Curriculum Vitae

PERSONAL INFORMATION Denis Lacombe

WORK EXPERIENCE

September 1993-September 1996 Medical Supervisor EORTC (Belgium)

October 1996-January 2007 Head of the Investigational Agent Unit EORTC (Belgium)

March 1996-November 2007 Head of EORTC Intergroup Office EORTC (Belgium)

March 1997-November 2007 Head of Pharmacovigilance Unit EORTC (Belgium)

March 1997-November 2007 Head of Regulatory Affairs Unit EORTC (Belgium)

January 1998-November 2007 Assistant Director Medical Affairs/New Drug Development Team EORTC (Belgium)

January 1998-December 2010 Chairman EORTC Institutional Review Board EORTC (Belgium)

January 1999-December 2010 Clinical Research Physician Brain Tumor EORTC (Belgium)

January 2003-December 2009 Head and Neck Tumor Group EORTC (Belgium)

November 2007-November 2010 Scientific Director EORTC (Belgium)

January 2009-December 2011 Clinical Research Physician Lung Group EORTC (Belgium)

January 2005-April 2015 Coordinator Fellowship Program

08/12/2020 European Medicine Agency Page 1/15 EORTC (Belgium)

November 2010-April 2015 Director, EORTC Headquarters EORTC (Belgium)

EDUCATION AND TRAINING

- Medical Doctor ()

- 1980 High School Graduation - French Baccalaureate France ()

- 1981 Medical School FR ()

1983- 1985 Pharmacology master composed of three certificates (France) Pharmacology master composed of three certificates: - General pharmacology General physiology - Basis of radio-isotopes use in medicine and radiobiology

- 1988 Medical Thesis (France)

1983- 1985 Master (United States) Fundamental and Clinical Pharmacokinetics Master Post-doctoral fellowship Roswell Park Cancer Institute

- 1990 CESAM (France) Preparation of French statistics degree

ADDITIONAL INFORMATION

Expertise

Publications 1.LACOMBE D., MEUNIER F. Patients rights: The specificity and requirements of high-quality clinical research and its impact on patient-doctor communication. Revue de Droit de la Santé (Ministère Belge) 1997-1998; 365: 405-411. 2.DE BOUYALSKI I., LACOMBE D. The Development of the Guidelines and Recommendations for European Ethics Committees by the European Forum for Good Clinical Practice. International Journal of Pharmaceutical Medicine 1997; 11: 125-127. 3.LACOMBE D. Ethical Issues in Cancer Clinical Trials: A European Perspective. European Journal of Cancer 1997; 33(2): 184-185.

08/12/2020 European Medicine Agency Page 2/15 4.LACOMBE D. Insuring International Clinical Trials. An Academic Viewpoint. Applied Clinical Trials 1998; 7(3): 24-29. 5.LACOMBE D., THERASSE P., MEUNIER F. Obstacles for Independent Transnational Clinical Trials in Europe. International Journal of Pharmaceutical Medicine 1998; 12(3): 133-136. 6.LACOMBE D. How will changes in GCP regulations affect non-profit organisations conducting academic clinical research? Good Clinical Practice Journal 1999; 6(1): 38-40. 7.VINHOLES J., COLEMAN R., LACOMBE D., ROSE C., TUBIANA-HULIN M., BASTIT P., WILDIERS J., MICHEL J., LEONARD R., NORTIER J., MIGNOLET F., and FORD J. Assessment of bone response to systemic therapy in an EORTC trial: preliminary experience with the use of collagen cross-link excretion. British Journal of Cancer 1999; 80(1/2): 221-228. 8.DUBOIS N., LACOMBE D. SAE Report Handling in a Multinational Academic Research Environment. Applied Clinical Trials 2000: 38-44. 9.PICCART MJ., GREEN JA., JIMENEZ LACAVE A., REED N., VERGOTE I., BENEDETTI-PANICI P., BONETTI A., KRISTELLER-TOME V., MENDIOLA FERNANDEZ C., CURRAN D., VAN GLABBEKE M., LACOMBE D., PINEL M-C., and PECORELLI S. Oxaliplatin or Paclitaxel in patients with platinum- pretreated advanced ovarian cancer: A randomized phase II study of the European Organization for Research and Treatment of Cancer Gynecology Group. Journal of Clinical Oncology 2000; 18(6): 1193-1202. 10.MARINUS A., LACOMBE D. Cancer Clinical Trials in Europe: issues and challenges, the academic point of view of the EORTC. Good Clinical Practice Journal 2000; 7(3): 15-18. 11.BRANDES AA., LACOMBE D., VECHT C. Future tends in the treatment of brain tumours. European Journal of Cancer 2001; 37(18): 2297-2301. 12.CAPONIGRO F., DITTRICH C., SORENSEN J.B., SCHELLENS JHM., DUFFAUD F., PAZ ARES L., LACOMBE D., DE BALINCOURT C., FUMOLEAU P. Phase II study of XR 5000, an inhibitor of topoisomerases I and II, in advanced colorectal cancer. European Journal of Cancer 2002; 38(1): 70-74. 13.VECHT C., VAN DEN BENT MJ., LACOMBE D. EORTC Brain Tumor Group: Achievements and perspectives. European Journal of Cancer 2002; 38(Suppl.4): S35-S38. 14.LACOMBE D., FUMOLEAU P., ZWIERZINA H., TWELVES C., HAKANSSON L., JAYSON G., LEHMANN F., VERWEIJ J. The EORTC and drug development. European Journal of Cancer 2002; 38(Suppl 4): S19-S23. 15.TWELVES C., CAMPONE M., COUDERT B., VAN DEN BENT M., DE JONGE M., DITTRICH C., RAMPLING R., SORIO R., LACOMBE D., DE BALINCOURT C., FUMOLEAU P. Phase II study of XR5000 (DACA) administered as a 120-h infusion in patients with recurrent glioblastoma multiforme. Annals of Oncology 2002; 13(5): 777-780. 16.BAEYENS AJ., LACOMBE D. Regulatory issues for clinical trials at EORTC: The way forward. European Journal of Cancer 2002; 38 (Suppl.4): S142-S146. 17.DEBBAUDT A., ROCHE L., LACOMBE D., BAEYENS AJ. EORTCs Regulatory Affairs Unit; Facilitating European Cancer Research. Applied Clinical Trials 2002; 61-66. 18.RAYMOND E., CAMPONE M., STUPP R., MENTEN J., CHOLLET P., LESIMPLE T., FETY-DEPORTE R., LACOMBE D., PAOLETTI X., FUMOLEAU P. Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme. European Journal of Cancer 2002; 38(10): 1348-1350. 19.LACOMBE D., REA LA., MEUNIER F. La nouvelle législation de lUE pourrait entraver la recherche clinique et académique sur le cancer. EJHP 2003; 3: 14-18. 20.LACOMBE D., BRANDES AA., VAN DEN BENT M. The European Organisation for Research and Treatment of Cancer Strategy for New Drug Development in Brain Tumors. Seminars in Oncology 2003; 30, No 6 (Suppl.19): 77-80. 21.LACOMBE D., REA LA., MEUNIER F. New EU legislation may hinder academic clinical cancer research. EJHP 2003; 3: 14-18. 22.MEUNIER F., LACOMBE D. European Organisation for Research and Treatment of Cancer's point of view. Lancet 2003; 362 (9384): 663. 23.LEHMANN F., LACOMBE D., THERASSE P., EGGERMONT AMM. Integration of Translational

