Pathways to Pre-Clinical Development Success: Focus on Biologics and ATMPs

Startdatum:

15.11.2018 - 14:00

Ort:

Conference Center, Technologiepark Heidelberg
Im Neuenheimer Feld 582
69120 Heidelberg
Anfahrt

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. The organizers 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.

   Topics:

  • 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

   Speakers:

  • Dr Dianne Jackson-Matthews, Chief Scientific Officer, ERA Consulting Group
  • Dr Lesley Earl, Associate Director, Nonclinical Programs, ERA Consulting (UK)
  • Dr Veronika Alt, Senior Consultant & Head of eCTD, ERA Consulting GmbH

   Who should attend?

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

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