How does a BioPharma Cluster ascend the ranks to secure a Top 3 position? What are the key factors propelling the BioHealth Capital Region to achieve its ambitious goal of ranking 3rd by 2023? Join us in this episode of BioTalk, where our host Rich Bendis speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News.

In this installment, Alex unveils the intricacies behind his latest Top 10 U.S. Biopharma Clusters, highlighting the impressive rise of the BioHealth Capital Region to its 3rd position. Learn about the origins of these rankings, the trends that have been identified for 2023, and the dynamic shifts within the BioPharma landscape on a regional scale.

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With federal funding and solutions that address major risks and aim to improve outcomes for warfighters and civilians, Polaris and Neuroene are set to continue their momentum as showcase companies in the DMV life science scene.

By Sam Hopkins

August 8, 2023

As the BioHealth Capital Region and other life sciences sectors continue to evolve and innovate, it’s crucial for start-ups and entrepreneurs to seize every opportunity to showcase their groundbreaking work. 

One of those incredible opportunities is this year’s 8th Annual BioHealth Capital Region Crab Trap competition, part of the 9th Annual BioHealth Capital Region Forum. This event has evolved significantly over the years, attracting applicants not only from the region but also from across the country and around the world. 

GAITHERSBURG, Md., Aug. 9, 2023 /PRNewswire/ -- Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

GERMANTOWN, Md., Aug. 9, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse^™ immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA.

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process – moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals, including those from federal labs, to broaden their understanding of technology transfer.

NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) -- NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

How does a region evolve to become a leading driver in the BioHealth Capital Region? What are the secrets behind the successful collaboration between various organizations like MCEDC (Montgomery County Economic Development Corporation), MTC (Maryland Tech Council), and the Maryland Department of Commerce? How does a serial biotech entrepreneur leverage his experience to grow a diverse cross-section of businesses, including life sciences, technology, cybersecurity, defense, and hospitality?

In this episode of BioTalk, host Rich Bendis chats with Brad L. Stewart, SVP of Economic Development for Montgomery County Economic Development Corporation (MCEDC). Brad's multifaceted career spans from being a Chief Executive Officer to leading expert teams in strategy and innovation, plus economic development specialists in Montgomery County.

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The Association of University Technology Managers (AUTM) has released its annual Licensing Survey for 2022, revealing promising trends in technology transfer across the United States and Canada. The survey's findings underscore the significant growth in research funding, the robustness of startup companies, and the evolving landscape of licensing.

U.S. Survey Highlights

In the United States, the survey reported record-breaking research expenditures, topping $91 billion in 2022. This marks a 9.5% increase from the previous year and the highest total in the survey's 30-year history.

QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in U.S. to aid in identifying patients with unresectable or metastatic gastrointestinal stromal tumors positive for the PDGFRA D842V mutation who may be eligible for treatment with AYVAKIT® (avapritinib) // First FDA-approved companion diagnostic to detect mutation in the platelet-derived growth factor receptor alpha gene associated with primary resistance to other drugs // Approval adds to QIAGEN’s leading portfolio in precision medicine, including now 12 FDA approved companion diagnostics

Prime Medicine to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to advance their innovative Prime Editing technology and develop a new class of one-time, potentially curative therapies

ROCKVILLE, Md., Aug. 01, 2023 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic partnership with Prime Medicine, Inc., a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies.

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

Virginia officials recognized AMPEL BioSolutions today for their dedication to identifying, training, and retaining STEM-trained workers, especially in the area of precision medicine.

The annual Virginia Talent + Opportunity (V-TOP) award is given on National Intern Day to employers who provide work-based learning opportunities, particularly to interns, who are essential to Virginia's economy and play a crucial role in developing the necessary skills for career success, as stated by Kirk Cox, President of VA Bus Higher Ed Council. Internships are the foundation for workforce development.

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)

BALTIMORE, MD, July 26, 2023– AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor.

CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.

"Completing our base-stage performance milestones ahead of schedule is a testament to our organization's dedication and commitment to healthcare innovation," said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV's product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort," added Le Roux.

