Stem cell program business plan
Leonard Zon, MD, and George Q. Daley, MD, PhD, launched the Stem Cell Program at Boston Children’s Hospital in 2004. These two physician-scientists had served on multiple corporate and nonprofit boards, and had experience as founding members of biotech start-ups.
They recognized the value of applying sound business principles and strategies to the new research program. In a startup, the process of planning is very efficient and every detail is taken into consideration, and they wanted to echo that process with the new program. Drs. Zon and Daley presented this concept to the Stem Cell Task Force, an advisory group made up of business, philanthropic, and biotech leaders with whom they meet regularly.
The plan lays out the milestones and investments necessary to bring the program’s first stem cell therapy to clinical trials within five years and deliver renewed hope to patients. Because research and especially stem cell science is an incredibly fluid and growing area of research, the business plan is designed to be flexible enough to accommodate changes in science, technology, and research options without compromising the goal. Once a year, the plan is reviewed in detail with the Stem Cell Task Force, progress is assessed, and essential changes to the plan are made based on changes in science.
hESC Research Review Process
Proposals are reviewed to insure that scientific, institutional, and legal standards will be appropriately met in the course of the research. The hospital’s Committee on Clinical Research (IRB) and the Office of Research Administration conduct a rigorous and detailed review of each hESC research proposal. These groups and others at the hospital provide ongoing counsel to researchers and physicians around all aspects of stem cell research.
As recommended by the National Academy of Sciences, all applications to conduct hESC research at Boston Children’s Hospital are also reviewed by an Embryonic Stem Cell Research Oversight Committee (ESCRO), which includes public representatives as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in human embryonic stem cell research.
No hESC work can be undertaken at Boston Children’s without project specific authorization from the ESCRO, the institutional IRB, and the Office of Research Administration.
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