Pharmaceutical productivity is down partly because of the industry's own inefficiencies. Industry observers often cite poor management of R&D and clinical development. Further complicating the life of biotech and pharma firms is the current pharmaceutical environment: stronger pricing pressure for prescription drugs, greater involvement of state and federal governments, more stringent regulatory and compliance requirements, and broader consumer choice.
To help succeed in the new pharmaceutical world, Charles Gombar, Ph.D., a vp and product development team leader at Wyeth Research, and his group came up with a new paradigm for clinical development at the company.
Wyeth's novel approach can also be applied by other companies.
During this weeks's GENcast, Dr. Gombar discusses the firm's new initiative, which is known as the Wyeth Clinical Development Model of the Future. He notes that the major theme of company actions is that Wyeth cannot adequately respond to the needs of the new and evolving environment using a traditional phased method to clinical development and instead must adopt a Learn and Confirm paradigm. Dr. Gombar defines Learn and Confirm and shows how it can be used to reduce costs and cycle times, improve consistency and decision-making, and increase efficiency, quality, and product success rates.