Title: How to lead to a successful IND submission

Time: November 18, 2024 (Monday), 8:00-9:00 am

Location: Multifunction Hall, 2nd Floor, Wang Changlai Building, Ningbo University Health Science Center

Speaker: Charles C. Zhang, Ph.D., DABT

Personal Introduction: 

Dr. Charles C. Zhang is the General Manager of BioPharma Consulting LLC, a firm he established to provide expert consulting in new drug development. As a seasoned entrepreneur and translational medicine expert, Dr. Zhang brings over 23 years of leadership in the biopharmaceutical industry in the USA, with a proven track record of guiding innovative therapies from early stages to regulatory submissions. His achievements include authoring 2 NDAs (one as the nonclinical biology lead), 1 PMA (medical device), 10 INDs, and 3 CTAs for global submissions, covering a wide range of modalities, including small molecules, biologics including monoclonal and biospecific, cell therapy, gene therapy (AAV), siRNA, and medical devices.

Dr. Zhang earned his Ph.D. in Pharmacology from the University of Arkansas for Medical Sciences in 2000. He is board-certified by the American Board of Toxicology (DABT), having maintained certification since 2005, and is currently pursuing an EMBA at the Kellogg School of Management at Northwestern University, set to graduate in 2025.

He has held pivotal roles in renowned organizations, including Toxicology Leader at the Bill & Melinda Gates Foundation’s Medical Research Institute (Gates MRI), Director of Nonclinical and Toxicology at Mallinckrodt Pharmaceuticals, Director of Nonclinical Development at Theragene Pharmaceuticals, Associate Director of Toxicology at Purdue Pharma, Corporate Toxicologist at Boston Scientific Corporation. In these roles, Dr. Zhang has spearheaded nonclinical development and safety assessments across multidisciplinary teams, focusing on addressing unmet medical needs through innovative drug programs.