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refining the various educational messages that will need to be delivered throughout the com mercialization process. Building a medicaledu cation strategy in parallel with the clinical development strategy can provide a significant competitive advantage. Not only does it enable the pharma company to build a better, more consistent understanding of the product in the medical community prelaunch and post launch, it can also drive more focused clinical trial strategies and lead to a more efficient use of medicaleducation dollars. Ideally, this plan ning process should start as early as 24 months to 36 months before the expected launch of the product. Finding the Right Partners The second focus for pharmaceutical manufac turers should be on finding the right medical education partners to help shape and deliver the message. Because there are a lot of poten tial partners to choose from, it’s wise to criti cally examine the capabilities of several to make sure the company selected is more than just a “vendor” that can do the basics. Pharma companies should look for meded partners with seasoned personnel, which includes peo ple who have experience not only from medi caleducation firms or ad agencies, but from the pharmaceutical or device company mar keting side as well. The team ought to include people who understand and can develop mar keting strategies, not just implement tactics.. Most important, they should look for people with handson experience in navigating through the world of guidelines and regula tions. A good partner can point out the land mines ahead and help clients avoid them. Quality Content For medicaleducation companies, the key to adapting to the guidelines is to focus Mark Rickards Chief Operating Officer REGULATORS AND REGULATIONS CADENT MEDICAL COMMUNICATIONS (formerly S.G. Madison), Irving, Texas, is the medicaleducation division of inChord. For more information, contact Mark Rickards via email at firstname.lastname@example.org, or call 9729291900.
The landscape for commercializing pharmaceutical products is changing rapidly due to the alphabet soup of new medical education guidelines from PhRMA, OIG, and ACCME. While some of the new guidelines are “voluntary” and involve self policing by the industry, others are mandates and carry with them the penalties of accrediting organizations and the federal government for those in violation. Given the increased complexity of medical education activities, many pharma and device manufacturers are struggling to know how to proceed. Some are becoming ultraconserva tive and abandoning anything in the market ing mix that has the slightest hint of contro versy. While that may appear to be the safe route, in reality, it is a move certain to create a competitive disadvantage. The key to adapting medical education programs in these changing times is using good judgment and focusing on the things that matter. When the complexities around the guidelines and the other changes facing the industry are peeled away, there is still a core set of facts that remain unchanged: 1.There will always be unmet needs in medicine. 2.Pharmaceutical and device companies will develop solutions for these needs. 3.The “story” about these innovative solutions will need to be told. A Parallel Process For pharmaceutical and device manufactur ers, the primary focus needs to be on develop ing products that have sound, credible scientif ic stories to tell. While that may be obvious, what’s not so apparent is the need early in the clinicaldevelopment planning process to focus on a prospective plan for building, shaping, and key to surviving change is to stay focused, work with the right people, and do the right thing. Adapting to New Guidelines: Pharma Manufacturers and Medical Ed Companies