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.
Read on to learn about:
- An interview with Professor Francesco Dazzi, Medical Lead Cell Therapy, BioPharmaceuticals R&D at AstraZeneca, on the company’s novel cell therapy pipeline for chronic diseases
- Patient and market access insights on leveraging CRISPR technology for hematologic diseases
- The evolving policy and regulatory landscape for cell and gene therapies
- Trends shaping the future of personalized medicine
- Steps for communicating the complex science to a variety of stakeholders