Chief Executive Officer, President and Director
Mr. Riley, a member of the Synthetic Biologics Board of Directors since March 2010 and Chairman of the Board from November 2011 to May 2012, was appointed as the Company’s President and Chief Executive Officer in February 2012. He has more than 20 years of experience in the biotechnology and pharmaceutical industries during which he negotiated numerous worldwide strategic corporate alliances, established joint ventures, and assisted in obtaining venture financings to support product development. Most recently, in addition to serving as Synthetic Biologics' Chairman, where Mr. Riley played an integral role in the formation of the Company¹s recent collaboration with Intrexon Corporation, he served as Managing Director of 526 Ventures, a life science-focused venture consulting firm with a commercial and traditional focus. Prior to this, he was a venture partner with QIC Bioventures Fund, the life science-focused venture component of the $70 billion Australian-based Queensland Investment Corporation (QIC). Over his career, Mr. Riley held senior positions within the mergers & acquisitions and in country management groups at both SmithKline Beecham and Pfizer. Additionally, he served as CFO and VP Corporate Development for Nichols Institute Diagnostics, later acquired by Corning and spun out to Quest Diagnostics, Inc. (NYSE: DGX). Mr. Riley holds a Bachelor of Science degree from Boise State University, completed coursework at UCSF/Berkeley in drug discovery/development and participated in a dual-degree graduate program (MBA/MIM) sponsored by Arizona State University and the Thunderbird School of Global Management.
Chief Financial Officer, Treasurer and Secretary
Steven Shallcross joined Synthetic Biologics in June 2015 as Chief Financial Officer, Treasurer and Secretary. Mr. Shallcross brings to Synthetic Biologics operational, financial and international biotech industry experience, as well as an established track record at leading the financial development and strategy for several publicly traded biotech companies. He served for four years as the Chief Financial Officer and Treasurer of Vanda Pharmaceuticals, Inc., leading the company through its successful IPO and follow-on offering. He most recently served as Executive Vice President and Chief Financial Officer of Nuo Therapeutics, Inc. and previously served as the Senior Vice President and Chief Financial Officer of Middlebrook Pharmaceuticals, Inc. (formerly Advancis Pharmaceutical Corporation). Mr. Shallcross also served as Executive Vice President and Chief Financial Officer of Innocoll AG (formerly privately held Innocoll Holdings, Inc.), a global, commercial-stage biopharmaceutical company specializing in the development and commercialization of collagen based products. In addition to his substantial biotech industry experience, Mr. Shallcross also held key leadership positions with a number of other companies, including serving as the Chief Financial Officer of Empire Petroleum Partners, LLC and Bering Truck Corporation, and Acting Chief Financial Officer for Senseonics. He holds an MBA from the University of Chicago’s Booth School of Business, a Bachelor of Science degree in Accounting from the University of Illinois, Chicago, and is a Certified Public Accountant in the State of Illinois.
Joseph Sliman, MD, MPH
Chief Medical Officer
From January 13,
Michael Kaleko, MD, PhD
Senior Vice President, Research & Development
Dr. Kaleko, Senior Vice President, Research & Development, joined Synthetic Biologics in March 2012 as the Scientific Director. He brings over 20 years of experience in the biotechnology/pharmaceutical sector, including eleven years at Genetic Therapy, Inc., a Novartis company, where he developed multiple gene transfer and gene expression platform technologies for hemophilia, cancer, diabetes and ocular diseases. In 2002, he co-founded Advanced Vision Therapies, Inc. to develop treatments for eye diseases, including an anti-inflammatory biological for multiple ocular indications. After selling the company in 2005, he continued as Chief Scientific Officer until 2010. Dr. Kaleko has published 62 peer-reviewed articles, filed over 30 patent applications and received the Novartis Pharma Research and Development Business Excellence Award for his work in the diabetes field. Dr. Kaleko earned ScB, MD and PhD degrees from Brown University, served his medical residency in internal medicine at Vanderbilt University and completed a fellowship in clinical endocrinology with a focus in gene therapy research at the University of Washington, Seattle.
Raymond D. Stapleton, Jr., PhD
Senior Vice President, Manufacturing
Raymond D. Stapleton, Jr., PhD, joined Synthetic Biologics in October 2015 as Senior Vice President, Manufacturing. Dr. Stapleton is a pharmaceutical and biotechnology executive with over 15 years of experience at Merck & Co., Inc., in manufacturing, operations, quality, science, technology, engineering and process development. He most recently served as Executive Director, Global Vaccine Technology and Engineering. During his tenure at Merck, Dr. Stapleton contributed to the scale up, tech transfer and manufacturing product launch of multiple billion dollar franchises including ISENTRESS® (oral solid dosage for AIDs), GARDASIL® (HPV vaccine), KEYTRUDA® (anti-PD-1 cancer mAb therapy), and performed process development for the cholesterol lowering therapy MEVACOR® (lovastatin). Dr. Stapleton earned a PhD in microbial ecology from The Center for Environmental Biotechnology at The University of Tennessee, Knoxville, and a BS degree in biology from Mary Washington College. Subsequently, he was the recipient of an Alexander Hollaender Fellowship for post-doctoral studies in the Environmental Science Division at Oak Ridge National Laboratory. Dr. Stapleton has served for 10 years as a member of the Journal of Industrial Microbiology and Biotechnology review board and is an ad hoc reviewer for several journals including Environmental Science and Technology, Antonie von Leeuwenhook, and Enzyme and Microbial Technology. He has co-edited a book, and co-authored patents, as well as several peer-reviewed manuscripts and presentations.
