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TEAM
Michael I. Sherman, Ph.D. – Co-Founder, Director, and Chairman
Dr. Sherman served as President of Iconic Therapeutics since its inception in 2002 until April 2007, at which time he became Chairman of the Board. Since 1999 he has also served as the Principal for Biotechnology and Pharmaceutical Consulting, LLC, a consulting service to pharmaceutical, biotechnology, device and medical software companies and universities. In 2006, Dr. Sherman became a Venture Partner at Elm Street Ventures of New Haven, CT. In addition to Iconic Therapeutics, Dr. Sherman has co-founded and served as President and/or CEO of six biotechnology companies formed to commercialize inventions by scientists at Yale University, The Johns Hopkins University and Memorial Sloan-Kettering Cancer Center: Pharmagenics, Inc., Prostagen, Inc., Molecular Staging, Inc., VaxInnate Corp., Protometrix Inc. and Affomix Corp. Prior to that he served as Director and Senior Director at the Roche Research Center, where he managed drug discovery efforts in Oncology, Virology, and Immunology. From 1971 to 1986, Dr. Sherman served as a member of the Department of Cell Biology of the Roche Institute of Molecular Biology, where he carried out and supervised research involving the molecular and cell biology of cancer and mammalian embryogenesis.
Kirk Dornbush – Co-Founder, President and Chief Financial Officer
Mr. Dornbush has served as Chief Financial Officer and Director of Iconic Therapeutics, Inc. since its inception in 2002. In April 2007, he was additionally appointed as President of the Company. As President, Mr. Dornbush is responsible for all day-to-day operations of the company. Since 1995, Mr. Dornbush has served as President of Diem Investments, a private investment advisory firm located in Atlanta, Georgia. He is also Manager of Diem Bioventures, LLC, an investor in Iconic. Prior to that, he served as President of Ripple Investments, Inc., a venture capital firm specializing in direct equity investments in the People’s Republic of China. Mr. Dornbush received his B.A. in English from The Colorado College and his J.D. from Boston University School of Law.
Patrick W. Trown, Ph.D. – Chief Scientist
Dr. Trown has been Iconic’s principal scientific consultant for the pre-clinical development of hI-con1 since the Company’s inception in 2003. He has advised the Company on a broad range of topics, including but not limited to, hI-con1 efficacy and potency testing, hI-con1 GLP safety studies and Iconic’s regulatory affairs.
Dr. Trown has been has been active in the Pharmaceutical/Biopharmaceutical industry for over 45 years. He held positions of increasing responsibility from researcher to Vice President at Lederle Laboratories, Hoffmann La Roche, Xoma Corporation, Onyx Pharmaceuticals and Jennerex Inc. He has extensive experience in preclinical research and development; biopharmaceutical chemistry, manufacture and control; international and domestic regulatory agency interactions.
In addition to his role as the principal scientific consultant for Iconic, Dr. Trown has also consulted for various biotechnology companies, including BioMarin Pharmaceutical, Onyx Pharmaceuticals, Astex Technology Ltd., Gryphon Therapeutics and Cell Genesys. During this time he wrote the Non-Clinical Pharmacology and Toxicology, Chemistry Manufacturing and Control and Investigators’ Brochure sections of a CTX; the Pharmacology and Toxicology sections of a BLA/MAA; the Preclinical Expert’s Report of a drug that received FDA and EU approval. He also wrote, compiled and submitted an IND for a New Chemical Entity oncology drug.
Adriana Manzi, Ph.D. – Quality Assurance
Dr. Manzi is currently the Head of Quality Assurance for Iconic and has advised the company on CMC related aspects since 2008. She has been instrumental in the management of contract manufacturers and testing laboratories, in the design of stability studies and validation of analytical methods as well as in set up of specifications for drug substance and drug product. Dr. Manzi has over 25 years of experience in biomolecules research and development. She has been the President and Principal Consultant of Manzi & Associates since its inception in June 2006. From 2001 to 2006 she served as the Senior Director of Research for Baxter Healthcare Corporation. From 1999 to 2001 she served as the Director of Analytical Development/Quality Control for Nextran, Inc. From 1998 to 1999 she was the Associate Director of Analytical Development at Cytel Corporation. From 1991 to 1998 she was the Director of Glycobiology Core and an Assistant Professor at the Cancer Center in the Department of Medicine at the University of California, San Diego. Dr. Manzi received her post doctorate in Biochemistry/Glycobiology in 1989 from the University of California, San Diego and her Ph.D in Organic Chemistry in 1984 from Universidad de Buenos Aires.
