Moise Khayrallah, PhD, CEO & Co-Founder
Stephen E. Butts, MBA, President, COO & Co-Founder
Mr. Butts has nearly 20 years of experience in the healthcare industry. Prior to co-founding Aerial, he was Co-Founder and Executive Vice President of Commercial Operations at Neuronex, Inc., a drug development company focused on treatments for seizure disorders. Mr. Butts was one of the original executives of Addrenex Pharmaceuticals, a specialty pharma start-up in Durham, NC. Mr. Butts played a key role in the company’s exit to Shionogi Pharma in November 2009. Additionally, he had assignments at BioBehavioral Diagnostics Company, Eli Lilly and Company, Glaxo Welcome, and Braintree Laboratories; where he held leadership positions in marketing and brand management, sales, new product planning and business development. Mr. Butts holds a BS in Business Administration and an MBA from the Kenan-Flagler Business School at UNC-Chapel Hill.
Gary Bream, PhD, Executive Vice President, Drug Development & Co-Founder
Dr. Bream has over 20 years experience in various research and development positions within the pharmaceutical industry. He brings over a decade of regulatory affairs and clinical research experience having most recently served as Vice President of Scientific Affairs for Addrenex Pharmaceuticals. At Addrenex he managed the clinical and regulatory strategy for the company’s portfolio of products in development. He was previously Senior Director of Regulatory Affairs and Strategic Drug Development Services at SRA, International (formerly Lineberry Research Associates). In this role, Dr. Bream was involved in all operational aspects of clinical research and regulatory affairs from pre-IND through NDA and Phase IV. Prior to SRA, he served in the Bioprocess Research and Development Group at Merck Research Laboratories in West Point, PA where he was involved in the development of the Varicella and Hepatitis A vaccines.
Dr. Bream has also held a postdoctoral position at Burroughs-Wellcome in Research Triangle Park, NC where he researched Human Papillomaviruses. He holds a doctorate in molecular biology from the University of California at Berkeley and a bachelor of science degree in microbiology from Pennsylvania State University.
Meg Powell, PharmD, Vice President, Corporate Development
Dr. Powell has over 12 years of experience in the pharmaceutical industry including assignments at Eli Lilly and GlaxoSmithKline. Prior to joining Aerial, Dr. Powell was the Vice President of the US Transformation Office for GlaxoSmithKline where she was responsible for leading the major strategic change program for GSK North America that resulted in a new commercial model. In addition to this role, Dr. Powell has held various positions in sales and marketing for US and Global development programs at all stages – from Phase 1 to post patent expiry. Dr. Powell received her Doctorate of Pharmacy degree from the University of North Carolina- Chapel Hill where she was a Hollingsworth Scholar. She also received a Masters of Business Administration from Stanford University.
Kenneth S. Freeman, PhD, Senior Director, Chemistry and Manufacturing
Dr. Freeman joined Neuronex and Aerial in April 2011 after 12 years of working in a broad range of positions within the pharmaceutical industry. He has worked with products in all phases of development from discovery to Phase IV, with experience in research and development, CMC and regulatory. Most recently he was in the Molecular Discovery Research organization of GlaxoSmithKline working with early stage drugs. Prior to GSK, Dr. Freeman was with Pfizer as a Research Scientist leading a team working on several of the first protein development projects within the Pharmaceutical Sciences division at Pfizer Global R&D. While at Pfizer, he also worked on small molecule formulation and analytical method development, where he authored the CMC sections of several IND submissions. He was a major CMC contributor to the successful world-wide filing of Caduet oral tablets (Lipitor/Norvasc combination therapy), and also managed the data collection and reporting for the approved regulatory filings of Exubera (inhaled insulin) and Zmax SR (azithromycin). In addition to his experience developing both small and large molecule pharmaceutical products, Dr. Freeman has worked on a variety of formulation types, including solid orals, topicals, transdermals, parenterals, suspensions, and metered dose inhalers.
