Cardinal Health Regulatory Sciences
Cardinal Health Regulatory Sciences (CHRS) is a fully integrated pharmaceutical consulting firm that provides regulatory, chemistry manufacturing and controls (CMC), nonclinical, clinical, medical writing, compliance (GMP, GLP, and GCP audits), state licensing, and regulatory publishing services and has been in business over 40 years. CHRS’ scientists have decades of experience with pharmaceutical and biotechnology products and medical devices. CHRS has an experienced team with expertise in the preparation, publishing, and submission of regulatory documents and applications to FDA (INDs, NDAs, BLAs, IDEs, 510Ks, PMAs, and DMFs) in electronic common technical document (eCTD) format. CHRS internal team will work as an extension of TAXIS’ development team, providing support and technical assistance in preparation and oversight of strategic development plans in the area of CMC, nonclinical, and clinical development as well as provide oversight and management of contract research organizations (CROs) in these same areas.
Rebecca Lamb-Wharton, PhD, Principle Scientist, Regulatory Affairs and Product Development, will provide regulatory and clinical consulting to TAXIS for the antibiotic product development program. Rebecca has over 16 years of experience in the pharmaceutical industry as a regulatory and clinical scientist involved in product development, management of IND and NDA submissions and post-approval maintenance activities, product labeling, serving as FDA regulatory contact on behalf of sponsors, and participating in FDA meetings. She will be the project lead at CHRS of the internal team of consultants, scientist, medical writers, document specialist, and publishers that will support TAXIS in product development and FDA submissions. She will work directly with TAXIS’ management team to aid in product development, FDA interactions, and IND preparation and submission to meet program deliverables and assess milestones for the development program.
Kristene Castle, Principle Scientist, Regulatory Affairs and Product Development, will provide scientific and nonclinical consulting expertise to TAXIS for the antibiotic product development program. Kristene leads nonclinical development programs from discovery to approval. She provides nonclinical development and regulatory strategy support and authors CTD regulatory submissions for pharmaceutical development programs. She provides nonclinical study oversight and management of nonclinical CROs. Kristene has more than 25 years of experience in the pharmaceutical industry as a regulatory toxicology professional or nonclinical scientist in research and development.
Andy Trammel, PhD, Principle Scientist, Chemistry Manufacturing and Controls, will provide scientific and CMC consulting expertise to TAXIS for the antibiotic product development program. Andy has been a formulation scientist with development experience in a variety of dosage forms and managing contract manufacturing organizations. In his current position he also has written and reviewed a number of FDA regulatory submissions for INDs through NDAs and post-approval supplements focused on CMC related topics. Combined, Andy has over 27 years of pharmaceutical development experience.
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.
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.
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.
Marshall Morningstar, Ph. D.
Marshall Morningstar is a pharmaceutical veteran with 20 years of experience managing small-molecule discovery teams in small biotechnology and large pharmaceutical companies. He is currently consulting for Sage Therapeutics (Neuroscience), Nimbus Therapeutics (Oncology), and Flatley Discovery Labs (Cystic Fibrosis). He was previously Director of Medicinal Chemistry at the Broad Institute directing a portfolio of neglected disease efforts. Before joining Broad, he was the Head of Chemistry for collaborative discovery efforts for GVK BIO, directing multiple programs in metabolic disorders, pain, and oncology research. Prior to GVK Bio, he spent over 11 years in the AstraZeneca infection group.
Marshall received a bachelor’s degree in chemistry from the University of California, Berkeley and a doctorate in synthetic organic chemistry from MIT.
Daryl Patrick, DVM, Ph.D., Diplomat, ACVP
Specialist in Nonclinical Development for over 30 years, starting with Merck where Dr. Patrick ultimately served as Vice President/Head, Worldwide Safety Assessment, responsible for all nonclinical aspects of potential drug development candidates. Also served on Research and Development Management teams responsible for strategic R&D planning and oversight of drug development programs through approval. He then served as Vice President, Nonclinical Development at Vertex Pharmaceuticals, leading the establishment of disciplines in Toxicology and ADME to support early development efforts, then served on Management oversight committees and was promoted to Vice President, Exploratory Development responsible for all nonclinical development activities and Clinical Pharmacology. For the past several years since retiring from Vertex Pharmaceuticals, Dr. Patrick has engaged in private consulting for biotechnology and life sciences companies focused on novel therapeutic targets, serving on Scientific Advisory Boards providing guidance on nonclinical development activities and engagement with regulatory agencies around the world.
Dr. Patrick earned his D.V.M. in Veterinary Medicine from Michigan State University and his Ph.D. in Veterinary Pathology from Iowa State University.
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.
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.
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.
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.
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.