Developing Cures, Creating Jobs - PhRMA
Research in Your BackyardDeveloping Cures, Creating JobsPHARMACEUTICALCLINICAL TRIALS IN THEPIEDMONT TRIAD REGIONDots show locations of clinical trials in the region.
Executive SummaryClinical Trials in the Piedmont Triad Biopharmaceutical research companies areconducting or have conducted more than 2,000clinical trials of new medicines in the PiedmontTriad in collaboration with Wake Forest UniversitySchool of Medicine, clinical research centers andhospitals (1999 to present). The Piedmont Triadconsists of 12 North Carolina counties, including:Alamance, Caswell, Davidson, Davie, Forsyth,Guilford, Montgomery, Randolph, Rockingham,Stokes, Surry and Yadkin. Of the more than 2,000 clinical trials, 902 havetargeted the nation’s six most debilitating chronicdiseases—asthma, cancer, diabetes, heart disease,mental illnesses and stroke.Economic Benefits of Clinical Trialsin North Carolina“The fact that we have top-notch university medicalschools, hospitals and specialty treatment centersin the 12-county Piedmont Triad has made ourregion a center of clinical research. And thatdistinction should cause more than a few ripplesof excitement, considering the resulting benefitsto patients and the regional economy. Since 1999,institutions like Wake Forest University and ForsythMedical Center in Winston-Salem, AlamanceRegional Cancer Center in Burlington and MosesH. Cone Regional Cancer Center in Greensboro haveconducted 2,007 clinical trials of potential newmedicines. Over 900 of those trials have targetedour most devastating chronic diseases—heartdisease, stroke, cancer, diabetes, mental illnessesand asthma.”— Dr. Johnny L. Williams, MDPresident, Old North State Medical Society Biopharmaceutical research companies have been asource of jobs, tax revenue and research spending inNorth Carolina, including the Piedmont Triad. A study by Battelle Technology Partnership Practicefound that in 2011 the industry supported morethan 226,000 jobs throughout the state, some ofthem in the Piedmont Triad. Wages and benefits for employees whose jobs weresupported by the biopharmaceutical sector resultedin about 787 million in federal taxation and 137million in state taxes.2 Biopharmaceutical research companies supportedthe generation of 50.3 billion in economic activityin the state two years ago, including the directeconomic output of the sector itself, the output ofthe sector’s vendors and suppliers and the outputgenerated by the buying power of its workforce. Company employees in North Carolina include lifesciences researchers, management executives, officePhRMA PHARMACEUTICAL CLINICAL TRIALS IN THE PIEDMONT TRIAD
“It is gratifying that biopharmaceutical companiesand local research institutions have includedmental illnesses as a target in their clinical trialsof new therapies in the Piedmont Triad. Over100 trials just in the Piedmont region alone havebeen aimed at mental health conditions and thatgives many of our patients renewed hope thateffective new medications are being developed.There is an acute need for improved treatmentthroughout North Carolina and in the PiedmontTriad. Statewide, about 335,000 adults and almost100,000 children live with serious mental illnessesand in the Triad area, 743 residents died fromsuicide and Alzheimer’s disease in 2012. We urgepharmaceutical sector researchers in our state tocontinue their efforts to develop new medicines.”— Sally CameronExecutive Director, NC Psychological Associationand administrative support workers, productionworkers, engineers, architects, computer and mathexperts and sales representatives. Biopharmaceuticalcompanies also supported the jobs of their vendorsand suppliers, including construction and IT firms.And the employees of biopharmaceutical companieshelp to support local restaurants, day care centersand other community businesses.About Clinical Trials In the development of new medicines, clinicaltrials are conducted to prove therapeutic safetyand effectiveness and compile the evidence neededfor the Food and Drug Administration (FDA) toapprove treatments. Clinical tests of new drugs are conducted in threephases and account for an average of seven of the10 to 15 years it takes to bring a new drug fromdevelopment to patients.RESEARCH IN YOUR BACKYARD DEVELOPING CURES, CREATING JOBS Clinical trials for a given drug or treatment involvethousands of volunteer patient participants, and thegeneration of tens of thousands of pages of technicaland scientific data. Clinical trials are responsible for about half of the 