Scientific Advisory Board
Richard J. White, Ph.D., Chairman
Dr. Richard White is a consultant to the biotech industry. After a post-doctoral fellowship on microbial biochemistry at Oxford, he began a career in infectious disease drug discovery. He has over 28 years of experience in the pharmaceutical industry holding positions of increasing responsibility at Lepetit, Glaxo, Lederle and finally at Bristol-Myers Squibb (BMS). At BMS, he was Vice President in charge of Infectious Disease Drug Discovery and was involved with the discovery/ development of the cephalosporins cefepime and cefprozil, as well as the AIDS drugs Videx® and Zerit®. Following this, Dr. White accepted a position at Versicor, where he became Chief Scientific Officer. He played a role in licensing and development of dalbavancin and anidulafungin, taking Versicor public, merging with Biosearch Italia to create Vicuron, and ultimately achieving a market capital of $1.9 billion when the company was sold to Pfizer in 2005. His research interests focus on the mechanism of action of and resistance to antimicrobial drugs, and the special role that natural products have played in treating infectious diseases. He was educated in England where he received his undergraduate degree in Biochemistry from the University of Manchester, and a Ph.D. in Microbial Biochemistry from the University of Oxford.
Paul G. Ambrose, Pharm. D., F.I.D.S.A.
Dr. Paul G. Ambrose is currently the director of the Institute for Clinical Pharmacodynamics (ICPD) at Ordway Research Insitute in Albany, NY. Dr. Ambrose is an honorary research fellow, Infectious Diseases at the Nuffield Department of Medicine, University of Oxford, Oxford, England, United Kingdom. Dr. Amrose's areas of scientific inquiry primarily involve anti-infective translational science, with the goal of improving patient care through the application of pharmacokinetic-pharmacodynamic (PK-PD) principles. Knowledge gained through the use of non-clinical (in vitro and animal) PK-PD infection models may be leveraged with human pharmacokinetic data in order to discriminate between potential dosing regimens and thereby increase the probability of positive clinical outcomes while minimizing the potential for drug-related toxicities. ICPD has successfully utilized this approach for support of regulatory decision-making and as support for Clinical and Laboratory Standards Institute susceptibility breakpoint determinations. Dr. Ambrose is the author of over 90 peer-reviewed scientific publications and approximately 100 scientific abstracts. Dr.Ambrose has served as an editor for four textbooks; most notably the first and second editions of Antimocrobial Pharmacodynamics in Theory and Clinical Practice. Finally, Dr. Ambrose is an editor of Antimicrobial Agents and Chemotherapy.
Christopher M. Cimarusti, Ph.D.
Dr. Christopher Cimarusti has vast leadership experience in pharmaceutical discovery, development and manufacturing at Squibb Corporation and Bristol-Myers Squibb. As a discovery chemist, Dr. Cimarusti synthesized the antihypertensive nadolol and the antibiotic aztreonam for the first time and designed their commercial processes. As a discovery leader, he co-led the antibiotic effort with Richard Sykes and became Director of Organic Chemistry for the Squibb Institute for Medical Research. Subsequently, he was responsible for all biological and chemical process development within Squibb Corporation, including technology transfer directly to manufacturing, monitoring ongoing production and optimization of existing processes. After the merger, he became Vice President of Process R&D within the Pharmaceutical Research Institute. He led a team that examined early development productivity and strategies were developed and implemented that led to a new paradigm for these activities. He was appointed Senior Vice President, Pharmaceutical Development and led a global staff of 1,200 engaged in the CMC disciplines for small and large molecules. He also had responsibility for global Clinical Supply Operations, Project Management and Portfolio Management. He was a member of the Institute Executive Committee and a co-leader and/or member of operating committees that oversaw exploratory development, full development and life-cycle management, and technology transfer. Dr. Cimarusti led the Executive-Committee commissioned "Approval Process Study", whose recommendations have contributed significantly to the recent success of BMS with new product approvals.
