Leading in the Combination Product Space: Insights for Improving External Engagement, and Internal Development and Management

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Manufacturing; Consumer Products; Medical Device


Companies Profiled:
Abbott; AbbVie; Allergan; AstraZeneca; Bayer; Boehringer Ingelheim; Kimberly-Clark; Merck; Mallinckrodt; Nevakar; Novartis; Novo Nordisk; Pfizer; UCB Pharma

Study Snapshot

In this research, Best Practices, LLC engaged 17 executives involved in the development and launch of combination products at 14 leading pharmaceutical, biotechnology and other healthcare companies through a benchmarking survey.

Key topics covered in this report include:

• Key external engagement approaches
• External engagement program staffing and investment
• Industry leaders in external engagement
• Challenges in post-marketing safety reporting
• Combination product development timeline
• Development phases and decision points
• Partner management
• IP protection

• Firms more likely to locate external engagement personnel in small, standalone group rather than within any single larger function: About half of companies (47%) have created an independent group to assess and drive external engagement within the combination product space. Some companies install their external engagement employees within Regulatory Affairs (13%), R&D (7%), Clinical Program Development (7%), Lifecycle Management (7%) or elsewhere.

• Companies spend an average of 5 years between demonstrated feasibility and launch: According to respondents, the combination product development cycle - starting with demonstrated feasibility and ending with market entry - can take between 2-10 years, depending on the product. The average development life cycle time is nearly 5 years.

• Analyze complaint data & market research to fuel continuous improvement: The top-rated sources for gaining critical feedback for continuous improvement are product complaint data and patient market research (rated “highly valuable” by 73% of companies), followed by physician market research (64%). Field sales and medical feedback is seen as only marginally helpful, while social media insights are not seen as reliable.

I.	Executive Summary: Overview and Insights	p. 3
	Summary of key findings	p. 4
	Benchmark class	p. 5
	Insights and recommendations	pp. 6-10
	Participant background	p. 11
II.	External Engagement in the Combination Product Space	p. 14
	Group organization	p. 15
	Strategy and tactics	p. 16
	Staffing and budget	p. 18
	Industry leaders – and why	p. 20
	Post-marketing safety reporting	p. 22
III.	Effective Combination Product Development and Management	p. 24
	Development phase gates and timelines	p. 25
	Effective management approaches	p. 33
	Demo device management	p. 38
	Feedback for continuous improvement	p. 39
	IP protection	p. 40
IV.	Appendix	p. 42
V.	About Best Practices, LLC	p. 44

• Group / internal function to which external engagement employees belong
• External engagement approach maturity curve
• Key external engagement strategies and tactics along the maturity curve
• Full-time staff members allocated to all external engagement policy activities
• Approximate total budget allocation to external engagement program for the combination product space
• Pharma or biotech companies considered to be the industry leaders for shaping combination product regulatory requirements and reasons for the same
• Biggest challenges for the industry in implementing the 2016 US FDA Final Rule on Post-marketing Safety Reporting for Combination Products

• Length of the entire combination product development process, beginning with demonstrated feasibility and ending with launch into the market
• Representative case studies: Company by company readouts of combination product development phase gates
• Drug/device co-development: Company A case study
• Long design, short verification and validation: Company B case study
• Long design, short verification and validation: Company C case study
• Protracted verification and validation: Company E case study
• Protracted verification and validation: Company F case study

• Managing the development of delivery devices in conjunction with development of own drug substance and drug product
• Executive insights on managing the development of delivery devices in conjunction with development of own drug substance and drug product
• Responsibility for managing the supply chain process for each kind of supplier
• Successful tactics in customizing management approach across different suppliers
• Group responsibility for the initial development of demo devices and for rolling up-to-date versions out to the field
• Valuable sources for obtaining feedback for drug delivery device improvements
• Biggest IP concerns relative to developing combination products in partnerships with other organizations
• Successful steps taken by benchmark partners to protect IP

• Drug-device co-development: Company X case study
  Drug-device co-development: Company Y case study