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In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

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Alex breaks down the potential consequences of FDA workforce cuts, particularly for small and mid-sized biotechs that depend on regulatory guidance, and offers perspective on how HHS and NIH budget proposals could reshape the national innovation infrastructure. The conversation covers everything from the impact of tariffs on manufacturing and supply chains to the slowing pace of M&A activity and venture capital investment trends. Alex also shares his insights on IPO strategy shifts, and whether the current biotech environment is poised for a rebound—or a broader realignment with global competitors. This is a must-listen episode for anyone navigating the uncertain waters of biotech in 2025.

Richmond, Virginia, April 22, 2025 (GLOBE NEWSWIRE) — Phlow Corp., a leading pharmaceutical contract development and manufacturing organization (CDMO) in America, announced today a significant expansion in its analytical capabilities, use of artificial intelligence (AI), workforce, and domestic infrastructure. Marking a period of exceptional growth and momentum, Phlow has more than doubled in size and now employs over 90+ highly skilled scientists and professionals dedicated to building a resilient, high-quality pharmaceutical supply chain on U.S. Soil.

Driven by its strategic purpose to create the future of how medicines are made by helping brilliant minds bring medicines to life through advanced development and manufacturing in America, Phlow has expanded its state-of-the-art laboratories in the Virginia Biotechnology Research Park in Richmond, Virginia. The expansion includes acquiring additional analytical capabilities, including advanced spectroscopy tools and high-resolution, high-mass accuracy mass spectrometry, adjacent to its existing process research and development lab, enabling Phlow’s talented team of scientists to develop and validate analytical methods. This enhancement allows Phlow to streamline processes and foster greater collaboration, ultimately reinforcing our commitment to delivering innovative solutions and high-quality products. Phlow’s expanded laboratory space now offers comprehensive analytical services, including industry-leading analytical solutions for drug assays, impurity characterization and control, purity analysis, and process optimization for cutting-edge technologies such as continuous flow chemistry.

From low-rate loan options to a tech-advanced platform, the National Institutes of Health Federal Credit Union offers compassionate, personalized banking services that save time and money for its members, who predominantly reside in the Washington, D.C., metro area.

Since 1940, the National Institutes of Health Federal Credit Union (NIHFCU) has primarily served the employees and contractors of the National Institutes of Health (NIH) and others simi- larly employed in the biomedical and health care industries. Its extensive experience in these communities positions the credit union to best serve the unique needs of this popula- tion, with branches both in surrounding areas and on NIH campuses. The credit union offers tailored loan programs such as special medical school lines of credit for soon-to-be medical practitioners, student loan refinancing options for current medical practitioners, and unique borrowing options for NIH international fel- lows. Today, NIHFCU makes membership available to virtually anyone, whether they work in or outside of the health care or bio-medical fields.

COLUMBIA, Md., April 23, 2025 — Welldoc^®, a digital health leader revolutionizing cardiometabolic care, announced today that it was Certified™ by Great Place to Work® for the fourth year in a row. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 94 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 37 points.

Great Place to Work is the global authority on workplace culture, employee experience and leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.

This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.

FREDERICK, Md., April 25, 2025 /PRNewswire/ — Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist-turned-entrepreneur Sue Carr, proudly announces that the company has received FDA 510(k) Class II clearance for its flagship product, FROG (Filter Removal of Glass), an all-in-one filter needle designed to enhance safety and efficiency in medication preparation and administration.

“I am humbly grateful and happy to announce that we officially received FDA 510(k) Class II approval of FROG,” said Carr. “This milestone is not just a win for Carr Tech—it’s a win for every healthcare worker who’s ever struggled with cumbersome drug prep protocols and every patient who deserves safer medication handling.”

FROG is the first and only all-in-one filter needle that eliminates multiple steps from the current multi-component method of drawing medication from glass ampoules. Traditional procedures often involve using separate filter and non-filter needles to prevent the risk of glass particle contamination—a process that is time-consuming, costly, and prone to error. FROG’s innovative design consolidates these steps, reducing procedural risk, streamlining workflow, and enhancing patient safety. 

Since 1940, the NIH Health Federal Credit Union (NIHFCU) has been providing affordable loans and banking solutions to the local biomedical and healthcare communities, including NIH’s civilian workforce and contractors and a lengthy list of other industry employers and organizations in the DMV.

The credit union industry has flourished for well over a century (1909 to be exact) with its “people helping people” philosophy to financial services. Today, while the NIHFCU has expanded its member eligibility requirements beyond the NIH and its affiliates, the recent Reduction in Force (RIF) activities of the federal government will have consequences for many of its members and their families. As NIHFCU has done many times throughout its history (the most recent being the COVID-19 pandemic), it has risen to the occasion to provide for its members who are experiencing direct financial hardship due to the RIF and to live up to the credit union industry’s “people helping people” values. 

