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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:


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?


With This Report You Will Be Able To:


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.


Key Topics Explored

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.


Expert Contributors To The Report:

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

Table Of Contents

The Role of Medical Affairs in a Successful Commercial Launch
1Executive summary 1
2Methodology and objectives3
3Contributors 4
4Introduction 5
41The key elements of medical affairs 7
5The medical affairs role builds from early development to pre-launch9
51When is medical affairs first involved with a potential new medicine?9
52Involvement from concept9
53Strategic involvement from early clinical trials10
54Increased activity during Phase III 12
6Planning for product launch14
61Working with the commercial team 14
62How can the medical function be more influential?16
63Evidence generation beyond the registration package 18
64Early engagement is vital for market access18
65Aligning market access with medical affairs19
66Generating the right evidence20
67Establishing what evidence will be required for reimbursement20
68Payer requirements vary 21
69Planning the medical affairs study programme 24
610Medical affairs studies add value to the RandD studies 24
611Understanding the data gaps24
612Deciding on a study programme25
613Being prepared for Phase IIIb and Phase IV26
614Planning local studies28
615Early real-world studies 28
617Developing a communications strategy30
618Strategic partnerships and customer engagement34
619KOL identification and mapping 34
620Medical provides expertise and credibility 36
621Advisory boards 38
622MSLs can help to identify local needs40
623Medical affairs as the bridge between RandD and commercial42
624Medical affairs activity increases from regulatory filing44
625Internal training 45
626MSL training45
627Sales and marketing 46
628The changing MSL role following regulatory approval 47
7Launch and post-launch48
71The medical affairs role broadens after initial launch48
72Product launch is an evolving process50
8Challenges remain for medical affairs53
81Financial resources and planning53
82Medical affairs still viewed as gatekeepers55
9Key findings58




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