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Pathways to Pre-Clinical Development Success - Focus on ATMPs

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Gustave Tuck Lecture Theatre, Wilkins Building, UCL

Gower Street

London

WC1E 6BT

United Kingdom

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Hosted by UCL's Translational Research Office and ERA Consulting, this event will introduce technical and regulatory strategies for pre-clinical development, with a focus on advanced therapy medicinal products (ATMPs). The sessions are designed to provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. We will aim to provide an understanding of pre-clinical development pathways and requirements for 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
• CMC issues that impact the development of gene and cell therapy programs
• Challenges in pre-clinical development of ATMPs
• Assay development
• Toxicology studies and their design


AGENDA:

12:00 – 12:30 Registration

12:35 – 12:45 Introduction to ERA and overview of agenda - Dr Dianne Jackson-Matthews

12:45 – 13:15 A Regulatory Strategy Adds Value in Pre-clinical Development - Dr Dianne Jackson-Matthews

13:15 – 13:45 Critical factors in Successful Pre-clinical Testing of ATMPs - Dr Lesley Earl

13:45 – 14:15 Focus on CMC development for cell therapies - Dr Pam Dhadda

14:15 – 14:45 CMC Considerations for Gene Therapies for Rapid Translation into the Clinic - Dr Houria Bachtarzi

14:45 – 15:15 Panel Discussion

15:15 – 16:00 Networking


This event is restricted to UCL staff and students only.

Please register using your UCL email address.


Biographies:
Dianne Jackson-Matthews, BSc (Hons), PhD, RAC
Chief Scientific Officer, ERA Consulting Group
Dianne has over 25 years of experience in pharmaceutical product development, spanning the areas of drugs, biologics, and cell/gene therapies in the US, Europe and Australia, with particular expertise in biotech/biosimilar products. Dianne has extensive development experience in the US biopharmaceutical industry, covering manufacture and bioanalytics for biotech products, small and large scale mammalian cell culture, fermentation process optimization/technology transfer, monoclonal antibody production, immunoassay and bioanalytical methods development and validation to ICH standards, and compliance to GMP and GLP requirements.

Lesley Earl, BSc, PhD, ERT
Associate Director, Nonclinical, ERA Consulting (UK)
Lesley provides expert regulatory and scientific advice with respect to human health to companies seeking development through the regulatory processes in the biopharmaceuticals sector. She has over 25 years’ experience in hazard characterisation and risk assessment in the pharmaceutical, agrochemical, chemical and food sectors. Lesley has worked as a senior toxicologist with multi-national companies in the fast-moving pharmaceuticals, foods and consumer goods sectors.


Pam Dhadda, PhD.
Regulatory Affairs Consultant in Advanced Biological Therapeutics, ERA Consulting (UK)
Pam has a strong background in the development of Advanced Therapeutic Medicinal Products, encompassing both academic research and manufacturing development activities. She has experience with compiling sections for an early phase ATMP IMPD and IND submission and supporting product/process development activities for a late stage ATMP.


Houria Bachtarzi, DPhil (Oxon), MPharm (Hons), M.R.Pharm.S
Senior Consultant, Regulatory Affairs – Gene and Cell Therapies, ERA Consulting (UK)
Houria has 10 years of experience working in research and development focusing on advanced biological therapies with strong academic track record in gene therapy for cancer and degenerative disorders; combined with 3 years of extensive CMC regulatory strategy and gap analyses for cell-based immunotherapy, genetically modified cells for tissue regeneration, in vivo and ex vivo gene editing, stem cell-based products, virally vectored gene therapy products and genetically engineered immune cells targeting cancer cells.


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Gustave Tuck Lecture Theatre, Wilkins Building, UCL

Gower Street

London

WC1E 6BT

United Kingdom

View Map

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