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Chronological Index of : Strategy

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  • Connecting dots in diabetes

    How Sanofi-Verily JV Onduo could improve day-to-day management of diabetes

    Onduo's plans to integrate disparate components of diabetes care could address what patient groups see as gaps in disease management.

    Published on 9/19/2016
  • A call to change incentives

    Why Jeremy Levin says executive compensation and drug pricing must be delinked

    Why Jeremy Levin says executive compensation and drug pricing must be delinked.

    Published on 9/19/2016
  • Dealing Denali

    Swarm of deals add pipeline and yield clues to Denali's CNS playbook

    Denali's unveiling of 11 deals yields the first look at how the company plans to use its war chest to target neurodegenerative diseases.

    Published on 9/12/2016
  • Haste, not waste

    24th BioCentury Back to School Issue: Revolutionize clinical development

    As costs increase and price pressures mount, the 24th Back to School essay says drug developers must revolutionize the 'D' in R&D.

    Published on 9/5/2016
  • Box: Adapting in AD

    Haste, not waste Adapting in AD The European Prevention of Alzheimer's Disease Consortium plans to launch an adaptive Phase II platform trial in AD next year that will not only identify candidates with a Bayesian …

    Published on 9/5/2016
  • Box: Framing the evidence

    Haste, not waste Framing the evidence This year, the Foundation for the National Institutes of Health is expected to publish a framework that will outline the basic evidence required for biomarker qualification …

    Published on 9/5/2016
  • Box: Making up for lost time

    Haste, not waste Making up for lost time AM-Pharma B.V. expects an adaptive Phase II study of its recombinant alkaline phosphatase will shave a year off the development timeline for the use of recAP in acute …

    Published on 9/5/2016
  • Box: Mod(ern) medicine

    Haste, not waste Mod(ern) medicine Novartis AG developed multiple comparison procedure modeling (MCP-Mod) to help ensure that the dose selected for Phase III is optimal from both a safety and an efficacy …

    Published on 9/5/2016
  • Box: Model citizens

    Haste, not waste Model citizens Pfizer Inc. adopted model-informed drug development as a companywide approach in 2005 with the aim of reducing the rate of late-stage study failures. According to a paper published…

    Published on 9/5/2016
  • Box: Naturally shorter

    Haste, not waste Naturally shorter Ionis Pharmaceuticals Inc. used data from a natural history study to identify an endpoint in spinal muscular atrophy that allowed its ongoing pivotal study to read out at least …

    Published on 9/5/2016
  • Box: Premarket pragmatism

    Haste, not waste Premarket pragmatism GlaxoSmithKline plc did a lot of upfront work to get its premarket pragmatic Salford Lung Study off the ground and is now exploring other diseases where it could gather real-…

    Published on 9/5/2016
  • Box: Regulatory oscillations

    Haste, not waste Regulatory oscillations Regulators in Japan and China may not be asking for more novel trials and modeling approaches to the extent FDA and EMA are, but that does not mean they aren't game. In …

    Published on 9/5/2016
  • Box: Trulicity adapts

    Haste, not waste Trulicity adapts In developing its regulatory package for Trulicity dulaglutide, Eli Lilly and Co. used computer simulations to determine the range of doses to be studied in its dose-finding trial…

    Published on 9/5/2016
  • Box: Woodcock's wish list

    Haste, not waste Woodcock's wish list CDER Director Janet Woodcock's prescription for better, faster drug development includes to-dos for industry, FDA and academic researchers that range from common-sense best …

    Published on 9/5/2016
  • Figure: Reasons for failure

    Haste, not waste Reasons for failure According to an FDA analysis of applications for NMEs submitted between 2000 and 2012, the most common reason for denying approval was a failure to select an appropriate dose. …

    Published on 9/5/2016
  • Figure: Seamless and speedy

    Haste, not waste Seamless and speedy Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE:MRK) used seamless Phase I protocols to gain rapid approval of targeted cancer agents. Pfizer's Xalkori crizotinib received …

    Published on 9/5/2016
  • Figure: Selecting for success

    Haste, not waste Selecting for success According to a BIO report on clinical success rates during 2006-15, 69% of all programs did not make it out of Phase II, and 42% failed to move from Phase III to filing. The …

    Published on 9/5/2016
  • Table: Basket case studies

    Haste, not waste Basket case studies At least six Phase II basket trials are studying one or more targeted agents across a range of cancers or cancer subtypes defined by a molecular signature, not by tissue of …

    Published on 9/5/2016
  • Table: Platform efficiencies

    Haste, not waste Platform efficiencies Platform trials can identify an effective therapy with fewer patients in less time and with a higher probability of success than a traditional two-arm study testing one drug …

    Published on 9/5/2016
  • Table: Platform prototypes

    Haste, not waste Platform prototypes At least seven platform studies that simultaneously test multiple therapies from different companies are ongoing or planned. The trials achieve operational efficiencies by …

    Published on 9/5/2016
  • Box: Panic and forget it

    Bug battle plan Panic and forget it The history of emerging infectious disease outbreaks over the past few decades reveals a consistent pattern. They start with a disease that has been previously identified but …

    Published on 8/1/2016
  • Box: Trying SAM

    Bug battle plan Trying SAM GlaxoSmithKline plc isn't waiting until it lines up funding for its proposed BioPreparedness Organization to start R&D on new vaccines for emerging infectious diseases. In July, GSK …

    Published on 8/1/2016
  • Check and mate

    Celgene thinks Jounce antibodies can treat cancers that checkpoint programs can't

    Celgene is betting that antibodies from Jounce can treat cancers that are unresponsive to checkpoint inhibitors.

    Published on 8/1/2016
  • Figure: ICOS to IFN gamma

    Check and mate ICOS to IFN gamma Inducible T cell co-stimulator (ICOS) is a cell surface receptor expressed on activated, but not naïve, CD4+ T cells. Initial activation of naïve CD4+ T cells requires two signals…

    Published on 8/1/2016
  • Bug battle plan

    GSK hoping a government funded unit will battle infectious diseases threats

    GSK is seeking government funding to create a BioPreparedness Organization to develop vaccines for emerging infectious diseases.

    Published on 8/1/2016

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