This presentation gives an insight into the membership benefits of Best Practices, LLC’s Medical Affairs Consortium. It also highlights some of the key benchmarks and best practices that emerged from Medical Affairs Consortium.
The Medical Affairs Consortium at Best Practices, LLC provides a dedicated platform to Medical Affairs Leaders to discuss top challenges, develop action oriented solutions, share best practices & lessons learned and explore current and future trends with regards to the Medical Affairs function and its interactions with other critical functions.
Topics for the Medical Affairs Consortium are usually determined by member requests. The Medical Affairs Consortium addresses three key areas:
• Building Strong Medical Affairs Capabilities
• Medical Affairs Launch Support Excellence
• Medical Affairs’ Critical Role in Health Economics & Outcomes Research
2. 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
4. 6
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)?
5. 6
Participants Found the MAC to be a Valuable Service
4.6
4.4
4.2
4.3
Quality of the survey results
deliverable
Value of the survey results
deliverable 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
6. Benefits of Becoming a MAC Member
6
Live
Discussions
With Other
Leaders
About
Medical
Affairs Issues
Access To
The Best
Practices’
Medical
Affairs
Database
Quarterly
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
Database
Quarterly
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
7. 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 Launch
75-90 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= Roundtable
The roundtable times are open to change (15-day range) for adjustment to members’ schedules.
8. A Majority of Survey Participants were from Mature Markets
Seventy-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
9. Universe of Learning: Research Participants from 2014 - 2015 Study
We 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
10. 6
Medical Affairs Consortium is A Three-Part Annual Project
We 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
12. Importance of Activities Changes According To Company Size
Company Size Influences Activities That Are Given Priority
38
Activity
Benchmark
Class
Large
Companies
Mid-Size
Companies
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 Importance
Lowest 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.
13. Page 13
asd
asd
Indirect
Reporting
Channels (e-mail,
online reports)
Medical Call
Centers
MedCom TLM
Clinical
Operations
MedEd
Internal
Training
MSL
Teams
HEOR Alignment of
Activities
High Importance to
Senior Management
Low Importance to
Senior 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 and
External 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 important
or 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
14. 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
16. 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
17. 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
17
Note: Pre-Launch captures 12-18 months before launch.
Post-launch captures 12-18 months after launch. Launch
18. MA Presents Higher Percentage of Total Investment after Launch
Medical 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
20. 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 Structure
Medical 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 not
report 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.
21. 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 Providers
Increasing Use
IncreasingUse
Workplace
productivity
Analysis of safety
Resource use
Cost Analysis
Analysis 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 safety
profile of the products.
22. Health Outcomes Data Utilized for Research Decisions in Young Groups, for
Market Access Decisions in Older Groups
22
N=18
Company Size
MaturityofHOGroup
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?
23. 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.
25. Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that
conducts work based on the simple yet profound principle that organizations can chart a course to superior
economic performance by leveraging the best business practices, operating tactics and winning strategies of
world-class companies.
6350 Quadrangle Drive, Suite 200
Chapel Hill, NC 27517
(Phone): 919-403-0251
www.best-in-class.com
Learn More About Our Company:
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