Meeting the challenges unique to cell and gene therapy research
Cell and gene therapy (CGT) represents a new frontier in the fight against many devastating diseases, including rare genetic disorders and certain 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.
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
The rapidly evolving regulatory landscape and new approval pathways and drug designations for CGTs require close attention to country, state and site requirements, multiple review board and specific site licensing requirements.
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
Game-changing therapies are elevating the dialogue around treatment costs and leading to unique, frequent pilot arrangements with payers that can be the subject of media coverage, investor speculation and patient concerns.
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.
The long-term follow-up required for CGT clinical trials adds significant complexity to the always-challenging issue of patient participation. We work to understand the real-world life experiences of patients over the course of the follow-up period – and that of their families as well. We plan for those real-world scenarios from the start, building in retention strategies that are adaptive and changeable over time. Read about how our Patient Voice Consortium supports our commitment to keeping patients at the center of innovation.