Scientific Advisors

Paul Ambrose, Pharm. D, FIDSA

Dr. Ambrose is recognized for his work in areas of scientific inquiry involving anti-infective translational science, with the goal of improving patient care through the application of pharmacokinetic-pharmacodynamic (PK-PD) principles. ICPD has successfully utilized this approach for support of regulatory decision-making and as support for Clinical and Laboratory Standards Institute susceptibility breakpoint determinations. He is the President of the Institute for Clinical Pharmacodynamics (ICPD) and has authored over 115 peer-reviewed scientific publications and approximately 200 scientific abstracts. Dr. Ambrose has served as an Editor of four textbooks; most notably the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice as the Editor of Antimicrobial Agents and Chemotherapy. He served as President of the International Society for Antimicrobial Pharmacology and currently serves as Chair of the United States Committee on Antimicrobial Susceptibility Testing (USCAST).

Dr. Ambrose is a member of the working group on ‘Skin and Skin Structure Infection-Community-Acquired Pneumonia’ for The Biomarkers Consortium at the National Institutes of Health, Bethesda, Maryland, USA and is a member of the ‘ReAct: Action on Antibiotic Resistance’ Working Group in Uppsala, Sweden.

He earned his doctorate in Pharmacy from the University of the Pacific, School of Health Sciences and a completed post-doctoral fellowship at Hartford Hospital in Hartford Connecticut.

Prof. David R. Andes, M.D.

Dr. Andes is a Professor in the Departments of Medicine and Medical Microbiology and Immunology at the University of Wisconsin and serves as both Head of the Division of Infectious Disease and Director of the Infectious Disease Fellowship Program. Dr. Andes is Board certified in infectious disease. His research focuses on identifying strategies to combat antimicrobial (especially antifungal) drug resistance. He has published his research in more than 230 papers, editorials, chapters and reviews, and 250 abstracts presented at national or international scientific meetings. His publications have been cited by other researchers more than 9,000 times (h-index 54) since the late 1990s providing much of the scientific underpinning of antifungal drug choice and dosing, definitions of clinical resistance, and the mechanisms of resistance and management of fungal biofilm infections.

Dr. Andes received a B.A. in Biology from St. Louis University. He earned his M.D. from University of Missouri, Columbia.

Helen W. Boucher M.D., FACP FIDSA

Dr. Boucher specializes in the care of immunocompromised patients, transplant-related infections, and S. aureus/MRSA infections. Her research focuses on antibiotic development, advocating for increased development of medicines to treat antibiotic-resistant diseases. She is director of the Infectious Diseases Fellowship Program and staff physician in the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center and Associate Professor of Medicine at Tufts University School of Medicine. Dr. Boucher is a member of the Board of Directors for the Infectious Diseases Society of America and the American Board of Internal Medicine Subspecialty Board on Infectious Disease. She has authored or coauthored numerous abstracts, chapters and peer-reviewed articles, which have been published in The New England Journal of Medicine, Antimicrobial Agents and Chemotherapy, Clinical Infectious Diseases, and Drugs. Dr. Boucher is a member of several professional organizations, including the Infectious Diseases Society of America, the American Society for Microbiology, and the American Medical Association. She has been included in Best Doctors in America since 2009, and she was selected Fellow and Member of the Board of Directors of the Infectious Diseases Society of America. Dr. Boucher was appointed Associate Editor of Antimicrobial Agents and Chemotherapy to the Infectious Diseases Recruitment Task Force of the Infectious Diseases Society of America, and the ICAAC Program Committee.

Dr. Boucher received her M.D. from University of Texas Medical School at Houston; Beth Israel Deaconess Medical Center.

Henry F. Chambers, M.D.

Dr. Chambers has been a member of the medical faculty at the University of California San Francisco (UCSF) for more than 30 years, where he is a professor of medicine and served as Chief of Infectious Diseases at San Francisco General Hospital from 1992-2013 and Director of the UCSF Infectious Diseases Fellowship Training Program from 2002-2013. He is a Fellow of the Infectious Diseases Society of America (IDSA) and of the American College of Physicians. He was also elected to the American Society of Clinical Investigation and the American Association of Physicians. He serves as editor for the Stanford Guide to Antimicrobial Therapy and has authored more than 200 original publications and textbook chapters in the areas of drug resistance, endocarditis, bacterial infections and staphylococcal diseases. He served as a member of advisory groups for the Centers for Diseases Control and Prevention, a member of the IDSA treatment guidelines committee for skin and soft tissue infections, and co-chaired the IDSA guidelines committee for treatment of methicillin-resistant Staphylococcus aureus infections. His clinical and research interests include antimicrobial drug resistance, staphylococcal infections, experimental therapeutics, and epidemiology and pathogenesis of disease caused by community methicillin-resistant Staphylococcus aureus.

