious leadership award in the life sciences industry” — The Life Sciences Voice Top Industry Leaders Award! It recognizes the industry's most creative minds working on important initiatives and delivering extraordinary results. Read more. https://bit.ly/3IMfVyC

Jacob Greenwood, Director of Business Development at CRB, joins BioTalk with Rich Bendis to discuss engineering in the industry, the Chesapeake Bay Area Chapter of ISPE, and his career in the BioHealth Capital Region.

Listen now via Apple https://apple.co/3lO9SQZ, Google https://bit.ly/41g3diC, Spotify https://spoti.fi/3xG8OkN, Amazon https://amzn.to/3SfEKpQ, and TuneIn https://bit.ly/3xG9M0I

NCI SBIR is hosting an informational webinarExit Disclaimer on funding and resources designed to assist cancer technology innovators get their projects to the market. This presentation is appropriate for both established small businesses and researchers interested in translating technologies to patients and/or marketplace.  Program Directors Sarra Djemil and William Bozza will cover topics, including:

On Friday, Maryland Gov. Wes Moore and Lt. Gov. Aruna Miller came to North Bethesda to meet with local leaders about a new research facility planned for the area.

“In order for this to be Maryland’s decade, it means it also must be Montgomery County’s decade,” Moore said following a meeting with leaders including County Executive Marc Elrich and county councilmembers. “And this is going to be an important component to actually making that happen.”

Governor Glenn Youngkin has announced the approval of over $66 million in state grants for four projects in the Biotechnology, Life Sciences, and Pharmaceutical Manufacturing Cluster that will help the BioHealth Capital Region continue to flourish as a top national biohub.

These initiatives are aimed at creating job opportunities, raising wages, and promoting economic growth throughout the Commonwealth. Governor Youngkin hopes that by accelerating the growth of the life sciences industry, Virginia will become a leading state in the biotech and pharmaceutical sectors, and improve economic opportunities in what are sometimes considered the BioHealth Capital Region’s “pocket hubs”.

Maryland business dedicated to developing telehealth solutions for remotely monitoring patients with eye and brain diseases

COLUMBIA, Md. (February 16, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of $150,000 into JuneBrain Inc., an organization focused on creating new ways for physicians to remotely monitor their patients.

GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that it has entered into an agreement to sell its travel health business to Bavarian Nordic (BVNRY) for a total value of up to $380 million, including potential future milestone payments. Under the terms of the definitive agreement, Bavarian Nordic will acquire the rights to VIVOTIF®, indicated for the active immunization to prevent typhoid fever, and VAXCHORA®, indicated for the active immunization to prevent cholera, as well as the development-stage chikungunya vaccine candidate CHIKV VLP. Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, California. Approximately 280 current Emergent employees are expected to join Bavarian Nordic as part of the transaction.

• If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use

GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) --  Today, Emergent BioSolutions Inc. (NYSE:EBS) announced the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN® (naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration.

The commitment and mission of growing the BioHealth Capital Region is being continued with new board member

ROCKVILLE, MARYLAND, February 14, 2023 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Dr. Michael Friedlander, Vice President for Health Sciences & Technology, Virginia Tech, to its Board of Directors. The BioHealth Innovation Board of Directors is a distinguished group of accomplished and respected leaders committed to the BioHealth Capital Region. Their wealth of experience and expertise provides invaluable guidance and support to BHI’s mission of translating market-relevant research into commercial success by connecting management, funding, and markets.

Modified agreement also includes the development of an updated vaccine in fall 2023

GAITHERSBURG, Md., Feb. 13, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced a modification to its existing agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). This agreement will maintain the U.S. public's access to Novavax' vaccine and support the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations, and a smooth transition to the commercial market.

By Sarah Ellinwood with contributions by Mark Nardone, Chris Frew, Sean Rae, Laura Frew, Jeff Caskey, and Heather Mudrick February 9, 2023

If you have lab experience and are looking to break out into industry or biotech, chances are you might be wondering what skills will make you competitive.

BioBuzz consulted with our colleagues, our expert recruiters at our sister company, Workforce Genetics, as well as perused scientist job listings to see what technical skills are in high demand.

Image: https://biobuzz.io

ATTN Awardees: #DYK that #NIAsbir has #Entrepreneurs-in-Residence? Our #EIRs, Diane Ignar, Ph.D., R.Ph., and John P. Reinhart, CPA, M.B.A., bring unique expertise and experience from the field. They provide innovator planning support, business development guidance, and more to #SBIR #STTR awardees. Learn more and connect with an #EIR today: bit.ly/3Ov55gH #NIAFunded

I want to share our team at NSF's $60 M initiative focused on driving more research translation out of universities, with a specific focus on universities with high research output but lower levels of research translation.

Accelerating Research Translation (ART) Program will provide institutions of higher education with $6 M (over 4 years) to:

• Create the necessary capacity and infrastructure to increase the speed and scale at which they translate technologies from lab to market
• Flexible seed funds to support promising projects with clear translational potential (up to 50% of budget)
• Develop training opportunities — especially for graduate students and postdoctoral researchers — to become entrepreneurs and/or seek translational research-oriented careers in the public and private sectors

First informational webinar is on February 21, 2023. RSVP here: https://nsf.zoomgov.com/webinar/register/WN_N-mFOgtjSkijCuOI7orPvw

Full program announcement: https://beta.nsf.gov/news/new-60-million-nsf-program-aims-increase-speed

Read more ...

