A Report on the Clinical Research Industry Cluster in Southeastern
Transcription
A Report on the Clinical Research Industry Cluster in Southeastern
A Report on the Clinical Research Industry Cluster in Southeastern North Carolina Created February 2013. Updated May 2014. The southeastern region’s NC Coast Clinical Research Initiative is a collaborative effort between clinical research companies, healthcare providers, economic developers, UNC Wilmington, and the North Carolina Biotechnology Center Southeastern Office, who identified both a need and a desire to strengthen the clinical research (CR) community in our area. The goals of the NC Coast Clinical Research Initiative, an economic development initiative, are to create greater cohesion between members of the clinical research community, to promote the clinical research cluster in the region and beyond, and to increase physician-led clinical research trials in the region, all for economic, societal, and health benefit to the southeastern region of North Carolina. The North Carolina Biotechnology Center provides long-term economic and societal benefits to North Carolina through support of biotechnology research, business, education and strategic policy statewide. Headquartered in Research Triangle Park, the Center has five regional offices, including the Southeastern Office in Wilmington, focused on regional biotechnology economic development. A Report on the Clinical Research Industry in Southeastern NC The Clinical Research industry cluster is vital to Southeastern North Carolina, supporting knowledge-sector jobs to strengthen the region’s diverse economy. Pharmaceutical Product Development (PPD), the third largest contract research organization (CRO) in the world, is headquartered in downtown Wilmington. PPD’s presence, along with Wilmington’s proximity to the Research Triangle Park, has helped the area attract other major CROs and to spawn entrepreneurial startups. Of the 25 CROs represented in the region, 3 have headquarters here. A multitude of additional local companies provide specific support to CROs in the area (more than 40 support companies), and the University of North Carolina Wilmington offers educational programs to support the industry’s workforce development needs. According to the Bureau of Labor Statistics, annual income of the over 2,500 local clinical research employees averaged $82,578 in 2012. Local healthcare providers already conduct clinical trials, often managed by CROs, but ample opportunity exists to increase the number of clinical trials conducted locally. The purpose of this report is to provide an industry snapshot to illustrate the impact of the clinical research industry on the area and to identify ways in which the cluster can grow. This report specifically addresses a three-county focus area that includes Brunswick, New Hanover, and Pender counties— formally known as the Wilmington Metropolitan Statistical Area. To determine what action steps are needed to enhance the local clinical research cluster, information pertinent to the clinical research industry has been compiled in this report. From this information, general conclusions are made with specific recommendations about how the number of local clinical trials can be increased and the local cluster of companies can grow. Open Clinical Research Studies in Wilmington In April 2014, there were 21,231 open clinical studies in the United States, 2,293 or 10.8% of which have an investigative site in North Carolina (ClinicalTrials.gov). Wilmington, NC was host to 109 open clinical studies. Of those studies, 13 were observational registries managed by companies, such as INC Research, located in Wilmington. As seen in Table 1: Clinical Trial Phases, the studies conducted in Wilmington range from phases I- IV. The focus of the studies in Wilmington varies widely; however, a large number of studies focus on cancer, arthritis, diabetes, and COPD, as seen in Table 2: Clinical Trial Focus Areas. Of the 20 cancer studies conducted in our area, 16 trials were funded by the National Institutes of Health (NIH). Table 1: Clinical Trial Phases Phase Number of Studies Phase I 1 Phase II 14 Phase III 56 Phase IV 19 Table 2: Clinical Trial Focus Areas Focus Number of Studies Cancer 20 Diabetes 15 Arthritis 10 COPD 8 Source: ClinicalTrials.gov 04/21/2014 1|Page Number of Clinical Trials Conducted in Areas Similar in Size to Wilmington Wilmington is well-positioned to increase the number of clinical trials conducted locally. Table 3: Comparison of Clinical Trials by City shows that, while the New Hanover County population is only slightly lower than in Buncombe County, the Wilmington area hosts significantly fewer trials than the Asheville area. A range of actions can increase the number of local clinical trials. Table 3: Comparison of Clinical Trials by City City/County Durham/Durham Chapel Hill/Orange Winston-Salem/Forsyth Charlotte/Mecklenburg Raleigh/Wake Asheville/Buncombe Greensboro/Guilford Greenville/Pitt Wilmington, NC/New Hanover High Point/Guilford Cary/Wake Fayetteville/Cumberland Number of Clinical Trials 2011 County Population 2011 Physicians per 10,000 (County Level) 899 544 524 468 205 153 130 114 109 57 33 16 272,314 135,776 354,878 940,697 925,938 243,855 495,231 170,263 206,774 495,231 925,938 327,643 74.7 94.4 47.0 27.7 23.8 35.4 24.3 45.4 32.4 24.3 23.8 16.6 Source: ClinicalTrials.gov, NC OSBM, & Cecil G. Sheps Center for Health Services Research Firms Recruiting Patients for Clinical Trials Several companies in Wilmington are devoted to clinical trial enrollment, including PMG Research and Trial Management Associates. These firms actively recruit patients in the Wilmington area to participate in a variety of observational and interventional clinical trials. Trial Management Associates has three focus areas—nephrology, gastroenterology, and dermatology. PMG Research works with clinical trials in a wider variety of therapeutic areas. Physicians and Medical Practices Engaging in Clinical Trials Over 19 medical practices in Wilmington have participated in at least 1 clinical trial (see contact information in Appendix 1: Medical Practices Engaging in Clinical Research). Wilmington also has more than 40 physicians conducting clinical trials. The focus areas of these clinical trials include arthritis, cancer, cardiology, dermatology, gastroenterology, internal medicine, nephrology, neurology, otolaryngology, psychiatry, pulmonology, and urology. In Wilmington, 45 clinical trials identify the medical groups participating in a particular clinical trial. A list of specific trials and the medical groups associated with each trial is listed in Appendix 2: Medical Practices Associated with Specific Clinical Trials. The list of practices engaging in clinical trials is based upon the most currently available data and is not complete, because many practices and studies choose not to release trial information to the general public. 