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
Mantej (Nimi) Chhina, MS, PHD, RAC, BioMarin Pharmaceutical Inc.
Nimi is a regulatory policy expert with strong understanding of FDA, ICH, and other global laws, regulations, policies, and guidances for regulation of medical products. She also has extensive biotechnological, translational, and clinical research experience. Nimi has strong scientific educational background with deep insight of biotechnology; and is highly specialized in human genetics and biomedical genetics. She got her BS (honors school, 2002) and MS (honors school, 2004) in human genetics from Guru Nanak Dev University in India. She undertook graduate studies in biomedical genetics from 2004 to 2006 at University of Rochester, NY, and got her PhD in biotechnology and functional genomics in 2010 from George Mason University, VA. During her time at the FDA, Nimi served in various positions in CDER’s Office of Medical Policy, including health science policy analyst and as team lead in the Division of Medical Policy Development. She joined BioMarin Pharmaceutical Inc. in 2017 as Director of Regulatory Policy & FDA Engagement. In her role, she provides strategic advice to the development programs, including gene therapy development. She works closely with internal teams on important topics including regulatory CMC, expedited program considerations, patient engagement, etc.
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 A. Donzanti, PhD, Genentech Inc.
Bruce A. Donzanti, 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 his accomplishments have included: 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 participating in many health authority drug safety inspections. Currently, he is a Senior Group Director for the Global Pharmacovigilance Innovation Policy and Regulatory Affairs at Genentech/Roche. His current focus is on potential utility of artificial intelligence in regulatory and drug safety activities.
Maurice (Maury) Emery, PharmD, PhD, Esperion Therapeutics
Maurice (Maury) Emery 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 and 3 years with the Seattle Genetics Clinical Pharmacology Group. After a very short retirement, he joined Esperion Therapeutics to assist with filing an NDA for a novel lipid lowering therapy. He has experience across all stages of drug development in the areas of oncology, inflammation, metabolic and cardiovascular therapeutics. He is a member of the American Society of Clinical Pharmacology and Therapeutics and has previously sat on their Board of Directors.
Donna Flesher, PhD, Amgen Inc.
Donna Flesher, received her PhD at Stanford University in the Program in Immunology under Dr. Paul J. Utz. Dr. 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, Dr. 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, 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. He is currently an independent consultant in Regulatory Affairs.
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).
Brad Jordan, PhD, Amgen Inc.
Brad Jordan, received his Ph.D. in Biochemistry from the University of Arkansas in Fayetteville and followed with a Postdoctoral fellowship at St. Jude Children’s Research Hospital in Memphis, TN. In his studies, Brad specialized in the use of high-field biomolecular NMR spectroscopy and its application to protein structure determination and drug discovery. After ten years in the Discovery Research organization at Amgen, Brad transitioned to a role in Global Regulatory and R&D Policy at Amgen where he currently serves as the Global Biosimilar Policy lead and specializes in the regulation of biologics and biosimilars.
Herve Lebrec, PharmD, PhD, Amgen Inc.
Herve Lebrec is a Scientific Director within the Comparative Biology and Safety Sciences Department at Amgen in San Francisco. He received a doctorate in Pharmacy and a PhD degree in Toxicology from the University Paris XI in 1992 and continued his training as a postdoctoral fellow at the USEPA in Research Triangle Park in 1992 and 1993. He then occupied Faculty positions at the School of Pharmacy Paris XI until 1999. His career in the pharmaceutical industry began in 2000 with a Research Specialist position in the Pathology and Toxicology Department of 3M Pharmaceuticals. While there, Dr. Lebrec advanced through positions of increasing responsibility and became Manager of the Pathology and Toxicology Department in 2005. In 2006, he joined the Comparative Biology and Safety Sciences Department at Amgen where he works as a Lead for small molecules, biologics, and cellular therapy-based projects. Dr. Lebrec also currently a co-chair of the immunotoxicology technical committee of HESI.
Ingrid Markovic, PhD, Genentech/Roche
Dr. Ingrid Markovic joined Genentech/Roche in 2018 as a Senior Director, U.S. Technical Regulatory Policy in Washington D.C. Office. In this role Ingrid is responsible for strategic oversight, assessment of, and advocacy for CMC Policies the U.S. and internationally, including establishing strategic relationship with internal and external stakeholders. Prior to this, Ingrid served as a Senior Science Advisor for CMC in the immediate Office of the Center Director at CBER, FDA where she was responsible for providing leadership, strategic roadmap and guidance for development, implementation and integration of CMC policy for biological and biotechnological products. She also served as a CBER Quality Lead for ICH Q12 since its inception, as well as for all other ICH Quality efforts. Before joining CBER, Dr. Markovic was in the Office of Biotechnology Products, CDER, FDA for 8 years where served as an Expert Review Scientist for Extractables & Leachables providing guidance for development and implementation of E&L regulatory review policy and she conducted regulatory review of CMC information in Biological License Applications (BLAs), post-approval supplements and other regulatory submissions both for innovator and biosimilar products. Ingrid holds a Ph.D. degree from University of Wisconsin, Madison with Thesis Research in Natural Products Chemistry and Post-Doctoral Training in Biochemistry and Biophysics in the Laboratory of Cellular and Molecular Biophysics at the National Institutes of Health, Bethesda, MD.
Jennifer Mercer, BioMarin Pharmaceutical Inc.
Jennifer Mercer has 30 years of experience in the pharmaceutical/biotechnology industry with a focus in Product Development, Cell Culture Process Development, Manufacturing, and Quality. Her main expertise is in in global regulatory CMC requirements for both large and small molecules, devices, and combination products to support clinical development and commercialization. Jennifer is an Executive Director, Regulatory Affairs, CMC.
Julie Kang Sallam, PharmD, Genentech Inc.
Julie Kang Sallam, 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.
Michael Quinn, PhD, Management Adviser
Michael Quinn, 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.
Martha Zanchi, PhD
Dr. Zanchi is Founder and Managing Director of Medinnovo LLC, a consultancy firm established to support the entrepreneurial community of Silicon Valley, and an Adjunct Professor with Stanford University’s School of Medicine in the Biodesign Program, where she participates in the strategic planning activities of the Biodesign Leadership Group and is the Lead Director of “Biodesign for Mobile Health,” an entrepreneurial course. Under Medinnovo, Dr. Zanchi has worked as a consultant, advisor or Board member with companies in the cardiovascular, imaging and mobile health industry, for some in acting executive positions joining the leadership teams at critical times of the company’s earliest stages. She is an advisor to student teams at Stanford University and a mentor at StartX, a startup accelerator.
Parnian Zia-Amirhosseini, PhD, Independent Consultant
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 independent consultant in Regulatory Affairs. She has over 20 years of experience working with small molecules and biologics in various stages of drug development and multiple therapeutic areas. She is currently an independent consultant in Regulatory Affairs.