1.2 billion average cost of developing one newcutting-edge biotechnology medicine. For patients, the trials offer another potentialtherapeutic option. Clinical tests may provide a newavenue of care for some chronic disease suffererswho are still searching for the medicines that arebest for them. Some trials are also conducted to compare existingtreatments while others are done to learn if a drugis appropriate for a particular patient population,such as children. Still others are conducted tofind ways to make existing approved drugs moreeffective and easier to use with fewer side effects. All clinical trials must be reviewed and approved byan Institutional Review Board (IRB), an independentcommittee of physicians, statisticians, local communityadvocates and others to ensure a trial is ethicallyconducted and patient rights are protected. Clinical trial progress reports must be submitted atleast annually to the FDA and IRB. All facilities that conduct or support biomedicalresearch involving patients must comply withfederal regulations and have an IRB.Clinical Trials in Piedmont Triad since1999—Completed and ActiveAll Clinical TrialsSix Major Chronic Diseases2,007902Source: www.clinicaltrials.govNote: Search criteria Piedmont Triad cities, North Carolina, United States;Phase 0, 1, 2, 3; industry only. Search performed 2/15/2014.3
Clinical Trials and Chronic Diseases Chronic diseases are a leading driver of risinghealth care costs with expenses totaling billionsof dollars every year. Chronic diseases pose the greatest threats to ournation’s health and our ability to treat and preventmedical conditions. Biopharmaceutical research companies aredeveloping new medicines to help treat thoseconditions that are taking an unprecedented tollon American lives, and many of these medicinesare being tested today in clinical trials in thePiedmont Triad. According to the U.S. Centers for Disease Controland Prevention (CDC), today, in the United States: Patients with chronic diseases account for75 cents of every dollar spent on health care. Since 1999, biopharmaceutical research companiesare sponsoring or have sponsored 902 clinicaltrials of potential new medicines in the PiedmontTriad alone for asthma, cancer, heart disease, Chronic diseases are the leading cause of deathand disability.Clinical Trials in the Piedmont TriadLocationAsthmaCancerDiabetesHeart DiseaseMental 1Greensboro1117414High m937121279Source: www.clinicaltrials.govNote: Search criteria Piedmont Triad cities, North Carolina, United States; Phase 0, 1, 2, 3; industry only. Search performed 2/15/2014. See Appendix for detailedinformation about these clinical trials. Disease columns will not match totals in the Appendix because some clinical trials are recruiting in more than one city.4PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
stroke, diabetes and mental illnesses. Of thesetrials, 117 are either not yet recruiting or are justnow seeking patients. The 117 trials are beingconducted at 158 sites in the Piedmont Triad. Biopharmaceutical companies are collaborating onthe tests with such prominent institutions as WakeForest University and Forsyth Medical Centerin Winston-Salem, Alamance Regional CancerCenter in Burlington and the Moses H. ConeRegional Cancer Center in Greensboro. Some of the medicines being clinically testedin the Piedmont Triad are new-generationbiotechnology treatments.“Much of the clinical research conducted inand around Winston-Salem in recent yearshas involved the development of cutting-edgetreatments. Many of these are listed in thenew Research in Your Backyard report. Here atTargacept, we are hard at work on treatmentsfor overactive bladder, Alzheimer’s disease anddiabetic gastroparesis. Our overactive bladdertreatment has completed recruitment into aPhase II clinical trial. We are collaborating withWake Forest University in connection with ourgastroparesis project, which has already beenevaluated for safety in earlier trials associatedwith other indications. Our work at Targacept,and the important work in our region, reflects anationwide trend: biopharmaceutical companiesare using biotechnology to develop hundredsof new medicines and vaccines as we seek toimprove our treatment of disease and ability topredict and prevent it.”— Stephen A. Hill, B.M. B.Ch., M.A., F.R.C.S.President and Chief Executive Officer, TargaceptRESEARCH IN YOUR BACKYARD DEVELOPING CURES, CREATING JOBS5
