Presented at the 6th Annual Pharmacovigilance Conference 2011 (London March 17th)

1. Social Media Considerations in Pharmacovigilance Sandeep Bhat, MSE

2. Disclaimer The following slides represent my thoughts, opinions, personal musings, attempts at using abstractions and creativity. They are are in no way representative of my employer MphasiS Ltd., or the company that represents its majority ownership (Hewlett-Packard Corp.)

4. Types

5. Disparities/Commonalities

6. How “we” think

7. Technology, Media

8. Influencers, Getting “Buy In”

9. Things to consider (things to think about)

12. Wiki

13. Twitter

15. www.doseofdigital.com

16. Wikipedia

17. www.wikipedia.org

18. Twitter

19. www.twitter.com

20. Platform Environments

22. CommonalitiesCharacteristics Social Media Hot topic: A “Trend” Highly Visible in public Everyone has an understanding of the benefit Everyone has an understanding of the harm Rapid – almost real time! Global Phenomena Source is always from the field Pharmacovigilance Sensitive topic Can be Highly visible to public Everyone can easily understand the benefit Everyone can easily understand the historical precept of risk/harm Intention to be rapid Going to be global Source is from the field

23. How Technology Professionalslook at it

24. Data Deluge Semantic Enablement SAP Legacy REFDB GSM NCBI Manual Curation

25. Data DelugeMining Algorithms

26. Data DelugeMetadata Management

27. How Media Professionals look at it

28. Social Media – Areas of Influence

29. Social Media –Influence Channels

31. Business Direction

32. Executive Visibility

35. Technologically

36. GovernanceControllers: Leaders: Information Management Quality and Compliance Legal Corporate Communications High Profiled Individuals

37. People, Process, Tools How Why Who What

38. Things to Think About

39. Earlier this year… (News about this) Should pharma harness social media for R&D? January 24, 2011 — 11:09am ET | By Tracy Staton http://www.fiercepharma.com/story/should-pharma-harness-social-media-rd/2011-01-24#ixzz1GqT7HyK1 When pharma folks talk about social networking, it's usually in a marketing or public relations context. Using Twitter to generate traffic to a disease-awareness website or to report news about a new drug; launching iPad apps to help patients manage their diabetes; monitoring blog comments for accuracy and responding with the facts. But a Boston Globe op-ed suggests that social media could be a new frontier for drug development. If pharma companies could gather real-world data from prescribers, they might find new uses for existing drugs. As the authors point out, Viagra resulted from side-effect reports in a cardiovascular trial, and some psychotropic meds trace back to a tuberculosis study. Through physician postings online, drugmakers might identify other unintended benefits of their meds.

40. Earlier this year… (News about this… cont’d) So why doesn't Big Pharma set something up? It could be a thorny FDA problem, given the ban on off-label promotion. But a greater fear might be its unintended consequences. Set up a networking site to find unanticipated benefits, and you might come up with unexpected safety problems instead. Very public safety problems, given that the reports would be online and out in the open. And such unverified safety problems could spook patients . Such is the double-edged sword of social media--it's a means of spreading both good and bad news. And like everything else online, it can't be tightly controlled. FiercePharma article posted on Jan 24, 2011 http://www.fiercepharma.com/story/should-pharma-harness-social-media-rd/2011-01-24#ixzz1GqT7HyK1

41. Lots of Information? Deluge of new information Uncontrolled context Unknown source

42. What you already do Active Surveillance Systems Expected, planned, monitored Spontaneous (unsolicited) event Unscheduled, Unknown

43. Truth? The question of accuracy? The question of truth? Source Data Verification Qualified and Educated Source

44. Temporally, when do you record A blog can list multiple parts of the same event Start, in the middle, at the end? How to you code a “Conversation”?

