Medical Affairs Consortium 2015 Building Strong Medical Affairs Capabilities

Table of Contents Medical Affairs Consortium Information Pgs. 3-9

Developing Top-Tier Medical Affairs Capabilities Pgs. 10-13

Medical Affairs Launch Support Excellence Pgs. 14-17

Medical Affairs’ Critical Role in HEOR Pgs. 18-22

About Best Practices, LLC Pgs. 23-24

Abbreviations & Definitions Pgs. 25-26

Medical Affairs Consortium Information

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The Medical Affairs Consortium is a unique opportunity for Medical Affairs

leaders to discuss key challenges, share best practices, develop action-

oriented solutions and explore current and future trends in regards to the

Medical Affairs function and its interactions with other critical functions.

What is the Medical Affairs Consortium (MAC)?

6

Participants Found the MAC to be a Valuable Service

4.6

4.4

4.2

4.3

Quality of the survey resultsdeliverable

Value of the survey resultsdeliverable to you

Quality of the roundtable discussion

Value of the roundtable discussion

Q. Please rate each of the following areas on the 1-5 scale.

Note: Excellent = 5 // Good = 4 // Fair = 3 // Needs Improvement = 2 // Poor = 1

N=10

Q. Would you repurchase the consortium and roundtable

discussions next year?

100% Replied Yes

Q. Would you recommend the consortium and roundtable

discussions to other Medical Affairs colleagues outside your

company?

100% Replied Yes

All the clients mentioned that they are willing to repurchase the consortium service as well as recommend it to their MA peers.

Client Satisfaction Survey Outcomes

Benefits of Becoming a MAC Member

6

Live Discussions With Other

Leaders About

Medical Affairs Issues

Access To The Best Practices’ Medical Affairs

DatabaseQuarterly

Live Webinars By

Best Practices’ Advisors

Three Part Reports and Customized

“Health” Check

Access To Best

Practices’ Research Advisors

Research Updates

Providing The Latest

Trends

MEDICAL AFFAIRS

CONSORTIUM

Live Discussions With Other

Leaders About

Medical Affairs Issues

Access To The Best Practices’ Medical Affairs

DatabaseQuarterly

Live Webinars By

Best Practices’ Advisors

Three Part Reports and Customized

“Health” Check

Access To Best

Practices’ Research Advisors

Research Updates

Providing The Latest

Trends

MEDICAL AFFAIRS

CONSORTIUM

6

Medical Affairs Consortium Timeline

Month-I Month-II Month-III Month-IV Month-V Month-VI Month-VII Month-VIII Month-IX Month-X Month-XI Month-XII

30-45 days

Survey Creation and Launch75-90 days

Data Analysis,Secondary Research & 1st Roundtable Client

Deliverable

1st RT*

30 days

1st Roundtable Summary Deliverable 45-60 days

Data Analysis,Secondary Research &

2nd Roundtable Client

Deliverable

2nd

RT*

30 days

2nd Roundtable Summary

Deliverable

3rd

RT*

45-60 days

Data Analysis,Secondary Research &

3rd Roundtable Client

Deliverable

30 days

3rd Roundtable Summary

Deliverable* Note: RT= RoundtableThe roundtable times are open to change (15-day range) for adjustment to members’ schedules.

A Majority of Survey Participants were from Mature MarketsSeventy-seven top biopharmaceutical executives responded to the three-part Medical Affairs Consortium survey during the 2014-2015 fiscal year. We created several segments based on location and company size through the responses that we got.

Color Code:Lower Number Higher Number

Universe of Learning: Research Participants from 2014 - 2015 StudyWe created several different segments through the responses that we gathered. You can see an example of company size based segmentation below.

Benchmark Class

4

Large Companies(Revenue > $10 Billion US in 2013) 

Mid‐Cap Companies($1‐10 Billion US in 2013)

Small‐Cap Companies (< $1 Billion US in 2013)

Company Size Based Segments

6

Medical Affairs Consortium is A Three-Part Annual ProjectWe create a different set of research every year after conversations with members. Member requests determine the Medical Affairs Consortium topics. The 2015 Medical Affairs Consortium was composed of the following three topical areas:

Developing Top-Tier Medical Affairs

Capabilities

• Effective Metrics for Medical Affairs Activities to Show Success to Stakeholders

• Communicating the Value of Medical Affairs• Coordinating the Global Medical Affairs Function• Managing Compliance and Information Exchange

Topics Research Areas

Medical Affairs Launch Support

Excellence

• Important Medical Affairs’ Activities that Support Launch • Thought Leader Tiering• Thought Leader Targeting and MSL Coverage• Launch Investment Level• Medical Affairs Launch Budget Allocation

Medical Affairs’ Critical Role in

Health Economics & Outcomes Research

• Longevity of Health Outcomes (HO) Groups• HO Group Leadership and Reporting Structure• HO Group Staff Levels• Medical Affairs’ Role in HO Activities• Medical Affairs Activities to Lead HO Data Collection and Utilization• Impact of HO Data on Important Medical Affairs Decisions

2015 MAC Research Parts

Copyright ©  Best Practices, LLC 11

Developing Top-Tier Medical Affairs Capabilities

Importance of Activities Changes According To Company Size

Company Size Influences Activities That Are Given Priority

38

Activity Benchmark Class

Large Companies

Mid-SizeCompanies

Small Companies

Medical publications and com.

