With extensive experience in cell and gene therapy (CGT) development, Premier Research offers comprehensive guidance to advance your innovative therapies from concept to commercialization. Having supported nearly 100 CGT projects globally in the past five years, our integrated services encompass regulatory strategy, nonclinical development, clinical trial execution, and long-term patient follow-up, all tailored to the unique complexities of CGT programs.
Why Choose Premier Research?
- Diverse Therapeutic Experience: Proven expertise across a broad range of CGT modalities, including in vivo gene therapies (e.g., AAV) and ex vivo gene-modified cell therapies (e.g., CAR-T, HSCs), spanning therapeutic areas such as rare disease and oncology.
- Comprehensive Regulatory Support: Strong relationships with global regulatory agencies enable us to navigate the evolving landscape of CGT approvals, facilitating an efficient path from early development through market authorization.
- Integrated Logistics Management: Expertise in managing complex vein-to-vein logistics for both allogeneic and autologous cell therapies including in-house CMC strategists and connections to CDMO partners, ensuring seamless coordination across the supply chain.
- High-Touch Site Engagement: Ability to onboard, training and upskill sites in addition to sourcing from an existing network of high-quality sites, helping to advance study activities in a highly competitive landscape.
- Patient-Centric Approach: High-touch patient engagement strategies designed to minimize burden, encourage retention, and simplify long-term follow-up, critical for the success of CGT trials.
- A Focused Approach to Safety: Robust clinician-lead medical monitoring supports critical safety and toxicity management.
Your Partner in Cell & Gene Development
Our dedicated CGT experts bring together scientific depth, operational excellence, regulatory understanding and commercial considerations to provide a holistic approach to product development. Whether you're just starting to asset the market, seeking to address regulatory challenges, need support designing a trial, or looking for a partner to develop and managing your CMC strategy, Premier can guide you every step of the way.
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