Medical & Scientific Affairs (M & SA)


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Medical & Scientific Affairs (M & SA) is a critical piece in the puzzle of building a GOOD to GREAT Healthcare Organization!

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  • Most companies have the following strategy: Operate in a large number of Disease Areas Focus on expanding product distribution Restrict their customer contact primarily to the doctor We propose a differentiated strategy Focus on key disease areas with high potential Engage with the patient directly while partnering with the doctor Going beyond product availability to providing an augmented product which includes services for disease management
  • Medical & Scientific Affairs (M & SA)

    1. 1. Medical & Scientific Affairs (M & SA) A critical piece in the puzzle of building organizational equity Dr Karthik Anantharaman Head of Medical Team Integrated Disease Management Pvt Ltd
    2. 2. Presentation outline <ul><li>A. Objective of M & SA function </li></ul><ul><li>B. Defining Roles & responsibilities of M & SA function </li></ul><ul><li>C. Evaluation of current structure </li></ul><ul><li>D. Future organization </li></ul><ul><li>E. Resource Planning </li></ul><ul><li>F. People Development Plans </li></ul>
    3. 3. Objective of M & SA function understood to be in line with the Vision of the organization <ul><li>To establish organizational image as a true Science & Research based organization through: </li></ul><ul><ul><li>High quality medical education initiatives </li></ul></ul><ul><ul><li>Dedicated scientific discussions focusing on Drug development and Pipeline </li></ul></ul><ul><ul><li>High quality research initiatives </li></ul></ul><ul><li>To increase access to pharmaceutical company medical function by the Field Force (substantial medico-marketing support to business development) </li></ul><ul><li>To increase access to pharmaceutical company medical function by the doctors: </li></ul><ul><ul><li>To be the preferred & trusted scientific partner of choice for the doctor </li></ul></ul><ul><ul><li>To be the preferred & trusted clinical partner of choice for the doctor </li></ul></ul>Market Leadership Partner of choice Employer of choice Patient
    4. 4. Roles & Responsibilities of M & SA understood to be in-line with Differentiated Strategic Intent of organization Customer Few Disease Management Many Product Therapeutic Areas Offering Doctor Patients IDM Scientific rigour for patented ‘first in class’ brands Establish both ‘Science’ & ‘Story’ of the brand Health Outcome Partner to physicians to improve patient outcomes Establish brand as a ‘SOLUTION’ & not a tablet Most Large Pharma Companies in India “ Differentiated” Intent
    5. 5. M & SA responsibility: The fine balance Scientific & Research based communication – Non product related, Focus on Disease Management, Guideline Compliance (fair, balanced, non-promotional, build organizational equity thru scientific excellence) Science based product related discussions / objection handling / query management
    6. 6. Vision & Mission Statements <ul><li>Vision </li></ul><ul><ul><li>Enhance patient health through excellence in scientific development. </li></ul></ul><ul><li>Mission </li></ul><ul><ul><li>Fulfill the therapeutic gaps between the drug and the disease. </li></ul></ul><ul><li>Objective </li></ul><ul><ul><li>Preferred scientific & clinical partner of choice to the KOL through enhancement of the medical excellence </li></ul></ul>Alignment to the organizational strategy Complete alignment for the flawless execution and implementation of the strategy in accordance with the business needs.
    7. 7. M & SA : The New Industry Model <ul><li>Paradigm shift in how Science has been communicated to the doctors till date. </li></ul><ul><li>Conventional Vs Unconventional (emerging) </li></ul><ul><li>Promotion Vs Education </li></ul><ul><li>Drugs Vs Disease </li></ul><ul><li>Push Vs Pull </li></ul><ul><li>Business development (predominantly the sales push model) Vs Developing the business (predominantly the scientific pull model) </li></ul><ul><li>Value addition Vs Value creation </li></ul><ul><li>Carpet bombing communication Vs Individualized Communication </li></ul>
    8. 8. D. Future H S A Working Model <ul><li>M & SA (Strategic & Implementers): </li></ul><ul><li>Discussion with M & SA on BU strategy and collection of M & SA inputs and ideas that could strengthen BU strategy </li></ul><ul><li>Implementation of HO driven & Region driven initiatives subsequent to discussion & scientific inputs from Team M & SA – scientific topics aligned to strategy & region specific needs, speaker selection & briefing, slides & CME material development </li></ul><ul><li>Scientific discussions with Physicians: Both 1-on-1 & Jointly with FF – to be customized to physician’s need: Guideline based, Disease management based, Patient profile/case study based, Product & competition based </li></ul><ul><li>Physician education on ‘High Risk Patient profiling/detection’ </li></ul><ul><li>Developing research projects in line with business strategy – Observational studies, Outcomes research </li></ul><ul><li>Medical support to the implementation of Post-Marketed Research Projects </li></ul><ul><li>Medical query management & Objection handling </li></ul><ul><li>Monthly medical