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Chronological Index of : Strategy

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  • Changing the subject

    23rd BioCentury Back to School Issue: Let patients show the way in drug development

    As 'value' becomes the rallying cry of payers, the 23rd Back to School essay says industry must help patients show the way throughout the product life cycle.

    Published on 9/7/2015
  • Box: Academy for advocacy

    Changing the subject Academy for advocacy The European Patients' Academy on Therapeutic Innovation is providing patients with formal training about drug development and regulatory and reimbursement decisions with …

    Published on 9/7/2015
  • Box: CDRH: Preferences in action

    Changing the subject CDRH: Preferences in action FDA's Center for Devices and Radiological Health established an important precedent when it used patient preference data to approve the Maestro Rechargeable System …

    Published on 9/7/2015
  • Box: Chartered territory

    Changing the subject Chartered territory UCB Group and the Parkinson's Disease Foundation are developing a charter to align their expectations, goals and work plan for a new company-patient collaboration, which …

    Published on 9/7/2015
  • Box: Convincing payers

    Changing the subject Convincing payers Anthem Inc.'s HealthCore Inc. subsidiary has been working directly with patients for more than eight years to get feedback on endpoints that are important to them and to …

    Published on 9/7/2015
  • Box: Founding framers

    Changing the subject Founding framers Biopharma companies and patient groups have launched the Patient-Focused Medicine Development consortium to develop best practices for patient involvement in drug development.…

    Published on 9/7/2015
  • Box: J&J's CompACt

    Changing the subject J&J's CompACt Johnson & Johnson and New York University School of Medicine are testing a model for evaluating compassionate access requests via an independent third party. The medical school …

    Published on 9/7/2015
  • Box: Legal-ease

    Changing the subject Legal-ease While FDA has endorsed patient engagement in both word and deed through its patient-focused drug development meetings, many drug companies say they do not feel safe engaging with …

    Published on 9/7/2015
  • Box: Patient focus 2.0

    Changing the subject Patient focus 2.0 FDA, biopharma companies and patient groups agree PDUFA VI should expand on the patient-focused drug development concept that was introduced in PDUFA V. The goal is to add …

    Published on 9/7/2015
  • Box: Patient power in Duchenne

    Changing the subject Patient power in Duchenne Parent Project Muscular Dystrophy provided a powerful demonstration of how a well-informed and sophisticated patient advocacy group can transform drug development in …

    Published on 9/7/2015
  • Box: Paying attention

    Changing the subject Paying attention The Canadian Agency for Drugs and Technologies in Health formally includes patient advocacy groups in health technology assessments and has begun incorporating their input …

    Published on 9/7/2015
  • Box: Reducing burdens

    Changing the subject Reducing burdens Several drug developers are evaluating ways to lower the burden of participating in clinical trials, including reducing the need for site visits and eliminating the risk that …

    Published on 9/7/2015
  • Box: Rules of engagement

    Changing the subject Rules of engagement UCB Group has developed a framework to ensure its employees engage with patients in ways that are both legally compliant and respectful of a patient's condition and privacy…

    Published on 9/7/2015
  • Figure: Applying preference research

    Changing the subject Applying preference research According to a draft guidance from FDA's Center for Devices and Radiological Health, patient preference research may be used throughout the product life cycle. …

    Published on 9/7/2015
  • Figure: Lack of participation

    Changing the subject Lack of participation According to a survey conducted between the end of 2010 and the fall of 2011 by the European Patients' Forum, just under half of the 40 HTA agencies that responded were …

    Published on 9/7/2015
  • Table: Pain points

    Changing the subject Pain points A sample of FDA's patient-focused drug development meetings reveals cases where patients want different endpoints, data or trial designs than companies and regulators use. Sources:…

    Published on 9/7/2015
  • Table: Preference methods

    Changing the subject Preference methods The Medical Device Innovation Consortium (MDIC) and FDA's Center for Devices and Radiological Health both describe a variety of patient-preference research methods. There is…

    Published on 9/7/2015
  • Table: Unmet need, indeed

    Changing the subject Unmet need, indeed Patient comments from a sampling of FDA's patient-focused drug development meetings have highlighted symptoms that are not adequately addressed by marketed drugs or most …

    Published on 9/7/2015
  • Green light for GeneWeave

    How GeneWeave technology fits Roche's plans to combat antimicrobial resistance

    Roche is buying GeneWeave's Smarticles technology to find the right drug for the bug in time to guide infectious disease treatment.

    Published on 8/24/2015
  • Guest Commentary: Overvaluing speed to market

    Why Priority Review vouchers might not be worth it

    Why Roger Longman says the market bubble in Priority Review vouchers signals the dramatic overvaluation of getting to market first.

    Published on 8/24/2015
  • Shifting MS spending

    How the multiple sclerosis market slowdown will affect new entrants

    Payers have finally found the means and will to combat MS spending increases and refocus negotiations on value metrics.

    Published on 8/17/2015
  • Figure: Inflection point?

    Shifting MS spending Inflection point? U.S. average wholesale price (AWP) data for MS drugs show double-digit growth rates are giving way to more moderate trajectories. The average compound annual growth rate (…

    Published on 8/17/2015
  • Figure: Slowing growth

    Shifting MS spending Slowing growth Aggregate sales of multiple sclerosis drugs from four major players have stalled over the last few quarters, largely due to the recent slowdown in products from Biogen Inc. (…

    Published on 8/17/2015
  • Table: Up next in MS

    Shifting MS spending Up next in MS At least eight new compounds are in Phase III or registration to treat multiple sclerosis, led by Zinbryta daclizumab. AbbVie Inc. (NYSE:ABBV) said it expects regulatory …

    Published on 8/17/2015
  • Figure: Exelixis' roller coaster

    Capitalizing on Cometriq Exelixis' roller coaster Exelixis Inc. (NASDAQ:EXEL) has seen its stock go on a wild ride since 2010, when it restructured twice and narrowed its focus to Cometriq cabozantinib for cancer.…

    Published on 8/10/2015

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