NORTON, Va. and PETERBOROUGH, ON, July 25, 2023 /PRNewswire/ - Solar Biotech Inc., a Norton, Virginia-based provider of complete sustainable and scalable biomanufacturing solutions, continues to build out its vertically integrated organization by acquiring Noblegen, an advanced digital biology company based in Peterborough, Ontario, Canada.

Noblegen will now operate under the name Solar Biotech Canada, continuing as the organization's food-grade-certified (SQF9) biomanufacturing and research & development hub in Canada. The new company will leverage both partners' strengths in microbiology and biomanufacturing to offer revolutionary biotech and synthetic biology ("SynBio") solutions for a wide range of applications.

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference's history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

• Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S. government to transition to post-approval procurement

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of CYFENDUS™ vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

Talented, diverse, and experienced leaders tapped to support Maryland’s economic engine for technology companies

COLUMBIA, Md. (July 20, 2023) – TEDCO, Maryland’s economic engine for technology companies, held its annual election for the board of directors’ executive officers, reaffirming another term for Chair Omar Muhammad of Morgan State University (MSU).

TEDCO’s full slate of executive officers are:

• Chair – Omar S. Muhammad
• Vice Chair – Ellen Flowers-Fields
• Secretary – Kathie Callahan Brady
• Treasurer – Jeffrey Rhoda
• Assistant Treasurer – Eben Smith

“I’m excited to continue serving on the board of directors. Our work has focused on supporting TEDCO’s mission of creating an enhanced, diverse and inclusive ecosystem throughout the state, and we look forward to continuing this mission through the various resources and programs TEDCO has to offer,” said Omar Muhammad, chair of the board. “In particular, I am excited to move forward with the Cultivate Maryland initiative, a major project that will support the growth of a diverse innovation economy thereby increasing Maryland’s competitiveness as an innovation economy and supporting larger retention and attraction of trained workers.”

Andrew Lees has received The Derek Horton Award in Industrial Carbohydrate Chemistry for outstanding contributions to industrial carbohydrate chemistry.

The Derek Horton Award in Industrial Carbohydrate Chemistry is awarded by the CARB division of the American Chemical Society and acknowledges distinguished achievements in and outstanding contributions to industrial carbohydrate chemistry.  Lees’ award was for his contributions to the field of protein polysaccharide conjugate vaccines, including the development of CDAP chemistry and a low-cost CRM₁₉₇ carrier protein.

Licensing agreement utilizing MilliporeSigma’s CRISPR genome-editing technology supports the advancement of Vita’s pipeline

‍Baltimore, MD, July 18, 2023 – Vita Therapeutics, Inc. today announced a licensing agreement between Vita and MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Under the agreement, Vita will leverage MilliporeSigma’s foundational CRISPR patents to advance the development of its preclinical asset VTA-100 for the treatment of limb-girdle muscular dystrophy (LGMD2A). Financial and other terms of the agreement were not disclosed.

“Our purpose is to impact life and health with science, empowering customers to deliver breakthroughs such as Vita's impactful, health-advancing research,” said Christopher Arnot, Director of Licensing and Business Development, Gene Editing, MilliporeSigma.

“For people with limb-girdle muscular dystrophy, the calpain 3 (CAPN3) gene is mutated in satellite cells,” said Douglas Falk, MS, Chief Executive Officer at Vita Therapeutics. “MilliporeSigma’s proprietary CRISPR genome-editing technology will allow us to insert a functional copy of the gene into those cells, taking us an important step forward in advancing the development of VTA-100 as a potential cell therapy.”

The Small Business Transition Grant application period is now open, providing a valuable opportunity for early-career academic scientists to transition into entrepreneurship. Graduating students and postdoctoral researchers who have engaged in technology discovery during their academic pursuits and are prepared to embark on a small business venture are encouraged to apply. The eligible technology must fall under one of the following categories: therapeutics and preventive agents, imaging technologies, interventional devices, and in vivo diagnostics, as well as in vitro and ex vivo diagnostics and prognostics.

