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CORPORATE MANAGMENT | Board of Directors| Business Advisors| Scientific Advisors
William Hearl, Ph.D. Dr. William Hearl, the founder of ITI, is an experienced and successful scientific businessman and entrepreneur. He worked closely with Dr. Tom August, Capital Genomix and Johns Hopkins University to capture the LAMP technology for ITI and start operations in 2006. His extensive experience in intellectual property management and business development led to the speedy sub-license of the LAMP technology to Geron within 30 days of initiating operations. Dr. Hearl is also the founder of Capital Genomix (CGI), a Maryland-based biomarker and drug discovery company and served as its first CEO from inception in 2000 until late 2002 when he assumed the role of Chief Scientific Officer. Dr. Hearl raised seed and Series A & B funding for CGI (~$5 million in cash/debt) and acquired the Dynex Technologies division of Thermo in a leverage acquisition deal. (Dynex was subsequently divested yielding a 10-fold return to the Company). He is also responsible for the acquisition and development of the core technologies of Capital Genomix: GeneSystem320 was licensed exclusively from MD Anderson Cancer Center and the ImmunoMouse was invented by Dr. Hearl. He also has an established record of scientific productivity over his 20 years of work in the biotech industry. He started his career as a bench scientist at Electro-Nucleonics and developed blood based diagnostics for HIV, HTLV-I and Hepatitis C. He later worked at Life Technologies (LTI, now Invitrogen) and directed the Immunodetection Group. His lab developed a number of innovative antibody based detection kits and reagents. He moved into scientific management when he became the Director of R&D at Kirkegaard & Perry Laboratories in 1994. Dr. Hearl has a Ph.D. in biochemistry from the University of Tennessee (Oak Ridge, Knoxville) and a B.S. from East Tennessee State University. Bernard C. Rudnick Bernard C. Rudnick is Founder and Executive Vice President of KSR Associates, LLC. He has 35 years of experience in executive-level strategy, finance, and management. He has held positions of CEO, COO, President, and Executive Vice President in a number of companies, and has been instrumental as a financial advisor to many more. He founded West Consumer Electronics, a business with revenues exceeding $60 million that achieved market leadership under his control.Mr. Rudnick has substantial experience investing and guiding investments in entrepreneurial companies and has led or co-led capital formation totaling over $270 million in the past several years. He is a founding member and principal of Diamond State Ventures, and has served on many corporate, charitable and governmental boards throughout his career. He has assumed multiple interim management positions while guiding companies through transition. Examples of this include interim CFO of AudioAudit and CEO of CA Technology Inc. Mr. Rudnick earned his BS in Biochemistry from Pennsylvania State University and was conferred a postgraduate degree in administration at Northwood University. His educational development work has included presentations to the Wharton Executive MBA alumni group as well as guest lectures at Weidner University. Teri Jones Heiland, Ph.D. Dr. Heiland is currently the Vice President of Research and Development at ITI and was one of the founding employees of the Company. Dr. Heiland is an experienced molecular biologist and holds multiple patents in the field of genomics. Prior to assuming the post as Vice President at ITI, Dr. Heiland led multiple research teams at Capital Genomix developing and validating GeneSystem320 and applying this technology to identify biomarkers associated with cancer. She has also worked closely with the development of the ImmunoMouse and is an expert in molecular biology and genomic analysis. Prior to joining Capital Genomix, Dr. Heiland worked as a senior scientist in R&D at Kirkegaard & Perry Labs (KPL) where she spent four years as a project leader on development and commercialization of six major kits and she was responsible for the utilization of GS320 with both cytokine and HIV model systems. She has facilitated the optimization of the GS320 assay and has been involved in work involving eukaryotic gene regulation since 1989. She has expertise in the fields of signal transduction, amphibian development, and gene regulation. Dr. Heiland is primary author on a number of publications that utilized extensive work with mRNA and cDNA and assays such as RT-PCR, RNAse Protection Assays, Northern Blotting, and library cloning and screening. Dr. Heiland obtained her Ph.D. in molecular biology at the University of Missouri-Columbia in 1993. Dr Heiland also currently has an appointment at Johns Hopkins University as a Visiting Scientist. Bruce F. Mackler, Ph.D., J.D. Dr. Mackler’s 27 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs, medical and in vitro diagnostic devices, manufactured by