Theorem Clinical Research

Articles Published in 2015

Vtesse forms scientific advisory board

Friday, March 27, 2015 01:47 PM

Vtesse, a rare disease company focused on developing drugs for Niemann-Pick Disease Type C (NPC) and other severe diseases with great unmet need, has formed its scientific advisory board (SAB). Comprising experts from a range of fields including pediatrics, translational medicine, biomarker research and genetics, the SAB will advise on clinical and regulatory strategy as well as product development for the company's lead candidate, VTS-270.

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Quest Diagnostics

Parkinson's Biomarker Initiative expands genetic study

Friday, March 27, 2015 01:26 PM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with a mutation of the GBA (glucosidase beta acid) gene. Participants will include people with or at increased risk to develop Parkinson's disease. Researchers hope that a greater understanding of the biology and clinical features of these participants will lead to therapies benefiting all Parkinson's patients and ultimately provide strategies to prevent disease onset.

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Mast to develop Vepoloxamer (MST-188) in chronic heart failure

Friday, March 27, 2015 01:15 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the company expects to begin dosing in a phase II study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.

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PRC Clinical updates management, launches east coast operations

Friday, March 27, 2015 11:54 AM

PRC Clinical, a Silicon-Valley-based CRO, has announced several management and executive appointments effective immediately. Mike Catelani will assume the role of chief financial officer and member of the board of directors. Daniel Head has been appointed to vice president of business operations, and Sue Dowden will assume the position of senior director of clinical operations. Tony Taricco, co-founder and current chief operations officer, has been appointed president and chairman of the board of directors.

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Ablynx, Merck extend ion channel research collaboration

Friday, March 27, 2015 11:21 AM

Ablynx, a biopharmaceutical company headquartered in Belgium, has extended its initial two-year research collaboration with Merck to develop and commercialize Nanobody candidates directed toward an undisclosed voltage gated ion channel.

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Report: Transparency, cooperation help reduce high prices for new medicines

Friday, March 27, 2015 11:19 AM

As the number of new medicines introduced in Europe rises, governments are finding it increasingly difficult to afford them, according to a comprehensive study released today by the WHO Regional Office for Europe. The study illustrates the challenges for national health systems, with specific examples, and shows that few countries in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness of new drugs; this hampers the value-assessment and decision-making processes.

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Clinicians, researchers and industry collaborate with the 100,000 Genomes Project

Friday, March 27, 2015 11:12 AM

Genomics England has announced a new collaboration as part of the 100,000 Genomes Project to accelerate the development of new diagnostics and treatments for patients. Ten pharma and biotech companies have come together to create the Genomics Expert Network for Enterprises (GENE) Consortium to oversee a year-long industry trial.

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Biomedical Catalyst to award $59M for new research

Thursday, March 26, 2015 03:00 PM

New treatments, diagnostics and medical technologies are set to benefit from an investment of $47 million through the Biomedical Catalyst (BMC)—a partnership between the Medical Research Council (MRC) and Innovate U.K. This MRC and Innovate U.K. funding will be further boosted by over $12 million of investment leveraged from industry, bringing the total investment for this round to $59 million.

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PPD first to migrate data to the Oracle Health Sciences Cloud

Thursday, March 26, 2015 02:58 PM

PPD is the first company to migrate trials from an on-site installation of Oracle Health Sciences’ Siebel Clinical Trial Management System to Siebel Clinical Trial Management System Cloud Service—creating a highly available, centralized trial database that lowers costs, simplifies management, improves the accuracy of multi-CRO clinical trial data and accelerates studies.

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National Institute of Mental Health issues strategic plan for research

Thursday, March 26, 2015 02:57 PM

The National Institute of Mental Health (NIMH) has issued a new strategic plan for research. Informed by the successes and challenges of recent years, the new plan updates the strategic objectives of its 2008 predecessor with the aim of balancing the need for long-term investments in basic research with urgent mental health needs.

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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