Team

Lynne Robertson

MS, PhD, Chief Operating Officer

Dr. Robertson has over 28 years of combined experience in the pharmaceutical industry and life sciences. Her primary area of expertise is the interpretation and application of regulatory requirements for timely, efficient, and cost effective health care product development.

Dr. Robertson has extensive experience the strategy and tactical operations related to the development of drug, device and biologics from concept to commercial launch.  Her expertise includes regulatory strategy development, clinical development, marketing application review, post submission and amendment/deficiency response development and filing, and due diligence evaluation of drugs, biologics and combo devices. In addition, she has extensive expertise in technical disciplines including formulation development (solid oral controlled and immediate release; transdermal/topical and parenteral), analytical method development and validation, process development and validation and GXP compliance.  Most recently, Principal and cofounder of Gwen Ryan Solutions, a pharmaceutical development consulting firm, established in 2004.  Since 2009, Dr. Robertson has been Executive Vice President of Regulatory and Development (Ade Therapeutics), where she served to guide the development of Ade’s flagship product Evitar, a novel treatment for postsurgical adhesions with the potential to become standard of care for that commercial space.

Dr. Robertson has also served as Executive Vice President of Product Development for Nostrum Technologies Inc., where she improved the R&D operations and led restructuring and remediation of the commercial operations, so that over a period of 16 months the company was able to file 8 product marketing applications and complete 2 consecutive FDA inspections with minimal observations;  Prior to that, she served as  Director of Regulatory Product Development (Quintiles Consulting), where she was a key contributor to building Quintiles Consulting regulatory offering  and instrumental in securing a $50MM NDA development project.   She has also held management and technical positions with various leading pharma companies including Schering Plough, Kos Pharmaceutical, Mylan Pharmaceuticals, and Wyeth Ayerst.

Dr. Robertson received her Ph.D. in Pharmacology and M.S. in Biochemistry from the University of Vermont.

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