Maryland-based biotechnology business working to save lives through innovative solutions

COLUMBIA, Md. (July 17, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 State Small Business Credit Initiative (SSBCI) investment into KaloCyte, Inc. This investment came through TEDCO’s Venture Funds.Elaine Haynes, KaloCyte CEO & President, a TEDCO portfolio company

“Blood is highly perishable, type-specific and blood shortages are common, so most emergency responders do not carry blood, delaying trauma patients access to this life-saving therapy” said Elaine Haynes, president and CEO of KaloCyte. “Thanks to the latest investment from TEDCO, KaloCyte can continue to research, develop, and advance ErythroMer towards clinical trials. With this innovative artificial red blood cell, we hope to save lives both on and off the battlefield.” TEDCO’s investment was matched by Vitalant, one of the nation’s largest nonprofit blood and biotherapies healthcare organizations.

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme "Global Breakthroughs for a Healthier Future." After a period of remote events, we're thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Applicants are encouraged to review the 2023 SBIR and STTR Omnibus Notices of Funding Opportunity (NOFOs).These NOFOs encourage small businesses to submit grant applications to NIH, CDC, and FDA for innovative ideas across the HHS mission space. The new NOFOs are listed below:

The Maryland Tech Council, the largest technology and life sciences trade association in the state, today welcomed a new chair and slate of technology and life sciences leaders to its board of directors. The new members join the board as MTC enjoys rapid growth in its membership, educational programs, and workforce development initiatives.

“I am thrilled to welcome these new members, who represent some of the most respected companies in Maryland’s innovation ecosystem,” said Kelly Schulz, CEO of the Maryland Tech Council. “Our ability to educate, connect, and advocate for members depends on diverse perspectives from creative and forward-thinking board members. I look forward to working with our board as we seek to make our state the destination of choice for innovators.”

New Device Provides an Effective, Hands-Free Solution to Stop Nosebleeds in Children and Adults

Adult and Pediatric NasaClip Sizes Provide Easy-To-Use Options for Chronic Nosebleed Sufferers, Healthcare Professionals, Parents, and Schools; First Available, U.S. Food and Drug Administration Registered Device with Age-Appropriate Sizing for Patients Aged 2 and Older

BALTIMORE, MD. (PRWEB) JULY 11, 2023

NasaClip, Inc., a Baltimore-based medical device company focused on improving the lives of patients with nosebleeds and the healthcare professionals who treat them today introduced the NasaClip, an easy-to-use device that provides constant, comfortable hands-free compression combined with intranasal sponges to stop nosebleeds quickly. NasaClip comes in an adult size for ages 14+, and pediatric size for children ages 2 to 13. It is the first nosebleed rescue device that provides adjustable nasal compression for children and adults and is registered with the U.S. Food and Drug Administration (FDA).

Baltimore-based Digital Health Startup is Working to End Medication Errors and Streamline Workflows in Long-Term Care Settings

Baltimore, Md. (July 11, 2023) – Impruvon Health (“Impruvon”), a Baltimore-based digital health startup, announced today that it closed a financing round to support surging demand from healthcare organizations for its enterprise medication management platform. The round is led by The Propel Baltimore Fund from TCP Venture Capital, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and New Dominion Angels.

Responding faster and more effectively to future public health challenges and emergencies will require the development of a specific, rapid acquisition vehicle. To achieve this, BARDA is launching the Rapid Response Partnership Vehicle (RRPV), the next generation of acquisition partnering to support U.S. health security.

In alignment with objectives outlined in the 2022-2026 Strategic Plan, BARDA seeks to leverage its Other Transaction Authority (OTA) to develop the RRPV. The RRPV will complement BARDA’s existing acquisition vehicles such as the Broad Agency Announcement (BAA) and the Easy Broad Agency Announcement (EZ-BAA) and will expand the mechanisms through which BARDA can rapidly partner with product developers prior to and during an emergency response. With the RRPV in place, BARDA will be able to leverage OTA agreements to meet the dynamic needs of the BARDA mission through a streamlined, expedited process.

The long-awaited grand opening of the Sfax University Simulation Center has finally arrived, marking a new era of innovative learning and development in Sfax, Tunisia. The cutting-edge center promises to provide a hub for experiential learning, creating a springboard for high-potential projects to flourish. In the run-up to the opening, the team at the Simulation Center, supported by Johns Hopkins University,  held a series of fruitful meetings with local stakeholders. During these sessions updates were shared, and attendees were encouraged to submit their high potential projects for consideration, initiating direct engagement with the local community.