08/12/2020 European Medicine Agency Page 3/15 Research in the European Organization for Research and Treatment of Cancer Research (EORTC) Clinical Trial Cooperative Group Mechanisms. Journal of Translational Medicine 2003; 1(1): 2. 24.BRIASOULIS E., PAVLIDIS N., TERRET C., BAUER J., FIEDLER W., SCHÖFFSKI P., RAOUL JL., HESS D., SELVAIS R., LACOMBE D., BACHMANN P., FUMOLEAU P. Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-New Drug Development Group. European Journal of Cancer 2003; 39(16): 2334-2340. 25.VAN DEN BENT M.J., GRISOLD W., FRAPPAZ D., STUPP R., DESIR JP., LESIMPLE T., DITTRICH C., DE JONGE MJA., BRANDES A., FRENAY M., CARPENTIER AF., CHOLLET P., OLIVEIRA J., BARON B., LACOMBE D., SCHUESSLER M., FUMOLEAU P. European Organization for Research and Treatment of Cancer (EORTC) open label phase II study on glufosfamide administered as a 60- minute infusion every 3 weeks in recurrent glioblastoma multiforme. Annals of Oncology 2003; 14(12): 1732-1734. 26.DITTRICH C., DIERAS V., KERBRAT P., PUNT C., SORIO R., CAPONIGRO F., PAOLETTI X., DE BALINCOURT C., LACOMBE D., FUMOLEAU P. Phase II study of XR5000 (DACA), an inhibitor of topoisomerase I and II, administered as a 120-h infusion in patients with advanced ovarian cancer. Investigational New Drugs 2003; 21(3): 347-352. 27.LACOMBE D., PASSIOUKOV A., HILL B. The need for innovative design in modern cancer clinical trials. Oncologie 2003; 5: 305-310.

28.LACOMBE D., CROTT R., MEUNIER F. EORTC Research and Development: Achievements and Future Perspectives. Advances in Experimental Medicine and Biology 2003; 532: 269-276. 29.LACOMBE D., CROTT R., MEUNIER F. New Anticancer Agents: An Embattled Future. Hospital Decisions Spring 2003: 149-151. 30.MEUNIER F., LACOMBE D. The EORTC and its Pan-European New Drug Development Program for Cancer. Business Briefing: Future Drug Discovery 2003: 14-15. 31.LACOMBE D., BUTLER-SMITH A., THERASSE P., FUMOLEAU P., BURTLES S., CALVERT H., MARSONI S., SESSA C., VERWEIJ J. Cancer Drug Development in Europe: A Selection of New Agents under Development at the European Drug Development Nework. Cancer Investigation 2003; 21(1): 137-147. 32.DITTRICH C., COUDERT B., PAZ-ARES L., CAPONIGRO F., SALZBERG M., GAMUCCI T., PAOLETTI X., HERMANS C., LACOMBE D., FUMOLEAU P. Phase II study of XR 5000 (DACA), an inhibitor of topoisomerase I and II, administered as a 120-h infusion in patients with non-small cell lung cancer. European Journal of Cancer 2003; 39(3): 330-334. 33.DUFFAUD F., BORNER M., CHOLLET P., VERMORKEN JB., BLOCH J., DEGARDIN M., ROLLAND F., DITTRICH C., BARON B., LACOMBE D., FUMOLEAU P. Phase II study of OSI-211 (liposomal lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group Study. European Journal of Cancer 2004; 40(18): 2748-2752. 34.SCHÖFFSKI P., RIGGERT S., FUMOLEAU P., CAMPONE M., BOLTE O., MARREAUD S., LACOMBE D., BARON B., HEROLD M., ZWIERZINA H., WILHELM-OGUNBIYI K., LENTZEN H., TWELVES C. Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group. Annals of Oncology 2004; 15(12): 1816-1824. 35.LACOMBE D., PASSIOUKOV A., MEUNIER F. De la découverte du radium aux thérapies ciblées. Une publication de l'European Organization for Research and Treatment of Cancer (EORTC) parrainnée par le Leem «Les entreprises du médicament», dossier cancer 2004. 36.DE BALINCOURT C., MARREAUD S., PLACCHI M., VANDAEL B., LACOMBE D. Project Management Platform in an academic environment: The EORTCs promising experience. Applied Clinical Trials 2004; 13(8): 28-32. 37.VAN DEN BENT MJ., STUPP R., BRANDES AA., LACOMBE D. Current and Future Trials of the EORTC Brain Tumor Group. Onkologie 2004; 27(3): 246-250. 38.PUNT CJA., DE JONGE MJA., MONFARDINI S., DAUGAARD G., FIEDLER W., BARON B.,

08/12/2020 European Medicine Agency Page 4/15 LACOMBE D., FUMOLEAU P. RFS2000 (9-nitrocamptothecin) in advanced small cell lung cancer, a phase II study of the EORTC New Drug Development Group. European Journal of Cancer 2004; 40(9): 1332-1334. 39.DE JONGE MJA., DROZ JP., PAZ-ARES L., VAN OOSTEROM AT., DE WIT R., CHOLLET P., BARON B., LACOMBE D., METTINGER K., and FUMOLEAU P. Phase II study on 9-nitrocamptothecin (RFS 2000) in patients with advanced or metastatic urothelial tract tumors. Investigational New Drugs 2004; 22(3): 329-333. 40.GIACCONE G., SMIT EF., DE JONGE M., DANSIN E., BRIASOULIS E., ARDIZZONI A., DOUILLARD JY., SPAETH D., LACOMBE D., BARON B., BACHMANN P., FUMOLEAU P. Glufosfamide administered by 1-hour infusion as a second-line treatment for advanced non-small cell lung cancer: a phase II trial of the EORTC-New Drug Development Group. European Journal of Cancer 2004; 40(5): 667- 672.

