From Lead to Clinical Supply: A Seminar on Strategic CMC Outsourcing at Hera Hub

⇒ Outsourcing in the Pharma Industry: Strategies for Successful Projects with Limited Budgets
Presented by Daniel E. Levy, Ph.D, CMC Outsourcing Consultant and Founder of DEL BioPharma

This presentation will explore strategic approaches to outsourcing in the Pharma Industry, emphasizing successful project execution within limited budgets through careful consideration of benefits, risks, cost containment, selection of the right CRO, timeline management, IP protection, and key contract models.

⇒ Deciphering Drug Substance Development: Navigating Key Stages
Presented by Juris Fotins, Ph.D., Principal Scientist Drug Substance Process Development at Ardena

Discover the key stages of drug development, from defining scope to GMP manufacturing. We will review critical elements such as chemical route evaluation, sourcing essential materials, and the development of manufacturing processes and analytical controls. Dive into the journey, exploring the creation of the first supply of non-GMP Drug Substance (DS) through the verification batch, followed by DS specification, GMP manufacturing, and release.

⇒ Strategic Approaches in Early-Phase Drug Product Development: Flexibility, Timing, and Budget Considerations
Presented by Dave Seghers, Ph.D., CMC Expert in Drug Product Formulation at Ardena

Navigate drug product development for early clinical phases by addressing formulation challenges such as limited drug substance availability, defining target profiles based on administration routes, maintaining phase-appropriate analytical methods, conducting stability studies for concept selection, implementing engineering batches, generating ICH stability data for regulatory submissions, and ensuring flexibility in GMP production slots.

Panel of experts moderated by Kurt Harrington, Founder and CEO Ventoux Biosciences, Inc

Our experts will address your queries on CMC outsourcing, drug substance and drug product development, enriched with insightful case studies. This interactive session offers you the opportunity to delve deeper into the insights shared during the presentations. Afterward, join us for a networking session, providing a relaxed environment for further discussions, collaborations, and networking opportunities among fellow industry professionals.