traditional and biotechnology processes (recombinant proteins, genomics, allergens, active and passive vaccines, cell and gene therapy). Dr. Mackler has advised financial groups on integrated FDA, technical and business issues, when performing due diligence assessments on biomedical opportunities prior to their making initial investments and during bridging. These due diligence activities integrate his business acumen from working in sales/manufacturing in a family textile business, owning and managing several bioservice businesses and being an university/NIH researcher for 15 years, prior to his 27 years in a FDA legal/regulatory practice with premier law firms. He has founded biomedical companies, established and implemented their regulatory strategies and also assisted in securing early stage funding. Dr Mackler has a Ph.D. and M.S. in the area of Immunology/Microbiology and has authored more than 100 published scientific papers and abstracts in immunology, immunopathology, allergy and diseases, as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Mackler has advised clients and venture capital groups on FDA regulatory approval strategies for their portfolio companies, regulatory/quality problems regarding establishing manufacturing facilities and how to effectively initiate product development and interact with FDA. Dr. Mackler has experience drafting and evaluating numerous FDA regulatory documents (e.g., INDs/NDAs, DMFs, and BLAs, Accelerated and Fast Track Approvals, Orphan Drug Designation applications. He has, as a U.S. agent, held IDEs/INDs and secured Treatment-INDs with substantial cost reimbursement, and has written successful Orphan Drug Development/SBIR grants and Designation applications; therefore, he is familiar with the nuances of these regulatory procedures. Dr. Mackler received his J.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania State University (1965), and his B.A. (Biology) from Temple University (1964). James W. Wishart James W. Wishart has been the President, CEO and a Director of Capital Genomix since 2002. Prior to 2002, Mr. Wishart was the founder of Odyssey Diagnostics Inc., and has served as the CEO of Odyssey Diagnostics Inc. since its inception in 2001. During 2002, he facilitated the merger of Odyssey Diagnostics, Inc. and Capital Genomix, Inc. From 1997 to 2001, he served as the President and CEO of DYNEX Technologies, Inc., which was a wholly owned subsidiary of Thermo Electron Corp., a $5.4 billion public company (TMO). From 1993 to 1997, Mr. Wishart served as the President and CEO of Spectra-Tech, Inc., a subsidiary of Thermo Optek Corp., a $250 million public company (TOC), and a worldwide leader in the development, manufacturing and marketing of FTIR microscopes, accessories and software for the analytical instrumentation market. Mr. Wishart received his BS degree from Geneva College and has served on several Boards of Directors, including those of Thermo BioAnalysis, Ltd., DYNEX Technologies, Inc., Spectra-Tech, Inc., and S.P. Japan, Inc. Board of Directors. J. Thomas August, M.D. Dr. J. Thomas August is a Distinguished Professor at the Department of pharmacology at Johns Hopkins University School of Medicine and is the inventor of the LAMP Technology. Dr. August started his career with a medical degree from Stanford University and trained in medicine as the resident house physician to Sir Stanley Davidson at the University of Edinburgh. His early academic appointments included Assistant Professor of Medicine, Stanford University School of Medicine; Associate Professor of Medicine assigned to Microbiology, New York University School of Medicine and Chairman, Department of Molecular Biology and Director, Division of Biological Sciences, Albert Einstein College of Medicine. In 1976 Dr. August was appointed Director of Pharmacology and Experimental Therapeutics at Johns Hopkins University School of Medicine. The focus of August research at Johns Hopkins included the use of monoclonal antibodies to identify cellular proteins including discovery in 1980 of a family of lysosome associated membrane proteins (and). Several laboratories with antibodies to LAMP showed its colocalization with the major histocompatibility class II (MHC-II) proteins that acts to deliver the antigenic peptide units of proteins to helper T cells. This finding prompted the development of DNA vaccines encoding antigen proteins as LAMP chimeras areas in order to target and enhance the delivery of the antigens to the helper T cell pathway. This research continues novel epitope-based vaccines to several viral pathogens including HIV, dengue, influenza, West Nile and others. Dr. August honors include appointments as a Markley Scholar in Medical Sciences; Fellow, John Simon Guggenheim Memorial Foundation; Fellow, Balliol College at Oxford University, Adjunct Professor of Medicine, National University of Singapore and an R37 NIAID Merit Award for HIV vaccine research. Back to the topBOARD OF DIRECTORS
