Advisory Board

William A. Clementi, Pharm.D., F.C.P., is a Managing Partner, Clementi-King, a full service provider of global regulatory services. He received his Doctor of Pharmacy/Pharmacology Degree from the University of Texas, where he later taught in the College of Medicine, the College of Dentistry and the Allied School of Public Health and also served as the Director of Clinical Pharmacokinetic Consult Service. He joined Searle/Lorex in the early 80’s where he held senior positions, including worldwide Director for Market Development. As a regulatory consultant, he has worked with nearly all the key FDA Offices and Centers, including CBER, CDER and CDRH and has filed various INDs and NDAs. Clementi & Associates Ltd. is the US Agent for several foreign companies, which it represents at Pre-IND, End-of-Phase II, and Pre-NDA meetings with the FDA. Dr Clementi has worked in the area of blood substitutes, topical therapies, photobiology, human growth hormone and antagonists and the detection and treatment of cancers. He is a 20-year member of ASCPT and ACCP.  

Peter Davis is a founding member of DaVinci Healthcare Partners, a world leader in cancer statistics and cancer market consulting.  He is an expert in the field of commercial and technology assessment for product evaluation and commercialization in the biomedical supply, equipment and device industries, as well as the pharmaceutical industry.  He has worked extensively in Europe and Asia.  Mr. Davis has held senior management positions at GlaxoSmithKline, Syntex, SRI International (Stanford Research Institute), MMC International, and has worked as an independent consultant. 

Brian M. Gallagher, Ph.D., was Chairman, Chief Executive Officer and President of CollaGenex Pharmaceuticals, Inc., a profitable, specialty pharmaceutical company with a focus in the dental, dermatology, cancer and critical care therapeutic categories.  Prior to that, he was President of Squibb Diagnostics, a large division of Bristol Myers Squibb.  He has also served in a variety of research, development, business development, marketing and strategic planning positions at both Bristol Myers Squibb and prior to that at the pharmaceutical division of E.I. Dupont de Nemours.  Dr. Gallagher also serves on the Board of Directors for CollaGenex Pharmaceuticals. Inc., TyRx Pharma, Inc., and Princeton Pharmaceuticals, Inc., and is the Chairman of the Board for IMCOR Pharmaceuticals, Inc.  He received a B.S. in Biology from St. Louis University and a Ph.D. in Biology from St. John’s University. 

Robert W. Lee, Ph.D., is currently Vice President, Pharmaceutical Development, Novavax, Inc.  Dr. Lee has more than 15 years of experience in pharmaceutical research and development (encompassing preformulation, drug delivery (especially NanoCrystal^® Technology as one of the founders of NanoSystems, a drug delivery company specializing in the formulation of water-insoluble drugs), formulation development, analytical sciences, sterile manufacturing, and technology evaluation and development.  Dr. Lee was Vice President of Research and Development for IMCOR Pharmaceutical Co.  

Barry Marrs, Ph.D., is currently Chairman and CEO of AthenaBio and serves as Executive Director, Fraunhofer Center for Molecular Biotechnology in Delaware.  At the DuPont Central Research & Development, he served in several capacities, including Director, Life Sciences.  Dr. Marrs left DuPont in1994 to become the founding CEO of Recombinant BioCatalysis, Inc., where he was appointed Chairman of the Board in 1996.  RBI has since changed its name to Diversa Corporation.  Dr. Marrs became President and founding CEO of Photosynthetic Harvest, Inc. in late1996, and served in that capacity until 1998.  He then was Director of Corporate Research for Hercules Inc. until 2001. 

Barton N Milestone, MD, is a Staff Radiologist at Fox Chase Cancer Center. Previously he has been an Associate Professor at Temple University Hospital. He holds patents related to imaging probes and non-invasive radiographic methods for analyzing body elements. He has numerous publications pertaining to imaging and oncology. Dr Milestone belongs to the Radiological Society of North America, the American Roentgen Ray Society, and the International Society of Magnetic Resonance in Medicine.