Stuart Builder, Ph.D. – Chemistry, Manufacturing, & Control
Dr. Builder is responsible for the review, implementation, and management of Iconic’s current upstream and downstream manufacturing process. Dr. Builder founded Strategic BioDevelopment, a senior scientific and business consulting entity, in 1998. Prior to that he was at Genentech, where his group was responsible for the downstream processing of more than 20 different recombinant proteins, among them plasminogen activator (TPA, the first recombinant human pharmaceutical made by cell culture). Prior to that, Dr. Builder was at Merck Sharpe and Dohme, where he worked on the fermentation and isolation of antibiotics and vaccines. Dr. Builder is the author of over 40 publications and is a co-inventor of more than 25 patents and patent applications. In 1992, he was elected a founding fellow of the American Institute for Medical and Biological Engineering. He has served as member of the Board of Directors and scientific advisor of several companies and a professional not-for profit organization.
Judy Gordon, D.V.M. – Regulatory Affairs
Dr. Gordon and her team are responsible for the submission of Iconic’s Investigational New Drug Application for wet AMD to the Food and Drug Administration. Dr. Gordon is Founder and President of ClinReg Consulting Services, Inc. Dr. Gordon brings almost 20 years of experience in pharmaceuticals, biologics, and medical devices to her consulting practice a clinical and regulatory consultant since 1998. Dr. Gordon was with Chiron Vision, a division of Chiron Corporation, from the company’s founding in 1986 through its successful acquisition by Bausch & Lomb in 1997. At Chiron Vision, Dr. Gordon served most recently as Sr. Vice President of R&D and as V.P. of Scientific Affairs, with responsibility for product development, clinical research, regulatory affairs, and regulatory compliance. Dr. Gordon has taken multiple PMAs and NDAs through the FDA review process, and has directed large-scale clinical trials of both devices and pharmaceutical products. In total, Dr. Gordon has prepared all or part of 16 successful PMA applications for novel devices. She served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel, chaired an industry-FDA working group on guidance documents for clinical trials of refractive surgery lasers, and as the industry representative to the Mediation Dispute Panel of the Center for Devices and Radiologic Health (CDRH).
Steven Schwartz, M.D. - Clinical Trials Advisor
Dr. Schwartz advises Iconic regarding the design and implementation of is phase 1/2a wet AMD clinical study. Dr. Schwartz is the Chief of the Retina Division at the Jules Stein Eye Institute at UCLA. He is a graduate of the University of Southern California School of Medicine. Following his internship at the Los Angeles County-University of Southern California Hospital, he served his residency at the UCLA School of Medicine in the Department of Ophthalmology and the Jules Stein Eye Institute. Dr. Schwartz was the recipient of a Retina/Uveitis fellowship at the University of London in the Moorfields Eye Hospital.
John W. Sharkey, Ph.D. – Business Development
Dr. Sharkey is responsible for advising Iconic on all its business development efforts. Dr. Sharkey was appointed Executive Vice President of Shionogi Pharma in January 2010 after serving as VP of Business Development since November 2007. In his current role, Dr. Sharkey leads the group responsible for all activities related to identifying and assessing partnering opportunities, including mergers, acquisitions, licensing and divestments. Dr. Sharkey is an experienced healthcare professional having worked in both the pharmaceutical and medical device segments of the healthcare industry. He most recently served as the President of Ophthalmic International (OI), a device company focused on the non-surgical treatment of glaucoma. Prior to joining OI, Dr. Sharkey spent 16 years with Novartis Pharmaceuticals in increasing positions of responsibility on both the technical development and commercial sides of the business, eventually being appointed VP, BD&L for the Ophthalmic Business Unit. Dr. Sharkey earned a Ph.D. in Chemistry from the University of Buffalo and a B.S. in Chemistry from the State University College of New York at Oneonta.