Clinical Trials in thePiedmont TriadClinical tests of new medicines are a vitally important partof the drug development and approval process—theyaccount for about half of the 1.2 billion average cost ofdeveloping a new drug and are conducted to determinethe safety and effectiveness of that treatment in patients.Clinical Trials for Top Chronic Diseases inthe Piedmont TriadAll Clinical TrialsClinical TrialsStill RecruitingAsthma5710Cancer35953Diabetes22022It’s essential that trials be conducted properly so that clinicians and drug reviewers can develop accurate assessmentsof the efficacy and safety of medicines when used bypatients. The FDA is a vigilant regulatory agency and itspharmaceutical review officers are effective in detectingflawed information.Heart Disease11414Mental Illness1127Stroke4011Questionable or confusing data can lead to lengthy delays inproduct approval or outright FDA rejection of a new drug.Total902117Some trials are also conducted to compare existing treatments and some are done to explore whether a drug isappropriate for a different patient population, such aschildren. Still others are conducted to find ways to makeexisting approved drugs more effective and easier to usewith fewer side effects.Biopharmaceutical research companies are looking forthe best physicians and research institutions to help designand conduct their clinical trials to determine whether amedicine is safe and effective. Side effects must be carefully documented and a determination made as to whetherthey occur too often and are dangerous.Clinical tests involve three phases, thousands of volunteerpatients, and are often conducted at multiple sites aroundthe country.6Chronic DiseaseSource: www.clinicaltrials.govNote: Search criteria Piedmont Triad cities, North Carolina, United States;Phase 0, 1, 2, 3; industry only. Search performed 2/15/2014. Some clinical trialsappear in more than one disease category.In the Piedmont Triad, biopharmaceutical companies areproviding funds to have trials conducted at the city’s wellrespected medical school, hospitals and clinical researchorganizations. According to U.S. News and World Report,Wake Forest University School of Medicine ranked46th among last year’s top 100 research-oriented medicalschools in the United States.PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
Asthma is a debilitating condition for more than 25 million Americans, including 7.1 million children under theage of 18. In North Carolina, 901,000 adults and 383,000children have been diagnosed with asthma, accordingto the State Center for Health Statistics (NCSCHS). In2009, the 12 Piedmont Triad counties were responsiblefor 15.8 percent of all emergency room visits due toasthma in North Carolina.Currently, 10 clinical trials of new asthma medicines arerecruiting patients in the Piedmont Triad. Trials are beingconducted in Greensboro, High Point, and at WakeForest University School of Medicine in Winston-Salem.Cancer, the second leading cause of death in the UnitedStates, now afflicts nearly 14 million Americans, accordingto the National Cancer Institute. In North Carolina, morethan 52,000 new cancer cases will be diagnosed this yearand 19,980 victims in the state will die, according to theAmerican Cancer Society. Piedmont Triad accounts forabout 19 percent of new cancer cases and cancer deaths inNorth Carolina, according to NCSCHS.Currently, 53 clinical trials of new cancer medicines arerecruiting patients in the Triad region. Biopharmaceutical companies are collaborating on the tests with suchprominent institutions as the Moses H. Cone RegionalCancer Center in Greensboro, the Alamance RegionalCancer Center in Burlington and the Wake ForestUniversity Comprehensive Cancer Center inWinston-Salem.Diabetes affects more than 25 million Americans—morethan 8 percent of the U.S. population—including 7 million people who are unaware they have the disease. InNorth Carolina, 9.8 percent of the population has beendiagnosed with diabetes, according to the U.S. Centers forDisease Control and Prevention (CDC). In 2012, Piedmont Triad counties accounted for nearly 17 percent ofdiabetes deaths in North Carolina, according to NCSCHS.Currently, 22 diabetes clinical tests are seeking patientsin the Piedmont Triad. The trials are being conductedResearch in Your Backyard Developing Cures, Creating Jobsat Triad Clinical Trials in Greensboro, and ClinicalResearch of Winston-Salem and Guilford NeurologicAssociates in Winston-Salem.Heart disease and stroke are the first and fourthleading disease causes of death in the United States andthe second and fourth in Forsyth County. According tothe American Heart Association, more than 83 