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MAF Forum July 2013- Regional MAF
- 1. Janssen is proudto feature artwork created by people affected by the illnesses and diseases we are committed to treating and preventing. Medical Affairs Forum Asia Pacific 2013 Setting up and managing Medical Affairs teams in the Asia Pacific Region Elena Rizova, MD, PhD VP, Head of Asia Pacific Medical Affairs Janssen July 22nd, 2013 1
- 2. Disclaimer • The viewsor opinions expressed by the speaker are solely his own and do not necessarily represent the views or opinions of any organisation. • Current employer : Janssen (Pharmaceutical Companies of Johnson & Johnson) Janssen Research & Development, LLC 210.12.2012
- 3. Agenda • What isthe role of Medical Affairs • Medical affairs in Emerging markets • Regional team : main role • Set up a regional team – The right balance : resources and competencies – Talents and talent development • Challenges in AP for Regional team Janssen Research & Development, LLC
- 4. What is therole of Medical Affairs? • To support the marketing and sales? • To be the Compliance reference: standards, processes, knowledge • To be the HCPs’ partner • To be the strategic partner of other functions (marketing, market access..) Janssen Research & Development, LLC 4
- 5. Discovery Phase IPhase II Phase III Phase III B Phase IV R&D Medical Affairs: • Ensure support for marketing activities • Support primary indications Role of Medical Affairs (15 years ago) 5
- 6. Discovery Phase IPhase II Phase III Phase III B Phase IV R&D Medical Affairs: Enhancing Scientific and Medical Value • Ensure strong scientific presence in the countries • Support primary indications • Strengthen the knowledge of the products and differentiate during launch and life cycle • Explore new indications • Ensure MAF input earlier in development programs Role of Medical Affairs now 6
- 7. Role of MedicalAffairs • Medical Leadership in the countries, responsible for: – Data Generation: clinical trials, registries, Early Access Programs, support for Investigator Initiated Activities – Data Dissemination: Publications, Medical Information, Medical Education, Medical Scientific Liaisons, Congress participation and training – Pharmacovigilance: safety reporting, safety input, medical issue management and risk management, Local Safety Officer development – Medical Compliance: Review and approval of all Medical & Scientific content, Learning & Development, SOPs, guidelines, policies, processes
- 8. Agenda • What isthe role of Medical Affairs • Medical affairs in Emerging markets • Regional team : main role • Set up a regional team – The right balance : resources and competencies – Talents and talent development • Challenges in AP for Regional team Janssen Research & Development, LLC 8
- 10. Scientific LeadershipFocus ofMAF in EMERGING COUNTRIES Source: Best Practices, LLC Q. What percentage of the total Medical Affairs spend was allocated to each of the following functions in the most recently completed fiscal year? (Total should equal 100%)
- 11. Tier 1 &2 Pharmerging market sales represent the highest contribution to growth 25% of global market by 2016 10yr CAGR, % Where to win? Tier 1&2 Pharmerging market sales Source.: IMS Market prognosis 2012-2016 September update, LC $ PharmaMarketSales,LC$bn 50 400 350 300 250 200 150 100 0 +14% 6 45 China +20% Brazil +14% Russia +13% India +15% All Other Pharmerging +10% 2016 355 149 46 25 23 112 2011 196 68 25 15 12 76 2006 94 24 127
- 12. 12 The Pharmaceutical Industryis Changing 1. http://www.fda.gov/ohrms/dockets/ac/02/slides/3841s1_03_Dean/sld006.htm Global R&D productivity is falling1 Pricing & Reimbursement are becoming more difficult Growth opportunities in “pharmerging” markets The commercialization of products is changing Continued pressure to manage profitable growth
- 13. Agenda • What isthe role of Medical Affairs • Medical affairs in Emerging markets • Regional team : main role • Set up a regional team – The right balance : resources and competencies – Talents and talent development • Challenges in AP for Regional team Janssen Research & Development, LLC 13
- 14. 14 • Lead thedevelopment and implementation of the AP MAF Regional Medical Strategy • Act as a role model and conduct vigilant oversight for compliance • Drive the development of Regional Clinical studies • Lead the development and implementation of Medical Education • Ensure early input in development programs • Support primary indications and explore new indications • Support the technical and scientific activities of Local Op Cos from pre-launch through lifecycle. Regional Medical Affairs MISSION
