1. Communicating Actionable Regulatory Intelligence João Duarte Regulatory Intelligence Strategy Leader H. Lundbeck A/S

2. Summary What is actionable regulatory intelligence? Who to communicate it to? When to communicate it? How to communicate it? What to do about it? Case Studies

3. What is actionable regulatory intelligence? Now what?

4. What is actionable regulatory intelligence? “Regulatory intelligence is the act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of the information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.” RI WG, DIA RA Community External developments or internal analysis with immediate interest for the internal R&D decision making and relevant actions to be taken.

5. What is actionable regulatory intelligence? Non-Actionable RIActionable RI Stand-alone and routine intelligence; Might only need analysis and storage; Important to follow but not necessarily to act upon (yet); Impact analysis to a minimum or reduced direct impact in the R&D landscape; Within the exclusive remit of RI function to manage and analyze; Limited influence over internal organisation or operations. Intelligence that tengentially impacts R&D setting; Requires communication scheme within the organisation; Puts the external environment into context with the internal to strengthen R&D business; Developments that can shape external environment (consultations); RI as coordinating function within the organisation to assess impact or shape the framework; Need for follow-up and integration.

6. What is actionable regulatory intelligence?

7. Information of high relevance for the R&D business Action very dependent on the impact of the topic to business or source. Thorough and quick impact analysis Communication: who, when, how? Actionable RI can have very different formats Press releases, regulatory communications, legal texts, guidance, etc. Important to have a process in place To ensure that a balance between communication and analysis is met. Reduce surprises Identify trends and expect potential regulatory developments as likely. Identify further steps Provide a thorough follow-up and manage knowledge.

8. «Thank you…should I do something on this?» «I appreciate it but this does not really apply to us.» «Is there a way I can unsubscribe from this mailing list?» Who to communicate it to? «Many thanks for this. But why are you sending it to me?» «Thank you but you forgot to send this to Division A, Department B, X, Y and of course Dr. Z...» «Dear sender, I have left the company.»

9. Who to communicate it to? Target audience?

10. Who to communicate it? Target audience defines response to RI An effective targeting is crucial for follow-up, compliance or feedback. Identify gaps in the impact analysis Regulatory intelligence often requires support from other functions. Managerial cascade Challenges and benefits – how to ensure vertical dissemination? Use layers of communication Broad general communication + narrow specific impact analysis. Use IT tools to support communication Specific software, organisational labelling, establish contact persons, etc.

11. When to communicate it? 0 Time Organisational Awareness Regulatory development RI Detection RI Analysis Communication Target Audience End of Analysis Analysis/Audience Balance

12. When to communicate it? 0 Time Organisational Awareness Regulatory development RI Detection RI Analysis Excessive Audience Other Detection PANIC!

13. When to communicate it? First (or at least second but better) than others RI has a pivotal role on being the main gateway for information. Thin balance between time and analysis Internal strategy on how much time to create the desired analysis. Stakeholder management Balance timing with expectations from the organisation (avoid panic!). Create synergies with other functions Avoid duplication of communication and misalignment. Prioritize topics within the organisation Shape expectations through consistent intelligence prioritisation.

14. How to communicate it?

15. RelevantImportantUrgent Bulletins Newsletters Documents Intranet Social media E-Mail Software Physically Phone

16. How to communicate it? Ends control the means The tools we use to communicate should support the nature of the RI. Target audience controls the ends Depending on the audience, different tools can be chosen as optimal. Format of intelligence can be strategic Using specific formats can support knowledge management further on. Effective message Key messages allied with an adequate format increase effectiveness. Use of innovative methods Rise of (internal) social networks and targeted software to support this.

17. What to do about it?

18. RI Compliance Knowledge Management Knowledge Sharing Value Compliance Intelligence Link to other functions Ensure compliance Avoid unexpected cases Follow-Up Efficient Storage « Toolification » Ensure compliance Avoid unexpected cases Business impact Mitigation

19. What to do about it? Transitional strategy How to transform regular intelligence into usable tools for the future? Compliance intelligence For functions with compliance responsibilities RI can be crucial. Ensure convenient knowledge management Dissemination > Follow-Up > Storage > Identification > Indexation. Build-up expertise In specific topic areas to the benefit of drug development or operational tasks in the organisation. Build-up best practices and avoid surprises Ensure that processes are optimized as experiences continue. Knowledge sharing: Holy Grail Ultimately contribute to enhance knowledge sharing capabilities within R&D.

20. Case Study #1 – EMA CHMP Highlights Communicable? YES (CHMP developments) Who? Regulatory, PhV, CI No unexpected info; General guideline information; Standard organisational matters. When? When possible (relevant) How? E-Mail, Newsletter What? Store in Newsletter

21. Case Study #2 – Competitive Intelligence Communicable? YES (Packages submitted, regulatory expectations) Who? CI, Regulatory, Clinical, Project Teams Important regulatory precedence information; Relevant for projects under development; Align with expected information previously gathered. When? As possible (important) How? Phone call, E-Mail, Newsletter What? Incorporate in tools, Newsletter

22. Case Study #3 – EMA CT Requirements Communicable? YES (interpretation of the law, implications, timelines) Who? Regulatory, Clinical, Publications, R&D Mgt. Relevant for compliance with regulatory requirements; Involved cross-functional interaction; Assessment of readiness of the organisation; Policy implications (new CT regulation); RI pivotal to inform and cascade the information. When? ASAP (Urgent) How? Meeting, e-Mail (general and specific), Newsletter What? Store in Newsletter

23. Many thanks! Feel free to contact me on DADS@lundbeck.com