Pathways to Pre-Clinical Development Success:
Focus on Biologics and ATMPs
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.
Heidelberg, November 15 at 2 pm
- 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
Download the Agenda.
- 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
Technology Park – Conference Center (Im Neuenheimer Feld 582, Heidelberg) – Directions
About ERA Consulting:
The ERA Consulting Group is one of the longest established and most experienced regulatory affairs and product development consulting groups serving the biopharmaceutical industry.
ERA has experience with a wide range of products (over 500 products to date), including recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, gene editing, somatic cell therapy and tissue-engineered products. ERA also works with innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. The specialised international team of more than 24 full-time professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which clients can benefit. ERA currently has five office locations (Germany, the UK (2), the USA and Australia), with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.