The Role of Regional Medical Advisor (RMA)-Field Medical. Dr. Aju Abraham Varghese Pfizer India. Feb 22 nd 2014

Transcription

1 The Role of Regional Medical Advisor (RMA)-Field Medical Dr. Aju Abraham Varghese Pfizer India Feb 22 nd 2014

2 Disclaimer The opinions expressed in this presentation are solely those of the presenter and do not necessarily reflect the opinions of any specific company, nor do they address any specific RMA team or structure. The purpose of this slide set is to merely to introduce the concept the RMA role and the potential value addition to the organization 2

3 Points for discussion Evolution and History of Regional Medical Advisor (RMA) role Focus of RMA team Key activities Performance metrics Challenges and conclusion 3

4 Evolution of RMA Medical Strategic Activities Develop Medical Brand Strategy Plan and strategize Product lifecycle Medical Communication Writing and support for Peer-reviewed publications Medical and scientific Communications Medical Information Services Respond to Drug information queries MEDICAL AFFAIRS Medical Education Training of internal teams Medical education to health care providers Health economics and outcomesresearch Patient/treatment related outcomes Health Technology Assessments Medical Field Teams Relationship management Communication of product related information Pharma Medical Affairs 2020 and beyond McKinsey & Company Report. 4

5 History 1967-Upjohn Company introduced Medical science Liaisons (MSLs) 3 types- Therapeutic, Educational and MSL coordinator E.R. Squib (currently BMS) is credited with the transition to a medical based teams Morgan D. K., et al. (2000). History and evolution of field-based medical programs. Drug Inform. J. 34,

6 Definition of RMA The RMA or MSL (Medical Science Liaison) is a therapeutic specialist (i.e. Oncology, Cardiology, CNS) within pharmaceutical, biotechnology, medical device, and CRO companies who have advanced scientific training and generally degrees in the life sciences (Ph.D., PharmD., MBBS, M.D.). The primary responsibility of the RMA is to establish, develop and foster collaborative relationships between thought leaders and the companies they represent via the advancement of science and medicine Morgan D. K., et al. (2000). History and evolution of field-based medical programs. Drug Inform. J. 34,

7 Why RMA? Decreasing relevance of traditional sales and marketing activities Customer access is declining for sale representatives Increased focus of HCPs on treatment options and patient outcomes. Declining sales forces as result of decreased spending and increased regulations Morgan D. K., et al. (2000). History and evolution of field-based medical programs. Drug Inform. J. 34,

8 Main Goals of Medical Affairs Provide optimal treatment through establishing unbiased, scientific evidence based value of product Understanding needs of patients Establish trust and credibility with healthcare providers and KOLs Pharma Medical Affairs 2020 and beyond. Matthias Evers, Edd Fleming, Arnab Ghatak, Jan Hartmann, Arif Nathoo, Ron Piervincenzi, Lawrence Wai, Ann Westra. McKinsey & Company 8

9 Customers of RMA Business Support Marketing Sales Regulatory Internal Safety Clinical Research Medical Communication R & D Corporate Affairs Training team Customer Insight Generation Allied Healthcare Professionals Academic Institutions External Key Opinion Leaders Thought Leaders Relationship Development 9

10 Focus of the RMA Team Building KOL Relationship Demonstrating Leadership in the Organization and Market Communicate KOL Insights back to organization Educating Stakeholders by Scientific Interactions & Education RMA Bridging the Gap between Pharma and KOL Understanding the unmet needs of HCPs and help to improve patient outcome 10

11 Scientific Communication Every scientific promotional material distributed to physicians is reviewed for compliance with the Indian Drugs and Cosmetics Act, company guidelines, and Organization of Pharmaceutical Products of India guidelines. It is important to provide updated, unbiased, accurate, and complete information to the healthcare practitioner. Evolving role of pharmaceutical physicians in the industry: Indian perspective. Anant Patil, Viraj Rajadhyaksha. Perspect Clin Res Jan-Mar; 3(1):

12 RMA Activities Internal Thought Leader, External Voice and Clinical Catalyst Product Development Activities Reporting information from KOLs Reporting SAEs related to products Facilitate Data Dissemination (Manuscripts, Publications, Press Releases, congresses) Preparing slide kits Literature search and writing support Literature based positioning, CMEs/RTMs Shaping Therapeutic Landscape Advisory Board ISPs on disease area Indian guidelines e.g Indian HT guideline, Portfolio activities Data Generation IIRs Interventional Review articles on the product Biostatistics, Research Methdology Workshops ICH GCP training KOL development Meetings: Group/ One on one Speaker development IIRs UEGs for local data generation CMEs, ISPs, Ad boards, Scientific engagements Field training Launch trainings New PSO trainings Refresher training Plan Of Action 12

13 Role Of RMA Across Product Development Spectrum Preclinical Phase I Phase II Phase III Phase IV Thought leader identification Competitive intelligence Therapeutic landscape monitoring Clinical Site/investigato r identification Facilitating knowledge exchange within the company and between company and thought leaders Generate awareness for companies new to industry or new to therapeutic category Scientific representation of company at scientific meetings Working with patient advocacy groups Assistance with clinical education, publication, communication, training and advisory programs Identify clinical training needs for company to support product launch Support of IIR Programs Support of Patient Registry Initiatives Specialized focus on allied healthcare professionals, including nurse practitioners and clinical companies 13

