Cell and Gene Therapies
Accelerating study start-up and delivering results with custom strategies and logistics solutions
Every Cell and Gene Therapy study requires an individualised approach. Working with ICON, your study will benefit from a tailored strategy delivered with flexibility and expertise. Our experience and how our business is structured enables us to support the needs of both Large Pharma and Biotech Cell and Gene Therapy developers.
We understand the specific challenges and needs of Biotech companies because more than 70% of our clients are Biotech companies (over 43% of those have less than100 employees).
Our Centre for Cell & Gene Therapy, established in 2018, enables ICON to centralise it’s Cell & Gene Therapy expertise, ensuring that experience and learning is curated and translated into best practice driving accelerated study execution. With more than 700+ Global Cell and Gene Therapy professionals across the organisation, your study is in capable hands.
CGT therapeutics experience in the last five years:
-
152
Studies conducted -
7,135
Patients involved -
2,561
Sites worldwide
ICON's extensive experience with Cell & Gene Therapies extends across all regions
ICON's Cell and Gene Therapy experience spans the globe. We have insight and expertise built from 150+ studies, inclusive of 20+ gene therapy studies, across 40+ countries including Asia Pacific.
Therapeutic expertise
ICON has deep therapeutic expertise and experience with indications in:
ICON’s flexible end-to-end engagement models support seamless transition from early engagement to commercialisation:
- Laboratory Solutions Flexible, agile and proactive laboratory solutions dedicated to global clinical development.
- FIRECREST Digital solutions improving the clincal trial experience for sites, patients and study staff.
- Clinical Trial Liaisons Specialists supporting site identification, activation and recruitment across all phases of development.
- Patient Recruitment Solutions ICON uses a patient centric approach to provide study specific patient recruitment and engagement strategies on a global basis.
- Patient Insights and Engagement Putting the voice of the patient at the center of drug development.
- Global Logistics ICON’s dedicated, specialised and highly experienced logistics team is here to support your study.
- Decentralised Clinical Trial Solutions End-to-end services, operational model and technology to deliver customised solutions.
- Real World Intelligence Optimising real world data to drive effective outcomes and achieve regulatory authorisation.
- Commercial Positioning Position your product for global success with our integrated solutions.
Laboratory Solutions
Flexible, agile and proactive laboratory solutions dedicated to global clinical development.
FIRECREST
Digital solutions improving the clincal trial experience for sites, patients and study staff.
Clinical Trial Liaisons
Specialists supporting site identification, activation and recruitment across all phases of development.
Patient Recruitment Solutions
ICON uses a patient centric approach to provide study specific patient recruitment and engagement strategies on a global basis.
Patient Insights and Engagement
Putting the voice of the patient at the center of drug development.
Global Logistics
ICON’s dedicated, specialised and highly experienced logistics team is here to support your study.
Decentralised Clinical Trial Solutions
End-to-end services, operational model and technology to deliver customised solutions.
Real World Intelligence
Optimising real world data to drive effective outcomes and achieve regulatory authorisation.
Commercial Positioning
Position your product for global success with our integrated solutions.
Our subject matter experts support “end to end” solutions to your Cell & Gene Therapy development
Full cycle drug development consulting services
ICON offers global, robust integrated asset development consulting, covering all phases of drug development, to virtual companies, start-ups, Biotechs, pharmaceutical, and medical device sponsors.
We offer full development and lifecycle support, from helping clients to develop target product profiles, study synopses, protocols, integrated development plans and regulatory position pieces. Our innovative solutions, such as the use of novel statistical design can optimise development efficiency.
Global specialised and GMP qualified CGT logistics coordinators
ICON’s dedicated and highly specialised global team of logistics professionals can map and oversee the “end-to-end” supply chain for your study. From the 150+ cell and gene therapy studies that our ICON teams have supported, we have built in depth understanding of the challenges associated with the Cell and Gene Therapy supply chain.
Regulatory
Cell and Gene Therapies are innovative and have been challenging traditional clinical trial models during recent years. The regulatory environment around Cell and Gene Therapy development is constantly changing and we understand that this can be difficult to navigate. ICON has 30+ years of regulatory experience and our clients can benefit from 100+ regulatory experts around the world. Our comprehensive regulatory consulting services include, for example, global requirements and regulatory strategy, global regulatory intelligence, global regulatory submissions and agency interactions, CMC and risk management strategy.
Market Access
Cell and Gene Therapies are complex and innovative. They are pushing the boundaries in drug development including access to market. To accelerate patient access skilled curation of market access strategies are critical to any developer’s development plans.
Our combined US and global market access team provides in-depth expertise to give clients an edge in supporting mission-critical pricing, market access, and reimbursement needs.
As the first dedicated market access group, we've been offering expertise in managed markets and payer strategies for 25 years. Our in-house team of experts guides clients through ever-changing market challenges, using innovation to demonstrate the value of their therapies to ensure access. It's what we do.
Rare Diseases
We understand the unique challenges rare disease patients face generally and in clinical research studies, compared to those in more common indications. We understand that every day without treatment means another day filled with doctors' appointments, lab work, postponed opportunities, and cancelled plans.
By maintaining focus on the patient, their family, and their quality of life, we can anticipate and mitigate risks, and efficiently conduct rare disease studies. We understand the critical success factors necessary to conduct rare disease studies, and we have the experience to back it up, including the conduct of 152+ studies across 2,561+ sites worldwide in the past five years. This includes 20+ gene therapy studies.
Cell & Gene Training Academy
Our 700+ Cell and Gene professionals, have built deep learning from both their involvement in the scientific, strategic and operational execution of these studies as well as having access to a high-quality training programme. This ICON developed training programme is externally (CPD) accredited.
Cell and gene therapies insights
Insights on delivering cell and gene clinical trials in multiple therapeutic areas based on lessons learned and best practices. Content includes whitepapers, webinar recordings, media articles, blogs. Subscribe for email alerts on latest Insights as they are published.