SOURCE: Institute for Pediatric Innovation

January 28, 2008 09:00 ET

Dr. Stephen Spielberg Joins Institute for Pediatric Innovation to Launch Pediatric Pharmaceutical Reformulation Program, Funded by Children's Mercy Hospitals and Clinics

Distinguished Pediatrician and Pharmacologist to Lead Pioneering Program to Accelerate Development of Pharmaceuticals Tailored for Children

CAMBRIDGE, MA--(Marketwire - January 28, 2008) - The Institute for Pediatric Innovation (IPI), Inc., a nonprofit focused on catalyzing the commercialization of products optimized for pediatric care, today announced the appointment of Dr. Stephen Spielberg to lead the organization's newly formed Pediatric Pharmaceutical Reformulation Program. Dr. Spielberg will serve as Principal Investigator for the five-year program, which will focus on tailoring existing pharmaceutical products for children's needs.

Dr. Spielberg was most recently 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.

IPI's Pediatric Pharmaceutical Reformulation Program will focus its efforts on existing drugs that already have FDA approval, are off patent and require reformulation into different dosages or delivery mediums to make them safe and effective for children.

Children's Mercy Hospitals and Clinics, recognized as one of the best pediatric medical centers in the nation, will provide initial funding for the program. In addition, Children's Mercy, along with other founding members of IPI's Consortium of Pediatric Hospitals, will dedicate staff resources to the program, supporting clinical trials and drug reformulation activity. The Consortium includes University Hospitals Rainbow Babies and Children's Hospital and the Lucile Packard Children's Hospital at Stanford as additional founding members.

"Pediatricians often need to prescribe drugs that have not been fully tested or made available in the best form for use with children," explained Don Lombardi, IPI's CEO and founder. "Everyone agrees that children deserve the same level of consistency and effectiveness in their medications as adults. This program aims to bring together resources and experts from the relevant public, private, nonprofit and for-profit entities to accelerate the development and testing of pharmaceuticals that will provide maximum value to kids."

Dr. Spielberg added, "The pediatric community is making tremendous progress on this issue as a result of the Best Pharmaceuticals for Children Act, the World Health Organization's 'Make Medicines Child Size' campaign and other progressive initiatives. But many medicines are still not optimally formulated for children. Having information on the right dose of a medicine for children is not sufficient. Properly formulated, validated products are needed to accurately and safely give medicines to children of different ages. I've joined IPI because I believe the timing is right, the technology is available and the partnerships are in place to drive real advances that can benefit children."

"Children's Mercy has been recognized for many years as a national leader in clinical pharmacology, so we are excited to team up with our partners at IPI to concentrate our efforts on bringing appropriate reformulated pharmaceuticals to the care of children," said Randall O'Donnell, President and CEO of Children's Mercy Hospitals and Clinics. "Dr. Spielberg's involvement with this project is a welcome step in our efforts to provide the best possible health care for children."

The Pediatric Pharmaceutical Reformulation Program: Initial Focus

IPI will be guided by its hospital consortium, a panel of experts and other collaborating organizations to define the most critical unmet clinical needs for better formulated drugs for children. The team, led by Dr. Spielberg, will set priorities for the development of the identified pharmaceuticals according to potential for clinical impact, formulation development requirements, clinical testing and regulatory pathway, and commercialization considerations. For the selected products, IPI will use novel collaboration strategies to generate funds from philanthropic, government, investor and corporate sources to underwrite development, regulatory approval and testing of the drugs.

About Dr. Stephen Spielberg

Dr. Spielberg served as Dean of Dartmouth Medical School from 2003 to 2007. Before joining Dartmouth, he was vice president for pediatric drug development at Johnson & Johnson Pharmaceutical Research and Development. His career in pediatric clinical pharmacology and human pharmacogenetics has included faculty and leadership positions at Johns Hopkins School of Medicine, the Hospital for Sick Children (University of Toronto) and Merck Research Laboratories. He was chair of the Pediatric Task Force for PhRMA, represented the pharmaceutical industry on the FDA Pediatric Advisory Subcommittee and on pediatric legislative initiatives in the U.S. and European Union, was the Rapporteur for the Pediatric ICH Initiative, ICH E-11, and was president of the American Society for Clinical Pharmacology and Therapeutics (2006). He has served as editor or on the editorial boards of numerous journals and is on the board of directors of the Foundation for the National Institutes of Health. Dr. Spielberg earned an AB degree in biology from Princeton University and an M.D. and Ph.D. (Pharmacology) from the University of Chicago.

About Children's Mercy Hospitals and Clinics

Children's Mercy Hospitals and Clinics is a 314-bed not-for-profit pediatric health center based in Kansas City, Mo. Founded in 1897, it has consistently been ranked as a top children's hospital nationally by Child magazine, which last year named its emergency room one of the top five in the nation. In addition, Children's Mercy was the first hospital in Kansas and Missouri to receive Magnet redesignation in 2007 for excellence by the American Nurses Credentialing Center. Its Pediatric Clinical Pharmacology program is the largest of its kind and is a cornerstone of a comprehensive research program.

About the Institute for Pediatric Innovation (IPI)

The Institute for Pediatric Innovation ( is a nonprofit organization that was formed to improve the health of children by increasing the availability of innovative medical products with the unique attributes required for pediatric care. IPI seeks to transform pediatric healthcare from a neglected orphaned market to a magnet for industry and investor interest. IPI is led by an experienced team of experts in licensing technology in pediatric medical care, commercializing medical technology, and marketing medical devices and pharmaceutical products. To date, IPI has received support from its consortium members along with the Ewing Marion Kauffman Foundation, Children's Medical Ventures, Inc., AGA Medical and Oxford Bioscience Partners.

Contact Information

  • Institute for Pediatric Innovation contact:
    Ross Trimby
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    Press contact:
    Barbara Heffner
    CHEN PR, Inc.
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