- 15. What structure inregional teams ? • What are the Company needs and strategy? • What is the maturity of the company: starting operations in AP or established company requiring transformation? • What is the company strategy ? • Main functions to be agreed with internal partners : – Therapeutic area experts – Medical Education – Medical Information – Pharmacovigilance – Processes and compliance – Patient related outcome group Janssen Research & Development, LLC 15
- 16. CONFIDENTIAL. FOR INTERNALUSE ONLY. NOT FOR DISTRIBUTION. 16 AP MEDICAL AFFAIRS AP Regional Medical Affairs department AP Medical Affairs work closely with the following internal groups: Global Clinical Operations, Research & Development, AP Strategic Marketing, AP Market Access, AP Communications, AP Regulatory Affairs and Country Medical Affairs teams. 7 Functional teams Accountable for developing AP Medical Education and Information strategies & content. Plan and execute regional Medical Education programs. Develop and roll out AP Medical Education workflow processes. Accountable for PRO data generation Embed a strong PV and compliance culture in AP. Plan and execute regional PV training programs and monitor compliance. Develop PV competencies, processes and tools to drive accountability and ensure compliance. Accountable for AP Medical Compliance, SOPs MEDICAL EDUCATION/Informa tion Patient related outcome MAF Processes PHARMACOVIGILA NCE Functional Areas THERAPEUTIC AREAs Accountable for AP medical strategy & scientific aspects for a group of compounds Therapeutic Areas: Immunology, (G, R, D) Psychiatry, Pain Oncology, Infectious Diseases and Vaccine , Diabetes PROGRAM MANAGEMENT Accountable for AP Business Planning, Project & Budget management.
- 17. Regional MAF teamis setting the direction • Long term vision – Establish the standards for compliance, GCP etc.. – Implement robust data generation & scientific partnership – Ensure strong scientific support for MKT and MA • Ensure Scientific credibility • Personal leadership – Articulated and clear thinking and communication – Complexity management – Provide solutions – High ethical standards – Set strategy – Autonomous Janssen Research & Development, LLC 17
- 18. Agenda • What isthe role of Medical Affairs • Medical affairs in Emerging markets • Regional team : main role • Set up a regional team • Challenges in AP for Regional team – Talent recruitment – Diversity of talents in the countries – Diversity of HC system in the Region – Patients and HCP expectations – Global team expectations Janssen Research & Development, LLC 18
- 19. The Asia Pacificregion is rich in diversity Singapore Popl: 5M Thailand Popl: 66M Vietnam Popl: 90,M Malaysia Popl: 28,7M Indonesia Popl: 245,61M Philippines Popl: 101M Australia Popl: 22M New Zealand Popl: 4M ... Japan Popl: 126M Korea Popl: 73MChina Popl: 1.4B India Popl: 1.1B ... Hong Kong Popl: 7M Taiwan Popl: 23,M Self pay Semi-reimbursed Reimbursed Some interesting facts about the AP region: • Population: At 4.1B, ~60% of the world's population reside in AP • Size: 52M KM2 or ~34% of land in the world • GDP Rank: GDP's in AP range from #2 to #56 • Languages: Over 2000 languages are spoken across AP 1. No ranking available Source: World Development Indicators 2011, Linguistic Society of America 19
- 20. © 2012, IMSHEALTH INCORPORATED OR ITS AFFILIATES. ALL RIGHTS RESERVED Pharma companies face internal and external hurdles Talent is a major issue of recruitment and retention How to win? Source: IMS Client Survey to Senior executive of the pharma industry in emerging markets, November 2012 N=85 Q2: What are the most important business issues that you face over the next 12 months? Q3: What business issues do you expect will become more important over the next 3-5 years? Over the next 12 months Over the next 3–5 years Business issues categorisation # of mentions Talent retention & recruit 9 Financial results (growth, operating margins/profitability) 9 Launch 8 Organizational & operational excellence 8 Portfolio management 3 Partnership management 2 TOTAL 39 Responses include only mentions related to business issues Business issues categorisation # of mentions Talent retention & recruit 11 Organisational & operational excellence 8 Financial results (growth, operating margins/profitability) 8 Partnership management 2 Portfolio management 2 TOTAL 31 December 201220 Pharmerging markets: Stretching expectations