41.TWELVES C., BIBBY M., LACOMBE D., BURTLES S. Drug Development in Europe: The Academic Perspective. Cancer Drug Discovery and Development; Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials and Approval, 2nd Edition 2004. Humana Press, Totowa, NJ, 2004, 381-399. 42.DIERAS V., BONNETERRE J., LAURENCE V., DEGARDIN M., PIERGA JY., BONNETERRE ME., MARREAUD S., LACOMBE D., FUMOLEAU P. Phase I combining a P-glycoprotein inhibitor, MS209, in combination with docetaxel in patients with advanced malignancies. Clinical Cancer Research 2005; 11(17): 6256-6260. 43.THEODORE C., GEOFFROIS L., VERMORKEN JB., CAPONIGRO F., FIEDLER W., CHOLLET P., RAVAUD A., PETERS GJ., DE BALINCOURT C., LACOMBE D., FUMOLEAU P. Multicentre EORTC study 16997: Feasibility and phase II trial of farnesyl transferase inhibitor & gemcitabine combination in salvage treatment of advanced urothelial cancers. European Journal of Cancer 2005; 41(8): 1150-1157. 44.STUPP R., MASON WP., VAN DEN BENT MJ., WELLER M., FISHER B., TAPHOORN MJB., BELANGER K., BRANDES AA., MAROSI C., BOGDAHN U., CURSCHMANN J., JANZER RC., LUDWIN SK., GORLIA T., ALLGEIER A., LACOMBE D., CAIRNCROSS JG., ELIZABETH EISENHAUER E., MIRIMANOFF RO., for the European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups and the National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma. The New England Journal of Medicine 2005; 352(10): 987-996. 45.PAOLETTI X., BARON B., SCHÖFFSKI P., FUMOLEAU P., LACOMBE D., MARREAUD S., SYLVESTER R. Using the continual reassessment method: Lessons Learned from an EORTC phase I dose finding study. European Journal of Cancer 2006; 42(10): 1362-1368. 46.DE JONGE MJ., DUMEZ H., VERWEIJ J., YARKONI S., SNYDER D., LACOMBE D., MARREAUD S., YAMAGUCHI T., PUNT CJ., VAN OOSTEROM A., on behalf of the EORTC New Drug Development Group (NDDG). Phase I and pharmacokinetic study of halofuginone, an oral quinazolinone derivative in patients with advanced solid tumours. European Journal of Cancer 2006;42(12):1768-1774. 47.MIRIMANOFF RO., GORLIA T., MASON W., VAN DEN BENT MJ., KORTMANN RD., FISHER B., RENI M., BRANDES AA., CURSCHMANN J., VILLA S., CAIRNCROSS G., ALLGEIER A., LACOMBE D., STUPP R. Radiotherapy and temozolomide for newly diagnosed glioblastoma: recursive partitioning analysis of the EORTC 26981/22981-NCIC CE3 phase III randomized trial. Journal of Clinical Oncology 2006; 24(16): 2563-2569. 48.VAN DEN BENT MJ., CARPENTIER AF., BRANDES AA., SANSON M., TAPHOORN MJ., BERNSEN HJ., FRENAY M., TIJSSEN CC., GRISOLD W., SIPOS L., HAAXMA-REICHE H., KROS JM., VAN KOUWENHOVEN MC., VECHT CJ., ALLGEIER A., LACOMBE D., GORLIA T. Adjuvant Procarbazine, Lomustine, and Vincristine Improves Progression-Free Survival but Not Overall Survival in Newly Diagnosed Anaplastic Oligodendrogliomas and Oligoastrocytomas: A Randomized European Organisation for Research and Treatment of Cancer Phase III Trial. Journal of Clinical Oncology 2006; 24(18): 2715-2722.

08/12/2020 European Medicine Agency Page 5/15 49.FIEDLER W., TCHEN N., BLOCH J., FARGEOT P., SORIO R., VERMORKEN J.B., COLLETTE L., LACOMBE D., TWELVES C. A study from the EORTC new drug development group: Open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. European Journal of Cancer 2006; 42(2): 200-204. 50.TAPHOORN MJ., VAN DEN BENT MJ., MAUER ME., COENS C., DELATTRE JY., BRANDES AA., SILLEVIS SMITT PA., BERNSEN HJ., FRENAY M., TIJSSEN CC., LACOMBE D., ALLGEIER A., BOTTOMLEY A. Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial. Journal of Clinical Oncology 2007; 25(36): 5723-5730. 51.MAUER M., TAPHOORN M., BOTTOMLEY A., COENS C., EFFICACE F., SANSON M., BRANDES AA., VAN DER RIJT C., BERNSEN H., FRENAY M., TIJSSEN CC., LACOMBE D., VAN DEN BENT MJ. Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study. Journal of Clinical Oncology 2007; 25(36): 5731-5737. 52.YUN HJ., BOGAERTS J., AWADA A., LACOMBE D. Clinical trial design limitations in head and neck squamous cell carcinomas. Current Opinion in Oncology 2007; 19(3): 210-215. 53.VAN HERPEN CM., LOCATI LD., BUTER J., THOMAS J., BOGAERTS J., LACOMBE D., DE MULDER P., AWADA A., LICITRA L., BERNIER J., VERMORKEN JB. Phase II study on gemcitabine in recurrent and/or metastatic adenoid cystic carcinoma of the head and neck (EORTC 24982). European Journal of Cancer 2008; 44(17): 2542-2545. 54.RAYMOND E., BRANDES AA., DITTRICH C., FUMOLEAU P., COUDERT B., CLEMENT PM., FRENAY M., RAMPLING R., STUPP R., KROS JM., HEINRICH MC., GORLIA T., LACOMBE D., VAN DEN BENT MJ. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Journal of Clinical Oncology 2008; 26(28): 4659-4665. 55.BERGMANN L., AAMDAL S., MARREAUD S., LACOMBE D., HEROLD M., YAMAGUCHI T., WILHELM-OGUNBIYI K., LENTZEN H., ZWIERZINA H. Phase I trial of r viscumin (INN: aviscumine) given subcutaneously in patients with advanced cancer: a study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001). European Journal of Cancer 2008; 44(12): 1657-1662. 56.HILDEBRAND J., GORLIA T., KROS JM., AFRA D., FRENAY M., OMURO A., STUPP R., LACOMBE D., ALLGEIER A., VAN DEN BENT MJ.; on behalf of the EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: Results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). European Journal of Cancer 2008; 44(9): 1210-1216. 57.GORLIA T., VAN DEN BENT MJ., HEGI ME., MIRIMANOFF RO., WELLER M., CAIRNCROSS JG., EISENHAUER E., BELANGER K., BRANDES AA., ALLGEIER A., LACOMBE D., STUPP R. Nomograms for predicting survival of patients with newly diagnosed glioblastoma: prognostic factor analysis of EORTC and NCIC trial 26981-22981/CE.3. Lancet Oncology 2008; 9(1): 29-38. 58.EISENHAUER EA., THERASSE P., BOGAERTS J., SCHWARTZ LH., SARGENT D., FORD R., DANCEY J., ARBUCK S., GWYTHER S., MOONEY M., RUBINSTEIN L., SHANKAR L., DODD L., KAPLAN R., LACOMBE D., VERWEIJ J. New response evaluation criteria in solid tumours: Revised Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45(2): 228-247. 59.TRIMBLE EL., ABRAMS JS., MEYER RM., CALVO F., CAZAP E., DEYE J., EISENHAUER E., FITZGERALD T J., LACOMBE D., PARMAR M., SEIBEL N., SHANKER L., SWART AM., THERASSE P., VIKRAM B., VON FRENCKELL R., FRIEDLANDER M., FUJIWARA K., KAPLAN RS., and MEUNIER F. Improving cancer outcomes through international collaboration in academic cancer treatment trials. Journal of Clinical Oncology 2009; 27(30): 5109-5114. 60.GULYBAN A., FENTON P., FLAMENT J., LACOMBE D., MEUNIER F. L'assurance qualité en radiothérapie à l'EORTC - 27 années d'expérience et perspectives. Revue Multidisciplinaire dOncologie et Hématologie 2009; 3(5): 180 185. 61.KOUWENHOVEN MC., GORLIA T., KROS JM., IBDAIH A., BRANDES AA., BROMBERG JE., MOKHTARI K., VAN DUINEN SG., TEEPEN JL., WESSELING P., VANDENBOS F., GRISOLD W.,

08/12/2020 European Medicine Agency Page 6/15 SIPOS L., MIRIMANOFF R., VECHT CJ., ALLGEIER A., LACOMBE D., VAN DEN BENT MJ. Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951. Neuro-Oncolology 2009; 11(6): 737-746.

