Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.
This article summarizes progress from the initial imaging biomarkers developed to evaluate tumor shrinkage in response to cancer therapeutics, to the challenges posed by contemporary treatment paradigms which may produce new patterns of response.
The many challenges sponsors face performing clinical trials led Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, to remark in 2017 that the clinical trial system is broken. But if that’s the case, how do we uncover the underlying problems and bring all stakeholders together to fix them?
There is a significant need to collect Real World Evidence (RWE) to demonstrate the benefit of these drugs in clinical practice which can then be used as the wrap around to demonstrate true clinical benefit and address all stakeholder needs.
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes.
The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval.
Learn how Q2 Solutions utilizes over 35 years of experience in infectious disease and immunology assay development and clinical diagnostic testing to provide you with solutions to meet your anti-infective and vaccine needs across the development continuum.
Learn more about how Q2 Solutions is providing best-in-class quality systems across a global vaccine network to ensure sample integrity for high-quality data delivery and better outcomes for your anti-infective or vaccine study.
Keep track of specimens collected, stored, shipped, tested and reported through innovative laboratory sample management .
DIA NOW enables on-demand, curated access to actionable insights across DIA's global platforms.
With emerging and re-emerging infectious diseases the development of new anti-infectives and vaccines presents many challenges. We understand these challenges and our scientific experts can provide you with the strategic guidance to develop and validate custom assays and provide you with the high-quality laboratory services you need to ensure regulatory success.
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As increasing regulatory and scientific complexities threaten R&D productivity, you need a partner with scientific competence, regulatory expertise and capacity to meet demanding timelines via tailored solutions.
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Access leading-edge technologies, scientific experts and Genomics Know-How®. Q2 Solutions | EA Genomics, advances science from understanding the human genome and disease biology to detecting the effects of therapies.
Medical and regulatory documentation developed by experienced medical writing teams plays a pivotal role in the success of a clinical research project.
Blinded Diagnostics has been engaged to provide point of care diagnostics services to support a global multi-center clinical trial.
PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical™ technologies and delivering related services for the clinical trials industry, today announced its operating results for the fourth quarter and full year of 2012.
Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, announced today that the first patient has been treated with LIPO-202 (Salmeterol Xinafoate for Injection) in its 500-patient Phase 2b "RESET" trial.
Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
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.
DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials.
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.
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
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.
The IP & Science business of Thomson Reuters, the world's leading source of intelligent information for businesses and professionals, today announced the publication of a new report that provides a comprehensive view of the potential effects of personalized medicine on drug research and development.
It’s now possible for clinical trial researchers to control time, thanks to PHT Corporation’s patented Time Travel technology.PHT is the world’s leading provider of systems used to collect patient-driven eData for clinical research.
Blinded Diagnostics recently announced the expansion of their diagnostic product portfolio with the addition of an extensive line of screening tests for drugs of abuse and alcohol from Express Diagnostics Int’l, Inc. (EDI) of Blue Earth, MN.
Peregrine Pharmaceuticals (
