Curriculum Vitae Ellen M. Cahill, CCRP Professional Address: Advanced Clinical Research Center of Houston Dr. Roger C. Willette, Principal Investigator 1051 Pineloch Drive, Suite 600 Houston, Texas 77062 Telephone: 832-284-4343 Fax: 832-284-4342 Email: ecahill@acrcofhouston.com Current Position: February 2012-Present Director, Research Operations Sr. Clinical Research Coordinator Education: Middlesex Community College, Middletown, CT Stone School of Business, New Haven, CT Membership: Certifications: SOCRA (Society of Clinical Research Associates) CCRP (Certified Clinical Research Professional) Current until 2013 Heart Savers CPR Re-Certification April 2011 IATA Shipping Infectious Substances and Dry Ice Standardized Joint Assessment Training Bristol-Myers Squibb October 2002 Clinical Research Quality and Standards-Ensuring National and International Study Success – September 2008 Conferences: Qualifications: Vast experience in subject screening and recruiting, conducting study visits and procedures, perform EKGs, administer study medication and assessments, collect and report AE and SAE data, complete source documentation/Case Report Forms and e/CRF data collection Provide leadership in planning, organizing and evaluating research activities and staffing Management and implementation of protocol specific activities for clinical trials according to GCP guidelines Negotiates, manages and oversees budget approval on behalf of Principal Investigator(s) Initiate and submit regulatory documents for approval and continuing review, attend Investigator Meetings for trial training and preparation Prepare source document templates, obtain CLIA/waiver as needed for site, laboratory specimen processing and phlebotomy Establish crash cart with emergency supplies and emergency protocol for research department Develop quality control procedures and documentation requirements as needed for drug storage and accountability Mentoring and training of research staff as needed Coordinate CPR training and certification for research staff, provide opportunities for continuing education and training in conducting successful clinical trials for research staff Experience with preparation and representation of research department for monitoring visits, sponsor and FDA audits for high enrollment Page Two Ellen M. Cahill, CCRP Curriculum Vitae-Continued Previous Professional Experience: August 2011-January 2012 Sr. Clinical Research Coordinator DM Clinical Research 12345 Jones Road Houston, Texas 77070 March 2010-August 2011 Research Department Manager The Center for Arthritis and Rheumatic Diseases, PC 816 Greenbrier Circle, Suite A Chesapeake, VA 23320 June 2001-February 2010 Director, Research Operations Sr. Clinical Research Coordinator Cahill Clinical Trials, LLC Leander, Texas 78641 Contracted to: September 2009-February 2010 Dr. Allen L. Mauldin Leander Healthcare Center Family Practice Research Department 2701 South Highway 183, Suite B Leander, Texas 78641 Contracted to: June 2001-January 2009 Walter F. Chase, MD, PA Rheumatology Research Division 1301 West 38th Street, Suite 609 & 605 Austin, Texas 78705 Clinical Research Experience: An Efficacy and Safety Study of an Approved Non-Steroidal Anti-Inflammatory Drug in Osteoarthritis. A Low-Dose Natural Human Biological Administered by the Oral Mucosal Route for the Treatment of Primary Sjogren’s Syndrome-A Phase 3 Clinical Study. A Double-Blind, Randomized Stratified Parallel-Group Study to Assess the Incidence of PUBs During Chronic Treatment With a New Non-Steroidal Anti-Inflammatory Drug in Patients with Rheumatoid Arthritis: US Cohort. Page Three Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Multi-Center, Double-Blind, Parallel Group Study Comparing the Incidence of Clinically Significant Upper Gastrointestinal Adverse Events Associated With a New Non-Steroidal Anti-Inflammatory Compound to That of a Bench Mark Non-Steroidal Anti-Inflammatory Drug in Patients With Osteoarthritis or Rheumatoid Arthritis. A Multi-Center, Double-Blind, Placebo Controlled COXX-2 Arthritis Medication As Compared to a Non-Steroidal for Safety and Efficacy in Treatment of Osteoarthritis. A Phase 1 and 2 Randomized, Double Masked, Placebo-Controlled Study of XXXXX to Assess Safety and Tolerability in Patients With Active Rheumatoid Arthritis. A Multi-Center, Double-Blind, Parallel Group Study Comparing the Effects On Renal Function and the Incidence of Gastro Duodenal Ulcer Associated With a COXX-2 in Two Doses With That of a Non-Steroidal in Patients With Osteoarthritis and Rheumatoid Arthritis. A Multi-Center, Randomized, Placebo-Controlled, Parallel Group, Double-Blind Study to Evaluate the Safety and Efficacy of a COXX-2 and a COXX-2 in Patients with Osteoarthritis of the Knee or Hip. A Multi-Center, Clinical Protocol to Evaluate the Long-Term Safety of a COXX-2 Twice Daily in Patients with Osteoarthritis or Rheumatoid Arthritis. A Multi-Center, Long Term, Open Label, Safety Study of XXXX in Combination with a Non-Steroidal in Patients with Osteoarthritis of the