As biotech venture investment continues to trend towards larger but fewer rounds, there can be an expectation that the companies have well developed execution plans for moving from discovery to clinic. With CMC being critically important to ensuring regulatory compliance, biotechs are having to develop these plans ahead of financing. 

Many of the decisions that shape a successful CMC strategy need to be made much earlier than initially expected. Decisions around drug product formulation, analytical testing methods, scalability and manufacturing, can have significant implications for timelines, costs, regulatory strategy and ultimately commercial production.

This webinar will explore how biotech companies can get CMC right from the start and build a strategy that supports development further down the line.

Agenda:
14.00-14.05: Welcome and Introduction from One Nucleus
14.05-14.20: What does a robust CMC Strategy look like in practice (Constanze Ochmann-Harding, Director of CMC, Epitopea)
14.20-14.35: Develop for Scale: Early Drug Product and Fill-Finish Decisions That Shape Clinical Success and Commercialisation (David Cox, Site Director, Eramol)
14.35-14.50: De-risking you CMC through an investor perspective (Claire Patterson, Thalassa Clara) 
14.50 – 15.00: Q&A
15.00: Close

This webinar is:

• Free for employees of One Nucleus member organisations;
• £75 + VAT for Non Members.