1. Overview of Medical Affairs
1/15/2020
Overview of Medical Affairs
Raleigh Malik, PhD
Sr. Clinical Research Scientist, Global Medical Affairs, Eli Lilly

2. Disclaimer
The views expressed in this presentation are my own and do not reflect the views of my employer.

3. Key Takeaways What is Medical Affairs
1/15/2020
Key Takeaways
What is Medical Affairs
What roles are in Medical Affairs
Importance of involving Medical Affairs early
PM support for Medical Affairs

4. Medical Affairs: Connecting Data and Outcomes
1/15/2020
Medical Affairs: Connecting Data and Outcomes
Industry Perspective
Medical Affairs evolved from a healthcare industry need to facilitate effective and legally compliant communications and interactions between life science companies and healthcare professionals.
Provide market-based strategic input
Communicate unmet medical needs and clinical requirements
Provide Strategic Input into Drug Development
Leverage deep product knowledge and disease understanding
Communicate Scientific Evidence
Generate Data and Real World Evidence
Oversee Data Production
Early engagement
is key to success
What is meaning of medical affairs? P.Crowley-Nowick, Jsmith;
Focus on Life Science Compliance: The Evolution of Medical Affairs DepartmentsBy Krist Werling, Holly Carnell, and Drew McCormick. McGuireWoods LLP, Chicago, IL
PUBLICATION:
Reinventing the Role of Medical Affairs March 15, Bain Brief
Loic Plantevin, Christoph Schlegal, and Maria Gordian
In our complex healthcare universe, the ability to generate real world data and communicate scientific evidence is a strong competitive advantage.
1. What is meaning of medical affairs? P.Crowley-Nowick, Jsmith; 2. Focus on Life Science Compliance: The Evolution of Medical Affairs Departments By Krist Werling, Holly Carnell, and Drew McCormick. McGuireWoods LLP, Chicago, IL; 3. Reinventing the Role of Medical Affairs Bain Brief. Loic Plantevin, Christoph Schlegal, and Maria Gordian

5. What is Medical Affairs?
1/15/2020
What is Medical Affairs?
Brings deep medical expertise to healthcare providers and payers, and provides relevant information to patients
Focuses on answering Customer questions
Brings clinical insights from customers back to the company to inform new product development and lifecycle planning.
Supports patients with educational tools
Can be a subset of the broader Medical Organization
Brings deep medical expertise to healthcare providers and payers, and provides relevant information to patients.
Focuses on answering Customer questions with customized clinical and real-world evidence
Brings clinical insights from customers back to the company to inform new product development and lifecycle planning.
Supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations.
Can be a subset of the broader Medical Organization that is made up of customer-facing functions, with staff at the affiliate, regional and corporate levels supporting HCPs, payers and patients.

6. Roles within Medical Affairs
Medical Information
Medical Education
Product/Brand specific Medical Representatives
Medical Science Liaisons
NOTE: The structure of Medical Affairs departments varies between companies

7. Medical Affairs: Work with who to do what? Medical Scientific Lead
Studies
Phase 3b/4
IIT
Medical
Clinical Research
Physician/
Scientist
Health Outcomes
Field Medical:
MSLs/OLs
Medical Education
Scientific
Disclosure
Advocacy
&
Thought Leaders
Medical Information
Project Manager
Scientific
Lead
Operational
Lead
Provide Medical Information
FAQs
Medical Letters
Customized Responses/Escalations
Preparation for Congresses
Support Medical Education
Congress Symposium
eCME
Support T.L. Engagement
Advisory Boards, etc.
Relationship management
Support SD (Publication Plan)
Abstracts
Posters
Manuscripts
Slide sets

8. Drug Development
Commercial
Decision

9. Make patient care better through exceptional engagement
1/15/2020
Medical Affairs: General Strategy
Make patient care better through exceptional engagement

10. Development owns Submission Medical Affairs owns Launch
1/15/2020
Clinical Development + Medical Affairs Partnership
Development
Medical Affairs
Development owns Submission
Before - During - After
Medical Affairs owns Launch
Before - During - After
Submission
Launch

11. Timing of Interactions
1/15/2020
Timing of Interactions
Why include Medical Affairs early:
The winners in an era of Big Data will transform
medical affairs teams into medical value teams with
three strategic roles:
Providing market-based strategic input to drug development and portfolio management & Communicating unmet medical needs and clinical requirements 3.
Reinventing the Role of Medical Affairs March 15, Bain Brief
Loic Plantevin, Christoph Schlegal, and Maria Gordian

12. Medical Affairs Customer Needs
1/15/2020
Medical Affairs Customer Needs
Development
Medical Affairs
Educate/ Inform
Customer Needs drive:
New Data / NILEX / NCE
Customer Input
Extended Medical Team
Medical Science Liaisons
Evidence & Outcomes Liaisons
Med Information (Call center) interactions
NILEX = new indications or line extensions
NCE = new chemical entity

