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

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!

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

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

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

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...

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

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)

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

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

Pharmaceutical Physician Ethics One Important Guiding Principle

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

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….

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