Changing the status quo of Drug Development

Optimizing the clinical trial process to increase the chance of clinical and commercial success is a hot topic across the pharmaceutical industry, as witnessed by the number and range of attendees at Pharmaceutical Business Review’s recent webinar ‘Perspective on the future of drug development’.

Nick Bennett, Research & Analysis Director, Healthcare, at Datamonitor, said: “Pharma is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies. A number of strategies can be implemented – either in isolation, but more effectively in combination – to optimize the clinical trial process and increase the chance of clinical, and ultimately, commercial success”.

Webinar attendees came from top global pharmaceutical companies, biotech companies, and leading clinical research organizations, confirming the growing interest in new approaches to drug development, including Adaptive Clinical Trials. The webinar panels’ experiences of scaling up to move adaptive trials into the mainstream provides key insight into the challenges of achieving organizational change, both internal and external, and what change means from a technology perspective.

Professor Don Berry, of Berry Consultants, stressed the importance of facing changes in strategies used in drug development. Berry said: “I have been encouraged by the FDA’s Critical Path Initiative which seeks to achieve better outcomes more cost effectively, such as the use of Adaptive Clinical Trials, the development of biomarkers, and a growing focus on translational medicine”.

Tessella’s Head of Clinical Trials Solutions, Tom Parke, commented: “As more information needs to be assimilated and more options opened up in how drug development can be carried out, the operational processes that support drug development will become increasingly complex. This poses a major challenge to pharmaceutical companies to prepare for this new world, as it requires new operating procedures that traverse existing departmental structures, changes in the skills base, integrated information management, better information flow and IT infrastructure to support these new processes”. Parke added: “organizations need to act now to prepare for these changes.”

To listen to a recorded version of the webinar please visit:
www.tessella.com/clinicaltechnologies

www.tessella.com