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FAMHP Speedy Assessment of Vaccines: EMA’s toolbox Bart Van der Schueren

FAMHP Speedy Assessment of Vaccines: EMA’s toolbox Bart Van der Schueren Brussels , 9th September 2017. Disclaimer.

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FAMHP Speedy Assessment of Vaccines: EMA’s toolbox Bart Van der Schueren

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  1. FAMHP Speedy Assessment of Vaccines: EMA’s toolbox Bart Van der Schueren Brussels , 9th September 2017

  2. Disclaimer The views expressed in this presentation are the personal views of the speaker and may not be understood or quoted as being made on behalf of or reflecting the position of EMA or one of its committees or working parties.

  3. No satisfactory method or if method exists, bring a major therapeutic advantage Eligibility to PRIME scheme Based on Accelerated Assessment criteria Introducing new methods or improving existing ones Meaningful improvement of efficacy (impact on onset, duration, improving morbidity, mortality) Medicinal products of major public health interest and in particular from the viewpoint of therapeutic innovation. • Potential to address to a significant extent an unmet medical need • Scientific justification, based on data and evidence available from nonclinical and clinical development

  4. For products under development yet to be placed on the EU market • Justification for eligibility to PRIME • Unmet medical need • Epidemiological data about the disease • Description of available diagnostic, prevention and treatment options/standard of care (SOC), their effect and how medical need is not fulfilled • Potential to significantly address the unmet medical need • Description of observed and predicted effects, clinical relevance, added value and impact • If applicable, expected improvement over existing treatments • Data required at different stages of development

  5. Nonclinical Phase I Exploratory • Confirmatory Entry points PRIMEeligibility and required evidence Confirmation Any sponsor SMEs Academia • Proof of principle • (For SMEs and academia only) • Sound pharmacological rationale, convincing scientific concept • Relevant nonclinical effects of sufficiently large magnitude and duration • Tolerability in first in man trials • Proof of concept • Sound pharmacological rationale • Clinical response efficacy and safety data in patients (exploratory trials) • Substantial improvement • Magnitude, duration, relevance of outcomes to be judged on a case by case basis

  6. What do we expect to grant eligibility? Unmet medical need No treatment or clear limitations of existing therapies Nonclinical data supporting pharmacological rationale (e.g. gene therapy) Clinical exploratory data on relevant endpoint If uncontrolled, use comparable historical control i.e. need sufficient information on baseline characteristics Magnitude of the effect size supporting major therapeutic advantage

  7. PRIME was launched in March 2016 • Factsheet in lay language • Q&A, templates, application form for applicants prime@ema.europa.eu

  8. PRIME eligibility recommendations adopted by 20 July 2017 • > 120 eligibility requests • 28 granted* • ~ 50% SMEs • ~ 50% Advanced therapies PRIME

  9. Early access tool, supporting patient access to innovative medicines. • Features of the PRIMEscheme • Written confirmation of PRIME eligibility and potential for accelerated assessment; • Early CHMP Rapporteur appointment during development; • Kick off meeting with multidisciplinary expertise from EU network; • Enhanced scientific advice at key development milestones/decision points; • EMA dedicated contact point; • Fee incentives for SMEs and academics on Scientific Advice requests.

  10. The innovation task force Informal early dialogue (SME) Proactivelyidentifyscientific, technical and regulatory issues related to emergingtherapies SME office Scientific advice Adaptive pathways Other development support activities

  11. 2: Focus on early access to innovation : Clinical trials

  12. Vaccines for pandemics • Procedures to speed up the availability of vaccines to protectagainstpandemic influenza • Mock up: strain of flu not circulating (quality, safety and immunogenicity, Authorizationunderexceptionalcircumstances) • Once pandemicdeclared: replace the flustrain in mock-up to straincausing the pademic rollingreview  variation

  13. Vaccines for pandemics • Procedures to speed up the availability of vaccines to protectagainstpandemic influenza • Emergency authorisationprocedure: complete package

  14. Federal Agency for Medicines and Health Products – FAMHP Place Victor Horta 40/40 1060 BRUXELLES tel. + 32 2 528 40 00 fax + 32 2 528 40 01 e-mail welcome@fagg-afmps.be www.afmps.be Contact

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