PFDD Program and the Evolving Role of Patients in Healthcare, Drug...
Recognizing the value of patient insights in drug development, FDA has made great efforts to integrate patient perspectives into its benefit risk framework for a number of disease areas through the...
View ArticleOff-Label Promotion: The Transition from Volume to Value
Last week, FDA and Amarin Corporation reached a negotiated settlement of a legal case concerning off-label promotion for use of a drug for an unapproved indication. The negotiation established...
View ArticleContextual Intelligence: Getting to the “Issues Behind the Issues” on the...
For healthcare companies, talk of “being customer-centric” is all the rage – especially when it comes to placing a value on their products. In the pharmaceutical and device arenas specifically, the...
View ArticleContextual Intelligence in Value Communications: Managing Stakeholder...
In my last post, I discussed the role that contextual intelligence (CI) (understanding stakeholder emotions, behaviors, and beliefs) plays in the collaborative and transparent communication of a...
View ArticleThe New FDA Focus: “Business as Usual” Now Includes Paying Attention to the...
In the “old days” (aka, last year), the FDA rarely mentioned the “cost of drug development.” The line between research and development (R&D) costs and regulatory was clear and not to be breached....
View ArticleGrowing the Choir: More Voices Joining the Healthcare Value Conversation –...
This year I was struck by a new vibe at ISPOR –the ‘must attend” conference for health economics outcomes research. ISPOR aspired to — and succeeded at — broadening its reach by replacing its usual...
View ArticleGetting Access Right in 2019: Break Down Pharma’s Silos. Convene the...
Continued from Part 1 – Growing The Choir: More Voices Joining The Healthcare Value Conversation A report published by Deloitte at the end of last year must have made for some sobering reading for...
View ArticleInvesting in Sustainable Healthcare: Part 1
A New Investment Trend for Pharma and Biotech Companies Investing Only in Companies that Deliver Scientific Innovation and Directly Address the Spiraling Costs of Healthcare In part 1 of our interview...
View ArticleInvesting in Sustainable Healthcare: Part 2
Attention Pharma and Biotech Companies Check Out This Advice for Attracting A New Type of Investor Continued from Investing in Sustainable Healthcare: Part 1. In part 2 of our interview with Swiss...
View ArticleA Winning Combination: Holistic Access Strategies and Strong Leadership
Jens Grueger, ISPOR President-Elect and former head of Global Access at F. Hoffmann-La Roche, explains in an interview with 3D Communications’ Kate Dion the importance of fully-integrated access...
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