SYN-004 Phase 3 Steering Committee

Milton Packer, M.D. (Chairman)

Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center

Milton Packer, MD, is an internationally recognized clinical investigator who has made many seminal contributions to the field of heart failure, both in understanding its mechanisms and defining its rational management.

Dr. Packer is widely recognized for his outstanding leadership abilities, having led the Division of Circulatory Physiology at Columbia University for 12 years, which he built into the nation’s most outstanding research group devoted to heart failure. He has been the principal investigator of more than 15 large international multicenter trials.

Dr. Packer has served frequently as a member of government advisory committees, study sections, task forces or Data and Safety Monitoring Boards for the NIH. He served as a member of the Cardiac and Renal Drugs Advisory Committee to the US Food and Drug Administration from 1986-1992 and then as its Chair from 1997-2001, and he continues to serve on various FDA advisory committees.

Dr. Packer was President of the Heart Failure Society of America from 2000-2002 and has served on numerous guidelines and standards committees for the American Heart Association and American College of Cardiology.

Dr. Packer spent most of his career in New York City, where he was the Dickinson Richards Professor and Chief of the Division of Circulatory Physiology at Columbia University. From 2004 until 2015, he was Professor and Chair of the Department of Clinical Sciences at the University of Texas Southwestern Medical Center at Dallas where he held the Gayle and Paul Stoffel Distinguished Chair in Cardiology.

Dr. Packer is currently the Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center, part of Baylor Scott & White Health.

Aparna Anderson, Ph.D.

Vice President and Chief Operating Officer - Statistics Collaborative, Inc.

Aparna Anderson, Ph.D., joined Statistics Collaborative, Inc. (SCI) in 2016 as Vice President and Chief Operating Officer.  Prior to joining SCI, she worked at Bristol-Myers Squibb Company (BMS) from 1997 to 2016 and was an Assistant Professor in the Division of Biostatistics at the University of Minnesota from 1995 to 1997.

For more than twenty years, Dr. Anderson has brought statistical and scientific perspectives to pipeline strategy, including proof-of-concept transition product development, due diligence for in-licensing and acquisitions, go/no-go decision-making, and phase 3 trial design.

During her tenure at BMS, Dr. Anderson provided statistical leadership for the clinical development of ipilimumab and nivolumab, two pioneering therapies in the field of immuno-oncology. For these contributions, BMS recognized Dr. Anderson in 2016 with the James B. D. Palmer Award for Excellence in Drug Development.

Dr. Anderson has contributed to clinical development in numerous therapeutic areas in addition to oncology, including rare diseases, neuroscience, pediatric indications, metabolic diseases, infectious diseases, and cardiovascular diseases.  She has developed statistical analysis plans and data set submission plans for study-level and integrated analyses, and she has contributed to clinical components of Common Technical Documents.

Dr. Anderson received a B.S. in Applied Mathematics from the University of California, Davis (1989) and her M.S. and Ph.D. in Biostatistics from the University of Washington (1995). In 1989-1990, she spent a year studying mathematics as a Fulbright scholar at the University of Göttingen, Federal Republic of Germany.

David M. Aronoff, M.D., FIDSA, FAAM

Professor and Addison B Scoville, Jr Chair in Medicine/Director, Division of Infectious Diseases – Vanderbilt University School of Medicine

David Aronoff, MD is Professor and Addison B Scoville, Jr Chair in Medicine and Director of the Division of Infectious Diseases at the Vanderbilt University School of Medicine. He is a Fellow in the Infectious Diseases Society of America and a Fellow in the American Academy of Microbiology. He received his Bachelor of Science degree in Microbiology from Indiana University and his Medical Degree from Tufts University in Boston. He completed internship and residency training in Internal Medicine at Vanderbilt University. Dr. Aronoff stayed at Vanderbilt to complete a clinical fellowship in Infectious Diseases and a research fellowship in Clinical Pharmacology. He then joined the faculty in Infectious Diseases at the University of Michigan where he also completed a research postdoctoral fellowship in Immunology. Dr. Aronoff remained at the University of Michigan until 2013, rising to the rank of Associate Professor with tenure in the Departments of Internal Medicine and Microbiology & Immunology. He returned to Vanderbilt in October, 2013.

