Clinical Advisors

SYN-004 (Ribaxamase) Advisors

Professor Mark Wilcox, MD, FRCPath

C. difficile Clinical Advisory Board (Chair)

Professor Mark Wilcox M.D., FRCPath, is a Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology at the Leeds Teaching Hospitals (LTHT), Professor of Medical Microbiology at the University of Leeds at their Institute of Biomedical and Clinical Sciences, as well as the lead on Clostridium difficile for Public Health England in the UK. Dr. Wilcox was formerly the Director of Infection Prevention, Infection Control Doctor and Clinical Director of Pathology at LTHT. He is deputy Chair of the UK Department of Health’s Antimicrobial Resistance and Healthcare Associated Infection Committee and is a member of the HPA’s Program Board on Healthcare Associated Infection & Antimicrobial Resistance. Dr. Wilcox has a track record of translational research, including providing the basis of clinical advice to the NHS. He has been the Principal/UK Investigator for several clinical trials of new anti-infective drugs and has provided clinical advice as part of the FDA/EMA submissions for the approval of several novel antimicrobial agents.

Curtis Donskey, MD

C. difficile Clinical Advisory Board

Dr. Curtis Donskey is Associate Professor of Medicine at Case Western Reserve University School of Medicine, as well as Chairman of the Infection Control Committee at the Louis Stokes Cleveland Veterans’ Affairs Medical Center. Dr. Donskey’s expertise and research focus includes the epidemiology and transmission of C. difficile infections in the elderly and in nursing home populations, as well as the infection control issues of antibiotic use. Dr. Donskey has moderated a number of national conferences on the epidemiology of C. difficile.

Ciarán P. Kelly, MD

C. difficile Clinical Advisory Board

Dr. Ciarán Kelly is Professor of Medicine at Harvard Medical School, as well as Director of Gastroenterology Fellowship Training and Medical Director of the Celiac Center at Beth Israel Deaconess Medical Center in Boston, MA. Dr. Kelly has longstanding clinical and research interests into the causes, diagnosis and treatment of Clostridium difficile infection, and he leads NIH-funded research on C. difficile colitis. Dr. Kelly has authored numerous clinical and basic research book chapters, invited reviews, and more than 100 peer-reviewed publications appearing in such journals as Infection & Immunity, American Journal of Physiology, Gastroenterology, Journal of Biological Chemistry, Journal of Clinical Investigation, The Lancet and New England Journal of Medicine.

Thomas Louie, MD

C. difficile Clinical Advisory Board

Dr. Thomas Louie is Professor of Medicine in the Department of Medicine and Microbiology-Immunology & Infectious Diseases at the University of Calgary in Alberta, Canada. Dr. Louie also serves as Infection Prevention & Control officer at Alberta Health Services and was the Medical Director of the Infection Prevention and Control Program in the Calgary Health Region 1998-2013. He is involved in clinical trials of new antimicrobial agents primarily for the treatment of C. difficile infection. Dr. Louie’s research interests include the ecology of hospital-acquired infections in patients receiving antibiotics and studies on the role of the gut microflora and its replacement by fecal transplantation for the treatment of recurrent C. difficile infection, and possible roles for the prevention of other nosocomial infections.

SYN-010 Advisors

Mark Pimentel, MD, FRCP(C)

IBS-C Clinical Advisory Board (Chair)

Dr. Mark Pimentel is Director of the GI Motility Program and Laboratory at Cedars-Sinai in Los Angeles, California. Dr. Pimentel completed his medical degree at the University of Manitoba and pursued a residency in Internal Medicine at the University of Manitoba Health Sciences Center in Winnipeg, Manitoba, Canada. His medical training includes a fellowship in gastroenterology at the UCLA Affiliated Training Program. Active in research, he has served as a principal investigator or co-investigator for numerous basic science, translational and clinical studies in such areas as IBS, and the relationship between gut flora composition and human disease. His work has been published in the New England Journal of Medicine, Annals of Internal Medicine, American Journal of Physiology, American Journal of Medicine, American Journal of Gastroenterology and Digestive Diseases and Sciences, among others. He has been invited to present his work at meetings, grand rounds and advisory boards in the United States and internationally. He is a diplomate of the American Board of Internal Medicine (Gastroenterology) and a fellow of the Royal College of Physicians and Surgeons of Canada. Dr. Pimentel is also a member of several medical associations including the American Gastroenterological Association, the American College of Gastroenterology, and the American Neurogastroenterology and Motility Society.

