Academic Research in Europe

Dra. Eva Carrasco

Scientific DirectorSpanish Breast Cancer Research Group

Type of clinical trials

Type 1:Designed and

sponsored by the Pharmaceutical

Industry, proposed to the Investigator and

accepted

Type 2:Designed and

sponsored by the Investigator, proposed to the Pharmaceutical Industry and accepted

Type 3:Designed and sponsored by the Investigator, not

supported by the Pharmaceutical Industry

Investigator sponsored clinical trials

Type 1:Designed and

sponsored by the Pharmaceutical

Industry, proposed to the Investigator and

accepted

Type 2:Designed and

sponsored by the Investigator, proposed to the Pharmaceutical Industry and accepted

Type 3:Designed and sponsored by the Investigator, not

supported by the Pharmaceutical Industry

Truly non commercialAcademic Trials

Is the academic research necessary?

Is the academic research necessary?

EORTC (2001)

“The 40% of the studies that have changed the management of

Cancer in the last 40 years have been sponsored by the Academy”

Is the academic research necessary?

YES!: there is a need to respond to “less” attractive questions for the pharmaceutical industry. “head to head” of already approved treatment options

Optimal duration of treatment

Studies needing a Long-term follow-up (adjuvant)

No drug-driven studies

Is the academic research necessary?

YES!: there is a need to respond to “less” attractive questions for the pharmaceutical industry. “head to head” of already approved treatment options

Optimal duration of treatment

Studies needing a Long-term follow-up (adjuvant)

No drug-driven studies

YES!: Need of high and quick recruitments of patients in clinical trials in cancer.

Is the academic research necessary?

Clinical trials

Clinical trials

Clinical trials

CT

Clinical trials

CT

Clinical trials

CT

Clinical trials

CT

Clinical trials

Before May 2004 After May 2004

Investigator clinical trial file

Academic clinical research issues

EU directive seems to be created thinking only on

registration of new compounds and

pharmaceutical industry research

Academic clinical research issues

Resources

Requirements

Academic clinical research issues

How to address these costs?

Public resources Charities Private sector (pharma industry)

How to address these costs?

0

100

200

300

400

500

600

700

800

Germany Denmark Spain France Italy The Netherland UK

Charities Public

4

1

2

64

413

1-61-1 2-2

Plus European funding: public_2007-2009 (265M€) and public-private_2007-2013 (2000M€)

Mill

ion

Eu

ros

(20

04

)

How to address these costs?

The role of funding and policies on innovation in cancer drug development. Panos Kanavos, Richard Sullivan, Grant Lewison, Willemien Schurer, Seth Eckhouse, Zefi Vlachopioti. European Cancer Research Managers Forum (ECRM). London School of Economics and Political Science, September 2009. Data of spending in R+D in oncology: Investment and Outputs of Cancer Research: from the Public Sector to Industry Public Industry. The Second Cancer Research Funding Survey. ECRM. European Cancer Research Managers Forum, Seth Eckhouse, Grant Lewison, Richard Sullivan, Septiembre 2007. Consulta de páginas webs en Octubre 2012: Webs pages:https://www.aecc.es/Paginas/PaginaPrincipal.aspx http://www.airc.it/ http://www.aicr.org.uk/ http://www.ailpescara.com/loginutenti.asp http://www.arc-cancer.net/ http://www.aphp.fr/ http://www.ayudas.net/Septimo_Programa_Marco_Investigacion_Desarrollo-11411BT1E2000R0P6O1PQ.html http://www.bmbf.de/en/ http://www.cancer.dk/om+os/The+Danish+Cancer+Society.html http://www.carreras-stiftung.de/ http://www.cnr.it/ http://www.cnrs.fr/ http://www.curie.fr/en http://dcs.kwfkankerbestrijding.nl/Pages/Home.aspx http://www.dfg.de/index.jsp http://www.en.fi.dk/councils-commissions/the-danish-council-for-independent-research/scientific-research-councils/medical-sciences http://www.fondazionefirc.it/ http://www.genomics.nl/ http://www.government.nl/ministries/vws http://www.inserm.fr/ http://www.isciii.es/ http://www.iss.it/chis/?lang=2 http://www.istruzione.it/web/hub/home https://www.krebshilfe.de/ http://www.legatumori.it/ http://www.ligue-cancer.net/ http://www.mineco.gob.es/portal/site/mineco/ http://www.obrasocial.lacaixa.es/ http://www.salute.gov.it/ http://www.wilhelm-sander-stiftung.de/cms/front_content.php http://www.zonmw.nl/en/

Indirect investment in oncology research: Health care systems Universities

Direct investment in oncology research: Basic/translational research

Drug development (clinical research)

Public funding

Data form 2006-2007. The role of funding and policies on innovation in cancer drug development. Panos Kanavos, Richard Sullivan, Grant Lewison, WillemienSchurer, Seth Eckhouse, Zefi Vlachopioti. 2009. European Cancer Research Managers Forum (ECRM). London School of Economics and Political Science, September 2009. Investment and Outputs of Cancer Research: from the Public Sector to IndustryPublic Industry. The Second Cancer Research Funding Survey. ECRM. European Cancer Research Managers Forum, Seth Eckhouse, Grant Lewison, Richard Sullivan, September 2007.

