Gary W. Goodson has 30+ years of experience in the pharmaceutical industry working in pharmaceutical product development, from pre-IND through market registration. Prior to founding Cornerstone Pharma Consulting, LLC, he held the positions of Director of Formulation Development at BioDelivery Sciences International, Independent Pharmaceutical Development Consultant and Product Development Manager at GlaxoSmithKline where his responsibilities spanned product development activities from candidate selection through commercial product launch.
His broad development experience includes drug delivery design, process development, scale-up, technology transfer, external partnerships, development and manufacturing through CRO and CMOs, due diligence evaluations and clinical manufacture. He has demonstrated excellence in solid dose, oral suspension, thin films, buccal films and metered dose aerosol development and a working knowledge of GMP, GLP, USP, FDA and ICH requirements. His strong communication, organizational and team player skills have led to a proven track record that includes 13 major marketed products.
He received his Bachelors of Science in Biology from Radford University in 1978. From 1978 to 1987, he held several scientific positions with SmithKline Beecham where he was involved in the formulation and development of Augmentin® Oral Suspension, Relafen® Tablets and Paxil® Tablets. In 1987 he joined Glaxo Inc. as a scientist in the Pharmaceutics Department where he was responsible for the design of large portions of Glaxo’s formulation development laboratories and Pilot Plant. He was a key member of numerous development project teams that successfully developed Ventolin® Inhalers, Epivir® Tablets, Combivir® Tablets and Ziagen® Tablets, Trizivir® Tablets, Kivexa® Tablets, Epzicom® Tablets and Treximet® Tablets. He directed CMC project teams that developed simplistic and bio-enhanced formulations for FTIH and Phase II studies resulting in optimized drug absorption of poorly soluble compounds. He was a key driver in establishing a global secondary technology transfer process for Glaxo Wellcome and for GlaxoSmithKline.
He has published and written book chapters, holds a patent in formulation design and has presented at multiple national conferences. His research interests include formulation design, process development and optimization of solid dosage forms and technology transfer.