James Mulshine, MD, until recently Head of the Experimental Intervention Section, Cell and Cancer Biology at the NCI, now serves as Associate Research Provost at Rush University Medical Center. Dr. Mulshine is a member of the American Society of Clinical Oncology, the American Association of Cancer Research, the International Association for the Study of Lung Cancer, and the American Federation of Clinical Research.  He sits on the editorial boards of Lung Cancer, Clinical Cancer Research, and the International Journal of Oncology.  He also serves as an editorial reviewer for Cancer, the New England Journal of Medicine, the British Journal of Cancer, and the European Journal of Cancer, among others.   

Rosaleen B. Parsons, MD, is the Chair of the Department of Diagnostic Imaging at Fox Chase Cancer Center. She previously had various appointments, including teaching posts, at Temple University Hospital and Mount Sinai Medical Center. She has been a reviewer for several radiology journals, has made numerous presentations, and has written dozens of publications in the field of Radiology. She also has participated in drug trials with imaging agents. Dr Parsons belongs to several Radiology Societies.  

Larry A. Sternson, Ph.D., is an experienced developer of drugs and pharmaceutical technology. In 1989, while a senior R&D executive at Sterling Winthrop Pharmaceuticals (a subsidiary of the Eastman Kodak Co.), Dr. Sternson was responsible for the identification and transfer of small particle technology from the photographic division of Kodak to Sterling Winthrop R&D. He subsequently managed the adaptation of this technology (later renamed NanoCrystal technology) for pharmaceutical applications (therapeutic and diagnostic image enhancement). At the time that Kodak divested its healthcare assets, Dr. Sternson acquired the Nanoparticulate technology from Kodak and formed the private company, NanoSystems, to further the development, validation and commercialization of Nanoparticulate technology. Under his management (as President & CEO), an intellectual property estate of 65 patents was developed, four pharmaceutical products were commercialized which incorporate Nano particulate technology (current in market sales in excess of $1.5B), and license agreements to access Nanoparticulate technology were executed with a number of major pharmaceutical companies, including AHP, Merck, Johnson & Johnson, Astra, BMS, Abbott, and Roche. 

William Mezzanotte, MD, FACCP, is Executive Director, Strategic Clinical Development at AstraZeneca Pharmaceuticals, focusing mostly on the company’s respiratory clinical trials and product development.  He has been involved in numerous FDA submissions and FDA meetings concerning inhalational drug products.  Recently he was assigned US Clinical oversight for new products in development in all therapeutic areas.   Prior to joining AstraZeneca, Dr. Mezzanotte worked at a multidimensional Pulmonary and Critical Care Medicine practice in Manchester, NH, where he oversaw the development of a complete pulmonary diagnostics and interventional bronchoscopy laboratory. Dr. Mezzanotte is a graduate of Villanova University and the University of Pennsylvania School of Medicine. After doing his residency and chief residency at Thomas Jefferson University Hospital in Philadelphia, he was a clinical and research fellow at the University of Colorado Health Sciences Center, and worked at the Denver Veterans Administration Medical Center and National Jewish Hospital for Respiratory Medicine. He is board certified in internal medicine, pulmonary medicine, critical care medicine and sleep medicine and has authored numerous articles dealing with sleep apnea and other respiratory issues. Dr. Mezzanotte is a member of the American College of Physicians, the American Thoracic Society, and the American College of Sleep Medicine. 

Sandy Weinberg, Ph.D. is presently Vice President for Regulatory and Quality Assurance at Tikvah Therapeutics.  Prior to that he served as Senior Director of Regulatory and BioDefense at GE Healthcare.  Dr. Weinberg's career includes academic responsibilities in biomedical entrepreneurship; consultant to the industry and the United States FDA; founder of a successful family of international biomedical companies; and regulatory advisor to the EMEA, South Korea Food and Drug Administration, Food and Drug Administration of China, and Canadian Bureau of Biologicals.  He is the author of fourteen regulatory books and more than one hundred related articles.  Dr. Weinberg serves as an International Ambassador for the Boy Scouts of America, and as Health and Safety advisor to the Atlanta Area Council of the BSA.  He serves on the advisory boards of three emerging companies.