Gina Stetsko, PhD

Senior Consultant, Product Development

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Novateur Advisor Since

2016

Field

Manufacturing, CMC, Regulatory

Specialties

Small Molecule Product Development, Drug Delivery, Drug & Device Combination Products

“We can assist entrepreneurs and management teams in making decisions and solving problems in the face of limited funding, human resources and time.”

Gina Stetsko, PhD
Senior Consultant, Product Development

Dr. Gina Stetsko is a senior pharmaceutical development and manufacturing executive with over 33 years experience, including 23 years in the start-up pharmaceutical field. Dr. Stetsko began her career in Product and Process Development in large pharma at Sandoz and Sterling Winthrop. At start-up companies, she served as Senior Director of Product Development at Ligand Pharmaceuticals, then as Vice President of Product Development and Preclinical, Vice President of Operations, and Vice President of Research Strategic Planning at Amylin Pharmaceuticals. Subsequently, she was Chief Scientific Officer at Eagle Pharmaceuticals and later Vice President of Research and Development at Flamel Pharmaceuticals in Lyon, France. Dr. Stetsko has built and managed teams to collaborate with several contract firms in the US and in Europe, and played a role in the approval of 12 products, including Bloxiverz®, Bydureon®, Panretin®, Symlin®, Targretin®, and Topotecan®. She was directly responsible for the launch of several of these products with virtual supply chains, including two drug devices. In addition, she managed a four-way alliance for the construction and staffing of a unique sterile, explosion-proof manufacturing facility for injectable Bydureon® microspheres, while Vice President of Operations at Amylin. Dr. Stetsko holds a PhD in Pharmaceutics from Purdue University.

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