Dr. Kohn is a graduate of Columbia College and the Columbia College of Physicians and Surgeons. He did 3 years of internship-residency at NY Columbia Presbyterian Hospital before becoming (in 1964) a Research Associate at the NIH. He then worked at the National Institutes of Health, National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) for 36 years, largely in the Public Health Service, where he achieved Medical Director (Capt.) Rank and was awarded both Meritoreous Service and Commendation Medals. By 1975, he became a section chief in in the first of two Research Laboratories (Biochemistry and Metabolism & Biochemical Pharmacology) and finished as a Section Chief in a Clinical Branch (Metabolic Diseases Branch). He has received numerous professional awards in recognition of research carried out under his direction at the NIH, including the Ingbar Award from the American Thyroid Association and an honorary degree of Medicine from the University of Chieti, Chieti, Italy, for his work on autoimmune diseases. He has been a member of the Editorial Boards of the Journal of Biological Chemistry, Endocrinology (twice), and Thyroid. In 2000 he moved to Ohio University where he worked in the Edison Biotechnology Institute (EBI) and the Department of Biomedical Sciences, Ohio University School of Osteopathic Medicine (OUCOM). He became President of IC when it was established in 2000 and became the John Edward Watson Chair of Diabetes Research at OUCOM in 2003. He retired from EBI and OUCOM to become Emeritus in 2008 and to serve full time as President of IC. He has over 415 publications 9 issued patents, and 20 or more pending patent applications. His work at OU with Prof Douglas Goetz helped get the funding to build the >30 million dollar Academic Research and Teaching Facility opened in 2010 and with Dr. Frank Schwartz helped establish the Diabetes-Cardiovascular Clinical Research Center which was cited by the State of Ohio for its excellence.

Dr. Napolitano is an Assoc. Prof. in the Chair of Endocrinology, Chieti University, Chieti, Italy. He received his MD and postgraduate degree in Endocrinology from the Universita “La Sapienza”, Rome, Italy. He did a post doc in the Department of Immunology in Middlesex Hospital, London, U.K., for 3 years then at the NIH in the Laboratory of Biochemistry and Metabolism, NIDDK, for 2 additional years. His studies in NIDDK were related to thyroid autoimmunity with a special interest in MHC Class I and II gene regulation in thyroid cells in collaboration with Dinah Singer, NCI. He then set up a new lab in Chieti (Italy) which is devoted to the study of thyroid autoimmunity, both basic and clinical. At present the main objectives are focused on: a) the role of the antibodies to the TSH receptor as a marker of autoimmunity and as a predictor of the evolution of Graves’ disease; b) the role of the increased expression of MHC Class I and II molecules on human vs rat thyroid cells for the development of autoimmune diseases; c) the effect of compounds derived from methimazole on the expression and activity of MHC Class I, MHC Class II and thyroid specific genes; d) the epidemiology of thyroid autoimmune diseases, including the role of iodine deficiency on autoimmunity. The general aim of the projects in the Chair of Endocrinology is therefore to transfer the knowledge derived from basic studies into clinical evidence; a typical example is the study of TSH receptor antibodies where the cloning of the TSH receptor, and the construction of chimeras with part of the LH/hCG receptor enabled the identification of specific epitopes that react with selective antibody populations in Graves’ sera. The aim now is to identify which clones of TSH receptor antibodies can be identified in the sera of Graves’ patients and to evaluate whether the ratio of different antibodies might be prognostic for the course of the disease. Dr. Napolitano has multiple Peer reviewed reports on MHC I promoter and regulation, 2 US patents issued, and 5 patent applications pending. He and Dr. Giuliani were critical in the clinical development of TSHR chimeras and the Thyretain assay.

(Baltimore, MD) – William Valente, M.D., FACP, MBA is Clinical Professor of Medicine at the University Of Maryland School of Medicine and Senior Consultant in Endocrinology at Mercy Medical Center. Board certified in Internal Medicine, and Endocrinology and Metabolism, Dr. Valente received his medical degree from the University of Maryland School of Medicine and completed his Internal Medicine residency and fellowship in Endocrinology and Metabolism at the University of Maryland and Baltimore Veterans Administration Hospitals. He completed a research fellowship in the Laboratory of Biochemical Biophysics at the National Institutes of Health under the direction of Dr. Leonard Kohn. He described the first monoclonal antibodies to the human thyrotropin receptor. His work helped resolve the controversy concerning the identity of auto antibodies in Graves’ disease.  He joined the clinical faculty at the University of Maryland  where he has remained for nearly three decades dedicated to excellence in practice, medical education, and compassionate care.
 