William Chey, MD

IBS-C Clinical Advisory Board

Dr. William Chey is a Professor of Medicine, Director of the GI Physiology Laboratory and Co-Director of the Michigan Bowel Control Program at the University of Michigan. Dr. Chey's clinical and research interests include: diagnosis and treatment of irritable bowel syndrome (IBS), constipation, fecal incontinence, gastroesophageal reflux disease (GERD) and "H. pylori" infection. He received his medical degree and training in Internal Medicine from Emory University School of Medicine and went on to complete a fellowship in Gastroenterology at the University of Michigan in Ann Arbor, remaining with the university for his academic career. The author of more than 250 manuscripts, reviews and book chapters, he serves on the editorial boards of several medical journals in the field of Gastroenterology. Dr. Chey is Editor-in-Chief of the American Journal of Gastroenterology and former Editor-in-Chief of Clinical & Translational Gastroenterology.

Gail M. Comer, MD

IBS-C Clinical Advisory Board

Dr. Gail Comer is a board-certified Gastroenterologist and Hepatologist. Dr. Comer has more than 16 years of experience in the pharmaceutical industry, having spent seven years at Abbott Laboratories as a Medical Director and six years in clinical development at Wyeth Research as Senior Medical Director, Senior Director of the BioTherapeutics Research Unit at Pfizer. She also served as the Chief Medical Officer at Synergy Pharmaceuticals before starting her own consulting business. Throughout her career in the pharmaceutical industry, she has focused primarily on gastrointestinal and inflammatory disorders. Dr. Comer was an Associate Professor of Clinical Medicine and Director of Endoscopy at The State University of New York at Stony Brook prior to joining the pharmaceutical industry.

Anthony J. Lembo, MD

IBS-C Clinical Advisory Board

Dr. Anthony Lembo is Associate Professor of Medicine at Harvard Medical School. Dr. Lembo also serves as the Director of the GI Motility Laboratory at the Beth Israel Deaconess Medical Center’s (BIDMC) Division of Gastroenterology in Boston, MA. He earned his undergraduate degree in Mathematics at Amherst College and his M.D. from Tufts Medical School. He subsequently completed his Internal Medicine Internship/Residency as well as Gastroenterology Fellowship at UCLA Medical Center in Los Angeles, CA. Following his fellowship, he joined the faculty at UCLA Medical Center where he was Co-Director of the Functional Bowel Disorders and GI Motility Center. In 1997, he joined the faculty at BIDMC. Dr. Lembo is actively researching the role of placebo in functional bowel disorders such as IBS and chronic constipation.

Philip Schoenfeld, MD, MSEd, MSc

IBS-C Clinical Advisory Board

Dr. Philip Schoenfeld is Professor of Medicine at the University of Michigan School of Medicine, Director of the University’s Gastrointestinal Epidemiology Training Program and staff physician in UM’s Specialized Functional Bowel Disorder Program. Dr. Schoenfeld completed his M.D. and Master’s Degree in Medical Education at the University of Pennsylvania School of Medicine and completed his Master of Science in Clinical Epidemiology at McMaster University School of Medicine. After completing his Internal Medicine residency at Naval Medical Center, Portsmouth, VA, he completed his Gastroenterology fellowship at National Naval Medical Center, Bethesda, MD. He is currently Associate Editor of Gastroenterology, past Associate Editor (Colon) for the American Journal of Gastroenterology, past Chair of the AGA’s Education Committee, past Chair of the AGA’s Clinical Practice Section. His research focuses on novel treatments for irritable bowel syndrome and quality improvement in colonoscopy. He has co-authored the “American College of Gastroenterology (ACG) Evidence-Based Position Statement on Management of Irritable Bowel Syndrome,” “ACG Evidence-Based Position Statement on Management of Chronic Constipation,” “ACG Guideline on Colon Cancer Screening” and “ASGE/ACG Position Statement on Quality Indicators in Colonoscopy.”

