FEATURED ARTICLES
A Chief Scientific Officer's Opinion On Clinical Outsourcing
Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.
WHITE PAPERS & CASE STUDIES
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Rare Diseases Clinical Trial Services
Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges.
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Point Of Care Hemoglobin Device Used In A Multicenter Study Of The Initiation Of Four Dosing Regimens Of ERYTHROPOIETIN Or The Treatment of Anemia Of Chronic Kidney Disease (CKD)
The primary objective of this study was to compare change in hemoglobin (Hb) from Baseline to the end of the study between the Q2W (every 2 weeks) and the Q4W (every 4 weeks) dosing regimens in subjects with anemia of CKD initiated on ERYTHROPOIETIN.
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Point Of Care Coagulation For Standardized Monitoring And Dose Adjustment During A Clinical Trial Of A Low Molecular Weight Heparin The study examined the use of a new low molecular weight heparin versus unfractionated heparin (UFH) among patients with ST-elevation myocardial infarction (STEMI) who had received fibrinolytic therapy and subsequently underwent percutaneous coronary intervention (PCI).
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Trends In Clinical Practice: Growth Of POCT Point-of-Care Testing (POCT) is most frequently defined as “clinical laboratory testing conducted close to the site of patient care, typically by clinical personnel whose primary training is not in the clinical laboratory sciences.
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A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study For Evaluation Of Efficacy And Safety Of Study Drug Versus Warfarin In Subjects With Atrial Fibrillation Atrial fibrillation (AF) is the most common type of arrhythmia in adults and becomes more common with increased age.
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The Case For The Use Of Point-Of-Care Testing In Pharmaceutical Clinical Trials Clinical trials that are designed to evaluate the efficacy of novel pharmaceuticals require a variety of diagnostic tests to be performed on all enrolled patients.
SERVICES & PRODUCTS
The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge. INC Research/inVentiv Health's Oncology team is uniquely qualified to manage that complexity.
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NEWS
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Piramal Enterprises' Diagnostic Division Launches QDx Instacheck
Piramal Enterprises’ diagnostic division recently announced the launch of “QDx Instacheck” Right-here-Right-now.
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Spectrum Pharmaceuticals Appoints Lee F. Allen, M.D., Ph.D., Industry Veteran, As Chief Medical Officer
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Lee F. Allen, M.D., Ph.D., as Chief Medical Officer. Dr. Allen will be responsible for leading the clinical development of Spectrum’s product pipeline, including belinostat, for which the Company anticipates an NDA filing mid-year, apaziquone, and glycol-free formulation of melphalan for both of which the NDA filings are expected in 2014. Dr. Allen brings over 15 years of biotech and pharma experience, as well as over 10 years of extensive research experience with over 40 papers published. He will report to Ken Keller, Executive Vice President and Chief Operating Officer. Spectrum also announced today that Dr. Steve Fruchtman, previously Chief Medical Officer at Spectrum, will take on the new role of Senior Vice President, Hematology and Oncology R&D, as of March 18, 2013. In this newly created position, he will report directly to Dr. Allen.
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Concert Pharmaceuticals Announces Completion of Enrollment in Phase 2 CTP-499 Clinical Trial
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
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Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
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Portola And Lee's Pharmaceutical Enter Into Agreement To Expand Phase 3 APEX Study Of Betrixaban Into China
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
HKSE : 0950) today announced an agreement to jointly expand the Phase 3 APEX study of betrixaban into China, with an option for Lee's to negotiate for the commercial rights to the drug in China. -
Amgen Announces Top-Line Results Of Phase 3 Aranesp® (darbepoetin alfa) RED-HF® Trial
Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
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Cell Therapeutics Begins Enrollment In Phase 3 PERSIST-1 Trial Of Pacritinib For The Treatment Of Myelofibrosis
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.
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Blinded Diagnostics Appoints Patricia H. Averette As VP, Business Development
Blinded Diagnostics announced the expansion of their business development efforts by appointing Patricia H. Averette, a seasoned health care professional with a solid background in Hematology Lab Diagnostics, as the new Vice President of Business Development.
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Immunovative Announces Regulatory Clearance To Conduct A Phase II/III Clinical Trial In Advanced Metastatic Breast Cancer For AlloStim™
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
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Fate Therapeutics Initiates Phase 2 Clinical Study Of ProHema For The Treatment Of Hematologic Malignancies
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced today the initiation of a randomized, controlled, Phase 2 multi-center study of its investigational hematopoietic stem cell therapy, ProHema, in adult patients undergoing double umbilical cord blood transplantation (dUCBT) for hematologic malignancy.
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Bio-Matrix' Regen BioPharma Initiates Pre-Clinical Study In Support Of HemaXellerate™ Cell Therapy
Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) announced today that its wholly owned subsidiary, Regen BioPharma, Inc., has contracted Cascade Life Sciences, Inc. to research the safety and efficacy of Regen's HemaXellerate™ product using mice models for testing
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Bayer's Investigational Riociguat Meets Primary Endpoint In Phase III Study Of Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.
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Lilly Diabetes Announces Positive Results Of Phase III Trials Of Dulaglutide In Type 2 Diabetes
Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.
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Hybrigenics Starts Phase II Clinical Trial Of Inecalcitol In Chronic Lymphocytic Leukemia
Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext in Paris, with a focus on research and development of new treatments against proliferative diseases, recently announces the start of a phase II clinical trial of oral inecalcitol in patients with chronic lymphocytic leukemia (CLL).