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Data from previous clinical trials can be extremely useful for discovering new indications and reducing overall R&D costs. Specialized skill sets are required to navigate the partnerships for gathering and interpreting this data, especially for older drug candidates. • Deploy open innovation partnerships for clinical validation success • Partner with patient advocates and government agencies • Build new economic incentives • Update your computational strategy
By demonstrating a new orphan indication for an existing therapeutic, you may be able to lengthen the period of exclusivity. By comparing the orphan approvals for both older and newer drugs, you can get a clearer picture of how viable this is as a business model.
• Target orphan drug indications to obtain extended periods of exclusivity for blockbuster therapeutics • Anticipate changes now that politicians and payers expect this • Weigh the prospect of changes to the orphan drug program, either legislatively or at the FDA level • Review orphan strategies to build value
• Map the data-gathering needs of multiyear therapeutics with undefined benefits, in a system that is typically PAYGO • Establish a timeline for value-based checks and rebates • Find the best approach towards CMS Best Price Reporting and determine if rebates can become more substantial • Maintain dialogue with CMS and payers
• Recall the employment and advancement patterns of biotech executives from previously underrepresented groups • Quantify the advances made in biotech leadership by women and people of color • Discuss other kinds of diversity, such as nationality, industry background, and ideology
• Review opportunities for biopharma companies to continue listening to patients long after a drug has launched, particularly as pediatric patients become adults and their needs evolve • Turn patient and physician insights into new formulations, new doses, and new storage options • Go beyond scientific innovation to address changing patient needs through ambassador and other programs
• Clarify why some industry insiders are wrong to think ambitious growth is impossible • Understand the odds and obstacles to growth success • Make the most of your assets during mergers and acquisitions
Managing Director, US Biotech Equity Research, RBC CAPITAL MARKETS
Dr. Kennen MacKay is Managing Director and Co-Head of RBC Capital Markets' Biotechnology Equity Research team. Kennen covers a range of Large & SMid-Cap biotechnology companies across a range of therapeutic indications & modalities: from small molecule precision medicines to antibody/protein... Read More →
• Compare the performance of build-to-buy deals, company creation, and option deals • Review deal structures most attractive to all stakeholders • Make sure teams can interface well enough for collaborations to move quickly
Give sufficient weight to whether prospective partners are truly compatible
Provide more details on how deals will be executed, how to leverage each organization, and how to deal with the cultural and workplace norms of each company
Lay the groundwork for broader partnerships by avoiding confusing pitfalls