04/21/2014 2|Page Health Professional Data Table 4: Health Professional Data by County lists the number and focus area of doctors available in the 3-county focus area, in 2010. An important statistic to note is the number of physicians per 10,000 residents. North Carolina has an average of 22.1 physicians per 10,000 residents and a rate of 7.8 primary care physicians per 10,000 residents. New Hanover County well exceeds the state average (32.2 per 10,000 residents) and is ranked in the top 10 counties in the state in both areas. Appendix 3: Health Professional Data for Selected NC Counties combines the data seen in Table 3 and Table 4 to illustrate the connection between the number of physicians and clinical trials being conducted. Based upon that data seen in Appendix 3, the presence of a greater number of physicians per 10,000 residents often results in a greater number of clinical trials. Upon request, additional information regarding the number of specialists in specific areas is available. Table 4: Health Professional Data by County New Hanover County Brunswick County Pender County 206,774 110,312 53,466 247 62 3 100 39 43 395 10 652 59 26 1 0 16 9 8 0 121 18 10 2 5 0 1 7 0 25 32.2 11 4.8 6 10.1 54 5.4 87 3.9 9 58 88 Pharmacists Registered Nurses Nurse Practitioners 240 2,864 130 81 534 29 23 191 14 General Hospital Beds 2014 Hospital Discharges 2011 647 21,055 110 12,012 43 5,697 2011 County Population Primary Care Physicians (* included in primary care physicians total) otal)Family Practice* General Practice* Internal Medicine* Obstetrics/Gynecology* Pediatrics* Other Specialties Federal Physicians Total Physicians Physicians per 10,000 Population Number of Physicians: State Rank (1=most physicians) Primary Care Physicians per 10,000 Population Number of Primary Care Physicians: State Rank (1=most physicians) p Source: Cecil G. Sheps Center for Health Services Research 04/21/2014 3|Page Contract and Clinical Research Organizations Wilmington is home to PPD Worldwide Corporate Headquarters, and a host of other large and small CROs operate in the city and region. Many of these companies continue to grow and develop in the Wilmington area. Currently, there are 25 CROs in the region with a total employment of more than 2,500. Additionally, the Wilmington area is home to at least 40 clinical research support companies, employing more than 200 individuals. Clinical research support companies provide very specialized services, such as biostatistics, clinical trial data management, laboratory testing services, medical writing, and patient recruitment to support other companies. The region is also home to at least 13 drug, medical device, and testing development companies, employing more than 50 individuals. These companies range in size from large, multi-national companies to small entrepreneurial ventures. Below is a list of the CROs and clinical trial support companies that are either headquartered in or have a presence in the Wilmington area, which includes New Hanover, Pender, and Brunswick Counties. Appendix 5: Contact Research Organization Contact Information provides each company’s contact information, as well as a synopsis of activities. Appendix 6: Clinical Research Support Company Contact Information provides each company’s contact information focus areas. Appendix 7: Drug, Medical Device, & Testing Development Company Contact Information lists the companies that develop pharmaceuticals, medical devices, and testing. Contract Research Organizations AAIPharma (HQ) Blitz Research Catalent Chiltern International Clinipace Worldwide Covance The EMMES Corporation ICON INC Research inVentiv Health Jubilant Clinsys Modoc Research (HQ) Novella Clinical 04/21/2014 OrphanReach PAREXEL International Perficient Pharm-Olam International PPD (HQ) PRA International Premier Research Quintiles Research Pharmaceutical Services Sarah Cannon Research Institute SynteractHCR Theorem Clinical Research Worldwide Clinical Trial 4|Page Clinical Trial Collaborators and Support Companies Biostatistics Biostudy Solutions (HQ) PharPoint Research Triangle Biostatistics, LLC Clinical Trials Data Management Clinical Ink OptumInsight SAS Clinical Trial Insurance Arthur J. Gallagher Risk Management Services Aquesta Insurance Services HR Support Babb McGrew (HQ) Hawthorne Search (HQ) Human Capital Solutions (HQ) Thinkingahead Independent Consultants Amanda Grim's GCP Audits (HQ) Argent Rx Solutions (HQ) BioClin Consulting (HQ) Biopharmaceutech International (HQ) Cape Fear Research Consultants (HQ) Coastal Pharmaceutical Consultants (HQ) DMS Clinical Research Services (HQ) Hashimoto Consulting Services (HQ) Hermes (HQ) KButler GxP Consulting (HQ) MSS Pharmaceutical Consulting (HQ) Navigator Life Science Advisory (HQ) Outsourcing Support Services, Inc (HQ) Pharmalogx (HQ) Rothermel Clinical Research Consulting (HQ) Spataro & Associates (HQ) Wagoner Consulting (HQ) Information Technology Bluewater Technology Partners (HQ) 04/21/2014 5|Page Clinical Trial Collaborators and Support Companies (continued) Laboratory Testing Services Eurofins Scientific Quality Chemical Laboratories (HQ) Solstas Lab Partners Wilmington Pathology Associates (HQ) Marketing A. Revell Communications (HQ) Bon's Eye Marketing (HQ) Medical Writing Modoc Research (HQ) Regulatory Writing Solutions (HQ) Patient Recruitment ClinEdge Endeavour Clinical Solutions MediciGlobal Inc PMG Research Trial Management Associates (HQ) Pharmaceutical Sales Training Proficient Learning (HQ) Drug, Medical Device, & Testing Development Drug Development Alvogen CardioPharma (HQ) Furiex Pharmaceuticals Leonard Consulting (HQ) MARBIONC Development Group (HQ) Osmotica Pharmaceutical (N.A. HQ) Wilmington Pharmaceuticals (HQ) Medical Device Development & Testing Baxano Surgical Cortech Solutions (HQ) OrthoKinetic Technologies (HQ) MindSkid Labs (HQ) Testing Development & Manufacturing AccuGenomics (HQ) MicroGuard Consulting (HQ) 04/21/2014 6|Page Regional Demographics The Wilmington area has a unique demographic composition. One important inclusion criteria considered in the clinical trials industry is age. In general, the age distribution within the threecounty focus area mimics national and state trends. However, New Hanover County has a largerthan-usual population of individuals ranging in age from 20-29 years old (see Table 5: Percentage of Young Adults in Southeastern NC). Brunswick County exhibits a similar trend among individuals over the age of 54 (see Table 6: Percentage of 55+ in Southeastern NC). Race and ethnicity may also be considered an inclusion factor in many clinical trials. None of the counties in the focus area have a racial composition that is similar to the state of North Carolina, as the representation of African Americans and Hispanics are lower than the state average. However, New Hanover County has similar race and ethnicity demographics to the United States (see Table7: Ethnic Composition). Table 6: Percentage of 55+ in Southeastern NC Table 5: Percentage of Young Adults in Southeastern NC 10% US NC Brunswick New Hanover 8.80% 4.50% 5.30% 4% 4.20% 2.00% 0% 10% 25 to 29 years 4.00% 5.90% 6.80% 20 to 24 years 6.00% 5.40% 5.60% 2% 8.00% 6.40% 6.30% 8.10% 6.50% 7.10% 4% 6.80% 6.60% 5.20% 7.90% 5.40% 6% 10.00% 7% 6.90% 4.40% 9.10% 5.30% 8% 0.00% US Pender 55 to 59 years 60 to 64 years 65 to 69 years NC Brunswick New Hanover Pender Source: 2012 US Census ACS 5-Year Estimates Source: 2012 US Census ACS 5-Year Estimates Table 7: Ethnic Composition 100.00% 6.06% 5.15% 5.01% 8.34% 16.35% 18.37% 14.64% 11.24% 21.45% 12.56% 76.29% 80.45% 20.00% 69.78% 40.00% 74.17% 60.00% 84.56% 80.00% 0.00% White alone United States North Carolina Black or African American alone Brunswick Hispanic or Latino New Hanover Pender Source: 2012 US Census ACS 5-Year Estimates 04/21/2014 7|Page Regional Health Data Health data can be useful when evaluating where to locate investigational sites. Areas with a higher prevalence of certain types of medical conditions are ideal for clinical trials aimed at treating those conditions. The higher rate can help to ensure that a larger number of potential participants for a study that meet the inclusion criteria are available. Appendix 4: Regional Health Statistics includes a number of health statistics from across Southeastern North Carolina. A broader approach to collecting this data was taken for several reasons. One consideration is that patients may already travel to Wilmington to receive treatment for certain healthcare issues and could easily participate in clinical trials being offered in the focus area. Another reason for including regional health statistics is that New Hanover Regional Medical Center has locations throughout the area. Additionally, doctors who have offices in both Wilmington and the rural counties could identify candidates from those areas, as well. Some highlights identified in Appendix 4: Regional Health Statistics include the large percentages of the population with diabetes living in the region. Of the 12 counties included in this data set, only Onslow and Brunswick counties have diabetes occurrence rates lower than the state average. Additionally, a relatively large number of individuals are classified as being obese. 