Workshop on the development of new medicines to treat tuberculosis

• Date:
  Friday, 25 November 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The workshop brings together experts and stakeholders from the academic, regulatory and industrial sectors to discuss key issues and new developments in the field of development of antimycobacterial medicines to treat tuberculosis. The presentations and discussions support the finalisation of the newly drafted addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to mycobacterium tuberculosis. The workshop will be broadcast live.

Documents

Agenda - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis)

AdoptedReference Number: EMA/427839/2016

List of participants - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis)

Reference Number: EMA/632391/2016

Presentation - Aims and objectives of the workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (Mair Powell)

Presentation - Topic 1 - In vitro models and animal models (Debra Hanna)

Presentation - Topic 1 - Selection of agents, doses and regimens for clinical study (David Barros)

Presentation - Topic 2 - Efficacy endpoints in clinical trials (Lawrence Geiter)

Presentation - Topic 2 - Endpoints that may correlate with cure (Gerry Davies)

Presentation - Topic 2 - Industry developers perspective (Robert Wallis)

Presentation - Topic 2 - Trial design considerations for evaluation of new treatment regimens, an academic perspective (Andrew Nunn)

Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens, Bedaquiline case study (Myriam Theeuwes)

Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens (Carl Mendel)

Presentation - Topic 3 - Evaluation of new treatment regimens, a clinicians perspective (Andreas Diacon)

Presentation - Topic 3 - WHO perspective (Christian Lienhardt)