Val

Principal CMC Consultant

Summary

Val has two decades of experience in pharmaceuticals manufacturing processes and controls development, creation of robust CMC strategies and execution plans, establishing global manufacturing networks to ensure continuity of clinical supply and capture regulatory milestones to enable successful marketing applications, and helping companies to transition from development into commercialization. Val has extensive experience in fast track, orphan and breakthrough therapy designated accelerated drug development. Val has been part of the teams that commercialized three drugs Incivek by Vertex, Zerbaxa by Cubist/Merck, Vafseo by Akebia in 2020, and he has overseen multiple commercial process validations, prepared marketing applications and interacted with FDA and other health authorities.

Core Expertise

  • API & Drug Substance Development, Synthetic Organic Chemistry
  • Analytical Controls, GMP Manufacturing & Process Validation
  • Complex Formulations: Low-Solubility APIs, Spray Drying, Oral Solid Dosage
  • CMC Strategy from Early Development to Commercial Launch
  • Regulatory Interactions: FDA, EMA, Health Canada, PMDA Japan

Career Highlights

  • API regulatory starting materials designation
  • Oral solid dose and sterile injectable formulation development and manufacturing
  • Enabled multiple first-in-human studies
  • Supported multiple phase 1 through phase 3 clinical studies
  • Led commercial processes validations
  • 20 issued US patents and 9 articles cited 700+ times in peer-reviewed publications

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