Navigating the challenges unique to cell and gene therapies
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 both for the investigators and companies pioneering this potentially transformative research and for the patients and families participating in it.
A holistic approach to developing cell and gene therapies
Our Cell and Gene Therapy Consortium is the hub for our knowledge and experience base in CGT preclinical/clinical development and commercialization.
It brings together the cross-functional capabilities needed to navigate the challenges unique to CGT development and commercialization and accelerate delivery.
The Consortium is where you will find professionals with deep CGT and therapeutic area expertise, including clinical trial delivery teams and subject matter experts in regulatory, consulting, commercial, early phase and real-world/late phase research and development.
This simplified model ensures that our collective knowledge and insights are fully leveraged to deliver solutions specific to the needs of each program.
Delivering operational excellence
Building on insights gained over our years of hands-on CGT trial experience and leveraging our Trusted Process® for delivery, our Consortium experts assist with operational complexities specific to CGT studies, including:
- Local IRB/IBC requirements
- Logistics management
- Cell processing
- Coordination of functional units at sites and vendors
Navigating product development strategy
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 boards and specific site licensing requirements.
We know this terrain intimately and use that in-depth knowledge to help inform CGT study designs, strategic decision-making, operational study planning and real-world evidence planning.
Supporting 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.
The Consortium includes pricing and communications experts to 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 biosimilar asset?
We listen and learn from patients every day
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.
At Syneos Health, helping companies develop rare disease therapies is something we take personally. It takes novel and integrated approaches, including early engagement of key stakeholders, to accelerate products to market and de-risk the development of critical patient therapies. Read about how our Rare Disease Consortium helps speed new rare disease therapies to patients and families who are waiting.
Passionate about collaborating for a cure?
Learn about how our Novel and Emerging Therapies team is applying novel approaches to cancer drug development, including cellular and gene therapies.