The Role of Medical Affairs in a Successful Commercial Launch
Drive greater product launch success by fully engaging the medical affairs department. Ensure maximum exposure and positive uptake of new therapies by harnessing their talents in scientific interpretation, evidence gathering, trial planning and KOL/payer engagement.
The Role of Medical Affairs in a Successful Commercial Launch is a research-based expert views report for industry management who must plan and execute product launch strategies. The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. Learn from the experience of 8 medical affairs professionals working for major pharma/biotech companies in the US and Europe.
Answering Key Questions:
FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.
FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.
The Role of Medical Affairs in a Successful Commercial Launch is a research-based expert views report for industry management who must plan and execute product launch strategies. The report is packed with actionable insights on how and where medical affairs can play a critical role in pre and post launch. Learn from the experience of 8 medical affairs professionals working for major pharma/biotech companies in the US and Europe.
Answering Key Questions:
- Early engagement: KOLs play a critical role in the clinical development of a product. At what development stage should medical affairs get involved as the potential new product progresses to launch?
- Late-stage study design: Phase III studies are critical for gaining regulatory approval – how can medical affairs help refine trial design?
- Involvement with launch planning: In what ways can medical affairs support their commercial colleagues and when should they get involved with launch planning?
- Evidence gathering: How do medical affairs studies contribute to a successful launch and how can “real world” studies help refine the value proposition?
- Effective communications: In which areas can medical affairs be influential when developing communication strategies that meets the needs of multiple stakeholders?
- Getting the message across: How can medical affairs play a critical role in training MSLs and commercial staff to ensure consistent and evidence-based product messaging?
- Post launch involvement: The broadening role of medical affairs after launch is becoming critical. Where, how and why?
- Market Access: What are the arguments for medical affairs taking a wider role in market access?
- Know why it is critical to involve medical affairs throughout the clinical development phase of a drug.
- Harness your medical team’s expertise for optimum product positioning.
- Build a powerful evidence-based case for your product through well thought out studies and research.
- Benefit from real world knowledge gained by MSL engagement with clinical experts and stakeholders.
- Use medical affairs to establish clear evidence-based communications and consistent product messaging.
- Appreciate to what extent medical affairs activity now goes well beyond data dissemination and governance.
- Understand key internal challenges medical affairs departments face.
- How medical affairs can play a greater role in market access and payer engagement.
- Medical affairs teams are trusted in the health community and knowing how to leverage their high-level stakeholder contacts can bring real commercial advantage.
- Medical affairs see the bigger picture and can often identify opportunities and issues that highly focussed R&D/commercial teams miss.
- Medical affairs is the bridge between R&D and commercial, and bring benefits and insights to both.
- Medical affairs teams often struggle to secure sufficient funding and value recognition for their ever widening workload – is this a lesson for senior management?
- Bottom line: With deeper market knowledge than R&D and commercial teams, medical affairs can add real value from product concept to Phase III trials and beyond.
- Global Medical Affairs Director – Top 10 Pharma Company
- Vice-President of Medical Affairs, US – Medium-sized Pharma Company
- Medical Director – Top 10 Pharma Company
- Former Vice President, Head of Medical Affairs Europe and Canada – Top 10 Pharma Company
- Global Medical Affairs Lead – Top 10 Pharma Company
- Franchise Head, Medical Communications – Top 10 Pharma Company
- Executive Medical Director, Medical Affairs – Top 10 Pharma Company
- Global Head of R&D and Medical Affairs – Biotech Company
FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.
FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.