Public funding: direct investment

0

200

400

600

800

1000

1200

Germany Denmark Spain France Italy The Netherland UK

Título del gráficoBasic research Clinical research

426M€

1.100M€

389M€

233M€144M€

33M€77M€

56

2

64

9

18Investment per capita

High number of financing organizations with small investment

Higher investment in the UK, followed by Germany, France and Italy.

Cancer research is considered a priority in the UK and the Netherlands, not in other EU countries (though increasing).

Mainly through indirect sources (health care systems and Universities).

Direct investment:

Mainly dedicated to basic research

Clinical research focused on early phases

Public funding in Europe: summary

Fragmentation

Distribution vs public investment: Similar to public investment in the UK. Higher than public investment in countries like Denmark

and Sweden. Almost non existence in countries like Spain or Ireland.

Many small organizations focused on specific cancer types

Some big organizations with a general focus and huge investment in cancer research (Trust42 in the UK)

Charities

Through big Pharma

Contribution trend to be underestimated (lack of information provided by industry):

In 2004 3.1 B € in R&D in cancer worldwide.

Estimated to be a quarter of the total cancer research investment.

Private sector

Increasing worldwide and specifically in Europe.

Public-private collaboration

Big drug development centres in academic environments.

Example of the NCRI in the UK

65%

35%

2003

Internal R&D investment External R&D investment

55%

45%

2012

Spanish data: source BD metrics (14th edition)

Cooperative Groups: objectives

The main objective is to promote independent academic research in the field of Oncology applied to a particular tumor type or several types of cancer, in order to translate this research into practical applicability to patients.

Other objectives include the dissemination of the obtained results and knowledge, contributing to the scientific evidence.

Contribution to continuous medical education.

Cooperative Groups: advantages

Access to a broad, well-established network of highly qualified investigators and specialized hospitals and research centres.

Input from internationally renowned opinion leaders in cancer research.

Expertise in clinical trial design, conduct and analyses.

Scientific credibility by having the study conducted independently.

Money savings.

Cooperative Groups: different models

According to area of research: Multiple tumour types Focused on one tumour type

According to geography: Local (one country) International:

Direct membership of investigators Network (group of groups)

Local CG in all types of cancer

ICORG is a non-profit association officially registered in Ireland in 1996

ICORG is a collaboration of three parties – the Irish Clinical Oncology Research Group (ICORG) in Dublin, the Clinical Research Support Centre (CRSC) in Belfast, and oncology professionals

throughout Northern Ireland and the Republic of Ireland.

Mission and aims

Mission: To enable Irish patients to gain early access to new cancer treatments.

Aims: To promote, design, conduct and facilitate clinical cancer

research in the island of Ireland. Clinical cancer research means the investigation of methods

of prevention, diagnosis, management and treatment of patients with cancer.

Affiliated members

20Institutions

Group structure

Local CG in breast cancer

GEICAM is a non-profit association officially registered in Spain on April 4th, 1995

From June 2009 GEICAM is also a foundation registered in the Spanish Ministry of Education.

Mission

“Promote clinical, epidemiological and translational research as well as education and divulgation in Breast Cancer”

Affiliated members

Medical Oncologists(n=399)

Pathologists/biologistspGEICAM (n=86)

Surgeons/gynecologistsqGEICAM (n=123)

Radiologists/Nuclear Medicine

dGEICAM (n=39)

Radiation Oncologists/Physics

rGEICAM (n=74)

Epidemiologists/Prevention Medicine

epiGEICAM (n=5)

Other: 3

PharmacologistsfGEICAM (n=1)

Total: 730 members working in 181 institutions

General Assembly(399 voting members)