refresher training to FF </li></ul><ul><li>Medico-marketing support to Institutional Business (KAMs) & Corporate Business </li></ul><ul><li>M & SA : </li></ul><ul><li>Conformance to Monthly Plan >80%: RBM, KAM, RTM, Corporate business, CSR to plug in tentative dates for activities yet to be finalized – allows M & SA work plan to be more accommodative without compromising on pre-planned commitments </li></ul><ul><li>One channel of communication to M & SA – Respective M & SA manager </li></ul><ul><li>M & SA deliverables to be linked to successful completion of scientific activities as required by business units: </li></ul><ul><ul><li>Ensuring appropriate use of therapy in the right patient profile to optimize patient outcomes through protocol development & compliance </li></ul></ul>M & SA activities shall have 2 components: Activities common to all members of M & SA + Activities specific to BU specific M & SA
    9. 9. M & SA Responsibilities on lines of Pharmaceutical Organizational Priorities (1) Direct Business Development Priorities (Conventional) (2) Incremental Business Development Priorities <ul><li>Increase number of prescriptions / prescriber </li></ul><ul><li>Increase in number of prescribers / product </li></ul><ul><li>Primarily driven by S & M Team – M & SA are medical support functions to S & M Team </li></ul><ul><li>Increase in treatment rate (number of patients receiving treatment) – The Real competition </li></ul><ul><li>Build Organizational Equity – Research & Science based, highly ethical organization </li></ul><ul><li>Primarily driven by M & SA – S & M are support functions to M & SA </li></ul>
    10. 10. Responsibilities of M & SA Sales Marketing RTM KAM M & SA Medical / MRL / Regulatory Corporate Business (1) Direct Business Development Priorities (Conventional)
    11. 11. Responsibilities of M & SA Sales PV IDM Office of Compliance M & SA Medical / MRL / Regulatory External Partnerships CSR (2) Incremental Business Development Priorities PCP / Patient Support Programs
    12. 12. Completing the picture: All Responsibilities of M & SA Sales Marketing RTM KAM PV IDM Office of Compliance M & SA Medical / MRL / Regulatory External Partnerships Corporate Business CSR CSA / Patient Support Counselors
    13. 13. <ul><li>Medical / MRL / Regulatory </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><li>CME Mgmt: </li></ul></ul></ul><ul><ul><ul><ul><li>Determining agenda based on Mktg Strategy </li></ul></ul></ul></ul><ul><ul><ul><ul><li>CME slide development </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Established Speaker Mgmt – briefing & orientation to key messages </li></ul></ul></ul></ul><ul><ul><ul><ul><li>New Speaker identification & development </li></ul></ul></ul></ul><ul><ul><ul><li>Objection handling </li></ul></ul></ul><ul><ul><ul><li>Medical Query management </li></ul></ul></ul><ul><ul><li>(2) Incremental Business Development Drivers </li></ul></ul><ul><ul><ul><li>Observational Studies - identify concept in line with strategy, protocol, approvals, investigator identification, documentation, implementation, data mgmt, publication </li></ul></ul></ul><ul><ul><ul><li>Ph 3 – investigator identification </li></ul></ul></ul><ul><ul><ul><li>IISP – investigator scientific support </li></ul></ul></ul><ul><ul><ul><li>Outcomes Research </li></ul></ul></ul>Defining individual responsibilities of M & SA
    14. 14. <ul><li>Marketing </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><ul><li>Strategic Planning – Monthly Inputs M & SA Managers </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Partnering in strategy implementation (Advocacy cadence) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>National Conference Newsletter development </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Competitive intelligence </li></ul></ul></ul></ul><ul><li>Sales </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><ul><li>Scientific Training </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Monthly knowledge refresher tests </li></ul></ul></ul></ul><ul><ul><ul><ul><li>SFE - Communication skills - Effective scientific probing of doctors – lead by example </li></ul></ul></ul></ul><ul><ul><ul><ul><li>JFW-KOL Mgmt </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Objection handling </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Medical Query management </li></ul></ul></ul></ul><ul><ul><li>(2) Incremental Business Development Drivers </li></ul></ul><ul><ul><ul><ul><li>Evidence Based Selling </li></ul></ul></ul></ul>Defining individual responsibilities of M & SA
    15. 15. <ul><li>KAM (Institutional Business) </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><ul><li>Institutional KOL Mgmt </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Institutional Disease Management Guideline / Protocol development </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Institutional CMEs </li></ul></ul></ul></ul><ul><li>Corporate Business </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><ul><li>Scientific presentation delivery to Corporate houses </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Medical support to Corporate business development </li></ul></ul></ul></ul>Defining individual responsibilities of M & SA