The Aronoff Lab studies serious bacterial infections, particularly those involving the reproductive tract and gastrointestinal system (Clostridium difficile). Dr. Aronoff has received numerous governmental and non-governmental research grants. He has published more than 170 peer-reviewed manuscripts, and several book chapters and invited commentaries.

Thomas Garvey, Ph.D.

Founder - Garvey Associates, Inc.

Since founding Garvey Associates, Inc. (GAI) in 1981, Dr. Garvey has been designing, conducting and analyzing clinical trials and programs of clinical trials for drugs, biologics, and medical devices. His work has also involved composing the clinical sections of many new drug applications (NDAs), writing and modifying drug labels and providing consultative assistance to sponsors directed at solving many of the other problems associated with developing, obtaining approval for and marketing drugs and biologics. All of these activities have involved frequent interactions with FDA’s reviewing divisions

Prior to founding GAI, he served as Supervisory Medical Officer in FDA's Division of Cardiovascular and Renal Drug Products (HFD-110) for five years while participating in basic research in the Digestive Diseases Branch of the National Institute of Diabetes, Digestive and Kidney Diseases at the National Institutes of Health.  He carried out basic research as a fellow in the Laboratory of Biochemistry in the Cancer Institute between 1969 and 1972 and completed his formal medical training in Internal Medicine at Georgetown in 1972-3 and in Gastroenterology at Massachusetts General Hospital from 1973-76. Until December, 2010, he also maintained a small practice of Internal Medicine and Gastroenterology.

Kevin W. Garey, PharmD, MS, FASHP

Professor and Chair of the Department of Pharmacy Practice and Translational Research – University of Houston College of Pharmacy

Kevin Garey, PharmD, MS, FASHP is a Professor at the University of Houston College of Pharmacy and Chair of the Department of Pharmacy Practice and Translational Research.  He is an Adjunct Professor at the University of Texas School of Public Health and a Clinical Specialist and Researcher at Baylor St. Luke’s Medical Center, Houston, Texas.  He received a Bachelor of Science in Pharmacy degree from Dalhousie University in Halifax, Nova Scotia, Canada, a Doctor of Pharmacy from SUNY Buffalo in Buffalo, NY, and a Masters of Science in Biometry from the University of Texas School of Public Health.

Dr. Garey is a member of the Infectious Diseases Society of American (IDSA) Standards and Practice Guidelines Committee and is a member of the IDSA-Society of Healthcare Epidemiology of America (SHEA) practice guidelines for C. difficile infection.  He is an active member of the Society of Infectious Diseases Pharmacists (SIDP) and the American Society of Health-system Pharmacists (ASHP). National awards include ASHP Best Practice Award in Health-system Pharmacy Administration (2010), the ASHP Drug Therapy Research Award (2007), and the SIDP Impact Paper in Infectious Diseases Pharmacotherapy Research Award (2007, 2012).  He received the University of Houston PLS leadership award in 2013.

Dr. Garey's research, supported by the National Institute of Health, the Centers for Disease Control and Prevention, and the pharmaceutical industry involves clinical and translational research in healthcare associated infections including post-surgical infections, candidemia, and Clostridium difficile infection.  He directs an anaerobic microbiology research laboratory that provides epidemic surveillance monitoring for C. difficile outbreaks supported by the Texas Department of State Health Services.

Stuart Johnson, M.D, FIDSA, DTM&H

Professor of Medicine – Loyola University Medical Center
Infectious Disease Clinician and Researcher - Hines VA Hospital

Dr. Johnson is an Infectious Disease Clinician and Researcher at the Hines VA Hospital and a Professor of Medicine at Loyola University Stritch School of Medicine at Loyola University Medical Center in Maywood, Illinois. Dr. Johnson received his MD degree from the University of Minnesota Medical School and completed his internal medicine residency and infectious disease fellowship training at the University of Minnesota Hospital and the Minneapolis VA Medical Center. He received a Diploma in Tropical Medicine and Hygiene at Mahidol University in Bangkok, Thailand and a Career Development Ward from the Department of Veterans Affairs. He is the past President of the Anaerobe Society of the Americas.

