1. June 29, 2018, Scitech Center, Mumbai

2. Medical Affairs Professionals - Welcome!
We Are All Here Today By Choice, To Accomplish….,
So Let’s Make The Most Of It !
Focus - on the moment, and future impact
Connect - with your colleagues
Engage - question, clarify, contribute, reflect and share your own thoughts and experiences
Respect - time, diverse thoughts and opinions
Enjoy - interaction, creating process, learning,
Feel Free To…..

3. Our Knowledge Enhancement And Learning Objectives Today (1/2)
At the end of this workshop, participants should be able / better able to:
Understand, discuss and describe the role, and key responsibilities thereof, of “A Sound Medical Affairs Professional”
Identify and describe the relevance of cultivating core “Medical Affairs Competencies” and “Medical Affairs Mindset”
Read and critique a “Statement of Core Competence” - Create (adopt / adapt / revise) and use a locally relevant “Statement of Competence”
State and explain the salient requirements (A,B, C, D, E) of this “Medical Affairs Mindset”

4. Our Knowledge Enhancement And Learning Objectives Today (2/2)
At the end of this workshop, participants should be able / better able to:
Understand and describe the need for “Real World Data/Evidence”, and an approach to creating Medical Development Plans that include locally relevant Clinical projects meeting unmet needs
Address regulatory requirements and scientific issues towards the successful design and conduct of a clinical study/project to collect real world evidence
Effectively “communicate and market” the research and “Real World Data/Evidence” to relevant stakeholders
Utilize and apply the workshop learning in current/future role and function

5. Our Workshop Agenda Today

6. Our Workshop Experts And Faculty Today….
Our Honour, Pleasure, And Privilege!

7. I Chose To Be/Become A Medical Affairs Professional Because…
A Few Moments Of Self-Reflection, To Begin With…
Group Exercise(s)
Discussion, Critique, Reflection, Learning
“Self-reflection is the school of wisdom”
Baltasar Gracian, , Spanish philosopher
I Chose To Be/Become A Medical Affairs Professional Because…

8. Discussion, Critique, Reflection, Learning
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Exploring Our Workshop Theme
And Relevance
Crafting …… Sound …… MEDICAL AFFAIRS Professionals…… CULTIVATING…… competencies…… MINDSET…… REAL WORLD EVIDENCE……

9. Discussion, Critique, Reflection, Learning
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Our Workshop Theme And Relevance
Your Thoughts?
“Group Poster”
Crafting …… Sound …… MEDICAL AFFAIRS Professionals…… CULTIVATING…… competencies…… MINDSET…… REAL WORLD EVIDENCE……

10. Crafting Sound Medical Affairs Professionals
Asia Region Medical & Regulatory Affairs
ASCENT: Product Physician Training Program - Step with Confidence into the Industry
Crafting Sound Medical Affairs Professionals
Crafting (Verb)
Art vs Science vs Craft?
Make, Shape, Mould with Skill, Care and Passion
What is Sound?
Effective, Reliable, Thorough, Healthy, Wholesome
Sound (Adjective)
What/Who are MAPs ?
Medical/Scientific Professionals in Health Care / Pharmaceutical Industry
Professionally Competent - Knowledge, Skills, Attitude
Medical Affairs Professionals
11 September 2007

11. Cultivating The Key MA Competencies And Mindset
The Medical Work of Pharmaceutical Physicians The Interface With Key Clinicians
“The pharmaceutical industry uses external clinical experts extensively in deciding research policy, evaluating problems and arriving at solutions. However, experience shows that unless the pharmaceutical physicians who interact with these external experts are of similar calibre, both intellectually and clinically, the relationship does not function well. This is as much medical work as a case conference in a hospital.”
Cultivating The Key MA Competencies And Mindset

12. Cultivating…..
Cultivating…To consciously put in effort to develop, improve, nurture, or grow something
(Patience, Care, Time)

13. What Is A (Core) Competency?
A competency is a measurable human capability (building block) that is required for effective (professional) performance.
A competency may be comprised of knowledge, and/or skill(s), and/or attitude/behaviour, or a cluster of two or more of these attributes.
Knowledge – What do I know?
Skill – What can I do?
Attitude – How will I do it?
“A Competency Needs To Be Cultivated…..”
Attitude

14. What Is A Mindset?
A Mindset is a collection of beliefs and thoughts that make up the mental attitude, inclination, habit or disposition that predetermines a person's interpretations and responses to events, circumstances and situations.”
“A Mindset Also Needs To Be Cultivated…..”

