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hamelinclara

Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines -- PHILAD... - 1 views

www.prnewswire.com/...f-new-medicines-170329346.html

Pharma Research TransCelerate

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  • Ten leading biopharmaceutical companies announced today that they have formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi launched TransCelerate BioPharma Inc. ("TransCelerate"), the largest ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.
  • financial and other resources, including personnel, to solve industry-wide challenges in a collaborative environment.
  • among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines,
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  • As shared solutions in clinical research and other areas are developed, TransCelerate will involve industry alliances including Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Contract Research Organizations (CROs).
  • "We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.
hamelinclara

Drug Makers Join Efforts in Research - NYTimes.com - 1 views

www.nytimes.com/...rt-to-streamline-research.html

TransCelerate

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  • One project would be to standardize the way data from clinical trials are recorded. That would make it easier for clinical trial investigators to enter data without having to remember each company’s format and to compare data from clinical trials. Similarly, TransCelerate will work on a common Internet portal that investigators can use to communicate with all drug companies, and also on standardizing efforts to qualify clinical trial sites and to train investigators. It will also work on a way for companies to easily procure one another’s already marketed drugs for use in comparative clinical trials.
hamelinclara

2012 in reflection : Article : Nature Reviews Drug Discovery - 1 views

www.nature.com/...nrd3927.html

Patent

shared by hamelinclara on 09 Jan 13 - No Cached
  • Last year saw the largest loss of revenue yet from major drugs due to patent expiries, but a continuation of 2011's higher level of drug approvals and new initiatives to address R&D challenges provide hope for the future.
  • In September 2012, the non-profit TransCelerate BioPharma was established by Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech and Sanofi, initially to focus on improving clinical trial processes.
  • Incentives to develop breakthrough products were one of the major themes in the fifth incarnation of the US Prescription Drug User Fee Act (PDUFA), authorized in July 2012, through which industry pays fees to the FDA for product review (Nature Rev. Drug Discov. 11, 586–588; 2012).
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