Day 2 of the Partnerships meeting in Orlando is over and while there is a day 3 tomorrow, I go home in the morning. I was lucky enough to be on two panels discussing clinical trials in emerging markets. Here are my highlights.
Day 1 - The morning was all pre-conference workshops so the mass of conference attendees were not evident yet. My panel of 4 experts on the emerging regions - Mark Lanfear, Julie Margules, Nagaraja Srivatsan and me - gave a 4 hour workshop in the morning with maybe 45 people in attendance, many of whom stayed for the whole 4 hour period. We divided up the world by regions and shared some of our experiences. Good discussion ensued. The session was blogged by Keith Russell, link here. Lunch was a meeting of the Partnerships Emerging Markets Advisory Board.
In the afternoon there were some additional sessions of contracts, RFPs, and phase 1 study design concerns, followed by the keynote speaker Ethan Zohn and a reception in the exhibit hall, lots of networking.
Day 2 - The keynote speakers were Dr Jack Dean, chairman of Partnerships and then Sen. Tom Daschle who gave an excellent talk about the policy points of Health Care Reform. He summarizes the debate in language refreshingly devoid of political heat )although I may not be unbiased as I supported the need for health care and insurance reform and thought the resulting law does not go far as it should). He said the key points of the debate were/are: 1. the role of government; 2. the complexity of a $2.5 trillion problem; and 3. the size and nature of the pie - how big will it be, and how big will be the slice that goes to each party? Daschle then described the solution - or at least as defined by the new law - as threefold: insurance reform, payment reform and access reform. Of the three, the insurance component has the most detail in the new law, phasing in a series of reforms in two year increments until 2018. Many of the most needed elements come in this year: no exclusions for pre-existing conditions in children, no recisions, no lifetime or annual limits, a small business tax credit, and rebates for seniors caught in the Rx drug gap in Medicare. Payment and delivery reforms have less detail, but they are intended to shift the reward from volume to value, incentivize wellness, end fee for service, encourage electronic medical records (1 out of every $5 spent in health care goes to administration, paper records), encourage the use of best practices and evidence based medicine.
In the afternoon I attended a talk by Michael Marcarelli of the FDA. He was refreshingly engaging and disarming about the business of compliance monitoring and reminded us all about the sponsor's responsibility to provide oversight for and service providers, including providing training for investigators and CROs. He made an odd anachronistic comment when answering a question near the end when he noted with apparent surprise that so many site monitors these days do not have medical degrees, and 'sometimes they (sponsors) even send Gal Friday to monitor'. I don't know where he has been all this time, but the industry realized literally decades ago that CRAs/monitors need not be medically qualified and even then most monitors in this country were nurses, never doctors. And the 'Gal Friday' comment was plain offensive.
Finally it was our turn again and this time my two colleagues - Larry Fiori and Graciela Racaro - and I shared a relatively brief 45 minutes sharing what are the different considerations when doing studies in the global space, particularly the newer countries. This session was blogged by Foreign Exchange Translations, here.