millionAmericans are affected by these diseases. In 2012, morethan 21,000 residents of North Carolina died from thesediseases and nearly 4,000 of them were from the Piedmont Triad, according to NCSCHS.Currently, 14 heart disease and 11 stroke clinical tests areseeking patients in the Piedmont Triad. The trials are being conducted at the LaBauer Cardiovascular ResearchFoundation in Greensboro and Forsyth Medical Centerand Wake Forest Baptist Medical Center in WinstonSalem.Mental illness affects about 61.5 million Americans whosuffer from some form of the disease—from anxiety todepression to addiction to Alzheimer’s disease. In NorthCarolina, about 335,000 adults and 99,000 children livewith serious mental health conditions, according to theNational Alliance on Mental Illness. In 2012, 743 residents from the Piedmont Triad died from suicide andAlzheimer’s disease, according to NCSCHS.Currently, seven clinical trials for mental health conditions are recruiting patients in the Piedmont Triad.Among the trials, a smoking cessation trial is beingconducted at the Duke Center for SmokingCessation-Winston-Salem Office.Physicians and patients can find out about clinical trials beingconducted all over the state in collaboration with local institutions by accessing www.clinicaltrials.gov, a database sponsoredby the National Institutes of Health. Information on clinical trials and medicines in development is also available rd, thewebsite of the Pharmaceutical Research and Manufacturers ofAmerica (PhRMA).7
What is the ClinicalTrial Experience?Clinical trials are research studies that grant participantsearly access to new medicines, which are being developed to help combat chronic and serious diseases. Byvolunteering for a clinical trial, patients take an activerole in their healthcare by helping researchers test newtreatments. In the Piedmont Triad alone, 902 clinical trials have targeted chronic conditions like asthma/allergy,cancer, diabetes, heart disease, mental illness and stroke.Phases of Clinical TrialsThere are three phases of testing used to evaluate potential new medicines:Phase I—This phase is designed to test the safety ofa new medicine. Researchers test the drug on a smallgroup of people (20-80) and evaluate safety aspectsof the drug, such as safe dosage range, the best way ofadministering the treatment (pill form vs. a shot forexample) and identifying what, if any, side effects theremay be.Phase II—This phase is designed to test effectivenessand safety. The treatment is given to 100 to 300 peopleto assess efficacy and try to identify less common sideeffects, which may appear when more people are tested.This phase is usually placebo-controlled and doubleblinded—neither patients nor doctors know if thepatient is getting placebo or the medicine.8Phase III—This phase is designed to confirm effectiveness and safety, monitor side effects and compare theunapproved drug being tested to commonly used medications from the market to determine which is moreeffective. A large group (1,000-3,000) receives this treatment, and like Phase II, it is usually placebo-controlledand double-blinded.Learning About and AccessingClinical TrialsPatients can learn about clinical trials several ways.Healthcare providers are aware of clinical trials beingconducted at hospitals, universities and other leadinghealthcare facilities, and these institutions can be valuable sources of information for patients looking toparticipate. Patients can also use hospital and universitywebsites to find the trials being conducted in their area.Wake Forest University School of Medicine lists clinical trials taking place at their facilities on their website,www.wakehealth.edu/BeInvolved. More information aboutclinical trials in the Piedmont Triad and how to volunteer for one can be found at http://centerwatch.com, aPhRMA-recommended website.PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