Many parties are involved when a life sciences startup is raising capital. This program will explore strategic and tactical considerations of equity financing for life sciences companies from the legal, investor, and start up perspectives. The panel discussion will cover investor outreach, presentation materials and potential sources and types of equity capital.

The panelists will also explore how to raise equity at various stages of the company’s life cycle, and how navigate fundraising hurdles such as the due diligence process, costs and commonly negotiated terms.

HERNDON, VA. (PRWEB) FEBRUARY 08, 2023

Global life expectancy has more than doubled over the last two centuries, from less than 30 years to more than 72 years.(1) Despite the advances during the ‘golden age of medicine’ throughout the first half of the 20th century, for persons living with rare diseases, 26% still die before the age of five, and depending on the severity of the disease, 37% have a reduced life expectancy.(2) Pharmaceutical companies were historically loathe to research and develop life-saving drugs and treatments for rare diseases because it wasn’t profitable marketing drugs to such a small segment of the population. Rare disease patients became known as ‘orphans,’ having been abandoned by prescription drug manufacturers.(3) In 1983, the U.S. Congress passed the Orphan Drug Act to incentivize drug manufacturers to pursue the development of drug treatments for rare diseases. Dr. Harsha Rajasimha is the Founder and Executive Chairman of the Indo-US Organization for Rare Diseases (IndoUSrare), a not-for-profit organization that seeks to bridge the gap between the western and eastern hemispheres when it comes to orphan diseases. He notes, “It has been 40 years since this watershed moment in the research and development of treatments for rare diseases. While we celebrate our significant progress, we must continue to look toward the still foggy road ahead.”

2022 was an incredibly productive year for American scientists. Biopharmaceutical researchers conducted over 7,000 clinical programs, including more than 3,000 for cancer, 182 for cardiovascular diseases, 111 for Alzheimer's, and 57 for Type II diabetes. Importantly, 77% of these therapeutics originated at small biotech companies working toward their first breakthrough.

The biggest controversy surrounding the Bayh-Dole Act — which allows academic institutions and private contractors to own and manage inventions they make with federal funds — is the false claim that the law allows the government to relicense patents on these inventions to ensure that prices of resulting products are “reasonable.” While this claim has been widely bandied about, it has been rejected by every administration that has considered it for the past 20 years because that’s not how the law works. Still, attempts to undermine Bayh-Dole in this way continue.

Dear scientific community,

The European programme ApogeeBio has launched the 2nd international call for 12 postdoctoral positions in Genopole biocluster, Paris region (FR).

It offers attractive allocations, up to €3000 net monthly salary for 24 months duration and hosting possibilities in both academic and private sectors within Genopole campus

The deadline is extended to February 28, 2023

ApogeeBio programme and its partners provide the fellows with a support in the income mobility organization and in setting  their career development plan after the postodoc period.

Please so not hesitate to share with your networks. More here >>> https://bit.ly/ApogeeBio2022Call

KaloCyte’s experimental synthetic red blood cell product ErythroMer could provide a solution to the high need for treating trauma in both military and civilian settings. The company was tapped to participate in a federally-funded program to develop a synthetic blood substitute.

Image: https://biobuzz.io/

Richmond, Virginia, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Phlow Corp., a U.S.-based public benefit corporation leveraging advanced manufacturing processes to re-imagine the domestic production of pharmaceutical products critical to U.S. healthcare, announced today the formation of the Phlow Business Advisory Board made up of internationally recognized pharmaceutical, biotech, and healthcare leaders who bring a wealth of knowledge and industry experience to the company; the addition of Melinda Hancock of Sentara Health System to Phlow’s Board of Directors; and the promotion of Dan Hackman from Chief Business Officer to President.

Stronger sales in Europe and the U.S. helped offset declining demand in Japan for the Medical Business Unit of Japanese industrial conglomerate Canon for the company’s fiscal 2022. The company said that sales in the medical division grew almost 7%, to the highest level in the history of the business unit.

For the year, Canon Medical saw sales of 513.3 billion yen ($3.970 billion), representing growth of 6.9% compared to the full-year 2021 numbers. The medical division’s income before taxes fell by 7% to 31.9 billion yen ($246.7 million) – the prior-year numbers were boosted by an increase in deductions related to a corporate acquisition.

Image: https://caseyinsights.com/

⦁ First placebo-controlled study of an engineered cell therapy

Gaithersburg, MD, January 31, 2023 – Cartesian Therapeutics, a fully integrated, clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases and cancer, has dosed the first participant in its Phase 2b randomized controlled trial (RCT) for generalized myasthenia gravis (MG), an autoimmune disorder that causes muscle weakness and fatigue. The RCT will evaluate the efficacy and safety of the company’s lead asset, Descartes-08, a first-in-class, RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T).

