James Wabby

James Wabby

James Wabby, MHMS is Executive Director of Regulatory Affairs, focusing on Emerging Technologies and CMC-Device at AbbVie, based in Irvine, CA. Wabby has over 15 years of experience in many facets of regulatory affairs, quality compliance and quality operations within the GxP regulated environment pertaining to Medical Devices, Combination Products, and Digital Medicine. Wabby regularly […]

Keith Morel

Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations. He has worked in the medical device industry since 2000. Prior to joining Qserve, […]

Kellie Moore

Kellie Ann Moore, Esq, is a practical business savvy attorney with over 19 years of experience providing legal counsel to pharmaceutical, biologic and medical device organizations for compliant conduct in conformance with FDA and international regulations. Moore thrives on helping organizations strategically (and contractually) drive their FDA-regulated products and R&D services forward. By mapping contractual relationships and identifying regulatory risk mitigation strategies proactively, Moore utilizes her unique […]

Dana Bell, PhD, MS

Dana Bell, PhD, MS, is an RA/QA consultant specializing in the development of registration strategies and quality systems for drugs, genetically-engineered and plasma-based products. She is a part-time faculty at USC Mann, Department of Regulatory and Quality Sciences. Previously, Dr. Bell was Senior Director of Global Regulatory Affairs at Baxter Healthcare Corporation. At Baxter, she […]

Meredith Smith

Dr. Meredith Smith is a behavioral scientist and health services researcher by training with over 15 years of professional experience in the pharmaceutical industry in the areas of health outcomes research, health policy, drug safety, and risk management. In her current role as Director of Risk Management at Alexion Inc., she oversees a state-of-the-art risk management […]

Michael Hamrell, PhD, RAC

Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA, FACRP is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located in the Central Coast region of California.  He has worked in drug development, clinical research and regulatory affairs for over 30 years.  His is a leading expert in GMP/GLP/GCP compliance and inspection readiness, […]

Samantha L. Yeung, PharmD, MS, BCCP

Samantha L. Yeung, PharmD, MS, BCCP is an Assistant Professor of Clinical Pharmacy at the University of Southern California (USC) School of Pharmacy. She graduated from the University of California, San Diego with a Bachelor of Science and Master of Science degree in Biochemistry/Cell Biology and went on to receive her Doctor of Pharmacy degree from […]

Vinson Lee

Vinson Lee, PharmD, MS, FCPhA, FAMCP is currently Vice President of Market Access at Coherus Biosciences, a biopharmaceutical company focused on expanding patient access to important, cost-effective medicines, and delivering significant savings to the U.S. healthcare system. Dr. Lee has over 16 years of experience in managed care pharmacy, the pharmaceutical industry, consulting, and academia. […]

Roger Clemens, DrPH

Dr. Roger A. Clemens has been part-time faculty within the Department of Regulatory and Quality Sciences at USC Mann since 2001.  He is also a faculty member in the Global Medicine program within the Keck School of Medicine.  He served as Scientific Advisor for Nestlé USA for more than 21 years, food science and nutrition […]

Yuna H. Bae-Shaaw, PharmD, PhD

Yuna H. Bae-Shaaw is a research assistant professor in the Department of Pharmaceutical and Health Economics at USC Mann. She is a pharmacist with an expertise in health outcomes research and data analysis. She received her PhD in Pharmaceutical Economics and Policy from the University of Southern California, where she defended her dissertation titled “Dementia […]

Paul Seidler, PhD

An expert in structural biology, neurodegenerative disorders and Alzheimer’s drug discovery. Our lab focuses on drug discovery, and initiatives to promote the betterment of public health. Our laboratory research is rooted in structural biology and biochemistry of neurodegenerative disease. We aim to develop inhibitors of tau aggregation, which is thought to drive neurodegeneration in Alzheimer’s disease […]