NeuMedics is a Seattle Based start-up that is developing novel therapeutics to treat and slow the progression of sight threatening complications of diabetes, such as Diabetic Macular Edema (DME). Globally, 21 million people are estimated to live with DME and every year, there are 75,000 new cases of DME in the United States alone. It is the primary cause of new incidences of blindness among adults aged 20–74 years.
Neumedics core expertise lies in our capability to reformulate known molecules with proven efficacy and safety into proprietary products for new indications. The team has decades of drug development and clinical expertise, having come from biotech start ups, large pharma and the FDA.
Our business model has three strategically important foundational components that we expect will drive the company’s growth in the large, underserved ophthalmic disease market:
- Identify where the “Quality of Life” for a patient is or will be severely impaired unless treated with a more efficacious drug or in combination with already approved therapies.
- Identify and develop innovative compounds and products that leverages established science to disrupt the way a market operates and provides a creative and new solution to a problem.
- Will the drug address an unmet medical need and through the healthcare system reduce the reliance on hospitals while delivering the care patients desire.
We are guided by a management team of experienced professionals with more than 40 years of collective industry experience in executive management, drug development and regulatory approvals. We have the proven ability to successfully manage all aspects of drug development through all phases of preclinical and clinical investigations and to transition drug candidates from investigational agents into commercial products.
Iain Duncan, CEO
Thirteen years in small and start-up pharma in executive positions; 20 years in various fortune 50 Corporations. Expert in virtual startups and multi-national outsourcing. Previously VP Manufacturing and Supply Chain Operations, with Horizon Therapeutics and directly managed Product Development, Manufacturing, Quality Control, Distribution and Logistics functions. Mr. Duncan formulated and developed Horizons’ lead product, DUEXIS© (patent pending co-author). Co- founder of NeuMedics, (Patent issued; co-author) co-founder of Corus Pharma Inc. (Patent issued; co-author) and served as its V.P. of Operations until Corus was acquired by Gilead in August 2006 for $365M. Mr. Duncan has been directly involved with the FDA approval of 3 drugs which are now commercial and the MAA approval of 2 drugs. Prior to Corus he worked with Chiron and was responsible for the integration of Pathogenesis into Chiron following its acquisition for $750M.
William Schwieterman M.D., CMO, VP and Chief Medical Officer
Expert in the clinical development of a wide range of investigational therapeutic agents; spent 10 years as a Supervisor at the FDA and as a clinical reviewer on numerous biological and pharmaceutical-based agents including Enbrel, Remicade, Pegasys, Xigris and Zenapax; has written numerous FDA guidance documents; extensive input as consultant and advisory board member on multiple successful trials; led clinical development teams-including presentations at 3 positive advisory committee meetings-to achieving marketing approval of two drugs (pegloticase and droxidopa). Dr. Schwieterman is a board-certified internist and a rheumatologist.
Carl Osborne, D.V.M., VP Development
Over 19 years of experience in all phases of drug development and commercialization. Dr. Osborne has extensive experience in international regulatory affairs and quality systems design and implementation. He is a former reviewer, toxicologist, and compliance officer at FDA where he worked extensively with the Centers for Drug Evaluation and Research, Veterinary Medicine, and Biologics Evaluation and Research. Dr. Osborne is a veterinarian, and has been involved in the development of over 350 products worldwide.
Barbara Wirostko, M.D., Scientific Advisor and Co-Founder
A board-certified ophthalmologist and a fellow of the American Academy of Ophthalmology, Dr. Wirostko maintains an academic research and clinical practice with the University of Utah’s Moran Eye Center as a Clinical Adjunct Associate Professor in Ophthalmology. From 2006-2010, she was Senior Medical Director within the Specialty division at Pfizer in NY overseeing the glaucoma portfolio. She led and was awarded for a successful Phase 3 regulatory filing to the European regulatory agency (EMA) for a pediatric glaucoma indication. From 2010-2012, she served as CMO at Altheos Inc. She serves on various editorial boards, scientific advisory boards and is a member of the Glaucoma Research Foundation Science Committee, and a grant reviewer for CIRM and chairs the yearly GTC Ocular Diseases and Drug Development Conference. She completed her glaucoma fellowship at Cornell University, NY and received her Ophthalmology training as well as her medical degree at Columbia University, College of Physicians and Surgeons in NY. She is an active member and fellow of the American Academy of Ophthalmology, a longtime member of ARVO, Women in Ophthalmology, and local state societies.
