139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

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In biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC).

In this episode of the Smart Biotech Scientist, host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders.

With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development.

Here are three key takeaways from this episode:

• Prioritize CMC Development Early: CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey.
• Understand Regulatory Differences: Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively.
• Leverage Existing Resources: Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach.

For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently.

In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive!

Connect with Rivka Zaibel:

LinkedIn: www.linkedin.com/in/rivka-zaibel/

ADRES - Advanced Regulatory Services Ltd.: www.adres.bio

Email: [email protected]

Next step:

Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call

Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech