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Boosting Drug Development T hrough Public-Private Partnerships – The IMI M odel. Hugh Laverty, S enior Scientific Project Manager. WRIC Brussels, 05 June 2013. Innovative Medicines Initiative: Joining Forces in the Healthcare Sector . 2 Billion €. I Billion €. I Billion €. Public.

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Boosting Drug Development

Through Public-Private Partnerships –

The IMI Model

Hugh Laverty,

Senior Scientific Project Manager

WRIC Brussels, 05 June 2013


Innovative Medicines Initiative:Joining Forces in the Healthcare Sector

2 Billion €

I Billion €

I Billion €

Public

Private

Partnership


IMI focus - Hurdles to better healthcare

  • Disease heterogeneity

  • Lack of predictive biomarkers for drug efficacy and safety

  • Insufficient pharmacovigilance tools

  • Outdated clinical designs

  • Socio-economic approaches not adapted to tailored therapies

  • Insufficient incentives to develop drugs for rare or complex diseases

  • Poor EU market conditions to create biotech companies

  • Lack of training programmes focusing on collaborative approaches


Key Concepts

“Non-competitive” collaborative research for EFPIA companies

Competitive calls to select partners ofEFPIA companies (IMI beneficiaries)

Open collaboration in public-private consortia (data sharing, wide dissemination of results)


- Optimized timelines

How it works

SMEs

Academic research teams

Hospitals

Step 2

Step 3

Step 4

Step 5

Step 1

  • The

  • Consortium

  • Signatures & project kick-off

  • Call Launch

  • 1st ranked EoI Selection

  • GB approval of 1st ranked FPP

  • negotiations start

Regulatory authorities

Patients’ organisations

18 weeks

9 weeks

6 weeks


How it works – Project Architecture

A Typical IMI Consortium

EFPIA

Private

Investment

in kind

(€ 1 billion)

Pharma 4

Pharma 1

Pharma 5

Pharma 2

Pharma 6

Pharma 3

SMALL AND MEDIUM-SIZED ENTERPRISES

ACADEMIA

EU Public

Funding

cash

(€ 1 billion)

PATIENTS’ ORGANISATIONS

HOSPITALS

REGULATORS


One IMI IP policy, multiple interests

  • Flexible Intellectual Property Rights policy allows to accommodate the interests of all stakeholders

  • Promotes knowledge creation, exploitation and disclosure → open innovation, open access

  • Ensures fair allocation of rights

  • Rewards innovation


The Evolution of IMI

From bottlenecks in industry to bottlenecks in society

  • Make Drug R&D processes in Europe more efficient and effective

  • and enhance Europe’s competitiveness in the Pharma sector

Idea generation

Basic research

and non-clinical

testing

Human testing

Regulatory

Approval

HTA and

Pharmacovigi-

lance

Primary focus of

early IMI calls

2007 SRA

Shift to addressing challenges in in society and healthcare

2011 SRA

SRA – Strategic Research Agenda


Key Figures from 40 on-going Projects

€587.5 mln

EFPIA ‘n kind

contribution

€ 580.7 mlnIMI JU

cash contribution

~ 4500 researchers

Improved R&D productivity of pharma industries

Innovative approaches for unmet public health needs

9regulators

18 patient org



Imi projects are delivering
IMI projects are delivering:

  • Robust validated models for drug development

  • Biomarkers and tools predictive of clinical outcomes - efficacy and safety

  • Potential new drug targets

  • Improving the design and process of clinical trials

  • “Big Data” solutions to leverage knowledge

  • Education and Training for new generation R&D scientists



Autism spectrum disorders (ASD):

Current situation

Sleep-medication

Incidence

  • 1 in 88 births

  • Males vs females

  • 4x frequent in males

    Strong Genetic link

  • 10-40% defined genetic alterations, High penetrance

    Treatment

  • No treatment for core symptoms

  • Risperdal and Abilify for irritability

    Synapse disorder

  • Various targets

Anti-depressants

Stimulants

Anti-convulsants

Courtesy: Autism Speaks – Rob Ring


Autism spectrum disorders (ASD):

European Situation 2012

  • No major strategy defined within Europe

  • No major or concerted efforts in drug discovery

  • No pre-clinical network

  • No clinical trial network

  • No translational network

  • No regulatory strategy

  • Late diagnosis and poor awareness (adults)

  • Poor knowledge of patients needs across life-course (teens into adulthood)

  • Wide range in treatment strategy with no evidence of efficacy

a concerted effort of key stakeholders is needed

Private Public Partnership


Eu aims
EU-AIMS

Launched April 2012


Advancements in Autism research

Identified 4933 de novo mutation based on sequencing 78 Icelandic parent–offspring trios (219 distinct individuals).

As a man ages, de novo mutations increase in his sperm offspring at increased risk of autism or schizophrenia.

Developed a new animal model replicating nonsyndromic autism. Demonstrated a reversal of the condition with specific therapy in mice opportunity clinical development of new treatments for autism.

Uncovered a key mechanism for controlling synaptic properties NL1 isoform-specific cis-interactions with ionotropicglutamate.

