Pre-reading material
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Moreland N.J., Waddington C., Williamson D., Sriskandan S., Smeesters P.R. Proft T., Steer A.C., Walker M.J., Baker E.N., Baker M.J., Lennon D., Dunbar R., Carapetis J. and Fraser J. Working towards a Group A Streptococcal Vaccine: Report of a Collaborative Trans‑Tasman Workshop. Vaccine (2014);32(30):3713-20.
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Goldman, S. (2014). PET imaging of garbage protein in Alzheimer’s disease: Does it require reappraisal of brain PET analysis? European journal of nuclear medicine and molecular imaging, 41(5), 813-815. doi:10.1007/s00259-014-2740-8
Challenges with advanced therapy medicinal products and how to meet them. Committee for Advanced Therapies (CAT); Nat Rev Drug Discov. 2010 Mar;9(3):195-201.
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective. Salmikangas P1,2, Schuessler-Lenz M3,4, Ruiz S5,6, Celis P7, Reischl I8,9, Menezes-Ferreira M10,11, Flory E12,13, Renner M14, Ferry N15,16. Adv Exp Med Biol. 2015;871:103-30.
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Vincent Wille, Pieter-Jan Mermans and Edouard Croufer. Making new product launch decisions in an uncertain environment, Arthur D.Little Prism magazine
Edouard Croufer, Françoise Simon, François Meurgey and Alexandre Meire. Putting patients at the center of a new biopharma business model, Arthur D.Little Prism magazine
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Michiel Verlinden, Timo Minssen, Isabelle Huys, IPRs in Biobanking: Risks and Opportunities for Translational Research, [2015] I.P.Q., Issue 2, 2015
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Robotic Mitral Valve Repair for Simple and Complex Degenerative Disease: Midterm Clinical and Echocardiographic Quality Outcomes. Suri RM, Taggarse A, Burkhart HM, Daly RC, Mauermann W, Nishimura RA, Li Z, Dearani JA, Michelena HI, Enriquez-Sarano M.Circulation. 2015 Nov 24;132(21):1961-8
How can innovative forms of clinical research contribute to deliver affordable cancer care in an evolving health care environment? Susen Burock, Françoise Meunier, Denis Lacombe – European Journal of Cancer (2013)49, 2777-2783
Academia-Industry Partnerships: Are we ready for new models of partnership? The point of view of the EORTC, an academic clinical cancer research organisation. Denis Lacombe, Susen Burock, Françoise Meunier – European Journal of Cancer 15 October 2012 (on-line publication exclusively), 1-7
The dream and reality of histology agnostic cancer clinical trials. Denis Lacombe, Susen Burock, Jan Bogaerts, Patrick Schoeffski, Vassilis Golfinopoulos, Roger Stupp – Molecular Oncology 8(2014) 1057-1063
European perspective for effective cancer drug development . Denis Lacombe, Sabine Tejpar, Roberto Salgado, Fatima Cardoso, Vassilis Golfinopoulos, Daniela Aust, Gunnar Folprecht, Arnaud Roth and Roger Stupp – Nature reviews, august 2014, volume 11 no.8
Lancet Oncol. 2015 May;16(5):522-30. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial.
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Informed consent: where are we in 2015? Foy MA. Bone Joint J. 2015 Sep;97-B(9):1159-61. doi: 10.1302/0301-620X.97B9.36506. Review.
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Intensive care unit research ethics and trials on unconscious patients.
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Eizirik DL, Sammeth M, Bouckenooghe T, Bottu G, Sisino G, Igoillo-Esteve M, Ortis F, Santin I, Colli ML, Barthson J, Bouwens L, Hughes L, Gregory L, Lunter G, Marselli L, Marchetti P, McCarthy MI, Cnop M The human pancreatic islet transcriptome: expression of candidate genes for type 1 diabetes and the impact of pro-inflammatory cytokines. PLoS Genetics, 8: e1002552, 2012 (“Faculty of 1000 Recommended”
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