Russ Altman, MD, PhD, CERSI Co-Director
Kathleen Giacomini, PhD, CERSI Co-Director
Terrence Blaschke, MD, Educational Program Advisor
Natalia Khuri, MBA, PhD, Educational Program Director
John M. Delaney, PhD, Amgen, Inc.
John Delaney, received his PhD in Microbiology at the University of Arizona under Dr. Harris Bernstein. He then went onto completing his doctoral work at the University of Utah under Costa Georgopolous. John is currently the Executive Director for Biologics Discovery at Amgen. His department is responsible for hit discovery for large molecule programs, including discovery of Therapeutic Antibodies. He also is Site Head for Amgen British Columbia.
Bruce Donzanti, PhD, Genentech
Bruce Donzanti, PhD, received his PhD in Pharmacology with a specialty in neuroscience. Following early careers in the military and academia, he has spent the past 25+ years in the pharmaceutical industry, holding positions in preclinical research, clinical research, medical affairs, and drug safety which have encompassed a number of therapeutic areas such as neurology, cardiovascular, and oncology. Many of these positions have involved global management and budgetary responsibilities. His accomplishments include: directing a clinical development program, completing 3rd party drug safety agreements, licensing due diligence activities, leading/participating in company integration activities, numerous publications and presentations, developing new neuropharmacological techniques, developing global drug safety programs/procedures and participanting in many health authority drug safety inspections, including at the EMA Pharmacovigilance Risk Advisory Committee (PRAC). Currently, he is a Senior Group Direct for the Global Pharmacovigilance Innovation Policy and Regulatory Affairs at Genentech.
Maurice (Maury) Emery, PharmD, PhD, Seattle Genetics
Maurice (Maury) Emery, PharmD, PhD, Seattle Genetics Maury received BS Pharm and PharmD degrees from the University of Minnesota. Following graduation, he joined the University of Utah faculty in Pharmacy Practice for 10 years where he attained the rank of Associate Professor with an emphasis in neonatal/perinatal medicine therapeutics. After a 3 year position in the post-marketing medical department at Bristol-Myers, he returned to the University of Washington to complete a PhD degree in Pharmaceutics in the laboratory of Ken Thummel. Following his completion of the PhD program, he joined Abbott Laboratories in Chicago supporting drug discovery for 4 years. Dr. Emery then spent 12 years at Amgen in the pharmacokinetics and clinical pharmacology groups. After a very short retirement, he has recently joined Seattle Genetics Clinical Pharmacology Group. He has experience across all stages of drug development in the areas of oncology, inflammation, metabolic and cardiovascular therapeutics. He currently serves on the Board of Directors for the American Society of Clinical Pharmacology and Therapeutics.
Donna Flesher, PhD, Amgen Inc.
Donna Flesher, PhD, received her PhD at Stanford University in the Program in Immunology under Dr. Paul J. Utz. Flesher is currently a Principal Scientist and Solid Tumor Therapeutic Area Lead in the Clinical Biomarkers & Diagnostics group at Amgen where she is responsible for the development and alignment of biomarker strategy across early and late stage clinical development programs as well as marketed products. In 2012, Flesher received an award for Amgen Excellence in Volunteering. She has over 10 years of experience in the biotechnology industry, where she has led cross-functional teams in both discovery research and translational sciences.
Ning F. Go, MD, Amgen Inc.
Ning F. Go, received her MD from the University of Beijing’s School of Medicine, her MA from the University of California in Berkeley in Arts and Immunology, and went to complete her postdoctoral fellowship at DNAX Research Institute and Stanford University. Dr. Go is currently a Principal Scientist in the Medical Science department at Amgen. Dr. Go’s expertise are in Vitro Diagnostics (IVD)/companion diagnostics (CDx) development in oncology and cardiovascular therapeutic areas and biomarker research.
Robert Harris, PhD, Independent Consultant
Robert Harris, PhD, received his PhD from the University of California in San Francisco in Pharmaceutical/ Medicinal Chemistry. He is a Regulatory and DMPK/Clinical Pharmacology expert with 20 years of early (pre-IND) through late-stage global drug development experience within both industry and FDA. Dr. Harris has extensive experience in leading both regulatory and DMPK teams, generating strategies for the development of small and large molecules across multiple therapeutic areas.