Victor Gonzalez, M.D. – Principal Investigator
Dr. Gonzalez is the founder of Valley Retina Institute, P.A., a state of the art medical and surgical Vitreoretinal practice serving the Rio Grande Valley. He received his medical degree from Harvard Medical School and performed an internship at Cedars-Sinai Medical Center. His residency at the Doheny Eye Institute at Los Angeles County Hospital was followed by a Vitreoretinal Fellowship at the Massachusetts Eye and Ear Infirmary of the Harvard Medical School.
Dr. Gonzalez has 15 years of clinical research experience during which he has served as the Principal Investigator on 24 trials and the Sub-Investigator on 4 trials, including 14 AMD trials.
Christine Gonzales, M.D. – Principal Investigator
Dr. Gonzales received her medical degree from the University of California, San Fransisco and served an internship in the Department of Internal Medicine at the Virginia Mason Medical Center in Seattle. Her ophthalmology residency at the Bascom Palmer Eye Institute of Jackson Memorial Hospital in Miami was followed by a vitreoretinal fellowship at the Jules Eye Institute at UCLA, where she then became a professor of ophthalmology.
Dr. Gonzales has been practicing at the Retina and Vitreous Center of Southern Oregon in Ashland, OR since 2008. She has 8 years of clinical research experience during which time she has served as the PI on 14 trials and the Sub-I on 17 trials. Of these trials, 16 of them have been AMD trials.
John Wells, M.D. – Principal Investigator
Dr. Wells graduated from Washington and Lee University and attended Emory University School of Medicine in Atlanta, Georgia. He completed two years of internal medicine and three years of ophthalmology residency at Emory. Dr. Wells then underwent specialized fellowship training in the diagnosis and management of medical and surgical retinal diseases for two years at Moorfields Eye Hospital in London, England, under the tutelage of Alan Bird and Zdenek Gregor.
Since 1995 he has been in practice limited to the diagnosis and treatment of diseases of the vitreous, macula and retina. He has special expertise in the treatment of patients with age-related macular degeneration, diabetic retinopathy, macular hole, retinal detachment, and inherited retinal diseases such as retinitis pigmentosa and macular dystrophies.
Dr. Wells has 11 years of clinical research experience. He has served as the PI on 13 clinical trials and has been the Sub-I on numerous others. He has worked on a total of 9 AMD trials.
Brian Sippy, M.D. – Principal Investigator
Dr. Sippy received his medical and graduate degrees from the University of Southern California. His internship in internal medicine and ophthalmology at the University of Utah Health Sciences Center was followed by a residency in ophthalmology at Emory University School of Medicine. Dr. Sippy was the recipient of two fellowships at Emory, one in vitreoretinal surgery and the other in ophthalmic pathology.
Dr. Sippy joined the staff at Rocky Mountain Eye Center in Missoula, MT in August 2003 and specializes in vitreoretinal surgery, ocular melanoma and cataract implant surgery. He has 8 years of clinical research experience. During that time, Dr. Sippy has served as the Principal investigator for numerous trials including 6 AMD trials.
Manju Patel, M.D. – Medical Monitor
Manju Patel is an MD with 14 years of experience in medical practice as an ophthalmologist and 11 years of experience in the pharmaceutical industry. Her most recent position was as Chief Medical Officer at Optherion Inc. where she was responsible for clinical strategy for the company’s key areas of focus, Age related macular degeneration, Atypical Hemolytic Uremic Syndrome (aHUS) and Dense Deposit Disease (DDD or MPGNII). Manju’s previous roles in the pharmaceutical industry include Global Clinical Lead for Macugen at Pfizer where she played a critical role in the regulatory submission to the FDA and EMEA, which resulted in the approval of and launch of Macugen in these regions. Her work has included the therapeutic areas of ophthalmology, renal and genitourinary. A graduate of the University of the Witwatersrand, South Africa, Dr. Patel did her ophthalmology training at the University of Natal, South Africa and a pediatric ophthalmology fellowship at the Great Ormond Street Hospital for Sick Children in London, UK.