What to ExpectSince clinical trials are often conducted in a doctor’soffice, patients may need to devote more time to physician visits and physical examinations. They may alsohave additional responsibilities, like keeping a daily logof their health. All prospective participants must sign aninformed consent document saying they understand thatthe clinical trial is research, and that they can leave thetrial at any time. After consulting with their healthcareproviders, patients can volunteer to participate, leadingto a pre-screening interview. If they fit the criteria andrequirements of the test, they can be enrolled.Patient ExpensesPatients should ask during pre-screening interviewswhat it will cost them to participate in a clinical trial.Clinical trial sponsors usually pay for all research-relatedResearch in Your Backyard Developing Cures, Creating Jobsexpenses and additional testing or physician visits required by the trial. Patients or their insurance companiesmay be asked to pay for any routine treatments of theirdisease. And it’s important to know some health plansdo not pay for clinical trials. Patients should make it apoint to learn if they or their insurance company will beassessed any fees and should determine if their insurancecompany will cover the expense of routine examinations. Patients who live a distance from the trial siteshould learn the clinic’s policy for covering travel costsand living expenses.The National Cancer Institute, for example, makes patients responsible for their own travel costs for the initialscreening visits. Once a patient is enrolled, the Institutewill pay for transportation costs for all subsequent trialrelated visits. These patients will receive a small per diemfor food and lodging.9
New GenerationMedicines in DevelopmentSome of the medicines that have been tested in thePiedmont Triad are cutting-edge biotechnology drugs.America’s biopharmaceutical research companies areusing biotechnology to develop hundreds of new medicinesand vaccines today. And the Piedmont Triad is one placewhere this research and development work is being done.Through biotechnology, new ways are being developed tonot only more effectively treat disease, but also to predictand even prevent it.Biotechnology medicines are developed through biological processes using living cells or organisms, rather thantraditional chemical synthesis, the mainstay of pharmaceutical development for decades.Such novel treatments use a variety of new approachesto treat disease. For example, a monoclonal antibody is alaboratory-made version of the naturally occurring immune system protein that binds to and neutralizes foreigninvaders. Interferons are proteins that interfere with theability of a cell to reproduce.Antisense drugs, meanwhile, are medicines that interfere with the communication process that tells a cell toproduce an unwanted protein. In addition, nanotechnology is being used in biotechnology research to providedrug-delivery systems, new treatments and diagnostics.10Some of the medicines in clinical testing in the Piedmont Triad feature these technologies. For example: A genetically-modified virus-based vaccine totreat melanoma is being studied at Wake ForestUniversity School of Medicine in Winston-Salem. A recombinant fusion protein to treat diabeticmacular edema is being studied at the Wake ForestUniversity Eye Center in Winston-Salem. A therapeutic vaccine designed to jump-start theimmune system to fight disease is in developmentfor melanoma in Winston-Salem. An engineered human antibody to reduceinflammation in psoriasis and psoriatic arthritis isin clinical trials in Greensboro, High Point andWinston-Salem.The biotechnology medicines and vaccines that are beingdeveloped today are helping to expand the frontiers ofscience and that could lead to more and better treatmentsfor patients. In the Piedmont Triad, as in other locations,this innovation is the result of a successful collaborationof biopharmaceutical companies and local researchinstitutions.PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
ConclusionBiopharmaceutical research companies’ close collaboration with clinicians and research institutions in thePiedmont Triad benefits patients, the local economy,and the advancement of science and patient care.Clinical trials provide stimulating biopharmaceuticalresearch work and a reliable source of revenue for theWake Forest School of Medicine, hospitals and localcontract research organizations, and the medicines be-Research in Your Backyard Developing Cures, Creating Jobsing tested are sometimes cutting-edge cell and proteintreatments with the potential to be safer and more effective than older chemical compound drugs.What’s more, patients in the Piedmont Triad considering participation in clinical trials have a wide range ofchoices, including 117 tests of new medicines for thesix most debilitating chronic diseases.11