62.PALLIS AG., SERFASS L., DZIADZIUSZKO R., VAN MEERBEECK JP., FENNELL D., LACOMBE D., WELCH J., GRIDELLI C. Targeted therapies in the treatment of advanced/metastatic NSCLC. European Journal of Cancer 2009; 45 (14): 2473 2487. 63.STERNBERG CN., DUMEZ H., VAN POPPEL H., SKONECZNA I., SELLA A., DAUGAARD G., GIL T., GRAHAM J., CARPENTIER P., CALABRO F., COLLETTE L., LACOMBE D. for the EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Annals of Oncology 2009; 20(7): 1264-1269. 64.VAN DEN BENT MJ., DUBBINK HJ., SANSON M., VAN DER LEE-HAARLOO CR., HEGI M., JEUKEN JW., IBDAIH A., BRANDES AA., TAPHOORN MJ., FRENAY M., LACOMBE D., GORLIA T., DINJENS WN., KROS JM. MGMT promoter methylation is prognostic but not predictive for outcome to adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors: a report from EORTC Brain Tumor Group Study 26951. Journal of Clinical Oncology 2009; 27(35): 5881-5886. 65.LEFEBVRE JL., ROLLAND F., TESSELAAR M., BARDET E., LEEMANS CR., GEOFFROIS L., HUPPERETS P., BARZAN L., DE RAUCOURT D., CHEVALIER D., LICITRA L., LUNGHI F., STUPP R., LACOMBE D., BOGAERTS J, HORIOT JC., BERNIER J, VERMORKEN JB.; for the EORTC Head and Neck Cancer Group and the EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. Journal of the National Cancer Institute 2009; 101(3): 142-152. 66.STUPP R., HEGI ME., MASON WP., VAN DEN BENT MJ., TAPHOORN MJ., JANZER RC., LUDWIN SK., ALLGEIER A., FISHER B., BELANGER K., HAU P., BRANDES AA., GIJTENBEEK J., MAROSI C., VECHT CJ., MOKHTARI K., WESSELING P., VILLA S., EISENHAUER E., GORLIA T., WELLER M., LACOMBE D., CAIRNCROS JG., MIRIMANOFF RO.; on behalf of the European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; the National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncology 2009; 10(5): 459-466. 67.VAN DEN BENT MJ., BRANDES AA., RAMPLING R., KOUWENHOVEN MC., KROS JM., CARPENTIER AF., CLEMENT PM., FRENAY M., CAMPONE M., BAURAIN JF., ARMAND JP., TAPHOORN MJ., TOSONI A., KLETZL H., KLUGHAMMER B., LACOMBE D., GORLIA T. Randomized Phase II Trial of Erlotinib Versus Temozolomide or Carmustine in Recurrent Glioblastoma: EORTC Brain Tumor Group Study 26034. Journal of Clinical Oncology 2009; 27(8): 1268-1274. 68.LACOMBE D., GORLIA T., BEAN JW., STUPP R., HEGI M., VAN DEN BENT MJ. The radical and the remedial. Public Service Review - European Union (Oncology) 2009; (17): 349-351. 69.BOGAERTS J., FORD R., SARGENT D., SCHWARTZ LH., RUBINSTEIN L., LACOMBE D., EISENHAUER E., VERWEIJ J., THERASSE P., for the RECIST Working Party. Individual patient data analysis to assess modifications to the RECIST criteria. European Journal of Cancer 2009; 45(2): 248-260. 70.CAPONIGRO F., LACOMBE D., TWELVES C., BAUER J., GOVAERTS AS., MARREAUD S., MILANO A., ANTHONEY A. An EORTC phase I study of Bortezomib in combination with oxaliplatin, leucovorin and 5-fluorouracil in patients with advanced colorectal cancer. European Journal of Cancer 2009; 45(1): 48-55. 71.LEJEUNE S., LIDARSSI M., MINAS V., LACOMBE D. Les assurances pour essais cliniques en Europe: une tour de Babel? Revue Multidisciplinaire dOncologie et dHématologie 2010; 4(7): 233-236. 72.PALLIS AG., SHEPHERD FA., LACOMBE D., GRIDELLI C. Treatment of small-cell lung cancer in elderly patients. Cancer 2010; 116(5): 1192 1200.

