60 Minutes To IND Success

By Matthew Pillar, Editor, Bioprocess Online

I met Daniela Drago, Ph.D. a few weeks before I invited her to be my guest on episode 85 of the Business of Biotech podcast. At the time, she was Chief Regulatory Officer at Aurion Biotech. Aurion’s initial candidate is a cell therapy that treats dystrophies that cause corneal blindness. That candidate is at various stages of clinical activity across Japan, the U.S., and the EU, and Dr. Drago was in charge of ensuring the efficient management of regulatory engagement across those three different regulatory jurisdictions. Our conversation was about global regulatory harmonization—or the lack thereof—and she was the perfect guest to discuss it from the trenches, where she was living it. Today, Dr. Drago is consulting on life sciences regulatory matters with NDA Partners, working as Scientific Strategist at 3D Communications, LLC, and serving as a UC San Francisco ACDRS Executive Committee Member and on its Faculty. Prior to her current role, she held regulatory affairs positions at Hoffman-La Roche, CLS, Reckitt Benckiser, Bausch & Lomb, Biogen, and was Associate Professor and Director, Clinical & Translational Research and Director, Regulatory Affairs at The George Washington University School of Medicine and Health Sciences.

My first exposure to Katalin (Kati) Abraham came much earlier. Back when she was working with Tunnell Consulting, she was a frequent guest author at Bioprocess Online. I interviewed Kati early in 2021, shortly after she joined X-Vax as Chief Regulatory & Preclinical Development Officer. That article focused on the pre-clinical development of the company’s therapeutic Herpes vaccine candidate. Prior to X-Vax and Tunnell, Kati directed international regulatory affairs at Merck, was VP of Regulatory Affairs at VaxInnate, and held multiple directorships of vaccine products at GSK. She’s been a leader in the biopharma regulatory space for nearly 35 years.

When it came time to plan out our Bioprocess Online Live! event schedule for 2023, regulatory challenges were top of mind. I slated an event on the topic for January 24^th at 11 AM ET. Daniela and Kati were the first calls I made. They’ll join me for the discussion, IND Success: Navigate Through The Regulatory Gray, and I hope you do, too. We’ll talk through common (and maybe some not-so-common) reasons for clinical holds, provide tips for avoiding and addressing them, and share best practices on how to navigate regulatory nuance and improve your chances for smooth submissions on your journey from development to the clinic.

You won’t want to miss this deep dive into the collective experience of two unparalleled international regulatory experts, and we’ll take your questions as we go. Register here.