Bernard D. King, MD, MBA

Chief Executive Officer

Dr. Bernard King has more than 25 years’ experience managing business and development operations in the pharmaceutical, medical device, biotechnology and CRO industries. In particular, he has directed, or been directly involved in, development programs for more than 100 pharmaceutical, medical device and biologics products. The products have addressed clinical targets in a broad range of therapeutic areas and the development programs have included more than 300 separate clinical trials in North America, Europe, Eastern Europe, Australia, New Zealand, South Africa and Asia. He has been President of Macnas Consulting International, Inc., for the past 15 years. During this period, Dr. King has provided strategic product development planning and execution services for pharmaceutical, biotechnology and medical device companies and due diligence consulting for venture capital, investment, and pharmaceutical firms. He has also served in several operational roles on behalf of clients including, President and CEO, Head of Development, VP Clinical Affairs, and VP Regulatory Affairs. Prior to starting Macnas, Dr. King was president and CEO of Predict, Inc. (bioinformatics), VP and General Manager for San Diego Operations for PAREXEL & Head of PAREXEL’s Emerging Growth Opportunities Group; EVP for Biological Sciences and Medical Affairs at Trega Biosciences; President of Segenix, a spinout of Advanced Tissue Sciences, where Dr. King had previously headed Research and Development; VP Worldwide Medical and Regulatory Affairs for ConvaTec, a BristolMyers Squibb subsidiary; and, Director of Clinical Investigation at SmithKline. Dr. King graduated cum laude from the University of Notre Dame, majoring in English and Pre-professional Studies, and received his MD from the Ohio State University College of Medicine. Following completion of residency training in Medicine and Pathology at Ohio State and his Cardiology fellowship training at the Mt. Sinai Medical Center in New York, he was an Assistant Professor in Medicine (Cardiology) and Physiology at New York Medical College. He is board certified in Cardiology and Internal Medicine. He received his MBA from the Wharton School of the University of Pennsylvania. Dr. King has authored a book on development entitled, Get It Right The First Time! Pharmaceutical Product Development: Intelligent Solutions for Challenging Issues.

Jay Birnbaum, PhD

Exec. Vice President, Global Product Development

Dr. Jay Birnbaum is a dermatology consultant specializing in ethical and OTC drugs, devices, and cosmeceuticals. His 30+ years of industry experience span the areas of discovery research, formulation, clinical R&D, regulatory and marketing. He has been involved in the development and commercialization of numerous products, including Lamisil antifungal products (the world’s largest selling dermatology brand), Apligraf (the first bioengineered, living skin equivalent), and Skin Caviar (the centerpiece of the upscale LaPrairie Skin Care brand). Dr. Birnbaum was a co-founder and CMO of Kythera Biopharmaceuticals, a company developing products in aesthetic dermatology. Kythera (whose lead product is now in Ph3) recently completed a successful IPO(NASDAQ:KYTH). Prior to starting his own consulting company in 1999, Dr. Birnbaum was VP, Global Project Management at Novartis/Sandoz, and held management positions in the Medical and Consumer Product Divisions of American Cyanamid Company (Wyeth). Dr. Birnbaum has served as a member of the Board of Directors of Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) and Excaliard Pharmaceuticals (acquired by Pfizer in 2011), as well as the SABs of multiple companies. He received a B.S. degree from Trinity College and a Ph.D. in Pharmacology from the Univ. of Wisconsin.

David Bullough, PhD

Head, Nonclinical Development

Dr. David Bullough is a nonclinical consultant with over 25 years of pharmaceutical R & D experience specializing in the development of small molecules and emerging new therapeutic modalities in multiple therapeutic areas. He was most recently the Vice President of Preclinical Development at RaNA developing new approaches to treating rare genetic CNS disorders and an Executive Director at Pfizer in Cambridge, MA where he led multiple global therapeutic teams advancing metabolic disease candidates from discovery into early development. Dr. Bullough was formerly the Vice President of Preclinical Development at Metabasis in La Jolla, CA, where he was responsible for Nonclinical Safety, DMPK, Bioanalytical, and Pharmaceutical Development, and for leading teams developing novel drugs targeting the liver and liver pathways for the treatment of metabolic, antiviral, and oncology diseases. Prior to joining Metabasis, Dr. Bullough was with Gensia, where he managed Cardiovascular Pharmacology and led a number of major discovery and development projects. Dr. Bullough was a research faculty member at UCSD in La Jolla, CA and received his Ph.D. in Biochemistry from the University of Cambridge in the UK.

