The Changing World of Drug Development

Published: 2014-02-27

We are glad to tell you that Chinese Clinical Oncology will launch a special issue on The Changing World of Drug Development in the second quarter of 2014. Our Guest Editor for this special issue is Dr. Christian Dittrich, from Center for Oncology and Hematology, Kaiser Franz Josef-Spital, Vienna, Austria.

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, 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:

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 and 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

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/United Kingdom

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/United Kingdom

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