Maximizing the Impact of Medical Affairs in Oncology Product Launches

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Chemical; Health Care; Diagnostic; Medical Device


Companies Profiled:
AbbVie; Alkermes; AstraZeneca; Boehringer Ingelheim; Celgene; Cipla; Clovis Oncology; Crescendo Bioscience; Curis; Daiichi Sankyo; Eisai; Exelixis ; GRAIL; Merck; Merck KGaA; Novartis; Roche; Sandoz; Sanofi Genzyme; Servier; Shire; Taiho Oncology; Takeda Pharmaceuticals; Torrent Pharmaceuticals Ltd.; Zydus Cadila

Study Snapshot

Best Practices, LLC engaged over 35 oncology Medical Affairs experts from 25 pharmaceutical and biotechnology companies in this research study through a benchmarking survey, interviews and a roundtable discussion.

Key topics covered in this report include:

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

• Develop, deploy and stick to a launch timeline: Use launch roadmap to coordinate the Medical Affairs activities with other functions, understand interdependencies, and which activities to prioritize and where to allocate funding
  
  
  • Develop timeline for critical launch activities around strategy, research, communications, data generation and other activities. Specify discrete and continuous activities.
  • Have a full Medical Affairs team 18-24 months before the launch, including securing the Medical Affairs field resources, leadership and project management milestones.

Sr. No.	Topic	Slide No.
I.	Launch Strategy and Work Plan	7
	Medical Affairs Role and Activity Effectiveness	15
	Ensuring Cross-functional Alignment and Collaboration	20
	Adapting to Ongoing Changes in Medical Affairs Landscape	24
	Medical Affairs Leading vs. Supporting Brand Teams	29
II.	Launch Timeline Overview	35
	Launch Timeline Details	37
III.	Launch Resourcing	45
IV.	Launch Enablers	50
	Technology	50
	Launch Preparedness Metrics	53
	Critical Success Factors and Major Pitfall	58
V.	Appendix	63
	Medical Affairs Role and Activity Effectiveness	63
	Launch Timeline	70
	Glossary	75

• Structuring the oncology launch framework
• Laying the groundwork for Medical Affairs oncology launch excellence
• Understanding the oncology disease landscape
• Setting medical strategic imperatives: Oncology launch value pyramid
• Setting aspirational behaviors for key stakeholders
• Planning oncology stakeholder engagement
• Planning resourcing and facilitating cross-functional collaboration

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

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

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

• Medical Affairs’ role in cross-functional oncology launch teams
• Leading/co-leading and supporting role played by Medical Affairs in different launch-related activities
• Oncology launch phase in which Medical Affairs groups lead/co-lead or support activities
• Major pitfalls encountered by Medical Affairs during oncology launch
• Drivers and benefits of leading/co-leading brand launch team in oncology

• Actual vs. ideal time to start oncology launch activities

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

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

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

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

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

• Medical Affairs’ role in oncology 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 oncology launch activities
• Involvement of Medical Affairs in medical information and regulatory related oncology launch activities
• Involvement of Medical Affairs in HEOR and medical/scientific communication related oncology launch activities
• Involvement of Medical Affairs in independent medical education and external engagement/collaboration related oncology launch activities
• Glossary