The rate of growth of CROs and CPMs has been in constant decline since 1990. Strategic alliances between pharmaceutical companies and major CROs dominate the marketplace. CROs are essentially perceived as commodity suppliers, and new CROs must offer specialised, niche services. The alliances between pharma companies and CROs differ in many respects from strategic alliances in other industries. Despite the fact that ICH GCP is now the most accepted GCP standard throughout the world, and has been published as a guideline in the Federal Register as an official FDA guideline, it is only a guideline and so investigators, nurses, ethical review boards and monitors all need to have complied with FDA GCP regulations when the inspector comes to call.
Cancer is a multi-parameter phenomenon and is elusive target in terms of drug therapy.
Major challenges include overcoming multi-drug resistence and the ethical inappropriateness of conducting Phase I clinical trials. The development of experimental rodent models to test novel anticancer agents is a possible solution. Funding is also a limiting factor, with an upsurge of research being located in Eastern Europe. Finally Dr Genne discusses his vision for the future in terms of gene therapy and other advances in biotechnology.