08/12/2020 European Medicine Agency Page 7/15 73.Awada A, Lacombe D, Liberatoscioli C. Design and performance of clinical trials in head and neck cancer. Curr Opin Oncol. 2010 May;22(3):184-5. doi: 10.1097/CCO.0b013e3283376aa8. Review. No abstract available. 74.PALLIS AG., WEDDING U., LACOMBE D., SOUBEYRAN P., WILDIERS H. Questionnaires and instruments for a multidimensional assessment of the older cancer patients: What clinicians need to know? European Journal of Cancer 2010; 46(6): 1019-1025. 75.PALLIS AG., PAPAMICHAEL D., AUDISIO R., PEETERS M., FOLPRECHT G., LACOMBE D., VAN CUTSEM E. EORTC Elderly Task Force experts' opinion for the treatment of colon cancer in older patients. Cancer Treatment Reviews 2010; 36(1): 83-90. 76.PALLIS AG., FORTPIED C., WEDDING U., VAN NES MC., PENNINCKX B., RING A., LACOMBE D., MONFARDINI S., SCALLIET P., WILDIERS H. EORTC Elderly Task Force Position Paper: Approach to the older cancer patient. European Journal of Cancer 2010; 46(9): 1502-1513. 77.PSYRRI A., LICITRA L., LACOMBE D., SCHUURING E., BUDACH W., OZSAHIN M., KNECHT R., VERMORKEN JB., LANGENDIJK JA. Strategies to promote translational research within the European Organisation for Research and Treatment of Cancer (EORTC) Head and Neck Cancer Group: a report from the Translational Research Subcommittee. Annals of Oncology 2010; 21(10): 1952-1960. 78.VAN DEN BENT MJ., DUBBINK HJ., MARIE Y., BRANDES AA., TAPHOORN MJ., WESSELING P., FRENAY M., TIJSSEN CC., LACOMBE D., IDBAIH A., VAN MARION R., KROS JM., DINJENS WN., GORLIA T., SANSON M. IDH1 and IDH2 mutations are prognostic but not predictive for outcome in anaplastic oligodendroglial tumors: a report of the European Organization for Research and Treatment of Cancer Brain Tumor Group. Clinical Cancer Research 2010; 16(5): 1597-1604. 79.VAN LAARHOVEN HW., FIEDLER W., DESAR IM., VAN ASTEN JJ., MARREAUD S., LACOMBE D., GOVAERTS AS., BOGAERTS J., LASCH P., TIMMER-BONTE JN., LAMBIASE A., BORDIGNON C., PUNT CJ., HEERSCHAP A., VAN HERPEN CM. Phase I clinical and magnetic resonance imaging study of the Vascular agent NGR-hTNF in patients with advanced cancers (European Organization for Research and Treatment of Cancer Study 16041). Clinical Cancer Research 2010; 16(4): 1315-1323. 80.PALLIS AG., GRIDELLI C., VAN MEERBEECK JP., GREILLIER L., WEDDING U., LACOMBE D., WELCH J., BELANI CP., AAPRO M. EORTC Elderly Task Force and Lung Cancer Group and International Society for Geriatric Oncology (SIOG) experts' opinion for the treatment of non-small-cell lung cancer in an elderly population. Annals of Oncology 2010; (4)21: 692706. 81.BRANDES AA., STUPP R., HAU P., LACOMBE D., GORLIA T., TOSONI A., MIRIMANOFF RO., KROS JM., VAN DEN BENT J. EORTC study 26041-22041: Phase I/II study on concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) with PTK787/ZK222584 (PTK/ZK) in newly diagnosed glioblastoma. European Journal of Cancer 2010; 46(2): 348-354. 82.SCHÖFFSKI P., BLAY J-Y., DE GREVE J., BRAIN E., MACHIELS J-P., SORIA J-C., SLEIJFER S., WOLTER P., RAY-COQUARD I., FONTAINE C., MUNZERT G., FRITSCH H., HANFT G., AERTS C., RAPION J., ALLGEIER A., BOGAERTS J., LACOMBE D. Multicentric parallel phase II trial of the polo-like kinase 1inhibitor BI 2536 in patients with advanced head and neck cancer, breast cancer, ovarian cancer, soft tissue sarcoma and melanoma. The first protocol of the European Organization for Research and Treatment of Cancer (EORTC) Network Of Core Institutes (NOCI). European Journal of Cancer 2010; 46(12): 2206-2215. 83.MEUNIER F., LACOMBE D., BEAN J. Collaborate and conquer. Public Service Review - European Science & Technology 2011; (11): 348 349.

84.WELLER M., GORLIA T., CAIRNCROSS JG., VAN DEN BENT MJ., MASON W., BELANGER K., BRANDES AA., BOGDAHN U., MACDONALD DR., FORSYTH P., ROSSETTI AO., LACOMBE D., MIRIMANOFF RO., VECHT CJ., STUPP R. Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. Neurology 2011; 77(12): 1156-1164. 85.STUPP R., TOSONI A., BROMBERG JE., HAU P., CAMPONE M., GIJTENBEEK J., FRENAY

08/12/2020 European Medicine Agency Page 8/15 M., BREIMER L., WIESINGER H., ALLGEIER A., VAN DEN BENT MJ., BOGDAHN U., VAN DER GRAAF W., YUN HJ., GORLIA T., LACOMBE D., BRANDES AA. Sagopilone (ZK-EPO, ZK 219477) for recurrent glioblastoma. A phase II multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) Brain Tumor Group. Annals of Oncology 2011; 22(9): 2144-2149. 86.HALL J., DAIDONE MG., PETERS GJ., HARBECK N., LACOMBE D., SLEIJFER S. Integrating collection of biospecimens in clinical trials: The approach of the European Organisation for Research and Treatment of Cancer (EORTC). Biopreservation and biobanking 2011; 9(2): 181-186. 87.Rampling R, Sanson M, Gorlia T, Lacombe D, Lai C, Gharib M, Taal W, Stoffregen C, Decker R, van den Bent MJ. A phase I study of LY317615 (enzastaurin) and temozolomide in patients with gliomas (EORTC trial 26054). Neuro Oncol. 2012 Mar;14(3):344-50. doi: 10.1093/neuonc/nor221. Epub 2012 Jan 29. 88.LACOMBE D., NEGROUK A., BEAN J. International investigator-driven clinical trials: challenges and opportunities for US-Europe cooperation through the US cooperative group networks. Clinical Investigation 2011; 1(4): 493-500. 89.MEUNIER F., BEAN J., LACOMBE D. Funding treatments, finding trials. Public Service Review - European Union (Oncology) 2011; (21): 210 211. 90.LACOMBE D., BEAN J., BOGAERTS J., BOTTOMLEY A., COLLETTE L., GILOTAY C., MARINUS A., MARREAUD S., RUYSKART P., SYLVESTER R., MEUNIER F. 50 years of the EORTC and the central role of the EORTC Headquarters. European Journal of Cancer 2012; 1 (Suppl. 10): 3-12. 91.WICK W., VAN DEN BENT M., VECHT C., BRANDES A., LACOMBE D., GORLIA T., ALLGEIER A., BAUMERT B., SOFFIETTI R., SANSON M., KARIM ABMF., MIRIMANOFF RO., TAPHOORN M., KROS M., HEGI M., STUPP R., on behalf of the EORTC BRAIN TUMOR GROUP. EORTC topics in neurooncology: The long path from a focus on neurological complications of cancer towards molecularly defined trials and therapies in neurooncology. European Journal of Cancer 2012; 1 (Suppl. 10): 20-26. 92.WHITTAKER S., KNOBLER R., ORTIZ P., VERMEER M., KARRASCH M., HASAN B., LACOMBE D., KEMPF W., DUMMER R., BAGOT M., on behalf of the EORTC CUTANEOUS LYMPHOMA TASK FORCE (CLTF). Major achievements of the EORTC Cutaneous Lymphoma Task Force (CLTF). European Journal of Cancer 2012; 1 (Suppl. 10): 46-50. 93.HALL J., BEAN J., BREYSSENS H., ENGELEN K., LACOMBE D., MEUNIER F. Accès aux échantillons biologiques: la clé pour les recherches cliniques en oncologie. Healthcare Executive 2012; 64: 47-50. 94.HALL J., BEAN J., BREYSSENS H., ENGELEN K., LACOMBE D., MEUNIER F. Accès aux échantillons biologiques: la clé pour les recherches cliniques en oncologie. Revue multidisciplinaire dOncologie et dHématologie 2012; 6(1): 8-13. 95.BEAN J., LACOMBE D., MEUNIER F. Fifty Years of Progress Against Cancer - The European Organisation for Research and Treatment of Cancer Celebrates its Achievements. European Oncology & Haematology 2012; 8(1): 10-13.

