1. Compliant Connections in an Increasingly Connected Population Connecting platforms into one campaign

2. Past Multichannel marketing Journal ads Fax Direct Mailers Paper detail aids Internet

3. Past

4. Present

5. Paper Detail Aids

6. Mailers

7. Audio Visual

8. Journal Ads

9. Audio-Visual

10. Trends A visible shift in media channels New ways to reach your audiences Increased opportunity to engage with costumers So what are some key considerations when creating multichannel marketing campaigns to engage patients, HCP and consumers in a digital environment?

11. Building an Omnichannel Campaign

12. Branded HCP App Branded patient website HCP direct branded mailer Social Media campaign Wellness/adherence reward program Corporate website Omnichannel Campaign Branded Patient App

13. Content (s.6.4.3) Access Control (s.6.5.6) Linkage (s.6.5.4)

14. Branded HCP App Branded patient website HCP direct branded mailer Social Media campaign Wellness/adherence reward program Corporate website Linkage Branded Patient App

15. Branded App – Patient support program Branded patient website Branded patient app to a patient branded website and vise versa – This is deemed acceptable and does not change the regulatory status of either platform

16. Branded App – Patient support program Branded patient website Branded HCP app to a patient branded website – This is deemed acceptable and does not change the regulatory status of either platform Branded patient website to a HCP app – This is not acceptable – different regulatory audiences.

17. Patient branded website to corporate website – Link from branded pre-gate landing page – Not acceptable – Link from any page post-gate – can link to the homepage Branded patient website Corporate website

18. Branded HCP App or HCP website Corporate website HCP branded app/website to corporate website – Link from branded pre-gate landing page – Not acceptable – Link from any page post-gate – can link to the homepage Corporate website to branded HCP app/website – Must link to the landing page – haven’t verified regulatory audience yet

19. Branded HCP App Branded patient website HCP direct branded mailer Wellness/adherence reward program Linkage

20. Branded App Branded patient website Wellness/adherence reward program Linkage HCP Mailer to promote: Branded HCP app Both pieces are considered branded and must be within the limitations of the TMA. Same regulatory audience Therefore can be linked HCP direct branded mailer

21. Branded App Branded patient website Wellness/adherence reward program HCP Mailer to promote: Branded patient website Different regulatory audiences: - HCP delivers service to patient therefore can have access to patient site - Patient cannot have access to promotional material – should not be granted access to HCP mailer *Note the patient website is subject to review as it is being promoted to the patient through the HCP HCP direct branded mailer

22. Branded App Branded patient website Wellness/adherence reward program HCP mailer to promote: Unbranded wellness/adherence program Branded HCP mailer – will require review of the program in the context of the brand Ensure it does not go beyond the limitations of the TMA (i.e. discussion of complications of the disease) Unbranded HCP mailer – (i.e. promote use of program to any patient with condition X regardless of sponsors therapy – acceptable linkage) HCP direct branded mailer

23. Branded HCP App Wellness/adherence reward program Branded patient or HCP app linking to an unbranded wellness/adherence reward program – Unbranded now has to be reviewed in the context of the brand – Copy which may have been acceptable in the unbranded context may now be challenged Branded Patient App

24. Wellness/adherence reward program Example: Patients adherence to their medication is important to ensure they get the full effect Adherence to your medication is important for controlling your hypertension and reducing your risk of long-term complications such as MI or stroke Branded HCP App Branded Patient App

25. Branded HCP App Social Media campaign Branded Patient App Branded HCP app or patient app linking to social media campaign

26. Social Media (s.6.5.9) Websites and applications that enable the user to create or share content or to participate in social networking It allows for user generated content (UGC) or dynamic content Content within areas that are under the sponsors control are subject to all the current rules and regulations for drug advertising and other activities

27. The sponsor of a site with UGC functionality looses some control over the message BUT retains much of the regulatory risk. Therefore… Social Media (s.6.5.9)

28. Start by asking yourself some questions to align the site with your risk tolerance How much control am I giving to the audience? Will I have site rules? What will they be? How will I communicate them? To what extent will the site be moderated? To what extent will I be monitoring? What will I be looking for? Social Media (s.6.5.9)

29. User Generated Content Can render a compliant page non-compliant Terms and Conditions Clear and accessible e.g. clear statement about what type of comments will be removed or modified May minimize frequency of misuse Monitoring the Conversation i.e. semantic, automatic filtering mechanism (brand key words, side effects etc.) Social Media (s.6.5.9)

30. Correcting misinformation: e.g. misinformation about company or disease Corrections must be made promptly. PAAB preclearance not required if limited precisely to the minimum needed to correct misinformation. Off-label discussions: Remove outright!! Adverse event monitoring: Not enough to only provide a statement referring reporters to the pharmacovigilance / medical department. Monitoring the Conversations :

31. Branded HCP App Social Media campaign Dynamic content on the social media platform therefore, ask yourself: – How is that content likely to change? – Does that change affect the regulatory status of my app? – What should I be aware of? Monitoring and moderating Branded Patient App

32. Social Media campaign Branded patient app linking to social media campaign – Branded (previously reviewed and approved by PAAB) - OK – Unbranded disease support group/chat room/blogger Sponsors responsibility to ensure that the content meets branded patient regulations – Violation could affect the acceptability of one or both channels Sponsor Branded SM Campaign Unbranded SM campaign 3 rd party controlled SM campaign

33. Branded HCP App Social Media campaign Branded HCP app linking to social media campaign Branded (previously reviewed and approved by PAAB) – HCP disease specific chatroom Sponsor is responsible for ensuring the content remains on label and meets advertising standards – Unbranded disease support group/chat room/blogger Sponsors responsibility to ensure that the content meets branded patient regulations – Violation could affect the acceptability of one or both channels Sponsor Branded SM Campaign Unbranded SM campaign 3 rd party controlled SM campaign

34. App Store: REVIEWS 1. This app provided me with all the info I needed to confidently prescribe my diabetes patient Jensulin 2. This app was no good. Froze all the time. Hard to find information I was looking for. Print outs would not load. 3. Jensulin saved my diabetes patients life. This app gave me so much information. Was easy to follow. Would recommend this app and Jensulin to anyone. 4. Hypoglycemia symptoms chart was not complete or user friendly. Options: Monitor Deactivate ‘Reviews’ section PAABPharma Identifies therapeutic area Absolute claims, identifies therapeutic area Identifies therapeutic area Ok

35. App Store: RELATED APPS Endeavour - Patient Support Lifestyle FREE Eating Well with Diabetes Food & Drink FREE Insulin Device Center Education Living with Diabetes Lifestyle Healthy Eating Food & Drink Talking Tom Cat Entertainment Childhood Diabetes Education Options: Monitor Remove/Deactivate this function PAABPharma

36. Branded HCP App Branded patient website HCP direct branded mailer Social Media campaign Wellness/adherence reward program Corporate website Omnichannel Campaign Branded Patient App

37. Now you should be ready to start your compliant connections. Questions?