9 of the 12 counties have a higher percentage of individuals who are considered obese (defined as BMI greater than or equal to 30) than the state average. Most notable are the obesity rates in Duplin and Robeson counties where 40% of the population is considered obese. It is important to note that obesity is linked to a range of other health issues according to the Center of Disease Control. These issues include heart disease, stroke, type 2 diabetes, cancers, hypertension, high cholesterol, liver disease, gallbladder disease, sleep apnea, respiratory problems, and osteoarthritis. New Hanover County also has a rate more than double the state average of persons being served at alcohol and drug treatment centers. Consequently, the location may serve as an exceptional location to evaluate medical advances for treating individuals with these types of addictions. Cardiovascular disease is another prominent medical condition in the region. From 2003 to 2007, Columbus, Robeson, Sampson and Scotland counties have had a larger proportion of residents hospitalized for medical conditions related to cardiovascular diseases, when compared to the state average. One of the most striking features related to cardiovascular medical conditions is the 5year hospitalization rates for strokes in 8 of the 12 counties, which are above the state average. In general, the region appears to have average incidence rates in terms of the number of cancer cases. However, there are some counties with cancer rates that are above average. For example, Onslow County has a substantially higher rate of individuals with lung cancer. The region also has a large number of hospitalizations due to septicemia, which may make the area a prime location to test new medical advances aimed at treating the illness. 04/21/2014 8|Page Recommendations Building Community Cohesion: The North Carolina Coast Clinical Research Initiative (NCCCRI) should continue working with CROs, UNCW, doctors, clinical trial patient recruitment companies, and other local business and community leaders to host networking opportunities and educational programs that strengthen the existing local cluster of companies (Current activity of the Events Team includes the Leadership Networking Series, the Lunch-andLearn Series and the Dinner Talk events, in addition to other targeted educational events and focus groups). Additionally, the NCCCRI should continue working with companies and education leaders to create educational programs, including internships, that develop the clinical research industry workforce (e.g., the BioStats Team focused on enhancing the statistics program and internship opportunities at UNCW). Promoting the Local Clinical Research Industry Cluster: The NCCCRI should continue to work with CR companies, economic developers, and others to raise awareness about and promote the local CR industry cluster in the region and beyond. In addition to local promotions, the NCCCRI Communications Team should develop and implement a large-scale marketing campaign to attract additional talent, companies, and clinical trials to the area. One component of this strategy is to represent the local CR industry cluster at events, such as the annual BIO International Conference as part of the N.C. Pavilion, and to target specific companies for recruitment. Increasing Local Clinical Trials: The NCCCRI should continue working with doctors, clinical trial patient recruitment companies, and CROs to recruit additional clinical trials to the area. When the health data is considered, along with the focus area and number of clinical trials, Wilmington could easily support additional clinical trials. Table 3: Comparison of Clinical Trials by City illustrates that areas slightly larger than New Hanover County, such as Buncombe County, support many more clinical trials than does Wilmington. The number of trials supported by a region is related more to the total number of available investigators than the size of its population. For instance, Asheville’s and Buncombe County’s medical centers include a greater number of physicians involved in research. The age of the population is another factor more important than the total population when considering a region’s capacity to host clinical trials. One potential way to increase the number of clinical trials in the Wilmington area is to establish a greater focus on clinical research at the regional medical center. For example, Mission Hospital in Asheville has established a Research Institute to attract and host clinical trials. Similarly, East Carolina University’s Brody School of Medicine in Greenville has established a clinical trials working group. While New Hanover Regional Medical Center (NHRMC), Wilmington’s primary hospital facility, does offer clinical trials through the Zimmer Cancer Center in conjunction with the University of North Carolina at Chapel Hill, NHRMC does not appear to offer clinical trials in any other therapeutic areas currently. 04/21/2014 9|Page Recommendations (cont.) Additional clinical trials should be targeted to match the specific medical conditions in the region in which there is higher prevalence, to increase the likelihood of obtaining the optimal number of patients. These medical conditions include the following: diabetes, obesity, alcohol and drug addiction, HIV and AIDS, septicemia, heart disease, and stroke. NCCCRI should target doctors who work in those specialty areas to gauge their interest in participating in clinical trials. The data from this report should be used to validate why doctors in those specific fields are being targeted to conduct trials and why ample opportunity exists to increase clinical trial enrollments. Clinical trials that have inclusion criteria related to requiring participation from patients aged 2029 or aged 55 and over should also be targeted. As Tables 5 indicates, New Hanover County has a significantly larger percentage of 20-29 year olds. Table 6, displays the advantages Brunswick County offers in terms of being able to produce clinical trial candidates over the age of 55. An additional benefit of the region is that the racial and ethnic composition mirrors the United States. Patient recruitment companies, such as Inclinix-PMG Research and Trial Management Associates, should be directly involved with attracting additional studies and recruiting additional physicians to participate in the trials, as well. Conclusion The Southeastern Region is home to a strong cluster of companies working in and supporting the clinical research industry with a full range of services, as well as educational support from UNCW and promotional support from local economic development leaders. Despite this worldclass clinical research cluster, the Wilmington area lags in the number of clinical trials being conducted locally. This report has outlined several strategies to increase the number of clinical trials conducted in the southeastern region, including targeting trials that focus on specific health issues that are prevalent in the greater Wilmington area. The NCCCRI should continue its work to increase the awareness and number of clinical trials in the area, to host events that connect the members of the clinical research community, and to work with key partners in a variety of other ways to strengthen the impressive clinical research cluster in the southeastern region. 