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Best Practices, LLC Strategic Benchmarking Research
Best Practices and the Role of Medical
Affairs in Oncology Launch Excellence
1
Table of Contents
 Executive Summary pp. 3-8
 Research Overview pp. 3
 Participating Companies pp. 4
 Key Recommendations pp. 5
 Abbreviations pp. 6
 Key Findings & Insights pp. 7-8
 Medical Affairs' Role in Launch Activities pp. 9-12
 Thought Leader Tiering pp. 13-16
 Thought Leader Targeting and MSL Coverage pp. 17-22
 Launch Investment pp. 23-27
 Medical Affairs Investment Allocation pp. 28-30
 Participant Overview pp. 31-34
 About Best Practices, LLC pp. 35-36
2
Field Research & Insight Development:
Eleven survey responses from Medical Affairs leaders at
biopharmaceutical companies within mature markets.
Additional deep - dive interviews with 5 selected Medical
Affairs executives - 4 VPs and 1 Sr. Medical Affairs Director.
Provide Leading Insights on:
• Identify critical success
factors for a strong Medical
Affairs launch support
• Define strategies for TL
targeting and communication
Research Objectives & Methodology
Research Objectives:
 Illustrate how Medical Affairs is involved in the launch process in leading Pharma and Biotech
companies focused on oncology therapies
 Highlight strategies for effective thought leader (TL) segmentation and relationship management
 Understand challenges in managing successful Medical Affairs launch support
 Identify industry drivers regarding new product commercialization
 Explore critical strategies for allocating Medical Affairs launch budget effectively
Business Objective:
This research delivers current data, insights and best practices from Medical Affairs leaders at top biopharmaceutical
companies. The benchmark data in this study will help companies focused on oncology therapies find better ways to develop
successful launch strategies.
3
Universe of Learning: Research Participants
This study engaged 11 executives from leading life sciences companies. The study analyzes companies that focus on oncology
therapies.
Benchmark Class
4
Segments and Abbreviations
5
Abbreviations:
• FBMT: Field-Based Medical Team
• Medical Affairs : Medical Affairs
• MedEd: Medical Education
• MedCom: Medical Communications
• MSL: Medical Science Liaison
• TA: Therapeutic Areas
• TBC: Total Benchmark Class
• TL: Thought Leader
• TLM: Thought Leader Management
Key Findings & Insights: Medical Affairs Launch Support Excellence
 Medical Affairs’ Role in Launch Activities: Medical Affairs is heavily involved in four launch activities
within participating organizations: Scientific Publications, Continuing Medical Education, Real World Data
Generation & Analysis, MSL activities.
 Medical Affairs leads TL Activities and plays a key role between companies and decision makers
during launch process. This requires companies to create strong MSL teams, acquire the right talent
and provide effective training.
 Medical Affairs also plays a critical role in internal education and guiding commercial strategies
regarding products. This provides Medical Affairs leaders with the opportunity to convey the needs
of key decision makers, thus companies to improve their products.
 Medical Affairs Investment Allocation: We have observed significant changes in Medical Affairs
investment allocation for two Medical Affairs activities between pre-launch and post-launch: Medical
Clinical Research Operations and Medical Education.
 Medical Affairs budget allocation must be flexible so that investment to certain areas can be
increased during launch.
 Activities related to communicating with thought leaders are crucial during launch process and
require a significant increase in budget allocation.
The following key findings and insights emerged from this study.
6
Medical Affairs leads scientific publications in 90% of companies. Continuing medical education, real world data generation
& analysis, and MSL activities are the next most lead Medical Affairs' launch activities.
N=10 - 11
Medical Affairs' Role: Please identify Medical Affairs’ role in each of the following activities that take place during
launch and pre-launch phases.