Thought Leader Management

Field-based medical team activities

HEOR

Alignment of company strategies with MA practices

Medical/Clinical operations

Continuing MedEd

Medical call centers

Internal training for commercial

Highest ImportanceLowest Importance

N= 28

While all of the large and mid-size companies segment think that field-based medical team operations and outcomes data utilization are very important or important for their senior management team, only three-fourths of the small company segment associates similar importance with these activities

N=11 N=10 N=7

Relevance to Senior Management: Please rank the relative importance of the following Medical Affairs activities to your senior leadership.

Page 13

asdasd

Indirect Reporting

Channels (e-mail, online reports)

Medical CallCenters

MedCom TLM

Clinical Operations

MedEd

InternalTraining

MSL TeamsHEOR Alignment of

Activities

High Importance to Senior Management

Low Importance toSenior Management

Direct F-to-F Reporting Channels

(Meeting, Presentations,

Briefings)

N=28

Savvy MA Leaders Align Topic Importance with Communication Channel

High External Focus

Both Internal andExternal Focus

High Internal Focus

Medical Affairs Topic/Channel Impact Map

Note: Size of the circles represents reporting level. Activities with high internal focus: Majority of the work is processed internally.Activities with high external focus: Majority of the work is related to external stakeholders (Ex:Payers, Providers, Patients, etc…)

More than 90% of the benchmark class believes that their senior management finds three Medical Affairs areas highly importantor important: Field-based medical teams operations, medical publications and communications and thought leader management.

Relevance to Senior Management: Please rank the relative importance of the following Medical Affairs activities to your senior leadership

Formal or Informal Meetings Are the Leading Communication Channel for Sharing Compliance

Sharing Compliance Challenges and Best Practices: How do you share compliance challenges and best practices across global and regional level?

Nearly 70% percent of the benchmark class prefers formal regional and global meetings to share compliance challenges and best practices. In addition, half of the participants also arrange informal / ad-hoc meetings and 25% use a company-wide software to communicate compliance information.

69%

50%

44%

25%

12%

Formal Regional and Global Meetings

Informal / Ad‐hoc regional and global meetings

Online updates (Ex: e‐mail, website, etc.)

Company‐wide software

Do not share compliance related information

Sharing Compliance Challenges and Best Practices

N=15% Respondents

47

Copyright ©  Best Practices, LLC 15

Medical Affairs Launch Support Excellence

MA leads two launch activities for 93% of the benchmark class: Scientific Publications and MSL Activities. In addition, the MA function is either leading or supporting Advisory Boards, TL Activities and Investigator & Site Identification in all participant companies.

N=27

Medical Affairs' Role: Please identify Medical Affairs’ role in each of the following activities that take place during launch and pre-launch phases.

93%

93%

86%

86%

61%

57%

41%

39%

37%

26%

22%

7%

14%

14%

21%

21%

59%

57%

44%

63%

59%

7%

7%

7%

4% 4%

4%

11%

14%

4%

15%

7%

15%

Scientific publications

MSL activites

Advisory boards

TL identification & development

Continuing medical educaion

Real world data generation & analysis

Investigator and site identification

Speaker training

Protocol design

Study/Site support & trouble shooting

Clinical research conduct

MA's Role in Launch Activities – Total Benchmark Class (TBC)Lead Support Plan to Participate in the Next 12 Months None

% Respondents

16

Majority Say MA Leads 6 out of 11 Launch Activities

At the earlier stage of pre-launch, companies focus on TL related factors such as TL’s patient demographics, Influence Network and Expertise. At the later stage of pre-launch, companies focus on a mix of factors, such as Product Qualifications, Therapeutic Area, Regional Diversity, Company’s Relationship with the TL.

TL’s Patient Demographic

TL’s Expertise

TL’s Influence Network

Therapeutic Area

Product Qualifications

TL’s Scientific Publications

Regional Diversity

Behavioral Segmentation

Pre-Launch Post-Launch

TL’s Experience

Company’s Relationship with the TL

“Creating a cross-functional plan for TL development before launch is a role that Medical Affairs can play successfully. TL management planning has to start way in advance because Medical Affairs needs time to prepare the market for disease awareness, understand key decision makers’ needs and create a value-based launch strategy for products.”

- Interviewed VP, Medical Affairs (Company B)

Timing of Strategies Used for Thought-Leader (TL) Tiering

TL Segmentation Starts Early In the Pre-Launch Stage

17Note: Pre-Launch captures 12-18 months before launch. Post-launch captures 12-18 months after launch. Launch

MA Presents Higher Percentage of Total Investment after LaunchMedical Affairs’ share in total launch investment increased from 18% to 20% during pre- and post-launch periods.

