About this Event
and , offer this workshop designed for scientists and entrepreneurs seeking a practical understanding of drug development up to first-in-human studies. Special attention will be given to the common grounds and particularities for small molecules, biologics, RNA medicines, and cell and gene therapies, providing a framework for selecting and implementing the optimal strategies for pre-IND enabling studies.
Key learning objectives:
- Understand the non-clinical studies required for first-in-human studies.
- Compare development requirements across different therapeutic modalities.
- Identify key non-clinical, CMC, clinical, and regulatory milestones.
- Explore real-world case studies from innovative development programs.
Agenda
09.30 - 09.40 Welcome by Grisha Domakowski, PCB’s Commercialization and Communication Director
09.40 - 11.15 Mariana Gomez, PhD, Zwiers Regulatory Consultancy's Drug Development – Principal Consultant
Introduction
Drug development
- CMC development
- Non-clinical development
- Clinical development
Regulatory affairs
- Who & How. Guidelines & Reviews
- Scientific Advice
- Other regulatory procedures: SME, ODD, CTA & IND
11.15 - 11.20 - Q&A
11.20 - 12.00 - Coffee networking
About the speaker
Mariana Gomez, PhD, Drug Development – Principal Consultant is a regulatory consultant with 10-year experience in drug development. She has supported multiple programs in early development stage, mainly as a non-clinical and clinical expert. She has worked with small molecules, antibodies, RNA therapies and several types of cell and gene therapies, including AAVs, CAR-Ts or TILs. She has thorough experience in oncology indications and rare diseases. Also, she participated in numerous interactions with regulatory agencies, including EMA and FDA.
Previously, Mariana worked as a scientist for over 12 years in Spain, US and Canada. She also served as an R&D Director in a start-up company for 3 years.
Event venue & nearby stays
Parc Científic de Barcelona - Sala Dolors Aleu, Baldiri Reixac, 4-10, Barcelona, Spain
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