MAF Forum July 2013- Regional MAF

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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

Disclaimer

• The views or 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 2 10.12.2012

Agenda

• What is the 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

What is the role 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

Discovery Phase I Phase 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

Discovery Phase I Phase 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

Role of Medical Affairs

• 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

Agenda







Scientific Leadership Focus of MAF 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%)

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 $

Phar

ma

Mar

ket

Sal

es, 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 12 7

12

The Pharmaceutical Industry is 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

Agenda







14

• Lead the development 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

What structure in regional 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


CONFIDENTIAL. FOR INTERNAL USE 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.

Regional MAF team is 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


Agenda




• 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


The Asia Pacific region 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: 73M China

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

© 2012, IMS HEALTH 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 2012 20 Pharmerging markets: Stretching expectations

Scientific Leadership EMERGINIG MARKET SEGMENT: 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

Challenges • For many companies, 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.


Main challenges in establishing 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


Attributes for Industry Professional 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.

-Perceptiveness-Industry work requires an 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

What patients might want 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


The Scope of Medical 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

CONFIDENTIAL. FOR INTERNAL USE ONLY. NOT FOR DISTRIBUTION.

28

Typical Product Life Cycle

R&D

Registration

Product Uptake

Peak Performance

Life Cycle Optimization

Pat

ien

ts t

reat

ed

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

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

Personal experience in Building AP MAF

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• 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

Why is Medical Affairs 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”


Medical Affairs Value Propositions 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

Pat

ien

ts t

reat

ed

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

Why MAF is unique?

• 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

What is the role 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..)


Personal statement :

My believe 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..

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MAF Forum July 2013- Regional MAF

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