Preclinical Development and Drug Metabolism / Pharmacokinetics
Deanne Garver, Ph.D Consultant. Formerly VP Preclinical Development, Adolor Corp.
Dr. Garver has seven years experience leading preclinical development at Adolor with her most recent position being Vice President, Preclinical Research and Development, having responsibility for all in-house and contract discovery research and development portfolios. In this capacity Deanne was responsible for all non-clinical development through NDA. Previously Dr Garver held positions of increasing responsibility in SmithKline Pharmaceuticals (now GlaxoSmithKline) with 8 years in Drug Metabolism and Pharmacokinetics, and 4 years in development project management leading 7 projects (three preclinical, one Phase I, one Phase II and two Phase III projects). Dr. Garver has a Ph.D. in Medicinal Chemistry from the Medical College of Virginia, having specialized in drug metabolism during her degree program as well as Postdoctoral work and faculty position at The Johns Hopkins School of Medicine.
Preclinical Development & Chemistry, Manufacturing & Control (CMC).
Saul Cherkofsky, Ph.D., Consultant. Formerly, Executive Director Pharmaceutical Development, Du Pont Merck.
Dr. Cherkofsky has over 30 years in pharmaceutical development and brings great depth of expertise in CMC as well as overall non-clinical development as well as medicinal chemistry. Trained as an organic chemist, Saul was most recently Vice President, Preclinical Development Adolor Corporation, where he managed as well as carried out in-house and contract non-clinical development and CMC, delivering four INDs and one NDA in 3 years. Previously Dr. Cherkofsky was Director, Medicinal Chemistry and subsequently Director, Chemical and Pharmaceutical Development, Du Pont Pharmaceuticals; Executive Director, Pharmaceutical Development, Du Pont Merck; and Vice President, Pharmaceutical Development, Symphony Pharmaceuticals. Dr. Cherkofsky received his BS in Chemistry from MIT and Ph.D. in Organic Chemistry from Harvard University.
Antibiotic Pharmacokinetics / Pharmacodynamics
William A. Craig, M.D., Professor of Medicine, University of Wisconsin Medical School and Professor of Pharmaceutics, University of Wisconsin School of Pharmacy, Madison, Wisconsin.
Dr. Craig has been the Head of the Clinical Pharmacology Section at the University of Wisconsin Medical School since 1979. He actively teaches as professor of medicine and professor of pharmaceutics at the University of Wisconsin. Dr. Craig earned his medical degree at Tufts University School of Medicine and completed his internship and residency in internal medicine at the University Of Wisconsin Medical School and a fellowship in infectious diseases at the University of Wisconsin and Madison Veterans Administration Hospital. He is board certified in internal medicine, with a subspecialty in infectious diseases. Dr. Craig is an Editor of Antimicrobial Agents and Chemotherapy and has recently chaired several infectious disease meetings and organizations. He also serves on the Subcommittee on Antimicrobial Susceptibility Testing for the National Committee for Clinical Laboratory Standards
Toxicology, Pharmacokinetics, and Safety Pharmacology
Senior Staff at Nerviano Medical Sciences Pietro Grossi, Ph.D. bioanalysis, pharmacokinetics, in vitro and in vivo metabolism;
Marco Brughera, D.V.M., E.R.T., Toxicology
Claudio Bernardi, D.V.M., E.R.T., Toxicolog
Nerviano (Milan), Italy http://www.nervianoms.com/Site/Welcome.asp.
Additionally, specific expertise in Toxicology, Pharmacokinetics, and Safety Pharmacology comes from this spin-out of Pfizer The Nerviano group provides Protez’s preclinical development support, with the individuals listed above being directly involved in development of the carbapenem antibiotic.
Clinical Development & Regulatory
Carbapenem Efficacy Trials
John Paul Quinn, M.D., FACP, Scientific Director, Chicago Infectious Disease Research Institute, Professor of Medicine, Rush University , Chicago, Illinois.
Dr. Quinn is a recognized expert and scholar in the treatment of bacterial infections, resistance to antibiotics, and the need for new antibiotics and their appropriate use in general, as well as specifically in carbapenem antibiotics. 23 years clinical experience infectious diseases. In addition to his 25 years medical experience and broad clinical responsibilities, Dr. Quinn has also been intimately involved in the development and commercialization strategy for numerous antibiotics, in particular for the carbapenems. He has served on advisory boards for Merck & Company for ertapenem & imipenem; Astra-Zeneca for meropenem and AZD 2563; Pfizer for linezolid; and Basilea for novel anti-MRSA beta-lactams. Dr. Quinn qualified in medicine at Rush Medical College, Chicago, and did infectious diseases fellowships at the University of Chicago, and the University Of Washington School Of Medicine, in the United States.
Clinical Development & Regulatory
Paul Blake, MB, FRCP, FCP, FFPM Chief Medical Officer
Avigenics Inc.; Protez Board of Directors
Dr. Blake is Chief Medical Officer of Avigenics. Prior to joining Avigenics, Dr. Blake was Executive Vice President of Worldwide Medical & Regulatory Affairs, Cephalon; and Chief Medical Officer at MDS Proteomics, Inc., a division of MDS International. Previously he was senior vice president and medical director for SmithKline Beecham Pharmaceuticals with responsibility for its worldwide clinical R&D operations. He also served as President and Chief Executive Officer of Proliance Pharmaceuticals, Inc., and held other senior clinical research and development positions with ICI Pharmaceuticals (now AstraZeneca) and
G.D. Searle & Co.
Dr. Blake qualified in medicine at London University and is a fellow of the American College of Clinical Pharmacology and the Royal College of Physicians in the United Kingdom. Dr. Blake sits on the Board of Directors of Protez Pharmaceuticals and ViaCell, Inc.
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