Knee. A Multi-Center, 4-Week, Randomized, Double-Blind, Placebo and Positive Controlled, Parallel-Group Study of XXXX Combination Therapy in Patients With Acute Osteoarthritis Pain of the Knee. A Comparison of the Analgesic Efficacy and Safety of XXXX versus Placebo in the Treatment of a Painful Flare of Osteoarthritis. A Multi-Center, Randomized, Parallel-Group, Open-Label Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of a COXX-2 versus Usual Care Administration of Prescription NSAIDS in a Managed Healthcare Setting in Patients with Osteoarthritis of the Hip, Knee or Spine. A Phase ll, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy and Tolerability of Three Intravenous Doses of XXXX in Patients with Rheumatoid Arthritis Receiving Methotrexate. A Twelve-Week, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Oral XXXX Once Weekly in Patients With Osteoporosis. A Multi-Center, Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of an Over-The-Counter (OTC) drug and a Prescription Non-Steroidal in the Treatment of Osteoarthritis of the Hip or Knee. Page Four Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Multi-Center, Double-Blind, Randomized, Parallel Group Comparison Study of the Safety of a COXX-2 versus a COXX-2 in Hypertensive Patients with Osteoarthritis. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of XXXX Given Monthly in Combination with Subcutaneous Injections of XXXX Given Twice Weekly to Subjects with Active Rheumatoid Arthritis. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of Two Different Doses of XXXX Given Monthly in Combination with Subcutaneous Injections of XXXX Given Twice Weekly to Subjects with Active Rheumatoid Arthritis: Long Term Extension Phase. A Phase llB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of XXXX Administered Intravenously to Subjects with Active Rheumatoid Arthritis While Receiving Methotrexate. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of Two Different Doses of XXXX Given Monthly to Subjects with Active Rheumatoid Arthritis While Receiving Methotrexate: Long Term Extension Phase. A Multi-Center, Randomized, Blinded, Placebo Controlled Study to Determine Long-Term Safety of Daily Subcutaneous Injections of XXXX in Patients With Rheumatoid Arthritis. A Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Treatment with XXXX and XXXX in Subjects with Rheumatoid Arthritis Receiving Methotrexate. A Multi-Center, Double-Blind, Placebo-Controlled, Randomized Six Week Comparison Study of the Efficacy of a COXX-2 and a COXX-2 in Relieving the Signs and Symptoms of Osteoarthritis of the Knee. A 26-Week, International, Multi-Center, Randomized, Double-Blind, Double-Dummy Parallel Group Active Controlled Endoscopic Study of Gastro Duodenal Effects of a COXX-2 in Two Separate Doses in Patients with Rheumatoid Arthritis Using XXXX TID, with a COXX-2 as Comparators. An Open-Label, Multi-Center Study of the Long-Term Safety of Intravenous XXXX in Rheumatoid Arthritis Patients Receiving Methotrexate Who Previously Participated in Study XXXX. A Multi-Center, Randomized, Parallel-Group, Double-Blind Study to Evaluate the Safety and Efficacy of a COXX-2, an Over-The-Counter (OTC) Drug, and a COXX-2 in Two Separate Doses in Patients With Osteoarthritis of the Knee. Page Five Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Analgesic Effect of a COXX-2 and Placebo in Patients with Chronic Lower Back Pain. A Multi-Center, Double-Blind, Placebo-Controlled, Randomized Six Week Comparison Study of the Efficacy of a COXX-2 versus a COXX-2 in Relieving the Signs and Symptoms of Osteoarthritis of the Knee. A Multi-Center, Phase ll, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial to Evaluate the Safety and Efficacy of Three Doses of XXXX versus Placebo and a Non-Steroidal AntiInflammatory in Patients with Osteoarthritis of the Knee. A Prospective Multi-Center, Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing XXXX Given Every Second Week With Methotrexate Given Weekly and the Combination of XXXX and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis. A Multi-Center, Phase ll, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of XXXX Given Intravenously on Rheumatoid Arthritis Patients with Active Disease Despite Receiving Methotrexate or Leflunomide. A Multi-Center, Efficacy and Safety Study of XXXX Delayed-Release Capsules in Two Different Doses versus Placebo for Prevention of Gastric Ulcers Associated with Daily NSAID Use in Patients at Risk. A Multi-Center, Efficacy and Safety Study of XXXX Delayed-Release Capsules in Two Different Doses versus Placebo for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued. A Multi-Center, Double-Blind, Randomized, Dose-Ranging, Parallel-Group Comparison of the Efficacy and Safety of Extended Release XXXX in Three Different Doses, a COXX-2 and Placebo in the Treatment of Osteoarthritis of the Knee And/Or Hip. A Multi-Center, Phase lll, Randomized Study Comparing the Safety and Efficacy of Oral XXXX versus Allopurinol in Subjects with Gout. A