Charlotte Merritt

Head, Regulatory Affairs

Ms. Charlotte Merritt has over 25 years of pharmaceutical industry experience focused on global regulatory strategy development, regulatory agency interface, regulatory business operations and organizational leadership. Her experience spans all phases of drug development and many therapeutic areas. Most recently, Ms. Merritt was an Executive Director of Global Regulatory Affairs at Merck & Co. where she contributed to the global registration of numerous important medical therapies (including Singulair®, Proscar®, Propecia®, and Emend®) and led many strategic and organizational transformation initiatives. Ms. Merritt received her BS in Biology from Albright College and her MBA from Washington University in St. Louis. She is a member of the Drug Information Association.

K. George Mooney, PhD

Exec. Vice President, Pharmaceutical Sciences

Dr. George Mooney has over 30 years prior industrial experience, most recently as VP for the Exploratory Development Portfolio at Pfizer and VP of Pharmaceutical Sciences, Pfizer Europe. Other former companies include at GD Searle, Boehringer Ingelheim (USA) and American Cyanamid Co. Dr. Mooney has been associated with more than 30+ NDAs and over 80 IND filings. He qualified as a Pharmacist in the UK (B.Pharm, MSc University of London) and gained his PhD at University of Kansas in Pharmaceutical Sciences. He is a William Pitt Fellow at Pembroke College Cambridge UK, a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain.

Leslie J. Schulze, CPA, CGMA

Chief Financial Officer

Leslie J. Schulze has over 15 years of accounting and finance experience, primarily as a senior biotech executive in start-up pharmaceutical R&D companies. Ms. Schulze has broad responsibilities for financial planning, accounting, treasury, human resources, and operations. Ms. Schulze has successfully built multiple streamlined operations’ teams from the ground up and she has effectively improved policies and procedures for finance, accounting, and operations to ensure accurate and timely budgeting, forecasting, financial reporting, and effective lines of communication amongst management teams. Ms. Schulze has also played a key role in venture capital (VC) financings, non-dilutive funding (including government contracts and grants), corporation collaborations, mergers and acquisitions, asset acquisitions/sales, and the development of corporate infrastructure. Ms. Schulze formed Cornerstone Business Solutions, Inc. in 2014 to provide CFO-level finance, accounting, and operations consulting services to start-up biotech companies. During this period, Ms. Schulze worked with a CEO in 2015 to re-acquire a drug, into a newly formed entity, that was previously sold to Axcan Holdings, Inc. (now Allergan) 5 years earlier and sold the now launched drug (Quinsair) to Raptor Pharmaceuticals Corp. (now Horizon Pharma) within the same year. Prior to Cornerstone, Ms. Schulze was co-founder and Vice President Finance and Administration at Rempex Pharmaceuticals, Inc., which was acquired by The Medicines Company in 2014. Prior to helping found Rempex in 2011, Ms. Schulze served as Controller and Director of Finance at Mpex Pharmaceuticals, Inc., which was acquired by Axcan Holdings, Inc. (now Allergan) in 2011. Prior to Mpex, Ms. Schulze was an Audit Manager at CBIZ Mayer Hoffman McCann, where she specialized in auditing small to mid-sized companies. Ms. Schulze received her bachelor’s degree in Accountancy from the University of San Diego and is a Certified Public Accountant and Chartered Global Management Accountant.

Howard Welgus, MD

Chief Medical Officer

Dr. Howard Welgus is a board-certified dermatologist. Most recently Dr. Welgus was the VP R&D and CMO for Nycomed U.S. (Fougera / PharmaDerm). From 1999 to 2009, Dr. Welgus served as VP R&D for both the Dermatology and Inflammation Therapeutic Areas of Warner Lambert and then Pfizer. In this capacity, he led a team of almost 200 R&D colleagues, moving ten dermatology compounds and nine arthritis compounds into clinical development and shepherded them through key proof of concept trials. Dr. Welgus received his medical, scientific and dermatology training at Washington University School of Medicine, and had served as Professor and Chief of Dermatology at both Barnes-Jewish Hospital and the Washington University School of Medicine. Dr. Welgus has published over 120 original scientific articles.