Henry J. (Hank) Kaplan, M.D. – Wet AMD Pre-Clinical Efficacy Studies
Dr. Kaplan is Evans Professor and Chairman, Department of Ophthalmology and Visual Sciences at the University of Louisville. Dr. Kaplan directs a program in experimental ophthalmology and is author or co-author on more than 200 scientific publications. He has led preclinical investigations on the effects of hI-con1™ in models of wet AMD. In addition to wet AMD, he specializes in uveitis and retinal transplantation. Dr. Kaplan also has an active clinical ophthalmology practice and has participated in the clinical evaluation of a number of ophthalmic drug candidates.
Dr. Kaplan and his team at the University of Louisville conducted numerous wet AMD pre-clinical efficacy studies using hI-con1 in a laser-induced CNV model in mice and pigs.
Timothy Olsen, M.D. – Wet AMD Pre-Clinical Efficacy Studies
Dr. Olsen is the F. Phinizy Calhoun Sr. Professor of Ophthalmology, the Chair of the Department of Ophthalmology, and the Director of the Emory Eye Center. Dr. Olsen’s clinical expertise is in age-related macular degeneration (AMD), diabetic retinopathy, complex retinal detachment surgery, and pediatric retinal disorders.
Dr. Olsen’s research is funded through the National Institute on Aging (NIA) at the National Institutes of Health (NIH). In conjunction with his key collaborators, Deborrah Ferrington, PhD, University of Minnesota, and Dr. Xiao Feng, MD, he has studied the proteomics of AMD. While director of the Minnesota Lions Macular Degeneration Center and with the assistance of the Minnesota Lions Eyebank, he and Dr. Feng developed the Minnesota Grading System (MGS) for AMD, which has won awards internationally.
Dr. Olsen and colleagues have characterized three modes of drug delivery to posterior segment tissues. First, while a fellow at Emory in Dr. Henry F. Edelhauser and Dayle Geroski’s lab, the transscleral route of drug delivery in human sclera was investigated. In conjunction with industry (iScience Interventional, Inc.), he developed a novel methodology for cannulatiion of the suprachoroidal space. Recently, as part of an NEI/NIH funded project with industry (Powerscope, Inc.), he and collaborators Amir Naqwi, PhD, Timothy Wiedman, PhD, and Chris Fandrey, developed a novel method of delivering drugs using aerosol nanoparticle delivery in the gas-phase of vitreoretinal surgery.
Dr. Olsen and his team at Emory are conducting a series of studies to fully characterize the nature of the immune response in the eye when hI-con1 is injected into a CNV model of wet AMD in pigs.
Alessandro Santin, M.D. – Cancer Pre-Clinical Efficacy Studies
Dr. Santin, a native of Italy, graduated with honors from the University of Brescia, Italy, where he also received his postgraduate training in Obstetrics & Gynecology. He held a fellowship in Gynecologic Oncology at the University of California, Irvine and an international fellowship in the Division of Gynecologic Oncology at the University of Arkansas for Medical Sciences, Little Rock, Arkansas. In 2000 he became a Clinical Assistant Professor and in 2004 an Associate Professor with tenure in the same division. Dr. Santin joined the Yale University faculty in the Section of Gynecologic Oncology as Professor in July 2008.
Among his many accomplishments, Dr. Santin was the recipient of the American Association of Cancer Research’s Young Investigator Award and the Italian Society of Gynecologic Oncologists Award for Translational Science. He has more than 100 original research and peer–reviewed publications, including multiple review articles and book chapters, and he has written extensively on a variety of gynecologic oncology topics, such as cancer of the ovary, endometrium and cervix, as well as tumor immunology and immunotherapy.