The Drug Discovery, Development and Approval ProcessIt takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.Clinical TrialsPhase IIPhase IIIFDAYears6.51.523.51.5TestPopulationLaboratory andanimal studies20 to 80healthyvolunteers100 to 300patientvolunteers1,000 to uateeffectiveness,look forside effectsConfirmeffectiveness,monitor adverse reactions fromlong-term usePurposeSuccessRateAssess safety,biological activityand formulations5,000compoundsevaluated5enter trialsFile NDA/BLA at FDAPhase IFile IND at FDADiscovery/Preclinical TestingReviewprocess/approvalPhase IVAdditionalpostmarketingtestingrequiredby FDA1approvedThe Drug Development and Approval ProcessThe U.S. system of new drug approvals isperhaps the most rigorous in the world.It takes 10-15 years, on average, for anexperimental drug to travel from lab to U.S.patients, according to the Tufts Center forthe Study of Drug Development. Only five in5,000 compounds that enter preclinical testing make it to human testing. And only one ofthose five is approved for sale.On average, it costs a company 1.2 billion,including the cost of failures, to get one newmedicine from the laboratory to U.S. patients,according to a 2007 study by the Tufts Centerfor the Study of Drug Development.the drug in people. The IND shows resultsof previous experiments; how, where and bywhom the new studies will be conducted; thechemical structure of the compound; howit is thought to work in the body; any toxiceffects found in the animal studies; and howthe compound is manufactured. All clinicaltrials must be reviewed and approved by theInstitutional Review Board (IRB) where thetrials will be conducted. Progress reports onclinical trials must be submitted at least annually to FDA and the IRB.Once a new compound has been identified inthe laboratory, medicines are usually developed as follows:Clinical Trials, Phase I—Researchers testthe drug in a small group of people, usuallybetween 20 and 80 healthy adult volunteers,to evaluate its initial safety and tolerabilityprofile, determine a safe dosage range, andidentify potential side effects.Preclinical Testing. A pharmaceutical company conducts laboratory and animal studiesto show biological activity of the compoundagainst the targeted disease, and the compound is evaluated for safety.Clinical Trials, Phase II—The drug is givento volunteer patients, usually between 100and 300, to see if it is effective, identify anoptimal dose, and further evaluate its shortterm safety.Investigational New Drug Application(IND). After completing preclinical testing, acompany files an IND with the U.S. Food andDrug Administration (FDA) to begin to testClinical Trials, Phase III—The drug is givento a larger, more diverse patient population,often involving between 1,000 and 3,000 patients (but sometime many more thousands),12to generate statistically significant evidenceto confirm its safety and effectiveness. Theyare the longest studies, and usually takeplace in multiple sites around the world.New Drug Application (NDA)/BiologicLicense Application (BLA). Following thecompletion of all three phases of clinicaltrials, a company analyzes all of the dataand files an NDA or BLA with FDA if the datasuccessfully demonstrate both safety andeffectiveness. The applications contain all ofthe scientific information that the companyhas gathered. Applications typically run100,000 pages or more.Approval. Once FDA approves an NDA orBLA, the new medicine becomes availablefor physicians to prescribe. A company mustcontinue to submit periodic reports to FDA,including any cases of adverse reactions andappropriate quality-control records. For somemedicines, FDA requires additional trials(Phase IV) to evaluate long-term effects.Discovering and developing safe and effective new medicines is a long, difficult, andexpensive process. PhRMA member companies invested an estimated 48.5 billion inresearch and development in 2012.PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
The Good News—Many Clinical Trials areStill RecruitingThere are 117 clinical trials of new chronic disease drugs recruiting patients in the Piedmont Triad. These trialstarget the most debilitating chronic conditions—cancer, heart disease, stroke, asthma, diabetes and mental illness.Clinical Trials in the Piedmont TriadLocationAsthmaCancerDiabetesHeart DiseaseMental 1Greensboro1117414High m937121279Source: www.clinicaltrials.govNote: Search criteria Piedmont Triad cities, North Carolina, United States; Phase 0, 1, 2, 3; industry only. Search performed 2/15/2014. See Appendix for detailedinformation about these clinical trials. Disease columns will not match totals in the Appendix because some clinical trials are recruiting in more than one city.Research in Your Backyard Developing Cures, Creating Jobs13