The event, presented by the Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce’s Office of Life Science, will spotlight the latest advancements in stem cell research and regenerative medicine technology. Attendees will have the opportunity to listen to elevator pitches from MSCRF’s portfolio companies, each showcasing their unique value proposition to a panel of investors. Additionally, the Showcase will include poster presentations highlighting promising technologies, fostering engagement and dialogue.

GAITHERSBURG, Md. & OAKLAND, Calif.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced its plans to acquire Fabric Genomics, a pioneer in AI-powered genomic interpretation. The transaction enables GeneDx’s leadership in the next phase of genomic medicine: decentralized testing with centralized intelligence.

“Healthcare is at an inflection point where integrating genomic insights into standard care is becoming essential – both for better clinical outcomes and for saving the healthcare system valuable dollars. To achieve this, we must evolve and provide adaptable solutions so this information can be used more proactively and without geographic constraints. Adding Fabric Genomics and their talented team moves us closer to that future, enabling our partners to deliver groundbreaking genomic insights to patients across the globe,” said Katherine Stueland, President and CEO of GeneDx.

On April 8, 2025, the Maryland MedTech Summit convened nearly 370 leaders from across the medical technology ecosystem at the University of Maryland, College Park, spotlighting the depth and diversity of the region’s growing MedTech community. Held at the Stamp Student Union as the flagship event of the inaugural Maryland MedTech Week, the summit offered a full day of programming, networking, and insights into the future of device innovation. This was the 2nd Annual Maryland MedTech Summit, and the Inaugural Maryland MedTech Week, which also featured investor-focused events hosted by Ecphora Capital, The LaunchPort, and the two-day MedTech Innovator East Coast Road Tour.

BioHealth Innovation, Inc. (BHI) was proud to serve as a sponsor of this year’s summit and sent a strong delegation of Entrepreneurs-in-Residence (EIRs), including Luis Gutiérrez, Albine Martin, Jon Kay, Ray Blanchard, and John Sullivan, all of whom provide strategic commercialization support to MedTech startups and early-stage companies across the BioHealth Capital Region and beyond.

BioHealth Innovation, Inc. (BHI) was proud to join innovators, resource partners, and public officials at the first-ever BioConnect event—a new platform designed to foster collaboration across Montgomery County’s life sciences community. Held at the University of Maryland Institute for Health Computing (UM-IHC) in North Bethesda, the event was co-hosted by Montgomery County, MCEDC, and UM-IHC, and marks the start of a recurring series aimed at deepening connections between startups, investors, and regional stakeholders.

BHI’s Executives-in-Residence Luis Gutiérrez, and Jennifer Butler attended the event alongside Montgomery County Councilmembers Andrew Friedson and Natali Fani-Gonzalez, offering an opportunity to express appreciation for the County’s continued support of the BHI EIR program and broader innovation infrastructure.

by Kate Andrews – Mark T. Esser, vice president for vaccines and immune therapies at pharmaceutical giant AstraZeneca, will be the inaugural chief scientific officer and leader of the Paul and Diane Manning Institute of Biotechnology at the University of Virginia, U.Va. announced Thursday.

Esser, who will join U.Va. May 1, earned a Ph.D. in microbiology in 1998 from U.Va.’s medical school, and has worked in translational medicine at AstraZeneca, MedImmune (which was acquired by AstraZeneca) and Merck. He was involved with development of Evusheld, a medicine that helped prevent and treat COVID-19; infection and cancer vaccine programs; human papillomavirus vaccines; and a monoclonal antibody that helps prevent RSV in infants.

The $350 million Manning Institute, launched in 2023 with a $100 million donation from Albemarle County investors Paul and Diane Manning, is a hub for biotech research, development and manufacturing at U.Va., which is building a 350,000-square-foot structure in Fontaine Research Park in Charlottesville that’s expected to open by late 2026 or early 2027, according to Paul Manning. A member of the university’s board of visitors, Manning founded PBM Products, an infant formula and baby food business, which he sold to Perrigo for an estimated $808 million in 2010. He then started PBM Capital, a private equity firm that invests in pharmaceutical and life sciences startups.

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

On April 1st, Georgetown University celebrated a landmark moment in its growing innovation ecosystem with a full-day dedicated to advancing research, entrepreneurship, and industry collaboration. Hosted by Georgetown’s Office of Technology Commercialization (OTC) in partnership with Georgetown Entrepreneurship, the day’s programming highlighted the university’s commitment to translating bold ideas into real-world solutions.

The day began with the Innovation Awards Luncheon, where outstanding inventors were recognized for their contributions to scientific advancement and commercialization. The Crystal Awards, in particular, honored researchers who are successfully bridging the gap between discovery and application, turning transformative research into real-world impact.

POTOMAC, MD / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer’s dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company’s efforts to accelerate the trial’s completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.

Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer’s disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer’s and related conditions.