Steering Committee(20+5+working

groups coordinators+

Scientific Director)Renewal every

three years

Group structure

GEICAM Headquarter

Dr. Joan Albanell. Coordinator

Dr. Federico Rojo. Coordinator

Dr. Agustí Barnadas

Dr. Juan de la Haba

Dr. José E. Alés

Dr. José M. López Vega

Dra. Laura Estévez

Dr. Ángel Guerrero

Dr. José A. López Gª Asenjo

Dr. Manuel de las Heras

Dr. Miguel Martín. Strategic Advisor

Dr. Ramón Colomer

Dr. Ander Urruticoechea. Coordinator netGEICAM

Dr. Emilio Alba

Dr. José Palacios

Dr. Enrique de Aláva

Dra. Ana Lluch

Dr. Enrique de Lerma

Dr. Ignacio Aranda

TRANSGEICAM

renewable every three years

NEOADJUVANT

Dr Miguel A. Seguí. Coordinator

Dr. Miguel Gil

Dr. Lourdes Calvo

Dr. Pedro Sánchez Rovira

Dr. Ignacio Chacón

Dr. Melcior Sentís

Dr. Ignacio Tusquets

Dr. Manuel Ramos

Dr. Isabel Álvarez

Dr. Helena García

Dr. Marta Santiesteban

Dr. Julia Jiménez

Dr. Antonio Piñero

ADJUVANT

Dr. Álvaro Rodríguez-Lescure. Coordinator

Dr. Amparo Ruíz

Dr. Manuel Ruíz Borrego

Dr. César Rodríguez

Dr. Mireia Margelí

Dr. Sonia Servitja Torno

Dr. Amparo González Sanchís

Dr. Luis de la Cruz

Dr. Carlos Jara

EPIDEMIOLOGY / CHEMOPREVENTION

Dr. José M. Baena

Dr. Marina Pollán. Coordinator Epi

Dr. Miguel Martín

Dr. Ignacio Tusquets

Dr. Montserrat Muñoz

Dr. Laura Estévez

Dr. Pedro Sánchez Rovira

Dr. José E. Alés. Coordinator Chemo

Dr. Carlos Jara

Dr. Beatriz Pérez Gómez

Dr. Lola Salas

METASTATIC

Dr. Antonio Antón. Coordinator

Dr. Miguel Martín.

Dr. Montserrat Muñoz

Dr. Ricardo Sánchez Escribano

Dr. Isabel Blancas

Dr. Isabel Lorenzo

Dr. Julia Jiménez

Dr. Antonio Piñero

FAMGEICAM

Dr. Ivan Márquez Rodas. Coordinator

Dr. Gemma Llort Pursals

Dr. Ignacio Blanco

Dr. Sonia Servitja

Dr. Teresa Ramon y Cajal

Dr. Raquel Andres

Dr. Santiago Gonzalez

Dr. Ana Laura Ortega

Dr. Ana Casas

Dr. Antonio González Martín

Dr. Enrique Barrajón

Dr. Ander Urruticoechea

Dr. Ramón Colomer

Dr. Encarna Adrover

Dr. Joan Albanell. Coordinador

Dr. Federico Rojo. Coordinador

Dr. Agustí Barnadas

Dra. Ana Lluch

Dr. Emilio Alba

Dr. Juan de la Haba

Dr. José E. Alés

Dr. José M. López Vega

Dra. Laura Estévez

Dr. Ángel Guerrero

Dr. Miguel Martín. Asesor estratégico

Dr. Ander Urruticoechea (netGEICAM)

Dr. Ramón Colomer

Dr. Alberto Ocaña

Dra. Marta Santisteban

Dr. Manuel de las Heras

Dr. José Palacios

Dr. José A. López Gª Asenjo

Dr. Enrique de Aláva

Dr. Enrique de Lerma

Dr. Ignacio Aranda

TRANSGEICAM

Trials approval process working groups

International GC in all cancer types

The EORTC was founded as an international organization under Belgian law in 1962 by eminent oncologists working in the EU

countries and Switzerland.It was named GECA and became the EORTC in 1968.

300 Universities or Hospitals 2500

Physicians

6000 new patients a year

30 countries

Aims and mission

The aims of EORTC are:to develop, conduct, coordinate, and

stimulate translational and clinical research in Europe to improve the management of cancer

and related problems by increasing survival but also patient quality of life.

European Union:Belgium: 3France: 7Germany: 1The Netherlands: 5United Kingdom: 2Italy: 1

Non-EU countriesSwitzerland: 2

Affiliated members

The primary interests of the EORTC are clinical trials that investigate strategic therapeutic questions that will influence medical practice or will fundamentally

improve the understanding of a disease.

The EORTC Scientific Strategy encompasses the following types of clinical trials: Large phase III academic trials aimed to change the

standard of care Trials with a strong translational research component Trials addressing rare tumor types Trials optimizing integration of new agents in therapeutic

strategies.

Scientific strategy

Group structure

Brain tumours Breast cancer Children´s Leukaemia Gastrointestinal tract cancer Genito-urinary cancers Gynaecological cancer Head and neck cancer Imaging Infectious diseases

Leukaemia Lung cancer Melanoma Pathobiology Pharmacology and Molecular

mechanisms group Quality of Life Radiation oncology Soft tissue and bone sarcoma

Groups and task forces

Cancer in de elderlyCutaneous lymphoma

Endocrine tumours

Groups

Task forces

International network in breast cancer

Association founded by leading European opinion leaders in 1999. Network of 49 cooperative

groups in 50 countries31

EUROPE

1CANADA

6LATIN-

AMERICA

8ASIA

2AUSTRALIA

Mission

BIG facilitates and accelerates breast cancer research at the international

level by stimulating cooperation between its members and other

academic networks, and collaborating with, but

working independently from, the pharmaceutical industry.

General Assembly(49 voting members)

Executive board:9 members

Renewal every four years

Group structure

Trials development and conduct

The “Lead” Model. Trials led and run by the “BIG Network”. BIG HQ acting as coordinating data centre and providing statistical leadership (BrEAST Data Centre and Frontier Science Research and Technology Foundation). HERA and ALTTO.

The “Co-Lead” Model. Trials led and run by a BIG Group, with one or more other partners, and in which the BIG HQ is involved as a “Co-Lead”. NeoOLYMPIA.

The “Supporter” Model. Trials supported by the BIG umbrella, with a limited role for BIG HQ. PENELOPEB.

Thanks!