Additional Advisors

Lewis Barrett

Commercial Strategy Advisor

Lew Barrett served as Senior Vice President, Commercial Strategy at Synthetic Biologics from August 2013 through April 2015. Former Assistant Vice President, Established Products at Pfizer and Vice President Global Business Manager, Infectious Diseases at Wyeth Pharmaceuticals, Mr. Barrett brings his expertise in the development, commercialization and launch of infectious disease product candidates to the Synthetic Biologics’ team. As the senior marketing executive, he successfully led, co-chaired or served on teams that focused on infectious diseases, oncology, transplantation and hemophilia during his 25-year career at Wyeth (acquired by Pfizer in 2009). He brings to Synthetic Biologics his expertise in U.S. and global strategy, branding, clinical development, medical affairs, supply chain, business development and strategic alliance management. He was instrumental in building the brand and led global commercialization efforts for Wyeth’s in-line IV antibiotic, Zosyn®/Tazocin® (the second IV antibiotic to achieve $1 billion+ in sales), and managed the U.S. launch of Wyeth’s broad-spectrum IV antibiotic, Tygacil®. Prior to joining Synthetic Biologics as Senior Vice President, Commercial Strategy, he served as an advisor to the company since September 2012. Utilizing his depth of experience in the anti-infective, hospital and biopharma fields, Mr. Barrett provides strategic consultation to the global life sciences field with a particular focus on brand strategy, lifecycle strategy, business development and strategic communications through LL Barrett Biopharmaceutical Consulting, LLC.

 Mr. Barrett holds an M.B.A. from Temple University and a B.S. in Biology from Stockton State College.

Charles B. Shoemaker, PhD

Infectious Disease Scientific Advisory Board

Dr. Charles Shoemaker has over 30 years of experience as a scientist in academia, government agencies and the biotechnology industry, and currently serves as Professor of Biomedical Sciences at Tufts University's Cummings School of Veterinary Medicine. Dr. Shoemaker’s laboratory at the Cummings School at Tufts is developing treatments for both the prevention and cure of intoxication from a number of microbial toxins, primarily bioterror threat agents such as Botulinum neurotoxins as well as toxins from Clostridium difficile, E. coli, anthrax and ricin. In addition, he co-leads the Molecular Helminthology Laboratory at Tufts, in which research is directed to the development of therapeutics and vaccines for parasitic worm infections. Prior to joining Tufts, he led the Animal Health Research Unit at the government-owned research company, AgResearch, in New Zealand. Previously he was on the faculty and conducted his research at Harvard University. He began his career as one of the original scientists at the formation of Genetics Institute, Inc., a highly successful biotechnology company in Boston that was later acquired by American Home Products and is now part of Pfizer (Wyeth). Dr. Shoemaker has published over 100 peer-reviewed scientific publications, authored five patents and four pending patents in the biotechnology area, and is currently the principal investigator of multiple sponsored research projects being conducted at Tufts, including more than $1 million per year in NIH funding.

Dr. Shoemaker holds a Ph.D. in Biochemistry from the University of Iowa and was a postdoctoral fellow at the Massachusetts Institute of Technology in the laboratory of Nobel Laureate, Dr. David Baltimore. He holds a B.S. in Biochemistry from the University of New Hampshire.

John Monahan, PhD

Research & Development Advisor

Dr. John Monahan served as Executive Vice President, Research & Development, at Synthetic Biologics from December 2011 until December 2015. Dr. Monahan is an experienced CEO-level executive of biotech companies focused on gene medicine and pharmaceutical companies with biotechnology research departments. He is currently also a board member of a number of private biotech companies. In 1992, he founded and built Avigen, Inc., a biotech company that pioneered and led the development of gene medicines based on AAV vectors, now an industry standard. Over a 12 year period as CEO of Avigen, Dr. Monahan took the company public through its IPO, raised over $235 million and led the company through a number of gene medicine Investigational New Drug (IND) applications. Prior to founding Avigen, Dr. Monahan served as Vice President - Research and Development at Somatix, another pioneering gene medicine company, Prior to that he was Director of Molecular & Cell Biology at Triton Biosciences (since merged with Berlex Laboratories). Prior to that he was Research Group Chief, Department of Molecular Genetics at Hoffmann-LaRoche, Inc. and Adjunct Assistant Professor, Department of Cell Biology at New York University. He earned a PhD in Biochemistry from McMaster University, Hamilton, Canada and a BS degree in Science from University College, Dublin, Ireland. Dr. Monahan has over 50 publications/reviews in the scientific literature and has made hundreds of presentations including public TV interviews, to scientific groups, investors and the public in general over the years.