Dear Readers,

The most fundamental challenge in today's market for pharmaceutical and biotechnology products can be summarized in two words: demonstrating value. The industry is continually being challenged by patients, providers, payers, and politicians to demonstrate value, not just in one dimension but in two.

• Demonstrating Value in Clinical Terms. With the topic of drug safety now being front-page news on a weekly basis, the challenge for drugs just entering the market is to balance the need for quick market success with the imperative to fully characterize its risk profile, thus generating the greatest return on investment. Covance Periapproval Services helps clients maximize market uptake while also minimizing risk. We use the term "periapproval studies" to encompass simplified safety and effectiveness studies, market acceptance research, and observational studies designed to assess aspects of a drug's effectiveness and impact on patient outcomes in real-world settings.
• Demonstrating Value in Economic Terms. In those cases where the front-page headline about a drug isn't about a safety issue, then it's a safe bet that the article focuses on the drug's price. My observation is that price has become the focus of attention not just for products costing $15,000, but even for breakthroughs selling for just $150. Covance Market Access Services has developed a market-leading array of services to help manufacturers demonstrate the economic value of their products, while also helping individual patients navigate their options for insurance coverage and/or patient assistance to enable the maximum number of patients to gain access to therapy.

Given that our most forward-thinking customers now focus on demonstrating value in both clinical and economic terms, we have expanded the scope of Covance Insights to cover the full spectrum of these twin challenges to the successful commercialization of medical breakthroughs. Moreover, we are expanding the mailing list to include customers of both Covance Periapproval Services and Covance Market Access Services. I expect that the cross-fertilization will help both groups think more broadly about demonstrating value to the many stakeholders we serve.

Sincerely,

Luis T. Gutierrez
President