Dr. Chambers received his B.A. from Centre College in Kentucky and earned his M.D. in Medicine from the Vanderbilt University School of Medicine, where he was class valedictorian. He completed training in Internal Medicine and Infectious Diseases at the University of California San Francisco.

Chris M. Cimarusti, Ph.D.

Dr. Cimarusti has broad experience in pharmaceutical discovery, development and manufacturing. He served as Vice President of Process R&D at the Pharmaceutical Research Institute and as SVP of Pharmaceutical Development. Dr. Cimarusti held executive leadership positions at Squibb Corporation and Bristol-Myers Squibb (BMS) in discovery and development, where he co-led the antibiotic effort and served as Director of Organic Chemistry for the Squibb Institute for Medical Research. He published more than 40 papers, and was inventor or co-inventor on more than 60 patents in the areas of cardiovascular, steroid, and b-lactam research, including both compound and process patents.

Dr. Cimarusti earned a Ph.D. in Organic Chemistry from Purdue University and completed Postdoctoral Research at Columbia University.

Shayne C. Gad, Ph.D.

Dr. Gad has more than 37 years of experience as a toxicologist, statistical consultant and manager on research and development in the biotechnology, medical device, pharmaceutical, chemical, consumer product and contract testing industries. He is recognized for his comprehensive understanding of toxicology, for which he provides expert witness testimony in cases regarding worker’s compensation, pharmaceuticals, medical devices, and occupational toxicology. He founded and has served as Principal for Gad Consulting Services for 23 years, where he has provided consulting support regarding design, conduct and evaluation of regulatory safety assessment and biocompatibility evaluation for drugs and devices for submission to FDA and equivalent regulatory agencies world-wide. Dr. Gad is primarily focused on providing preclinical, clinical, regulatory, and statistical study support programs for more than 400 clients in more than 29 different countries. Dr. Gad has authored or edited 47 books, including the Handbook of Product Safety Evaluation and the Drug Discovery Handbook. He also has published more than 100 articles in journals such as the Journal of Toxicology and Environmental Health and Journal of Fire Sciences.

Dr. Gad received a B.S. in Chemistry and Biology from Whittier College. He earned a Ph.D. in Pharmacology and Toxicology from University of Texas at Austin.

Prof. David C. Hooper, M.D.

Dr. Hooper’s expertise is rooted in the molecular mechanisms of bacterial resistance to antimicrobial agents with a focus on quinolone resistance in Staphylococcus aureus and Escherichia coli. He previously served as President of the American Society for Microbiology, where he is currently the Meetings Board Chair. He is board certified in Internal Medicine and Infectious Disease, and Chief of the Infection Control Unit and Associate Chief and Fellowship Program Director of Division of Infectious Diseases at Massachusetts General Hospital.

Dr. Hooper received his B.A. in Microbiology from University of Texas at Austin. He earned his M.D. in Medicine from Washington University, and an Honorary M.A. from Harvard University.

James B. Kahn, M.D.

Dr. Kahn is a Board-certified Infectious Diseases specialist and the founder and principal of JBK Strategic Consultations, LLC, where he provides Infectious Disease expertise to the Pharmaceutical Industry. He has nearly two decades of experience as an expert in policy modeling in health care, cost-effectiveness analysis, and evidence-based medicine. Dr. Kahn practiced independent medicine for almost 20 years prior to joining Johnson and Johnson, where he was responsible for the development of ofloxacin and levofloxacin at their Ortho-McNeil affiliate for more than 16 years. Dr. Kahn has authored and co-authored almost 140 peer-reviewed scientific papers and presentations. He remains an active member of national and international Infectious Diseases societies, including ASM,IDSA, ISID, and ESCMID. Dr. Kahn served two years as an EIS Officer at CDC and then did his I.D. fellowship under Mort Swartz at the MGH.

Dr. Kahn earned a B.A. from Harvard University. He earned his M.D. from Harvard Medical School.

Gail McIntyre, Ph.D.

Dr. McIntyre has more than 23 years of experience in the drug discovery and development industry at both biotechnology and pharmaceutical companies. She authored more than 30 regulatory submissions and is a board certified toxicologist with extensive experience in moving compounds through lead optimization and clinical development onto the market. Dr. McIntyre is also board certified in Clinical Pathology (hematology and clinical chemistry) by the American Society of Clinical Pathology. She served as head of Pharmaceutical Product Development LLC’s compound partnering business for 12 years before securing the position of Senior Vice President of Research at Furiex Pharmaceuticals, Inc., where she served from April 1, 2010 until December 2015.

