Thérapie cellulaire et génique
Meeting the challenges unique to cell and gene therapy research
La thérapie cellulaire et génique (TCG) représente une nouvelle frontière dans la lutte contre de nombreuses maladies dévastatrices, y compris les troubles génétiques rares et certains cancers.
It also poses unique challenges and uncertainties for the investigators and companies pioneering this potentially transformative research, and for the patients and families participating in it.
Having conducted more than 140 cell and gene therapy studies in the past five years, our unique engine for cell and gene therapy development engine enables rapid activation of our scientific, medical, regulatory and operational expertise to help you realize the promise of your innovation.
A holistic approach to help you reduce complexity and risk, maximize ROI, and support your commitment to patients
Our dedicated CGT development team allocates 300+ cell and gene experts from across our Clinical, Medical Affairs and Commercial teams to deliver complex CGT development programs.
Through strong alignment and dedicated expertise focused on your challenges, we help overcome complexity and reduce ambiguity, minimizing risk and maximizing ROI. As your cell and gene therapy clinical research organization (CRO), you will have a dedicated single point of contact on each project who will collaborate with your clinical leads, oversee the chain of custody at each step and streamline processes to support sites and patients.
This focused approach ensures we’re providing you with the right team of experts from across the development and commercialization spectrum, and that our collective knowledge and insights are fully leveraged to deliver solutions specific to the needs of each program.
Designed to address your unique challenges
Streamlined protection for the chain of custody
The CGT development journey is often riddled with “try and fail” experiences – in many cases involving the handling and transport of patient-specific, living cells, making expert logistical stewardship paramount. Building on insights gained over our years of hands-on CGT trial experience and leveraging our Trusted Process® for delivery, we partner with hand-selected providers ensure consistent, compliant, high-quality cell material and cryopreservation to accelerate development and minimize customer burden. Our partnership with Cryoport and BioLife enables us to become your single point of contact for standardizing and integrating logistics management pertaining to cellular collection, cold storage and cryopreservation.
Global perspective combined with regional expertise to streamline approval pathways
Le contexte réglementaire en évolution rapide et les nouvelles voies d'approbation et les désignations de médicaments pour les TCG nécessitent une attention particulière aux exigences du pays, de l'état et du centre, des comités d'examen multiples et des exigences spécifiques en matière de permis de centre.
We know this terrain intimately and use that in-depth expertise to help inform CGT study designs, strategic decision-making, operational study planning and real-world evidence planning.
Elevating the dialogue to support pricing and market access
Les thérapies qui changent la donne élèvent le dialogue autour des coûts de traitement et conduisent à des programmes pilotes uniques et fréquents avec les payeurs qui peuvent faire l'objet d'une couverture médiatique, de spéculation des investisseurs et des préoccupations des patients.
Syneos Health pricing and communications experts help companies execute complex and innovative arrangements, contextualize them for non-payer audiences and support the environment in which negotiations occur.
Ready to see how Syneos Health can support you in every aspect of developing your CGT innovation?
Tous les jours, nous écoutons les patients et nous apprenons d’eux.
Le suivi à long terme requis pour les essais cliniques de la TCG ajoute une complexité significative à la question toujours difficile de la fidélisation des patients. Nous nous efforçons de comprendre les expériences réelles de vie des patients, ainsi que celles de leurs familles, au cours de la période de suivi. Nous planifions ces scénarios réels dès le départ, en intégrant des stratégies de fidélisation adaptatives et évolutives au fil du temps. Découvrez comment notre consortium Voix des patients soutient notre engagement à garder les patients au centre de l’innovation.
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