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

Agenda:
10.00-10.20: Registration and refreshments
10.20-10.30: Welcome and Introduction 
10.30-11.15: Session 1 – What does a robust CMC Strategy look like in practice (Constanze, Director of CMC, Epitopea)
11.15-12.00: Session 2 – Develop for Scale: Early Drug Product and Fill-Finish Decisions That Shape Clinical Success and Commercialisation (David Cox, Site Director, Eramol)
12.00-12.15: Comfort Break
12.15-13.00: Session 3 – De-risking you CMC through an investor perspective (speaker TBC) 
13.00: Networking Lunch
14.00: Close

Event is kindly hosted by...

This seminar is:

• Free for One Nucleus Gold, Partner and Corporate Sponsor/Patron members;
• £30 + VAT for One Nucleus Silver Members;
• £50 + VAT for Non Members.