96.FAIRCHILD A., BAR-DEROMA R., COLLETTE L., HAUSTERMANS K., HURKMANS C., LACOMBE D., MAINGON P., POORTMANS P., TOMSEJ M., WEBER DC., GREGOIRE V. Development of clinical trial protocols involving advanced radiation therapy techniques: The European Organisation for Research and Treatment of Cancer Radiation Oncology Group approach. European Journal of Cancer 2012; 48(7): 1048-1054. 97.FRANCESCHI E., STUPP R., VAN DEN BENT MJ., VAN HERPEN C., LAIGLE DONADEY F., GORLIA T., HEGI M., LHERMITTE B., STRAUSS LC., ALLGEIER A., LACOMBE D., BRANDES AA. EORTC 26083 phase I/II trial of dasatinib in combination with CCNU in patients with recurrent glioblastoma. Neuro-Oncology 2012; 14(12): 1503-1510. 98.LALAMI Y., SPECENIER PM., AWADA A., LACOMBE D., LIBERATOSCIOLI C., FORTPIED C., EL- HARIRY I., BOGAERTS J., LANGENDIJK JA., VERMORKEN J. EORTC 24051: Unexpected side effects of a phase I study of TPF induction chemotherapy followed by chemoradiation with

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08/12/2020 European Medicine Agency Page 10/15 114.LACOMBE D., BUROCK S., MEUNIER F. Academia-Industry Partnerships: Are we ready for new models of partnership? The point of view of the EORTC, an academic clinical cancer research organization. European Journal of Cancer 2013; 49(1): 1-7. 115.GORLIA T., WU W., WANG M., BAUMERT BG., MEHTA M., BUCKNER JC., SHAW E., BROWN P., STUPP R., GALANIS E., LACOMBE D., VAN DEN BENT MJ. New validated prognostic models and prognostic calculators in patients with low-grade gliomas diagnosed by central pathology review: a pooled analysis of EORTC/RTOG/NCCTG phase III clinical trials. Neuro-Oncology 2013; 15(11): 1568-1579. 116.JAMAL R., GOODWIN RA., TU D., WALSH W., LACOMBE D., EISENHAUER EA. Performance of multinomial designs in comparison with response-based designs in non-randomized phase II trials of targeted cancer agents. Annals of Oncology 2013; 24(7): 1936-1942. 117.SHASH E., NEGROUK A., MARREAUD S., GOLFINOPOULOS V., LACOMBE D., MEUNIER F. International Clinical Trials Setting for Rare Cancers: Organizational and Regulatory Constraints The EORTC perspective. Ecancermedicalscience 7: 321. 118.GORLIA T., DELATTRE JY., BRANDES AA., KROS JM., TAPHOORN MJ., KOUWENHOVEN MC., BERNSEN HJ., FRENAY M., TIJSSEN CC., LACOMBE D., VAN DEN BENT MJ. New clinical, pathological and molecular prognostic models and calculators in patients with locally diagnosed anaplastic oligodendroglioma or oligoastrocytoma. A prognostic factor analysis of European Organisation for Research and Treatment of Cancer Brain Tumour Group Study 26951. European Journal of Cancer 2013; 49(16): 3477-3485. 119.PAOLETTI X., LE TOURNEAU C., VERWEIJ J., SIU L., SEYMOUR L., POSTEL-VINAY S., COLLETTE L., RIZZO E., IVY P., OLMOS D., MASSARD CH., LACOMBE D., KAYE SB., SORIA JC. Defining dose- limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international survey. European Journal of Cancer 2014; 50(12): 2050-2056. 120.LIU Y., LACOMBE D., STUPP R. The changing world of drug development: an academic research organizations perspective on the seven wonders of the future world of anti-cancer drug development. Chinese Clinical Oncology 2014; 3(2): 1-7. 121.LACOMBE D., TEJPAR S., SALGADO R., CARDOSO F., GOLFINOPOULOS V., AUST D., FOLPRECHT G., ROTH A., STUPP R. European perspective for effective cancer drug development. Nature Reviews Clinical Oncology 2014; 11(8): 492-498. 122.LACOMBE D. How Europe can develop better, cheaper cancer drugs. Cancer World 2014; (60): 49-54. 123.LACOMBE D., Director of the European Organisation for Research and Treatment of Cancer, discusses the organisation's multidisciplinary work towards improving cancer clinical trials. International Innovation 2014; (140): 15-17. 124.NEGROUK A., LACOMBE D., TRIMBLE EL., SEYMOUR M. Clinical research for rare cancers: is it a reality in the global regulatory landscape? The international rare cancer initiative. Expert Opinion on Orphan Drugs 2014; 2(5): 1-8. 125.LACOMBE D., BUROCK S., BOGAERTS J., SCHÖFFSKI P., GOLFINOPOULOS V., STUPP R. The dream and reality of histology agnostic cancer clinical trials. Molecular Oncology 2014; 8(6): 1057-1063. 126.Bogaerts J, Sydes MR, Keat N, McConnell A, Benson A, Ho A, Roth A, Fortpied C, Eng C, Peckitt C, Coens C, Pettaway C, Arnold D, Hall E, Marshall E, Sclafani F, Hatcher H, Earl H, Ray-Coquard I, Paul J, Blay JY, Whelan J, Panageas K, Wheatley K, Harrington K, Licitra L, Billingham L, Hensley M, McCabe M, Patel PM, Carvajal R, Wilson R, Glynne-Jones R, McWilliams R, Leyvraz S, Rao S, Nicholson S, Filiaci V, Negrouk A, Lacombe D, Dupont E, Pauporté I, Welch JJ, Law K, Trimble T, Seymour M. Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative. Eur J Cancer. 2015 Feb;51(3):271-81. doi: 10.1016/j.ejca.2014.10.027. Epub 2014 Dec 24. Review. 127.POSTEL-VINAY S., COLLETTE L., PAOLETTI X., RIZZO E., MASSARD C., OLMOS D., FOWST C., LEVY B., MANCINI P., LACOMBE D., IVY P., SEYMOUR L., LE TOURNEAU C., SIU LL., KAYE SB., VERWEIJ J., SORIA JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly

08/12/2020 European Medicine Agency Page 11/15 targeted agents - Dose- Limiting Toxicity and Toxicity Assessment Recommendation Group for Early Trials of Targeted therapies, an European Organisation for Research and Treatment of Cancer-led study. European Journal of Cancer 2014; 50(12):20402049. 128.Kros Jm, Huizer K, Hernandez-lain A, Marucci G, Michotte A, Pollo B, Rushing E, Ribalta T, French PJ, Jaminé D, Bekka N, Lacombe D, Van Den Bent Mj, Gorlia T. An evidence-based diagnostic algorithm for glioma: analysis of the results of pathology panel review and molecular parameters of EORTC trials 26951 and 26882. J Clin Oncol 2015; 33 (17):1943-1950. 129.Bean J, Varin E, Szepessy E, Lacombe D. NGS and EORTC's SPECTA hope for cancer patients. HHE 2015:3-5. 130.Lacombe D, Tabernero J, Voest E. Translating basic research to the patient's bedside. ESMO Website, 2015. 131.Lawler M, Siu LL, Rehm H, Alterovitz G, Burn J, Calvo F, Lacombe D, Tean T, North KN, Sawyers CL. All The Worlds a Stage: Facilitating Discovery Science and Improved Cancer Care through The Global Alliance for Genomics and Health. Cancer Discov 2015; 5 (11):1133-1136. 132.Menis J, Besse B, Lacombe D. Methodology of clinical trials in lung cancer . Chin Clin Oncol 2015 (44):1-10.