04/21/2014 10 | P a g e Report Notes Data Sources and Methodology Data used in this report was gathered from variety of sources, including governmental and educational institutions. Information related to the number and types of clinical trials being conducted in the area was gathered from ClinicalTrials.gov. Data regarding the medical practices engaged in clinical trials and the trials being conducted at each practice was compiled from CenterWatch.com and ClinicalTrials.gov. The Cecil G. Sheps Center for Health Services Research, supported by UNC – Chapel Hill, served as the source for the number of health professionals, hospital beds, and discharges. Demographic information was acquired from the 5Year American Community Survey, conducted by the US Census Bureau, and the NC Office of State Budget and Management. Health data was gathered from the North Carolina Health Data Explorer, supported by East Carolina University. Information and statistics related to the number and types of companies in the area was gathered from LinkedIn and through surveys of each company’s website. Report Rationale In many cases the North American Industry Classification System (NAICS) can be used to estimate the impact a particular industry has on a local economy. However, the local clinical research cluster is multi-disciplinary, and NAICS does not accurately capture the industry cluster’s impact. The most commonly used NAICS code for clinical research is 541711 research and development in biotechnology. In 2012, the US Bureau of Labor Statistics Quarterly Census of Employment and Wages estimated 1,895 individuals in the Wilmington area were classified as NAICS 541711 employees and combined to earn an average salary of $82,578. While NAICS 541711 captures many employees of the clinical research industry, it does not include important components such as health services, biostatistics, and patient recruitment. The purpose of the Report on the Clinical Research Industry Cluster in Southeastern NC is to examine local employment data in a deeper, more comprehensive way to provide a more accurate illustration of the local cluster, in a way that NAICS codes do not allow. Acknowledgement Thank you to Emmit Owens for his significant contribution to the creation and updates of this report. 04/21/2014 11 | P a g e Appendix 1: Medical Practices Engaged in Clinical Research Medical Practice Name Address City Atlantic Dermatology Associates, P.A. 1099 Medical Center Dr. #201 Carolina Dermatology & Skin Cancer Surgery Knox Clinic Pediatrics, PLLC Phone Number Wilmington NC Zip Code 28401 1814 Glen Meade Road Wilmington NC 28403 (910) 254.3544 2304 Delaney Avenue Wilmington NC 28403 (910) 763-3349 New Hanover Regional Medical Center Zimmer Cancer Center New Hanover Regional Medical Center Betty Cameron Women & Children's Hospital Wilmington Gastroenterology Associates 2131 S. 17th Street Wilmington NC 28403 (910) 343.7000 2131 S. 17th Street Wilmington NC 28403 (910) 343.7000 5115 Oleander Drive Wilmington NC 28403 (910) 362-1011 Wilmington Health, PLLC 1202 Medical Center Dr. Wilmington NC 28401 (910) 343-9991 Coastal Carolina Radiation Oncology 1988 S 16th S Wilmington NC 28401 (910) 251-1839 New Hanover Medical Group PA 1960 S 16th Street Wilmington NC 28401 (910) 343-9991 Carolina Arthritis Associates 1710 South 17th Street Wilmington NC 28401 (910) 762-1182 Wilmington Psychiatric Associates 2311 Canterwood Dr. Wilmington NC 28401 (910) 362-1010 UNC Wilmington, Department of Psychology 600 S. College Rd. Wilmington NC 28403 (910) 962-3000 04/21/2014 State (910) 251-9944 Appendix 1 Dermatology Associates, P.A. 6781 Parker Farm Road, Suite 300 Wilmington NC 28405 (910) 763-1555 Cape Fear Heart Associates 1725 New Hanover Medical Park Dr. Wilmington NC 28403 (910) 815-3420 Coastal Urology, PLLC 1099 Medical Center Dr, Ste 101 Wilmington NC 28401 (910) 254-9995 Coastal Surgery 1411 Physicians Dr. Wilmington NC 28401 (910) 343-0811 University Physicians 2221 S. 17th St. Wilmington NC 28401 (910) 815-5081 INC Research (call centers) 1011 Ashes Dr. Wilmington NC 28405 (910) 341-3300 Source: CenterWatch & ClinicalTrials.gov 04/21/2014 Appendix 1 Appendix 2: Medical Practices Associated with Specific Clinical Trials Specific Study Phase Medical Practice Focus Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis Oropharyngeal Administration of Mother's Colostrum for Premature Infants Phase 3 N/A Atlantic Dermatology Associates Betty Cameron Women & Children's Hospital Psoriasis N/A Phase 3 Carolina Arthritis Associates, PA Carolina Arthritis Associates, PA Carolina Arthritis Associates, PA Carolina Arthritis Associates, PA Coastal Carolina Radiation Oncology Coastal Carolina Radiation Oncology Phase 3 Phase 3 Coastal Carolina Radiation Oncology Center Coastal Carolina Radiation Oncology Center Cancer Phase 2 Phase 3 Phase 2|Phase 3 Coastal Carolina Radiation Oncology Center Coastal Carolina Radiation Oncology Center Coastal Surgery Specialists Caner Observational Study of the Use of KRYSTEXXA® in Refractory Chronic Gout Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Patients (DARWIN2) Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Patients (DARWIN1) Cardiovascular Risk and Preventive Care in Prostate Cancer Patients Receiving Radiation and Hormone Therapy Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis 04/21/2014 Phase 3 Phase 2 Phase 2 N/A Infection|Enterocolitis, Necrotizing|Ventilatorassociated Pneumonia Chronic Gout Psoriatic Arthritis Rheumatoid Arthritis Rheumatoid Arthritis Prostate Cancer Breast Cancer Lung Cancer Prostate Cancer Peripheral Arterial Disease Appendix 2 An Evaluation of Neurofeedback Efficacy in Adults With ADHD A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis Adenovirus Vaccine Pregnancy Registry Phase 3 A Global Imatinib and Nilotinib Pregnancy Exposure Registry Ribavirin Pregnancy Registry Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy An Observational Study of Pregnancy And Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta In Combination With Herceptin, or Kadcyla During Pregnancy or Within 6 Months Prior To Conception (MotHER) The Savella Pregnancy Registry A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication The Cymbalta Pregnancy Registry N/A ADHD N/A Department of Psychology, UNC Wilmington Dermatology Associates; New Hanover Medical Research Associates INC Research N/A INC Research Phase 4 Phase 4 Phase 4 INC Research Glivec/Gleevec and Tasigna Birth Defects INC Research Birth Defects INC Research Breast Cancer & Pregnancy N/A INC Research Fibromyalgia N/A INC Research HIV Infection N/A INC Research Pregnancy Psoriasis Breast Cancer Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis New Biomarkers Evaluating Ovarian Cancer Phase 3 N/A Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Phase 3 Medical Development Center New Hanover Regional Medical Center New Hanover Regional Medical Center Phase 3 New Hanover Regional Medical Center 04/21/2014 Psoriasis Adenovirus Adnexal Mass Breast Cancer Appendix 2 Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer S0819: Carboplatin/Paclitaxel With or Without Bevacizumab and/or Cetuximab in Stage IV or Recurrent Non-Small Cell Lung Cancer Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer Cosmetic Evaluation of Lumpectomy Versus Oncolytic Mammoplasty With Bilateral Breast Reduction for Early Stage Breast Cancer Phase 3 New Hanover Regional Medical Center Cancer Phase 3 New Hanover Regional Medical Center Colorectal Cancer Phase 3 New Hanover Regional Medical Center Phase 3 New Hanover Regional Medical Center Endometrial Cancer, Fatigue, & Neurotoxicity Cancer Phase 3 New Hanover Regional Medical Center Lung Cancer Phase 2 New Hanover Regional Medical Center Cancer N/A Breast Carcinoma Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Phase 3 New Hanover Regional Medical Center; Coastal Carolina Radiation Oncology Center New Hanover Regional Medical Center; Coastal Carolina Radiation Oncology Center New Hanover Regional Medical Center; Coastal Carolina Radiation Oncology Center PDD and GSK Call Prostate Cancer Belimumab (BENLYSTA®) Pregnancy Registry 04/21/2014 Phase 3 N/A Prostate Cancer Systemic Lupus Erythematosus Appendix 2 12-Week Study of Plecanatide for CIC (The CIC3 Study) Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS) Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe Smoking Cessation Study In