DC Discussion Group

ICH Q12 | April 9 15:00 EDT | Rockville, MD

Join us in-person on April 9 for a focused discussion on ICH Q12 featuring panelists from government and industry, including Andrew Chang, Novo Nordisk Inc. Network with DC-area CASSS members. Registration for this free opportunity will close April 7.

Register for DC Discussion Group

Location:
IBBR (University of Maryland - Institute for Bioscience and Biotechnology Research)
9600 Gudelsky Dr
Rockville, MD 20850

Attendance and Substitution Policy

CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.

Despite ICH Q12’s promise of science-based lifecycle flexibility, adoption remains limited, often due to perceived industry hesitancy. In reality, organizations are actively exploring Q12, but progress is slowed by internal constraints, the need for a mindset shift, and the challenge of integrating Q12 into quality systems. Defining and justifying non-Established Conditions (non-ECs) is particularly complex, with inconsistent recognition of benefits and resource-intensive cross-functional evaluation. This session brings together industry and agency perspectives to share practical strategies for credible and feasible Q12 implementation. Discussion will focus on building risk-proportionate ECs and defensible non-ECs, leveraging prior knowledge—especially for platforms like monoclonal antibodies and delivery devices.

Andrew Chang
Novo Nordisk Inc.

Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is a member board director for CASSS-Sharing Science Solutions and the chair for PDA Biopharmaceutical Advisory Board (BioAB).  At his current capacity as a Vice President, Quality and Regulatory Compliance, Novo Nordisk Quality, 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, Chang 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 the co-chair for BIO Cell and Gene Manufacturing Therapy Task Force, a member of PhRMA and BIO’s International Regulatory Policy 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, Chang  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, Chang 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, Chang received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.