Pharmaceutical Executive-08-01-2019

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.

Outlining the critical steps for companies in controlling market exclusivity for their gene therapies.

Advice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.

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 takeaway messages from the Zolgensma pricing storm

Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.

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.

How to navigate the production and reimbursement intricacies of bringing regenerative medicines from bench to bedside.

Exploring the EU’s struggles and new efforts in promoting cell and gene drugs.

Pharm Exec highlights a recent fireside chat between Veeva’s Matt Wallach and Jeffrey Marrazzo, CEO of Luxturna maker Spark Therapeutics.

More signs of alignment between startups, pharma, and payers.

Outlining three practices that are key to navigating today’s multiplayer agency landscape - and getting more value from each external vendor.

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.

Click the title above to open the Pharmaceutical Executive August 2019 issue in an interactive PDF format.

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.