Join Dr. Grace Lee and Dr. Frederik Deroose as they discuss important considerations and challenges during the Investigational New Drug (IND) application process, with a focus on cell and gene therapy.
Product development for innovative therapies, particularly Advanced Therapy Medicinal Products (ATMPs), requires careful planning and cross-functional collaboration to enable a fast path to Investigational New Drug (IND) application. This is especially crucial and challenging for biotech companies transitioning from research-focused environments to clinical development. The process involves coordinating various aspects of non-clinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) timelines, while also navigating partnerships, vendor selection, and regulatory challenges. This presentation will provide key considerations for ATMP development with a focus on CMC development to deliver clinical material for patients.
Key Topics Include:
- Create a comprehensive development plan that integrates multiple functional areas
- Prioritize critical aspects of product characterization and manufacturing (CMC)
- Strategically select and manage external partnerships and vendors
- Stay informed about evolving regulatory guidelines and expectations
- Categories: Clinical Research, Drug Discovery & Development, Pharmacology, Toxicology
- Tags: chemistry, Clinical Applications, clinical research, drug development, drug discovery, drug manufacturing, drug safety, drug screening, IND, pharmaceutical, pharmacology, safety pharmacology
Presenters
Grace Lee, PhD, MBA, CQA
Founder
Elevalue Consulting LLC
Frederik Deroose, PhD
Vice President Chemistry & CMC
Discovery, Process Development and Manufacturing
Scientist.com