Healthy Adolescent Smokers International Hernia Mesh Registry Phase 3 Phase 3 Phase 3 N/A PMG Research PMG Research Chronic Idiopathic Constipation Chronic Idiopathic Constipation Diabetic Foot Ulcer PMG Research Diabetic Foot Ulcer Phase 3 Phase 2 Phase 3 Phase 2 Phase 1 PMG Research Diabetic Foot Ulcers PMG Research Dyslipidemia PMG Research Psoriasis PMG Research PMG Research Restless Legs Syndrome Rheumatoid Arthritis Phase 4 N/A PMG Research Smoking Cessation University Physicians Hernia Ventral Hernia|Incisional Hernia Hepatitis C PMG Research A Prospective, Multi-Center Study of Phasixâ„¢ Mesh for Ventral or Incisional Hernia Repair. N/A University Physicians HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea N/A Trial Management Associates Wilmington Medical Research N/A Obstructive Sleep Apnea Source: ClinicalTrials.gov & CenterWatch 04/21/2014 Appendix 2 Appendix 3: Health Professional Data for Selected NC Counties* Number of Clinical Trials Largest Cities 2011 County Populations Primary Care Physicians (* included in primary care physicians total) Family Practice* New Hanover County Durham County Forsyth County Mecklenburg County Orange County Wake County Guilford County Buncombe County Pitt County Cabarrus County Cumberland County 101 793 511 507 503 223 205 163 105 33 19 Wilmington Durham WinstonSalem Charlotte Chapel Hill Raleigh, Cary Greensboro, High Point Asheville Greenville Concord Fayetteville 206,774 272,314 135,776 354,878 940,697 925,938 243,855 495,231 170,263 327,643 206,774 209 442 322 452 890 807 290 425 235 193 209 61 81 99 127 232 235 124 144 65 66 61 General Practice* 2 3 1 2 3 6 3 1 3 1 2 Internal Medicine* 79 205 113 187 314 246 86 137 88 60 79 Obstetrics/Gynecology* 30 52 38 39 132 102 40 61 29 26 30 Pediatrics* 37 101 71 97 209 218 37 82 50 40 37 Other Specialties 460 1592 960 1216 1717 1401 573 780 538 351 460 Federal Physicians 12 154 13 36 35 22 77 3 15 203 12 Total Physicians 669 2034 1282 1668 2607 2208 863 1205 773 544 669 Physicians per 10,000 Population 32.4 74.7 94.4 47.0 27.7 23.8 35.4 24.3 45.4 16.6 32.4 6 2 1 3 8 13 5 12 4 32 6 10.1 16.2 23.7 12.7 9.5 8.7 11.9 8.6 13.8 5.9 10.1 9 2 1 5 12 18 7 19 3 49 9 Pharmacists 240 640 308 522 1004 1124 328 465 203 233 240 Registered Nurses 2864 6418 3388 6567 10923 9726 4307 5878 3487 2895 2864 Nurse Practitioners 130 371 198 250 455 377 168 230 149 112 130 General Hospital Beds 2010 647 1,302 724 1,689 2,192 1,362 735 1,068 734 556 647 21,055 27,502 10,900 43,305 87,817 80,658 24,931 57,726 19,347 33,785 21,055 Number of Physicians: State Rank (1=most physicians) Primary Care Physicians per 10,000 Population Number of Primary Care Physicians: State Rank (1=most physicians) Hospital Discharges 2009 *Sorted by number of clinical trials 04/21/2014 Source: US Census, ClinicalTrials.gov, & Cecil G. Sheps Center for Health Services Research Appendix 3 Appendix 4: Regional Health Statistics The health data used in this appendix was gathered from a variety of sources listed below each chart. Additionally, a short explanation of the data is provided beneath each chart. Percentage of Adult Population with Diabetes (2005-2009) 18% 16.3% 16% 14.3% 13.1% 14% 12% 10% 10.8% 9.0% 10.7% 8.8% 8.8% 10.8% 10.6% 10.3% 11.5% 8.3% 8% 6% 4% 2% 0% Source: North Carolina Health Data Explorer The percentage of the adult population with diabetes is calculated by dividing the estimated number of adults with diabetes by the total population. 45% 40% Percentage of Adult Population Considered Obese* (2005-2009) 39.78% 32.66% 31.74% 31.54% 27.72% 30% 28.20% 35% 25% 39.56% 31.29% 33.17% 36.86% 34.33% 27.89% 24.89% 20% 15% 10% 5% 0% Source: North Carolina Health Data Explorer *Defined as BMI greater than or equal to 30 The percentage of the adult population considered obese is calculated by dividing the estimated number of adults considered obese by the total population. 04/21/2014 Appendix 4 Percentage of Population with HIV & AIDS (2010) 0.40% 0.36% 0.35% 0.30% 0.26% 0.25% 0.29% 0.28% 0.25% 0.31% 0.29% 0.28% 0.23% 0.21% 0.20% 0.13% 0.15% 0.10% 0.05% 0.11% 0.12% 0.13% 0.13% 0.15% 0.10% 0.12% 0.07% 0.12% 0.12% 0.14% 0.10% 0.12% 0.05% 0.06% 0.00% HIV Disease Cases Living as of 2010 AIDS Disease Cases Living as of 2010 Source: North Carolina Health Data Explorer The percentage of population with HIV or AIDS is calculated by dividing the number of individuals living with HIV or AIDS by the total population of each county. Percentage of Persons Served at State Alcohol and Drug Treatment Centers (2009-2010) 0.14% 0.11% 0.12% 0.10% 0.08% 0.08% 0.06% 0.04% 0.02% 0.05% 0.07% 0.06% 0.05% 0.04% 0.04% 0.01% 0.02% 0.03% 0.03% 0.02% 0.00% Source: North Carolina Health Data Explorer The percentage of persons served at state alcohol and drug treatment centers is calculated by the number of individuals treated at state alcohol and drug treatment centers by the total population of each county. 04/21/2014 Appendix 4 Average Annual Number of Cardiovascular Disease Hospitalizations per 100,000 (2003-2007) 3500 3013 3000 2714 2500 2000 2249 3026 2121 1948 1738 2843 1766 1523 1399 1500 1199 1045 1000 500 0 Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census Cardiovascular disease includes all diseases of the heart or blood vessels. The hospitalizations during the 5-year period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same individual. Average Annual Number of Heart Disease Hospitalizations per 100,000 (2003-2007) 2500 2,198 2000 1,776 1,533 1500 2,089 2,074 1,196 1000 1,483 1,314 1,009 922 1,164 845 678 500 0 Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census Heart disease is limited to diseases of the heart. The hospitalizations during the 5-year period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same individual. 04/21/2014 Appendix 4 Average Annual Number of Coronary Heart Disease Hospitalizations per 100,000 (2003-2007) 1,163 1200 1,003 1000 800 600 733 693 594 556 520 938 380 400 373 399 426 276 200 0 Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census Coronary heart disease is due to the narrowing of blood vessels that supply blood to the heart. The hospitalizations during the 5 year period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same individual. Average Annual Number of Stroke Hospitalizations per 100,000 (2003-2007) 500 451 400 300 449 395 293 200 395 345 331 396 324 269 253 195 180 100 0 Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census Stroke is the sudden loss of consciousness due to a rupture or occlusion of blood vessels that lead to the brain. The hospitalizations during the 5 year period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same individual. 04/21/2014 Appendix 4 Cancer Incidence Rate per 100,000 (2005-2009) 700 600 577.8 543 500.1 500 472.2 497.8 442 436.4 402.7 418.9 511.2 491 422.8 385.8 400 300 200 100 0 Source: North Carolina State Center for Health Statistics; 2010 US Census The cancer incident rate includes each case of cancer regardless of site. The cases are aggregated and calculated on a per 100,000 person basis. Colon/Rectum Cancer Incidence Rate per 100,000 (2005-2009) 70 59.4 60 50 40 52 45.5 45.1 44.4 38.1 46.3 46.1 40.4 34.9 41.7 39.5 33.7 30 20 10 0 Source: North Carolina State Center for Health Statistics; 2010 US Census The colon/rectum cancer incidence rate is limited to cancers located in the colon and rectum. The cases are aggregated and calculated on a per 100,000 person basis. 04/21/2014 Appendix 4 Lung/Bronchus Cancer Incidence Rate per 100,000 (2005-2009) 120 100.9 96.1 100 75.9 80 70.8 73.1 76.8 81.8 80 81.4 79.7 71.1 75.9 67.2 60 40 20 0 Source: North Carolina State Center for Health Statistics; 2010 US Census The lung/bronchus cancer incidence rate is limited to cancers located in the lungs and bronchi. The cases are aggregated and calculated on a per 100,000 person basis. Female Breast Cancer Incidence Rate per 100,000 (2005-2009) 180 160 137 140 139.2 138.8 127.6 125.9 126.8 136 108.9 120 100 157.2 154.1 156.4 154.5 94.8 80 60 40 20 0 Source: North Carolina State Center for Health Statistics; 2010 US Census The female breast cancer incidence rate is limited to cancers located in female breast. The cases are aggregated and calculated on a per 100,000 person basis. 