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Jul 2016
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First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines

Online Event
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Overview

This webinar will present a set of case studies on:

  • Integrated single and multiple ascending dose studies combining healthy volunteer and POC investigations
  • Real-time adaptive GMP manufacturing to enable dose, formulation and product changes within a clinical protocol in response to emerging clinical data
  • Continuous supply of clinical trial material (CTM) to global clinical sites post-Phase I, avoiding the need for tech transfer and scale up prior to Phase II

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