February 21, 2012 ·
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Industry Insights from Paul Meade, M. Sc., MPH
While the Mayans might have been good at developing a cosmic calendar with 27,000-year cycles, I will try to venture only one or two years out and predict some developments within the healthcare system.
I dare say the Mayans had great foresight about changes, even if they never invented the wheel, but clearly they missed the fact that 2012 was an election year in the United States, and that predicting change became no mean task with orders of magnitude of difficulty. Nonetheless, I will attempt to gaze into my crystal ball and give my predictions for the next little while.
The promise of personalized medicine has been swirling around in the minds of brilliant people for well over a decade now, but we are patiently awaiting the results to impact our daily lives. Throughout the past 10-15 years, advances in the personalized medicine field have been somewhat slow to appear on the landscape. We should not be too discouraged by this advancing timeline, since we are still waiting for a cure for cancer after many decades of highly-funded research. Yet, each day, scientists are discovering more and more biomarkers with the potential to move us closer the reality of personalized medicine.
These biomarkers are not only predicting diseases—they are identifying companion diagnostics, indicating response levels to ... read more »
March 17, 2011 ·
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Industry Insights from Paul Meade, M.Sc., MPH
The Physician Payment Sunshine Provision is a part of the Patient Protection and Affordable Care Act passed by the U. S. Congress in March of last year. The provision will go into effect on January 1, 2012. Many people in the healthcare industry are struggling to determine if this provision is a good thing or a bad one. Truth be told, it is a bit of both—good, in that it ensures complete transparency among health care providers and manufacturers of pharmaceuticals and medical devices, and bad, because it may expose the benefits some healthcare professionals gain from interacting with some manufacturers.
For years, healthcare professionals have been interacting with manufacturers in many ways; when providers offer their professional services, they expect and receive compensation for their time and knowledge, as would experts in any other industry. Every industry has its experts, and healthcare is no exception. There are healthcare experts in a variety of functional areas and in all therapeutic areas. These experts have medical information and knowledge that is valuable to healthcare manufacturers as they develop and commercialize their products and services. Acting as consultants to industry manufacturers, experts offer guidance in the development of new products, from determining unmet medical needs to suggestions on how to price new products.
Is it fair to compensate ... read more »
January 7, 2011 ·
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Prateek Peres-da-Silva, an intern at Thought Leader Select and student at the University of North Carolina’s Kenan-Flagler Business School, recently sat down with Dr. Maher “Max” Noureddine, Thought Leader Select’s departing chief scientific officer, to discuss his achievements at the company, as well as his vision for the non-profit he is launching to improve the professional lives of health care providers. Peres-da-Silva is a junior at UNC, double-majoring in business and biochemistry.
Prateek Peres-da-Silva: In part one of the interview, we talked about your work for Thought Leader Select. For the rest of our conversation, I’d like to hear your take on the future. What are your plans for the new year?
Max Noureddine: I stepped down from my position with Thought Leader Select to focus completely on establishing and running a new non-profit entity, which I have named The Institute for Advanced Career Development (IACD).
Prateek Peres-da-Silva: In some of our previous conversations, you have mentioned that there will be several mentoring programs, aimed at educating healthcare and legal professionals, set up under the institute’s umbrella. Can you tell us more about these programs?
Max Noureddine: One of the immediate objectives of the IACD is to provide healthcare professionals and scientific researchers with training and mentorship on how to shape their careers to become effective leaders in their areas of specialty. The sustained, ... read more »
December 16, 2010 ·
In the Field with Neil: Observations from Neil Mellor, Business Development Consultant
“When the US sneezes,” as they say, “Canada catches a cold.” This cliché could not be more apt for the Canada pharmaceutical executive when it comes to managing relationships with key opinion leaders (KOLs). Canada is still a long way off from having similar regulatory activity to the US, with regard to governing interaction with healthcare professionals, but Canadians should pay attention to what is happening south of the border.
The Office of the Inspector General (OIG) is a well-known entity to any US pharmaceutical sales representative, product manager, sales or marketing executive. The OIG is a division of the US Department of Health and Human Services and has strict powers governing how the US pharmaceutical industry engages with KOLs and promotes pharmaceutical products. According to The OIG’s website (http://oig.hhs.gov/), “The OIG’s duties are carried out through a nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components.” The OIG has sweeping powers to investigate, prosecute and fine, if necessary, or even invoke jail terms. Since 2000, over $11.7 billion in legal settlements have been collected by the OIG from pharma companies promoting off-label usage of their products or violating the agency’s expectations of how the industry should interact with KOLs.
Canada ... read more »