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Regulatory and Marketing Symbiosis from Concept to Commercialization

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For successful commercialization, the relationship between the seemingly opposing forces of Marketing and Regulatory need to be aligned very early on in the process. In this webinar, we will examine how Marketing and Regulatory must collaborate closely to design a product, develop support to substantiate its claims, and promote it for both optimal market adoption and regulatory compliance. These represent the best Good Promotional Practices.

As such, we will explore why it is critical for regulatory and marketing to create a symbiotic relationship in support of the claims strategy from the initial design review, including during development of clinical trials and sales materials.

We will also decode the common personality traits of your marketing and regulatory colleagues and give you concrete examples of how to work together more synergistically. A regulatory-marketing interaction framework to support cross-functional symbiosis will be introduced, and we will discuss balancing needs, wants and tradeoffs. Lastly, we will touch briefly on the need to gain consensus by putting it in writing via an SOP or other signed document.

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Regulatory and Marketing Symbiosis from Concept to Commercialization

  1. 1. RAPS Live Webcast<br />Originally recorded on 30 June 2011<br />Regulatory and Marketing Symbiosis from Concept to Commercialization<br />www.goodpromotionalpractices.com<br />Elsa Chi Abruzzo, RAC, FRAPSPresident, ARAC LLC<br />Maureen Shaffer, VP Life Sciences, Prolifiq and Editor/Publisher, GPP<br />
  2. 2. RAPS Live Webcast Archive<br />Available for purchase here and http://www.raps.org/publications-amp-resources/raps-store/product-detail.aspx?ProductId=1236576<br />More RAPS webcasts available on-demand here and http://www.raps.org/publications-amp-resources/raps-store/on-demand-webcasts.aspx<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  3. 3. Agenda<br />Housekeeping & Introductions(5 min)<br />Regulatory and Marketing Symbiosis (60 min)<br />Present why it is crucial for regulatory and marketing to collaborate from the initial design review through product and clinical testing to sales launch and beyond<br />Decode the common personality traits of your marketing or regulatory colleagues and how to work more synergistically<br />Apply the regulatory-marketing interaction framework to support cross-functional symbiosis<br />Describe the role of SOPs to memorialize the regulatory-marketing interface throughout the product life cycle<br />Questions and Answers (20 min)<br />Closing Remarks(5min)<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  4. 4. Speaker Introductions<br />Elsa Chi Abruzzo<br />President, ARAC, LLC<br />Regulatory Blogger at GPP<br />Maureen A. Shaffer<br />Vice President, Life Sciences, Prolifiq<br />Executive Editor and Publisher, GoodPromotionalPractices.com<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  5. 5. Criticality of Regulatory and marketing SymbiosisIt’s all about the numbers<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  6. 6. 40% Drop in Stock Price Overnight<br />1<br />DOJ probe<br />$3.8M & CIA<br />AtriCure stock plunges amid marketing probe. Wall Street Journal, 11/04/2008. <br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  7. 7. Where the Regulatory Rubber Meets the Marketing Road<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />2<br />
  8. 8. FDA, DOJ and Qui Tam Coming After Med Devices<br /><ul><li>In pharma, “we are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.” “That makes our job harder.”
  9. 9. “You still see a fair amount of wild west behavior in some of these smaller companies, particularly in the biotech and medical device sectors, where you are not necessarily going to have a whole compliance team set up that is deeply immersed in these issues.” </li></ul>3<br />Rx Compliance Report, “Federal prosecutors report slowdown in the filing of new fraud claims, say less egregious violations cited”, Vol. IX, Issue 9/July 21, 2010. <br />http://goodpromotionalpractices.com/2010/12/10/off-label-whistleblower-suits-slower-and-subtler/<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  10. 10. 400x More Individuals; 50% Mgmt<br />4<br />Jailing Individuals: What’s Next in Fraud and FCPA<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  11. 11. Today’s Business Environment<br />On vs. off-label is complicated<br />Indications + Claims<br />Physicians choose use<br />Industry must find non-burdensome way to responsibly provide information<br />Off-label physician use<br />AF, Ortho/Bone protein, Peds<br />Requires industry cross-functional rigor and control<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />5<br />http://goodpromotionalpractices.com/2011/05/27/7-new-insights-to-preventing-off-label-sales-promotion/<br />