Graham Jang, PhD, MBA, Regulus Therapeutics Inc.
Graham Jang received a B.S. in Biology from the University of Cincinnati, a Ph.D. in Pharmaceutical Chemistry from UCSF under Dr. Leslie Z. Benet, an MBA from the Wharton School (U Penn), and completed a post-doctoral fellowship at an INSERM (Institut National de la Santé et de la Recherche Médicale) lab in Montpellier, France. Graham has 19 years of industry experience in all stages of drug discovery and development for both small and large molecules, gained at Bristol Myers-Squibb, nearly 14 years at Amgen Inc. (including key roles in multiple drug approvals and as head of Clinical Pharmacology), and as the Head of Clinical Pharmacology and Translational Medicine at Seattle Genetics Inc. He is currently Vice President of Drug Metabolism & Pharmacokinetics at Regulus Therapeutics Inc. (La Jolla, CA).
Ai Ching Lim, PhD, Amgen, Inc.
Ai Ching Lim, PhD, received her PhD in Chemistry from the California Institute of Technology under Prof. Jackie Barton . She has 20 years of biotechnology industrial experience with increasing responsibility leading multi-disciplinary teams focused on the delivery of novel biotherapeutics. Dr. Lim has been at Amgen for 13 years and is currently the Director of Biologics and Therapeutic Discovery. Dr. Lim leads the Protein Technologies groups in South San Francisco and Boston.
Lauren Murphree Mihalcik, PhD, DABT, Amgen Inc.
Lauren Murphree Mihalcik, PhD, DABT, is a Senior Scientist at Amgen in the department of Comparative Biology and Safety Sciences. She received her PhD in Pharmacology from the University of Virginia under Joel Linden. She spent eight years as a pharmacology/toxicology reviewer in the Division of Metabolism and Endocrinology Products at FDA/CDER, where she was responsible for reviewing nonclinical data supporting more than 100 IND and NDA applications. At Amgen, Mihalcik is a project team representative, responsible for the nonclinical safety strategy for many drug development programs in inflammation, oncology, cardiometabolic disease, and biosimilars.
Branden Reid, PhD, Janssen Pharmaceutical Companies of Johnson & Johnson
Branden Reid, PhD, received his PhD from the Johns Hopkins School of Medicine in Biomedical Engineering. He is currently an Associate Director of Global Regulatory Affairs at Janssen Pharmaceutical Companies of Johnson & Johnson. Branden provides regulatory strategy for combination products across multiple therapeutic areas. Prior to Janssen, Branden was a global regulatory lead at Becton, Dickinson, and Company, where he provided regulatory strategy for medical devices and in vitro diagnostic devices. He began his career at the FDA, as a Senior Reviewer in the CDRH Gastroenterology Devices Branch and Renal Devices Branch, where he also was the lead drug device combination product reviewer.
Julie Kang Sallam, PharmD, Genentech
Julie Kang Sallam, PharmD, received her PharmD from the University of Michigan. Sallam currently is the Senior Group Director of Commercial Regulatory at Genentech. She is responsible for managing commercial regulatory staff across all therapeutic areas and ensuring that marketing communications are in compliance with applicable laws, regulations and guidelines.
Mary Ann Smith, MSc., Novartis Pharmaceuticals Corporation
Mary Ann Smith is the Regulatory Policy Director for Digital Medicine and Medical Devices with Novartis. She joined Novartis in 2009 and currently focuses on regulatory policy in the area of digital solutions and software as a medical device, technology applications to support patients and pharmaceutical clinical trials, and combination products with a focus on drug delivery systems. Ms. Smith also provides regulatory strategic input to a number of Novartis venture backed companies. Ms. Smith has over 20 years of increasing quality and regulatory responsibilities including positions at companies such as Nektar Therapeutics, Abbott Laboratories and Hitachi Chemical Diagnostics. Ms. Smith has also held positions in market analysis with Stanford Research Institute and Business Development with Brand Institute.