J. Carl Craft, M.D.
Dr. J. Carl Craft was the Chief Scientific Officer for Medicines for Malaria Venture (MMV) in Geneva from 2002-2008. MMV has grown from a portfolio of 11 projects to the present portfolio with 20 projects; three in Phase III clinical trials, four in Phase I/II, one in preclinical development and 12 projects in discovery. To date MMV has raised over $250 million to support the largest ever anti-malarial drug development portfolio. Prior to this Dr. Craft worked at Abbott Laboratories in Anti-Infective Development. He joined Tulane University in the Department of Pediatrics Infectious Diseases and Department of Pathology. At Tulane, he was the Director of Pediatric Closed at the Care Charity Hospital of New Orleans and Director of The Clinical Microbiology Laboratory Tulane Medical Center. He served for two years in the Navy with a rank of Lieutenant Commander and was Chief of Pediatrics at the U.S. Naval Regional Medical Center, Guam, M.I. He was a Research Fellow in Pediatric Infectious Diseases at The University of Texas, Southwestern Medical School under Drs. John Nelson and George McCracken. He did his residency in Pediatrics at Milwaukee Children's Hospital. He received his M.D. from The George Washington University, Medical School.
Sherwood L. Gorbach, M.D.
Dr. Sherwood Gorbach holds professorships in the Departments of Public Health, Medicine and Molecular Biology and Microbiology at Tufts Medical School. He is also a Professor in the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy. He has conducted studies of enteric infections and nutrition in India and Latin America. Based on extensive investigations on the intestinal microflora, Dr. Gorbach began studies of anaerobic bacteria in surgical and gynecological infections in 1969. He introduced clindamycin as an anti-anaerobe drug and showed that it was efficacious in treating intra-abdominal infections. He and his colleagues conducted the first randomized, clinical trial of anaerobic infections by studying clindamycin-aminoglycoside versus cephalothin-aminoglycoside in penetrating abdominal trauma. In collaboration with Ron Nichols and Robert Condon, the neomycin-erythromycin bowel prep was devised and tested in patients. He participated in the VA Hospital multicenter trials that established this regimen as a safe and effective bowel prep for elective colon operations, lowering postoperative wound infections from 39% to 8%. He participated in many antibiotic drug trials including those involving clindamycin, cefoxitin, cefotetan, amikacin, vancomycin, bacitracin, imipenem, and ciprofloxacin. He and his colleagues at Tufts reported in 1978 that Clostridium difficile was the cause of pseudomembranous colitis and then described the cytotoxin assay which is still used for diagnosis. Dr. Gorbach researched lactic acid bacteria and fermented milk products. Along with Dr. Barry Goldin, he undertook a discovery program for improved probiotic strains. As a result of this effort, Lactobacillus GG (LGG) was discovered in 1985. Research on the beneficial properties of LGG continues to this day. This probiotic is now marketed in 40 countries as a dairy product or in a tablet form. Dr. Gorbach has been continuously funded as a principal investigator by the National Institutes of Health for research in gastrointestinal infections and nutrition. He was awarded a MERIT Award in 1986 for studies of diet and breast cancer. Currently he is principal investigator on a Center grant for studying nutrition and metabolic issues in drug abusers with HIV in four cities in the USA and in India, Vietnam and Argentina. Dr. Gorbach has published over 550 papers and has authored nineteen books and he serves as editor of Clinical Infectious Disease. He earned his M.D. from Tufts University School of Medicine. After an internship and residency in internal medicine at Cornell-Bellevue Medical Center, he returned to the New England Medical Center for a fellowship in infectious disease. He received additional postgraduate training in parasitology and entomology at the London School of Hygiene and Tropical Medicine and in gastroenterology at the Hammersmith Royal Postgraduate Medical School in London.
David Krause, M.D.
Following a decade in the practice of internal medicine, Dr. Krause spent 12 years at SmithKline Beecham in vaccine development in the U.S., leading several worldwide clinical development groups. Upon the merger of SmithKline and Glaxo, he assumed new responsibilities, including North America Health Outcomes and Policy Development. Upon joining Vicuron in 2002 and prior to Vicuron's acquisition by Pfizer Pharmaceuticals, he assumed responsibilities for clinical development and NDA submissions including an antibiotic directed at infections caused by S. aureus, including methicillin-resistant variants. He attended Temple University School of Medicine and trained in internal medicine at the Medical College of Pennsylvania and Temple University Hospital. Dr. Krause is the author of numerous scientific publications and abstracts and is a Fellow of the American College of Physicians.
Ronald N. Jones, M.D.