Dr. Valente  served as Chairman of the Department of Medicine at St. Agnes Healthcare; Chief of Endocrinology and Metabolism at both St. Joseph Medical Center and Mercy Medical Center; and as Director of the Nuclear Medicine Thyroid Unit at University of Maryland Hospital. He earned a Masters of Business Administration at The Johns Hopkins University. He has been involved for over two decades as the president of InterThyr Research Foundation. He currently serves as a senior officer and co director of the TSH receptor diagnostic section in InterThyr Services, Inc.

Dr. Valente has authored over 50 publications and abstracts and has served as a reviewer for both the Journal of Clinical Endocrinology and Metabolism and the Journal of Endocrinologic Investigation Thyroid. An experienced clinician, teacher, and researcher, Dr. Valente’s major research interests are nuclear medicine and in thyroid disorders.

He has numerous honors and awards to his credit, including the Sam Asper Award for clinical excellence awarded by the American College of Physicians. He is a member of many professional organizations, including The Endocrine Society, American Thyroid Association, Fellowship in the American College of Physicians and he remains active in clinical research on thyroid disorders.

Dr. Giuliani is an Assist. Prof. in the Dept. of Endocrinology, Chieti University, Chieti, Italy. He received his MD and Ph. D. from the Dept. Endocrinologia, U. Chieti, then did a post-doc at the NIH for 3 years. He was a Visiting Research Scientist at Ohio University, thereafter. Dr. Giuliani has multiple Peer reviewed reports on MHC I promoter and regulation. He was Critical in the clinical development of TSHR chimeras and the Thyretain assay. He has now turned his attention to the effect of C10 on Graves’ mouse models and atherosclerosis in partially pancreatectomized diabetic rat models, particularly effects on PAI-1.

Dr. Schwartz is the current JO Watson Chair for Diabetes Research, Professor of Endocrinology, and Director of the ARHI Endocrine/Diabetes Center at the Ohio University College Medicine (OUCOM). He is a product of WV University School of Medicine. He has served on the Board of Directors of the Diabetes Control Programs in both WV and OH. His research interests range from the regulation of immune response by gonadal hormones and their modulation of autoimmune disease, role of toll like receptors in pathogenesis to type 1 and type 2 diabetes,  to the use of artificial intelligence to manage insulin pumps. He directed the clinical testing of Thyretain® in the US at Ohio University.

Director of Cardiovascular Medicine and the Cardiac Catheterization Laboratory in O’Bleness Memorial Hospital, Athens, Ohio, and Associate Professor of Cardiology at Ohio University. He serves full time on the staff of the Interventional Cardiology and Vascular Medicine group of MidOhio Cardiology and Vascular Consultants, Inc. and Riverside Hospital in Columbus, Ohio. He is a graduate of Ohio State University and received his DO from Ohio University. He trained at the Cleveland Clinic Foundation where he had an Interventional Cardiology Fellowship. He did thrombolytic therapy research and has over 40 Peer Reviewed Publications in interventional cardiology. He is an editor of the Journal of Carotid and Neurovascular Intervention

