Pharmaceutical Clinical Trials in New York in State Taxes and More Than $646 Million in Federal • Clinical Trials Are Responsible for 45 to 75 Percent of Taxation
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Research in Your Backyard Developing Cures, Creating Jobs PHARMACEUTICAL CLINICAL TRIALS IN Dots show locations of clinical trials in the state. NEW YORK Executive Summary Clinical Trials in New York State • Biopharmaceutical research companies are “The biotechnology industry, including conducting or have conducted more than 6,200 biopharmaceutical research and the clinical trials of new medicines in collaboration development of new medicines, is an important with the state’s clinical research centers, university and growing part of New York State’s economy. medical schools and hospitals (1999 to present). Biopharmaceutical research firms frequently • Of the 6,282 clinical trials, 3,255 target or have work in partnership with hospitals, medical targeted the nation’s six most debilitating chronic schools and other research institutions, which diseases—asthma, cancer, diabetes, heart disease, facilitates the participation of New Yorkers in mental illnesses and stroke. thousands of clinical trials throughout the state. Biopharmaceutical research is also a boon to • These 6,282 New York-based clinical trials local economies in New York, supporting an represent approximately one-third of all clinical estimated 201,000 jobs and generating millions trials in the United States. in tax revenues.” —Nathan Tinker, Executive Director, “For many patients with chronic health problems New York Biotechnology Association and other serious medical conditions, the opportunity to participate in clinical trials for new treatments offers great hope, promise, and piece of mind. With thousands of clinical trials Economic Benefits of Clinical Trials being conducted all over New York State, patients in New York State have access to additional therapeutic options that would not otherwise be available to them. • Biopharmaceutical research companies have been an important source of jobs, tax revenue and research These additional therapeutic options provide an spending in New York. alternative for patients where other treatments have failed. Clinical trials help save patients’ • A study by Archstone Consulting found that in lives and paves the way for cures—leading our 2008 the industry supported more than 201,000 communities to a better, healthier future.” jobs throughout the state. — Geri Barish, President, • Employees working directly for the companies were 1 in 9: The Long Island Breast Cancer Action Coalition paid $2.8 billion, leading to more than $99 million 2 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN NEW YORK in state taxes and more than $646 million in federal • Clinical trials are responsible for 45 to 75 percent of taxation. the $1.2 billion average cost of developing one new cutting-edge biotechnology medicine. • Biopharmaceutical research firms that year also invested $2.1 billion in research and development • Biopharmaceutical companies frequently hire local and supported $50.9 billion in products and research institutions to conduct the tests. services. • For patients, the trials offer another potential • Company employees in New York include life therapeutic option. Clinical tests may provide a new sciences researchers, management executives, office avenue of care for some chronic disease sufferers and administrative support workers, engineers, who are still searching for the medicines that are architects, computer and math experts and sales best for them. representatives. • All clinical trials must be reviewed and approved by an Institutional Review Board (IRB), an About Clinical Trials independent committee of physicians, statisticians, local community advocates and others to ensure • In the development of new medicines, clinical a trial is ethically conducted and patient rights are trials are conducted to prove therapeutic safety protected. and effectiveness and compile the evidence needed for the Food and Drug Administration (FDA) to • Clinical trial progress reports must be submitted at approve treatments. least annually to the FDA and the IRB. • Clinical tests of new drugs are conducted in three • All facilities that conduct or support biomedical phases and account for an average of seven of the research involving patients must comply with 10 to 15 years it takes to take a new drug from federal regulations and have an IRB. development to patients. • Clinical trials for a given drug or treatment involve Clinical Trials and Chronic Diseases thousands of volunteer patient participants, and the • Chronic diseases pose the greatest threats to our generation of tens of thousands of pages of technical nation’s health and our ability to treat and prevent and scientific data. medical conditions. • According to the Centers for Disease Control and Clinical Trials in New York since 1999— Prevention, today, in the United States: Completed and Active • Patients with chronic diseases account for All Clinical Trials Six Major Chronic Diseases 75 cents of every dollar spent on health care. 6,282 3,255 • Chronic diseases