Maryland is home to a thriving business ecosystem in science and technology, and FITCI’s new partnership with Venable LLP, a leading law firm with 900 attorneys and offices in Washington D.C. and across the country, is about to make navigating these complex fields more accessible for members. As the “oldest & newest” incubator in Frederick, FITCI has a long-standing commitment to nurturing startups that keep this county - and the region – economically healthy. With Venable joining as a sponsor, entrepreneurs now have better access to a powerful ally in overcoming FDA regulatory, intellectual property (IP), and funding challenges.
The People of Venable
Led by Frederick native Jeremiah Kelly and his partner, Frederick resident Justin Coen, Venable’s Food and Drug Law team brings a wealth of experience to the table, having worked for the Food and Drug Administration (FDA) and Department of Defense’s Defense Health Agency and the U.S. Army Medical Research and Development Command (DOD/USAMRDC). In fact, the duo played a pivotal role in Operation Warp Speed’s $87 billion in COVID response from 2020 to 2023, negotiating the terms for every vaccine contract, monoclonal antibody, small molecule antiviral, all international vaccine donations, and every industrial-based expansion project contract and agreement.
Kelly started his career As a toxicology researcher at the U.S. Army Center for Environmental Health Research at Fort Detrick and then spent eight years in the Commissioner’s Office at the U.S. Food and Drug Administration (FDA), followed by a 12 years as the Chief of the FDA Regulatory Law Division at USAMRDC. Mr. Coen spend years on the Hill at the Senate Finance Committee and, before joining Venable, spent 6 years as the internal Senior Regulatory Counsel for the Joint Program Executive Office for Chemical, Biological, Nuclear and Radiological Defense (JPEO-CBRND) also at Fort Detrick. Together, their background experiences uniquely position them to assist FITCI startups in navigating FDA regulatory pathways for drugs, biologics and devices with precision and insight.
“Helping companies deliver medical breakthroughs is our ultimate driver,” Kelly explains. Both he and Coen are well-versed in securing non-dilutive funding for startups, drawing from their extensive federal government experience. For startups, this means access to critical early-stage funding that doesn’t dilute ownership—a significant benefit to companies working in highly regulated fields like biotech, pharmaceuticals, and medical devices. “We aim to help our clients navigate the complexity of FDA regulations and engagement with the R&D elements of the Federal Government,” Coen explains.
Key benefits: Full-Spectrum Support with Venable
Venable’s team specializes in helping startups strategize their FDA regulatory approach from pre-clinical phases through post-market compliance. They offer comprehensive assistance with Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and other approval mechanisms crucial for getting products to market.
Many startups seek alternative funding sources beyond traditional equity financing. With extensive experience helping clients navigate federal grants and contracts, Venable supports startups in identifying and pursuing non-dilutive funding options through avenues like Cooperative Research and Development Agreements (CRADAs) and Other Transaction Authority (OTA) agreements.
Venable’s comprehensive capabilities extend beyond FDA and funding. FITCI members may benefit from learning about IP protection strategies, engaging support during mergers and acquisitions, contract negotiation, and deal structuring. Venable’s multidisciplinary approach ensures that startups have all the resources they need, from protecting their innovations to executing critical business transactions.
For startups looking for a quick, affordable assessment, Venable’s “regulatory health check” provides a high-level evaluation of their FDA and regulatory strategy, typically within the first week. “A regulatory health check gives startups a clear evaluation of their technology and approach,” explains Coen. These insights are essential to avoid missteps in FDA pathways, protect valuable IP, and negotiate terms beneficial for collaborations, especially with federal agencies.
Known for its expansive, full-service legal support, making it a “one-stop shop” for all the legal needs a startup might encounter, Venable’s breadth of expertise is particularly beneficial for FITCI companies and other businesses located close to Fort Detrick.
Ongoing FITCI Engagement & Mentorship
Jeremiah and Justin are committed to helping early-stage entrepreneurs thrive. They will host monthly office hours at FITCI, where members can start conversations about these important issues - at no cost. They also created the Venable Ventures program, a full service, reduced-cost option for startups and early-stage companies. As dedicated educators, the Venable team also looks forward to leading seminars and training sessions at FITCI on essential topics.
“Our team is very good at what we do,” insists Kelly. “You can't afford to not protect your intellectual property. You can't afford to go down the wrong FDA regulatory approach. That’s a dead-end road. And you really can't afford to enter into agreements without fully understanding the risks and benefits of those terms and conditions.”
Through this partnership, Venable enhances FITCI’s ecosystem and reinforces Maryland’s reputation as a thriving hub for science and technology innovation. This collaboration is a powerful asset for any startup working toward new breakthroughs in health, technology, and beyond, ensuring that Frederick’s entrepreneurial community continues to flourish and inspire future leaders.
For more information or to schedule an initial consultation, contact Jeremiah Kelly at jkelly@Venable.com or Justin Coen at jcoen@Venable.com, office +1 202.344.4638.