Dr. Ronald Jones is an Adjunct Professor of Medicine at Tufts University School of Medicine in Boston, Massachusetts and is President/CEO of JMI Laboratories. He is a fellow in the American Society of Clinical Pathologists, the College of American Pathologists, the American Academy of Microbiology, the Infectious Disease Society of America and numerous other organizations. He has served on or chaired numerous committees or subcommittees of the Clinical and Laboratory Standards Institute (formerly the National Committee for Clinical Laboratory Standards) over the last 25 years (recipient of the Eilers Award in 2001, the highest award given by the CLSI), and is also a member of the advisory council for antimicrobial agents of the U.S. Pharmacopeia. Dr. Jones has authored over 1,300 peer-reviewed publications on a variety of topics relating to the comprehensive evaluation of new antimicrobial agents, antimicrobial susceptibility test development, and resistance mechanisms and their phenotypic expression or molecular epidemiology. He has also authored a number of book chapters, hundreds of abstracts, pamphlets, and monographs, sits on the editorial board of several international peer-reviewed journals, and is currently the Editor-in-Chief of Diagnostic Microbiology and Infectious Disease, a well known international publication. He has been the principal global investigator for the SENTRY Antimicrobial Surveillance Program and the MYSTIC Programme, as well as a regional monitor for other resistance surveillance networks (ZAPS, ZAAPS, SMART, LEADER, SPAR, SCOPE etc). Dr. Jones obtained his medical degree from the University of Oregon, where he also served an internship and residency in Anatomic and Clinical Pathology. He is board certified in anatomic and clinical pathology by the American Board of Pathology.
Ronald Nardi, Ph.D.
Dr. Ronald Nardi is currently the Chief Scientific Officer and Vice President of R&D at BioValve Technologies, a drug-device combination specialty pharma company. Prior to joining Biovalve, he was the CSO and Executive Vice President of Global R&D at Ferring Pharmaceutical A/S, an international biopharmaceutical company based in Denmark. He was the head of R&D at Ferring Pharmaceutical Inc., Ferring's US subsidiary, before assuming the Global R&D position. Dr. Nardi has been involved in drug discovery and development for 30 years. He joined the industry in the Department of Clinical R&D at Wyeth Laboratories. He joined Glaxo, Inc. working in Clinical R&D and Clinical Pharmacology and led a drug discovery laboratory working on GI therapies and the brain-gut axis. He worked at Parke-Davis in drug discovery and clinical drug development. Dr. Nardi received his Ph.D. in Pharmacology/Toxicology from Rutgers University and has worked across the drug discovery/development disciplines from target validation and molecule characterization to clinical pharmacology, regulatory approvals and the medical-marketing interface.
André G. Pernet, Ph.D., M.B.A.
Dr. André Pernet is currently President of Quark Biotech, a company devoted to the treatment of diabetes, lipid disorders and associated pathologies. He serves on the Board of Directors of Kaleidos Pharmaceuticals, Inc. and ViroChem, representing its major Quebec investors, FSTQ (both companies privately held). He also is on the Scientific Advisory Board of Targanta, a private Canadian firm. Dr. Penet was on the Boards of Celeris Corporation, Synsorb, Advanced Pharma and Genescape and on the Scientific Board of Pathogenesis. He served as Chairman & CEO of Genset, a European genomic company which was successfully sold to Serono. He previously worked for Abbott Laboratories as a research chemist after obtaining degrees in Management, Chemical Engineering and a Ph.D. in Chemistry. He served in several research management positions after joining Abbott's pharmaceutical products division. He was named divisional vice president of anti-infective research and development in the same division and was then promoted to divisional vice president to head the worldwide development of pharmaceuticals. Dr. Pernet was elected corporate officer and Vice President, Pharmaceutical Products Research and Development, heading an organization of 2,700 scientists with an annual budget responsibility of $600 million. During his tenure, he developed drugs in the areas of schizophrenia, manic depression, analgesia, epilepsy, prostate hypertrophy, anti-infective and stroke. Among his accomplishments is the worldwide development of the antibiotic Biaxin (clarithromycin), the sales of which peaked at $1.2 billion. He spearheaded the AIDS research at Abbott and developed Norvir, one of the three breakthrough protease inhibitors which together reduced mortality in AIDS patients by 74%, and he initiated the discovery and development of Kaletra, now a major therapeutic tool in HIV treatment. Dr. Pernet's team was awarded the Prix Galien International, which is considered one of the highest distinctions for medical and scientific contribution.
Peter S. Ringrose, Ph.D.
