FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients
Because of the inherent complexity of cell and gene development, Precision mobilizes a made-to-fit team of cross-functional, multidisciplinary experts who are study tested and help our clients solve pre-clinical, clinical, regulatory and commercial challenges.
Our experience developing multiple types of cellular therapies gives us the understanding to develop bespoke solutions for each therapeutic cell type including CAR-T cells, stem cells, and tumor-infiltrating lymphocytes. With leadership in gene therapy immunogenicity, a regulatory team that coordinates therapeutic and companion diagnostic strategy, and a focus on executing end-to-end clinical trials, Precision is well-positioned to guide successful gene therapy development.
Few solution providers for cell and gene therapies can offer the pioneering expertise of Precision. Fewer still have integrated the specialized capabilities that can help compress timelines and find efficiencies throughout a development process that will almost certainly encounter scientific and logistical complexities.
From pre-clinical through registration studies, our experts are leaders in the advancement of cell and gene therapy development, leveraging the research interests of the sites to build clinical enthusiasm, supporting the logistical complexities of these trials, and addressing complex safety issues.
From pre-clinical through registration studies, our experts are leaders in the advancement of cell and gene therapy development, leveraging the research interests of the sites to build clinical enthusiasm, supporting the logistical complexities of these trials, and addressing complex safety issues.
Cell and gene therapy research requires specialized expertise to support successful translation from the bench to the clinic. We deliver, with a broad array of both established and Precision-engineered platforms targeted specifically to the needs of cell or gene therapy development, and thought leaders who are helping shape the therapeutic and regulatory landscape.
Cell and gene therapy research requires specialized expertise to support successful translation from the bench to the clinic. We deliver, with a broad array of both established and Precision-engineered platforms targeted specifically to the needs of cell or gene therapy development, and thought leaders who are helping shape the therapeutic and regulatory landscape.
The success of your cell or gene therapy ultimately relies on accurate identification of appropriate candidates for treatment. These treatments often require a Companion Diagnostic (CDx). Precision has the required specialized clinical development, biomarker assay, regulatory strategy and commercialization capabilities.
The success of your cell or gene therapy ultimately relies on accurate identification of appropriate candidates for treatment. These treatments often require a Companion Diagnostic (CDx). Precision has the required specialized clinical development, biomarker assay, regulatory strategy and commercialization capabilities.
