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Pharmaceutical Executive-08-01-2019
Pharmaceutical Executive
A Look Back & Forward on Innovation
August 20, 2019
From the Editor
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In a sit-down with editors from our group publications, former FDA Commissioner Scott Gottlieb chatted with Pharm Exec on several topics, including the evolution of pricing and reimbursement for novel therapies-and the access fixes needed for future.
Routes to Exclusivity in Cell-Based Therapy Development
August 14, 2019
Features
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Outlining the critical steps for companies in controlling market exclusivity for their gene therapies.
Gene Therapy: Managing the Clinical Trial Minefields
August 13, 2019
Features
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Advice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.
The Call to Cure: Geoff MacKay, AVROBIO
August 12, 2019
Features
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Pharm Exec speaks with Geoff MacKay, co-founder and CEO of AVROBIO, about the company’s mission to advance potentially curative lentiviral-based gene therapies, his career building businesses and innovation in regenerative medicine, and his most important quest to date-moving gene therapy into the mainstream.
Four Takeaways from the Zolgensma Pricing Storm
August 10, 2019
Features
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Four takeaway messages from the Zolgensma pricing storm
FDA Faces ‘Explosion’ in Growth of Gene Therapies
August 08, 2019
Columns
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Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.
Mapping Out the Future of Cell and Gene Therapy
August 08, 2019
Features
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The cell and gene therapy space remains fertile territory for growth, exploration, and discovery. How applying a data-driven model may be the best way to approach this complex ecosystem and assess the innovations of tomorrow.
High-Stakes Manufacturing: Mitigating the Risks
August 08, 2019
Features
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How to navigate the production and reimbursement intricacies of bringing regenerative medicines from bench to bedside.
Gene Therapy: How ‘Advanced’ is Europe?
August 08, 2019
Features
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Exploring the EU’s struggles and new efforts in promoting cell and gene drugs.
Luxturna: A Vision for Curative Therapy Access
August 08, 2019
Features
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Pharm Exec highlights a recent fireside chat between Veeva’s Matt Wallach and Jeffrey Marrazzo, CEO of Luxturna maker Spark Therapeutics.
Can EU Seize the Chance of Pooling Genomic Data?
August 07, 2019
Columns
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Efforts in motion for cross-border sharing, but barriers are many
The Shrinking Disconnect in Digital Therapeutics
August 01, 2019
Columns
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More signs of alignment between startups, pharma, and payers.
Three Tips to Managing Multiple Agency Partners
August 01, 2019
Columns
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Outlining three practices that are key to navigating today’s multiplayer agency landscape - and getting more value from each external vendor.
Using FDA’s ‘PIE’ Recipe to Enhance Patient Access
August 01, 2019
Columns
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How R&D organizations can leverage FDA’s final guidance on pre-approval information exchange (PIE) to engage with payers prior to approval and launch.
Pharmaceutical Executive, August 2019 Issue (PDF)
August 01, 2019
Issue PDF
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Click the title above to open the Pharmaceutical Executive August 2019 issue in an interactive PDF format.
Country Report: Spain
August 01, 2019
Special Sponsored Section
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With Spain enjoying an economic rebound, pharma and medtech multinationals are seeing the country as a top-tier investment destination once more-thanks to improved market access, quality but affordable manufacturing capabilities, and an enviable clinical research base.