The Parkinson's Pipeline Project was initiated in 2001 in response to the lengthy, rigorous process of science, which has provided people with so many medical miracles, and to the trends in research and politics.  Spurred by increases in research funding and the resulting advances of science, the project focuses on working with industry to deliver the cure.  As illustrated in the diagram, the project endeavors to fill the gaps between scientific research and new treatments and between scientific discovery and cures for patients. Advances in Research Funding and Science The emphasis on brain science in the "Decade of the Brain", along with continually growing investments in basic science at NIH and elsewhere, are adding knowledge of neuro-science an accelerated rate.  The burgeoning reservoir of new scientific knowledge is ripe for translation into dramatic improvements in treatment for a number of neuro-degenerative diseases. Parkinson's in particular is poised for a breakthrough. Beginning with the passage of the Udall Act in 1997, the PD community has been successful in raising awareness and obtaining public research funding for PD. Indeed more is known about Parkinson's disease than any other brain disease, and in the context of large and growing (public and private) investments in bio-medical science, PD has become a target of emphasis by the National Institutes of Health (NIH). The NIH Parkinson's Research Agenda adopted in 2000 calls for $950M in new research funding over 5 years, including significant efforts in clinical trials and collaboration with industry.  Dr. Zerhouni, appointed Director of the NIH in 2002, has now targeted PD to become the example of a  paradigm of disease oriented research with an emphasis on translational research and coordination of efforts across Institutes. In a strong partnership with the NIH, Parkinson's advocates work to keep attention focused on results meaningful to patients.  The first item of business in the NIH-PD Community partnership is collaboration on recruitment, retention and protection of  human subjects in clinical trials.   Advocacy and Industry When advocates in Washington met in 1999 with Dr. Harold Varmus, Director of NIH, he said, "you should be lobbying industry."  Working from the knowledge produced by science (NIH’s primary mission), he viewed the role of industry as developing, manufacturing and distributing the treatments. Now, ever closer to a cure, advocates are enlisting private industry to widen the battle. The dynamics of the pharmaceutical industry are an important element in the delivery of the cure. Development of a new drug is a very long and costly endeavor with highly uncertain outcome. Murphy’s law, “whatever can go wrong will go wrong,” is in full force when it comes to intervening in the biochemistry of the brain. In addition corporate strategies, investor expectations, and the size, maturity, and profitability of the company are also important factors in determining the amount of investment devoted to developing a drug.  Considerable research efforts are underway by the pharmaceutical industry. Based on available information, we have compiled a comprehensive listing of translational and clinical research underway by private industry including stage of development and enrollment information where applicable: Drugs in Development for Parkinson's Disease The Pipeline Starting from basic science the hunt for new treatments requires a lengthy process of experimental and translational research and clinical evaluation by sponsors, who are mostly in the pharmaceutical and biotechnology industry, to create new drugs and procedures.  This process is governed by regulatory agencies, such as the FDA (U.S. Food and Drug Administration) and the EMEA (European Medical Evaluation Agency), who set standards for the demonstration of safe and effective use of new treatments by humans before they are available to the public.  The translational research process alone takes a minimum of five years, usually more. The clinical research process usually takes another five or more years.  According to the Tufts Center for the Study of Drug Development, the average time from scientific discovery to approval is now 14.2 years.  Neurological treatments are longer than the average. As the ultimate customer of both the regulatory agencies and Industry, patient groups have a stake in the results of the evaluation process for new treatments.  Science is inherently slow, and for those with a serious degenerative disease time is an enemy.  Patient groups have common interests with pharmaceutical manufacturers, who have time limited patent rights, to expedite this process. Actualization of a cure (See Illustration) for Parkinson's disease involves a series of steps starting with translation of basic research into medical interventions, which must then be proven to be safe and effective, and lastly, must be accessible to the population.  All the science of the NIH and private foundations plus all the resources of private industry available to discover and create a breakthrough treatment are funneled through a critical evaluation and review process of 10 to 15 years or more by the FDA.  Even then the cure is not automatically available to everyone; it must be filtered through the health care system before it reaches patients.  The pipeline project and the companion  Quadpac (Quality Access and Delivery of Parkinson's Care) program are designed to take those extra steps to realize the cure.