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Ardena – From Lead to Clinical Supply: A Seminar on Strategic CMC Outsourcing

February 22 @ 11:30 am - 2:00 pm


Live Seminar in San Francisco

Participate in our upcoming seminar tailored for biotechs engaged in new drug development of small molecule therapeutics. With concise presentations by seasoned experts in drug development, we’ll cover the journey from lead selection to clinical supply. Gain insights into strategic outsourcing in the Pharma Industry, navigating risks, rewards, and cost considerations specific to biotech needs. Explore key stages of Drug Substance and Drug Product formulation development, from project design to GMP manufacturing. Understand the benefits of integrated drug substance and drug product development for early clinical phases, emphasizing flexibility and budget considerations crucial for biotech success. This seminar offers a comprehensive exploration for biotech professionals navigating the complex landscape of drug development.



11:30am : Welcome and Registration

12:00pm : Introduction and presentations

⇒ 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.

1:00pm : Q&A and Networking Lunch

Panel of experts moderated by Mehdi Paborji, SVP, Technical Operations of Ashvattha Therapeutics

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 lunch, providing a relaxed environment for further discussions, collaborations, and networking opportunities among fellow industry professionals.


February 22
11:30 am - 2:00 pm
Event Category:


Northern California


The Lighthouse Cafe
685 Gateway Boulevard
South San Francisco, CA 94080 United States
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