Charles V. Grudzinskas, Ph.D. Dr. Charles Grudzinskas is a Co-Founder and Principal in NDA Partners, LLC, an organization that delivers value through a unique combination of premier drug development expertise, strategic advice and proven clinical development and management practices that lead to rapid, efficient, effective and economical development and commercialization. Dr. Grudzinskas is a consultant to the Center for Drug Development Science (CDDS) at Georgetown University Medical Center and to MdBio, an organization that is dedicated to assisting bioscience companies become successful in Maryland. Dr. Grudzinskas also consults on the strategy and tactics of drug development, regulatory strategies and program management, working across the full range of emerging and mature companies and is called upon frequently to assist both large and small companies prepare for FDA meetings. Dr. Grudzinskas is an Adjunct Professor in the Department of Pharmacology at Georgetown University. W. Barry McDonald Mr. McDonald has over 35 years experience in the health care industry as an operating executive and consultant and is of McDonald & Associates, a strategic and transactional global health care advisory firm. He manages client assignments globally in the medical diagnostics, biotechnology, medical device and life science sectors, and also provides interim CEO management services to companies in these sectors. Prior to joining The Sage Group, Mr. McDonald was President and CEO of MAST/Hitachi and simultaneously headed an executive staff within Hitachi Chemical corporate, which was responsible for new technology assessments, acquisitions, and business development activities for Hitachi Chemical's life sciences business worldwide. Previously, he was with Hycor Biomedical, as Senior Vice-President of Sales, Marketing and Business Development, where he was instrumental in establishing a new strategic direction for the company, and developing its global distribution network and in acquiring two companies, which expanded Hycor's business globally. Mr. McDonald's entrepreneurial experience was gained as President and CEO of Photest Diagnostics, a company concentrating on novel, homogeneous fluorescent immunoassays for the point-of-care (POC) market. As a venture capital backed emerging company, he was responsible for the turnaround in Photest, commercialization of its technology, and its ultimate sale to a European corporation. Mr. McDonald’s technical and scientific competencies were developed through academic degree programs and medical school experiences. His broad health care business expertise has been augmented through participation in international strategic management schools in France, Japan, and in the United States at Wharton Business School and Columbia University. Mr. McDonald's academic experiences include an M.D./Ph.D. program at the University of Kentucky, Albert Chandler Medical School, an M.S. in Microbiology and Genetics and a B.S. in Biochemistry and pre-med from The University of Southern Mississippi. Ronald P. Thiboutot, Ph.D., Ronald P. Thiboutot, Ph.D., is Senior Vice President of Science and Technology for the Life Sciences Greenhouse of Central Pennsylvania. His responsibilities include identifying promising new areas of technology, reviewing science and business opportunities, and investing in seed stage opportunities. Dr. Thiboutot is managing director of the LSGPA Tech Fund. In this capacity, Dr. Thiboutot oversees technical due diligence of the funded companies and provides technical and business mentoring to funded applicants. Dr. Thiboutot sits on six corporate and economic development boards and provides interim CEO services for selected start-ups as required. Prior to joining the Life Sciences Greenhouse, Dr. Thiboutot was President of RT Consultants, Inc. which provided technical, equipment procurement, and facility design consulting services to the US and EU pharmaceutical industry. Among his other employers were Wyeth Pharmaceuticals, where he was the Plant Director of the vaccine manufacturing facility located in Marietta, PA; Bristol-Myers Squibb, where he worked in the international technology transfer division; and Baxter Travenol. Dr. Thiboutot holds a Bachelor of Science, Masters of Science, and Ph.D. from the Massachusetts College of Pharmacy, and has been active in numerous U.S. and International pharmaceutical trade organizations during his 25 years in the pharmaceutical industry. Back to the topBUSINESS ADVISORY BOARD
