Bench to patient in record time;Conducting trials in the Ebola

outbreak

Professor Trudie Lang, University of Oxford

Rapid research response

Rapide Platform Target Product Profile

Rapide BCV Trial Key Milestones Grant awarded to study start = 4months

Grant awarded DM system Protocol Drug Selected Contracts Ethics -- Oxford Ethics - Liberia Import license Export drug Final agreements First Patient

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1Sept Oct Nov Dec Jan

The Epidemic and research

Monthly new cases

March 14 Jan 15

Grant awarded First patient

Sept 14

Lost 6 weeks

Nov - Dect14

Total

cases

21,000

Total

cases

21,000

Clinical research responses to ID outbreaks are usually fragmented and too late

time

Public Health Response

Preclinical Research Response

Clinical Research Response

What is Bill Gates Afraid Of?"I rate the chance of a nuclear war within my lifetime as

being fairly low," says Gates. "I rate the chance of a widespread epidemic, far worse than Ebola, in my lifetime,

as well over 50%.”

Outbreak Mode

Inter-Epidemic Mode

Outbreak Mode Committee (OMC):Standing committee that convenes when the Coordinator is contacted in relation to a new specific ID outbreak to discuss the appropriate Outbreak Mode (1, 2 or 3)Composition: Herman Goossens (Chair), Menno de Jong, Marion Koopmans, Peter Horby

Outbreak Research Preparation Mode

Outbreak Research Team (OTC)Ad-hoc PREPARE expert committee

1

Outbreak Research Mobilisation Mode2

Outbreak Research Team (ORT):•PREPARE Executive Board;•ad-hoc PREPARE experts;

Planning and implementation of preparatory work necessary to achieve operational readiness to initiate clinical research response to specific ID outbreak if and when needed.

Outbreak Research Response Mode3

Outbreak Research Team (ORT):•PREPARE Executive Board;•ad-hoc PREPARE experts;•Ad-hoc external experts if necessary;

Planning and implementation of clinical research response to specific ID outbreak, building on the generic clinical research activities and preparedness activities in PREPARE.

Outbreak Research Plan: Outbreak Research Plan:

GA decision, EC (tacit) approval

GA decision, EC (tacit) approval

GA decision, EC (tacit) approval

GA decision, EC (tacit) approval

GA decision, EC (tacit) approval* * *

*

*

0** *

Assessing operational readiness in the network and development of clinical protocol if needed