133.Baumert BG, Hegi ME, van den Bent MJ, von Deimling A, Gorlia T, Hoang-Xuan K, Brandes AA, Kantor G, Taphoorn MJB, Hassel MB, Hartmann C, Ryan G, Capper D, Kros JM, Kurscheid S, Wick W, Enting R, Reni M, Thiessen B, Dhermain F, Bromberg JE, Feuvret L, Reijneveld JC, Chinot O, Gijtenbeek JMM, Rossiter JP, Dif N, Balana C, Bravo-Marques J, Clement PM, Marosi C, Tzuk-Shina T, Nordal RA, Rees J, Lacombe D, Mason WP, Stupp R. Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1521-1532. doi: 10.1016/S1470-2045(16)30313-8. Epub 2016 Sep 27. 134.Lacombe D. Quietly orchestrating the clinical research revolution. Cancerworld 2015; 68:4-10. 135.Lacombe D. Framing the frameworks. Pan European Networks: Science & Technology 2015; 17:220-223. 136.S. Marreaud, D. Lacombe, V. Golfinopoulos. ESMO Handbook Cancer Diagnosis and Treatment Evaluation. Treatment Evaluation of Activity: From Global to Personalised. 2015, 63-66. 137.Evrard S, Audisio R, Poston G, Caballero C, Kataoka K, Fontein D, Collette L, Nakamura K, Fukuda H, Lacombe D. From A Comic Opera To Surcare An open letter to whom clinical research in surgery is of importance. Ann Surg 2016; 264 (4):911-912. 138.Kataoka K, Nakamura K, Caballero C, Evrard S, Negrouk A, Shiozawa M, Collette L, Fukuda H, Lacombe D. Collaboration between EORTC and JCOG-how to accelerate global clinical research partnership. Jpn J Clin Oncol. 2017 Feb 20;47(2):164-169. doi: 10.1093/jjco/hyw159. 139.Højgaard L, Löwenberg B, Selby P, Lawler M, Banks I, Law K, Albreht T, Armand JP, Barbacid M, Barzach M, Bergh J, Cameron D, Conte P, de Braud F, de Gramont A, De Lorenzo F, Diehl V, Diler S, Erdem S, Geissler J, Gore-Booth J, Henning G, Horgan D, Jassem J, Johnson P, Kaasa S, Kapitein P, Karjalainen S, Kelly J, Kienesberger A, La Vecchia C, Lacombe D, Lindahl T, Luzzatto L, Malby R, Mastris K, Meunier F, Murphy M, Naredi P, Nurse P, Oliver K, Pearce J, Pelouchov J, Piccart M, Pinedo B, Spurrier-Bernard G, Sullivan R, Tabernero J, Van de Velde C, van Herk B, Vedsted P, Waldmann A, Weller D, Wilking N, Wilson R, Yared W, Zielinski C, Zur Hausen H, Le Chevalier T, Johnston P. The European Cancer Patient's Bill of Rights, update and implementation 2016. ESMO Open. 2017 Jan 6;1(6):e000127. doi: 10.1136/esmoopen-2016-000127. eCollection 2016. Review. 140.Tanis E, Caballero C, Collette L, Verleye L, den Dulk M, Lacombe D, Schuhmacher C, Werutsky G. The EORTC Strategy for Quality Assurance in Surgical Clinical Research: Assessment of the past and moving towards the future. Eur J Surg Oncol 42 (8): 1115-1122, 2016. doi: 10.1016/j.ejso.2016.04.052. Epub 2016 Apr 27. 141.Mark Trusheim, Allison Ackerman Shrier, Zoran Antonijevic, Robert A. Beckman, Robert Campbell, Cong Chen, Keith Flaherty, John Loewy, Denis Lacombe, Subha Madhava, Joseph OConnell, Harry Selker, Laura Esserman. PIPELINEs: Creating comparable clinical knowledge

08/12/2020 European Medicine Agency Page 12/15 efficiently by linking trial platforms. Clinical Pharmacology and Therapeutics 100(6): 713-729, 2016. doi: 10.1002/cpt.514. Epub 2016 Oct 19 142.Trusheim M, Shrier Ackerman A, Antonijevic Z, Beckman B, Campbell R, Chen C, Flaherty K, Loewy J, Lacombe D, Madhava S, O'connel J, Selker H, Esserman L. PIPELINEs: Creating comparable clinical knowledge efficiently by linking trial platforms. Clin Pharmacol Ther 2016; 100 (6):713-729. 143.Lawler M, Banks I, Law K, Albrech T, Armand Jp, Barbacid M, Barzach M, Bergh J, Cameron D, Conte P, de Braud F, de Gramont A, De Lorenzo F, Diehl V, Diler S, Erdem S, Geissler J, Gore- Booth J, Henning G, Hojgaard L, Horgan D, Jassem J, Johnson P, Kaasa S, Kapitein P, Karjalainen S, Kelly J, Kienesberger A, La Vecchia C, Lacombe D, Lindahl T, Lowenberg B, Luzzatto L, Malby R, Mastris K, Meunier F, Murphy M, Naredi P, Nurse P, Oliver K, Pearce J, Pelouchov J, Piccart M, Pinedo B, Spurrier-Bernard G, Sullivan R, Tabernero J, Van de Velde C, van Herk B, Vedsted P, Waldmann A, Weller D, Wilking N, Wilson R, Yared W, Zielinski Ch, zur Hausen H, Le Chevalier T, Johntson P, Selby PM. The European Cancer Patient's Bill of Rights, update and implementation 2016. ESMO Open, http://esmoopen.bmj.com/content/1/6/e000127 144.O'Connor JPB, Aboagye EO, Adams JE, Aerts HJWL, Barrington SF, Beer AJ, Boellaard R, Bohndiek SE, Brown G, Brady M, Buckley DL, Chenevert TL, Clarke LP, Collette S, Cook GJ, deSouza NM, Dickson JC, Dive C, Evelhoch JL, Faivre-Finn C, Gallagher FA, Gilbert FJ, Gillies RJ, Goh V, Griffiths JR, Groves AM, Halligan S, Harris AL, Hawkes DJ, Hoekstra OS, Huang EP, Hutton BF, Jackson EF, Jayson GC, Jones A, Koh DM, Lacombe D, Lambin P, Lassau N, Leach MO, Lee TY, Leen EL, Lewis JS, Liu Y, Lythgoe MF, Manoharan P, Maxwell RJ, Miles KA, Morgan B, Morris S, Ng T, Padhani AR, Parker GJM, Partridge M, Pathak AP, Peet AC, Punwani S, Reynolds AR, Robinson SP, Shankar LK, Sharma RA, Soloviev D, Stroobants S, Sullivan DC, Taylor SA, Tofts PS, Tozer GM, van Herk M, Walker-Samuel S, Wason J, Williams KJ, Workman P, Yankeelov TE, Brindle KM, McShane LM, Jackson A, Waterton JC. Imaging biomarker roadmap for cancer studies. Nat Rev Clin Oncol 2017; 14:169186. http://doi.org/10.1038/nrclinonc.2016.162. 145.Negrouk A, Lacombe D, Cardoso F, Morin F, Carrasco E, Maurel J, Maibach R, Aranda E, Marais R, Stahel RA.Safeguarding the future of independent, academic clinical cancer research in Europe for the benefit of patients. ESMO Open. 2017 Aug 3;2(3):e000187. doi: 10.1136/esmoopen-2017-000187. eCollection 2017. 146.Aapro M, Astier A, Audisio R, Banks I, Bedossa P, Brain E, Cameron D, Casali P, Chiti A, De Mattos-Arruda L, Kelly D, Lacombe D, Nilsson PJ, Piccart M, Poortmans P, Riklund K, Saeter G, Schrappe M, Soffietti R, Travado L, van Poppel H, Wait S, Naredi P. Identifying critical steps towards improved access to innovation in cancer care: a European CanCer Organisation position paper. Eur J Cancer. 2017 Sep;82:193-202. doi: 10.1016/j.ejca.2017.04.014. Epub 2017 Jul 7. 147.Salgado R, Moore H, Martens JWM, Lively T, Malik S, McDermott U, Michiels S, Moscow JA, Tejpar S, McKee T, Lacombe D; IBCD-Faculty. Societal challenges of precision medicine: Bringing order to chaos. Eur J Cancer. 2017 Oct;84:325-334. doi: 10.1016/j.ejca.2017.07.028. Epub 2017 Sep 4. 148.Kempf E, Bogaerts J, Lacombe D, Liu L. 'Mind the gap' between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research. Eur J Cancer. 2017 Nov;86:143-149. doi: 10.1016/j.ejca.2017.08.028. Epub 2017 Oct 4. 149.Tryfonidis K, Hartmann K, Morfouace M, Lacombe D. From bench to clinical trials the EORTC experience in biology-based clinical cancer research. J Egypt Natl Canc Inst. 2017 Dec;29(4):171-176. doi: 10.1016/j.jnci.2017.09.001. Epub 2017 Nov 6. Review. 150.Salgado R, Moore H, Martens JWM, Lively T, Malik S, McDermott U, Michiels S, Moscow JA, Tejpar S, McKee T, Lacombe D; IBCD-Faculty. Steps forward for cancer precision medicine. Nat Rev Drug Discov. 2018 Jan;17(1):1-2. doi: 10.1038/nrd.2017.218. Epub 2017 Nov 24. 151.Broes S, Lacombe D, Verlinden M, Huys I. Toward a Tiered Model to Share Clinical Trial Data and Samples in Precision Oncology. Front Med (Lausanne). 2018 Jan 29;5:6. doi: 10.3389/fmed.2018.00006. eCollection 2018. 152.Langendijk JA, Orecchia R, Haustermans K, Zips D, Balosso J, Lacombe D, Lievens Y, Weber