  12. 12. Can’t we all just get along?Decoding your colleagues<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  13. 13. Opposing Forces?<br />Regulatory<br />Approving and Complying<br />FDA and friends<br />Safety<br />Marketing<br />Promoting and Educating<br />Customers<br />Revenue<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  14. 14. Regulatory: Have You Ever…<br />Spent time and effort on a submission for something sales struggled to sell?<br />Heard “I need you to sign this today. It has to go to the printer this afternoon.”<br />Been surprised by a warning letter or subpoena for promotional activities?<br /> And, wondered about Marketing?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  15. 15. Poll: If you are in Regulatory,<br />Do you prefer time to think important things over?<br />Do you notice if someone puts up a new mailbox on your route to work?<br />Are you a planner who is not a fan of surprises? Do you like closure?<br />Answer Options:<br />Yes, most of the time<br />Usually<br />Sometimes<br />No, rarely<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  16. 16. Marketing: Have You Ever…<br />Spent money and effort on something regulatory won’t approve? Or had to pull promotional material back from field?<br />Heard “there is no data to support that” when that was your entire campaign?<br />Felt trapped between sales revenues and regulatory rules?<br /> And, wondered about Regulatory?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  17. 17. Poll: If you are in Marketing,<br />Do you work out your tough decisions by talking to someone?<br />Have you ever walked out of a meeting and been more concerned because of the person’s tone of voice than what they said?<br />Do you like trying new things? Do you value possibilities and flexibility?<br />Yes, most of the time<br />Usually<br />Sometimes<br />No, rarely<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  18. 18. All Good, Different POV Requires Respect<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />Tieger & Tieger, 1995. Do What You Are: Discover the Perfect Career for You Through the Secrets of Personality Type.<br />
  19. 19. High Information + Low Value Diversity<br />Effective: Embrace, experience and manage disagreements: don’t avoid<br />Relationships as important as tasks<br />Distinguish process vs. task conflict<br />Efficient: Find a common ground around a shared value<br />Why Differences Make a Difference: A Field Study of Diversity, Conflict, and<br />Performance in Workgroups, Jehn et al, http://links.jstor.org/sici?sici=0001-8392%28199912%2944%3A4%3C741%3AWDMADA%3E2.0.CO%3B2-Q<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  20. 20. Regulatory marketing framework<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  21. 21. Regulatory-Marketing Interaction Framework<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  22. 22. Design with the patient in mind<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  23. 23. Which Disease?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  24. 24. Where are the Patients?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  25. 25. Which Site(s) of Service?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  26. 26. “The world is changing”, November 2008, Awopetu.<br />Who is the Customer?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  27. 27. Who Are the Patients?<br />Age groups<br />Activities<br />Relationships<br />Who is most likely to want new therapies?<br />Who is motivated? Why?<br />58% go online first!<br />Source: 2005 Health Care Survey, conducted by GMI and Media Screen (March 2005).<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  28. 28. Where/Which Countries?<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  29. 29. How Do You Reach Them?<br />“In 2010, …digital content is changing the way physicians practice medicine,” said Meredith Ressi, VP of research at Manhattan Research. “Professional use of smartphones and online user-generated content are no longer early adopter activities of a tech-savvy few – these types of activities are the norm for the majority of physicians today.” <br />HBR, “Stop Delighting Your Customer”, July 2010. Self service = Web, Voice Prompts, Chat or Email, Person = Phone interaction; Manhattan Research’s Taking the Pulse report, 2010. n=2000 US Physicians<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  30. 30. Poll<br />How many regulatory, legal and compliance folks have seen detailed market data for their products? <br />Yes<br />Sometimes<br />Infrequently<br />No, rarely<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  31. 31. Poll<br />How many regulatory, legal and compliance folks have seen detailed market data for their products at concept review?<br />Yes<br />Sometimes<br />Infrequently<br />No, rarely<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  32. 32. Test with the patient in mind<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  33. 33. Commercial Launch Plan<br />Merge Marketing and Regulatory Plans into one Commercialization Plan <br />Focus on Claims with Claims strategy <br />Bench testing protocols for regulatory submission<br />Clinical protocols and CRFs<br />Global sales forecasts for the sought indications<br />Promotional, educational and PR materials<br />Sales training materials<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  34. 34. Make It Personal<br />Would you want your grandmother:<br />Treated with this?<br />Reading this material and making a decision?<br />The Newspaper Test<br />Written up next day in local paper<br />Read by family, friends, neighbors<br />Written by smart but unfriendly reporter<br />If close to the lines, it is out<br />Quick Tip #1<br />http://youtu.be/A0mNKh7lYE4<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  35. 35. Balancing Needs vs. Wants<br />Ask 4 questions:<br />Is it in the best interest of the patient?<br />Does it serve the common good?<br />Does it drive healthcare costs up or down?<br />What is the risk vs. benefit?<br />Revenue<br />Timing<br />Corporate risk<br />Public perception/Court of public opinion<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  36. 36. The Habitual Mind<br />When something is a habit, the PFC signals the STN at a very low rate<br />Conserves cognitive resources<br />Make decisions more efficiently<br />When doing something different, as simple as looking at dots in a different order, your PFC signals your STN at a very high rate<br />Doing something new or making a difficult decision requires motivation. Without significant motivation, we default to our habits.<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />Stressed brains rely on habit - The Scientist - Magazine of the Life Scienceshttp://www.the-scientist.com/blog/display/55873/#ixzz0oQJehP79<br />
