Hardware Podcasts

261 - Getting Pharma/Device Products Into Clinical Trials: INDs, IDEs & FDA Meetings

Let's Combinate · 2 Nov 2026 · 37m

What this episode covers

Dr. Robert Bilkovski, a fractional chief medical officer and author of 'Make Your Story Believable,' explains the clinical development strategy for drug-device combination products, focusing on getting INDs and IDEs approved for first-in-human studies. He details the process of bridging known drugs to new delivery devices, such as autoinjectors, and the critical role of pre-IND and Q-Submissions in aligning with the FDA on study design, endpoints, and manufacturing quality. Bilkovski emphasizes the importance of site selection, IRB approval, and sponsor oversight, noting that early feasibility studies in regions like Latin America can de-risk both development and investment before US trials.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Hospira, GE Healthcare, Abbott Molecular, Flu Guide
Products
Make Your Story Believable

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