N=6‐9

$16,508,000 $19,080,000

$3,006,250 $3,757,143

Launch Investment

Average Launch Investment Average MA Launch Investment

18% 20%

18

Launch Investment: Please indicate the total and global MA launch investment for the product you supported during each time period.

Note: Pre-Launch captures 12-18 months before launch. Post-launch captures 12-18 months after launch.

Pre-Launch Post-Launch

Copyright ©  Best Practices, LLC 19

Medical Affairs’ Critical Role in Health Economics &Outcomes Research

20

Health Outcomes Shifts to Whom It Reports in Last 4 Years

45%39%

52%

11% 11%17%

27%

4%

2009 (N=33) 2011 (N=18) 2015 (N=23)

Change in Reporting StructureMedical Affairs Clinical Affairs Sales and Marketing

“I think if you have somebody with the right vision, it doesn't necessarily matter where the HO department is sitting, but I believe you have higher chances to find somebody with a right vision in Medical Affairs.

The commercial function might not have as much understanding of what health outcomes really entails to. As a result, commercial may see this critical function as a very narrow role.”

- VP, Medical Affairs – Company B

Reporting Structure: To whom does the Health Outcomes group(s) report?

While 52% of the HO groups report to Medical Affairs within the benchmark class, a quarter of the companies’ HO groups do notreport to clinical affairs, medical affairs or commercial. Since HO is a recent trend, some companies still haven’t clarified the reporting structure for these groups.

Type of Health Outcomes Data Used Changes with the Audience

N=18

Utilizing the Health Outcomes Data: Choose the top three type of Health Outcomes data that you use with the following stakeholders:

Use of HO Data to Inform Different Stakeholders

Patients ProvidersIncreasing Use

Incr

easin

g Us

e

Workplace productivity

Analysis of safety

Resource use

Cost AnalysisAnalysis of efficacy

Economic analysis

Quality of life

Burden of illness

Type of HO Data Mostly Used with

Payers and Patients

Type of HO Data Mostly Used

with Payers and Providers

Type of HO Data Mostly Used with Providers

Payers

While payers are interested in learning about cost analysis and overall economic impact of a certain product, patients need to understand the impact of the product on quality of life and providers want to know about disease management aspect and safetyprofile of the products.

Health Outcomes Data Utilized for Research Decisions in Young Groups, for Market Access Decisions in Older Groups

22N=18 Company Size

Mat

urity

of H

O G

roup

HO Program≥ 4Yrs.

HO Program< 4Yrs.

Medium & Small Companies.

Large Companies

Effect of HO Data on Critical Decisions

Identifying future Health Outcomes

research areas

Generating market access strategies

Creating scientific publication strategies

Reimbursement strategies

Creating drug formulary inclusion

tactics

Generating supportive materials

for marketing

Clinical trials and development

Supporting price forecast

Mature HO Groups Young HO Groups

Mature HO groups know how to utilize

HO Data for reimbursement and

market access

Young HO groups utilize HO Data

mostly to create clinical and scientific research strategies

While HO data heavily informs scientific research decisions in companies with young HO groups, this type of data is used more for Market Access purpose in companies with mature HO groups.

Informing Decisions: How effective is the Health Outcomes data to inform following decisions within the Medical Affairs function?

Generalist Model Provides A Better Fit for HO Data Communication

Generalist vs. Specialist Models

Inquiry Resolved

Inquiry Resolved

Customer

Customer

Specialist HOLs

Generalist HOL

• Interviewed executives tend to favor a generalist model, with HOLs typically covering all major products for an assigned region.

• The preference for generalization over specialization by product or therapeutic area is customer driven, with customers favoring “one stop shopping” and a single point of contact.

• To ensure that “generalists” have deep as well as broad knowledge, companies provide high volumes of training.

Biopharmaceutical companies are favoring a generalist model for their field-based HO staff.

About Best Practices, LLC

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Best Practices®, LLC is an internationally recognized thought leader in the field of best practicebenchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm thatconducts work based on the simple yet profound principle that organizations can chart a course to superioreconomic performance by leveraging the best business practices, operating tactics and winning strategies ofworld-class companies.

6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517(Phone): 919-403-0251www.best-in-class.com

Learn More About Our Company:

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Abbreviations & Definitions

26

BEST PRACTICES,®

LLCCopyright ©

Abbreviations & Definitions

6

• MAC: Medical Affairs Consortium

• MA: Medical Affairs

• HO: Health Outcomes

• HEOR: Health Economics and Outcomes Research

• RT: Roundtable

• MSL: Medical Science Liaison

• TL: Thought Leader

• TLM: Thought Leader Management

• LCS: Large Companies Segment

• MCS: Medium-Size Companies Segment

• SCS: Small Companies Segment