Innovation in pharma drug product development often includes re-engineering materials, processes and/or products to meet cGMP part 211 compliance. In this case study, we will outline several cross-functional challenges that were encountered and resolved.
VP Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting
Ray Sison is a pharmaceutical professional with over 25 years in the industry successfully leading drug product development and commercialization efforts. He is currently the VP of Pharmaceutical Outsourcing and Tech Transfer for xCell Strategic Consulting, provider of Subject Matter Expertise and execution in the advancement of drug products, medical devices and combination products. By creating a methodology focused on CMO/CDMO analysis, selection, and management, he specializes in setting up supply chain partnerships for virtual, specialty and multi-national pharmaceutical companies. Ray earned a MS in Industrial Engineering (Pharmacy) from Long Island University in 1995.
Recent highlights include:
Establishing a supply chain for a clinical stage development company to support the commercialization of a 505(b)2 NDA drug/device combination product that is currently pending FDA approval. The supply chain enhanced the value of the out licensed drug product.
Identified and procured a high quality OTC manufacturer with unique dosage form capabilities for an Rx product line extension, then acted as the drug product program manager as a cGMP Part 211 compliant mfr line was commissioned and quality systems were upgraded.
Championed development programs for unique dosage delivery systems at virtual and specialty pharmaceutical companies resulting in expanded IP portfolios and more efficient commercialized platform technologies including solid oral, liquid, pulmonary and nasal delivery systems.
Previously, he was a Business Development Manager at Patheon Inc, a provider of pharmaceutical development and manufacturing services. Ray served as the Associate Director of Solid Oral Dosage Forms at MircoDose Therapeutx and Strategic Business Manager at Shionogi Qualicaps. Ray's core competencies include: Contract manufacturing |contract negotiation | alliance management | SRM | CMC | drug product development.