Dow Pharmaceutical Sciences
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Very few new drugs have been approved for the treatment of dermatology diseases. The challenges and unique requirements of dermatology drug development will be discussed including regulatory, preclinical and clinical issues and strategies for successful product development. Rapid early proof-of-concept, life cycle management and 505b2 approaches will be discussed, as well as risk management and minimization of attrition.
Mr. Calvarese has more than 30 years of dermatology, pharmaceutical, biotechnology and medical device industry experience. He has managed the approval of 10 NDAs, 3 ANDAs, and numerous 510ks/PMAs and over 50 INDs. His experience in clinical research runs from conception and development of study protocols through regulatory approval. He has successfully defined/assessed a variety of regulatory strategies covering various stages of development from pre-IND to post marketing life cycle management of new chemical entities and biologics in many therapeutic areas. Prior to his current role, Mr. Calvarese served as Director of Clinical & Regulatory Affair at Penederm where he oversaw clinical and preclinical development and managed the company’s regulatory approval strategy and process. Mr. Calvarese was formerly Vice President of Regulatory, Clinical and Quality for Fibrogen, Inc., where he was a member of the strategic and new product planning executive team and responsible for all clinical, regulatory and quality functions. Mr. Calvarese has extensive drug and device development experience through his work with other organizations including Collagen Corporation, Advanced Surgical Intervention, Inc., Advanced Biosearch Associates, Pfizer Hospital Products Group and the UCLA School of Medicine.