08/12/2020 European Medicine Agency Page 13/15 DC, Grau C, Troost EGC. Prospective data registration and clinical trials for particle therapy in Europe. Radiother Oncol. 2018 Jul;128(1):9-13. doi: 10.1016/j.radonc.2018.06.001. Epub 2018 Jul 7. Review. 153.Pilette C, Brightling C, Lacombe D, Brusselle G. Urgent need for pragmatic trial platforms in severe asthma. Lancet Respir Med. 2018 Aug;6(8):581-583. doi: 10.1016/S2213-2600(18)30291-1.

154.Negrouk A, Lacombe D. Does GDPR harm or benefit research participants? An EORTC point of view. Lancet Oncol. 2018 Oct;19(10):1278-1280. doi: 10.1016/S1470-2045(18)30620-X. Epub 2018 Oct 1. 155.Kataoka K, Kaider-Person O, Kasper B, Starlinger P, Caballero C, Menis J, Hendriks LE, Terada M, Collette L, Nakamura K, Lacombe D, Fukuda H. Responding to the challenges of international collaborations between the east and the west - report of the first JCOG-EORTC symposium and a perspective from young JCOG and EORTC investigators. Jpn J Clin Oncol. 2019 Jan 1;49(1):96-99. doi: 10.1093/jjco/hyy155. 156.Lacombe D, Bogaerts J, Tombal B, Maignen F, Osipienko L, Sullivan R, Golfinopoulos V. Late translational research: putting forward a new model for developing new anti-cancer treatments that addresses the needs of patients and society. Mol Oncol. 2019 Mar;13(3):558-566. doi: 10.1002/1878-0261.12431. Epub 2019 Jan 19. Review. 157.Lacombe D, O'Morain C, Casadei B, Hill K, Mateus E, Lories R, Brusselle G. Moving forward from drug-centred to patient-centred research: A white paper initiated by EORTC and developed together with the BioMed Alliance members. Eur Respir J. 2019 Feb 21;53(2). pii: 1801870. doi: 10.1183/13993003.01870-2018. Print 2019 Feb. 158.Lacombe D, Quaglio G, Lejeune S, Saesen R, Rübig P. Establishing treatment optimisation as part of personalised medicine development. Eur J Cancer. 2019 May;113:96-97. doi: 10.1016/j.ejca.2019.03.014. Epub 2019 Apr 15. 159.Salgado R, Solit DB, Rimm DL, Bogaerts J, Canetta R, Lively T, Lyerly K, Span PN, Bateman-House A, Makady A, Bergmann L, Nagai S, Smith C, Robson M, Savage M, Voest E, Sweeney C, Lambin P, Thomas M, Harris L, Lacombe D, Massard C; IBCD-Faculty. Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology. Eur J Cancer. 2019 Jun;114:128-136. doi: 10.1016/j.ejca.2019.03.025. Epub 2019 May 3. 160.Lacombe, D., Golfinopoulos, V., Negrouk, A., & Tombal, B. (2020). Clinical research in Europe: Who do we do all that for? Journal of Cancer Policy, 23(October 2019), 100217. https://doi.org/10.1016/j.jcpo.2020.100217

Projects

Memberships Corresponding Member of the American Association for Cancer Research (AACR) Member of the European Society of Medical Oncology (ESO) Member of the American Society of Clinical Oncology (ASCO) Member of the Belgium College of Pharmaceutical Medicine (till 2011) Lecturer for the 3rd cycle of pharmacology applied to pharmaceutical industry, (Pharmed) Free University of Brussels 2003-on going Member of the Scientific Advisory Group Oncology (SAG) of Committee for Medicinal Products for Human Use (CHMP) at EMEA/EMA (10/2006). Member « Comité dorientation stratégique de la direction scientifique-Comite de revue des protocoles (COS-CRP) UNICANCER France (05/2008-2015) Président Conseil Scientifique du Centre G-F Leclerc (2009-2018) Member of the CIR2C (French INCa) (2014-2017) Member of the General Assembly of WIN (2014-2016) Member of Commission Expert Group on Cancer Control (2014-on going) Member of Vlerick Business School, Advisory Board Fellow of the European Academy of Cancer Sciences (2015)

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