Description
The Institute for Pediatric Innovation (IPI) is a nonprofit whose mission is to catalyze development of medical products for the care of children. One of IPI’s major efforts is its Pediatric Pharmaceutical Reformulation Program, which focuses on existing medicines that already have FDA approval, and that require reformulation to enhance their safe, effective, and compliant use in children. IPI has partnered with Children’s Mercy Hospital and together they are utilizing novel strategies for developing drug products that are specifically adapted for children. In doing so, IPI and CMH are playing a leadership role in transforming the pediatric market from an orphan that has been largely ignored by industry into a magnet for investment and innovation by industry, investors, philanthropy and government.
IPI works in consultation with the Federal Drug Administration, National Institute of Child Health and Human Development, United States Pharmacopeia, World Health Organization and other public and private organizations, to define needs and work toward the development of new medicinal products for children. IPI will work with partnering organizations to help develop initial formulations, and with commercial entities that can convert concepts into products for pedicatric use that are manufactured and marketed according to Good Manufacturing Practice (GMP) standards.
Key Staff
Stephen Spielberg, MD, PhD, is the Principal Investigator for IPI's Pediatric Pharmaceutical Reformulation Program. Dr. Spielberg is with Children's Mercy Hospital in Kansas City where he is the Marion Merrell Dow Chair in Pediatric Pharmacogenomics and Director of Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital. Most recently, Dr. Spielberg was the Dean of Dartmouth Medical School and is a Professor of Pediatrics, and of Pharmacology and Toxicology. He is a leader in pediatric research and an internationally recognized children's health advocate.
Don Lombardi, is the President/CEO and Founder of IPI. Mr. Lombardi, established the Intellectual Property Office at Children’s Hospital Boston and built it over 15 years to a highly successful technology transfer organization. His 16-person department generated tens of millions of dollars in license revenue based on six licensed medical products on the market and twelve more in clinical development. Under his leadership, the Intellectual Property Office instituted exemplary business practices for case and patent management, technology marketing, financial management, staff development, compliance and quality assurance.
Goals
• Secure third party funding for developing Enalapril and Amlodipine and initiate product development
• Complete Product Opportunity Analyses for five additional products in the cardio-renal care portfolio, target funding sources for these products, and develop funding proposals.
• Reconvene the United States Pharmacopoeia stakeholders conference to review progress to date, discuss additional areas of product need, and further assess strategies to make pediatric reformulations for drugs commercially feasible.
• Participate with CMH, KU, Beckloff Associates, and Kansas BioScience Authority in evaluating the feasibility of a for-profit entity located in greater Kansas City to facilitate commercial development of reformulated products for pediatric care.
To learn more about the IPI Pediatric Pharmaceutical Reformulation Program, please contact Jean-Paul Chaurand at 816-627-3403 or visit IPI’s website at http://www.pediatricinnovation.org/.
