December 23, 2025

Securing non-dilutive funding is often a turning point for early-stage companies looking to scale while preserving ownership. Federal programs such as SBIR, STTR, and state-backed translational grants can provide critical capital, but the process is complex, competitive, and time-intensive without the right strategy.

In a recent presentation delivered to Johns Hopkins Technology Ventures, BioHealth Innovation’s Director of Client Engagement, Jon Nelson, shared a practical overview titled “Unlocking Federal Funding: SBIR, STTR, and Other Non-Dilutive Opportunities.” The session walks through how startups can assess eligibility, understand agency timelines, and build stronger submissions for programs supported by NIH, NSF, ARPA-H, and other federal partners. Rather than focusing on theory, the discussion centers on what reviewers look for and how teams can position both their technology and commercialization plan more effectively.

By: Kwame Ulmer - BHI EIR: The U.S. Food and Drug Administration (FDA) has faced unprecedented internal disruption this year, with widespread reports of organizational turnover and significant staff reductions. While the news often focuses on the broader political and administrative changes, those of us who work intimately with the agency know that the real, measurable impact is at the operational level—particularly within the Center for Devices and Radiological Health (CDRH).

I believe a specific, targeted staffing reduction at CDRH represents a risk to both public health and medical device innovation. This opinion is informed by over 10 years at the FDA working in various roles and an additional decade advising hundreds of MedTech companies of all sizes

The Specifics: Loss of Institutional Knowledge and Operational Bandwidth

The reduction in force (RIF) we are observing in CDRH is not uniform; it is impacting two key groups whose collective absence creates a critical gap in organizational execution of the dual mandate to protect and promote public health.

by Jonathan Kay, MPP, Managing Partner, Health Market Experts & BioHealth Innovation, Inc. Entrepreneur-in-Residence

Last week, we introduced our series, Optimizing Launch Messaging. We began by encouraging testing communications rather than guessing about what will work best.

Testing provides data and evidence. Evidence matters in prevention, diagnosis, and treatment. Likewise, evidence matters when it comes to the performance of messaging and communications. It’s an important reminder for leaders in marketing, commercialization, medical affairs, communications, and others.

Tactic #2: Know Your Stakeholders to Avoid a One-Size-Fits-All Approach

In healthcare, a one-size-fits-all approach is a recipe for noise, not impact.

BioHealth Innovation is expanding its Entrepreneurs in Residence (EIR) network and is seeking experienced leaders at the intersection of biohealth and advanced technologies, including artificial intelligence and quantum computing.

This call is for seasoned operators with a strong commercialization background. Ideal candidates have taken innovations from concept through market entry, licensing, spinout, or acquisition, and understand the realities of regulatory pathways, customer discovery, fundraising, and scale. Experience working with startups, academic technologies, government labs, or early-stage venture-backed companies is essential. EIRs serve in a part time advisory role with BHI, working flexibly alongside other professional commitments while contributing hands on commercialization expertise.

INCHEON, South Korea, ROCKVILLE, Md. and LONDON , Dec. 21, 2025 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced that its wholly owned U.S. subsidiary, Samsung Biologics America, has entered into a definitive agreement to acquire 100% of Human Genome Sciences from GSK (LSE/NYSE: GSK). This strategic move secures Samsung Biologics' first U.S.-based manufacturing site, a significant expansion of the company's global footprint and its long-term commitment to the U.S. market.

Located in Rockville, Maryland, the facility sits at the center of one of the key U.S. bio-clusters...

GAITHERSBURG, Md., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.

Topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement...

Montgomery County is funneling nearly $7.5 million into its life sciences and tech startup ecosystem after signaling an intention last year to nurture its next wave of early-stage companies with two new funds.

The Montgomery County Economic Development Corp. and the county government said Monday they are now doling out the grant dollars to a total of 55 young companies, roughly one-third of its applicant pool, working to get new therapies and technologies to market. Thirty of the 55 operate in life sciences and biotech, a sector that’s crucial to the local economy.

“We want small companies with strong ideas to have a real shot at growing here, and that means investing early, supporting commercialization, and removing barriers that too often hold people back,” County Executive Marc Elrich said in a statement.

