I am a Life Sciences industry veteran with 30+ years-experience in the development and successful commercialization of bio/pharmaceuticals as well as combination products. A person whose experience includes clinical development, regulatory affairs, go-to-market strategy/operations and product lifecycle management.
I consider myself to be an ethical and highly respected leader. Having a track record in multiple organizations of leading scientific teams to collaborate in development and eventual regulatory approval of nearing 100 applications worldwide, e.g., A/NDAs, 505(b)2, PAS, IND, etc.
After so many successes, the entrepreneur spirit within me led me to become the CEO of Ayd BioPharma Consulting Group LLC “Ayd Group” which I founded in 2015.  Ayd Group is an entrepreneurial-minded consulting firm that provides technical support and expert advice to Life Sciences companies regulated by the U.S. Food and Drug Administration (“FDA”) as well as international regulatory bodies. Ayd Group focuses in the following core areas:
CMC Strategy &Technical SupportPreclinical & Regulatory ScienceClinical and Regulatory Affairs SupportQuality Systems & ComplianceProduct Lifecycle ManagementDue DiligenceIn my prior life I was Chief Scientific Officer and EVP of Pharmaceuticals at Regulatory Compliance Associates LLC (RCA), a consulting firm to life science companies. Prior to joining RCA, I held several senior executive positions including Global VP, Innovation & Development, Fresenius Kabi, where I had direct responsibility for a $2.5B Generic Drug pipeline and was a part of the M&A deal team. Prior to this I was Global VP, One2One, Hospira (now Pfizer) 3rd Party CDMO, where I led an R&D organization of >100 scientists on four continents and had direct P/L responsibility. I have held C-level positions in startup biotech companies while they went through the IPO process and have also held executive positions in mid-sized, to Fortune 100 to multinational corporations.I would love to talk with you and see how might be of service to each other, now or in the future.
All the best, Sharon