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., Hannah Jin, AstraZeneca, and Paresma (Pinky) Patel, Gilead Sciences, Inc. Network with DC-area CASSS members. Registration for this free opportunity closed April 7.

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

Visible Particles | June 4 15:00 EDT | Rockville, MD

Join us in person on June 4 at the DC Discussion Group for a discussion on visible particles. Network with DC-area CASSS members. Registration for this free opportunity closes June 2.

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

Register for DC Discussion Group

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. 

Hannah Jin
AstraZeneca

Hannah Jin is an Associate Director, CMC Regulatory Affairs - Devices & Digital Therapeutics at AstraZeneca. In this role, she leads regulatory strategies for a diverse portfolio of inhaled and parenteral drug-device combination products with a focus on lifecycle management and post-approval changes.

Ms. Jin leverages a strong technical foundation to drive regulatory success. Prior to her current role in regulatory affairs, she managed the technical design and development of combination products as a device engineer within AstraZeneca’s parenteral device development organization. Her interest in devices began with her early experience in design research and strategy for combination products and pharmaceuticals at Johnson & Johnson, where she was introduced to the creation and analysis of patient journeys. These collective experiences allow her to bridge the gap between patient-centered design, technical execution, and the evolving global regulatory landscape.

Paresma (Pinky) Patel
Gilead Sciences, Inc.

Paresma (Pinky) Patel, Ph.D. is Director of Regulatory CMC Policy & Advocacy at Gilead Sciences, where she leads chemistry, manufacturing, and controls (CMC) regulatory advocacy in support of global health authority filings. In this role, she represents Gilead in multiple external forums and advances regulatory policy initiatives, including implementation of ICH M4Q (R2), ICH Q12, and evolving assessment standards.

Prior to joining Gilead, Dr. Patel spent a decade at the U.S. Food and Drug Administration (FDA) (2015–2025), holding positions of increasing responsibility within CDER’s Office of Pharmaceutical Quality. Her roles included Reviewer, Branch Chief, and ultimately Division Director in the Office of Product Quality Assessment III. As Division Director, she led teams responsible for the evaluation of CMC information, with a primary focus on drug substance quality across all stages of development. During her FDA tenure, she also contributed to numerous strategic initiatives and the development of regulatory policies and guidelines.

Earlier in her career, Dr. Patel worked as a medicinal chemist at the National Institutes of Health. She earned her Ph.D. in Organic Chemistry from The Scripps Research Institute (2010) and completed a postdoctoral fellowship at the California Institute of Technology (2012).