Academic Research in Europe Dra. Eva Carrasco

Academic Research in Europe Dra. Eva Carrasco Scientific Director Spanish 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 commercial Academic 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?

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.

Clinical trials

Clinical trials

Clinical trials

Clinical trials CT

Clinical trials CT

Clinical trials CT

Clinical trials CT

Academic clinical research issues Investigator clinical trial file Before May 2004 After May 2004

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 Requirements Resources

How to address these costs? Public resources Charities Private sector (pharma industry)

How to address these costs? 800 700 Charities Public Million Euros (2004) 600 500 400 300 200 4 2 100 0 1 1-1 2-2 4 4 Germany Denmark Spain France Italy The Netherland UK 1 3 1-6 6 Plus European funding: public_2007-2009 (265M ) and public-private_2007-2013 (2000M )

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/

Public funding Indirect investment in oncology research: Health care systems Universities Direct investment in oncology research: Basic/translational research Drug development (clinical research)

Public funding: direct investment 1200 1000 Basic research Clinical research Título del gráfico Investment per capita 1.100M 18 800 9 600 400 5 426M 6 2 6 389M 4 200 0 233M 144M 77M 33M Germany Denmark Spain France Italy The Netherland UK Data form 2006-2007. The role of funding and policies on innovation in cancer drug development. Panos Kanavos, Richard Sullivan, Grant Lewison, Willemien Schurer, 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 in Europe: summary 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: Fragmentation Mainly dedicated to basic research Clinical research focused on early phases

Charities 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)

Private sector 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.

Public-private collaboration Increasing worldwide and specifically in Europe. 2003 2012 35% 45% 65% 55% Spanish data: source BD metrics (14th edition) Internal R&D investment External R&D investment Big drug development centres in academic environments. Example of the NCRI in the UK

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 20 Institutions

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) Pharmacologists fgeicam (n=1) Epidemiologists/ Prevention Medicine epigeicam (n=5) Radiologists/Nuclear Medicine dgeicam (n=39) Radiation Oncologists/Physics rgeicam (n=74) Surgeons/gynecologists qgeicam (n=123) Pathologists/biologists pgeicam (n=86) Other: 3 Total: 730 members working in 181 institutions

Group structure GEICAM Headquarter General Assembly (399 voting members) Renewal every three years Steering Committee (20+5+working groups coordinators+ Scientific Director)

Trials approval process working groups 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 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 ADJUVANT METASTATIC Dr. Ana Casas Dr. Álvaro Rodríguez-Lescure. Coordinator Dr. Antonio Antón. Coordinator Dr. Antonio González Martín Dr. Amparo Ruíz Dr. Miguel Martín. Dr. Manuel Ruíz Borrego Dr. Enrique Barrajón Dr. Montserrat Muñoz Dr. César Rodríguez Dr. Ander Urruticoechea Dr. Ricardo Sánchez Escribano Dr. Mireia Margelí Dr. Ramón Colomer Dr. Isabel Blancas Dr. Sonia Servitja Torno Dr. Amparo González Sanchís Dr. Isabel Lorenzo Dr. Encarna Adrover Dr. Luis de la Cruz Dr. Julia Jiménez Dr. Carlos Jara Dr. Antonio Piñero TRANSGEICAM TRANSGEICAM FAMGEICAM Dr. Joan Albanell. Dr. Joan Coordinator Albanell. Coordinador Dr. Miguel Dr. Martín. Miguel Martín. Strategic Asesor Advisor estratégico Dr. Federico Dr. Rojo. Federico Coordinator Rojo. Coordinador Dr. Ramón Dr. Colomer Ander Urruticoechea (netgeicam) Dr. Ivan Márquez Rodas. Coordinator Dr. Agustí Barnadas Dr. Ramón Colomer Dr. Agustí Barnadas Dr. Ander Urruticoechea. Coordinator Dr. Gemma Llort Pursals Dra. Ana Lluch netgeicam Dr. Alberto Ocaña Dr. Juan de la Haba Dr. Ignacio Blanco Dr. Emilio Alba Dra. Marta Santisteban Dr. Emilio Alba Dr. José E. Alés Dr. Sonia Servitja Dr. Juan de la Haba Dr. Manuel de las Heras Dr. José Palacios Dr. José M. Dr. López José Vega E. Alés Dr. José Palacios Dr. Teresa Ramon y Cajal Dr. José M. López Vega Dr. Enrique Dr. José de Aláva A. López Gª Asenjo Dr. Raquel Andres Dra. Laura Estévez Dra. Laura Estévez Dra. Ana Dr. Lluch Enrique de Aláva Dr. Santiago Gonzalez Dr. Ángel Guerrero Dr. Ángel Guerrero Dr. Enrique de Lerma Dr. Enrique de Lerma Dr. Ana Laura Ortega Dr. José A. López Gª Asenjo Dr. Ignacio Aranda Dr. Ignacio Aranda Dr. Manuel de las Heras renewable every three years

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 30 countries 2500 Physicians 6000 new patients a year

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.

Affiliated members European Union: Belgium: 3 France: 7 Germany: 1 The Netherlands: 5 United Kingdom: 2 Italy: 1 Non-EU countries Switzerland: 2

Scientific strategy 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.

Group structure

Groups and task forces Brain tumours Breast cancer Children s Leukaemia Gastrointestinal tract cancer Genito-urinary cancers Gynaecological cancer Head and neck cancer Imaging Infectious diseases Groups Task forces Cancer in de elderly Cutaneous lymphoma Endocrine tumours Leukaemia Lung cancer Melanoma Pathobiology Pharmacology and Molecular mechanisms group Quality of Life Radiation oncology Soft tissue and bone sarcoma

International network in breast cancer Association founded by leading European opinion leaders in 1999. Network of 49 cooperative groups in 50 countries 31 EUROPE 1 CANADA 6 LATIN- AMERICA 2 AUSTRALIA 8 ASIA

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.

Group structure General Assembly (49 voting members) Executive board: 9 members Renewal every four years

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. PENELOPE B.

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