His main research interest and focus has involved the epidemiology, pathogenesis, and treatment of Clostridium difficile infection. He is actively studying variant strains of C. difficile and the role of the various toxins in the pathogenesis of C. difficile disease. His clinical experience in the treatment of patients with recurrent CDI has translated into studies helping to define optimal management of these infections. He is currently the Principal Investigator of a multi-center study with the VA Healthcare system designed to define optimal management of early recurrences of CDI. He is also a co-chair of the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) CDI Guidelines Committee.

Dr. Brandon Bookstaver, Pharm.D., FCCP, FIDSA, BCPS, AAHIVP

Associate Professor and Director of Residency & Fellowship Training - University of South Carolina College of Pharmacy

Dr. Brandon Bookstaver, Pharm.D., is an associate professor and vice chair in the Department of Clinical Pharmacy and Outcomes Sciences at the College of Pharmacy. He also maintains a practice site in infectious diseases at Palmetto Health Richland. He received his doctor of pharmacy degree from the University of South Carolina College of Pharmacy in 2004. He completed a pharmacy practice residency (2004-2005) and an infectious diseases specialty residency (2005-2006) at Wake Forest University Baptist Medical Center. Dr. Bookstaver is a board-certified pharmacotherapy specialist with added qualifications in infectious diseases and an HIV expert through the American Academy of HIV Medicine. His research areas include antimicrobial lock therapy, Clostridium difficile infections, antimicrobial dosing in obesity, HIV adherence and pharmacy trainee scholarship.

Bookstaver has received numerous teaching and research awards, including most recently the 2011 American College of Clinical Pharmacy New Educator award, University of South Carolina Clinical Teaching Award (2012) and the South Carolina Pharmacist of the Year for 2011-2012. He has served on a number of regional and national groups including the Southeastern Pharmacy Residency Conference executive committee (chairman, 2011-2012), the South Carolina Society of Health-System Pharmacists (president, 2013) and the ACCP Infectious Diseases PRN (chairman-elect, 2013). He has published more than 35 peer-reviewed publications in a number of high impact pharmacy and medical journals and recently released the well-respected text Roadmap to Postgraduate Training, a blueprint for students and preceptors on preparing for residency and fellowship training.

Dr. Eric Dubberke, M.D., MSPH:

Associate Professor of Medicine, Director, Section of Transplant Infectious Diseases - Washington University School of Medicine

Dr. Dubberke is a Professor of Medicine at Washington University School of Medicine in St. Louis, where he has been a faculty member in the Division of Infectious Diseases since 2005. He is an Associate Hospital Epidemiologist at Barnes-Jewish Hospital, Medical Director of Infection Control at Missouri Baptist Medical Center, and is the Clinical Director of the Transplant Infectious Diseases service at Washington University. He attended medical school at University of Illinois at Chicago, and did his medicine and infectious diseases training at Barnes-Jewish Hospital/Washington University.  He received a Master’s of Science in Public Health from St. Louis University.

His main research interests are in the epidemiology, diagnosis, treatment, and prevention of Clostridium difficile infection (CDI). Dr. Dubberke has over 130 publications, and made the Thomson Reuters / Clarivate Analytics list of Highly Cited Researchers from 2015 to the present. He was the lead author for the CDI component of the Society for Healthcare Epidemiology of America (SHEA) Compendium to Prevent Healthcare Associated Infections, and was on the IDSA/IDSA CDI clinical guidelines update committee. He has also represented SHEA as a Key Informant for the AHRQ Evidence-based Practice Center C. difficile review and at the Department of Health and Human Services Road Map to Eliminate HAI 2013 Action Plan Conference.

Shira Doron, M.D.

Attending Physician; Associate Hospital Epidemiologist and Antimicrobial Steward; Associate Professor, Tufts University School of Medicine

Dr. Shira Doron is the physician head of the Antimicrobial Stewardship Program at Tufts Medical Center in Boston, Massachusetts where she is also the Associate Hospital Epidemiologist. She is an Associate Professor of Medicine at Tufts University School of Medicine. Dr. Doron received her medical training at George Washington University School of Medicine/Health Sciences; University of California-San Diego Medical Center; George Washington University Medical Center and Tufts Medical Center. Dr. Doron works under contract with the Massachusetts Department of Public Health through a grant from the CDC to support antimicrobial stewardship and infection prevention efforts by long term care facilities in the region. Her research focuses on antimicrobial resistance, prudent antibiotic use, probiotics and the microbiome.