Ms. Usher has over 23 years of experience in regulatory affairs and pharmaceutical drug development having served in senior leadership roles both in industry and contract research organizations. Ms. Usher has authored and/or managed more than 75 regulatory submissions including clinical trial applications, marketing applications and associated regulatory authority meeting packages. Her experience covers multiple therapeutic areas including metabolic/endocrine, oncology, gastroenterology, antimicrobials and analgesia.
Additionally, Ms. Usher has extensive experience in CMC development including cGMP auditing. Currently she provides general regulatory and compliance consulting to pharmaceutical companies in various stages of development. In her last role in the biotech industry, Ms. Usher led the regulatory strategy and submission activities including liaising with regulatory authorities worldwide resulting in the approval of the company’s lead compound. Prior to her role in biotech, she was head of North America/Latin America Regulatory Affairs and Medical Writing department for a large CRO.
Ms. Usher received her BS Chemistry degree from North Carolina State University and completed her Regulatory Affairs Certification in 1994
Vincent H. Tam, Pharm.D., BCPS (Infectious Diseases)
Vincent H. Tam received a B.S. from the National University of Singapore, Singapore and his Pharm.D. from Albany College of Pharmacy in Albany, New York. He completed an infectious diseases pharmacy residency at Detroit Receiving Hospital in Detroit, Michigan and a clinical pharmacology / infectious diseases fellowship at Albany Medical College. He is currently a full Professor (tenured) at the University of Houston College of Pharmacy in Houston, Texas. He is board certified in pharmacotherapy with added qualifications in infectious diseases.
Dr. Tam is the (co-) author of over 140 peer-reviewed publications in antimicrobial pharmacokinetics / pharmacodynamics and infectious disease therapeutics. He is on the Editorial Boards of Antimicrobial Agents and Chemotherapy, and Journal of Global Antimicrobial Resistance. He has also served as a grant proposal reviewer for the National Institutes Health (NIH) and an ad hoc reviewer for more than 20 journals such as the Clinical Infectious Diseases, International Journal of Infectious Diseases, Journal of Antimicrobial Chemotherapy, Journal of Clinical Pharmacology, and Lancet Infectious Diseases.
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.
Dean L. Shinabarger, Ph.D.
Dr. Shinabarger is CEO and owner of Micromyx, a microbiology services company located in Kalamazoo, Michigan. He received a B.S. in Biology in 1982 from Emporia State University and a Ph.D. in Microbiology from Louisiana State University in 1986. As a postdoctoral fellow in the laboratory of Dr. Leo Parks at North Carolina State University, Dr. Shinabarger studied sterol synthesis in yeast. In addition, he completed a second fellowship at the University of Illinois College of Medicine in Chicago under Dr. Chakrabarty, investigating Pseudomonas aeruginosa pathogenesis as related to cystic fibrosis patients’ lung infections. Dr. Shinabarger’s industrial career began in 1992 at Proctor & Gamble Pharmaceuticals in their anti-infective discovery program.
After 2 years, he moved to Upjohn Pharmaceuticals to join the discovery and development team working on the oxazolidinone class of antibacterial agents. Dr. Shinabarger played a major role in elucidating the mechanism of action/resistance to linezolid and represented Pharmacia during the FDA review and eventual approval of Zyvox in 2000. After Pfizer acquired Pharmacia in 2003, Dean exited the company and co-founded Micromyx, a microbiology services company that specializes in preclinical R&D for biotech, pharma, and animal health companies that are actively engaged in antibacterial and antifungal research.
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.
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.
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.
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.
Prof. Zemer Gitai
Zemer Gitai is a Professor of Molecular Biology at Princeton University. He graduated with a bachelor’s degree from MIT in 1996. After completing his graduate studies at UCSF in 2002, Dr. Gitai became a postdoc in the lab of Dr. Lucy Shapiro at Stanford University where he pioneered the study of the MreB actin-like cytoskeleton in Caulobacter crescentus. Dr. Gitai joined the faculty of Princeton University as an Assistant Professor of Molecular Biology in 2005. He was promoted to Associate Professor with tenure in 2012, to Professor in 2015, and named the Edwin Grant Conklin Endowed Chair in Biology in 2016. He is currently the Director of Graduate Studies for the Department of Molecular Biology.
Dr. Gitai’s research focuses on the cell biology of bacteria. His lab studies how cells self-organize across spatial scales, using quantitative, molecular, and engineering approaches to understand to understand problems such as cell shape formation, cytoskeletal function, metabolic organization, and community structure. His work discovered new components of the bacterial cytoskeleton, new functions for bacterial polymers in metabolism, compartmentalization, and chromosome dynamics, and established the importance of protein assembly for unexpected processes like metabolism and pathogenesis. Most recently, Dr. Gitai’s lab has revealed the importance of mechanical factors like flow and surface association in shaping bacterial behaviors like host-pathogen interactions. Dr. Gitai’s achievements have been recognized by many prestigious awards, including the NIH Director’s Pioneer Award, the NIH New Innovator Award, the Beckman Young Investigator Award, and the HFSP Young Investigator Award.