Sophie J. Bakri, MD., is Professor of Ophthalmology and Director of the Vitreoretinal Surgery Fellowship at the Mayo Clinic
Dr. Bakri is a specialist in diseases and surgery of the retina and vitreous, in particular, age-related macular degeneration, diabetic retinopathy, and repair of complex retinal detachments. She undertakes both clinical and translational research in the pathogenesis and treatment of retinal diseases. Dr. Bakri completed a vitreoretinal fellowship at the Cleveland Clinic Foundation and her residency at Albany Medical College, New York. She graduated from the University of Nottingham Medical School, England, where she obtained her degree in Medicine and Surgery, and Bachelor of Medical Sciences. She is Board-Certified by the American Board of Ophthalmology. Dr. Bakri has authored over 110 peer-reviewed papers and 17 book chapters on retinal diseases. She is a principal investigator on numerous multicenter clinical trials on novel drugs for retinal disease. She is the Editor-in-Chief of the book “Mayo Clinic on Vision and Eye Health”, and is on the Editorial Board of the American Journal of Ophthalmology, Retina, Seminars in Ophthalmology and Clinical and Surgical Ophthalmology. She is an active member of the Macula Society, the American Academy of Ophthalmology and the American Society of Retinal Specialists. She has received an Achievement Award from the American Academy of Ophthalmology, an Honor Award from the American Society of Retina Specialists and is listed in Becker’s 135 Leading Ophthalmologists in America.
Karl Herrup, PhD is head of the Division of Life Sciences at Hong Kong University of Science and Technology
Dr. Herrup is a professor in the Department of Cell Biology and Neuroscience at Rutgers University and the recently appointed head of the Division of Life Sciences at Hong Kong University of Science and Technology. He received his bachelor’s degree from Brandeis University in Waltham, MA and his Ph.D. in Neuroscience from Stanford University in 1974. After two postdoctoral fellowships – in Neurogenetics at Children’s Hospital/Harvard Medical School, and in Neuropharmacology at the Biozentrum in Basel Switzerland – he joined the faculty of the Human Genetics Department of Yale Medical School in 1978. He became Director of the Division of Developmental Neurobiology at the E. K. Shriver Center in Waltham, MA in 1988. In 1992 he moved to Case Western Reserve University Medical School and University Hospitals of Cleveland where he directed the Alzheimer’s Center from 1999 through 2005. In 2006 he moved to the Piscataway/New Brunswick campus of Rutgers University where served as chair of the Department of Cell Biology and Neuroscience from 2006-2012.
Timothy P. Walbert
Mr. Walbert has been the President and Chief Executive Officer of Horizon Pharma Inc since 2008 and its Chairman since 2010. Mr. Walbert served as president, chief executive officer and director of IDM Pharma, Inc., a public biopharmaceutical company that was acquired by Takeda America Holdings, Inc., or Takeda, in June 2009. Prior to IDM, Mr. Walbert served as executive vice president, commercial operations at NeoPharm, Inc., a public biopharmaceutical company. From 2001 to 2005, Mr. Walbert served as divisional vice president and general manager, immunology, where he led the global development and launch of the multi-indication biologic HUMIRA, which exceeded $10.0 billion in 2013 sales, and divisional vice president, global cardiovascular strategy at Abbott, now AbbVie. From 1998 to 2001, Mr. Walbert served as director, CELEBREX North America and arthritis team leader, Asia Pacific, Latin America and Canada at G.D. Searle & Company. From 1991 to 1998, Mr. Walbert also held sales and marketing roles with increasing responsibility at G.D. Searle, Merck & Co., Inc. and Wyeth. Mr. Walbert received his B.A. in business from Muhlenberg College, in Allentown, Pennsylvania. Mr. Walbert serves on the board of directors of XOMA Ltd. (NASDAQ: XOMA), Raptor Pharmaceutical Corp. (NASDAQ: RPTP), Egalet Limited (NASDAQ: EGLT), the Biotechnology Industry Organization (BIO), the Illinois Biotechnology Industry Organization (iBIO), ChicagoNEXT, a World Business Chicago (WBC) led council of technology leaders and the Greater Chicago Arthritis Foundation. Mr. Walbert was also recently appointed by Illinois Governor Pat Quinn to the Illinois Innovation Council.
Mr. Simonetti has been President, Chief Executive Officer, and a director of VLST Corporation (VLST), a privately held biotechnology company dedicated to advancing immunotherapy treatments for cancer and autoimmune diseases, since November 2005. From 1999 to 2005, Mr. Simonetti was employed at Dendreon Corporation, a NASDAQ-listed biotechnology firm, serving in various capacities including Chief Financial Officer, Senior Vice President of Finance, and Treasurer. From 1991 to 1998, he was employed at Amgen Inc., serving as Vice President of Operations and Finance and Director of Colorado Operations of Amgen BioPharma. From 1984 to 1991, he worked at Genentech, Inc., first as a scientist in its Medicinal and Analytical Chemistry Department and later as a financial analyst and group controller. From 2005 to 2011, Mr. Simonetti served on the Board of Directors of Icagen, Inc. based in Durham, North Carolina. He is a member of the Deans executive advisory board for the Albers School of Business and Economics at Seattle University. Mr. Simonetti received a Master of Science degree from the University of California, Davis and a Master of Business Administration degree from the University of Santa Clara.