are the leading cause of Source: www.clinicaltrials.gov Note: Search criteria = New York, Phase I, II, III; industry only. death and disability. Search performed 4/17/2012. • Chronic diseases are a leading driver of rising health care costs with expenses totaling billions of dollars every year. DEVELOPING CURES, CREATING JOBS • A PARTNERSHIP BETWEEN BIOPHARMACEUTICAL COMpaNIES AND STATE RESEARCH INSTITUTIONS 3 Clinical Trials in New York Communities Location Asthma Cancer Diabetes Heart Disease Mental Illness Stroke Albany 1 22 11 7 6 3 Amherst — 2 — 1 4 — Binghamton — 1 2 1 — 1 Bronx 2 51 4 12 8 3 Brooklyn 3 8 7 7 25 1 Buffalo — 59 9 10 9 5 Commack — 17 — — 2 — Fresh Meadows — 6 — — 11 — Great Neck 2 9 1 — 1 — Kingston — 2 1 3 2 1 Lake Success 1 45 — — — — Manhasset — 7 — 2 3 — Mineola 2 4 6 3 — 2 New Hyde Park 1 21 5 1 — — New York City 5 331 23 34 64 9 Poughkeepsie — 9 — 4 — 2 Rochester 5 42 7 11 38 5 Staten Island — 10 1 1 2 — Syracuse 4 32 4 5 2 1 Troy — 10 1 3 — — Utica 2 7 — 3 — — West Seneca — — 6 2 3 2 White Plains — 7 1 1 1 1 Williamsville — 1 1 6 — 2 Source: www.clinicaltrials.gov Note: Search criteria = New York, Phase I, II, II; industry only. Search performed 4/17/2012. See Appendix for detailed information about these clinical trials. Disease columns will not match totals in the Appendix because some clinical trials are recruiting in more than one city. 4 PhRMA • PHARMACEUTICAL CLINICAL TRIALS IN NEW YORK University of Rochester-Strong Memorial Clinical Trials for Top Chronic Diseases Hospital in Rochester, the Joslin Diabetes Center in Syracuse, and the University of Clinical Trials Chronic Disease All Clinical Trials Still Recruiting Buffalo in Buffalo. Asthma 67 12 • Many of the medicines being clinically tested here are new-generation biotechnology treatments. Cancer 1,917 481 Diabetes 355 46 Heart Disease 242 50 Mental Illness 623 111 “These are challenging economic times. Our growing biotechnology and biopharmaceutical Stroke 51 16 sector is a critical part of New York’s past, Total 3,255 716 present and future. We need to ensure that the Source: www.clinicaltrials.gov research that takes place across the state in Note: Search criteria = New York, Phase I, II, III; industry only. Search performed hospitals, medical schools and other institutions 4/17/2012. Some clinical trials appear in more than one disease category. is fully supported. This research is what sets us apart from other regions in the country and it • Biopharmaceutical research companies are generates huge numbers of jobs and investment developing new medicines to help treat those into New York.” conditions that are taking an unprecedented toll — Mike Oates, President and CEO, on American lives, and many of these medicines Hudson Valley Economic Development Corporation; are being tested today in clinical trials throughout NY BioHud Valley New York. • Since 1999, biopharmaceutical research companies are sponsoring or have sponsored 3,255 clinical trials of potential new medicines in New York state alone for asthma, cancer, heart disease, stroke, diabetes and mental illnesses. Of these trials, 716 are either not yet recruiting or are just now seeking New York patients. • Many of the state’s clinical tests involve collaborations with such respected local institutions as Mount Sinai School of Medicine, Beth Israel Hospital, New York University Medical Center, and Columbia University Medical Center in New York City, the DEVELOPING CURES, CREATING JOBS • A PARTNERSHIP BETWEEN BIOPHARMACEUTICAL COMpaNIES AND STATE RESEARCH INSTITUTIONS 5 Clinical Trials in New York Clinical tests of new medicines are a vitally important part of the drug development and approval process—they ac- Clinical Trials for Top Chronic Diseases count for 45 to 75 percent of the $1.2 billion average cost Clinical Trials Chronic Disease All Clinical Trials of developing a new drug and are conducted to determine Still Recruiting the safety and effectiveness of that treatment in patients. Asthma 67 12 Cancer 1,917 481 Some trials are also conducted to compare existing treat- ments and some are done to learn if a drug is appropriate Diabetes 355 46 for a different patient population, such as children. Still Heart Disease 242 50 others are conducted to find ways to make existing ap- Mental Illness 623 111 proved drugs more effective and easier to use with fewer Stroke 51 16 side effects. Total 3,255 716 It’s essential that trials be conducted properly so that Source: www.clinicaltrials.gov Note: Search criteria = New York, Phase I, II, III; industry only. Search performed clinicians and drug reviewers can develop accurate as- 4/17/2012. Some clinical trials appear in more than one disease category. sessments of the efficacy and safety of medicines used by patients. The FDA is a vigilant regulatory agency and its around the country. In New York, biopharmaceutical pharmaceutical review officers are effective in detecting companies have the opportunity of conducting trials flawed information. at the states’ well-respected university medical schools, comprehensive cancer centers and clinical trial research Questionable or confusing data can lead to lengthy delays centers.