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Public Private collaborations to optimise translational research and pathways to patients: IMI
Magda Chlebus, Director Science Policy
Warsaw, 22 May 2015
EFPIA
Aim of the European Federation of Pharmaceutical Industries & Associations is to promote pharmaceutical discovery and development in Europe and to bring to the market medicinal products in order to improve human health worldwide.
EFPIA’s represents the pharmaceutical industry operating in Europe. Its direct membership includes 33 national associations and 41 leading companies. Two specialised groups within EFPIA represent vaccine manufacturers – Vaccines Europe, with 17 member companies) and European / emerging bio-pharmaceutical companies – EBE with +/- 50 member companies.
“Partners in Research” is constituted of non-pharma companies that collaborate in the IMI public-private membership. This constituent entity, created in June 2014, counts 5 members.
E F P I A - D E C E M B E R 2 0 1 4 2
3
Evolution: science and technology
Science more exciting and promising than ever More diverse R&D toolbox Life science integrates more disciplines every day
Evolution: the industry (-ies?)
From vertical integration to externalisation and open collaboration
From market access to patient access and outcomes From products to therapies From pharma only/mainly to ecosystems where we do not
always hold the keys of success
Elias A. Zerhouni, President Global R&D, SanofiEditorial in Science Translational Medicine, January 2014
‘We must acknowledge that no single institution, company, university, country, or government has a monopoly on innovation.’
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HUMAN & ANIMAL
Complementary investments: NIH and private sector in biomedical research
8
Product
Idea
Basic Research
Translational research
Clinical research
U.S. Private Sector: $51 B
National Institutes of Health: $31 BTufts Center for the Study of Drug Development, Jan, 2015
IMI – Europe’s partnership for health
> €5 bn
Partnership2008 - 2024
€2.5 bn€2.5 bn
Essential features for research and policy agendas
Public private partnership Companies and public partners work together Industry cost is not reimbursed: it is our in kind contribution Public partners (including companies up to 500 mio turnover) cost is
reimbursed by EU: grants for collaborating with industry
Industry defines the research agenda and projects Beyond the shelf – impact on research, regulatory and medical practice
Managed by a neutral broker that allows participation of authorities and patients
“Institutionalized” – legitimacy of direction and outputs
1 0
IMI2 Strategic Research Agenda
Strategic Research Agenda: reduced attrition, faster patient access, improved outcomes
!!
First five big themes
Therapeutic Areas and Cross-cutting Themes
Neuro-degenerationSuccessfully prevent and treat dementia and other neurodegenerative diseases
Prevention and treatment of immune-mediated diseaseAdvance immunological understanding to deliver new medicines and new and better vaccines
Metabolic disorders Tackle all phases of disease and its complications, including prevention and early interception
Infection controlAddress big societal problem related to multidrug resistance and develop new and better vaccines
Translational SafetyDevelopment of new human biology platform to predict toxicity and safety during early drug development
Differentiating Enablers for all themes
Towards early and effective patient access to innovative prevention and treatment solutions (MAPPs):
• Target validation based on human biology• Stratified medicine, precision medicine • Innovation in clinical trials • Data generation and interpretation (knowledge
management)• Prevention, disease interception, patient
adherence (incl. societal acceptance of vaccines)
• Effect on medical practice and outcomes (health/disease management)
• Regulatory framework (including pharmacovigilance)
• Patient access
New Big Challenges under consideration
Real World Evidence and for Better Outcomes
Advanced Therapies “industrialisation”
Biomarker Strategy
One Health
T I T L E O F T H E P O W E R P O I N T 1 4
Topic definition phase
Typical IMI project life cycle
Negotiation phase
Stage 1
Identification of topics and willingness to collaborate by industry partners
Signature of Project Agreement and Grant Agreement
Submission of proposals by public consortia
& evaluation by independent experts
Patients’ organisations
Academic research
teams
Regulators
Hospitals
SMEs
Mid-size enterprises
Industryconsortium
Stage 2
Preparation of full proposal & evaluation by independent experts/ethical panel
industryconsortium
Applicantconsortium
Call launch
Selected team
merges with
industry
Definition of
contractual terms
Project launch!
Over 7 000 researchers
59 public-private consortia
An international, cross-sector community
764 acade
micteams
146 SMEs
433 EFPIA teams
25 patient orgs
17 regulators
Programme across products lifecycle
New Drugs for Bad Bugs programme
Topic 1:COMBACTE
a) CT networks and CT design
b) Clinical Development of
Antibiotics
Topic 2 : TRANSLOCATION
Research penetration and
efflux Gram-negatives
Data Hub and Learning from R&D
experience
Topic 4: DRIVE ABDriving re-
investment in R&D and
Responsible use of
Antibiotics
Topic 5:Clinical
development of antibacterial agents for
Gram-negative antibiotic resistant
pathogens
Topic 6: Systemic
Antibacterials against hospital
acquired infections
Topic 7: Inhalational
Antibacterials in Cystic
Fibrosis and COPD
DISCOVERY ACCESSDEVELOPMNENTCT NETWORKS
Topic 3 : ENABLE
Discovery & development of
new drugs combatting
Gram–negative infections
DEVELOPMENTCT NETWORKS
ND4BB Information Centre – All data generated is submitted and is accessible to all consortium partners
It works! IMI delivers on Innovation and Health - a few examples:
Established robust validated models for Alzheimer, Diabetes, Schizophrenia, Asthma
Developed clinically relevant biomarkers for Alzheimer, Diabetes, Schizophrenia, Asthma
Established robust tools for drug safety prediction, prevention and monitoring
Establishment and regulatory submission of key standards and tools for drug development in infectious diseases, COPD, diabetes
Improved clinical trial design (shorter/smaller trials) and process in schizophrenia, pain, autism
Co-funding of antibiotics and vaccines development Projects launched and planned on use of real life data
and alignment of regulators and payers data requirement
Uptake by Regulators has started (guidance, biomarkers)
IMI2 vision: European Partnership for Health
Addressing healthcare priorities identified by the WHO 2013 report
Strategic Research Agenda aimed at progressing the vision of stratified medicines: prevention, treatment and health management
Entire product cycle from discovery, through development to healthcare delivery and access models
Collaboration across sectors to harness all knowledge and technologies which can contribute to IMI2 vision - diagnostics, imaging, IT, medical devices, …
Need more information?
EFPIA Science Policy Team
Mail: [email protected]
IMI office
Mail: [email protected]
National Contact Point
