Antibiotic Bootcamp - How Does a Molecule Become a Physical Medicine to be Given to a Human

Explore the intricate journey of transforming a molecule into a physical medicine for human use in this comprehensive 1 hour 49 minute workshop from the American Society for Microbiology's Antibiotic Development Bootcamp. Delve into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) with expert discussants from Spero Therapeutics, Tedor Pharma Inc, and Syner-G Pharma Consulting. Learn about the challenges in CMC, technical stage-gate deliverables, GMP starting materials, clinical supply processes, and regulatory considerations. Gain insights into the complexities of drug development, from raw materials to commercial production, including validation, volumetric efficiency, and registration stability programs. Understand the importance of planning, timelines, and potential product changes throughout the development process. This workshop, part of the 2017 ASM/ESCMID Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance, offers valuable knowledge for professionals in the pharmaceutical and microbiology fields.

Intro
Challenges in CMC
Kick Off Meeting
CMC acronyms
Drug companies
Phase 3 trials
Drug requirements
Evan Hecker
Dr John OBrien
CMC Process
Technical Stagegate Deliverables
GMP Starting Material
Supplying the Clinic
Raw Materials
Supply the Clinic
Supporting Clinical Development
Validation
Commercial
Volumetric Efficiency
Registration Material
Points to Consider
Planning
Timeline
Changing the Product
Regulatory CMC
Bridge the Clinical Program
Registration Stability Program