Val

pharmaceuticals manufacturing processes and controls development

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

Technical:

  • API, drug substance, synthetic organic chemistry, analytical controls, and manufacturing
  • Formulations, low solubility and permeability APIs, spray drying, oral solid form

Strategy and execution:

  • Architect of CMC strategies leading to commercialization of new molecular entities
  • Development projects from pre-IND to commercial process validation

Contract development and manufacturing:

  • Built supply chains with manufacturing organizations in North America, Europe, Asia
  • Process validation, inspection readiness and commercial life cycle management

Regulatory:

  • Interactions with regulatory agencies: FDA, EMA, Health Canada, PDMA 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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