- 21. Scientific LeadershipEMERGINIG MARKETSEGMENT: THOUGHT LEADER MANAGEMENT GROWING IN IMPORTANCE Q. In your recent experience, have the following Medical Affairs functions become more or less important to the overall success of your company ? Source: 2012, Best Practices, LLC
- 22. Challenges • For manycompanies, the role of MAF is not very clear to its business partners, sometimes even within the MAF organization itself • Scope of MAF in different companies varies • MAF is integrate more with other functions, especially in market access. • KOLs often can't distinguish the difference between a sales rep and MSL and treat MSL visits/calls as reps, thereby reducing their effectiveness • In China, there are talent issues at all levels. It's estimated that the MAF community in China is less than 5,000. Janssen Research & Development, LLC 22
- 23. Main challenges inestablishing Regional team • External – find the right talent (leadership and expertise) – Differentiate from other customer facing functions : MKT – Establish trusted relationship with HCP • Internal – Define and agree on the scope of the MAF function – Establish norms of business conduct between the functions – Cross-functional collaboration & approach – Establish metrics for MAF performance Janssen Research & Development, LLC 23
- 24. Attributes for IndustryProfessional in MAF – 6P’s -Personality-A desirable candidate should be enthusiastic and must have the desire to work as part of a team. A person graduating at the top of his class would be of little value to the industry if he is ill-equipped to deal effectively with non-medical peers, sales representatives, or the general public. -Presentation-Written and verbal communication is among the cornerstones of a person's effectiveness. Industry professionals spend a great deal of time representing their firms as scientific meetings, consultants' meetings, seminars, symposia, teleconferences, and in community service for the public. -Prominence-You need not be well known, but physicians or TA leads who have achieved some measure of distinction from their peers, either academically or in practice, are very desirable candidates for industry positions, particularly for the research area.
- 25. -Perceptiveness-Industry work requiresan excellent knowledge of medicine, but perceptiveness drives the industry professional to anticipate the future needs of the health-care community and how a firm's products can best meet those needs. Foresight will help the industry-based professional direct a product team's efforts toward the best end. -Prior specialty training- Although a specialty is important, further training in a subspecialty makes a physician all the more attractive and useful to the industry. -Practice Experience- One aspect of medicine that has not changed since the day of Hippo craters is the experience of the senses. Medicine is learned and remembered through the bands, eyes, and ears. There is no substitute for first- hand application of the healing art Michael L. Carter, MD
- 26. What patients mightwant from Medical Affairs • An understanding of the specific needs of Asian patients Changing patterns of disease and demography; Asian epidemiology Expertise in “Asia-Pacific medicine” • Participation in clinical trials Global trials; local studies • Access to medicines Availability, Accessibility, Affordability • Well informed doctors and HCPs An MSL community Well trained medical representatives Access to accurate, balanced Medical Information • Company support for its products Ethical behavior and an evidence-based approach Good Medical Governance Janssen Research & Development, LLC 26
- 27. The Scope ofMedical Affairs has Changed Core Medical Affairs Activities in AP • Support for regulatory activities • Phase IV studies • IIS programs • Advisory boards • Basic Medical information • Scientific communications • KOL advocacy development • Review of promotional material • Critical Issue Management Newer Areas for Medical Affairs • Value propositions • Credibility with key influencers and customers • Build scientific credibility via peer-to-peer communication (MSLs) • Medical input to shape product& Brand strategy • Epidemiology and risk-management • Insights into patient needs, stakeholder requirements and Health care channels • Scientific and medical platforms for product communication • E-education and use of new media • Insights into what physicians, patients and payers need to know, understand and believe to ensure safe and appropriate use of medicines • Scientific Partnership with Academy
