BioHealth Innovation Weekly for April 29, 2025

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April 29, 2025

BioHealth at a Crossroads: Alex Philippidis on Policy Shifts, Investment Trends, and What’s Ahead on BioTalk

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.

Listen now via your favorite podcasting platforms:
Apple: https://apple.co/3EHj6IE
Spotify: https://spoti.fi/3EIid2q
iHeart: https://ihr.fm/3Ykuq46
Amazon: https://amzn.to/4jR5byw
YouTubePodcasts: https://bit.ly/4lQrHcD
TuneIn: https://bit.ly/2M60Wmx

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.

Phlow Corp. Expands Analytical Capabilities and Embraces Artificial Intelligence-Driven System, Ushering in a New Era of Modern Medicine Manufacturing in America

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.

Lending a Helping Hand: the National Institutes of Health Federal Credit Union

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.

Sonavex Receives FDA 510(k) Clearance for EchoMap™ Device

Baltimore, MD (April 28th, 2025) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s EchoMap™ device. Sonavex’s EchoMap leverages 3D ultrasound and AI algorithms to empower dialysis technicians without prior ultrasound experience to visualize the target fistula or graft before cannulation.

Welldoc Certified as a Great Place to Work® for Fourth Consecutive Year

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.

Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle

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.

Precision for Medicine and PathAI Announce Strategic Collaboration to Advance AI-Powered Clinical Trial Services and Biospecimen Products

Collaboration will deliver innovative AI-powered pathology tools and quality control enhancements to accelerate clinical trials and biomarker discovery

BOSTON and FREDERICK, Md., April 25, 2025 /PRNewswire/ --Precision for Medicine, a leading provider of next generation drug development research and services, and PathAI, a global leader in digital pathology, today announced a strategic collaboration to partner on developing novel AI-based technologies and to integrate PathAI's advanced digital pathology and analysis capabilities across Precision for Medicine's clinical trial and biospecimen operations.

This collaboration includes use of several PathAI technologies and establishes an agreement to offer novel tools and analytical services that address emerging needs in biomarker discovery, spatial biology, and tissue-based clinical research. Through this collaboration PathAI's tools and services will help augment Precision for Medicine's proprietary pipeline providing biopharma clients with access to imaging workflows offered through Precision for Medicine's integrated laboratory and clinical trial services.

TEDCO’s Maryland Innovation Initiative Announces FY2025 Technology Assessment Awards

Over $1 million awarded to 7 university projects

COLUMBIA, Md., (April 24, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the next round of Maryland Innovation Initiative (MII)’s Technology Assessment awards, marking a significant milestone in promoting the commercialization of groundbreaking research from Maryland's prestigious academic research institutions. The Technology Assessment award is a nine-month project that builds on strong preliminary data that demonstrates the technology’s utility for specific commercial applications beyond basic research.

“The Technology Assessment phase of our program provides non-dilutive funding to advance technologies with commercial potential,” said Abi Kulshreshtha, MII’s executive director. “In this award cycle, the Maryland Innovation Initiative staff and technical reviewers selected seven projects from a competitive pool of applicants, which altogether received grants totaling more than $1 million to advance innovations ranging from new cancer therapeutics to inclusive AI-driven education technology solutions.”

Digitalis Commons - Notes on Catalyzing Health & Changes in the Scientific Stack

The U.S. biomedical innovation system is world-leading, built by a century of federal investment that peaked last year at $50 billion. That foundation has been thrown into uncertainty by shifts in policy under the second Trump Administration aimed to reduce spend, shift research priorities, and divest from universities. While these changes have appeared to many to come on suddenly, they reflect long-growing concerns with the U.S. scientific system—initiated by issues with trust and reproducibility, barriers to accessing knowledge, and structural limitations on creative risk-taking.

The scientific community is actively seeking additional funders to step in and fill the anticipated funding gap, which may be as big as $20B annually. New pledges are starting to be made. At the state level, California is advancing a bill to fund general scientific research and Texas is advancing a bill to fund Alzheimer’s research. Both of these states have a history of scientific funding, including through the California Institute for Regenerative Medicine and the Texas Cancer Prevention and Research Institute of Texas (CPRIT). Corporate pledges are also happening—Recursion Pharmaceuticals has funded a pre-seed accelerator designed to close gaps in SBIR funding—and groups outside of the US are launching opportunities for funding or training that are aimed at US-based scientists. Other potential sources of funding include philanthropies, family offices, regional governments, private investors, disease foundations, and crowd-funding. If contributions from these groups rise to meet the anticipated $20B funding gap, the system will shift fundamentally—from one organized around a central funder to one sustained by a kaleidoscope of funders. This transition will open-up new and interesting opportunities.

Compremium AG Appoints Dr. Kolaleh Eskandanian to Lead New Division of Pediatrics and Special Populations

Swiss MedTech leader taps renowned pediatric innovation expert to serve as Chief Strategy and Innovation Officer and Head of Pediatrics

BERN, SWITZERLAND / ACCESS Newswire / April 23, 2025 / Compremium AG, a pioneering Swiss medical technology company, announced today the appointment of Kolaleh Eskandanian, PhD, MBA, as Chief Strategy and Innovation Officer and Head of its newly formed Division of Pediatrics and Special Populations.

Dr. Eskandanian, a global leader in pediatric innovation, joins Compremium from Children's National Hospital in Washington, D.C., where she most recently served as Vice President and Chief Innovation Officer, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation, and founding executive of Innovation Ventures. Her appointment marks a strategic milestone in Compremium's expansion into pediatric and special populations, reinforcing its commitment to developing precision diagnostics and next-generation health technologies for patients worldwide.

BizJournals: Phlow touts expansion, investment in Richmond and Petersburg

By Drew Hansen - Assistant Managing Editor - April 23, 2025 - Richmond pharmaceutical ingredient company Phlow Corp. said Tuesday it has expanded its laboratories at the Virginia Biotechnology Research Park and doubled in size to more than 90 scientists and skilled professionals.

The public benefit corporation said it has expanded its labs by acquiring additional analytical capabilities, including advanced spectroscopy tools to analyze chemical composition and develop and validate analytical methods from its scientists.

Phlow said the new capabilities allow it to streamline its processes and will open it up for more collaboration.

Clasp Therapeutics Begins First Human Trial of New Immune Therapy Designed to Precisely Attack Cancer Cells

Clasp Therapeutics Doses First Patient in Phase 1 Clinical Trial With a First-in-Class T-Cell Engager Designed to Target Cancer Cells With Absolute Specificity

CAMBRIDGE, Mass. & ROCKVILLE, Md.--(BUSINESS WIRE)--Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T-cell engagers (TCEs), today announced dosing of the initial patient in the GUARDIAN-101 phase 1 trial of CLSP-1025, the first tumor-specific TCE to enter clinical development. CLSP-1025 exclusively targets cancer cells expressing the p53R175H mutation, a mutation associated with a wide range of solid tumors, including colorectal, pancreatic, lung, gastric, esophageal, gynecological, and prostate cancers.

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

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.