Capabilities and Competencies in the New Medical Affairs: A Roadmap To Success. Charlotte Kremer Charlotte Raabe - Hielscher Mary Alice Dwyer

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1 Capabilities and Competencies in the New Medical Affairs: A Roadmap To Success Charlotte Kremer Charlotte Raabe - Hielscher Mary Alice Dwyer 1

2 External Trends in Healthcare: Are We Ready? 1. Increasing importance of new decision makers; requiring wider definition of Product Value 2. New types of Medical and scientific information (Real World) accessible to all 3. New tools of engaging with HCPs, payers and patients 4. Greater public scrutiny on interactions between pharma and medical stakeholders with increasing compliance and transparency expectations globally 2

3 Internal Trends: Are We Ready? Earlier involvement in the life cycle to be ready at launch P1/P2a P2b P3 Submission Post Approval Medical Strategies Timing of MA Involvement Gathering of external HCP and HTA insights Scientific Exchange and Medical Information Data Generation Publications Launch 3

4 Internal Trends: Are We Ready? Integrated strategic approach Gather market input systematically Create global-level Medical Strategies Input Country and Customer Input Share Medical Plans In alignment with Clinical Development and the Commercial function 4

5 Critical Success Factors: Are We Ready? Know what Value means and deliver this Value Know the key customers and tailor to their information needs Be the proactive strategic leader internally Have the right capabilities and be a life long learner 5

6 MAPS Survey Identifies Gaps and Opportunities 26% have no experience developing a phase 3b/4 clinical trial plan 29% say they have no experience with developing a RWE data plan Survey Date: January 12, 2018 n = 73 6

7 MAPS Survey Identifies Needs for Education Biggest needs are: TA/product Medical Affairs Planning Improving cross-functional collaboration while maintaining compliance Survey Date: January 12, 2018 n = 73 7

8 and for Competency Development 96% agree developing competency in using data to convey real word evidence is valuable 89% indicate demonstrating value to patients, providers, payers and caregivers is valuable Survey Date: January 12, 2018 n = 73 8

9 Competencies for Medical Affairs The evolution to strategic partner and the impact on Talent Development and Acquisition 9

10 From Support to Strategy Yesterday - Support Function Was created when medications became more complex and the amount of required data increased HCPs asked for more scientific expertise than provided by the Sales Reps MA embedded in the local organization and often part of Commercial, acting as support. Reviewed and ensured compliance for promotional material Value and effectiveness measured in on the impact on revenue and sales. Today - Strategic Partner Independent Function with global outreach and standards Provides strategic support throughout product lifecycle Matrix Management - partnering with multiple internal functions Provides medical/scientific guidance to external stakeholder incl. health system executives, payers, advocacy groups policy makers and HCPs Evolvement of new roles Gathers and communicates evolving medical customer insights to internal stakeholder 10

11 ..acting as the bridge Medical Affairs R&D Commercial With the evolution of Medical Affairs from a local support function, often embedded in the commercial organization, to a full-fledged STRATEGIC PARTNER, acting as the bridge between R&D and Commercial and higher external requirements AS A RESULT - A NEW PROFILE OF TALENTS WITH BROADER SKILLS ARE REQUIRED 11

12 The Critical Medical Affairs Competencies Support Strategy Article Managing Talents in the MA Function, 2013 McKinsey & Comp. and Korn/Ferry International 12

13 The broad experience approach.. Pursuing a senior leadership career implicates having leadership responsibilities Without crossdivisional/functional development there is a lack of important experiences This weakens the foundation for the future career development and leadership capabilities The career ladder has a weaker base VS Prior to pursuing a senior leadership career the employee should seek to transfer between divisions and functions. A transfer provides the employee with a broader set of experiences and knowledge This gives the employee the exposure to gain important capabilities and serves as stronger foundation for their future leadership career The career ladder has a broader base 13

14 Capabilities and Competencies in the New Medical Affairs Implementation of new programs Mary Alice Dwyer, PharmD 14

15 Approach to a Medical Affairs Learning and Development Initiative Identification and prioritization of critical gaps Venue Audience How to ensure sustained learning? 15

16 Identification and Prioritization of Critical Gaps What are the potential capability areas? Business acumen Communication with impact Cross-functional collaboration Stakeholder management Strategic planning and execution Decision making 16

17 Venue What are the options? Hands-on classroom format Classroom format enabling real and virtual participation Live web-based courses Independent modular training Cost considerations Travel vs virtual participation Leveraging other courses across the business Leveraging external support and experts 17

18 Audience Is it role specific? All Medical Affairs, or a subset (role dependent curriculum)? Are the needs different? Is it a global audience or a specific local audience? Is there a variation of capabilities? Emerging markets vs established medical teams Could there be language barriers? 18

19 How to ensure sustained learning Leadership and manager buy-in and support is critical Encourage Sr. Leaders to participate as speakers and mentors Include projects to make it real and embed the learning in daily work Make it engaging with interactive breakout sessions Consider buddy and on-the-job mentoring systems 19

20 Questions for part 1 1. What are in your opinion the top 3 trends that drive the demand for new capabilities for Medical Affairs? 2. What are in your opinion the top 3 Critical Success factors to demonstrate Medical Affairs value internally and externally? 20

21 Questions for part 2 3. Is there any specific competence missing? 4. What are the top 3 gaps in competencies that you would benefit from developing? 5. How would an ideal development path within MA look like? 21

22 Questions for part 3 6. Are there best practices in design and implementation of Capability programs that the speakers did not mention? 7. In your opinion, what is the most important Medical Affairs role that capability programs should focus on? 22