  37. 37. Approve with the patient in mind<br />At Design Freeze,<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  38. 38. FDA Regulatory Authority<br />At base, FDA regulates information about products, i.e. “claims”<br />Claims must be truthful, not misleading, fairly balanced and substantiated<br />The areas of general vs. specific indication/claims and dissemination of off-label information present special issues<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  39. 39. Under 21 CFR 801.4,the words “intended uses” … refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. …<br />Concept of Intended Use<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  40. 40. Off-Label Use Rules<br />If promoted off-label, a device may be deemed “misbranded” or “adulterated”<br />The uses promoted are “intended uses” under 21 CFR 801.4<br />If an intended use is for other than the approved indication, the lack of approval and inadequate labeling make device “adulterated” and “misbranded”<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  41. 41. The Inconvenient Truth about Change Management, McKinsey, May 2008.<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  42. 42. launch with the patient in mind<br />At [name of review],<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  43. 43. Primary Filters<br />Must be truthful and non-deceptive<br />Must have evidence to back up claims<br />Cannot be unfair<br />Risk Communication Guidance<br />Fair and balanced<br />Transparency<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  44. 44. Top Off-Label Complaints<br />http://goodpromotionalpractices.com/2011/04/08/top-three-off-label-marketing-strategies-and-tactics/<br />http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000431<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  45. 45. Get a Cross-Functional PRC<br />Quick Tip #2<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />http://goodpromotionalpractices.com/2011/02/04/3-best-practices-webinars-for-content-copy-review/<br />
  46. 46. PACE for PRC<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br /><ul><li>Promotional Content Dissemination by your Sales Force (Prolifiq Webinar)
  47. 47. Real-life Compliance Solutions for Dissemination of Content (AdvaMed Webinar)
  48. 48. Promotional, Scientific, and Educational Content Review Strategies (RAPS Webinar) </li></li></ul><li>Net Impression Review<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  49. 49. Concept Review for PRC<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  50. 50. Final Approval<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  51. 51. Training the sales force<br />Build compliance into sales processes<br />Validate that approved content is properly managed<br />PRC retains visibility to use of content<br />Communications History Records<br />Post Approval Considerations<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  52. 52. Follow Good Reprints Guidance<br />Quick Tip #3<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  53. 53. If it isn’t documented, it didn’t happen<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  54. 54. Write it Down<br />Creating a document will require discussion and consensus<br />Signatures build belief<br />Through product life cycle<br />e.g. Design control SOPs<br />Require signature of both parties<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  55. 55. Good Promotional Practices<br />Written & Oral Promotion = Labeling<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  56. 56. Systematic Content Creation<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  57. 57. Systematic Content Control<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  58. 58. Human Factors for Content<br />Human factors is the science and the methods used to make devices easier and safer to use. The Human Factors team advances the FDA’s patient safety mission by distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. We work with manufacturers to help ensure the application of Human Factors engineering to the design of new products. We also help device users through identification and investigation of use-related errors.<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />
  59. 59. Put Social Media in your SOPs<br />Quick Tip #4<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />http://goodpromotionalpractices.com/2011/02/03/70-of-medical-companies-need-social-media-procedures/<br />
  60. 60. Questions & Answers<br />Elsa Chi Abruzzo, RAC, FRAPS<br />President and CEO, ARAC<br />abruzzorac@gmail.com<br />Maureen Shaffer<br />Executive Editor and Publisher, GoodPromotionalPractices.com<br />VP Life Sciences, Prolifiq<br />maureen.shaffer@prolifiq.net<br />(c)2011 Good Promotional Practices (goodpromotionalpractices.com) and RAPS. <br />

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