Cell & Gene Therapy

Dedicated Cross-functional Team

Allucent has a dedicated team of cross-functional experts and cell and gene therapy consultants focused on optimizing strategy, study design, and delivery who have successfully managed CGT clinical trials in the past. This expertise helps ensure that your clinical trials are designed and executed effectively, with an understanding of potential pitfalls and best practices specific to cell and gene therapies.

Regulatory Strategy & Support

We have extensive knowledge of regulatory agencies and their specific biologics guidelines including CMC development and manufacturing strategies for cell and gene therapies. Our ongoing, extensive interactions with regulatory groups provide us with the opportunity to maintain an awareness of current FDA and EMA regulations, expedited pathways, guidelines, and positions regarding cell and gene therapy development programs. These interactions include the FDA’s division of the Center for Biologics Evaluation and Research (CBER), CGT branches of the Office of Therapeutic Products, Canada’s HPFB, and the successful navigation of the EU CTR.

Study Design

Allucents regulatory, biostatistical, modelling, and clinical pharmacology experts have expertise in designing and implementing complex and adaptive trial designs tailored to CGT clinical trials that allow for modifications based on interim data without compromising the integrity of the trial including seamless phI/II designs, basket trials and master protocols.

Patient Recruitment & Retention

Allucents dedicated Patient Engagement team offers a robust CGT clinical trial site network of over 260 clinical sites worldwide with the necessary infrastructure and experience to conduct cell and gene therapy clinical trials, including facilities equipped for complex procedures like apheresis and cell processing.

We offer tailored strategies to support patient recruitment for CGT clinical trials including consent, engagement, diversity and compliance, and long-term follow-up.

To ensure patient participation is more accessible and less burdensome Allucent implements on-site, decentralized, and hybrid trial designs such as those that include DCT, telemedicine, remote monitoring, digital health tools and wearables.

Preferred Partners

Our Cell and Gene Therapy Solutions Center boasts a comprehensive list of preferred partners, ensuring seamless coordination, and superior support for CGT clinical trials including central labs, ePRO, IMP manufacturing to stringent GMP standards, and logistics and supply chain partners to manage the specialized requirements of cell and gene therapies.

Oncology

Allucent has significant expertise in developing and managing immunotherapies specifically for cancer treatment, such as CAR-T and TCR therapies. We understand the most important factors in oncology CGT clinical trials and leverage deep expertise in cancer biology, developing innovative and adaptive trial designs, ensuring rigorous regulatory compliance, implementing targeted patient recruitment and engagement strategies, and utilizing advanced data management and safety monitoring to address the unique complexities of cancer treatment and the immune system.

Rare Diseases

Cell and gene therapies are increasingly being explored for rare diseases, particularly on rare cancers and rare neurological disorders. Allucent understands the challenges associated with recruiting patients with rare diseases for CGT clinical trials and provides solutions that can address geographically dispersed patient populations, underdiagnosis, stringent eligibility criteria, logistical and financial barriers, regulatory and ethical considerations, the need for patient and healthcare provider engagement, data privacy concerns, and the emotional and psychological impact on patients and families.

Autoimmune

Allucent possesses a deep understanding of the rapidly evolving landscape of auto-immune and cell and gene therapy. We recognize that these groundbreaking fields represent a paradigm shift in medicine, offering the potential to treat and even cure diseases at their fundamental level. We stay abreast of the latest scientific advancements, regulatory developments, and clinical trial outcomes to ensure we provide our clients with the most cutting-edge and effective solutions. Our dedicated CGT team is committed to navigating the complexities of this dynamic landscape, from the intricacies of gene editing technologies to the challenges of immune system modulation, to help our partners achieve their goals and bring life-changing therapies to patients in need.

Neurosciences

Allucent has specialized expertise in multiple neurological disorders, developing advanced trial designs specific to neurological CGT therapies and their targeted delivery methods, ensuring robust regulatory compliance, implementing tailored patient recruitment strategies in collaboration with renowned KoLs, site networks and patient advocacy groups, and utilizing advanced data management and safety monitoring tailored to the unique challenges of the central nervous system.