Dr. Ambesi-Impiombato is a Full Prof. of General Pathology, and Chair of the Dept. of Experimental and Clinical Pathology and Medicine, University of Udine, Udine Italy. He is currently a member of the Biolab Science Group of the European Space Agency, E.S.T.E.C., Noordwijk (Netherlands) and of the Dalmier-Benz Aerospace Equipment Support Equipment Study group. He has 7 patents and more than 70 Peer reviewed publications. He received his medical training in the 2nd Faculty of Medicine at the U. of Naples, Naples, Italy, and had teaching appointments in the Institute of General Pathology there. He worked with Rosalind Pitt Rivers in Mill Hill, London, and then at the NIH for several years before going to Udine. In Udine he has had multiple positions: Chairman of the Department of Experimental Pathology and Medicine, Coordinator of the Ph. D. program in Clinical Science and Technology, President of the University Hospital, and Director of the Geriatric School. He has won the Harrington-De Vischher Prize of the European Thyroid Association. At the NIH he collaborated with Hayden Coon to develop non-tumorogenic cell cultures that grew on defined media; he and Dr. Coon hold multiple patents that allow continuous cell culture of non-transformed human cells. In the last 15 years, the main interest has been the characterization and utilization of normal, continuous cell strains expressing in vitro their tissue-specific functions. Most of his publications of this period deal with in-vitro studies on thyroid patho-physiology and on hormones and growth factor mechanisms of action. He developed and uses the differentiated, epithelial thyroid follicular cell strain FRTL5, reported in 1980 by him and Dr. Coon. This cell strain, probably one of the most stable and differentiated among normal cells growing in continuous culture in vitro, is also widely used worldwide in clinical tests for thyroid autoimmune diseases and for hormonal bioassays. It has been used in several basic research studies on hormonal mechanisms of action, as well as in studies of clinical application. More recently, FRTL5 are being employed in microgravity and space research. Preliminary studies have been and are conducted on ground, in pseudo-microgravity in clinostat and in hypergravity in centrifuge. A real-microgravity experiment involving FRTL5 cells was flown by E.S.A. in the MASER-7 sounding rocket mission (Kiruna, Sweden May 1996) and in the MASER-9 mission (Kiruna, Sweden March 2002), in the Foton/Soyuz mission (in 2007) and in the Space Shuttle/International Space Station (ISS) Esperia mission (again in 2007). Currently, Prof. Ambesi is participating in the Tissue Sharing “Mouse Drawer System” Space Shuttle/ISS STS-129 mission (2009-2010). He is active in “Humanizing Tomorrow’s Biomedicine” with special emphasis on Bioethics as applied to Clinical Practice. He actively collaborates in this area with Radboud Universiteit in Nijmegen, The Netherlands.

David is President, Jackson Biotechnology Advisors (2001-present) with expertise that includes strategic planning for field of operation and specific product targets; leveraging of novel technology assets; intellectual property analysis; evaluation, advising, and restructuring of R&D managements and organizations; as well as identification and recruitment of Scientific Advisory Boards, officers, and senior scientists. His clients have included small to large private and publicly held biotechnology, pharmaceutical, and diagnostics companies including one of the world’s largest chemical and materials sciences companies and the first company to gain FDA approval for a DNA-sequencing-based diagnostic test for drug-resistant viruses. He serves as member and/or chairman of multiple boards of directors, scientific advisory boards, and management committees. Dr. Jackson has degrees in Molecular Biology from Harvard College and Stanford where he got a Ph. D.; he then post-doced with Paul Berg at Stanford in recombinant DNA technology. His academic experience includes being an Asst. and Assoc. Professor, University of Michigan Medical School (1972-81) and Executive Director, Maryland Biotechnology Research Institute (1986) (a consortium of four biotechnology institutes affiliated with the University of Maryland). His industrial experience includes being VP R&D, Genex Corp. (the 4th biotech company founded in the US) (1980-85); Director, Biotechnology Research, Du Pont (1986-90) where he focused on anti-viral drug discovery, large-scale human cell culture under cGMP conditions, discovery and evaluation of molecular diagnostic reagents, micro-organism fermentation, and downstream processing of human proteins under cGMP and BSL-3 conditions; Sr. Director, Drug Discovery Research, Du Pont Merck Pharmaceutical Company (1991-96) where his focus was anti-infective drugs, anti-cancer drugs, biotech reagent and technological support for all therapeutic area, and headed the team responsible for commercial development of anti-HIV drugs; Executive VP, R&D and Corporate Development, Nexell Therapeutics (1996-2000) where his responsibility was for an FDA-approved system (hardware, software, and biologicals) for isolating hematopoietic stem cells for human cancer and transplant therapy, RNA-based drugs and anti-cancer drugs; and VP R&D, EluSys Therapeutics (2000) where his work centered on novel immunobiological drug therapies

Anthony Schwartz, MS graduated from Ohio University in 2007 in engineering. He then went on to become the first graduate from Ohio University's Biomedical Engineering program in 2008. During his undergraduate and graduate studies, he and his colleagues evaluated the effect of IC’s lead compound, C10, for the treatment of cancer and diabetes. He is a co-inventor on the patent for C10 and has published several peer-reviewed papers on therapeutic and diagnostic development. Additionally, he has founded several start-up companies and is the President of the XTELL Corporation. Currently, he is finishing his PhD in Biomedical Engineering and MBA at the Colorado State University focusing on novel treatments of osteosarcoma. In parallel, he is also pursuing the equine clinical trials for the use of C10 in septic shock/colic at the Colorado State’s nationally recognized veterinary hospital.

