Regulatory Considerations For Biotech Startups

On through the clinic: regulatory considerations for emerging biotechs

With the move into clinical studies, emerging biopharmas turn the page to an exciting new chapter in their stories. This is a time of dramatic change, due in no small part to a rapid ramp-up in face time with regulatory agencies and the expectation of data transparency that ensues. Under the watchful eye of regulators, the CMC team must walk the tightrope between having an efficient process and maintaining product quality. Medical affairs specialists assume increasingly important roles as they bridge patient/provider influences and the CMC team. Ongoing gap analyses keep the business in a constant state of refinement — driving improvement in everything from purity and yield of the drug substance through scale-up to planning how to commercialize and market a successful therapy. And data analysts do double-time to ensure master files are up to the FDA’s expectations. It’s a lot for a small team to manage.

Fortunately, the whirlwind of simultaneous activity that biopharma leaders might be seeing for the first time isn’t entirely uncharted territory. We caught up with several startup veterans for insight and inspiration on navigating clinical-stage regulatory considerations. This ebook offers a collection of that advice from:

• Dr. Edith Perez, Chief Medical Officer, Bolt Biotherapeutics
• Dr. Nathan Ihle, VP of CMC and Quality, Bolt Biotherapeutics
• Cristian Hernández-Cuevas, COO, Andes Biotechnologies
• Dr. Pablo Valenzuela, CEO, Andes Biotechnologies
• Dr. Robert Hariri, Chairman and CEO, Celularity
• Dr. Shabbir Anik, Chief Technical Operations Officer, Sutro Bio

We hope you learn from the wisdom of these biopharma pros, and we invite you to peruse a host of content and resources for new and emerging biotechs at cytiva.com/emergingbiotech.