Request Expert

Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief Scientific Officer for one of the largest global contract development and manufacturing organizations (CDMO) in the industry. Expert was also the past Divisional Vice President of Global Pharmaceutical & Analytical Sciences at Abbott, the Chief Scientist and SVP of R&D at Ventaira, Senior Director at Pfizer, Pharmacia, Searle, and Associate Director, Section Manager and Senior Principal Scientist at Boehringer Ingelheim.

He has managed drug product development programs through preformulation, solid form identification and characterization, formulation, process development, GMP clinical trial supply manufacture, scale up, technology transfer, product validation, analytical method development and validation, lot release testing, stability testing, specifications development, IND, NDA and BLA CMC sections of regulatory submissions, device development, drug - device combination products, and package development. Expert has extensive experience with both small molecule and large molecule (biologic) drugs, and has considerable experience with solid oral dosage forms (tablets, capsules, softgels, lipids in hard gelatin capsules, powder in bottle), parenteral dosage forms (lyophilized vials, sterile liquid in vials, prefilled syringes, pens and auto-injectors, micro-needle injectors, needle free injectors), inhalation dosage forms (metered dose inhalers, dry powder inhalers, aqueous based systems), topical dosage forms (gels, creams, ointments), nasal spray dosage forms, and ophthalmic dosage forms. Expert has directed development of NCEs, NBEs and life cycle management programs. He has contributed to the commercialization of over 30 pharmaceutical products, and several hundred compounds evaluated in clinical and pre-clinical testing. Some notable drug products that Expert has contributed to include: Humira®, Humira® Pen, Humira® Pre-filled Syringe Japan, TriCor® No Food Effect tablet, Kaletra® tablet, Trilipix® capsule, Norvir®/Aluvia® tablet, Zemplar® tablet, Uloric® Tablet, Simcor® tablet, Celebrex® capsules, Bextra® tablets, Deramaxx® tablet, Dynastat lyophilized vial, Inspra tablet, Somavert®, Zyvox®, Xalatan®/ Xalcom®, Atrovent® HFA inhaler, Combivent® HFA inhaler, Berotec HFA® inhaler, Berodual® HFA inhaler, and Spiriva® Handihaler. He has experience with device development and drug-device combination products. Expert is adept at developing dosage form strategies suitable for the physical chemical properties of the drug, developing appropriate CMC regulatory strategies and in managing pharmaceutical development operations to deliver drug product technology on-time and on budget. Expert has managed product development organizations with over 600 scientists. His teams have been equally proficient in developing drug product technology inhouse or through utilization of contract development and manufacturing service organizations. At Patheon, Expert turned around a contract development business to demonstrate over 9% YOY top line growth and over 20% improvement in EBITDA YOY. His PDS organization supported between 300-400 active dosage form development programs for approximately 300 clients. Expert has expertise in conducting due diligence investigations of drug development programs, drug delivery companies & technologies and CDMO drug product development companies. He has successfully managed integrations post acquisitions.

Array

Two month assignment to review and provide expert assessment of drug delivery technologies across broad drug delivery spaceOne year assignment to aid development of a business plan for a commercial manufacturing organization interested in expanding into pharmaceutical development services marketOngoing assignment to guide an emerging pharma company develop strategy for dosage form development, select outsourcing providers, manage providers and provide clinical trial supplies for clinical studies and CMC section of INDEngagement to provide due diligence support for a potential drug delivery technology acquisitionProvide perspectives across CDMO space for venture capital firms following pharmaceutical outsorcing trends and consolidations