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Patient involvement prior to regulatory Scientific Advice

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Stefan Herdinius
Increasing patient involvment
Patient involvement prior to regulatory Scientific Advice

Publicada em: Saúde e medicina
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Patient involvement prior to regulatory Scientific Advice

  1. 1. Patient involvement prior to regulatory Scientific Advice 16 November 2015 EUPATI Webinar Stefan Herdinius UCB Biopharma
  2. 2. The Scientific Advice process 2 High-level description for clinical development
  3. 3. Case - Few existing treatment options 3 Background Autoimmune disease Other concomitant autoimmune diseases very common Currently symptomatic treatment - no systemic treatment available Advisory board jointly with clinical experts and patients prior to regulatory scientific advice focused on new potential systemic treatment to address disease immunologically
  4. 4. Case - Few existing treatment options 4 Advisory board with patients and physicians Questions to patients to inform scientific advice request: How to address the prevalence of concomitant diseases and the need in the larger patient population? What is most important to treat first? ■ The primary autoimmune disease or other concomitant diseases? Key outcomes of advisory board for supporting scientific advice: Polypharmacy (the use of four or more medications) due to concomitant diseases Typical development is in patients without concomitant diseases Key input to support scientific advice request from regulators Providing additional data and information for regulators Better basis for advice
  5. 5. Conclusions 5 Patient involvement prior to scientific advice Patient input before initiation of clinical development and scientific advice requests is of great importance Makes better plans and informs the scientific advice process before it starts Gives context to reality of disease and how we can address patients needs while meeting regulatory requirements This is one example of many, where patients can collaborate in the medicines development process
  6. 6. Thanks! 6