The City of Rockville has issued a request for proposals to hire a qualified consulting firm to develop a comprehensive economic development strategic plan. The consultant will analyze current economic conditions, market trends, and regional dynamics affecting Rockville’s growth. Working closely with city staff, elected officials, and community stakeholders, the firm will identify strengths, challenges, and opportunities across business development, real estate, and tourism. The plan will establish clear priorities, long-term goals, and actionable strategies to guide investment, support local businesses, and attract new employers. Once adopted, the strategy will serve as a practical roadmap for policy decisions and economic initiatives designed to strengthen Rockville’s competitiveness and quality of life.

IonQ Vice President and GM of Quantum Platform Matthew Keesan joins BioTalk for a clear look at how they are advancing quantum computing from its home base in the BioHealth Capital Region. He shares the story of IonQ's Maryland roots and explains quantum computing in straightforward terms for listeners seeking a high-level understanding. The conversation moves into why biohealth leaders should track the hardware race, what distinguishes IonQ's approach, and how quantum is already being paired with AI to strengthen modeling and analysis. Keesan walks through early use cases showing traction today, challenges common myths about timelines, and shares which biohealth applications he expects to gain mainstream momentum by 2030.

If your organization follows a calendar-year budget and has funds that need to be committed before the end of 2025, you can lock in your sponsorship for the 2026 BioHealth Capital Region Week now. Early confirmations help us plan next year’s program and allow you to reserve your place in advance.

We are already reviewing improvements for 2026, including moving table sponsors to a higher-traffic area and shifting the registration desk closer to the front entrance. Suggestions for speakers, panels, and themes are welcome.

To confirm your support or share ideas, email Rich Bendis at rbendis@biohealthinnovation.org and Andy Eckert at aeckert@biohealthinnovation.org.

We appreciate your partnership and look forward to building another strong BHCR Week together.

Maryland has awarded a $5 million grant to assist College Park quantum computing company IonQ Inc. with the buildout of its forthcoming 100,000-square-foot headquarters.

The grant, part of a series of awards totaling $69.5 million announced by Gov. Wes Moore's office on Wednesday, is the latest installment of state funding to support the fast-growing company. It follows a previous $5 million grant IonQ received from Maryland in September for its new headquarters as part of the state's $1 billion Capital of Quantum initiative.

The company's future headquarters, set to take shape within College Park's 150-acre Discovery District research park, will accommodate about 250 local employees, up from the more than 100 workers it employs out of its current home at 4505 Campus Drive.

IonQ hasn't shared a timeline on when it plans to start building its new headquarters other than noting it aims to have its first phase operational in early 2027. It will include space to accommodate a data center, laboratories and offices.

BETHESDA, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today provided evidence, for the first time in Parkinson’s Disease (PD), of a reduction in glucocerebrosidase (GCase) substrate in cerebrospinal fluid (CSF).

Decreased GluSph in CSF is an indication of increased GCase activity in the brain

All individuals with elevated levels of glucosylsphingosine (GluSph) in the CSF displayed large decreases back towards levels observed in healthy individuals after 90 days of treatment with GT-02287. Importantly, the change observed in GluSph in CSF was a prespecified exploratory endpoint of this Phase 1b study. Elevated GluSph, a hallmark of GCase dysfunction, has been shown to increase the aggregation of alpha synuclein and to impair mitochondrial function and other intracellular processes in neurons.

SynaptixBio, the only company licensed to commercialise a treatment for a rare, deadly disease, says the Priority Review Voucher scheme is a lifeline for smaller biotechs

On December 1st, the US House of Representatives passed a bill that reauthorises the Food and Drug Administration’s (FDA) priority review voucher (PRV) programme, which is designed to incentivise rare disease drug development.

The PRV program contains a ‘sunset clause’ that means it must be periodically reauthorised. In December 2024 this didn’t happen for various reasons, including debate over its effectiveness and concerns about high PRV prices.

Dan Williams, CEO at SynaptixBio, which is developing a drug to treat...

COLUMBIA, Md., (December 16, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced two investments in LASARRUS totaling $75,000 from the organization’s Pre-Seed Builder Fund. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

“With more than 16 million people in the nation suffering from COPD, we need a better solution that can meet patients where they are at,” said Lloyd Emokpae, CEO of LASARRUS. “Thanks to TEDCO, we look forward to continuing forward, providing another solution for COPD patients across Maryland and beyond.”

LASARRUS, based in Baltimore, Md., is a company dedicated to advancing...