Drug Development: from Bench to First-in-Human

Drug Development: from Bench to First-in-Human. An Integrated Journey Across Small Molecules, Biologics, RNA and Cell & Gene Therapies
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.