04/21/2014 Appendix 4 Prostate Cancer Incidence Rate per 100,000 (2005-2009) 300 243.8 250 216.8 200 158.3 150 140.2 118.3 141 124.3 139 103.1 109.4 108.9 95.1 83.8 100 50 0 Source: North Carolina State Center for Health Statistics; 2010 US Census The prostate cancer incidence rate is limited to cancers located in prostate. The cases are aggregated and calculated on a per 100,000 person basis. Percentage of Total Hospital Discharges Related to Septicemia 6.00% 5.01% 5.00% 4.00% 3.00% 2.61% 2.90% 2.14% 2.00% 1.67% 1.22% 2.40% 2.40% 1.47% 1.46% 1.30% 1.00% 0.00% 0.00% 0.00% Source: NC Hospital Inpatient Discharge and Ambulatory Surgery Center Data The percentage of total hospital discharges related to septicemia is determined by calculating the percentage of the total hospital visits caused septicemia. It is important to note that the hospital in Bladen County did not have any cases while Hoke County does not have a hospital 04/21/2014 Appendix 4 Appendix 5: Contact Research Organization Contact Information AAIPharma Services Corp. www.aaipharma.com (910) 254-7000 Fax: (910) 815-2300 2320 Scientific Park Drive Wilmington, NC 28405-1800 AAIPharma Services provides drug product developments services such as formulation development, analytical chemistry and manufacturing. The company's solid-dose and parenteral manufacturing facilities provides clinical and commercial supplies on contract. Blitz Research http://www.blitzresearch.com (910) 332-4000 5512 Business Drive Wilmington, NC 28405 Blitz Research offers a wide range of services including pharmacovigilance, patient recruitment, and market analysis. Catalent www.catalent.com (919) 481-4855 Fax: (919) 481-4908 P.O. Box 13341 Research Triangle Park, NC 27709 Catalent is a full-service CRO focusing in the development, delivery and supply of pharmaceuticals. Chiltern International www.chiltern.com (910) 338-4760 Fax: (910) 799-1467 2528 Independence Blvd., Suite 101 Wilmington, NC 28412 Chiltern is a leading, full service, global Contract Research Organization with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas and contract staffing solutions. 05/31/2013 Clinipace Worldwide Inc. www.clinipace.com (919) 224-8800 Fax: (919) 321-2322 P.O. Box 14684 Research Triangle Park, NC 27709 Clinipace is a clinical research software company that provides a single, integrated data capture and study management platform for post-approval research and registries. Covance www.covance.com (888) 268-2623 Fax: +86 10 6569 4119 210 Carnegie Center Princeton, NJ 08540 Covance is provides comprehensive drug development services with focuses in nonclinical development, clinical development, and periapproval and market access. The EMMES Corporation www.secure.emmes.com/emmesweb 301-251-1161 401 N. Washington St., Suite 700 Rockville, MD 20850 EMMES offers services as a professional partner to clinicians, scientists, and program leaders. EMMES provides the full range of Contract Research Organization expertise necessary to conduct clinical research with a firm scientific basis that is fully compliant with national and international regulatory guidelines. Appendix 5 ICON Clinical Research www.iconclinical.com (919) 294-2200 Fax: (919) 294-2360 79 TW Alexander Drive, 4501 Research Commons, Suite 300 Durham, NC 27709 ICON provides drug development and clinical services, from compound selection to Phase I-IV clinical studies, in areas including oncology, cardiovascular and biosimilars. INC Research (Wilmington) www.incresearch.com (910) 509-4700 Fax: (910) 509-4701 1011 Ashes Drive Wilmington, NC 28405 INC Research specializes in providing clinical trials services to support global Phase I - Phase IV studies, and we offer deep therapeutic clinical trial expertise across a wide variety of indications, as well as for special populations, such as women and pediatrics. inVentiv Health http://www.inventivhealth.com (609) 951-6800 504 Carnegie Center Princeton, NJ 08540 InVentiv offers a full suite of services that support Phase I (first-in-human) through Phase IV (post-launch) clinical trials. Jubilant Clinsys www.clinsys.com (919) 518-8888 Fax: (919) 848-8461 8540 Colonnade Center Drive, Suite 407 Raleigh, NC 27615 Jubilant Clinsys is a scientifically focused contract research organization that provides pharmaceutical, biotechnology and medical device companies with a full range of services in support of Phase I – IV drug and device development 04/21/2013 Modoc Research Services www.modocresearch.com (910) 777-2671 Fax: (910) 777-2676 219 Racine Drive, Suite D Wilmington, NC 28404 Modoc Research Services works with biotechnology and pharmaceutical companies to develop and conduct Proof of concept (POC) and Phase I-II clinical trials. They offer a full range of support services. Novella Clinical (Wilmington) www.novellaclinical.com (910) 791-8438 Fax: (910) 791-8317 575 Military Cutoff Road, Suite 100 Wilmington, NC 28405 Novella Clinical is a full service clinical research organization dedicated to clients in the oncology, medical device and biopharmaceutical industries. OrphanReach www.orphan-reach.com (413) 821-0022 1408 Main Street Agawam, MA 01001 OrphanReach is the first of its kind Global Service Alliance dedicated to Orphan and Rare Disease Drug Development offering the full spectrum of clinical development services. PAREXEL International Corp. www.parexel.com (919) 544-3170 Fax: (919) 544-3410 2520 Meridian Parkway, Suite 200 Durham, NC 27713 Parexel provides drug-development and launch services, including clinical development, integrated advanced technologies, regulatory affairs consulting and commercialization services. Appendix 5 Pharm-Olam International www.pharm-olam.com (919) 237-4300 Fax: (919) 237-4301 P.O. Box 14089 Research Triangle Park, NC 27709 Pharm-Olam provides Phase I-IV clinical research services with focuses on data services and pharmacovigilance. PPD www.ppdi.com (910) 251-0081 Fax: (910) 762-5820 929 N. Front St. Wilmington, NC 28401 PPD, a global contract research organization, provides drug discovery, development and lifecycle management services to pharmaceutical, biotechnology, medical device, academic and government organizations. PRA International www.praintl.com (919) 786-8200 Fax: (919) 786-8201 4130 Park Lake Ave., Suite 400 Raleigh, NC 27612 PRA International, a global CRO, provides serves clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Premier Research www.premier-research.com (215) 282-5500 1500 Market Street Philadelphia, PA 19102 Premier Research is a global contract research organization (CRO) serving biotech, pharmaceutical, and medical device corporations. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; and oncology. 04/21/2013 Quintiles www.quintiles.com (919) 998-2000 Fax: (919) 998-2003 4820 Emperor Blvd. Durham, NC 27703 Quintiles is a contract research organization that provides clinical- and productdevelopment services for pharmaceuticals, biosimilars and medical devices. Research Pharmaceutical Services www.rpsweb.com (215) 540-0700 Fax: (215) 540-0770 520 Virginia Drive Fort Washington, PA 19034 Research Pharmaceutical Services provides comprehensive global Phase I-IV clinical development solutions to the Pharmaceutical, Biotechnology, Medical Device and Diagnostic industries. Sarah Cannon Research Institute www.sarahcannonresearch.com (877) 691-7274 3322 West End Ave., Suite 900 Nashville TN 37203 Sarah Cannon Research Institute works with sponsors at all levels on study design, data analysis, interpretation, protocol development, and clinical study reports. SynteractHCR (760) 268-8200 Fax: (760) 929-1419 5759 Fleet Street, Suite 100 Carlsbad, CA 92008 SynteractHCR is a full-service CRO with more than two decades of success delivering customized Phase I-IV clinical trial solutions, contributing to numerous product approvals across multiple therapeutic areas. Appendix 5 Theorem Clinical Research www.theoremclinical.com (484) 679-2400 Fax: (484) 679-2410 630 Allendale Road King Of Prussia, PA 19406 Theorem Clinical Research combines Phase I–IV solutions with specialized therapeutics expertise to execute perfectly aligned trials. Worldwide Clinical Trials www.wwctrials.com (310) 786-9100 Fax: (310) 786-9102 401 N. Maple Drive Beverly Hills, CA 90210 Worldwide Clinical Trials is a global CRO that provides full-service drug development services to the pharmaceutical and biotechnology industries. 