Chief Executive Officer, Chief Financial Officer, Treasurer and Secretary
Mr. Shallcross was appointed as the Company’s Interim Chief Executive Officer on December 5, 2017 and has served as the Company’s Chief Financial Officer, Treasurer and Secretary since joining the Company in June 2015. Mr. Shallcross brings to the Company 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. From May 2013 through May 2015, Mr. Shallcross served as Executive Vice President and Chief Financial Officer of Nuo Therapeutics, Inc. (formerly Cytomedix, Inc.). In January 2016, Nuo Therapeutics, Inc. filed a voluntary petition for relief under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware and on April 25, 2016, the Bankruptcy Court entered an order granting approval of Nuo’s plan of reorganization. From July 2012 to May 2013, Mr. Shallcross held the offices of Executive Vice President, Chief Financial Officer and Treasurer of Empire Petroleum Partners, LLC, a motor fuel distribution company. From July 2011 to March 2012, Mr. Shallcross was Acting Chief Financial Officer of Senseonics, a privately-held medical device company located in Germantown, MD. From January 2009 to March 2011, he 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. He also 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 and previously served as the Senior Vice President and Chief Financial Officer of Middlebrook Pharmaceuticals, Inc. (formerly Advancis Pharmaceutical Corporation). In addition, Mr. Shallcross also served as the Chief Financial Officer of Bering Truck Corporation. 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.
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.
Deb Mathews, PharmD
Vice President, Medical Affairs
Deb Mathews, PharmD, joined Synthetic Biologics in May 2016 as Vice President, Medical Affairs. In this 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.