IMPACT Therapeutics appoints head of regulatory affairs

Impact Therapeutics has made Dr. Chun-Pyn Shen head of Regulatory Affairs, VP. Reporting to the CEO directly, Dr Shen will lead the Department of Regulatory Affairs, which is responsible for the formulation and execution of global regulatory strategy for all IMPACT pipeline products.

Company executives say Dr. Shen has nearly 30 years of experience in bio-pharmaceutical industry and academic research. Before joining IMPACT Therapeutics, he served as VP, global project head at DymaniCure Biotechnology. He has a broad experience in regulatory affairs and pharmaceutical R&D, starting his industry career from Merck & Co. where he spent 11 years. After a brief stint in a regulatory consulting firm, he joined Adaptimmune as director, clinical research and development, and subsequently Questcor/Mallinckrodt as director, R&D. He then spent four years in Merck KGaA. In his capacity as director, Global Regulatory and Scientific Policy (U.S. and China), Dr. Shen made significant contribution to the approval of Bavencio (avelumab) for multiple oncology indications in the United States. He then served as the RA head and strategy consultant to the CEO at Hengenix Biotech (an affiliate of Shanghai Henlius Biotech).

“We are very pleased to welcome Dr. Shen on board,” says Dr. Jun Bao, CEO. “IMPACT Therapeutics has always maintained global development strategy for our pipeline. As more of our products enter the clinical stage, it becomes critical to have a global regulatory affairs strategy and a strong leader to execute the strategy. We believe that Dr. Shen’s is such a leader with his extensive experiences in the industry. We look forward to his leadership to take IMPACT product development to a new level.”

Dr. Shen will split his time between the United States and Shanghai offices. “I am thrilled to join Impact Therapeutics as head of Regulatory Affairs,” he says. “I look forward to working with my colleagues to strengthen the company’s regulatory affairs capability.”