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Formulation and Delivery
Chalk Talk

The Flexibility Factor: Adaptive Formulation Strategies That Drive Clinical Success

Monday, November 10, 2025
12:30 PM - 1:15 PM CT
Location:Spotlight Stage C, Aisle 3800, Exhibit Hall

Sponsored By 
Formulation and Delivery Partner Presentation-Formulation

    Chalk Talk Presenter(s)

  • Anthony James

    Executive Director, Business Development
    Altasciences
    Cypress, California

  • LS

    Lisa Sanford

    Vice President Business Development
    Altasciences
    Overland Park, Kansas

Description: In early-stage clinical development, speed and adaptability are critical to avoiding costly delays and advancing toward market approval. A “Pharmacy On-Demand” approach enables real-time formulation adjustments during first-in-human studies—so emerging clinical data, not assumptions, determines the optimal dose and excipient mix before scaling up to full GMP manufacturing.

The process begins with early formulation work and seamlessly transitions to producing small GMP batches under streamlined “GMP-light” conditions, ready for immediate clinical use. This methodology conserves valuable API, accelerates decision-making, and ensures the formulation moving forward is supported by solid evidence.

By maintaining momentum from proof-of-concept through to commercial readiness, this strategy helps drug developers bring therapies to patients faster and with greater confidence.

Learning Objectives:

  • Understand the concept of Pharmacy On-Demand and its role in R&D formulation.
  • Explore how adaptive formulation strategies reduce development risk and conserve valuable API.
  • Examine the impact of these approaches on first-in-human trials. Learn how flexible strategies streamline the transition from early-stage development to full-scale GMP manufacturing and commercialization.