Companies are downsizing not only in terms of people, but in terms of the number of products they can reasonably support the development of
Boston, MA (Vocus) May 8, 2009
Children's Hospital Boston launched a new Technology Development Fund aimed at advancing promising early-stage hospital technologies, such as drugs, diagnostic tests and medical devices. The program will ultimately spend more than $1 million per year to fund projects that are not traditionally carried out in academic labs but are necessary for technology validation, including large-scale animal studies, prototype development and advanced pre-clinical testing.
Traditionally, research institutions often partnered with companies to carry promising laboratory findings into preclinical and clinical development, which can be a lengthy and expensive process. Today, the changing business climate is evaporating interest in early-stage technologies. "Companies are downsizing not only in terms of people, but in terms of the number of products they can reasonably support the development of," says Erik Halvorsen, Ph.D., director of Technology and Business Development at Children's. "If the number of programs they can support are limited, they want them to be less risky and at a later stage in their development."
Innovations coming out of the labs at academic institutions and research hospitals are considered early stage - generally not having been validated in animal models or with clinical data. Current statistics show that the average cost and time to develop a drug is now estimated at $1 billion and 10+ years (Pharmaceutical Manufacturers Association/Tufts Center for the Study of Drug Development: http://www.phrma.org/files/2008%20Profile.pdf) with fewer than 10 percent of investigational new drugs filed for new molecular entities (NME) ever progressing beyond the investigational stage to approval (From FDA: http://www.fda.gov/cder/guidance/6384dft.htm). The combination of these factors has created a "gap" between National Institute of Health (NIH) funded basic research and the late stage technologies now sought by companies and investors.
In order to address this gap and fulfill its mission to increase the translation of its research into potentially life saving products, Children's has decided to take action by launching the Technology Development Fund--even in the current challenging economic times. Combined with Children's Translational Research Program, these resources provide a complementary source of stimulation and facilitation for development of preclinical, and ultimately, human translational trials seeking to improve the care of patients with serious diseases.
"While the idea of a technology development fund is not novel, the approach Children's is taking in setting up the fund certainly is," says Halvorsen.
To narrow the gap and provide a clear path to market for its innovations, Children's is implementing a three pronged approach that combines an investment of capital into the technology, an external advisory board, comprised of industry leaders in therapeutic, diagnostic and device product development, and a network of preferred contract research organizations (CROs) to execute the project plan.
The external advisory board will work with the hospital to select promising technologies for development and, along with the investigators, generate a specific project plan. The hospital will then engage CROs to carry out the plan-which cannot typically be done in a hospital environment. To insure that milestones are being adequately met, the hospital also intends to take an active role in managing the awarded projects. The newly appointed Technology Development Manager, Monique Yoakim-Turk, Ph.D., will work with members of the advisory board who will play a mentorship role to selected projects--coordinating the projects, communication and deliverables between the hospital, the investigators and the CROs.
Collaborations and licenses through Children's Technology and Innovation Development Office (formerly the Intellectual Property Office) have produced nine major products that are now on the market, including a medical device to close holes in the heart and two anti-cancer therapies. In 2008, research funding at Children's Hospital Boston totaled over $180 million and TIDO received 116 Invention disclosures and executed 20 licensing and 37sponsored research and clinical trial agreements with industry.
The Children's Hospital Boston Technology Development Fund Advisory Board includes:
Dean Banks, MBA, CEO Connective Orthopeadics
Alan Crane, MBA, Venture partner, Polaris Venture Partners
Russ Granzow, VP Strategic Business Dev, Philips
Stanley N. Lapidus, Director/Founder/Chairman of the Board, Helicos Biosciences Corp
Larry Miller, MD, Founding Partner, Mediphase Funds
Stuart Pollard, PhD, VP Scientific and Business Strategy, Alnylam
Ken Rhodes, PhD, VP Discovery Neurobiology, Biogen Idec
Jay Schnitzer, MD, PhD, Associate Chief Medical Officer, VP, Boston Scientific Corp; Joseph Smith, MD, PhD, FACC, VP Emerging Technologies, J&J
Beverly Teicher, PhD, VP Oncology Research, Genzyme Corp
Josh Tolkoff, MS Eng, Managing Director, Ironwood Capital Management, LLC; Daphne Zohar, Founder, Managing Partner, PureTech Ventures
Children's Hospital Boston is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 13 members of the Howard Hughes Medical Institute comprise Children's research community. Founded as a 20-bed hospital for children, Children's Hospital Boston today is a 396-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about the hospital and its research visit: http://www.childrenshospital.org/newsroom.