News

By Conor Gowder & Mark Skinner

The Feb. 7, 2025, memo from the NIH Office of the Director (NOT-OD-25-068), now on hold because of two federal judge actions, announced the implementation of a flat 15% Facilities and Administrative fee (F&A) “across all NIH grants.” While the historic average F&A, or indirect cost rate, paid for by NIH is between 27 and 28%, the memo stated, the agency has previously allowed private small businesses without a negotiated F&A rate to charge up to 40% on their SBIR/STTR awards without further justification, drastically lowering their administrative burdens. Thus, a flat 15% fee on F&A if ever implemented would likely lead to some hardship for the small businesses.

The sixth cohort will undergo the first iteration of the program’s new structure

COLUMBIA, Md., (February 13, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the sixth SBIR/STTR Proposal Lab cohort that will consist of 28 companies. Through this program, companies will learn about foundational skills in business planning, commercialization and proposal writing.

“TEDCO is committed to uplifting Maryland’s entire ecosystem; one way we do that is by providing opportunities to engage with experts and receive comprehensive training materials,” TEDCO CEO Troy LeMaile-Stovall explained. “The success of this program has prompted its growth into two parts – one focusing on foundational skills and the second focusing on opportunities to enhance quality and submission readiness of the proposals.”

As we celebrate Women in Science Day and Women’s History Month, we are proud to spotlight the women of Volition.  From driving groundbreaking innovation to shaping strategic direction, our team do a fantastic job and we’d like to kick off the month of celebrations by featuring our female Directors on our Board.

The women on our Board of Directors are at the forefront of advancing science, fostering inclusivity, and paving the way for the future of health and medicine.

Dr. Ethel Rubin, who joined our Board in September 2024, has dedicated over 20 years to the life sciences sector, driving innovation and commercialisation strategies. Her advice to young women entering science? “Let your intellectual curiosity guide you.” She encourages future scientists to be true to themselves in choosing their career paths—whether they’re solving real-world problems or diving deep into basic biology. Ethel also highlights the importance of perseverance:

TG Therapeutics to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support the development and commercialization of azer-cel, its allogeneic CD19 CAR T cell therapy program, for the treatment of autoimmune diseases

ROCKVILLE, Md., Feb. 12, 2025 (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, today announced they are entering into a strategic platform license (SPL) with TG Therapeutics, a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.

Under the terms of the agreement, TG Therapeutics obtains non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.

By Brian Darmody: While the Maryland economy is facing budget uncertainties, the state can help surmount these challenges by growing private growth industries, converting research into jobs, connecting the region, and attracting federal funding from those few federal budgets (defense and economic competitiveness) that are likely to grow.

Here’s how:

Winning the technology race with China will be a bipartisan effort in Congress and with the White House and state of Maryland has a role to play. The Department of Defense (DOD) R&D budget is expected to grow, including its University Affiliated Research Centers (UARCs) that ensure essential engineering and technology capability are maintained.

New Study Highlights Importance of Measuring Well-Being in Mental Health Research

WASHINGTON (February 10, 2025) – A new study published in Nature Mental Health underscores the critical role of assessing well-being in clinical research and treatment. 

Led by Fallon Goodman of the George Washington University, the study highlights how well-being, beyond the absence of mental illness, is essential for long-term health outcomes, including resilience, recovery, and overall quality of life.

Despite its importance, well-being is often overlooked in mental health research. The study identifies challenges in measuring well-being, such as inconsistencies in assessment methods, and offers recommendations to improve research approaches. By incorporating well-being metrics into clinical trials and treatment evaluations, researchers and clinicians can gain a more comprehensive understanding of mental health and enhance patient outcomes.

BALTIMORE, Jan. 23, 2025 /PRNewswire/ — LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has filed for CE Mark registration for Lumina.

Lumina is the first product from LifeSprout’s proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

“The CE-mark submission marks a significant milestone for LifeSprout and brings Lumina an important step closer to benefiting patients,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout and Associate Professor of Plastic and Reconstructive Surgery and Biomedical Engineering at Johns Hopkins.

GERMANTOWN, Md., Feb. 06, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it has filed for CE Mark registration for the Eversense^® 365 CGM system.

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.

In an interview with ACT Associate Editor Don Tracy, Peter Ronco, CEO, Emmes, discusses the “Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma” session.
ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma session. Can you provide a brief synopsis of what the session entailed?

Ronco: When we kicked off this morning, Andy Lee spoke in the main session about how he has leveraged Merck and their clinical trial development group to execute a portfolio of work. That model works well for Merck—they have the money and resources. However, many mid-sized and small biotechs don’t have that level of funding and can’t afford to hire thousands of CROs.