Total Council Members: 7
Ground Zero Pharmaceuticals, Inc. (GZP) provides services in regulatory affairs and product development across many therapeutic areas, in the management of medical product portfolios and technology assessment, in pharmaceuticals, biologics and medical devices. GZP provides expert strategic and tactical guidance for our clients to help develop their products, build their firms, set the appropriate priorities from their pipelines and obtain marketing approvals. Our top priority is to maximize the efficiency of the therapeutic development process by reducing duplicative work, proactively identifying issues, and facilitating interactions with regulatory agencies, financiers and outside vendors. They have offices in Irvine, California, and Melbourne, Australia, with Associates throughout the US, Australia, Canada and Sweden.
Director of Regulatory Affairs
Ground Zero Pharmaceuticals, Inc.![]()
Dr. Jim Barquest is currently the Director of Regulatory Affairs at Ground Zero Pharmaceuticals, Inc. He provides strategic regulatory, quality system, regulatory compliance, submission preparation and project management consultation to device, drug,...
Director
Ground Zero Pharmaceuticals, Inc.![]()
Chaline S. Brown, PharmD, is Director of Clinical Affairs at Ground Zero Pharmaceuticals in Irvine, CA. Dr. Brown has over eleven years of experience in the pharmaceutical industry focusing on pharmacogenetics and clinical drug development. Among her...
Clinical Expert
Ground Zero Pharmaceuticals, Inc.![]()
Victoria Chazin, PhD, is a Clinical Expert at Ground Zero Pharmaceuticals, Inc. in Irvine, CA. Dr. Chazin is also an Independent Clinical and Regulatory Consultant. She has more than 12 years’ experience in drug and biologics development and clinical...
Michael HamrellConsultant
Ground Zero Pharmaceuticals, Inc.![]()
Michael R. Hamrell, PhD, is the President of MORIAH Consultants and a Strategic Regulatory Affairs Consultant for Ground Zero Pharmaceuticals in Irvine, CA. Dr. Hamrell has extensive experience in regulatory affairs, clinical research and drug development...
Nonclinical Expert
Ground Zero Pharmaceuticals, Inc.![]()
Duane Lakings, PhD, is a Nonclinical Expert in Pharmacology, Pharmacokinetic, and Toxicology at Ground Zero Pharmaceuticals in Irvine, CA. Dr. Lakings is also Principal and President at Drug Safety Evaluation Consulting. He has over 30 years of experience...
Manager
Ground Zero Pharmaceuticals, Inc.![]()
Michele F. Smith is currently Manager of Business Development at Ground Zero Pharmaceuticals in California. Ms. Smith manages early contact with clients providing the necessary materials and /or communications needed. She also maintains central electronic...
Consultant
Ground Zero Pharmaceuticals, Inc.![]()
Debra Vallner, PhD, is a Consultant in Regulatory Program Management at Ground Zero Pharmaceuticals in Irvine, CA. Dr. Vallner has over 25 years of experience in the pharmaceutical industry. She most recently was VP of Product Development at InteKrin...
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