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.
Timothy D. Costello, Ph.D.
Dr. Costello has more than 30 years in the Chemical and Pharmaceutical industry, primarily in the area of Process R&D. He has experience spanning all facets of scale-up chemistry, from discovery and prototyping through taking routes for pharmaceutical active ingredients into commercial production. In addition, he has experience in managing drug product formulation, production, and packaging for all clinical phases. Dr. Costello has held a variety of positions, most recently as Senior Director for all CMC activities at Furiex Pharmaceuticals. Furiex Pharmaceuticals recently received approval of an NDA, filed by Furiex, shortly after acquisition by Allergan, Inc.
Dr. Costello received a B.S. from Duke University in North Carolina and earned his Ph.D. from University of Pittsburgh.
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.
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.
Keith A. Bostian, PhD.
Dr. Keith Bostian is an entrepreneur scientist with a distinguished career in industry and academia. He has held executive operating roles leading R&D, project management, licensing, legal, intellectual property and marketing functions, and has held advisory roles at the seed, pre-seed, and investment stage for numerous others, securing over $280 million in financing from corporate partners and investors.
Dr. Bostian is founder of a number of biotechnology companies, including Microcide, Iconix, Mpex, Vanta Bioscience and Prokaryotics, financed by leading venture capital firms, all with successful exit strategies, covering a broad cross-section of technologies, including: (i) pharmaceuticals (antimicrobials, inflammatory disease, cardiovascular disease and oncology), (ii) genomics and database technology (chemogenomics, toxicogenomics, transcriptional profiling, computational science), and (iii) life-science services (agriculture, food science, chemical manufacturing, medical device, vaccine and biologics). As Head of Microbiology and Molecular Genetics at Merck, he was responsible for the discovery and development of new anti-microbial agents, as well as for the discovery of new leads from natural products for all of Merck’s worldwide drug discovery programs.
Dr. Bostian is an inventor on numerous patents in drug discovery and genomics, and has led efforts resulting in numerous clinical candidates including a first-in-class anti-fungal antibiotic caspofungin, (marketed as CANCIDAS®), which was taken into development under his leadership at Merck, an aerosol fluoroquinolone (Aeroquin®, Quinsair (EU), developed at Mpex for cystic fibrosis MDR infections, recently approved in Europe and Canada, and pending in the US, and a proprietary probiotic, Anaban™, approved in European markets.
Dr. Bostian is a fellow of the American Academy for Microbiology, and was a member of the faculty at Brown University, and an American Cancer Society Postdoctoral Fellow. Dr. Bostian is currently Dean of the NJ Center for Science, Technology & Mathematics and Technology Transfer at Kean University, and founder and CEO of the Institute for Life Science Entrepreneurship (ILSE), a non-profit innovation accelerator established to advance early stage academic-industry translational science in the NJ/NYC area.
Alan G.E. Wilson, PhD, Fellow ATS, FRSC
Alan G. E. Wilson, PhD, ATS, FRSC is currently Vice President of Drug Metabolism, Pharmacokinetics, and Toxicology and Pathology at Lexicon Pharmaceuticals, the Woodlands, Texas. He is internationally recognized in drug metabolism and pharmacokinetics and has over 30 years of experience working on product discovery and development for both small molecules and bio-therapeutics. His expertise is in the translation of early discovery data into the clinic with extensive experience in the conduct of pharmacokinetics in Phase 1-3 clinical studies and PK, PK/PD and population PK modeling. He has significant hands-on experience with the regulatory and GLP requirements for the conduct of ADME, PK and safety assessment studies to support regulatory submissions and clinical studies. He has contributed to, and led, successful IND, NDA and MAA submissions.
Prior to joining Lexicon, Dr. Wilson held senior management and leadership positions with major international pharmaceutical and life science companies (chemical, agricultural chemicals, pharmaceutical) including Monsanto, Searle, Pharmacia and Pfizer. He has been involved with the registration of a number of successful marketed products with experience in a number of therapeutic areas including cardiovascular, endocrinology (particularly diabetes), ophthalmology, arthritis, pain, NASH, and has extensive experience working with global regulatory agencies.
Dr. Wilson has Board of Director and Scientific Advisory experience with several companies. He is Board Certified in Toxicology and has over 130 publications, including editorship of several books. He has been an invited speaker and presenter at numerous domestic and international conferences. Dr. Wilson received his Ph.D. in Drug Metabolism/PK from the University of Surrey, U.K. and his B.Sc. in Biochemistry from the University of Surrey, U.K.