Andrew Chang

Novo Nordisk Inc.
Vice President, Quality and Regulatory Compliance
Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is skilled in interpersonal relationships combined with knowledge of science and law, which is used to bring about impactful data-driven and risk-based decision-making process and results. At his current capacity as a Vice President, Quality and Regulatory Compliance, Regulatory Policy & Intelligence, Global Regulatory Affairs, Novo Nordisk, Inc. he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspections. Since 2013, Andrew has represented Novo Nordisk at several work groups in industry trade organizations, e.g., PhRMA and BIO to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the regulatory authorities. He is a member of PhRMA and BIO’s International Regulatory Policy and Global Quality and Manufacturing work groups, and representing PhRMA as an expert and topic leader to ICH Q12 Expert Work Group and implementation work group, respectively for developing and implanting guideline on Pharmaceutical Products Lifecycle Management. Prior to industry, Andrew had 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). While at FDA, Andrew was known as a leading FDA and CBER spokesperson and has presented the FDA perspective at many national and international meetings. 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. During his tenure in the FDA, Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.

Related Articles

Potency Measurements for Cellular and Gene Therapy Products
Technical
Potency Measurements for Cellular and Gene Therapy Products

Cell and gene therapy (C&GT) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C&GT products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...

Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Features
Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...

Post-approval Change Management for Cell and Gene Therapy Products
Features
Post-Approval Change Management for Cell and Gene Therapy Products

Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...

Comparability Considerations for Cellular & Gene Therapy Products
Features
Comparability Considerations for Cellular & Gene Therapy Products

Cell and gene therapy (C&GT) products comprise a rapidly growing field of innovative medicines that hold the promise to treat and, in some cases, cure diseases that are otherwise untreatable. In this article, we provide points to consider when evaluating the comparability of C&GT when changes are made in their manufacturing processes.