1. EXECUTIVE SUMMARY1
2. METHODOLOGY AND OBJECTIVES
3. CONTRIBUTORS
4. INTRODUCTION5
4.1. The key elements of medical affairs 7
5. THE MEDICAL AFFAIRS ROLE BUILDS FROM EARLY DEVELOPMENT TO PRE-LAUNCH 9
5.1. When is medical affairs first involved with a potential new medicine?.9
5.2. Involvement from concept 9
5.3. Strategic involvement from early clinical trials.10
5.4. Increased activity during Phase III12
6. PLANNING FOR PRODUCT LAUNCH 14
6.1. Working with the commercial team 14
6.2. How can the medical function be more influential? 16
6.3. Evidence generation beyond the registration package18
6.4. Early engagement is vital for market access 18
6.5. Aligning market access with medical affairs 19
6.6. Generating the right evidence.20
6.7. Establishing what evidence will be required for reimbursement 20
6.8. Payer requirements vary 21
6.9. Planning the medical affairs study programme 24
6.10. Medical affairs studies add value to the R&D studies24
6.11. Understanding the data gaps.24
6.12. Deciding on a study programme.25
6.13. Being prepared for Phase IIIb and Phase IV.26
6.14. Planning local studies.28
6.15. Early real-world studies 28
6.17. Developing a communications strategy 30
6.18. Strategic partnerships and customer engagement 34
6.19. KOL identification and mapping 34
6.20. Medical provides expertise and credibility36
6.21. Advisory boards38
6.22. MSLs can help to identify local needs 40
6.23. Medical affairs as the bridge between R&D and commercial.42
6.24. Medical affairs activity increases from regulatory filing 44
6.25. Internal training 45
6.26. MSL training 45
6.27. Sales & marketing 46
6.28. The changing MSL role following regulatory approval 47
7. LAUNCH AND POST-LAUNCH.48
7.1. The medical affairs role broadens after initial launch 48
7.2. Product launch is an evolving process 50
8. CHALLENGES REMAIN FOR MEDICAL AFFAIRS 53
8.1. Financial resources and planning 53
8.2. Medical affairs still viewed as gatekeepers.55
9. KEY FINDINGS.58
2. METHODOLOGY AND OBJECTIVES
3. CONTRIBUTORS
4. INTRODUCTION5
4.1. The key elements of medical affairs 7
5. THE MEDICAL AFFAIRS ROLE BUILDS FROM EARLY DEVELOPMENT TO PRE-LAUNCH 9
5.1. When is medical affairs first involved with a potential new medicine?.9
5.2. Involvement from concept 9
5.3. Strategic involvement from early clinical trials.10
5.4. Increased activity during Phase III12
6. PLANNING FOR PRODUCT LAUNCH 14
6.1. Working with the commercial team 14
6.2. How can the medical function be more influential? 16
6.3. Evidence generation beyond the registration package18
6.4. Early engagement is vital for market access 18
6.5. Aligning market access with medical affairs 19
6.6. Generating the right evidence.20
6.7. Establishing what evidence will be required for reimbursement 20
6.8. Payer requirements vary 21
6.9. Planning the medical affairs study programme 24
6.10. Medical affairs studies add value to the R&D studies24
6.11. Understanding the data gaps.24
6.12. Deciding on a study programme.25
6.13. Being prepared for Phase IIIb and Phase IV.26
6.14. Planning local studies.28
6.15. Early real-world studies 28
6.17. Developing a communications strategy 30
6.18. Strategic partnerships and customer engagement 34
6.19. KOL identification and mapping 34
6.20. Medical provides expertise and credibility36
6.21. Advisory boards38
6.22. MSLs can help to identify local needs 40
6.23. Medical affairs as the bridge between R&D and commercial.42
6.24. Medical affairs activity increases from regulatory filing 44
6.25. Internal training 45
6.26. MSL training 45
6.27. Sales & marketing 46
6.28. The changing MSL role following regulatory approval 47
7. LAUNCH AND POST-LAUNCH.48
7.1. The medical affairs role broadens after initial launch 48
7.2. Product launch is an evolving process 50
8. CHALLENGES REMAIN FOR MEDICAL AFFAIRS 53
8.1. Financial resources and planning 53
8.2. Medical affairs still viewed as gatekeepers.55
9. KEY FINDINGS.58