13. Timing of Interactions
1/15/2020
Timing of Interactions
Why include Medical Affairs early:
The winners in an era of Big Data will transform
medical affairs teams into medical value teams with
three strategic roles:
Providing market-based strategic input to drug development and portfolio management & Communicating unmet medical needs and clinical requirements
2. Communicate scientific evidence 3.
Reinventing the Role of Medical Affairs March 15, Bain Brief
Loic Plantevin, Christoph Schlegal, and Maria Gordian

14. Creation and Dissemination of Information
Clinical Development-Medical Affairs Partnership:
Who does what?
Creation and Dissemination of Information
Development
Medical Affairs
Channels
(Tailoring/Customizing)
Customer Facing Education
Medical Liaisons
Outcomes Liaisons
Medical Information
Internet
Pricing Dossiers
Analyst Reports
Press Releases
Sales Force
Data Generation
Regulators
Investigators
Peer-reviewed
Scientific Community
Affiliates
Healthcare Professionals
Pricing and Reimbursement
HCPs
Patients
Clinicians
Investor Community
Media
Etc.
Data Disclosure (Primary)
Data Dissemination (Secondary)
Data Publicly Available (Tertiary)
Deliverables
(Content Creation)
Medical Letters
Submissions
Regulatory Docs
Manuscripts
Posters
Clinical trials
Health Outcomes
Phase

15. Pricing, Reimbursement Access (PRA)
1/15/2020
Communicate Scientific Evidence
Provide support to whom for what? r
Marketing
(Commercialization)
Pricing, Reimbursement Access (PRA)
HCP & Consumer materials
Peer to Peer Product education
Institutional
Market Research
Consult on Payer Medical questions and review materials

16. “But you could say this…”
1/15/2020
Communicate Scientific Evidence
Commercial/PRA develops product materials for Payers, HCPs, patients (US)
Med Affairs involved from idea generation through creation and approval
Medical Legal Review (MLR) Process: The internal approval process for promotional product materials/tactics
Involved
Medical
Regulatory
Legal
Commercial
In place to ensure alignment with regulatory promotion requirements
“You can’t say THAT…”
“But you could say this…”

17. Timing of Interactions
1/15/2020
Timing of Interactions
Why include Medical Affairs early:
The winners in an era of Big Data will transform
medical affairs teams into medical value teams with
three strategic roles:
Providing market-based strategic input to drug development and portfolio management & Communicating unmet medical needs and clinical requirements
Communicate scientific evidence
3. Oversee the effort to produce Big Data and real-world evidence
Reinventing the Role of Medical Affairs March 15, Bain Brief
Loic Plantevin, Christoph Schlegal, and Maria Gordian

18. Health Outcomes Medical Affairs:
1/15/2020
Medical Affairs:
Strong Partnership with Health Outcomes
Health Outcomes
Study support for Health Outcomes studies
Manuscript authoring
Dossier creation
AMCP/HTA Dossier
Budget Impact Model
Escalated Customer questions from Outcomes Liaisons
External collaborations

19. Timing of Interactions
1/15/2020
Timing of Interactions
Why include Medical Affairs early:
The winners in an era of Big Data will transform medical affairs teams into medical value teams with three strategic roles:
Providing market-based strategic input to drug development and portfolio management & Communicating unmet medical needs and clinical requirements
Communicate scientific evidence
Oversee the effort to produce Big Data and real-world evidence
To do all those things effectively, medical value teams need to be an integral part of cross-functional product development and product management teams…and with all pharma functions along the value chain…
Reinventing the Role of Medical Affairs March 15, Bain Brief
Loic Plantevin, Christoph Schlegal, and Maria Gordian

20. Medical Affairs PM Support
Develop and oversee timeline for Medical Brand Plan (Product strategy)
Oversee Medical Business Planning Process (resourcing, deliverables, budget)
Support execution of yearly Brand Medical Buisness Plan
Provide cross functional project management support to ensure execution of key deliverables:
Advisory boards
Slide deck updates
MLR process
Medical education tactics
MA deliverables at key data disclosures (medical letters)
Oversee operations for Medical Affairs Phase IV clinical trials or post hoc analyses
Timeline
Budget Deliverables
Product Launch support/excellence
1/15/2020

21. Medical Affairs PM Top Responsibilities$
Budget
Estimate costs for new work (tactics)
Ensure accurate budget forecasts
Explain variances between actuals and forecasts
Change management!!
Leadership
Lead strategy development and execution of the launch and post-launch support plan
Encourage teamwork, connections, and clear communication.
Ensure clarity and remove barriers
Help team members stay calm, focused, motivated, etc.  
Yvelina
Timeline and Scope
Work with team to define operational strategy
Create and optimize timelines and monitor progress
Proactively mitigate risk
Ensure team is executing approved work

22. 1/15/2020
Questions