Maximizing the Impact of Medical Affairs in Product Launch

Industries Profiled:
Pharmaceutical; Biotech; Biopharmaceutical; Chemical; Health Care; Diagnostic; Medical Device; Consumer Products; Clinical Research; Laboratories


Companies Profiled:
AbbVie; AcelRx; Alcon Laboratories; Alkermes; Alnylam Pharmaceuticals; AstraZeneca; Bausch Health; Boehringer Ingelheim; Celgene; cipla; Clovis Oncology; Crescendo Bioscience; Curis; Daiichi Sankyo; Dermira; Eisai; EMD Serono; Exelixis ; Fidia; GE Healthcare; Gedeon Richter ; GRAIL; Grifols; Imbrium Therapeutics; Lundbeck; Medacta; Merck; Merck KGaA; Merz Pharma; Novartis; Orchard Therapeutics; Roche; Sandoz; Sanofi Genzyme; Sanofi; Santen; Servier; Shire; Taiho Oncology; Takeda Pharmaceuticals; Torrent Pharmaceuticals Ltd.; Vertex Pharmaceuticals; Vifor Pharma; Zydus Cadila

Study Snapshot

Best Practices, LLC engaged over 60 Medical Affairs leaders from 44 pharmaceutical, biotechnology and medical device companies in this research study through a benchmarking survey, interviews and a roundtable discussion.

Key topics covered in this report include:

• Launch Strategy and Work Plan
• Launch Timeline Overview
• Launch Resourcing
• Launch Enablers

A. Improve cross-functional collaboration (1) and alignment (2)


1. Strengthen launch team effectiveness by setting clear roles and responsibilities for what each function, including Medical Affairs, must execute.
2. Improve launch team alignment by deploying work timelines and increasing strategy transparency 24 months before the launch.

B. Develop, deploy and adhere to a launch timeline


1. Use launch roadmap to coordinate Medical Affairs activities with other functions, understand interdependencies, and prioritize activities and funding allocation.
2. Start early to ensure sufficient funding and timing to deliver on activities.

C. Develop and deploy launch enablers to ensure continuous improvement and efficient processes


1. Develop and deploy strategic performance metrics along with more tactical metrics.
2. Share best practices, work progress and critical information through a launch room (war room).
3. Enable a feedback loop to leverage insights from the field to influence launch team’s activities.

I.	Study Findings	4
	Executive Recommendations	4
II.	Launch Strategy and Work Plan	5
	Medical Affairs Role and Activity Effectiveness	14
	Ensuring Cross-functional Alignment and Collaboration	19
	Adapting to Ongoing Changes in Medical Affairs Landscape	23
	Medical Affairs Leading vs. Supporting Launch Teams	28
III.	Launch Timeline Overview	34
IV.	Launch Resourcing	44
V.	Launch Enablers	49
	Launch Preparedness Metrics	49
	Critical Success Factors and Major Pitfalls	54
	Technology	59
VI.	Appendix	63
	Full Recommendations	63
	Participant Demographics	67
	Medical Affairs Role and Activity Effectiveness	69
	Launch Timeline	76
	Glossary	81

• Product launch: Medical Affairs role through 1990s to 2019 and beyond
• Structure of the launch framework
• Laying the groundwork for Medical Affairs launch excellence
• Understanding the disease landscape
• Setting medical strategic imperatives
• Setting aspirational behaviors for key stakeholders
• Planning stakeholder engagement
• Planning resourcing and facilitating cross-functional collaboration

• Growth in Medical Affairs’ role across multiple areas in recent years
• Lead and support role of Medical Affairs
• Medical Affairs’ effectiveness in launch activities

• Collaboration with internal groups to ensure successful launch
• Medical Affairs’ role in cross-functional teams
• Tactics to improve cross-functional collaboration and work alignment

• Medical Affairs’ focus area
• Change in Medical Affairs’ launch role within the last 3 years – Research and data generation
• Change in Medical Affairs’ launch role within the last 3 years – Data dissemination and communication
• Change in Medical Affairs’ launch role within the last 3 years – Education and organizational support

• Medical Affairs’ role in cross-functional launch teams
• Leading/co-leading and supporting role played by Medical Affairs in different launch-related activities
• Launch phase in which Medical Affairs groups lead/co-lead or support activities
• Major pitfalls encountered by Medical Affairs during launch
• Factors that facilitate Medical Affairs leadership and benefits of leading the launch team

• Actual vs. ideal time to start launch activities

• Launch timeline – Planning and budgeting Medical Affairs work
• Launch timeline – Building Medical Affairs team and deploying progress trackers
• Launch timeline – Organizational support and data generation
• Launch timeline – Education and advisory boards
• Launch timeline – Leading internal communication and building medical data
• Launch timeline – Publications and medical congresses
• Launch timeline – Engaging key external stakeholders

• Medical Affairs staffing and investment breakdown before and post launch
• Medical Affairs launch investment per medical FTE
• Before and post launch budget allocation for key activities
• Before and post launch staffing allocation for key activities

• Existence of launch dashboard at benchmark companies and reported metrics usage by category type
• Potential drug launch metrics (reported & Best Practices generated) – Strategy planning, project management, education and organizational support
• Potential drug launch metrics (reported & Best Practices generated) – Communications and stakeholder engagement
• Potential drug launch metrics (reported & Best Practices generated) – Stakeholder engagement

• Critical factors that drive successful launch for Medical Affairs
• Six steps to a stronger launch
• Major pitfalls for Medical Affairs during launch
• Six pitfall areas at launch

• Communication tools used by Medical Affairs during launch and their relative popularity
• CRM and collaboration tools used by Medical Affairs during launch and their relative popularity
• Content management and materials building tools used by Medical Affairs during launch and their relative popularity

• Complete executive insights and recommendations
• Participant therapeutic areas
• Medical Affairs’ role in launch planning and research activities
• Medical Affairs’ role in education, data dissemination and organizational support activities
• Effectiveness of launch research activities
• Effectiveness of education activities
• Effectiveness of communication and data dissemination activities
• Effectiveness of Medical Affairs organizational support activities
• Involvement of Medical Affairs in evidence generation and FBM related launch activities
• Involvement of Medical Affairs in medical information and regulatory related launch activities
• Involvement of Medical Affairs in HEOR and medical/scientific communication related launch activities
• Involvement of Medical Affairs in independent medical education and external engagement/collaboration related launch activities
• Glossary