Contact Information: Institute for Pediatric Innovation contact: Ross Trimby COO 617-401-2375 Press contact: Barbara Heffner CHEN PR, Inc. 781-672-3112
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
| Source: Institute for Pediatric Innovation
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 (www.pediatricinnovation.org) 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.