1. The Evolving Role Of Medical Affairs (MA)
INMAS 2018
Mumbai, 10 March 2018
The Evolving Role Of Medical Affairs (MA)
Dr. Aamir Shaikh
Founder, Assansa

2. Session Outline Drivers Of MA Evolution. The Evolving:
Pharmaceutical Industry Environment
Expectation From Stakeholders
Pharmaceutical Industry Focus
Medical And Technology Frontiers
Evolving The Role Of Medical Affairs!
A Personal Wish!

3. The Evolving Pharmaceutical Industry Environment
The Evolving Pharmaceutical Industry Environment... Not Just Different - Complex and Unique!
“Perhaps no other business engages the worlds of science, business, economics, health, human rights, governments, and social welfare as much as the pharmaceutical industry.” (Michael Santoro – In: Ethics and the Pharmaceutical Industry, 2007)
Health Care / Pharmaceutical Industry
Sectors, Products and Services
Payers, Providers, Professionals
Government
and Regulators
Patients and Consumers
Academia, Institutes

4. The Evolving Expectation From Stakeholders
The Evolving Expectation From Stakeholders... Shouldering Greater Human Rights And Social Responsibility

5. The Evolving Pharmaceutical Industry Focus
The Evolving Pharmaceutical Industry Focus... Inward To Outward Looking - Customer and Patient Centric
Once, The 4 Ps
Product
Price
Place
Promotion
Evolving 4 Ps..
Product
Patient
Physician
Payer
..Today, The 4 As
Awareness
Acceptability
Affordability
Accessibility

6. The Evolving Medical And Technology Frontiers The Intersection - A Rapid, Disruptive, Convergence
Medical Advances - Personalized, Predictive, Patient- centric, Outcomes-oriented, Value-driven
Clinical Research vs Clinical Practice - Blurring Boundaries
Regulatory Sciences - Advancing, Playing Catch Up
Big Data - Data Sciences Aiding Clinical Sciences
Technology - Digital, Virtual, Internet Of Value
Artificial Intelligence - It’s Genuine
Others...

7. Asia Region Medical & Regulatory Affairs
ASCENT: Product Physician Training Program - Step with Confidence into the Industry
Let’s do an exercise….. and talk
The Evolving Role Of Medical Affairs
Evolving The Role Of Medical Affairs
Evolving The Role Of Medical Affairs…..
Reaffirming Our Role (And Pledge) As Pharmaceutical Physicians / Medical Affairs Professionals
Cultivating MA Capabilities
The MA Competencies
The MA Mindset
Crafting “A Best In Class” MA Team
Developing A MA Community / MA Leadership
11 September 2007

8. Reaffirming Our Role (And Pledge) As Pharmaceutical Physicians / Medical Affairs Professionals
Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of the marketing of medicines for the benefit of patients and the health of the community. (Specialty training curriculum For
Pharmaceutical medicine August 2010 Joint Royal Colleges of Physicians)
The responsibility of the pharmaceutical physician within this process is to guard the interests of patients by working to standards which ensure that research studies are conducted according to Good Clinical Practice (GCP), that safety data are collected, acted upon and reported to the highest international standards and that all communication with medical professionals and patients is accurate and ethical. (Good Pharmaceutical Medical Practice – Jan 2003)

9. Cultivating The Medical Affairs Competencies
2) Clinical Trial Evaluation, Design, Execution, Publication
3) Regulatory And Life Cycle Management
4) Post Marketing Commitments And Benefit / Risk Management
5) Aligning Science, Commerce and Business Ethics
6) Pharmaceutical Business Operations, HCP/KOL Interactions
7) People Skills , Management, Leadership, TL/KOL Engagement
MA Competency Theme
1) TA Knowledge / New Product Evaluation / Development
Statement Of MA Competence
Customized For Evolving Medical Affairs
Customized For Country / TA / MA Function

10. Cultivating The Medical Affairs Mindset
This MA Mindset Is Characterized / Demonstrated By:
Accountability: To Self, And Multiple Stakeholders (Patients First)
Balance: Coupled With Sound Judgment And Decision Making
Clarity: Purpose, Thought, Speech, And Action
Developmental Focus: Towards Business, Self, And Others
Ethical Approach: In Thought And Behavior, Integrity In Action

11. Pharmaceutical Physician Ethics One Important Guiding Principle

12. Crafting “A Best In Class” MA Team What Does This Really Require / Look Like?
Be “Sought And Selected” From The Best Available MA Talent Pool
Undergo Rigorous Education And Training To Build “Sound “MA Capabilities” - “Competencies, Mindset, Governance, Culture, And MA Teams” - Visible Success
Build And Manage “Internal Interfaces” With Marketing, Sales Teams, And Others – Strive For A “Sound Medical-Marketing Partnership” - Deliver Well For The Organization
Create, Nurture, And Leverage “External Customer Relationships”, Built On Ethical And Scientific /Medical Platforms - Deliver Well For The External Stakeholders
Be “Recognized, Respected And Trusted ” By Patients, Health Care Professionals / Medical Community / Other Stakeholders
Derive “Professional Development, Personal Enrichment And Growth” Through Career
At All Levels, “Lead And Be Led” By Sound Medical Affairs Managers And Leaders – Sound Leaders Demonstrating Wholesome Leadership

13. A Personal Wish “Indian Medical Affairs Society”
Developing A Medical Affairs Community / Leadership "Of, For, And By The Next Generation Of MA Professionals"
A Personal Wish “Indian Medical Affairs Society”
The Time Is Right….

14. Thank You!
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