Professor Chemical and Biomolecular Engineering, Ohio University. His laboratory seeks to achieve a fundamental understanding of the biochemistry and biophysics that underlie cell adhesion processes.  In addition, it focuses on developing technology to target drug carriers to select segments of the vasculature as a means of achieving directed drug delivery.  He has submitted several patent applications related to these topics.  Dr. Goetz was a post-doc at Harvard Medical School & Brigham and Women’s Hospital, a Research Assistant in the Duke University Marine Lab.; a Process Engineer at Eli Lilly and Company, and an Assistant Professor of Biomedical Engineering in The University of Memphis. He is an American Heart Association Established Investigator

Dr. Deosarkar is a graduate of Babasaheb Ambedkar Technological University, Lonere, India (2002). He received an M.S. at the University Institute of Chemical Technology, Mumbai, India (2003), where he was a senior research fellow, and in 2010 obtained a Ph. D. in Chemical Engineering from the Ohio University Russ College of Engineering, Athens, OH. During his doctoral work in the Department of Chemical and Biomolecular Engineering at Ohio University, the major focus of his research was the development of novel therapeutic and diagnostic approaches for atherosclerosis. Part of this work serve as the preliminary data included in an SBIR Phase I application. He published several peer-reviewed publications on molecular therapeutics and diagnostics for atherosclerosis. He works at the interface of biology and engineering and leads IC’s research site in Athens, OH, where IC is performing pre-clinical research and development for a lead therapeutic compound for auto-immune inflammatory diseases and cancer as well as evaluating a diagnostic for vulnerable plaques.

Reed Smith, LLP
Sergio Garcia (Lead & Executive Counsel)

Licensing & corporate structure, San Francisco, CA. Sergio is Chair of the Global Technology Transactions Team at Reed Smith. He is a recognized leader in the San Francisco Bay Area and is one of the premier counselors for companies in a number of important sectors, including biotechnology, healthcare, medical device, and cleantech. Mr. Garcia received his J.D. from the University of California, Berkeley, Boalt Hall School of Law, and a B.A. from Stanford University. Mr. Garcia also served as a Fulbright Professor of Law in the areas of comparative business law, intellectual property and antitrust law. Mr. Garcia’s practice focuses on advising public and private companies, venture capital firms and entrepreneurs on a wide range of legal and business issues. These include structuring and negotiating complex technology transactions, such as international and domestic strategic alliances, joint ventures and inbound and outbound licensing agreements, as well as other transactions involving intellectual property. Mr. Garcia also advises on the commercial technology and intellectual property aspects of mergers, acquisitions, venture financings and public equity financings, including initial public offerings and follow-on stock offerings. Mr. Garcia’s clients have included enterprises in industries ranging from biotechnology, medical device, cleantech, retail and financial services, internet, and computer software. Previously, Mr. Garcia served as Vice President, Legal and General Counsel of PDL BioPharma, Inc. where he negotiated strategic alliances and collaborations with leading pharmaceutical and biotechnology companies. He also was responsible for compliance and SEC reporting, corporate governance, acquisitions and follow-on stock and convertible note offerings.  One of Sergio’s more notable recent transactions was his representation of the University of California and Lawrence Berkeley National Lab in connection with a $500 million ten-year research collaboration with British Petroleum for the development and commercialization of alternative fuel technologies through the Energy Biosciences Institute, created specifically for this purpose.

William McNichol, (Patent Attorney)

Mr. McNichol received B.A., M.S., and J.D. degrees from Villanova University. He concentrates his practice in the representation of technology-based enterprises in a broad range of intellectual property matters, including the prosecution of patent applications, re-examination and reissues; trademark registration applications, oppositions and cancellation proceedings; and the preparation of patent validity and infringement opinions in anticipation of litigation and new product introduction. Bill has an extensive background in drug, biotech and other medical technology intellectual property litigation, including patent, copyright, and trademark infringement matters in both the courts and U.S. International Trade Commission. Recognized in 2005 through 2007 as one of the Best Lawyers in America; he currently is an Adjunct Professor of Law at Rutgers University School of Law and has served as an Adjunct Professor of Law at the University of Pennsylvania