Ms. Smith holds a Bachelor of Science degree in pharmacy, from Purdue University, and a Master of Science degree in technology management, from Pepperdine University. She has also completed the American Course on Drug Development and Regulatory Science at UCSF. Additionally, she provides instructional support for the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) in the Bioengineering department. Ms. Smith has served on the Board of Directors for International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and continues to support a number of working groups. She has served as a mentor with the Healthcare Businesswomen's Association. Ms. Smith is also a registered pharmacist.
John Sullivan, MB ChB, Amgen Inc.
John Sullivan is an Executive Medical Director for Global Safety Nephrology/Inflammation at Amgen. Sullivan received his MB ChB (MD equivalent) from the University of Otago in Dunedin, New Zealand. He then completed training in internal medicine and is a Fellow of the Royal Australasian College of Physicians (FRACP) as well as a Fellow of the American College of Physicians. Following fellowship training in Clinical Pharmacology at the University of Toronto and the Addiction Research Foundation, he joined the Faculty of Medicine at Brown University and then Johns Hopkins where he was an Associate Professor. He joined Bayer Pharmaceuticals before Amgen where he has worked in Clinical Pharmacology, Regulatory and Safety. Sullivan was also a former committee member on the FDA Advisory Committee on Drug Safety and Risk Management.
Michael Quinn, PhD, Management Adviser
Michael Quinn, PhD, received his PhD in Biomedical Engineering from the University of Southern California. He is currently a management adviser for early stage medical device companies and helps to guide product development activities, build company infrastructure, and develop regulatory strategies. Over the course of his career, he developed numerous medical products as an engineer and helped start new companies as an entrepreneur and executive team member.
Parnian Zia-Amirhosseini, PhD, Sarepta Therapeutics
Parnian Zia-Amirhosseini received her PhD in Pharmaceutical Chemistry from the University of California, San Francisco working in Leslie Benet's laboratory. She is currently an Executive Director in Regulatory Affairs at Sarepta Therapeutics. She has over 20 years of experience working with small molecules and biologics in various stages of drug development and multiple therapeutic areas.
Murray M. Lumpkin, MD, MSc, Bill and Melinda Gates Foundation
Murray M. Lumpkin, MD, MSc became Deputy Director – Integrated Development and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation in January 2014. Dr. Lumpkin served at the US FDA for 24 years prior to joining the Gates Foundation. He started his career at the US FDA as Director of the Division of Anti-Infective Drug Products in the FDA Center for Drug Evaluation and Research (CDER). He then became Deputy CDER Center Director for Review Management, primarily responsible for oversight and management of the Offices of Drug Evaluation and their new drug review divisions, along with the offices that oversaw post-marketing surveillance and epidemiology and the advisory committee office. For 10 years at FDA, he was the Deputy Commissioner for International Programs, during which time the FDA established its foreign offices and concluded most of the bilateral arrangements it has with counterpart agencies. During his final two years at FDA, he served as Senior Advisor to the Commissioner on Global Issues. He did his post-graduate medical training at the Mayo Clinic and the London School of Hygiene and Tropical Medicine and is a board-certified pediatrician with subspecialty expertise in pediatric infectious diseases and in tropical medicine and hygiene.
Zili Li, MD, MPH, US FDA
Zili Li, MD, MPH, currently is Associate Director for Global Affairs, Office of Generic Drugs at US FDA. Prior to rejoining FDA at the end of 2015, Dr. Li held a variety of positions of increasing responsibility at Merck and the Bill & Melinda Gates Foundation, including the head of China R&D and executive director for global regulatory strategy. Between 2000 and 2005, Dr. Li also worked at US FDA as medical team leader for new drug reviews. Over past 10 years, Dr. Li has given many lectures on the comparison of regulatory systems in the US and China. He was the recipient of special recognition awards from China FDA and US FDA respectively for educational efforts related to regulatory system strengthening in China. Dr. Li, earned his medical degree from Peking Union Medical College, and completed his residency training at Johns Hopkins. He held two master’s degrees in public health.