AURP’s BioHealth Caucus will examine topics, including:

• Economic impact of the biotech industry in the U.S.
• New biotech hubs growing in VA, NC, OK, MO, and NH
• Building the biotechnician workforce
• Bio innovation impact from the federal multi-billion-dollar CHIPS + Science Act
• Significance of the Bayh-Dole Act and life science IP to keep the U.S. competitive
• Bio manufacturing in space
• Award winning life science incubators, accelerators, and labs
• Importance of the business press covering the biotechnology community
• NIH funding for small business bio hubs
• Emerging role of quantum computing in drug discovery
• Special presentations from state bio infrastructure in MA and MD
• Plus, an optional tour of Harvard’s Science and Engineering building and Harvard Allston Enterprise Research Park

The newly established Advanced Research Projects Agency for Health (ARPA-H) will accelerate cutting-edge biomedical and health research, moving discoveries from the laboratory to patients more quickly, sustainably and equitably than ever before. As the agency seeks to remove roadblocks to solving some of the biggest challenges in health today, Montgomery County, Md., is uniquely positioned to support this crucial federal agency and the ideal home for ARPA-H.

Image: MCEDC

TEDCO, Maryland’s economic engine for technology companies, Tuesday announced the selection of 24 Maryland companies to participate in the FY2023 FAST SBIR/STTR Proposal Lab cohort.

This program, now in its fifth year, supports companies in the cohort, allowing them to work with TEDCO experts on preparing polished proposals for up to $275,000 in federal awards through the SBIR/STTR Phase 1 program.

The companies in this year’s cohort encompass a variety of technology disciplines, from medical devices to quantum computing to even biomanufacturing.

Prince George's County, Maryland based Medcura’s is pioneering a proprietary biosurgical technology that has repeatedly demonstrated the rapid arrest of difficult-to-control surgical bleeding. With help from TEDCO, a Maryland based venture capital leader, Medcura is working to become the next standard of care in surgical bleeding management. In the television program “Stephen Hawking’s Science of the Future” Medcura was featured in an episode as a top innovative product of this decade for its ability to quickly stop bleeds using naturally abundant and highly economical ingredients.

Click here for more.

GAITHERSBURG, M.D. – Transwestern Real Estate Services (TRS) announces Quality Biological, Inc. has signed a 24,000-square-foot lease at Shady Grove Development Park, a 745,000-square-foot, 10-building mixed-use project in Gaithersburg, Maryland. Transwestern Senior Vice Presidents Guy Copperthite and Jim Darby represented Quality Biological in negotiations with property owner Minkoff Development Corporation.

Quality Biological has provided contract manufacturing solutions to the life science and biotech research industry for nearly 40 years. The company takes occupancy of its new space in July 2023.

Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft Transplantation in Animals

Research Study to Assess the Role of TNX-1500 in the Prevention of Heart Xenograft Rejection

Preclinical Xenotransplantation Studies are Expected to Support Regulatory Filings for TNX-1500

CHATHAM, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-1500¹, an Fc-modified humanized monoclonal antibody directed against CD40-ligand. UMB’s preclinical studies will utilize genetically-modified porcine hearts supplied by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS, Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.

CHARLOTTESVILLE, Va., Jan. 31, 2023 /PRNewswire/ -- AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic pain syndromes, such as fibromyalgia. Revealed in the peer-reviewed journal Lupus Science and Medicine, the paper details AMPEL's breakthrough approach to characterize the underlying disease activity from gene expression data obtained from patient blood samples.

The FibroGENE^® lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test that could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL's initial focus is fibromyalgia that affects Lupus patients, but the test can be used for millions of Americans diagnosed with fibromyalgia every year.

GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ -- Deka Biosciences ("Deka"), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985).

Germantown’s Precigen Inc. (NASDAQ: PGEN) has raised $75 million in a public offering that closed Friday and intends to use the proceeds to speed development of its experimental treatments for multiple rare diseases.

The clinical-stage biotech, which is developing gene and cell therapies for cancers, autoimmune disorders and infectious diseases, sold 42.86 million shares of common stock for $1.75 each. The company also gave the underwriters an option to buy up to 6.43 million additional shares in the 30 days after it filed an updated prospectus Jan. 26 with the Securities and Exchange Commission.

This free 1:1 virtual session is 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 request a feedback session, please send a non-confidential pitch deck, and a short description of the input you’re seeking from the EIRs, to Sarah Miller   This email address is being protected from spambots. You need JavaScript enabled to view it.,this)" rel="noreferrer">This email address is being protected from spambots. You need JavaScript enabled to view it.  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. 

By Cho KyooHong

On Jan. 9, the Ministry of Health and Welfare reported to President Yoon Suk Yeol concerning its 2023 plan, of which the main tasks include leaping forward as a leading country in the field of biohealth through human resource cultivation, deregulation and export support.

Noting that a large number of quality jobs can be created as the biohealth industry grows, President Yoon called for strong support from the government for domestic enterprises to be up to global standards, which requires a tax benefit corresponding to that of the semiconductor sector, capacity development and a solid industrial ecosystem.

Image: Minister of Health and Welfare Cho Kyoo-hong