Risk and Reward in the Pharmaceutical Lifecycle: A Panel Discussion

Recently, major changes in drug safety reporting and enforcement have placed enormous pressure on the Food and Drug Administration (FDA), which in turn is prompting pharmaceutical companies to proactively reduce potential risk.


5 January 2010

Recently, major changes in drug safety reporting and enforcement have placed enormous pressure on the Food and Drug Administration (FDA), which in turn is prompting pharmaceutical companies to proactively reduce potential risk. In this new regulatory environment, a major convergence of trends is making conditions tougher and more uncertain than we’ve ever seen. The key question is: How do we respond?

Drug information not only must be relevant and accessible to authorities virtually on-demand in order to meet strict parameters, but also it requires complete confidentiality. This kind of data isn’t just sensitive — it’s a key strategic asset for knowledge-based industries like pharmaceuticals.

In response to this challenge, Intralinks brought together a panel of experts this December to discuss the current environment in the pharmaceutical industry around drug safety and regulatory requirements. The live webcast, co-sponsored by Pharmaceutical Executive, offered me the great opportunity to sit alongside Christopher Milne, Deputy Director and Lead Policy Adviser, Tufts University Center for the Study of Drug Development; Gail Farfel, PhD, GM Group Consulting; and Dr. Jingping Mo, Senior Director, Epidemiology, Safety and Risk Management, Pfizer Inc., on the panel, “Risk, Reward and the Pharmaceutical Life Cycle: Managing Information as a Strategic Asset.

Our group discussed some of the chief concerns key decision makers in the pharmaceutical community are facing with new regulatory demands, including how best to raise the level of productivity in data management at low cost. We spoke in-depth about these issues to a broad group of attendees, including risk/safety managers, chief medical officers, and clinical development coordinators from major companies including Merck, Abbott, Pfizer, and Schering-Plough.

Moderator William Looney, Editor in Chief of Pharmaceutical Executive began the conversation with a detailed summary of the current state of regulatory initiatives on reporting and compliance for drug safety and risk. The panelists then had a fruitful discussion about how companies are managing this changing risk landscape, from a strategic, procedural and operations point of view, and how new tools and best practices from Intralinks can offer a competitive advantage.

During the panel, we asked the webcast participants about how industry issues are affecting them. When asked “What is the most important issue regarding the use of a web-based solution for information exchange with sites,” it became immediately clear that security was the overwhelming concern of respondents. (See chart below.)

Question 2

Here are some other interesting findings resulting from the polling questions:

  • 47.5% of respondents said “initiating clinical studies to assess risk” was the primary way new regulatory requirements for risk management plans impacted their day-today operations; and
  • 80.8% of respondents cited “receiving serious adverse event reports” as the safety/pharmaceutical co-vigilance functions they would most use web-based systems for.

Question 1

As we enter 2010, there is little doubt the road to drug safety-related compliance will be a bumpy one, full of new costs and unforeseen barriers. However, armed with the right information and appropriate tools, my colleagues and I are confident that the pharmaceutical industry will meet — and beat — this challenge head on. It the end, the imperative is to use technology to aid in predicting and monitoring safety signals, since better treatment for patients is our ultimate goal.

If you’re interested, a replay of the webcast is available here.