Dr. Freeman earned his PhD in Analytical Chemistry at Duke University, where his research was focused on protein characterization and enzyme catalysis in water-in-oil microemulsions. He earned his BS degree in Chemistry from the University of North Carolina – Wilmington.
David Ward, MD, Medical Director
Dr. Ward has a 24-year, broad experience managing large clinical and preclinical teams in all stages of drug development at small and large pharma companies. He brings to Neuronex a wealth of strategic knowledge in drug development and regulatory filings in several therapeutic areas, including cardiovascular, GI, CNS, and metabolic/hormonal. From 1985 to 1991, he served in several executive R&D positions with SmithKline & French and later SmithKline Beecham where he lead clinical development programs for Coreg® and Tagamet®. In 1992, he joined Sphinx Pharmaceuticals as VP of Clinical Development and Regulatory Affairs and in 1995 he joined Incara Pharmaceuticals where he led the R&D efforts in several therapeutic areas. Most recently, Dr. Ward was Senior VP at TransTech Pharma where he built the company’s in-house expertise in CMC, toxicology, regulatory affairs, and clinical development. Most recently, he was the Medical Director for Addrenex Pharmaceuticals responsible for the clinical development and safety monitoring of the company’s product portfolio.
Dr. Ward received his medical degree from Case Western Reserve University Medical School and became Board-certified in Internal Medicine after completing residencies at Baltimore City Hospital, Johns Hopkins University Hospitals, and University of North Carolina Memorial Hospitals.
Karen Adams, CFO
Karen Adams has a 30 year career as a finance professional working with companies across a broad range of industries with the last 15 years focused on life sciences and technology. After starting her career as an Internal Auditor with International Paper Company, Inc., Ms. Adams has held financial leadership positions with companies in the retail, software, professional services and biotechnology industries.
Most recently, Ms. Adams was the CFO for Addrenex Pharmaceuticals during the company’s successful acquisition by Shionogi Pharma. While Ms. Adams’ life sciences experience has been primarily focused on early-stage, privately funded companies she was brought on as Assistant Controller at Millennium Pharmaceuticals, Inc. during its merger with COR Therapeutics – among the largest such mergers in the history of the biotech industry at that time. After Millennium Pharmaceuticals, Ms. Adams went on to work with several early stage biotechnology ventures including Surface Logix, Inc., Compound Therapeutics, Inc., Galenea Corporation, BG Medicine, Inc., and Micell Technologies, Inc. Ms. Adams’ contribution was concentrated on the creation of dynamic, integrated financial forecasting models as well as the implementation of core business structure. Ms. Adams graduated from Boston College earning a BS in Management, majoring in Finance.
Paul Ketteridge, RPh, Regulatory Advisor
Mr. Ketteridge has over 25 years experience in the medical/pharmaceutical regulatory field. He has served in senior management positions with the National Institutes of Health and the U.S. Food and Drug Administration. As a Consumer Safety Officer with the FDA, Mr. Ketteridge’s responsibilities included review of IND and NDA submissions for compliance with scientific, legal and administrative requirements. Assignments included anti-retroviral drug products and drugs for the treatment of opportunistic infections in AIDS patients. Most recently Mr. Ketteridge was the Regulatory Advisor for Addrenex Pharmaceuticals. While working with Addrenex, the company received an NDA approval and successfully filed an sNDA with the FDA. Mr. Ketteridge also served as Vice President of Quality and Regulatory Affairs with Cytran, Inc. Prior to that position, he served as a pharmaceutical and device regulatory consultant specializing in aiding early stage development companies with writing and reviewing INDs, NDAs, and PMAs, and designing clinical protocols for FDA/IRB or foreign equivalents submission. Mr. Ketteridge also served as Regulatory Affairs Officer at a Seattle-based biopharmaceutical firm, where he was responsible for U.S. and international regulatory submissions.