45. Feedback to the public Can Social Media be reasoning we can use to promote “good” communication (and eventual reporting) of safety concerns – back to the public audience? We seek to obtain at the onset 4 relevant fields Via the right outlets/channels, message are: VERY IMPACTFUL VERY RAPID

46. Last Week (News about this) Looking for Guidance, Pharma Left Waiting Industry Would Prefer Some Sort of Rulemaking for Social Media, but FDA Delays March 07, 2011 – By: Rich Thomaselli http://adage.com/article/news/drug-makers-wait-fda-ruling-social-media-dtc-ads/149214/ The biggest regulatory issue involving the pharmaceutical and health-care industries is actually a lack thereof. The Food and Drug Administration has continually delayed the announcement of new advertising guidelines for online and social-media marketing -- despite holding public hearings on the topic more than 15 months ago -- leaving drug makers and health-care agencies alike in no-man's land with a lack of clearly defined principles for internet advertising.

47. Last Week (News about this … cont’d) Now, after anticipating changes that were hoped to be as broad as the landmark 1997 FDA guidelines regarding direct-to-consumer broadcast advertising of prescription drugs, the industry is preparing for little movement from the status quo when it comes to social media. Twice in February 2011, Tom Abrams, the head of FDA's Division of Drug Marketing, Advertising and Communications, suggested that little will change. On Feb. 8, speaking at the ePharma Summit in New York, Mr. Abrams conceded that the process is "taking longer than we thought," but added, "We owe it to you to get this right," according to Medical Marketing & Media. But part of the delay, he said, was concern on the part of FDA that social-media platforms such as Twitter and Facebook would not be around in the future. "We did not want the guidances to become quickly outdated," Mr. Abrams said.

48. Last Week (News about this … cont’d 2) On Feb. 22, speaking at the Drug Information Association's annual marketing meeting in Washington, D.C., Mr. Abrams said, "There will be guidance on some specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy.“ "We took it as Tom Abrams saying there's going to be some social-media guidance but it's not going to change the rules," John Kamp, director of the Coalition for Healthcare Communication, told Advertising Age. "This is going to be a pretty serious disappointment to pharma companies hoping there would be some kind of change in DDMAC's attitude." "The problem," said one health-care ad-agency president, who asked not to be identified, "is that the digital space is so vastly different from traditional 30-second spot advertising that the [current] guidelines don't apply online. There needs to be significant change, and it doesn't appear there's going to be."

49. A reason for better communication? Can Social Media be used to promote good communication (and eventual reporting) of patient safety – back to the public audience? Professionals obtaining the relevant 4 fields Via the right outlets/channels, message are: VERY IMPACTFUL VERY RAPID

50. Impact Social Media already has impacted the community of medical practitioners www.sermo.com Social Media has impacted the community of patients: www.patientslikeme.com Social Media has impacted the community of medical education Social Media has impacted the community of medical care facilities Mayo Clinic

51. Scope This is a massive movement Potential immediate impact Large scale pandemic/epidemic/outbreak Vaccine “gone wrong” Use all your employees to be stewards

52. “Sample” Social Media Guideline Roche Social Media Principles (in short): 7 Rules for PROFESSIONAL online activities Speaking “on behalf of” Roche Follow the Roche Group Code of Conduct and Communications Policy. Follow approval processes for publications and communication. Mind Copyrights and give credit to the owners. Use special care if talking about Roche products or financial data. Identify yourself as a representative of Roche. Monitor your relevant social media channels. Know and follow our Record Management Practices. 7 Rules for PERSONAL online activities Speaking “about” Roche Be conscious about mixing your personal and business lives. You are responsible for your actions. Follow the Roche Group Code of Conduct. Mind the global audience. Be careful if talking about Roche. Only share publicly available information. Be transparent about your affiliation with Roche and that opinions raised are your own. Be a “scout” for sentiment and critical issues.

53. “Sample” Social Media Guideline

54. “Sample” Social Media Guideline

55. Academic Article Linguistics and Text Mining

56. Academic Article Linguistics and Text Mining

57. IOMPresentation

59. Types

60. Disparities/Commonalities

61. How “we” think

62. Technology, Media

63. Influencers, Getting “Buy In”

64. Things to consider (things to think about)