    16. 16. <ul><li>RTM (Capability Enhancement Team) </li></ul><ul><ul><li>(1) Direct Business Development Support (Conventional) </li></ul></ul><ul><ul><ul><li>Annual training calendar </li></ul></ul></ul><ul><ul><ul><li>Presentation & Communication skills </li></ul></ul></ul><ul><ul><ul><li>Training Manuals & Training slides </li></ul></ul></ul><ul><ul><ul><li>Self reading refresher modules for FF </li></ul></ul></ul><ul><li>IDM: CSAs, Patient Support Counselors </li></ul><ul><ul><li>(2) Incremental Business Development Drivers </li></ul></ul><ul><ul><ul><ul><li>Medical training to CSAs </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Partnering with CSAs in roll-out of Disease Management </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Offer patient risk & clinical outcomes management tool to physicians </li></ul></ul></ul></ul>Defining individual responsibilities of M & SA
    17. 17. <ul><li>CSR </li></ul><ul><ul><li>(2) Incremental Business Development Drivers (Organizational Equity building) </li></ul></ul><ul><ul><ul><li>Assistance extended to doctors running charitable weekend clinics, NGOs, etc – H S As may volunteer in such initiatives </li></ul></ul></ul><ul><li>Office of Compliance (SOPs of Sales & Marketing Practices) </li></ul><ul><ul><li>(2) Incremental Business Development Drivers (Organizational Equity building) </li></ul></ul><ul><ul><ul><ul><li>Compliance training imparted to FF </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Helping FF in managing difficult to manage physicians to understand our Ethics, V & S </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Regional Compliance Contact for FF for all S & M policy related queries </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Quarterly refresher to FF on Compliance </li></ul></ul></ul></ul>Defining individual responsibilities of M & SA
    18. 18. <ul><li>External Partnerships (Eg: Sugar Clinics) </li></ul><ul><ul><li>(2) Incremental Business Development Drivers (Organizational Equity building) </li></ul></ul><ul><ul><ul><li>Medical training for Sugar Clinic medical & para-medical staff </li></ul></ul></ul><ul><li>Pharmacovigilance </li></ul><ul><ul><li>(2) Incremental Business Development Drivers </li></ul></ul><ul><ul><ul><ul><li>Regional PV contact for marketed products and research activities conducted in the post-marketed environment </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Timely reporting of all AEs within pre-specified timelines as per PV Reporting SOPs </li></ul></ul></ul></ul><ul><ul><ul><ul><li>End-to –end AE reporting mgmt </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Continuously monitor the safety of our marketed products </li></ul></ul></ul></ul>Defining individual responsibilities of M & SA
    19. 19. Role of Team M & SA in Business Strategy Strategy building team BUD + Marketing + NBM Head – M & SA Output = BU Strategy Strategy roll-out team Medical Advisor Marketing Manager M & SA Manager M & SA Implementation Pre-implementation (if any) (blue) & Post-implementation (green) M & SA Inputs / feedback Into BU Strategy (Attachment 1)
    20. 20. M & SA : Feedback & Performance Management Customers of M & SA Internal customers (Sales & Marketing) External customers (Doctors) *RBM feedback on respective M & SA(monthly) (Attachment 4) **Training feedback (Attachment 5) M & SA Mgr Consolidated monthly feedback to individual M & SA Individual Coaching & Counseling Supervisor Doctor feedback (consolidated monthly): **CME quality feedback (Attachment 6) **Medical Query quality feedback (Attachment 7) M & SA Manager Monthly Field trip report (Attachment 8) Assessment of Business Enabling Capabilities Assessment of Technical & Management capabilities Assessment of Technical capabilities *Reported on last working day of the month **incorporated in monthly report
    21. 21. PPG/KRA Alignment of Team M & SA Head M & SA Regional M & SA Mgr Regional M & SA Mgr M & SA M & SA Regional M & SA Mgr M & SA Medical Director S & M Director (consolidated for all BUs) BU specific (Aligned to BUD’s PPG) BU specific (Aligned to BUD’s PPG) BU specific (Aligned to BUD’s PPG)
    22. 22. Resource Planning - Methodology Variables Weightage CoP Network (Region-wise) (Focus segment for KOL Management) 50% Field Deployment 50% Number of medico-marketing activities based on BU strategy
    23. 24. Back-up Slides
    24. 25. Scope for future M & SA Job enrichment <ul><li>Identifying new molecules, analysing their potential, presenting it to the marketing department (with medical SWOT analysis), conducting trial to get permission from the DCGI and finally presenting it to the DCGI. </li></ul><ul><li>Planning & implementation of medical inputs in marketing strategies [ Pre-launch, launch & post –launch] emphasising on medical aspects and their prioritisation. </li></ul><ul><li>Responsibility of all medical implications of marketing strategies, w.r.t organisation of strategic phase IV trials and their publication in accordance with SOPs. </li></ul><ul><li>Retrieving medical information / preparing medical inputs, post launch medical support. </li></ul><ul><li>New product ideation, analysis, comparative assessment etc., </li></ul><ul><li>Key products identification through Desk research, industry intelligence, global trends, patent expiry & grids , inputs from BD managers and IP </li></ul><ul><li>Business case & prioritisation thru market interest and forecast </li></ul>