Preparedness for emerging pathogens: challenges and needs

Menno de JongDepartment of Medical Microbiology

Academic Medical Center, University of Amsterdam&

Centre for Tropical MedicineUniversity of Oxford

Conflict of interest disclosure I have no, real or perceived, direct or indirect conflicts of interest that relate to this

presentation. I have the following, real or perceived direct or indirect conflicts of interest that relate to

this presentation: Affiliation / financial interest Nature of conflict / commercial company name

Tobacco-industry and tobacco corporate affiliate related conflict of interest

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SARS CoV 2003 Flu H5N1

2004 Flu H1N12009 MERS CoV

2012 Flu H7N92013 Ebola

2014

Emerging infectious disease threats during the past decade

Pillars of epidemic preparedness

• early recognition and containment– surveillance– clinical awareness– infection control

• prediction– understanding emergence– surveillance– modelling

• (pre)clinical research– pathogen & disease characterization– prevention & treatment

• funding– rapid responses

The risk of emergence of emerging infectious diseases is high in regions where capacity to recognize and contain these is low.

Hotspots for (re-)emergence of zoonotic (a) or vector-borne (d) pathogens

Jones KE et al.

Drivers: - socio-economic (population density/growth) - environmental (latitude, rainfall) - ecological (richness wildlife species)

There are many known unknowns..

MDR-TB

CTX-MESBLs

…and how about the unknown unknowns?

“Laboratory Medicine is the weakest component of Health systems”

Laboratory capacity for EID threats:opportunities for cross-talk?

Hospital Microbiology

HIV program(Johns Hopkins)

Hospital Microbiology

TB program (GFATM)

Makerere University Kampala, Uganda

H. Adam Malik HospitalMedan, Indonesia

Eurosurveillance, Volume 20, Issue 25, 25 June 2015

MERS-CoV in South Korea

Ebola in Spain and the US

Pillars of epidemic preparedness

• (pre)clinical research– pathogen & disease characterization– prevention & treatment

• early recognition and containment– surveillance– clinical awareness– infection control

• prediction– understanding emergence– surveillance– modelling

• funding– rapid responses

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

16

Infe

cted

pati

ents

Public Health response

Preclinical research response

time

clinical research response

Public Health measures

Pathogen characterization

JAMA. 1918;71:1311

Clinical research

1918 2009Pandemic responses: influenza

vs

Clinical research is essentialin the face of emerging epidemics

• Observational studies– clinical and severity spectrum, risk factors– pathogen shedding and infection control– pathogenesis and clinical management

• Intervention studies– optimize clinical management and prevention

severe

symptomatic

asymptomatic

Global hurdles for timely clinical research during epidemics

• Health care capacity– clinical services unprepared and overwhelmed

• Collaboration and coordination– fragmented observations, studies– academic careers

• Ethical, administrative, regulatory, logistical– 621 days: the average time from development of a clinical research

protocol to recruitment of a patient*

* Academy of Medical Sciences UK. A new pathway for the regulation and governance of health research. 2011.

Rare diseases

European definition: < one person per 2,000

US definition: < 200,000 individuals in the US

Fischer A, Borensztein P, Roussel C (2005) The European Rare Diseases Therapeutic Initiative. PLoS Med 2(9): e243. doi:10.1371/journal.pmed.0020243

Source: Eurodis. Rare Diseases in numbers. 359

Source: Eurodis. Rare Diseases in numbers

SARS

H5N1 / H7N9

MERS-CoV

Unpredictable emergence

Geographically dispersed globally….

http://rambaut.github.io/MERS-Tools/cases2.html Accessed 03 Sept 2015

…and locally

MERS-CoV cases

Identify and solve hurdles for rapid clinical research responses

Advance development of standardized protocols, consent forms, case report forms and logistical plans. Available, translated, peer-reviewed, pre-approved and readily adaptable.

Open access and sharing throughout the process of research.

Networking and building of trust in peace time for joint research during epidemics.

Change in the approach of the academic community, funders, ethical committees, global agencies and local institutions.

Build: Human capacity. Data systems. Laboratory capacity. Bio-banks.

Clinical research in the context of epidemics needs a new paradigm: better prepared and ready to act.

International Severe Acute Respiratory and Emerging Infection Consortium

Federation of clinical networksLaunched in 2011

Open access protocols Pre-approvals

Outbreak clinical research

PREPARE Platform foR European Preparedness Against (Re-)emerging Epidemics

2014-2019

27 partners:

academia, clinical networks, societies, industry

Coordinators: Herman GoossensUniversity of Antwerp

Menno de JongUniversity of Amsterdam

OUR MISSION

To establish PREPARE as the European clinical research framework

for harmonised large-scale clinical research studies on infectious diseases

prepared to rapidly respond to any severe infectious disease outbreak

providing real-time evidence for clinical management of patients and for informing public health responses

European clinical research network- from primary care to intensive care -

European Community and Hospital care networks

Primary Care Network

> 600 general practitioners

in 19 European countries

> 700 hospitals

in 35 European countries

Hospital Care Network

Embedded internationally

European diagnostic laboratory support

Fit-for-purpose patient oriented

pathogenesis studies

European multi-center clinical trials, adding new arms to adaptive trial design as and when needed

Out

brea

k

Resp

onse

Infe

cted

pati

ents

Public Health response

Preclinical research response

clinical research response

time

Fast-forward clinical research during epidemics to improve clinical and pulic health management

• early recognition and containment– surveillance– clinical awareness– infection control

• prediction– understanding emergence– surveillance– modelling

• clinical research– pathogen & disease characterization– prevention & treatment

• funding– rapid responses

Epidemic preparedness research: European Union-supported efforts

2009-2016€ 36 M

2015-2020€ 21 M

2014-2019€ 24 M

GloPID-R 2015-2020€ 3 M

COllaborative Management Platform for detection and Analyses of (Re-) emerging and foodborne outbreaks in Europe

An enabling platform for early recognition and containment of infectious disease outbreaks by generating, sharing and comparing genomic information of pathogens across sectors, time and locations, with contextual metadata.

2015-2020

29 partners

Coordinators:

Frank AarestrupTechnical University of Denmark

Marion KoopmansErasmus Medical Centre

AcknowledgementsPREPARE

COMPARE

ANTIGONE

GloPID-R-sec