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Study Helps Pharmaceutical Industry Navigate Shifting Landscape of Combination Product Development

CHAPEL HILL, N.C., Jan. 18, 2019 /PRNewswire/ -- The pharma industry recognizes the potential value of attacking complex diseases such as cancer through new therapies that utilize combinations of FDA-approved products.

However, the path from design and development to filing and approval for these combination products is not straightforward and comes with a daunting set of complexities. Some of these challenges include simultaneously developing a drug and device for testing and working with external vendors for materials and manufacturing.

To help organizations navigate the shifting landscape of combination product development, research and consulting leader Best Practices, LLC conducted a new study to provide insights into how healthcare companies can improve the way they develop and launch combination products.

Leading in the Combination Product Space: Insights for Improving the External Engagement, and Internal Development and Management" is a 44-page study that will inform product and leadership teams about:
  • Key external engagement approaches
  • Development phases and decision points
  • Timing, staffing and investment
  • Partner management
  • IP protection

Seventeen executives from 14 leading pharma, biotechnology and other healthcare companies participated in this research through a benchmarking survey and executive interviews.

The research found that Intellectual Property (IP) protection is a major concern and it is imperative to involve legal departments in combination partnerships. Combination product partnerships present real IP risks to most drug manufacturers. Among the concerns cited by benchmark partners were: Infringement, reverse engineering, IP ownership, confidentiality of external partners, and lack of proactive legal expertise. Industry counterparts suggested the following steps to reduce risk and protect assets: adopt a proactive approach with legal expertise in patenting, vetting and contracting with partners; use non-disclosure agreements; use firewalls to prevent reverse engineering; and include legal experts even in technical discussions with device partners.

Best Practices, LLC conducted this study to help pharma and biotech companies improve the way they develop, manage and commercialize new combination products.

To learn more about this report, download a complimentary report excerpt at

For related research, visit our Best Practices, LLC Web site at


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

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