% Respondents
7
Majority Say Medical Affairs Leads 5 out of 9 Launch Activities
90%
80%
80%
80%
60%
50%
40%
40%
40%
10%
10%
10%
40%
40%
60%
60%
40%
10%
20%
10%
10%
20%
Scientific publications
Continuing medical educaion
Real world data generation & analysis
MSL activites
Investigator and site identification
Protocol design
Speaker training
Study/Site support & trouble shooting
Clinical research conduct
Medical Affairs' Role in Launch Activities
Lead Support Plan to Participate in the Next 12 Months None
Launch Increases Medical Affairs Resource Allocation for Medical
Education and Outcomes Research
Medical Affairs' investment in the medical/clinical research operations is ceased after the launch, and distributed to Medical
Education and Outcomes Research.
N=5 % Respondents
Investment Allocation: Please indicate the percentage of total Medical Affairs launch investment allocated to
each of the following Medical Affairs activities during each time period.
8
33%
16%
12%
12%
12%
8%
7%
8%
13%
15%
11%
9%
Field-based medical team investment
Medical/Clinical research operations
Medical communications and publications
Thought leader management
Medical education
Medical information / call centers
Outcomes research
Medical Affairs Investment Allocation
Pre-Launch Post-Launch
Role of Payers and Patients is Becoming More Critical
The life sciences industry is going through important changes on the company, product and market levels.
Past Now Future
Company
Market
• High focus on Primary Care
• Mature markets oriented
commercial strategies
• High focus on Specialty Care
• Increased interest in
emerging markets
• Low communication with
key decision makers at the
product development stage
• Prescribers are the primary
target
• Competition is high among
only branded products
• High focus on Specialty Care
• Increased investment in
emerging markets
• Payers are more dominant
in decision making
• Critical to work with decision
makers with strong
influence network
• More competition, as more
generics come into the
market after patent
expirations
• Increasing importance of
patients in addition to
payers
• Higher interest in value-
based decision making
• HEOR data is having a
more critical effect on
decision making
Product
• High focus on brand
management, marketing
and sales
• Low attention on payers,
pricing and health
economics
• Small molecule products
with high patent risk
• High focus on payer
marketing and market
development
• Creation of value-based
strategies
• More complex molecules
with less patent risk
• High focus on early stage
commercial assessment
• More usage of payer
insights to guide evidence
generating clinical programs
• Higher product complexity:
Genetic profiling and
biomarkers
9
About Best Practices, LLC
10
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:
11

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Medical Affairs Role in Oncology Launch

  • 1. Best Practices, LLC Strategic Benchmarking Research Best Practices and the Role of Medical Affairs in Oncology Launch Excellence 1
  • 2. Table of Contents  Executive Summary pp. 3-8  Research Overview pp. 3  Participating Companies pp. 4  Key Recommendations pp. 5  Abbreviations pp. 6  Key Findings & Insights pp. 7-8  Medical Affairs' Role in Launch Activities pp. 9-12  Thought Leader Tiering pp. 13-16  Thought Leader Targeting and MSL Coverage pp. 17-22  Launch Investment pp. 23-27  Medical Affairs Investment Allocation pp. 28-30  Participant Overview pp. 31-34  About Best Practices, LLC pp. 35-36 2
  • 3. Field Research & Insight Development: Eleven survey responses from Medical Affairs leaders at biopharmaceutical companies within mature markets. Additional deep - dive interviews with 5 selected Medical Affairs executives - 4 VPs and 1 Sr. Medical Affairs Director. Provide Leading Insights on: • Identify critical success factors for a strong Medical Affairs launch support • Define strategies for TL targeting and communication Research Objectives & Methodology Research Objectives:  Illustrate how Medical Affairs is involved in the launch process in leading Pharma and Biotech companies focused on oncology therapies  Highlight strategies for effective thought leader (TL) segmentation and relationship management  Understand challenges in managing successful Medical Affairs launch support  Identify industry drivers regarding new product commercialization  Explore critical strategies for allocating Medical Affairs launch budget effectively Business Objective: This research delivers current data, insights and best practices from Medical Affairs leaders at top biopharmaceutical companies. The benchmark data in this study will help companies focused on oncology therapies find better ways to develop successful launch strategies. 3
  • 4. Universe of Learning: Research Participants This study engaged 11 executives from leading life sciences companies. The study analyzes companies that focus on oncology therapies. Benchmark Class 4