Roscoe M. Moore, JR., D.V.M., Ph.D., D.Sc. Former Assistant United States Surgeon General and Until his retirement in December 2003, Dr. Roscoe M. Moore, Jr. served with the United States Department of Health and Human Services (HHS) and was for the last twelve years of his career the principal person responsible for development support within the Office of the Secretary, HHS, with primary emphasis on Continental Africa and other less developed countries of the world (e.g., Indonesia, Malaysia, and Vietnam). He was the principal liaison person between the HHS and Ministries of Health in Africa with regard to the development of infrastructure and technical support for the delivery of preventive and curative health needs for the continent. Dr. Moore received his undergraduate and Doctor of Veterinary Medicine degrees from Tuskegee Institute; his Master of Public Health degree in Epidemiology from the University of Michigan; and his Doctor of Philosophy degree in Epidemiology from the Johns Hopkins University. He was awarded the Honorary Doctor of Science degree in recognition of his distinguished public health career by Tuskegee University. Dr. Moore was a career officer within the Commissioned Corps of the United States Public Health Service (USPHS) entering with the U.S. National Institutes of Health and rising to the rank of Assistant United States Surgeon General (Rear Admiral, USPHS) within the Office of the Secretary, HHS. He was selected as Chief Veterinary Medical Officer, USPHS by Surgeon General C. Everett Koop. Dr. Moore served as an Epidemic Intelligence Service Officer with the U.S. Centers for Disease Control and Prevention. Dr. Moore has conducted clinical research on infectious diseases such as Venezuelan equine encephalitis, tuberculosis, listeriosis, psittacosis, human Orf, malaria, and HIV/AIDS. He has carried out epidemiological research on a number of chronic and molecular diseases, for example, lead toxicosis, occupational and environmental cancers, and sickle cell disease. He has evaluated the safety and effectiveness of medical devices, and conducted relevant epidemiological research on the utilization experience and human health effects of medical devices and radiation. Dr. Moore has written or co-authored over 100 publications covering a broad range of public health issues. Tama Copeman, Ph.D. Dr. Tama Copeman is the founder of Alcyone*7, a technology and business development advisory company focusing on physical and life sciences. Tama has contributed to numerous early stage companies through Alcyone*7, and as an advisory board member to Mid Atlantic Diamond Ventures and the Ben Franklin Technology Partners technical advisory committee. She has 34 years experience in executive-level strategy and risk, business development, general management and operations, ventures and equity investments, international partnerships, technology and product development, intellectual property strategy and competitive analysis, solution innovation and human capital. Over the years, Tama has taken many products to market and has managed product portfolios supporting businesses with total revenue of about $ 1 billion and intellectual property valued in excess of $ 200 MM. Earlier, Dr. Copeman developed computational molecular models and simulated complex chemical and physical systems. Dr. Copeman has MS., and Ph.D. degrees in Chemical Engineering from Lehigh University and has completed Executive Education courses at Stanford, MIT, and the University of Chicago. Robert Rager Mr. Robert Rager is Founder and President of Practical Memory Institute, LTD, a bio-behavioral health company developing proprietary programs for human memory fitness from NIH funded research. A former General Electric Presidential Exchange Executive serving in the USDA’s Foreign Agricultural Service, Mr. Rager has over 30 years of business and venture management experience with companies including General Electric, Project Software & Development, Inc., Potomac Industries, Ltd., Compact Disc Incorporated and Practical Memory Institute, LTD. Mr. Rager earned a BA in Chemistry from Hunter College of the City University of New York, holds patents in computer diskette storage devices and has served as Principal Investigator for over 15 Small Business Innovation Research (SBIR) grants awarded by various NIH Institutes. Tim Coleman, Ph.D. Dr. Tim Coleman is a scientist and senior manager with more than 15 years experience in biotechnology and biopharmaceutical organizations including Human Genome Sciences (HGS), Correlogic Systems, Inc., Lonza Walkersville, Inc. His areas of expertise include genomics, proteomics, molecular biology, recombinant protein expression, purification and characterization. While at HGS, Dr. Coleman contributed to the clinical development of several therapeutic protein projects. He also served as Team Leader on a project exploring the applications of plasmid DNA vector for use in Transient Gene Therapy. Prior to joining Lonza, Dr. Coleman served as the VP of Research and Development at Correlogic Systems where he directed and managed the development of OvaCheck™, a blood test for the early detection of ovarian cancer. Currently he is the Senior Director of QC Testing Services at Lonza Walkersville where he is responsible for in-process and product release testing of non-regulated and regulated products including Cell Therapy products and Nucleic Acid vaccines. Dr. Coleman received his doctorate degree in Cellular and Molecular biology from Ohio University. Back to the topSCIENTIFIC ADVISORY BOARD
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