Christopher T. da Costa, MD, PhD, MBA, FACP
Vice President, Clinical Development
Christopher da Costa, MD, PhD, MBA, FACP joined Synthetic Biologics in January 2017 as Vice President, Clinical Development. Dr. da Costa brings to Synthetic Biologics experience in clinical development, medical affairs, drug safety, and regulatory affairs gained in several large pharmaceutical and smaller biotechnology companies. He has over 15 years’ academic and industry experience in multiple therapeutic areas, primarily in vaccines and infectious diseases, but also including critical care, organ transplantation, hematology, and neuroscience. Most recently, he served as Global Medical Director, Clinical Development and Medical Affairs, working with Asahi Kasei Pharma America on Thrombomodulin as a novel therapy for sepsis and for early allograft dysfunction in liver transplantation. Additionally, he previously served as Director of Clinical Development (tuberculosis vaccines) with Aeras, Senior Medical Director (Infectious Diseases) with Pfizer, Compound Development Team Leader with Janssen Alzheimer Immunotherapy, Director of Clinical Development (MMR and Varicella vaccines) with GlaxoSmithKline, and Associate Director of Regulatory Affairs (vaccines) with Merck. He also has over 20 years’ clinical practice experience in hospital medicine, infectious diseases, wound care, and hyperbaric medicine. He is a Fellow of the American College of Physicians and Member of the Infectious Diseases Society of America. Dr. da Costa gained his undergraduate and medical degrees at The University of Zambia, Masters and PhD degrees at the London School of Hygiene & Tropical Medicine (UK), and Physicians’ Executive MBA at Auburn University’s Raymond J. Harbert College of Business.
Klaus Gottlieb, MD, FACG
Vice President, Clinical & Regulatory Affairs
Klaus Gottlieb, MD, FACG, joined Synthetic Biologics in June 2015 as Vice President, Clinical & Regulatory Affairs. Dr. Gottlieb is an experienced board-certified internist and gastroenterologist with a strong clinical science, business and drug development background. He has led cross-functional teams in a variety of settings in industry, academia, private practice and with the FDA. He joins Synthetic Biologics after serving as Senior Medical Director-Therapeutic Strategy Lead Gastroenterology of Quintiles, a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services. At Quintiles, Dr. Gottlieb served as Global Medical Advisor for three separate large Phase 3 inflammatory bowel disease (IBD) trials and provided significant input on the shaping, design and evaluation of numerous IBD and other gastrointestinal (GI) clinical trials throughout all stages of development programs. Prior to joining Quintiles in 2013, he was with the FDA in Silver Spring, MD as a Senior Clinical Reviewer for the Division of Gastroenterology and Inborn Errors Products. Previously, he spent 11 years at Sacred Heart Medical Center, a 500-bed full service hospital in Spokane, WA. Dr. Gottlieb graduated from medical school in 1987 and received a Dr. med. degree from the University of Bonn, Germany, for experimental research conducted in Medical Microbiology, a Masters of Business Administration degree from Indiana University in 2000 and a Masters of Science in Biotechnology from Johns Hopkins University in 2012. Widely published, his academic contributions have been recognized by an appointment as Professor of Medicine (Clinical) at George Washington University and the following elected fellowships: Fellow American College of Physicians, Fellow American College of Gastroenterology, Fellow American Society of Gastrointestinal Endoscopy.
Deb Mathews, PharmD
Vice President, Medical Affairs
Deb Mathews, PharmD, joined Synthetic Biologics in May 2016 as Vice President, Medical Affairs. In this newly created position, she will be responsible for all medical affairs-related activities, with a focus on supporting late-stage clinical development for the Company's two lead GI microbiome-focused drug candidates. Dr. Mathews is a pharmaceutical and biotechnology executive with over 20 years of clinical and medical affairs experience with specialized therapeutic focus in both infectious disease and oncology. Most recently she served as Executive Medical Science Lead at Bayer Healthcare Pharmaceuticals, Inc. Prior to this, Dr. Mathews served in various strategic medical affairs leadership roles at Novartis, AstraZeneca, Tibotec Therapeutics and GlaxoSmithKline, Inc. Dr. Mathews received a Doctorate of Pharmacy degree from Florida A&M University. Her credentials also include HIV specialist certification from the American Academy of HIV Medicine and membership with the American Society of Microbiology.