ABCs of the FDA: How to Set a Preclinical Roadmap
For pharmaceutical and biotech startups, moving a program or product from discovery through development can be an arduous task. Fortunately, there are ways to make a winding series of steps as simple as “A, B, C.” On Tuesday, Oct. 20, as part of their “How to…Workshop” series, JLABS @TMC hosted an event at TMCx entitled, “ABCs of the FDA – How to…Set a Preclinical Roadmap,” designed to give entrepreneurs the tools to ensure a smooth drive through their regulatory pathway.
“The ABCs of the FDA is one of the events that we put together for entrepreneurs and startups in the pharmaceutical and medtech community all throughout Texas,” said Emmanuelle Schueller, head of JLABS @TMC. “We want to help provide you with the resources and expertise to bring your technologies to patients and consumers. We hope that this session will address many of the challenges that you face as pharma and biotech startups.”
Key among those challenges includes designing a safe and druggable molecule—a biological target that is known to bind with high affinity to a drug that can withstand the rigors of preclinical testing in support of First in Human (FIH) trials, human Proof of Concept (POC), and ultimately global drug registration.
“Let’s start with finding the best molecule,” said Michael Kelly, Ph.D., senior scientific director with Janssen Research and Development, who led the workshop. “If you’ve come up with a therapeutic target that you think might have some beneficial effect on some human disease, and have already identified a small molecule or biologic that has a high affinity for that target, you’ve already gotten some indications that it might be worth pursuing. The question is this: do you now have a new molecular entity that you’re willing to invest millions and millions of dollars in?”
In answering that question, the session highlighted several design considerations to optimize drug disposition and safety characteristics in the discovery phase, ensuring that the preclinical road to development will have minimal bumps along the way. Leveraging more than 25 years of preclinical experience working for small and large biopharmaceutical companies, Kelley aimed to impart some of his industry insights in an interactive and informal manner.