In this report, we interview patients, researchers, and biopharmaceutical leaders to explore the complex landscape for the development of cell and gene therapies and share commercial recommendations from our specialist teams.
Cell and gene therapies represent a paradigm shift in the development of pharmaceutical products.
Not only do these treatments often promise to cure disease, they also represent an evolution in the manufacture and delivery of products. As a result, cell and gene therapies are synonymous with complexity.
Manufacturers developing cell and gene therapies face a steeper climb to commercialization compared with traditional biopharmaceutical products. While there is significant innovation in this space, few cell and gene therapies reach the market.
Additionally, those that do have been marred by supply chain and manufacturing challenges, along with healthcare infrastructure barriers, including a lack of treatment sites for administering therapies.
These factors affect the scalability of these products and the patient and healthcare professional experience. Add to this a fast-paced global policy and regulatory landscape in which policymakers and regulators struggle to upskill fast enough to keep up with the evolving high science. Payers require more support than ever to understand the novel data and make decisions regarding these therapies.
Patients and healthcare professionals alike are entranced by the promise of the treatments but require support in understanding the risks and benefits of novel cell and gene therapies.
Understanding the barriers and risks early in drug development is paramount for ensuring these therapies deliver on their promises for patients.
Drawing on our experience working with biopharmaceutical innovators on the commercialization and launch of cell and gene therapies, we have developed a series of articles on the evolving landscape, which we present in this publication.
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