Multi-Center, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of COXX-2 and Placebo in Patients With Rheumatoid Arthritis. A Multi-Center, Double-Blind, Randomized Three Arm, Two Period, Crossover Study to Compare a COXX-2, an Over-The-Counter (OTC) Analgesic, and Placebo in Patients With Osteoarthritis of the Hip or Knee. A Double-Blind, Placebo Controlled, Randomized Comparison Study of the Efficacy and Safety of a New Non-Steroidal Anti-Inflammatory Drug and a Bench Mark Non-Steroidal Anti-Inflammatory Drug in Treating Signs and Symptoms of Osteoarthritis. Page Six Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Multi-Center, 12 Week Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy of a COXX-2 QD Compared to Placebo in Patients with Chronic Lower Back Pain. A Multi-Center, Double-Blind, Placebo Controlled, Randomized Two Week Comparison Study of the Efficacy and Tolerability of a COXX-2 versus a COXX-2 in Relieving the Signs and Symptoms of Osteoarthritis of the Knee. A Phase lll, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXXX Alone or in Combination Therapy with Methotrexate versus Methotrexate Alone in Subjects with Active Rheumatoid Arthritis And Inadequate Response to Methotrexate. A Phase lll, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Use Study to Evaluate the Safety and Tolerability of XXXX Administered Intravenously to Subjects with Active Rheumatoid Arthritis With or Without Medical Co-Morbidities Receiving Disease Modifying Anti-Rheumatic Drugs (DMARDS) and/or Biologics Approved for Rheumatoid Arthritis. A Phase lll, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXXX versus Placebo in Subjects with Active Rheumatoid Arthritis on Background DMARDS Who Have Failed Anti-TNF Therapy. A Phase lllB, Multi-Center, Randomized, Double-Blind Study to Evaluate Remission And Joint Damage Progression in Methotrexate Naïve Early Erosive RA Subjects Treated With XXXX plus Methotrexate Compared with Methotrexate. A Phase lll, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Comparative Study of XXXX or Infliximab in Combination with Methotrexate in Controlling Disease in Subjects with Rheumatoid Arthritis Having an Inadequate Response to Methotrexate. A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily XXXX versus Placebo in the Treatment of Subjects with Osteoarthritis of the Knee NonResponsive to Naproxen and Ibuprofen. A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of XXXX in Patients with Osteoarthritis or Rheumatoid Arthritis. A 13-Week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy of XXXX (BID) in Patients with Fibromyalgia. Page Seven Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Long-Term, Open-Label, Safety Trial of XXXX in Patients with Fibromyalgia. A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study to Evaluate the Safety and Efficacy of Oral XXXX in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis. An 8-Week, Multi-Center, Randomized, Double-Blind, Placebo-Group Trial of XXXX Gel 1% in Patients with Primary Osteoarthritis of the Hand. A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the XXXX Gel 1% for the Relief of Signs and Symptoms in Patients with Osteoarthritis of the Knee. A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Single Dose Comparison of the Analgesic Activity of XXXX and Placebo in Subjects with Shoulder Pain. A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Safety and Efficacy of XXXX in Subjects with Pain from Moderate Lateral Epicondylitis. A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Safety and Efficacy of XXXX in Subjects with Low Back Pain. A 6-Month, Double-Blind, Placebo-Controlled, Durability of Effect Study of XXXX for Pain Associated with Fibromyalgia. A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Pharmakenectics of Two Doses of a Candidate DMARD, XXXX 120 mg. and 240mg. Administered with Ongoing Methotrexate Treatment in Patients with Active Rheumatoid Arthritis. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase lll Study of the Efficacy, Tolerability and Safety of XXXX Topical Patch in the Treatment of Pain Associated with Tendonitis or Bursitis of the Shoulder, Elbow or Knee. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase lll Study of the Efficacy, Tolerability and Safety of XXXX Topical Patch, 20% (XXXX) in the Treatment Of Pain Associated with Tendonitis or Bursitis of the Shoulder, Elbow or Knee. A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral XXXX in Subjects with Gout. An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration Of XXXX/XXXX in Subjects with Moderate to Severe Chronic Non-Malignant Pain. Page Eight Ellen M. Cahill, CCRP Curriculum Vitae-Continued A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of The Safety and Efficacy of XXXX in Adults with Moderate-to-Severe Pain due to Osteoarthritis of the Knee. An Open-Label, Multiple-Dose, Study of the Safety and efficacy of XXXX in Adults with Pain Due to Osteoarthritis of the Knee. A Phase 3, Randomized, Multi-Center, Double-Blind Study Comparing the Analgesic Efficacy of Extended Release XXXX to Placebo in Subjects with Osteoarthritis. A Phase 3, Open-Label Period Followed by a Randomized, Double-Blind, PlaceboControlled Study of the Analgesic Efficacy and Safety of Extended Release XXXX Compared to Placebo in Subjects with Chronic Low Back Pain. A Long-Term, Open-Label, Safety Study of XXXX Capsules in Subjects with Chronic Moderate to Severe Nonmalignant Pain. