{"id":12601,"date":"2014-01-01T00:00:00","date_gmt":"2014-01-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/show086\/"},"modified":"2014-01-01T00:00:00","modified_gmt":"2014-01-01T00:00:00","slug":"show086","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/talk\/show086\/","title":{"rendered":"Risk Mitigation and Its Impact on Pharma Marketing"},"content":{"rendered":"

Risk Mitigation and Its Impact on Pharma Marketing Click Here for Additional Resources<\/a><\/p>\n

A conversation with Jeff Fetterman<\/b>, President and CEO of ParagonRx, about developing a Risk Evaluation and Mitigation Strategy (REMS) that clinicians will consider useful and that would raise their intent to prescribe.<\/p>\n

Aired LIVE on: <\/p>\n

Monday, September 28, 2009<\/b> Listen to internet radio<\/a> with Pharmaguy<\/a> on Blog Talk Radio<\/p>\n

You may also visit this Pharma Marketing Talk Segment Page<\/b><\/a> to listen to the audio podcast.<\/p>\n

This show and ALL Pharma Marketing Talk shows are available as podcasts via PMT on iTunes<\/b><\/a> (FREE!).<\/p>\nBackground<\/b><\/p>\n

Risk management. REMS (Risk Evaluation and Mitigation Strategy). Danger management of your product’s life cycle.<\/p>\n

These topics are all crucial to brand managers and marketing executives. Did you know that a Risk Evaluation and Mitigation Strategy (REMS) can be a win-win-win situation for you, your product, and the patient? Or that the longer you wait in the product development process to start thinking about REMS, the more you will lose control of your product’s future?<\/p>\n

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. <\/p>\n

Many Marketing people intuitively suspect any attempt to guide appropriate use of their fledgling product \u2013 such as a REMS or other risk management program \u2013 is going to negatively affect sales and reputation. But the facts don\u2019t support the belief. Programs that define and guide appropriate use of medications minimize patient risk, address regulatory concerns, enhance proficient use by healthcare professionals, and preserve market access for patients who may benefit. All of these benefit a new product launch. <\/p>\n

“Appropriate use” can have benefits beyond launching a new product. Our guest will summarize some of these benefits and present some physician survey data in support.<\/p>\nQuestions\/Topics Discussed<\/b> <\/p>\n