Maybe it’s the medical school ambiance. Or the end of a long Boston winter.

But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical School. It’s organized by a technology vendor, Outcome, which specializes in registries and post-marketing projects. The event runs on May 14-15. This is the registration page.

The conviviality of the conference is a bit surprising, given an A-list of rock-star-worthy speakers plucked from the Rolodex of Richard Gliklich, Outcome’s president and CEO. He says the tone of the meeting is a reflection of the shared biographical paths of some of the speakers. “Many of them come from the same roots,” he says. “You have someone from industry who went to medical school with someone from the FDA.”

Heavy Hitters

So who’s coming from FDA? CDER director Janet Woodcock and Gerald Dal Pan, director of the office of surveillance and epidemiology. From pharma? Joseph Camardo, senior VP of global medical affairs at Wyeth. Jerome Premmereur, vice president medical risk management, Sanofi-Aventis. From the heights of power? Republican Mark McClellan, ex-FDA boss, ex-economics professor, current chair of the Reagan-Udall foundation and scholar at the slightly liberal Brookings Institution think tank.

Short of actually going to Europe, the Outcome meeting is a good way to acquaint oneself with what is going on in the EU, and this year has the usual kernel of high quality speakers from the EMEA, Canadian and Indian regulatory bodies. Plus Michael Kelly from National Institute for Health and Clinical Excellence (NICE) in the UK. NICE, of course, is a government body that tries to assess both medical benefits and costs; it could be a model for similar efforts (assuming an eventual end to political gridlock) in the U.S.

Phase IV Panorama

Gliklich says the meeting will review the entire post-approval landscape. He’s reluctant to single out any particular presentation, but notes that Wyeth’s Camardo will “speak on how the interactions with the FDA and other agencies are going, how they could be improved, how the organization could better align, and what PDUFA reauthorization means from an industry perspective.”

Richard Platt, one of Gliklich’s colleagues at Harvard, is an ambulatory medicine physician. He will be discussing the use of claims data in drug safety signal detection. Another colleague, Sebastian Schneeweiss, will discuss the notion of comparative effectiveness. “It’s a very hot topic,” says Gliklich. “It’s going to be a primer on what is comparative effectiveness and what is its role in decision making.”

Gliklich says that no matter what shifts in the political environment in 2009, demand for post-approval data from the public and regulatory authorities is unlikely to abate. “There is going to be more or a lot more call for this kind of information,” he says.

Inadequate Systems

Gliklich freely concedes that some of the existing ways to identify and examine safety signals leave much to be desired. “We don’t have a systematic approach to surveillance and safety reporting,” he says.

What is the solution? “I’m hesitant to say technology is the answer,” he says, noting that medical claims data, however voluminous or detailed, may or may not produce true epidemiological signals. There are gaps in clinical knowledge, he suggests, rooted in the post-approval landscape as it stands now. “We have a voluntary safety reporting program,” says Gliklich. “That’s true in the U.S. and other countries. As a result, we are often guessing about how significant an issue really is.”

His firm, Gliklich reports, is growing at a healthy clip. He says large contract research organizations have been going after registries and post-approval work more energetically. “They are gaining some business, there is no question. But we’re very bullish on our ability to compete,” he says.

Outcome has a new office outside Geneva, Switzerland and the outlines of a joint venture in India.  Says Gliklich: “We’re prequalifying sites in major disease groups so that we don’t get surprised by issues of infrastructure or English [fluency] or patient access.”

Editor’s note: The agenda for the Post-Approval Summit at Harvard can be found here. This is a ClinPage story about Outcome’s assistance in publishing a best practices guide to registries, and another story about last year’s meeting.