15. Real World Evidence (RWE) Some Essential Terminology And Definitions
Real World Research (RWR) refers to research investigating and evaluating health care issues of relevance to patients and public in “real life clinical settings”
Real World Data (RWD), in general, are observations of effects based on what happens after a clinical practice decision (treatment) is made where the clinician- researcher has minimal or no control over who gets what treatment, and has minimal or no control on the medical management of the patient beyond observing outcomes.
Real World Evidence (RWE), in general, is the organization of RWD to be informative, and infers a degree of actionability. RWE facilitates our health care related decision making and choices.
Outcomes Research (OR) is an interdisciplinary science, investigating and evaluating the impact of prevention and/or treatment on patients’ clinical, economic and humanistic outcomes in “real life clinical settings”
OR quantifies the value of health care practices and interventions
OR focuses on end results (outcomes) that people experience and care about

16. Real World Evidence (RWE) In Summary, And In Essence
Real World Evidence (RWE) is aggregation and analysis of real world data (RWD), collected outside the constraints of conventional RCTs. RWE is used to assess product’s safety, efficacy to effectiveness translation, cost effectiveness and differentiation.1, 2
1. Alison Cave, What are the real-world evidence tools and how can they support decision making(Internet) [Accessed 9/01/2018] 2. U.S. Department of Health and Human ServicesFood and Drug Administration, 2017.Use of Real-World Evidence toSupport Regulatory Decision-Makingfor Medical Devices  [Accessed 9/01/2018]

17. Medical Affairs (MA) 1 Cultivating Core MA Competencies
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Medical Affairs (MA) 1 Cultivating Core MA Competencies
What Are The Core Medical Affairs Competencies?
How Can They Be Cultivated?

18. Discussion, Critique, Reflection, Learning
Group Exercise(s)
Discussion, Critique, Reflection, Learning
What Are The Core Medical Affairs Competencies?
How Can They Be Cultivated?
Statement of competence in pharmaceutical medicine. IFAPP/PharmaTrain2012.
Frontiers in Pharmacology Pharmaceutical Medicine and Outcomes Research August 2013 Volume4 Article105

19. The Medical Work of Pharmaceutical Physicians The Interface with Key Clinicians
“The pharmaceutical industry uses external clinical experts extensively in deciding research policy, evaluating problems and arriving at solutions. However, experience shows that unless the pharmaceutical physicians who interact with these external experts are of similar calibre, both intellectually and clinically, the relationship does not function well. This is as much medical work as a case conference in a hospital.”

20. MA Competency Themes / Statement Of Competence
Group Exercise(s)
Discussion, Critique, Reflection, Learning
MA Competency Themes / Statement Of Competence
Perception (Personal) Scores
Competency Themes
Operational Expertise
Reading, Reflection, Discussion, Critique
My Own Score
(1-10)
1) TA Knowledge / New Product Evaluation / Development 1
2) Clinical Research/Trial Design, Execution, Publication 2
3) Regulatory and Life Cycle Management 3
4) Post Marketing Commitments and Benefit / Risk Management 4
5) Aligning Science, Commerce and Business Ethics 5
6) Pharmaceutical Business Operations 6 7
7) People Skills ,
Management, Leadership, HCP/TL/KOL Engagement
Personal Score
Statement of competence in pharmaceutical medicine. IFAPP/PharmaTrain2012.
Frontiers in Pharmacology Pharmaceutical Medicine and Outcomes Research August 2013 Volume4 Article105

21. CULTIVATING Reading, Reflection, Discussion, Critique
MA Competency Themes / Statement Of Competence “Cultivating" Core Medical Affairs Competencies
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Competency Themes
Operational Expertise
Reading, Reflection, Discussion, Critique
My Own Score
(1-10)
1) TA Knowledge / New Product Evaluation / Development
CULTIVATING 1
2) Clinical Research/Trial Design, Execution, Publication
Deliverable 1 / Home Assignment
Personal (Individual) Scores For Reflection And Personal Development 2
3) Regulatory and Life Cycle Management 3
Deliverable 2 / Home Assignment
Statement Of MA Competence
Customized For Evolving Medical Affairs
Customized For Country / TA / MA Function
4) Post Marketing Commitments and Benefit / Risk Management 4
5) Aligning Science, Commerce and Business Ethics 5
6) Pharmaceutical Business Operations 6
Deliverable 3 / Home Assignment
“MY” Personal Development
Plan (PDP) – Implementation And Learning 7
7) People Skills ,
Management, Leadership, HCP/TL/KOL Engagement
Personal Score e
Statement of competence in pharmaceutical medicine. IFAPP/PharmaTrain2012.
Frontiers in Pharmacology Pharmaceutical Medicine and Outcomes Research August 2013 Volume4 Article105

22. “Cultivating" Core Medical Affairs Competencies MY PDP, MY Learning
6/27/2019
Group Exercise(s)
Discussion, Critique, Reflection, Learning
“Cultivating" Core Medical Affairs Competencies MY PDP, MY Learning
“CULTIVATING”
My PDP
My Learning 22