Dr. Peter Ringrose was appointed as Chair of the U.K. Government's Biotechnology and Biological Sciences Research Council (BBSRC) in 2003. He was Chief Scientific Officer of Bristol-Myers Squibb and President of the Pharmaceutical Research Institute. At BMS he was responsible for the development of aripiprazole (Abilify), cetuximab (Erbitux), atazanavir (Reyataz), gatifloxacin (Tequin), Entecavir, abatacept, ixabepilone and muraglitazar. Dr. Ringrose was Senior Vice President for Worldwide Drug Discovery and Medicinal R&D Europe with Pfizer. During his time at Pfizer, Dr. Ringrose was responsible for teams involved in the discovery and development of amlodipine (Norvasc), fluconazole (Diflucan), doxazosin (Cardura), sildenafil (Viagra), dofetilide (Tikosyn), darifenacin (Enablex), elitriptan (Relpax), voriconazole (Vfend). He was Division Director of Chemotherapy, Infectious Diseases and Molecular Sciences at the Sandoz Research Institute and held scientific positions with Hoffman La Roche. Dr. Ringrose has served on numerous scientific and educational advisory committees, including the Policy Advisory Board of the Centre for Medicines Research International, the Science and Regulatory Executive for PhRMA (Pharmaceutical Research and Manufacturers of America), the U.S. Council on Competitiveness, past-Chairman of the Hever Group of Pharmaceutical R&D Heads, the editorial board of Expert Opinion on Investigational Drugs, the Center for Advanced Biotechnology and Medicine New Jersey and the Association of British Pharmaceutical Industries (ABPI) Scientific Committee. He was a past Board member of Pfizer and of ImClone Systems Inc., and chaired the Europa Bio Congress session on new cancer therapies in Vienna 2003. He currently serves on the Board of Cambridge Antibody Technology as a non-executive director and is Chairman of CAT's Scientific Advisory Board and Remuneration Committee. He is also a non-executive director on the Boards of Astex Technology, Cambridge and Rigel Pharmaceuticals. He is a member of the SAB of Accenture Life Sciences and of Merlin Biosciences. Dr. Ringrose also serves on the Board of Governors of the New York Academy of Sciences, is a William Pitt Fellow of Pembroke College, Cambridge and Chair of the College Corporate Development Committee, is a member of the University of Cambridge Chemistry Advisory Board and was appointed to the Chancellor's Court of Benefactors at the University of Oxford in 1998. He is a Council Member of the Foundation for Science and Technology U.K. Dr. Ringrose gained his Master's degree and Ph.D. from the University of Cambridge (Corpus Christi College) in Biochemistry and Molecular Microbiology and was awarded the Francis Bacon scholarship.
James V. Heck, Ph.D.
Dr. James Heck joined Merck Research Laboratories in 1976, where he rose through the ranks to Vice President, Medicinal Chemistry. For eight years he guided a research team of approximately 250 scientists, who were responsible for moving more than 15 candidates into development. Among these was Cancidas, a systemic antifungal agent that was approved by the FDA in 2001. He retired from Merck at the end of 2006, and currently maintains a consulting practice with 13 clients. Dr. Heck received his Ph.D. in Organic Chemistry from Harvard University in 1976 after working four years in the laboratories of Professor R.B. Woodward.
Yoshi Ichikawa, Ph.D.
Dr. Yoshi Ichikawa most recently served as the Senior Director for Chemisty at Optimer Pharmaceuticals where he oversaw all chemistry-related programs, including the discovery of macrolides and aminoglycosides through Optimer's proprietary glyco-optimization technology, arthritis, and cancer vaccine. He has over 19 years of experience in both chemical/enzymatic synthesis and biology of small molecules to complex carbohydrates. He was a Professor at Johns Hopkins University School of Medicine, where he worked on inhibitor design for key enzymes, including glycosyltransferases and DNA repair enzymes.
Keshav Deo, Ph.D.
Dr. Keshav Deo currently serves as vice president of the Chemical Research Division of Wockhardt Research Center,Aurangabad, India. Dr. Deo has held positions within the research and development divisions of various Indian pharmaceutical companies. He began his career with Lupin, followed by Tata Pharma, Sun Pharma, Dai-Ichi Laboratories, Ranbaxy and Alembic Limited. Dr. Deo is a member of several national and international chemical research societies and scientific advisory boards. He is recognized as a supervisor for the Ph.D. degree programs of several Indian universities. Globally, he has filed more than 120 patent applications. Prior to beginning his professional career with Lupin, Dr. Deo earned his Ph.D. from Central Drug Research Institute in Lucknow, India, in 1989, under the direction of Dr. D.S. Bhakuni. He earned his Master’s degree from Agra University, Agra in 1985. His research interests include chemo and region selective reductions, asymmetric catalysis and insightful process development of significant active pharmaceutical ingredients.