Dr. McIntyre received her B.A. in Biology from Merrimack College. She earned M.S. and Ph.D. degrees in Biochemistry and Biophysics from the University of North Carolina at Chapel Hill.

Louis Donald Saravolatz, M.D., MACP

Dr. Saravolatz is recognized for his research in infectious disease, specifically in the areas of new drug therapies and rapid diagnostic microbiologic tests. He is currently Professor of Medicine and Chairman of the Department of Internal Medicine at St. John Hospital & Medical Center. The hospital is affiliated with Wayne State University School of Medicine, where he also serves as Director of Department of Medicine Molecular Biology Laboratory. Prior to his current role, he directed the infectious disease training program at Henry Ford Hospital for 14 years. Dr. Saravolatz has authored more than 400 articles, text book chapters, invited reviews and scientific presentations and serves as a member for over 16 professional societies, including The American College of Physicians, Infectious Disease Society of America and The American College of Epidemiology and the Royal Society of Medicine (London). He has received numerous honors and awards for his teaching ability and clinical expertise in infectious diseases and was made a Master of the American College of Physicians. In 2005, Dr. Saravolatz was awarded the academic achievement in medical management from the American College of Physicians Executive.

Dr. Saravolatz received his B.S from University of Michigan and earned his M.D from University of Michigan Medical School.

Lynn Silver, Ph.D.

Dr. Silver’s expertise spans more than 30 years in the antibacterial discovery area. Her experience includes 21 years at Merck Research Laboratories where she conducted research and supervised groups involved in discovery efforts for new antibacterials in natural products and chemical collections, support of chemical synthetic projects on improved antibacterials, pre-clinical evaluation of antibacterial drug candidates and the study of antibacterial resistance. Dr. Silver has experience with many biotech start-ups, small and large pharmaceutical companies and venture capitalists in a variety of projects involving antibacterial discovery. Throughout her career, she authored significant research papers and reviews in the field of bacterial genetics, physiology, and biochemistry, as well as discovery and analysis of antibacterial agents. She is a member of ASM, the Editorial Board of Antimicrobial Agents and Chemotherapy, ASM Branch Lecturer, and is a member of several biotechnology company Scientific Advisory Boards.

Dr. Silver earned a doctorate at Tufts University in Molecular Biology and Microbiology and did her postdoctoral work on bacterial DNA replication at the Université de Genève, and on DNA replication biochemistry of bacteriophage T4 at the NIH.

Prof. Paul K. Wilkinson, Ph.D.

Dr. Wilkinson has a broad range of industry experience that spans more than 27 years. He taught undergraduate and graduate courses in Biopharmaceutics and Pharmacokinetics at Auburn University School of Pharmacy and The University of Connecticut School of Pharmacy. Early in his career, Dr. Wilkinson worked at Merck in Special Drug Delivery and Formulation Development in the Veterinary arena, where he developed the ruminal retentive osmotic bolus for ivermectin (with ALZA Corporation). Prior to TAXIS, he lead the cross functional Chem-Pharm Teams at J & J Pharmaceutical Research and Development, LLC and played a vital role at R.P. Scherer Corporate Research and Development Center and Mediventures, Inc. in Ann Arbor, M., in the development of Quicksolv, an oral disintegrating tablet delivery system. Dr. Wilkinson authored a chapter in Drug Delivery Devices – Fundamentals and Applications titled Special Delivery Devices for Animals. He also authored an additional chapter in Specialized Drug Delivery Systems, which is entitled “Softgels: Manufacturing Considerations”. Dr. Wilkinson is currently the president of Wilkenson Chem-Pharm Solutions, LLC.

Dr. Wilkinson received a B.S. in Pharmacy from The University of Connecticut. He earned his M.S. in Pharmaceutical Chemistry and Ph.D. in Pharmacy (Pharmacokinetics) from The University of Michigan.

Kip Vought

Mr. Vought has more than twenty years of expertise in drug development, including new drugs and generics treating various indications, for the US, European, Canadian, and Australian markets. He currently serves as Vice President of Regulatory and Strategic Development for Clinipace Worldwide, where he prepares comprehensive regulatory assessments, including clinical nonclinical and Chemistry Manufacturing Control (CMC) and drug development plans. Mr. Vought has extensive experience with agency meetings including PIND, EOP1, EOP2 and PNDA, and significant market experience in preparing and submitting clinical trial applications (e.g., INDs/IMPDs), market applications (e.g., NDA/MAA/NDS) and generic market applications.

Mr. Vought earned his B.S in Chemistry from University of Miami, Florida and received his Regulatory Affairs Certification from Regulatory Affairs Professional Society (USA).