Late in the Game

March 1, 2007
Randall Hurban, Elisa Cascade
Successful Product Manager's Handbook

If your medical affairs group is increasingly asking for more money to finance late-phase research, your company is not alone. Spending across all drug phases is currently growing at approximately 12 percent per year, and some analysts predict that Phase IIIb/IV investment may be the fastest-growing component of drug development. Why is there need for more money? Here are some reasons why late-phase investment is good for your brand.

If your medical affairs group is increasingly asking for more money to finance late-phase research, your company is not alone. Spending across all drug phases is currently growing at approximately 12 percent per year, and some analysts predict that Phase IIIb/IV investment may be the fastest-growing component of drug development. Why is there need for more money? Here are some reasons why late-phase investment is good for your brand.

Product Differentiation

Achieving blockbuster status over the next few years will require evidence—safety and outcomes—beyond Phase III trials to motivate increasingly cautious primary care physicians to adopt new products.

This data will also push cost-conscious payers to add new products to formularies. The findings will likely support both new label indications as well as studies solely for publication purposes. One rapidly growing area for new label indications is patient-reported outcomes; FDA draft guidance from February 2006 discusses the use of patient-reported outcomes to support labeling claims.

For-Publication Studies

Results from a medical affairs personnel survey conducted during a Phase IV conference indicate that investment in for-publication-only studies will increase over the next four years. Although some operating procedures make it difficult to conduct these studies, an analysis of drugs such as Lipitor and Diovan demonstrate significant use of this type of late-phase research.

Investigator Satisfaction

No less than the data itself, product managers should be concerned about how the study will affect the company's relationships with its investigators. Including late-phase techniques to supplement patient recruitment, enhance patient retention, and decrease investigator burden will enhance the investigator experience.

Drug Safety

Drug safety has been a hot topic in the press over the past few years, so it's not surprising to find drug safety as a driver for growth in late-phase investment. If FDA adopts recommendations made by the Institute of Medicine, specific areas of change could, and will most likely, include:

  • Oversight to make sure companies fulfill Phase IV study commitments

  • Mandatory dissemination of positive and negative study findings through a common Web site, such as clinicaltrials.gov

  • Implementation of a safety data review five years after launch

What Does This Mean for You?

Brand managers should recognize that the market is at a turning point when it comes to late-phase studies.

Successful products will be those that have a comprehensive, strategic clinical plan to provide real-world data to physicians and payers—immediately post-launch—to increase comfort around product safety and provide a reason for access and use.

Elisa Cascade is vice president of Quintiles strategic research and safety. She can be reached at elisa.cascade@quintiles.com.

Randall Hurban is vice president of global business development for Quintiles. He can be reached at randall.hurban@quintiles.com