April 17, 2013 ·
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Industry Insights from Paul Meade, M.Sc, MPH
Allison Murphy and I had the pleasure of participating in the MSL Society’s inaugural global conference and gala in Philadelphia earlier this month. At Thought Leader Select, we always enjoy the opportunity to meet some of our great colleagues in medical affairs in the pharmaceutical, biotechnology, and device industries, but this event proved to be really special.
Since joining our company last year, Allison has continued to make a real impact in the medical affairs community. After serving much of the last decade in Eli Lilly’s medical affairs division in support of the company’s endocrinology portfolio, Allison has brought a wealth of medical affairs expertise to Thought Leader Select. This expertise has continued to evolve, even as a consultant, through her membership and advisory board participation with the MSL Society, a dynamic group that we are proud to support as a company.
Dr. Samuel Dyer, the founder and head of the MSL Society, approached us a few months ago, asking for help with the burgeoning organization’s first global event. As a veteran of the industry myself, I have participated in many events through the years, as a participant, speaker, and sponsor. I must admit that I was more than a little skeptical about another conference/event series emerging in a space with ... read more »
April 10, 2012 ·
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Industry Insights from Kristen Smithwick
Last week proved to be another interesting week for the developing Sunshine Act. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) sent a pivotal memo to Acting CMS Administrator Marilyn Tavenner. The senators urged the agency to publish a final rule no later than June 2012 and to respond to several questions related to implementation.
Senators Grassley and Kohl want the agency to begin gathering transparency data this year, and they’re not willing to give CMS any wiggle room for delays. To meet the senators’ timeline, CMS will need to address comments and recommendations from numerous interested parties, especially the Pharmaceutical Research and Manufacturers of America (PhRMA), the Advanced Medical Technology Association (AdvaMed), and the Biotechnology Industry Organization (BIO). We covered a number of areas questioned in Part 1 of this blog. In this post, we’ll mention just a few additional areas of concern.
Definition of Applicable Manufacturer and Separate vs. Consolidated Reporting – Questions and concerns abound when it comes to defining applicable manufacturers, especially as the definition impacts requirements for separate vs. consolidated reporting for entities with common ownership. The challenge for CMS will be to ensure the definitions of applicable manufacturers and common ownership are broad enough to meet the public’s demand for transparency, while being specific enough to protect the ... read more »