Concept paper on the development of Medicinal products for the treatment of Autism Spectrum Disorder

21 March 2013


Clinical Investigator Networks

COMBACTE

Combatting Bacterial Resistance in Europe

Establishment and training of European clinical investigators with the expertise and resources required to participate in global trials


Innovative rodent touchscreen technology

  • The rodent touchscreen technology is applied, validated and extended in NEWMEDS (schizophrenia) and PharmaCOG (Alzheimer’s)

  • Jointly developed as industry standard by Orion, UCAM, Janssen, Lundbeck, Roche, Abbott, Lilly, Pfizer

  • Pharmacologically validated for testing of pro-cognitive agents


Optimizing schizophrenia trials

Proposed ways to reduce required numbers of patients needed for antipsychotic trials while preserving 90% power (p<.05)

Based on resampling of data from 34 such trials (n=11,670 patients) data from Astra Zeneca, Janssen, Lilly, Lundbeck, Pfizer

Sample sizecan be reduced from 79 to 46 patients per arm by targeting trials

In addition the trial duration can be reduced from 6 to 4 weeks

Current mix =70% female; 20% early episode; 40% enriched

Enriched=prominent positive and negative symptoms

Early episode=under 3 with 4 or more years of illness

Note: Per patient cost 6wk study $70,000-$100,000


Systems Biology Approach

in Severe Asthma


Systems Biology Approach

in Severe Asthma

Diagnosis and definition of severe asthma: an international consensus

Bel EH et al. 66: 910, 2011

An integrative system biology approach to understanding pulmonary diseases

Auffray C. et al. 137: 1410, 2010

Developed various “omics” platforms based on genetic, proteomic, metabolomic, breathomic biomarkers

Generated a preliminary phenotype ‘handprint’ by combining molecular, histological, clinical and patient-reported data

Cohort clinical trial recruitment target reached

1025 subjects, 726 adults, 299 children - 14 Europeancentres

175 000 samples, 1 500 variables measured, and ~ 3 000 data points


http://www.ubiopred.european-lung-foundation.org/


Patient Reported Outcometools in COPD

  • Selected activity monitors for precisely capturing the Physical Activity (PA)

  • Developed a conceptual framework around PA

  • Selected the most appropriate parameters based on patient input

  • Conducted pre –validation study on 230 subjects

  • Official interactions initiated with EMA for qualification advice


European Lead Factory

  • All partners will have access to unique high-quality Joint European Compound Library

  • ≥ 300.000 compounds from industry partners – €60m

  • 200.000 compounds from public partners

  • Industry-like lead discovery platform available for public projects - focus on

  • value generation

  • Addressing ‘intractable targets’

  • 48 high throughput screening projects per anno

  • Sustainable model to establish independent business entity


European Lead Factory

Coordinated by Bayer, Managing Entity: TI Pharma


Exploiting Electronic Health Records

Academic perspective

  • Provide tools and services to better plan and conduct academic trials

  • Facilitate comparative effectiveness research

    Pharmaceutical perspective

  • Improve patient recruitment process and study design

  • Better understanding of real patient populations

  • Support observational and outcomes research studies in real-world settings

  • Enable more cost effective research and clinical trials

    General Healthcare perspective

  • Facilitate the re-use of EHR data to more efficiently manage public health issues

  • Enabling safer and more evidence-based diagnosis and treatment


Think Big’

Research on human diseases at an unprecedented scale

  • Access to information on 40 million patients through EHR

  • Alzheimer’ disease: research on 10-times more subjects than ADNI(Alzheimer's Disease Neuroimaging Initiative)

  • Metabolics research on > 20,000 obese & Type 2 diabetes subjects

  • Linkage of clinical and “omics” data

  • Development of a secure (privacy, legal) modular platform

  • Continue to build a network of data sources and relevant research

  • 58 partners (3 consortia + Efpia)

  • >200 scientists involved

  • 14 European countries represented

  • Total budget €56.4m

  • “3 projects in one”

28


Advancements in benefit-risk assessment methodologies

  • Case study Natalizumab

  • Indication - Relapsing remitting

  • approved 2004

  • license withdrawn 2005

  • reintroduced due to patient demand 2006

  • severe side effects:

    • Progressive Multifocal Leukoencephalopathy

  • Data source - EPAR

  • Comparators:

  • placebo, Avonex, Copaxone


Within the next 5 years the patients academy will
Within the next 5 years, the Patients‘ Academy will…

  • develop and disseminate accessible, well-structured and user-friendly information and education on medicines R&D

  • build expert capacity by training patient advocates,and competencies among patients and the public

  • create the leading public library on medicines R&D: 7 languages, “creative commons” license

  • facilitate patient involvement in R&D to partner up with academia, authorities, industry, ethics committees


Mapping Collaborative Networks – Call 1-3

Collaborative publications

among IMI researchers

Data & analysis: Thomson Reuters (Custom Analytics & IP Solutions)


Collaborative activity fostered by IMI

Collaborations between researchers engaged in IMI projects – Call 1-3

(until 08)

Data & analysis: Thomson Reuters (Custom Analytics & IP Solutions)


How public private partnerships move personalized medicine forward
How public-private partnerships move personalized medicine forward

Addressing key scientific challenges

Developing tools to translate scientific advances into regulatory guidelines

Considering new pathways to accelerate patient access to innovative therapies

Providing a neutral platform that fosters collaboration betweenstakeholders


IMI - The Neutral Trusted Party

Fosters large scale industry collaboration and engagement with scientific community

Promotes active involvement of patients, regulators and payers

Enables innovation via join effort where singular approach has failed so far

Facilitates Intellectual Property agreements


The measures of success

New model developed & published

In house implementation by industry

Setting new standards

Impact on regulatory guidelines


THANK YOU !

www.imi.europa.eu


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