04/21/2013 Appendix 5 Appendix 6: Clinical Research Support Company Contact Information Biostatistics Biostudy Solutions www.biostudysolutions.com (910) 792-9706 Fax: (866) 830-3720 4008 Caesar Court Wilmington, NC 28405 Biostudy Solutions provides pharmacokinetic and statistical services and study design related to BA/BE testing. PharPoint Research (Wilmington) www.pharpoint.com (910) 790-0482 Fax: (866) 589-4865 1985 Eastwood Road, Suite 100 Wilmington, NC 28403 PharPoint Research provides contract clinical management, programming, and biostatistics consulting and operational services. The company's biostatistics practice is based in its Wilmington office Triangle Biostatistics http://www.trianglebiostatistics.com (888) 316-3544 Fax: (888) 316-8753 1900 S. Main St., Suite 108 Wake Forest, NC 27587 Triangle Biostatistics has experience in regulatory submissions worldwide and provides a variety of Statistical consulting and programming services. 04/21/2014 Clinical Trials Data Management Clinical Ink http://www.clinicalink.com (336) 714-7402 100 N Cherry St Winston-Salem, NC 27g101 Clinical Ink offers electronic source documents-providing the first true Electronic Source Record (ESR) in the clinical trials market. OptumInsight http://www.optuminsight.com (888) 445-8745 Fax: (952) 833-7201 13625 Technology Drive Eden Prairie, MN 55344 OptumInsight specializes in improving the performance of the health system by providing analytics, technology and consulting services that enable better decisions and results. SAS Institute www.sas.com (919) 677-8000 Fax: (919) 677-4444 100 SAS Campus Drive Cary, NC 27513-2414 SAS software accelerates knowledge discovery in biomedical product development. Appendix 6 Clinical Trial Insurance Arthur J. Gallagher Risk Management Services www.ajg.com (910) 509-9000 Fax: (910) 509-9006 1430 Commonwealth Drive, Suite 302 Wilmington, NC 28403 Walker Taylor Agency/Arthur J. Gallagher Risk Management Services serves the pharmaceutical and life sciences industries for property, casualty insurance, professional liability and executive liability protection. Aquesta Insurance Services (Glasgow Hicks Insurance Agency) www.aquesta.com (910) 794-6100 3807 Peachtree Avenue Wilmington, NC 28403 Glasgow Hicks Insurance Agency provides insurance for the life science and clinical trial industries. Human Resources Support Babb McGrew www.babbmcgrew.com (910) 791-8570 Fax: (910) 791-8579 6209 Oleander Drive, Suite 102 Wilmington, NC 28403 Babb McGrew is a full service life science executive search firm serving pharmaceutical, biotechnology, healthcare and marketing companies. 04/21/2014 Hawthorne Search http://hawthornesearch.com (910) 798-1800 Fax: (910) 798-2811 1319 Military Cutoff Road, Suite CC #147 Wilmington, NC 28405 Hawthorne Search is a recruitment firm with specialization in recruiting for the pharmaceutical and biotechnology industries. Human Capital Solutions www.humancs.com (910) 332-3535 Fax: (910) 509-9833 1437 Military Cutoff, Suite 201 Wilmington, NC 28403 HCS is a business consulting firm specializing in executive search, human resources consulting, leadership, learning and employee development, business strategy, lean manufacturing and quality systems and personal coaching. ThinkingAhead Executive Search http://www.thinkingahead.com (910) 509-3831 Fax: (910) 509-3832 700 Military Cutoff Rd, Suite 305 Wilmington, NC 28405 ThinkingAhead is an executive recruiting firm with offices in the United States and Europe. The Wilmington Office focuses on Pharmaceutical and Medical Device recruitment. Independent Consultants Amanda Grim's GCP Audits (919) 349-4798 403A Harper Ave. Carolina Beach, NC 28428 Amanda Grim's GCP Audits offers GCP audits and training. Appendix 6 Argent Rx Solutions www.argentrx.com (910) 547-3355 1925 Hallmark Lane Wilmington, NC Argent Rx Solutions provides customized market and financial consulting for pharmaceutical companies. BioClin Consulting LLC www.bioclinconsulting.com (910) 398-7769 6603 Wheatfields Court Wilmington, NC 27411 BioClin Consulting provides clinical trial management services. Biopharmaceutech International linkedin.com/pub/david-johnston/1/633/1aa [email protected] A biotechnology and pharmaceutical consultancy specializing in helping growing companies with strategic advice. Cape Fear Research Consultants www.capefearresearch.com (910) 399-2220 4217 Pine Hollow Road Wilmington, NC 28412 Cape Fear Research Consultants provides clinical trials services including report writing, auditing, site selection and monitoring, training and education. Coastal Pharmaceutical Consultants, Inc (910) 259-8877 7950 Old River Road Burgaw, NC 28425 Coastal Pharmaceutical Consultants provides regulatory and quality consulting services, including assistance with product development regulatory strategies, consulting on GMP and GCP issues, and assessment of QC and QA functions. 04/21/2014 DMS Clinical Research Services 2330 Cedar Hill Road Leland, NC 28451 DMS Clinical Research Services has expertise in conducting, monitoring, and managing clinical trials. Hashimoto Consulting Services www.lanihashimoto.com (910) 617-6385 925 Rivage Promenade Wilmington, NC 28412 Hashimoto Consulting Services bridges patients and research providing patient recruitment services and consulting for pharmaceutical, biotechnology, and medical device clinical trials. Hermes, LLC www.hermesllc.com (910) 375-5454 331 Cape Fear Blvd. Wilmington, NC 28401 Hermes designs, develops and implements research projects, as well as provides technical assistance and training services. KButler GxP Consulting, LLC 113 Wyndham Way Wilmington, NC 28411 KButler GxP Consulting provides QA compliance expertise to pharmaceutical companies. MSS Pharmaceutical Consulting, Inc. 2017 Woodwind Drive Leland, NC 28451 MSS Pharmaceutical Consulting provides expertise in clinical monitoring, CRA resourcing, and CRA management. Appendix 6 Navigator Life Science Advisory www.navigatorlsa.com (910) 233-5037 Navigator Life Science Advisory is a consulting firm that specializes in drug discovery and development, drug safety, preclinical and clinical, FDA and EU regulatory affairs. Outsourcing Support Services, Inc www.outsource-support.com (317) 408-0286 Outsourcing Support Services offers services in outsource management, QA facility audits, and preclinical study monitoring. Pharmalogx LLC www.pharmalogx.com 2108 Forest Lagoon Place Wilmington, NC 28405 Pharmalogx provides advisory services to life science companies, particularly in the areas of manufacturing, compliance and organizational structuring. Rothermel Clinical Research Consulting LLC (910) 579-5263 631 Eastwood Park Road Sunset Beach, NC 28468 Rothermel Clinical Research Consulting provides contract medical writing and consulting, specializing in oncology clinical research. 