Regulatory Expertise for Early-Stage Biotechs | BioPharma Unscripted! Ep.5

BioPharma Unscripted!

Regulatory Expertise for Early-Stage Biotechs | BioPharma Unscripted! Ep.5
Join Marcus Metcalfe in conversation with Ming Ewe as they explore the critical role of regulatory expertise in early-stage biotech companies and advanced therapy development.
In this insightful discussion, Ming shares her extensive experience as a regulatory mentor for biotech startups, explaining why engaging regulatory professionals early can prevent costly mistakes and streamline development pathways. She highlights common pitfalls that young companies face, including failing to "start with the end in mind" and underestimating the complexity of regulatory requirements.
Ming provides practical examples from her work helping clients navigate challenging regulatory scenarios, from rescuing clinical trial applications to securing valuable designations that enhance development timelines. She explains the important distinctions between different types of regulatory expertise and why startups need to understand these differences when building their team.
Whether you're involved with an early-stage biotech or considering how regulatory strategy fits into your development plans, this episode offers valuable insights that could save you significant time and resources.
In this episode you'll learn:
Why early regulatory involvement is crucial for biotech success
Common regulatory pitfalls that startups encounter
The value of regulatory designations like PRIME and RMAT
How external regulatory mentorship differs from internal expertise
The importance of having the right regulatory specialist for your specific needs
Chapters:
00:00 Introduction and background
01:40 Ming's role as a regulatory mentor
03:30 Common pitfalls for early-stage biotechs
05:10 The importance of regulatory designations
07:45 Distinguishing between regulatory specialties
09:50 Case study: Rescuing a clinical trial application
12:20 Navigating complex regulatory scenarios
15:40 The value of external regulatory expertise

Connect with Marcus and Elucid8: https://www.linkedin.com/in/marcus-metcalfe-8938a35/ Marcus helps US & European Biotech & Pharmaceutical clients by providing Interim/Fractional & Advisory consultants for operational & strategic needs.

I also work selective Executive Search (perm) projects.
I have helped Clients when there is no headcount, when they can't find the right permanent candidate, when they have a spike in business, as an alternative to an external vendor or for those simply needing an extra pair of hands.
If you need a partner with an extensive network in HEOR and Market Access - this is his sweet spot.

He has placed over 120 HEOR and Market Access candidates during my time across US and Europe.
With his business partners, he covers the below functional areas.
• Biometrics • Business Development
• Clinical Research • Drug safety & Product safety
• Engineering • Health Economics
• Medical Affairs • Market Access
• Regulatory Affairs • Compliance/Quality Assurance
• Marketing & Medical • Scientific & Preclinical
• Communications

Sponsor Message

This episode is brought to you by www.elucid8.co - Connecting Talent, Strategy, and Investment to Transform Life Sciences

Podcast produced by www.podforge.co.uk