The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

Old Publications

Actual developments in European regulatory and health technology assessment of new cancer drugs – what does this mean for oncology in Europe?
L. Bergmann, H. Enzmann, K. Broich, A. Hebborn, S. Marsoni, L. Goh, J. F. Smyth and H. Zwierzina. Ann Oncol (2014) 25 (2): pp. 303-306. doi: 10.1093/annonc/mdt488 First published online: 10 December 2013

Present and future breast cancer management—bench to bedside and back
A positioning paper of academia, regulatory authorities and pharmaceutical industry
R. Bartsch1,2, S. Frings3, M. Marty4, A. Awada5, A. S. Berghoff1,2, P. Conte6, S. Dickin7,
H. Enzmann8, M. Gnant2,9, M. Hasmann10, H. R. Hendriks11, A. Llombart12, C. Massacesi13,
G. von Minckwitz14,15, F. Penault-Llorca16,17, M. Scaltriti18, Y. Yarden19, H. Zwierzina20 &
C. C. Zielinski1,2* for the Biotherapy Development Association (BDA)

BDA 7th Alpine meeting: Meeting the Current and Future Challenges of Oncology Drug Development
Breakout session on “The Current and Future Challenges of Targeted Therapy in HTA Evaluation” Moira Howie, Kathy Oliver, Angela Timoney and Gordon McVie.
Ecancer, published 23 may 2013

The preclinical and clinical activity of aviscumine: a potential anticancer drug.
Zwierzina H, Bergmann L, Fiebig H, Aamdal S, Schöffski P, Witthohn K, Lentzen H.
Eur J Cancer. 2011;47(10):1450-7.

Molecularly targeted therapies for colorectal cancer: Strategies for implementing translational research in clinical trials.
Zwierzina H, Bardelli A, Ciardiello F, Gariboldi M, Håkansson L, Lambrechts D, Lind GE, Loeffler-Ragg J, Schmoll H, Siena S, Tabernero J, Van Cutsem E.
Curr Opin Mol Ther 2010;12(6):703-11

Investigator-initiated trials of targeted oncology agents: why independent research is at risk?
Bergmann L, Berns B, Dalgleish AG, von Euler M, Hecht TT, Lappin GL, Reed N, Palmeri S, Smyth J, Embacher-Aichorn S, Zwierzina H; Biotherapy Development Association.
Ann Oncol 2010;21(8):1573-8.

The capacity of the immune system to control cancer
Håkansson L.
Eur J Cancer 2009;45(12):2068-70.

Improving the efficacy of cancer immunotherapy
Copier J, Dalgleish AG, Britten CM, Finke LH, Gaudernack G, Gnjatic S, Kallen K, Kiessling R, Schuessler-Lenz M, Singh H, Talmadge J, Zwierzina H, Håkansson L.
Eur J Cancer 2009;45(8):1424-31.

Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective
McCabe C, Bergmann L, Bosanquet N, Ellis M, Enzmann H, von Euler M, Jönsson B, Kallen KJ, Newling D, Nüssler V, Paschen B, de Wilde R, Wilking N, Teale C, Zwierzina H; Biotherapy Development Association.
Ann Oncol 2009;20(3):403-12. Review.

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)
Bergmann L, Aamdal S, Marreaud S, Lacombe D, Herold M, Yamaguchi T, Wilhelm-Ogunbiyi K, Lentzen H, Zwierzina H; European Organisation for Research and Treatment of Cancer.
Eur J Cancer 2008;44(12):1657-62.

Strategies for harmonization of next-generation oncology drug development. A report from the third Alpine meeting of the Biotherapy Development Association.
Guest Editors: Zwierzina H, Bergmann L, deBock A, Hirschfeld S.
Eur J Cancer Supplements 2007;5(9): pp. 1-52.

Pharmacoeconomics behind next-generation oncology drug development.
H. Zwierzina a, J. Liliemark b, A. deBock, pp. 2.

The basic economic problem – interaction of all stakeholders required. p4-5
Max E. Scheulen, pp.4-5.

Erlotinib in pancreatic cancer.
L. Bergmann, J.W. Goethe, pp. 7-8.

Biomarkers and translational research.
V. Nuessler, P. Démolis, S. Schwoch, pp. 10.

Development of biomarkers: What are the scientific hurdles?
L. Håkansson, pp. 10-11.

Progression-free survival as an end-point in clinical trials of biotherapeutic agents.
Lothar Bergmann, Steven Hirschfeld, Charles Morris, Sergio Palmeri, pp. 23-28

Vaccines: A rapidly evolving technology – Are the hurdles being addressed?
L. Håkansson, A. Dalgleish, K.J. Kallen, M. Schuessler-Lenz, pp. 29-32.

How can biomarkers become surrogate endpoints?
B. Berns, P. Démolis, M.E. Scheulen. pp. 37-40.

Clinical trial design issues: Session 1.
R. Milsted, T. Hinz, C.C. Zielinski, pp. 41.

Clinical trial design issues: Session 2.
H.X. Chen, A. Tinetti, H. Zwierzina, pp. 46.

Phase I investigation of recombinant anti-human vascular endothelial growth factor antibody in patients with advanced cancer.
Jayson GC, Mulatero C, Ranson M, Zweit J, Jackson A, Broughton L, Wagstaff J, Hakansson L, Groenewegen G, Lawrance J, Tang M, Wauk L, Levitt D, Marreaud S, Lehmann FF, Herold M, Zwierzina H; European Organisation for Research and Treatment of Cancer (EORTC).
Eur J Cancer 2005;41(4):555-63.

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.
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; European Organization for Research and Treatment of Cancer New Drug Development Group.
Ann Oncol 2004;15(12):1816-24.

Molecular imaging and biological evaluation of HuMV833 anti-VEGF antibody: implications for trial design of antiangiogenic antibodies.
Jayson GC, Zweit J, Jackson A, Mulatero C, Julyan P, Ranson M, Broughton L, Wagstaff J, Hakannson L, Groenewegen G, Bailey J, Smith N, Hastings D, Lawrance J, Haroon H, Ward T, McGown AT, Tang M, Levitt D, Marreaud S, Lehmann FF, Herold M, Zwierzina H; European Organisation for Research and Treatment of Cancer Biological Therapeutic Development Group.
J Natl Cancer Inst 2002;94(19):1484-93.

PET and PK analysis of the humanized monoclonal anti-VEGF antibody HuMV833. An EORTC Biological Treatment Group phase I study.
Gordon C. Jayson, Jamal Zweit, Clive Mulatero, David Hastings, Peter Julyan, Malcolm Ranson, Jeremy Lawrance, Alan McGown, Alan Jackson, Leif Hakannson, John Wagstaff, Gerard Groenwegen, Frederick Lehmann, John Wagstaff, Dan Levitt, Tao Tang, Heinz Zwierzina.
Proc AACR 2001,42, abstract 4470

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