The Good News—Many Clinical Trials are Still Recruiting(continued)Asthma—Leading InstitutionsConducting Clinical TrialsHeart Disease—Leading InstitutionsConducting Clinical TrialsWake Forest University School of Medicine,Winston-SalemClinical Research of Winston-Salem, Winston-SalemCancer—Leading InstitutionsConducting Clinical TrialsAlamance Regional Cancer Center, BurlingtonCornerstone Hematology/Oncology, High PointMoses H. Cone Regional Cancer Center, GreensboroPiedmont Hematology Oncology Associates, PLC,Winston-SalemWake Forest Baptist Medical Center, Winston-SalemWake Forest University School of Medicine,Winston-SalemDiabetes—Leading InstitutionsConducting Clinical TrialsClinical Research of Winston-Salem, Winston-SalemGuilford Neurologic Associates, Winston-SalemForsyth Medical Center, Winston-SalemGuilford Neurologic Associates, Winston-SalemLeBauer Cardiovascular Research Foundation,GreensboroWake Forest Baptist Medical Center, Winston-SalemWake Forest University School of Medicine,Winston-SalemMental Illness—Leading InstitutionConducting Clinical TrialsDuke Center for Smoking Cessation-Winston-SalemOffice, Winston-SalemStroke—Leading InstitutionsConducting Clinical TrialsClinical Research of Winston-Salem, Winston-SalemGuilford Neurologic Associates, Winston-SalemTriad Clinical Trials LLC, Greensboro14PhRMA Pharmaceutical Clinical Trials in the Piedmont Triad
AppendixThe clinical trials listed here involve tests that have not yet started recruiting patients or are just now seekingvolunteers to participate. This information is potentially valuable to patients still seeking effective treatments fortheir chronic diseases. These trials provide a new therapeutic option to discuss with physicians.Those interested in obtaining more information about certain trials can use the URL code listed for each test tolog onto www.clinicaltrials.gov, the clinical tests database of the National Institutes of Health.Asthma(10 clinical trials recruiting)Study 1:A 6 Month Safety Study Comparing Symbicort WithInhaled Corticosteroid Only in Asthmatic Adults 444430Study
Clinical Trials in the Piedmont Triad Clinical Trials for Top Chronic Diseases in the Piedmont Triad Chronic Disease All Clinical Trials Clinical Trials Still Recruiting Asthma 57 10 Cancer 359 53 Diabetes 220 22 Heart Disease 114 14 Mental Illness 112 7 Stroke 40 11 Total 902 117 Source: www.clinicaltrials.gov
TABLE 2: R&D as a Percentage of Sales, PhRMA Member Companies: 1981–2019 *Revised in 2007 to reflect updated data. Source: Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2020. Function Dollars Share Pre-Human/Pre-Clinical 13,034.3 15.7% Phase I 7,26
The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to comment on the Department of Health & Human Services (HHS) request for information (RFI), HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. PhRMA represents the country's leading innovative biopharmaceutical research companies,
Source: Adis R&D Insight Database1. Industry Efforts for Patients: Bringing New Treatments and Cures to the Market PhRMA members continue to deliver new and innovative products to Japanese patients 25% of all product approvals in 2017 and 2018 were developed by PhRMA Japan’s 12 members of which 41%
The 21st Century Cures Act (Division A of P.L. 114-255) Congressional Research Service Summary The 21st Century Cures Act (P.L. 114-255) was signed into law on December 13, 2016, by President Barack Obama. On November 30, 2016, the House passed the House amendment to the Senate amendment to H.R. 34, the 21st Century Cures Act, on a vote of 392 .
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative pharmaceutical research and biotechnology companies, which are devoted to developing medicines that allow patie
There are natural cures for virtually every disease. There are non-drug and nonsurgical methods to prevent and cure almost all illness. The drug companies, the government, and a host of other organiza-tions do not want you to know what these natural cures are. This book
The 21st Century Cures Act (Cures Act) was signed into law on December 13, 2016. Among the . by the HIPAA rules (e.g., is not a business associate with a BAA with the actor) and/or does not meet the
Consider the task of buying a copy of AI: A Modern Approach from an online bookseller. Suppose there is one buying action for each 10-digit ISBN number, for a total of 10 billion actions. The search algorithm would have to examine the outcome states of all 10 billion actions to find one that satisfies the goal, which is to own a copy of ISBN 0137903952. A sensible planning agent, on the .
