Driving cell and gene advanced therapy development from candidate identification through market authorization
Developing advanced therapies involves making critical Chemistry, Manufacturing and Controls (CMC) decisions and managing complex clinical studies while navigating through an evolving regulatory and reimbursement environment.
The Cell and Gene Therapy team from IQVIA can provide the data, expertise, and services that help you transcend the challenges faced in the development and commercialization of cell and gene therapies.
Strategic and operational services customized to your therapy:
Our dedicated team of experts combine cell and gene therapy expertise with the capabilities of the IQVIA CORE to address your needs throughout the development pathway.
We have a proven track record supporting a range of clients, from academics to emerging biotech and established pharmaceutical companies, in:
- Evaluating the specific needs of the cell and gene therapy to develop a strategic GMP manufacturing plan that reduces complexity, time, and risk
- Developing a regulatory strategy to facilitate successful pre-IND / IND meetings and achievement of expedited programs (e.g., RMAT)
- Preparing a Target Product Profile to guide the development plan and communicate product attributes to stakeholders
- Executing clinical trials, including identifying sites suitable for advanced therapies and recruiting hard-to-find patients
- Preparing evidence for pricing and reimbursement to navigate market access and uptake barriers
Comprehensive network of partners to respond to your needs:
The Cell and Gene Therapy group works in close collaboration with our alliance partners to address the unique challenges in cell and gene therapy manufacturing and nonclinical research.
Through our partnership with the California Institute for Regenerative Medicine (CIRM), we have access to the Alpha Stem Cell Clinics network that provides experienced sites for your stem-cell based therapies for more reliable and rapid study startup.