Dinesh Mistry

Dinesh has over 27 years of industry experience with over 26 years in EU/US regulatory strategy and submissions in in all phases of development (phases I-IV) in a variety of indications including orphan. He has led several meetings with FDA, EMA and MHRA.

Experienced with new chemical entities, biologicals and more recently cell & gene therapy products e.g., AAV2. Dinesh was the global regulatory lead for the early Pfizer pain portfolio up to proof of concept.

He has therapeutic and regulatory experience in Ophthalmology, Neurology, Pain, Rare Diseases, Respiratory, immunology, dermatology, diabetes type 1 and 2, biosimilars. Has supported and led strategic submissions such as IND, fast track, breakthrough, PRIME, orphan designations, pediatric plans.