23. TA Knowledge / New Product Evaluation / Development
MA Competency Theme TA Knowledge / New Product Evaluation / Development
TA Knowledge / New Product Evaluation / Development
Sound knowledge - ability to build / possess knowledge that is quickly retrievable, useful, and situation-specific
Product / Brand - Label; Key Attributes and Messages; Programs and Tools
Disease - Human Systems; Epidemiology; Etiology; Clinical Features; Diagnosis; Management; Advances
Therapy Area - Landscape; Guidelines; Insights
Governance and Compliance - SOPs, Guidelines, Regulation, Policy
Industry Knowledge - Pharmaceutical; Health Care; Other Allied

24. MA Competency Theme 1 TA Knowledge / New Product Evaluation / Development
In India, Unmet Need / New Product Is More Than Just Innovator New Drugs. Innovation Opportunities With Generics…
Unmet Medical Needs
“New Drugs”
New Indications
New Formulations
New Doses, Regimens
New Fixed Dose Combinations
Generic Medicine Sales Market Share, 2016 (%)
Light Blue = Emerging APAC Markets,
Source: BMI Sep 2017

25. MA Competency Theme 2
Clinical Research / Trial Evaluation, Design, Execution, Publication
Research Question / Primary Objective ?
Prevalence – Descriptive, Cross -sectional
Incidence - Cohort
Cause - (in order of reliability) Cohort, case -control, cross sectional
Prognosis - Cohort
Treatment effect
(Efficacy) – RCT, interventional
(Effectiveness) - Real World, Usually Observational

26. MA Competency Theme 2
Clinical Research / Trial Evaluation, Design, Execution, Publication
In India, Clinical Research Is More Than Just Clinical Trials. Locally Relevant, Cost-effective, Clinical Programs, In Traditional, And Real World Settings…
HTA
HEOR
Screening
Incidence Prevalence
Surveys
Risk -Factors
Diagnostics
CR / CP Instruments
Clinical Trials
Others…

27. MA Competency Theme 6 Pharmaceutical Business Operations
“Medical Affairs” Must Contribute, and Must Often Lead and Show the Way…
Then, The 4 Ps
(Internal Focus)
Product
Price
Place
Promotion
To The 4 Ps...
(Gradual Shift)
Product
Patient
Physician
Payer
Today, The 4 As
(External Focus)
Awareness
Acceptability
Affordability
Accessibility

28. Cultivating The Medical Affairs Mindset
This MA Mindset Is Characterized / Demonstrated By: A B C D E

29. 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

30. Accountability to Self, and Multiple Stakeholders
Profession
Team
Business
Organization
Society at Large
Above all, Patients and Consumers
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)

31. Balance, Coupled with Sound Judgment and Decision Making
Commercial Goals vs Patient Interest
Business vs Profession, and Professional Ethics
Speed vs Quality
Risk vs Benefit (Beyond Product)
Confidentiality vs Disclosure
Global vs Local
Ego vs Reality
Business vs Self Development
Medical vs Marketing
Work vs Life

32. Clarity of Purpose, Thought, Speech, Action
Setting Direction
Showing the Way
Seeking, and Providing Solutions
Communicating Clearly and Openly
Foresight and Insight
Leadership

33. Developmental Mindset Towards Business, Self, and Others
Business (Medical) Development
Approach/Tool - Medical Development Plan (MDP)
Self (Individual) Development (Personal and Professional)
Approach/Tool – Personal Development Plan (PDP)
Others (Manager/Leader)
Approach/Tool - Managerial/Leadership Development Plan (LDP)

34. Ethical Approach, Thought, Behavior, And Integrity In Action
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Physician vs Pharmaceutical Physician - Ethical Dilemmas
Guiding Principles for Pharmaceutical Physicians - Nov 2010

35. Pharmaceutical Physician Ethics One Important Guiding Principle

36. 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
My Score (Scale ) – A ( ), B ( ), C ( ), D ( ), E ( )

37. Putting It All Together Cultivating Role & Responsibility, Competency, Mindset
Managing Perceptions,
And Aligning Expectations Is Vital…
…..As Is Ensuring The Rights And Well Being Of Research Participants…

38. Discussion, Critique, Reflection, Learning Putting It All Together
Group Exercise(s)
Discussion, Critique, Reflection, Learning
Putting It All Together
Our Workshop Theme And Relevance
Your Thoughts?
“Group Skit”
Crafting …… Sound …… MEDICAL AFFAIRS Professionals…… CULTIVATING…… competencies…… MINDSET…… REAL WORLD EVIDENCE……

39. Knowledge / Resource Item / Home Assignment - 1
Reading, Reflection, Discussion, Critique

40. Knowledge / Resource Item / Home Assignment - 2
Reading, Reflection, Discussion, Critique

41. Knowledge / Resource Item / Home Assignment - 3

42. Lunch – Food For Thought….

43. Thank You! Good Luck!
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