Cell and Gene Therapies

Accelerating study start-up and delivering results with custom strategies and logistics solutions

ICON’s flexible end-to-end engagement models support seamless transition from early engagement to commercialisation:

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.


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.

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