14 Targeted Messages for Each Customer Segment Customer Interests/Orientation Customer Segment Influence Cascade Field Group Message Type Novel basic science & clinical research Disease mechanisms Physician education Defining standards of practice TL Academic RMA 1 Science Disease 2 Product Updates in clinical research Disease mechanisms Physician education Improving patient outcomes Community TL/Specialist RMA/PSO 1 Disease Product 2 Science Direct Patient Care Improving patient outcomes Primary Care PSO 1 Disease Product 2 Science 14

15 RMA role in Brand Strategy Thought Leader Insights and Opinions Communication to brand Teams Impact on Brand Strategy and Tactics RMAs help brands understand key market dynamics and perceptions 15

16 What s the difference? MA vs. RMA Medical Advisor (MA) Product launchprelaunch, launch, post-launch Medical brand strategies Pharmacovigilance Research activities Review and evaluate the scientific content of promotional and training materials Provide accurate product knowledge Product training to sales representatives and marketing colleagues Create database of scientific product-specific information Provide scientific support for exhibits during national meetings Competitive intelligence: Remain updated with journals and other scientific literature Regional Medical Advisor (RMA) Interact with physicians and KOLS on: IIRs Scientific communication Data generation & Dissemination Capacity building Pipelines in the drug development Strategic execution Evolving role of pharmaceutical physicians in the industry: Indian perspective. Anant Patil, Viraj Rajadhyaksha. Perspect Clin Res Jan-Mar; 3(1):

17 Soft Skills Needed For an RMA Ability to travel heavily Passion to build scientific relation Strong communicati on skills Ability to teach and learn Experience in therapy area assigned Soft Skills Business acumen Good Oral and Writing skills Strong interpersonal skills Creativity & Innovative thinking 17

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19 Commercial team/sales Force What s The Difference? SR Vs. RMA Regional Medical Associate team Provide product details to customers To provide samples To provide customer service Performance and goals are based on sale of drug Interact with thought leader/ physicians Disseminates evidence-based Data Develop relationships Identify patient-centric unmet needs of HCPs To answer questions (not to Prompt questions!) To provide customer service 19

20 Scientific Communication with Health Care Providers and KOLs Rising regulatory concerns Measuring the overall influence over company s success Constant measurement and re measurement due to fluctuating needs of Medical Affairs KOL relationship is the top priority From: Considerations for the Development and Communication of MSL Metrics. Ed Cunningham, PharmD Eisai Inc, Edith Eby, PharmD Pfizer Inc. 20

21 Metrics for RMA Performance Quantitative No. of KOL interactions No. of CME conducted No. of IIRs No. of trainings for doctors and field force No of Advisory boards No. of Publications Qualitative Feedback from Internal and External customers by survey Quality of IIRs Written Feedback of Ad boards Quality of data published CME feedback 21

22 Emerging Trends New Tools & Tactics Profiling KOLs with better software platforms Identifying and developing newer KOLs database Keeping updated about newer and future events in the market place New Roles & Responsibilities Early Engagement in New product Programs More involvement in pipeline discussion Greater coordination between Product development and RMA program New Environments Increased regulatory oversight of Pharma and KOL interactions High costs of conducting programs and travel Greater agility to deal with Fast moving and fast changing relationships 22

23 Internal Audience External MSL Activities To Strengthen Market Leadership in 2020 Virtual ad boards Online Surveys of virtual communities of physicians Open source collaboration on unanswered questions (e.g. input into development) Surveillance and feedback (e.g. understand product use, flag safety concerns) Trial Patient recruitment Virtual medical information (MI) Recruitment of & collaboration with traditional key-opinion leaders (KOLs), speakers & investigators. Cultivation of online KOLs Virtual KOL presentations Virtual RMA interactions with physicians ecme ( & other training) Collection of information from across functions (e.g.; marketing, sales, R&D ) Translation of insights into new opportunities Sharing information & insights back and forth across functions Up to date process & content training Knowledge collection & Management Knowledge dissemination Types of Activities From: Pharma Medical Affairs 2020 and beyond. Matthias Evers, Edd Fleming, Arnab Ghatak, Jan Hartmann, Arif Nathoo, Ron Piervincenzi, Lawrence Wai, Ann Westra. McKinsey & Company 23

24 Essence of RMA Building Trust Based Relations With KOLs, on Scientific And Educational Platforms, For Better Patient Outcomes 24

25 References 1. Pharma Medical Affairs 2020 and beyond McKinsey & Company Report Morgan D. K., et al. (2000). History and evolution of field-based medical programs. Drug Inform. J. 34, Chin J. (2004). Biotechnology's special forces: Field-based medical science liaisons. J. Comm. Biotechnol. 10, Wolin M. J. et al. (2001). The emerging role of medical affairs within the modern pharmaceutical company. Drug Inform. J. 35, Marrone C. M., et al. (2007). Survey of medical liaison practices across the pharmaceutical industry. Drug Inform. J. 41, Malecha S. E., et al. (2000). The applied therapeutics team: An innovative model of drug information in the pharmaceutical industry. Drug Inform. J. 34, Holt R. J., et al. 8. (2001). Making markets and the global medical information imperative: The heat is on! Drug Inform. J. 35, Chin J.(2007). Measuring performance of field-medical programmes: Medical science liaison metrics consensus. J. Comm. Biotechnol. 13, Marrone C. M., et al. (2008). Survey of medical liaison practices No. 2: Assessing training techniques and demonstrating value of medical liaisons. Drug Inform. J. 42,

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