  • 5. Segments and Abbreviations 5 Abbreviations: • FBMT: Field-Based Medical Team • Medical Affairs : Medical Affairs • MedEd: Medical Education • MedCom: Medical Communications • MSL: Medical Science Liaison • TA: Therapeutic Areas • TBC: Total Benchmark Class • TL: Thought Leader • TLM: Thought Leader Management
  • 6. Key Findings & Insights: Medical Affairs Launch Support Excellence  Medical Affairs’ Role in Launch Activities: Medical Affairs is heavily involved in four launch activities within participating organizations: Scientific Publications, Continuing Medical Education, Real World Data Generation & Analysis, MSL activities.  Medical Affairs leads TL Activities and plays a key role between companies and decision makers during launch process. This requires companies to create strong MSL teams, acquire the right talent and provide effective training.  Medical Affairs also plays a critical role in internal education and guiding commercial strategies regarding products. This provides Medical Affairs leaders with the opportunity to convey the needs of key decision makers, thus companies to improve their products.  Medical Affairs Investment Allocation: We have observed significant changes in Medical Affairs investment allocation for two Medical Affairs activities between pre-launch and post-launch: Medical Clinical Research Operations and Medical Education.  Medical Affairs budget allocation must be flexible so that investment to certain areas can be increased during launch.  Activities related to communicating with thought leaders are crucial during launch process and require a significant increase in budget allocation. The following key findings and insights emerged from this study. 6
  • 7. Medical Affairs leads scientific publications in 90% of companies. Continuing medical education, real world data generation & analysis, and MSL activities are the next most lead Medical Affairs' launch activities. N=10 - 11 Medical Affairs' Role: Please identify Medical Affairs’ role in each of the following activities that take place during launch and pre-launch phases. % Respondents 7 Majority Say Medical Affairs Leads 5 out of 9 Launch Activities 90% 80% 80% 80% 60% 50% 40% 40% 40% 10% 10% 10% 40% 40% 60% 60% 40% 10% 20% 10% 10% 20% Scientific publications Continuing medical educaion Real world data generation & analysis MSL activites Investigator and site identification Protocol design Speaker training Study/Site support & trouble shooting Clinical research conduct Medical Affairs' Role in Launch Activities Lead Support Plan to Participate in the Next 12 Months None
  • 8. Launch Increases Medical Affairs Resource Allocation for Medical Education and Outcomes Research Medical Affairs' investment in the medical/clinical research operations is ceased after the launch, and distributed to Medical Education and Outcomes Research. N=5 % Respondents Investment Allocation: Please indicate the percentage of total Medical Affairs launch investment allocated to each of the following Medical Affairs activities during each time period. 8 33% 16% 12% 12% 12% 8% 7% 8% 13% 15% 11% 9% Field-based medical team investment Medical/Clinical research operations Medical communications and publications Thought leader management Medical education Medical information / call centers Outcomes research Medical Affairs Investment Allocation Pre-Launch Post-Launch
  • 9. Role of Payers and Patients is Becoming More Critical The life sciences industry is going through important changes on the company, product and market levels. Past Now Future Company Market • High focus on Primary Care • Mature markets oriented commercial strategies • High focus on Specialty Care • Increased interest in emerging markets • Low communication with key decision makers at the product development stage • Prescribers are the primary target • Competition is high among only branded products • High focus on Specialty Care • Increased investment in emerging markets • Payers are more dominant in decision making • Critical to work with decision makers with strong influence network • More competition, as more generics come into the market after patent expirations • Increasing importance of patients in addition to payers • Higher interest in value- based decision making • HEOR data is having a more critical effect on decision making Product • High focus on brand management, marketing and sales • Low attention on payers, pricing and health economics • Small molecule products with high patent risk • High focus on payer marketing and market development • Creation of value-based strategies • More complex molecules with less patent risk • High focus on early stage commercial assessment • More usage of payer insights to guide evidence generating clinical programs • Higher product complexity: Genetic profiling and biomarkers 9
  • 11. 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: 11