Pharmaceutical, biotech and medical device companies need to move new products into the market quickly to obtain sufficient benefit from a limited patent life and to compensate for development costs which can exceed $800 million per drug. Most major pharmaceutical manufacturers spend an average of 15% of sales on R&D. Given this substantial outlay and the long development cycle, companies have struggled to find ways to speed the introduction of new products into the marketplace. Strategies typically employed to compress R&D time include developing improved operational and management processes and the use of advanced technology. Technologies such as high throughput screening, combinatorial chemistry and genomics are at the forefront of transformational approaches intended to surmount a fundamental challenge facing the industry.
The issues involved in effectively carrying out research and development are complex and transcend science. The regulatory environment is a key component that essentially affects every stage of the process. For example, clinical development activities not performed in compliance with Good Clinical Practices (GCP) expose a company to risks that include delays in approval, wasted investments, litigation and settlement costs due to product liability, and reputational harm. Industry observers consider the area of clinical development to be the next major area of government investigations and urge companies to focus on the design and implementation of processes and controls that will mitigate development risks. This belief is supported by a noticeable increase in the number of intense and unannounced FDA inspections of clinical sites across the industry.
In a time of rising development costs and declining pipeline productivity, R&D organizations are expected to deliver greater value while their resources and budgets are increasingly constrained. Operational efficiency has become critical for success. In order to ensure organizations are well-positioned to meet this challenge, PwC’s Integrated Operations and Business Planning Services for R&D helps organizations deliver more value in the development chain by utilizing an integrated operations and business planning framework to support key business decisions and strategies across the entire development portfolio. Using this framework, organizations can more effectively execute their development pipeline and leverage the value of integrated resource management, project and portfolio management, and financial management.