04/21/2014 Spataro & Associates www.clinicalsupplysolutions.com (919) 491-0844 Fax: (866) 242-1908 1787 Riverbend Drive Burgaw, NC 28425 Spataro & Associates provides pharmaceutical consulting and training services in the areas of clinical supply chain operations, project management, process excellence, and compliance. Wagoner Consulting www.wagonerconsultingllc.com 910-386-9019 PO Box 15729 Wilmington, NC 28408 Wagoner Consulting provides cost-effective professional regulatory and quality assurance consulting services in the areas of medical devices, biologic products, pharmaceuticals, and consumer products. Information Technology Bluewater Technology Partners http://www.bluewatertechnc.com 109 Braxlo Ln. Wilmington, NC 28409 Bluewater Technology Partners is an innovative consultancy focused on information technologies for life sciences, pharmaceuticals, biotechnology and bioanalytical as well as general information technology initiatives. Appendix 6 Laboratory Testing Services Marketing Eurofins Scientific www.eurofins.com (866) 324-8691 14100 Park Meadow Drive, suite 110 Chantilly, Virginia 20151 Eurofins operates one of the industry's leading central laboratories worldwide, supporting clinical trials in more than 50 countries across six continents. A.Revell Communications www.arevell.com (919) 909-1097 11 Church Street Wilmington, NC 28401 A.Revell public relations, events and creative marketing services helps you refine your message and proclaim your position to the market. Quality Chemical Laboratories www.qualitychemlabs.com (910) 796-3441 Fax: (910) 796-3425 3400 Enterprise Drive Wilmington, NC 28405 Quality Chemical Laboratories offers contract analytical and microbiological testing services to pharmaceutical companies, including raw-material and finished-product testing, stability testing, method development and validation. Bon's Eye Marketing www.bonseyeonline.com (910) 399-2700 Fax: (866) 830-3270 4008 Caesar Court Wilmington, NC 2840 Bon’s Eye Marketing provides a full range of services specifically tailored to CROs including: Media and PR, Online Marketing, Brand Building, and Market Messaging. Solstas Lab Partners www.nextwavelabs.com (910) 202-2400 Fax: (910) 202-2499 1915 S. 17 St., Suite 100 Wilmington, NC 28401 Solstas Lab Partners provides medical laboratory testing services to hospitals, nursing homes, home health, clinics, urgentcare facilities and other businesses. Wilmington Pathology Associates www.wilmingtonpathology.com (910) 362-9511 Fax: (910) 362-9512 1915 S. 17 St., Suite 100 Wilmington, NC 28401 Wilmington Pathology Associates offers surgical pathology and cytopathology diagnostic services. 04/21/2014 Medical Writing Regulatory Writing Solutions https://sites.google. com/site/regulatorywritingsolutions/ourcompany (910) 794-5283 Regulatory Writing Solutions provides professional regulatory medical writing and consulting services to the pharmaceutical, biotechnology, and CRO industries Modoc Research Services www.modocresearch.com (910) 777-2671 Fax: (910) 777-2676 219 Racine Drive, Suite D Wilmington, NC 28404 Modoc Research Services works with biotechnology and pharmaceutical companies to develop and conduct Proof of concept (POC) and Phase I-II clinical trials. They offer a full range of support services. Appendix 6 Patient Recruitment ClinEdge www.clin-edge.com (857)496-0054 137A Lewis Wharf Boston, MA 02110 ClinEdge provides a range of marketing and patient recruitment services as well as a range of clinical operations services. PMG Research of Wilmington www.pmg-research.com/wilmington (910) 799-5500 Fax: (910) 799-1002 1907 Tradd Court Wilmington, NC 28401 PMG Research of Wilmington conducts Phase II, III and IV clinical trials in a wide range of therapeutic areas. Endeavour Clinical Solutions www.endeavour-clinical.com 127 E. 4th Street Corning, NY 14830 Endeavour provides consultative services for global clinical development and health outcomes intended to transform clinical research participation from study planning and feasibility through patient enrollment, retention, and improved health outcomes. Pharmaceutical Sales Training Proficient Learning www.proficientlearning.com (910) 509-0104 Fax: (910) 509-9105 1900 Eastwood Road, Suite 15 Wilmington, NC 28403 Proficient Learning offers sales training in medical devices, oncology pharmaceuticals and offers fully customizable training MediciGlobal www.mediciglobal.com (484) 674-6800 1014 West 9th Ave. King of Prussia, PA 19406 MediciGlobal is a specialty patient recruitment-retention firm serving the clinical trials industry. Trial Management Associates, LLC www.trialmgt.com (910) 338-1555 Fax: (866) 826-1581 1302 Medical Center Drive Wilmington, NC 28401 Trial Management Associates is a clinical research management company that manages and executes Phase II-IV industrysponsored clinical research studies. 04/21/2014 Appendix 6 Appendix 7: Drug, Medical Device, & Testing Development Contact Information Drug Development Alvogen www.alvogen.com (973) 796-3400 10 Bloomfield Avenue Pine Brook, NJ 07058 Alvogen is an international, privately-owned specialty pharmaceutical company focused on the development, manufacturing and marketing of generic pharmaceuticals, biosimilar products and OTC (over-thecounter medicines). CardioPharma www.cardio-pharma.com (910) 791-1361 Fax: (910) 794-1829 100-A Eastwood Center Drive, Suite 117 Wilmington, NC 28403 CardioPharma develops combinatorial products to treat cardiovascular disease. Furiex Pharmaceuticals www.furiex.com (919) 456-7800 3900 Paramount Parkway, Suite 150 Morrisville, NC 27560 Furiex Pharmaceuticals conducts and finances early-stage preclinical and proofof-concept drug development to clinical milestones with partner companies. MARBIONC Development Group LLC www.marbionc.org (910) 962-2330 Fax: (910) 962-2410 5600 Marvin K. Moss Lane Wilmington, NC 28409 MARBIONC Development Group is a notfor-profit organization that develops and markets new products and technologies derived from marine and aquatic organisms. Osmotica Pharmaceutical Corp. www.osmotica.com (910) 509-0114 Fax: (910) 509-0115 1205 Culbreth Drive, Suite 200 Wilmington, NC 28405 Osmotica Pharmaceutical specializes in drug-delivery technologies and neurologybased therapies, including a treatment for Parkinson's disease. Wilmington Pharmaceuticals www.wilmingtonpharma.com (910) 509-0097 Fax: (888) 482-8024 P.O. Box 16509 Wilmington, NC 28408 Wilmington Pharmaceuticals patientfriendly, fast-dissolving formulations for established medicines with an unmet patient need for simpler, more reliable dosage forms. Leonard Consulting, LLC (910) 232-3281 2201 S. Live Oak Pkwy Wilmington, NC 28403 Leonard Consulting provides consulting services focused on development of novel NDA products and 505(b)(2)/Abridged Hybrid products in the US and EU. 04/21/2014 Appendix 7 Medical Device Development & Testing Testing Development and Manufacturing Baxano Surgical www.baxanosurgical.com (910) 332-1700 301 Government Center Drive Suite 100. Wilmington, NC 28403 Baxano Surgical is a medical device company focused on designing, developing and marketing products to treat degenerative conditions affecting the spine lumbar region. AccuGenomics www.accugenomics.com (910) 332-6522 Fax: (910) 679-4263 1410 Commonwealth Drive, Suite 105 Wilmington, NC 28403 Accugenomics develops gene expression tests to diagnose and monitor cancer treatment. Cortech Solutions www.cortechsolutions.com (910) 362-1143 Fax: (910) 362-1147 1409 Audubon Blvd., Unit B1 Wilmington, NC 28403 Cortech Solutions is the single source for sales and support for all the tools a neuroscientist needs for advanced brain research. MicroGuard Consulting LLC www.microguardconsulting.com (910) 616-0066 4837 Wedgefield Drive Wilmington, NC 28409 MicroGuard Consulting provides microbiology consulting services to pharmaceutical and biotechnology companies. MindSkid Labs www.MindSkidLabs.com 910-202-2202 Wilmington, NC 28405 MindSkid Labs is a virtual medical device company. Our vision is to research and develop innovative medical devices, which improve surgical outcomes and patient care. Our customers are Ophthalmologists who conduct cataract surgery. OrthoKinetic Technologies LLC www.orthokintech.com (910) 253-9883 Fax: (910) 253-9884 2790 Creekbridge Court Southport, NC 28461 OrthoKinetic Technologies is a consulting and testing company who guides orthopedic and neurosurgical medical device companies in the areas of regulatory and preclinical strategies for FDA submissions. 04/21/2014 Appendix 7