CASSS – Sharing Science Solutions is pleased to announce Andrew Chang and Jamie Moore have been elected and Kathy Lee reelected to the Board of Directors. They will join the twelve-member board responsible for governance and strategic direction of the association. Chang and Moore are both honored to have been elected by their peers to the CASSS Board of Directors.
Reflecting on why he chose to seek a seat on the board, Chang recalled, “I was introduced to CASSS prior to the first WCBP in 1997, while I was serving at CBER/FDA. The open and science-based discussions taking place at those conferences came to define well characterized biologics – a significant milestone in the history of biopharmaceutical development and regulation in the US.” He hopes to continue this tradition to the global sphere. "Using science to resolve regulatory challenges in a more collaborative way has been a major benefit of the CASSS community in my career."
Chang is Vice President of Quality and Regulatory Compliance, Quality Intelligence and Inspection at Novo Nordisk, Inc. Previously Chang served more than 11 years in US FDA most recently as an Associate Director for Policy and Regulation, Acting Deputy Director, Lab Chief and Senior Regulatory Scientist in the Division of Hematology, Center for Biologics Evaluation and Research (CBER).
Chang received his BSc in Pharmaceutical Chemistry from China Pharmaceutical University and his Ph.D. in Biochemistry from State University of New York Health Science Center at Brooklyn. He completed a post-doctoral fellowship at the National Institutes of Health in 1995.
Chang served as the FDA co-chair for the 2005 and 2006 WCBP symposiums and helped initiate the CMC Strategy Forums in Europe and, most recently, China. In addition, Andrew was an expert and topic leader to ICH Q12 Expert Work Group and implementation work group, helping develop the guideline on Pharmaceutical Products Lifecycle Management. He also served as the FDA deputy topic leader for developing ICH Q5E guideline and the FDA observer for European and US Pharmacopeia’s Expert Groups on Blood and Blood Derived Products.
Moore’s volunteerism in professional associations began in graduate school when she worked with AAPS to increase the awareness of industrial opportunities for graduate students. Now, having recently transitioned to a small start-up after more than 20 years with Genentech, a Member of the Roche Group, she views her election to the board as an opportunity to advance the cause of diversity, equity and inclusion in the association and in the industry. Said Moore, “I believe CASSS can also play a critical role in advancing racial and gender equality – we should be looking at the composition of all committees and conference representation to ensure that we are doing all we can to be allies and sponsors for underrepresented groups.”
Moore is currently Senior Vice President and Head of Protein & Process Sciences and Manufacturing at CytomX Therapeutics, in South San Francisco, California. Prior to that, Moore spent more than 20 years in various roles in pharmaceutical development at Genentech, a Member of the Roche Group. After receiving her bachelor of science degree in chemistry, she received her Ph.D. from the University of California at San Francisco.
Moore's volunteer positions with CASSS include serving as a founding member of the scientific organizing committee for the Higher Order Structure Conference, including co-chairing the symposium in 2015 and 2016; and serving as the Industry Co-Chair of WCBP in 2019.
Chang and Moore join the board as Julia Edwards of Genentech, a Member of the Roche Group and Kathy Lee of Merck & Co., Inc. assume the offices of President and Vice President / Secretary, respectively. The board officers are elected by their fellow board members to two year terms. Edwards and Lee look forward to leading the organization through an update of the strategic plan as we navigate the post-COVID world.