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May-June Clinical News and Product Briefs



News Briefs 

Eli Lilly and Company announced it will begin sharing its clinical trial data with scientific researchers through www.clinicalstudydatarequest.com. This website, which houses data from several clinical trial sponsors, was created in support of ongoing efforts by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to increase access to and transparency of clinical trial results with researchers around the world. The portal differs from previous Lilly data-sharing sites in that an independent scientific review panel, in which Lilly will not be involved, will be responsible for granting access to clinical trial data after reviewing research proposals from applicants. Press release 

Natera, Inc. and the International 22q11.2 Foundation entered a partnership to raise awareness about 22q11.2 deletion syndrome and the importance of early diagnosis. The partnership aims to encourage scientific research, influence current medical practice and raise awareness among the medical community and general population. One of the most common human genetic disorders, 22q11.2 deletion syndrome (“22q”) occurs when a small piece of the 22nd chromosome is missing, and it can lead to severe clinical outcomes. Natera’s Panorama test is currently the only non-invasive prenatal test on the market that uses a SNP-based approach to screen for chromosomal abnormalities, including microdeletions like 22q. Press release 

For more detailed coverage of recent developments in prenatal diagnostics, see “A European Look at the Changing Landscape of Prenatal Testing.”

The American Society of Human Genetics and the Jackson Laboratory will team up to produce educational programs to integrate genetic and genomic advances into healthcare. ASHG members and Jackson Laboratory faculty have jointly organized and taught an annual, two-week “Short Course on Medical and Experimental Mammalian Genetics” for more than 50 years. Through the new collaboration, the Jackson Laboratory and ASHG will further coordinate their educational activities by developing complementary programs. The first joint educational program will aim to educate primary care physicians on cancer genetic testing, and is slated for launch in November 2014 at the new Jackson Laboratory for Genomic Medicine in Farmington, Conn. Press release 

Comprehend Systems’ Comprehend Clinical platform was selected to manage site data in Versartis’ clinical trial of a treatment for growth hormone deficiency. Versartis selected Comprehend Clinical, a cloud-based platform, for its ability to provide the clinical operations team with real-time access to data from multiple sources, for trial management and safety review. Press release 

Celmatix began a clinical trial for Polaris, a platform that aims to help doctors at fertility clinics design personalized treatment plans based on a couple's specific clinical metrics. The predictive models that power Polaris are the first to show side-by-side comparisons of a patient's cumulative chances for success with in vitro fertilization (IVF) now and in the future, timed intercourse, and non-IVF treatments. The clinical study will enroll 1,000 patients. Celmatix’s preclinical analyses, using retroactive data, found Polaris to be more accurate than published predictive models on fertility treatment outcomes, but this trial will be the first test of Polaris in an active clinical setting. Press release 

New Products 

Aptiv Solutions, a subsidiary of ICON that designs and implements adaptive trials, released ADDPLAN DF 3.0, which uses statistical methodologies to prevent under and over-estimation of a drug’s maximum target dose (MTD) during Phase I dose escalation trials. Accurate estimation of MTD minimises safety and efficacy issues leading to late phase clinical trial failures and is of particular importance in oncology. ADDPLAN DF 3.0, which benefited from beta testing feedback from ADDPLAN DF Consortium members at Eli Lilly, Janssen, and Novartis, simulates and allows comparison of the 3+3, mTPI, CRM, and Bayesian logistic regression models for estimating MTD. Press release 

For more on Aptiv Solutions and the development of ADDPLAN DF, see “Taking on an Adaptive Dose Response Model.”

MolecularHealth announced the official launch of TreatmentMAP, its cancer treatment decision support offering, which was first made commercially available this April. TreatmentMAP uses the results of next generation sequencing genetic tests to identify treatment options for each individual patient. The company has two available versions of its offering: TreatmentMAP Targeted Panel, the largest gene panel commercially available today, covering several thousand variants across 500 genes that have been associated with cancer outcomes; and TreatmentMAP Whole Exome, the first commercially available whole exome analysis for cancer, which examines the genes of both the tumor and germline. Both testing options incorporate SafetyMAP, a proprietary identification of drug target safety or resistance effects that uses the FDA’s Adverse Event Reporting Systems as an input for analysis. Both tests results in simple-to-understand reports delivered to the patient’s medical team. Press release 

For more detailed coverage of MolecularHealth’s service, see “MolecularHealth Enters the American Cancer Genomics Market.”

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, released a web-based version of its risk-based monitoring platform that helps sponsors to determine the quality and integrity of their clinical trial data. The web-based CSM software as a service offering will enable customers to upload clinical data for assessment, visualize the findings and interact with analyses. CluePoints' products are driven by the company's SMART engine, which provides customers with the ability to check data quality across all clinical subjects, sites, regions and countries involved in a trial, while documenting where and why any anomalies have occurred. Product page 

For more information on CluePoints’ SMART engine, see “CluePoints’ Statistical Strategies Enhance Risk-Based Monitoring.”

Infosys produced a cloud-based version of its Clinical Trial Supply Management (CTSM) solution, a collaboration platform for pharmaceutical companies and contract research organizations (CROs). The new cloud-based version of the CTSM solution offers a set of tools to manage complex clinical trials, covering demand and supply planning as well as distribution across clinical sites. The on-premise version of the solution has been used to manage clinical trial processes at a number of large global pharmaceutical companies across the U.S. and Europe. Press release 

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