Transcript An global plan to fight against terrorism in synergie with Russain

Towards a global plan to
fight against bioterrorism
in synergy with Russian
Federation
Novosibirsk 2004-09
bioterrorism = a worldwide
threat
the threat of re-emergent and new
emergent diseases
Partnership with Russian
Federation = Great opportunity:
- high-level scientists
- expertise
- high-level containment facilities
• Many initiatives…in order to fight against
bioterrorism and re-emergent and new emergent
diseases, and some of them in the scope the G8
 Need of coordination
• an effective and common synergy with
Russian Federation
• an overview of the research programs and
their implementation
an international tool of coordination
in order to increase the efficiency of our
common fight against terrorism in synergy
with Russian Federation
= a 3-steps master
plan :
- before
- during
- after
= a global response and preparedness plan
against bioterrorism and re-emergent and
new emergent diseases
 Programs of the partnership in
synergy with Russian Federation
PREPAREDNESS



Development of
detection tools
(diagnostic +
environmental)
Development of
prophylactic means
(vaccines,…) +
therapeutic means
(novel antibacterial and
antiviral) +
immunotherapy
Development* of animal
models for toxicological
and pharmacological
studies
CRISIS
MANAGEMENT
Stockpiles of
REHABILITATION
development of
drugs and vaccines detection tools for
circumscription of
Stock of
contamination
environmental kits of (perhaps the same
detection
ones than those
Stock of diagnostic used in
kits of detection
preparedness step)
Development of
new
decontamination
means
 Programs of the partnership in
synergy with Russian Federation
 IN THE STEP OF PREPAREDNESS
 Development* of animal models for toxicological
and pharmacological studies
*Requirements for these developments:
It is necessary to improve and/or develop referential and
recognized animal models by the national competent
authorities in order to permit the registration of
marketing authorizations of new drugs. These models
involve use of tools as pharmaco and toxico genomics,
proteomics, metabonomics.
WHY DO WE NEED DEVELOPMENT OF
VALIDATED ANIMAL MODELS ?
LIFE OF DRUG PRODUCTS
Animal Biomarkers
Human Biomarkers
?
REGULATORY
AGENCIES PHASES
?
Programs of the partnership in
synergy with Russian Federation
These animal models should be evaluated at the international level
By each regional Regulatory Agencies and Pharmaceutical industry
representatives
According OECD and ICH guidelines
Validated by ICH, ILSI HESI and WHO organisations
Preliminary requirement for
Russian Federation and also other
partners
GLP, GCP, GMP and ICH Recommendations facilities and training
Create, or identify, a department, or an agency, inside the Russian Health
Ministry in order to perform inspections and audits for non-clinical and
clinical studies and to deliver conformity certificates to international
standards
in order to achieve R&D (to take into account the results coming from
search) in view of pharmaceutical production for sale on the
international market strict quality control standards must be
observed such as Good Manufacturing Practices, Good Laboratory
Practices, ICH Recommendations. Such essential regulations are
now being introduced in Russian Federation
 Programs of the partnership in
synergy with Russian Federation
 IN THE STEP OF PREPAREDNESS
 Development of detection tools (diagnostic +
environmental)
*Requirements for these developments :
There is a lack of detection tools for many existing
and emerging pathogenes.
 Programs of the partnership in
synergy with Russian Federation
 IN THE STEP OF PREPAREDNESS
 Development of therapeutic means (novel
antibacterial and antiviral)
*Requirements for these developments :
There is a great need in this field because of the
unefficacy of the existing drug product.
 Programs of the partnership in
synergy with Russian Federation
For each topic of this master plan, it
would be fine if a special dossier (file)
should be written by the country
responsible for the action, with indication
of:
 who does what,
 with whom
 what kind of complementary action
 possible other cooperation
 ….
 Members and observers of
OECD
 Defined, reinforced and applied the future rules of
biosecurity for Biological Resource Centres
- BRC’s - (definition of operating and exchanges
rules for a global network of BRC’s in progress,
under the aegis of OECD)
A Biological Resource Centre is a center which
holds and supplies biological material with
authentification and long-term sustainability. It
can keep highly pathogen strains
 Each country, that is to say:
nationally
 In preparedness step:
Domestic biosecurity legislation and law
reinforcement
From now on, apply quality management
systems as a powerful tool for biosecurity
(global traceability of staff, materials,
operations, storage,….) in Biological
Resource Centres
 In crisis management step:
Governmental responses plans
implementation
 Towards an international
synergy:
all together
 In preparedness step:
– Reinforcement of the international cooperation
and criminalization against trafficking and
fraudulent use of pathogens and toxins: towards
an international traceability and cooperation in
order to fight against fraudulent use of
pathogens as the dispositions of the UN
narcotic psychotropes convention?
– Development and reinforcement of
epidemiological network and global system alert
under the aegis of WHO, OIE, FAO (diagnostic
detection tool, training,…)
 Towards an international
synergy:
all together
 In crisis management step:
 Harmonization of national, regional and
international response plans, for notably
interoperability, in connection with WHO, OIE,
FAO and according to WHO, OIE, FAO
policies
 Reinforcement of the global epidemiological
network
Thank you for your attention
and your… patience!
Dr Hervé Raoul + 33 1 69 26 56 99
[email protected]
Dr Dominique Masset + 33 1 55 87 35 84
[email protected]
Dr Isabelle Daoust-Maleval, + 33 1 71 75 80 75
[email protected]