The changing world of drug development
Drug development in oncology is undergoing a substantial shift nowadays. The drivers for this are multi-factorial. On the one side, drug development is performed more rationally than ever, profiting from the scientific advances in molecular biology in general and the elucidation of the various “omes” from genome to metabolome in particular. On the other side, it is based on enormous technological progress, e.g., in the field of genome sequencing, and in that of adequate handling of the resulting plethora of data. The high attrition rate of oncologic drugs under development in the past and the pressure from the side of the payers make it necessary to find permanently new answers for and adaptations of the process of drug development. In this context, it is necessary to respect arguments and views from the various perspectives of all the relevant stakeholders.
Together with a group of international experts from different perspectives of drug development, Dr. Christian Dittrich from Center for Oncology and Hematology, Kaiser Franz Josef-Spital, Vienna, Austria, is going to launch a special issue on the Changing World of Drug Development in Chinese Clinical Oncology (CCO) in June 2014.
This special issue will illustrate the respective role of patients, laboratory, clinical trials, drug companies, regulatory bodies, and also the economic principle in drug development, aiming at facilitating drug research in the near future.
The topics to be covered in this special issue are as follows:
♦ Editorial: the Changing World of Drug Development
Christian Dittrich; Austria
♦ The Spectrum of Clinical Trials Aiming at Personalizing Medicine
Christophe Le Tourneau, Maud Kamal, Maria Alt, Loic Verlingue, Vincent Servois, Marie-Paule Sablin, Nicolas Servant, Xavier Paoletti; France
♦ Drug Designs Fulfilling the Requirements of Clinical Trials Aiming at Personalizing Medicine
Sumithra J. Mandrekar, Daniel J. Sargent; USA
♦ Integrative Oncology Drug Discovery Accompanied by Preclinical Translational Research as Prerequisite for Clinical Development
Jens Hoffmann; Germany
♦ Translational Research as the Determining Element in the Actual Process of Novel Drug Development
Nadia Harbeck; Germany
♦ Functional and Molecular Imaging in Cancer Drug Development
Yan Liu; Belgium
♦ Interdisciplinary Challenge of Developing Combined Radio-Drug-Therapies
Philippe Maingon; France, Vincent Gregoire; Belgium
♦ An Academic Research Organization’s Perspective
Yan Liu, Denis Lacombe, Roger Stupp; Belgium
♦ A Global Pharmaceutical Company’s Perspective
Susan Galbraith; UK
♦ Medicine Adaptive Pathways to Patients (MAPPs): Using Regulatory Innovation to Defeat Eroom’s Law
Duane Schulthess, Magda Chlebus, Richard Bergström, Karin Van Baelen; Belgium
♦ The Regulatory Bodies’ Perspective
Iordanis Gravanis, Camille Vleminckx, Bertil Jonsson, Francesco Pignatti; UK
♦ The Positioning of Economic Principles under the Changing Conditions of the Novel Drug Developmental Process in Cancer
Nils Wilking, Ulla Wilking, Bengt Jönsson; Sweden
♦ And Now for Something Completely Different: Drugs that work! The Patients’ Perspective
Peter Kapitein; The Netherlands
Acknowledgements
Disclosure: The author declares no conflict of interest.