- 28. CONFIDENTIAL. FOR INTERNALUSE ONLY. NOT FOR DISTRIBUTION. 28 Typical Product Life Cycle R&D Registration Product Uptake Peak Performance Life Cycle Optimization Patientstreated Launch Patent Expiry Peri-launch Review study design, Share regional data generation gaps, investigator/site selection, Act as Study physicians, Investigator meetings, Assist in regulatory dossier preparation, HA presentation, responding to HA queries, Responding to safety signals, reviewing Medical Education, Internal training, Medical Information, Promotional material review, Medical Affairs studies, IIS, Value proposition to reimbursement agencies Medical Education, Internal training, Medical Information, Promotional material review, Medical Affairs studies, IIS, Health outcomes research, label expansion
- 29. Medical Affairs –Customer Facing Organization Impacts Company •Compliance •Reputation •Customer driven insights Product •Safe & Effective Use •Market Access •Evidence – addressing specific local needs •Appropriate inclusion in local standard of care Global Regional Local Health Care Professionals Patients Payors Regulators Advisory Bodies Special Interest Groups
- 30. Personal experience inBuilding AP MAF 30 • Define scope AP MAF • Initiated MAF regional team:(hired 3 ) • MAF basic processes and JD • Support to countries for TA 2011: Build the Foundation • Launched transformational initiative • Established MAF Regional team • Form cross functional regional team • Established enabling functions Regional Med Ed. program management , training • Initiated 2regional studies 2012: Add Enabling Elements 2013: Continuous Improvement • Develop further the MAF processes and compliance MAF : • Refinement of MAF teams in the countries • Regional data generation
- 31. Why is MedicalAffairs Unique? • Primary source of scientific support throughout the lifecycle • Plays within the evolving rules of regulatory compliance and take advantage of the external & internal drivers • Is built on a sound organizational model that is compliant and integrated in a “one-stop-shop” approach • Develops unique Value Propositions – As a catalyst and a player in maximizing a brand potential – As a unique bridge between R&D and Commercial – As a leader in characterizing, generating and communicating evidence-based value to key stakeholders • The Patient remains our most important customer – Medical Affairs is uniquely placed to focus on patient needs – “Good Medicine is Good Business” Janssen Research & Development, LLC 31
- 32. Medical Affairs ValuePropositions a Catalyst and a Player in shaping the Health Care and appropriate treatment of patients, Maximizing the therapeutic potential of new treatment solutions leading to safe and appropriate use of J&J medicines Collaboration with R& D Medical Education Medical Communications Regulatory Support Registration/Label Expansion Outcomes Solutions Rapid Uptake Higher Peak potential Longer time in Market Patientstreated Launch 1 2 3 Years-3 -2 -1 Training (MAF/Marketing/Others) Shape the Disease area internally & externally ( guidelines, policies, scientific knowledge exchange with societies, govt bodies) Data generation : compartive effectiveness, big data
- 33. 33 Why MAF isunique? • MAF brings our company closer to be part of healthcare systems • Deep TA insights to understand physicians’ practice values • Unique combination of clinical expertise and understanding of company strategies • Multi-faceted customer facing medical people who understand the TA(s) and its environmental factors • To build trusting credible relationships with physicians and offer medical scientific perspectives in the treatment proc
- 34. What is therole of Medical Affairs? • To build the Medical strategy • To be the HCPs’ partner in terms of knowledge transmission of Company products, scientific knowledge? • To be the Reference for the countries : standards, processes, knowledge • To be the strategic partner of other functions (marketing, market access..) Janssen Research & Development, LLC 34
- 35. Personal statement : Mybelieve is that as a Pharma Company, we could serve a bigger cause then only developing and delivering drugs by generating innovative projects and solutions to serve patients’, HCP’ needs. My vision is that Medical affairs could contribute to the improvement of health care in Asia Pacific and the Company success. Medical affairs could play a broader role in satisfying the needs of external stakeholders beyond KOL such as policy makers, scientific societies, hospital administration etc..