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study Of XXXX Capsules in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee. A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of XXXX in Subjects with Systemic Lupus Erythematosus (SLE). A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either XXXX or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers. A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of XXXX in Patients with Osteoarthritis of the Knee or Hip. A Randomized, controlled study of XXXX on the treatment and prevention of gout flares in patients with frequent flares, who have pre-defined morbidities and for whom NSAIDS and colchicine are contraindicated, not tolerated or ineffective. Bristol-Myers Squibb-IM101-235. A Randomized, Head-to-Head Study to Compare the Efficacy and Safety Of Subcutaneous Abatacept versus Subcutaneous Adalimumab, Both with Background Methotrexate, in Biologic-Naïve Subjects with Rheumatoid Arthritis. Vertex Pharmaceuticals/PPD. A 12-Week, Double-Blind, Randomized, Parallel-Group PlaceboControlled Study of 4 Doses of VX-509 in Subjects with Active Rheumatoid Arthritis. (May 2010-Ongoing) Page Nine Ellen M. Cahill, CCRP Curriculum Vitae-Continued Centocor/Parexel-CNTO148ART3002. A Golimumab, Phase 3b, Multicenter, Switch Assessment of Subcutaneous And Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (Enbrel®) or Adalimumab (HUMIRA®). (July 2010-Ongoing) Ardea Biosciences/Pharm-Olam International-RDEA594-203. Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients with an Inadequate Hypouricemic Response with Standard Doses of Allopurinol. (August 2010-Ongoing) Sanofi-Aventis-DRI11073. A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Patients with Ankylosing Spondylitis (AS). (August 2010-Ongoing) AstraZeneca/Quintiles. A Phase lll, Multi-Center, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDS. (August 2010-Ongoing) Genentech, Inc./PPDi. A Phase ll, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared with Adalimumab in Combination With a DMARD In Patients With Active Rheumatoid Arthritis. (September 2010-Ongoing) UCB Biosciences, Inc./i3 Research. A Phase 4, Multicenter, Randomized, 52-Week Study to Evaluate the Routine Assessment of Patient Index Data (RAPID3) Compared to the Clinical Disease Activity Index (CDAI) to Prospectively Predict Treatment Success at 52 Weeks Based on a Treatment Decision at Week 12 in Subjects with Moderate to Severe Rheumatoid Arthritis Receiving Certolizumab Pegol (CZP). (November 2010-Ongoing) Eli Lilly and Company/Parexel International. A Phase 3, Multicenter, Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE). (November 2010-Ongoing) Eli Lilly and Company/Parexel International. A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to one or more TNF-a Inhibitors. (November 2010-Ongoing) Novartis Pharmaceuticals. A Randomized, Double-Blind, Active-Controlled Study of Canakinumab (ACZ885) Pre-Filled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide For Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients. (March 2011-Ongoing) Page Ten Ellen M. Cahill, CCRP Curriculum Vitae-Continued Takeda Pharmaceuticals/Covance. A Multicenter, Randomized, Active-Control, Phase 3b Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol In Subjects with Gout and Cardiovascular Comorbidities. (May 2011-Ongoing) Glaxo-Smith Kline. A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate Vilanterol Inhalation Powder 100/25mcg with Placebo on Survival in Subjects with Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease. (August 2011-Ongoing) Forest Research Institute, Inc. A 52-Week, Double-Blind, Randomized, Placebo-Controlled, ParallelGroup Study to Evaluate the Effect of Roflumilast 500µg on Exacerbation Rate in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteriod. (August 2011-Ongoing) Tioga Pharmaceuticals. A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS). (2009-Ongoing) Givens Imaging. Evaluation of Capsule Endoscopy with Pillcam® COLON 2 in Visualization of the Colon. (June 2011-Ongoing) Salix Pharmaceuticals. A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Budesonide Foam Twice Daily for 2-Weeks, Followed by 2mg/25ml of Budesonide Foam vs. Placebo Once Daily for 4-Weeks in Patients with Mild to Moderate Ulcerative Proctitis or Protosigmoiditis. (2009-Ongoing) Synergy Pharmaceuticals, Inc. A Randomized, 12-Week, Double-Blind, Placebo-Controlled, RepeatDose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC). (January 2012-Ongoing Exact Sciences. Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study. (December 2011-Ongoing)