Dr. Santin’s clinical interests include cancer of the ovary, uterus, vagina, cervix and vulva; intraperitoneal chemotherapy, tumor immunology and immunotherapy; and tumor angiogenesis, radiation biology, and experimental therapeutics in gynecologic oncology.
His current research interests include immunotherapy for ovarian and endometrial carcinomas refractory to standard treatment modalities, development of therapeutic vaccines against Human Papillomavirus (HPV) infected genital tumors, and the use of monoclonal antibodies against chemotherapy–resistant gynecologic malignancies. Dr. Santin is a member of the Society of Gynecologic Oncologists, Chair of the Gynecologic Oncology Group’s phase II study of cetuximab treatment of cervical cancer, and a featured expert on HPV vaccines and cervical cancer for the news media.
Dr. Santin and his team at Yale University conducted a series of invitro studies to evaluate hI-con1 activity against uterine serous papillary adenocarcinoma (USPC) and clear cell carcinoma ovarian cancer, two highly aggressive gynecological cancers.
Trial Runners, LLC – Clinical Research Organization
Iconic selected Trial Runners, LLC as its CRO for its phase 1/2a wet AMD clinical trials. Trial Runners was founded in 2006 by Patrick Healy and Jill Healy in Dickinson, ND. Together they bring over 25 years of clinical research management experience. Since their launch in June 2006, Trial Runners has worked globally with more than 2200 patients (half of which were enrolled in wet AMD trials) across more than 15 clinical studies in all phases of development. Prior to joining Trial Runners, many members of its team worked on the pivotal trial for Macugen®, the first-in-class intravitreal treatment for wet AMD.
Mrs. Healy received her bachelors degree from North Dakota State University in 1996. After graduating, she worked at Schering-Plough and Hoffman-LaRoche as a monitor and lead CRA. In 2001, Mrs. Healy joined Eyetech Pharmaceuticals as the Associate Director of its Clinical Department. In addition to her responsibilities for managing Eyetech’s pivotal, phase 3 Macugen® clinical trial, she hired, trained, and mentored the company’s CRA staff personnel.
Mr. Healy received his bachelors degree from the State University of New York at Stony Brook in 1995, and his Masters of Public Health from the University of South Carolina School of Public Health in 1997. After graduating, he worked at Schering-Plough and Hoffman-LaRoche in various monitoring, CRA, and managerial roles. In 2001, Mr. Healy joined Eyetech Pharmaceuticals to co-manage the pivotal phase 3 clinical trial for Macugen®. He worked in Pfizer’s Department of Neurology managing post-marketing clinical trials for Relpax® before rejoined Eyetech in 2004 as Associate Director of Medical Strategy.
Laureate Pharma, Inc. – Contract Manufacturing Organization
Laureate Pharma, Inc. is Iconic’s commercial cGMP contract manufacturer. Laureate specializes in mammalian cell based monoclonal antibody and recombinant protein development, scale-up, and production for clinical and commercial supply. Laureate is a full service contract manufacturing organization (CMO) providing development and cGMP manufacturing services in its FDA registered facilities in Princeton, New Jersey. The company is dedicated to supporting the development and commercialization of biopharmaceutical, drug and diagnostic products for pharmaceutical, diagnostic and biotech companies.
The company provides a wide range of product development and manufacturing services from cell line optimization and process design to development of full-scale cGMP protein production, purification and aseptic filling, in addition to corresponding testing, validation, analytical and regulatory support.
Charles River Laboratories – GLP Safety Studies
Charles River has designed and implemented Iconic’s GLP safety studies. For more than 60 years Charles River has been helping global partners accelerate drug discovery and development by providing them with tailored research models and preclinical and clinical support services. Their offerings span the entire drug development process, from discovery through market approval, providing its clients a seamless partnership throughout.
From the global standardization of their research models, to the high standards they set for their professional team and their state-of-the-art facilities and technologies, Charles River can customize their products and services to meet customer’s specific research needs. With facilities around the world, Charles River has been the ideal partner for moving hI-con1 from animals to humans in a rational, cost-effective, and timely manner.