Bethesda, MD — March 28, 2025 – Solaxa Inc., a biopharmaceutical public benefit corporation focused on rare neurological conditions, has announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B).

This pivotal-powered study will be funded in part by a $7.3 million dollar grant awarded to Dr. Susan Perlman, MD, at the University of California, Los Angeles by the Congressionally Directed Medical Research Program. Solaxa will serve as the regulatory sponsor of the trial and partner with leading ataxia centers of excellence. Additional clinical trial sites will be announced later this year.

There are currently no FDA approved therapies for SCA27B, a rare hereditary ataxia. “We are thrilled to move one step closer to impacting the lives of people living with SCA27B,” said Christian Walker, CEO & Founder of Solaxa.

Emily Seymour | InsideNoVa Mar 28, 2025 – George Mason University held the grand opening of its new life sciences and engineering building in Manassas on Thursday, celebrating the addition to its Science and Technology Campus.

The $107 million project supports the university’s growing need for specialized instructional labs, classrooms and support spaces for students, officials said. The building has classrooms and more than 30 different lab spaces for teaching, design and fabrication, offering hands-on learning for students across a number of disciplines.

University leaders celebrated the opening Thursday, joined by local leaders, including Virginia Del. Luke Torian, Del. Ian Lovejoy, Del. Briana Sewell, state Sen. Danica Roem and several members of the Prince William Board of County Supervisors.

Biosensor company receives additional funding to continue development and research

COLUMBIA, Md., (March 19, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Hememics Biotechnologies, Inc. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage businesses in Maryland.

“I am excited to be a part of Hememics’ mission to transform the future of diagnostics,” said John Warden, CEO of Hememics Biotechnologies, Inc. “Thanks to TEDCO’s latest investment, we are looking forward to continuing our growth and development. If you’re an entrepreneur in Maryland looking to flourish, I highly recommend connecting with TEDCO; there are several resources and opportunities the organization can offer – it’s so much more than just funding.”

BALTIMORE–(BUSINESS WIRE)–Sapio Sciences, the science-aware™ lab informatics platform, today announced the integration of the NVIDIA BioNeMo platform into the Sapio Lab Informatics Platform. This integration brings AI-driven computational drug discovery directly into Sapio ELN (Electronic Lab Notebook), helping to streamline workflows and improve decision-making in drug discovery.

With the BioNeMo platform, researchers can accelerate drug discovery by leveraging science-specific AI frameworks, pre-trained models, and generative AI tools to streamline the identification of potential drug candidates and improve target selection accuracy. NVIDIA BioNeMo provides scientists with a framework for training and deploying large biomolecular language models at supercomputing scale.

The National Institutes of Health (NIH) is vital in driving scientific discovery and economic growth across the United States. Recent reports from United for Medical Research (UMR) and Forbes highlight just how impactful NIH funding has been—generating $94.58 billion in economic activity in FY2024 alone and supporting more than 407,000 jobs nationwide. For every $1 invested, NIH research funding returns $2.56 in economic impact.

For the BioHealth Capital Region (BHCR)—home to NIH, the FDA, and a growing network of research institutions and life sciences companies—this funding is critical. NIH grants fuel the work of startups, researchers, and small businesses developing groundbreaking technologies in biotech, AI-driven drug discovery, personalized medicine, and advanced therapeutics. Without sustained investment, the entire innovation ecosystem is at risk, impacting job creation, commercialization efforts, and, ultimately, patient outcomes.

COLLEGE PARK, Md.–(BUSINESS WIRE)– IonQ, Inc. (NYSE: IONQ), a leader in the quantum computing and quantum networking industries, today announced that under its “at-the-market” equity offering program (the “ATM Program”) it has sold a total of 16,038,460 shares of its common stock for an aggregate amount of approximately $372.6 million, netting aggregate proceeds of approximately $360 million.

The Company has determined that it has raised a sufficient amount under the program to meet its currently anticipated capital needs. The Company also determined that given overall recent market disruptions, the trading prices for its shares, and the overhang from having an ATM Program in effect, the ATM Program should be terminated. The Company has therefore terminated the ATM Program today and a prospectus supplement will be filed under Rule 424(c) reflecting such termination.

GAITHERSBURG, Md. and BASEL, Switzerland, March 12, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS), a leading public health company that delivers protective and life-saving solutions to communities across the world, and Rocketvax Ltd, one of Switzerland’s next-generation vaccine companies and a member of the Swiss Rockets Ltd family of companies, today announced entry into an agreement for Emergent’s strategic financial investment into Swiss Rockets Ltd, the parent company of Rocketvax Ltd, to support research, infrastructure development, and the expansion of Swiss Rockets’ innovative biotechnology portfolio. This endeavor underscores Emergent’s commitment to supporting Swiss Rockets’ broader mission of pioneering breakthrough medical technologies.