Don’t Whine About the FDA: How to Talk so Regulators Will Listen
Bob Seevers is a master storyteller. Before you ask him if he’ll tell stories to your kid’s first grade class, you have to understand one thing: the stories he shares are not about The Three Little Pigs, Curious George or Diary of a Wimpy Kid.
No, Bob’s stories are about promising medical devices and drug candidates. And they’re intended for a very specialized audience, the U.S.
Food and Drug Administration (FDA). Rather than entertain, the purpose is to streamline the FDA regulatory process, which is infamous for being confusing, time consuming and costly.
As a senior advisor at Pearl Pathways, there’s nothing Bob likes better than grooming clients to become master storytellers so they can tell their story in a way FDA regulators understand and how they want to hear it. (With not even a peep of a whine!)
Now he’s ready to share his insight with you.
On Thursday, February 7, 5:45 pm at Leaf Software, Bob will share 25 years worth of experiences on the inside track of the FDA in a special VisionTech-SOPE event titled: Don’t Whine About the FDA: How to Talk so Regulators Will Listen.
The topic is important to a diverse audience that includes:
- Life sciences startups with medical devices or drug candidates facing or in the process of securing FDA clearance
- Physician entrepreneurs considering their own startup.
- Angel investors looking for a greater understanding of investable companies that require an FDA approval to advance to commercialization.
At the core of Bob’s discussion and generous question and answer segment is how best to present your story so your drug or device moves smoothly through the regulatory process. Here’s a taste of what you’ll learn:
“FDA reviewers are solid scientists who have seen good work and bad, including cases where folks have tried to cheat. Reviewers know where to look for information. Best to build trust by giving them what they want.”
“The entrepreneurs I’ve had the pleasure to work with have worked their butts off getting their device or drug to this point. They can’t help but tell a reviewer, ‘We’ve tested this and it’s good.’ Don’t give in to this temptation. There’s no shortcut; the FDA needs to see your data.”
“It’s tempting to tell FDA reviewers everything, but I advise clients to cut 80 percent of what they want to say. At the first meeting, all you need is a high level summary that gets to core of your device or drug. The FDA will take it from there.”
Intrigued? We sure are. Bob’s “inside baseball” perspective on how best to navigate the FDA regulatory processes was earned at the FDA itself and at Eli Lilly and Company. He spent eight years at the FDA as a team leader, managing a staff of PhD reviewers for the evaluation of CMC sections of INDs and NDAs. During his 16 years with Lilly, Bob was a principal regulatory scientist, leading the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules. He’s also served as a World Health Organization invited lecturer on drug development.
Additionally, Bob’s knowledge spans all major therapeutic areas with specific expertise in CNS, endocrine, metabolism, autoimmune, oncology, pediatric drug formulation and clinical research, radiopharmaceuticals, and drug delivery systems.
“Don’t Wine About the FDA: How to Talk so Regulators Will Listen” with Pearl Pathways’ Bob Seevers is set for Thursday, February 7, 5:45 pm, less than two weeks away. Space is limited. RSVP here> Find directions to Leaf Software here>