Skip navigation

Innovation Seminar: Pathways to Pre-Clinical Development Success, focus on biologics and ATMPs

13:30 - 17:30

The Cambridge Building, Babraham Research Campus, Cambridge CB22 3AT
22 March 2018
This event will introduce technical and regulatory strategies for pre-clinical development, with a focus on biologicals and advanced therapy medicinal products (ATMPs). The sessions are designed to provide attendees with a regulatory scientific approach for successful translation of biologicals and ATMPs into the clinic. We will aim to provide an understanding of pre-clinical development pathways and requirements for biologicals and ATMPs leading to the most expedited regulatory strategy in Europe, the US and beyond. Potential challenges in the development and registration of these products will also be discussed, to provide practical advice as well as highlight key aspects determining successful regulatory submissions. 

  • The value of regulatory strategies in the early development of ATMPs and biologics
  • CMC issues that impact pre-clinical development programs
  • Challenges in pre-clinical development, particularly for complex therapies
  • Assay development
  • Toxicology studies and their rational design
  • How to select a CRO for nonclinical studies
  • Case studies in the pre-clinical world 

Who should attend?

  • R&D scientists 
  • Biotech entrepreneurs
  • Industry related professionals
  • Students and Post-doctoral scientists
  • Investors


13.30 - Networking over tea/coffee

14.00 - Welcome from One Nucleus

14.05 - A Regulatory Strategy Adds Value in Pre-clinical Development
Dr Dianne Jackson-Matthews, ERA Consulting

14.35 - Quality Counts in Pre-clinical Development for Cell and Gene Therapies
Dr Pam Dhadda, ERA Consulting

15.05 - Tea and coffee

15.30 - Critical factors in Successful Pre-clinical Testing
Dr Lesley Earl, ERA Consulting

16.30 - Networking reception

17.30 - End

If you would like to register for this event, please contact Aline

Title: Innovation Seminar: Pathways to Pre-Clinical Development Success, focus on biologics and ATMPs
Start: 2018-03-22 13:30:00Z
End: 2018-03-22 17:30:00Z