Althea Technologies Inc. – Drug Product Analytics
Dr. Alan Herman, Vice President of Product Development and Chief Scientific Officer of Althea Technologies, designed and managed the development of hI-con1’s drug product analytics package. Prior to joining Althea, Dr. Herman was the Senior Director of Quality Control at Tercica, Inc. From 2000 to 2003 he served as an industry consultant specializing in comparability. From 1989 to 2000, Dr. Herman was Amgen’s Director of Analytical Research & Development and later Director of Process Analytical Laboratories. From 1984 to 1989, Dr. Herman was a Scientist at Genentech in the Process Development and Pharmaceutical R&D departments. From 1977 to 1984, Dr. Herman was a Scientist in the vaccine research department of Merck & Co. Dr. Herman received his Ph.D. in 1975 in protein chemistry from Duke University. Dr. Herman completed his post-doctoral studies in tumor virus chemistry at Duke University in 1977.
David Guyer, M.D. - Advisor
Dr. Guyer is currently a venture partner at SV Life Sciences. Prior to that, Dr. Guyer was the chief executive officer, co-founder and a director of Eyetech Pharmaceuticals, Inc., a position he held for six years. Dr. Guyer led Eyetech through private financing rounds totaling approximately $170 million, completing a $157 million initial public offering and a secondary financing. The company also developed and gained FDA approval for Macugen, a product to treat macular degeneration, which Eyetech partnered with Pfizer in a deal valued at over $750 million. In 2005, Eyetech was sold to OSI for $900M. Prior to founding Eyetech, Dr Guyer was professor and chairman of the department of ophthalmology at the NYU School of Medicine.
Herbert M. (Bob) Pinedo, M.D. - Advisor
Dr. Pinedo is Professor of Medical Oncology at the Free University in Amsterdam and Vice chairman of the Board of the Dutch Medical Research Council. He is an internationally renowned oncologist who has previously tested many agents for their effects on cancer patients. Dr. Pinedo's work focuses on translational research, particularly with respect to drug resistance, angiogenesis and immunology. He serves on numerous editorial boards including Clinical Cancer Research. Dr. Pinedo currently serves on the boards of Bionumerik Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc and Jennerex.
Zhiwei Hu, Ph.D. - Advisor
Dr. Hu is a Research Scientist in the Department of Molecular Biophysics and Biochemistry at Yale University. He is a co-inventor of the hI-con1™ technology. He and his colleagues have published a number of scientific papers in the Proceedings of the National Academy of Sciences describing experiments elucidating the effects of hI-con1™.
E. Jonathan Soderstrom, Ph.D. – Director
Dr. Soderstrom is Managing Director of the Office of Cooperative Research at Yale University. Since 1996, he has participated in the formation and operation of more than 25 new companies. Previously, he was Director of Program Development for Oak Ridge National Laboratory (ORNL) and Director of Technology Licensing for Martin Marietta Energy Systems. Dr. Soderstrom was a founding board member and past president of the Association of Federal Technology Transfer Executives and a member of the Licensing Executive Society and Association of University Technology Managers.
William Konigsberg, Ph.D. – Director and Scientific Advisor
Dr. Konigsberg is a Professor in the Department of Molecular Biophysics and Biochemistry, at Yale University. He has been an ad hoc consultant to the National Science Foundation, the American Cancer Society and the Heart and Lung Institute of the National Institutes of Health. He is a member of the Sidney Kimmel Cancer Center Scientific Advisory Board. Dr. Konigsberg is a leading authority on tissue factor, the target of hI-con1™.
Robert Dornbush – Director
Mr. Dornbush currently serves as an executive consultant to senior officials at Southern California Edison, a division of Edison International. Prior to his engagement with Edison, he served a number of years as healthcare partner for a consulting firm in Silicon Valley. As former President and CEO of the Dornbush Group, he has extensive entrepreneurial experience in starting, developing and optimizing businesses in manufacturing and in distribution. He continues to participate as a partner in biotechnology, high technology, and real estate ventures.
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