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Thérapies géniques

Your partner in developing cell, gene and other advanced therapies

Leverage our global gene therapy experience

No matter where you are or where you intend to go, you can rely on our global experience and expertise in advancing gene therapy trials across:

  • North America (Canada, United States)
  • South America (Brazil, Peru)
  • Europe (Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, Switzerland, Turkey, United Kingdom)
  • Africa (South Africa)
  • Asia Pacific (Australia, China, India, Japan, South Korea, Taiwan)

73

Gene therapy studies

734

Centres

11 306

Patients

Our therapeutic area experience in gene therapy

Our 73 gene therapy studies have included ophthalmology (30 %), hematology (24 %), neuroscience (22 %), oncology (11 %), endocrinology and metabolism (6 %) along with cardiovascular, urogenital, infectious disease and general medicine (<6 %).

These studies have spanned multiple modalities, such as AAV, retroviral vector, plasmid DNA, and other viral and non-viral delivery systems (e.g., adenovirus, LNP) and gene editing (e.g., CRISPR, meganucleases) as well as natural history/non-intervention studies.

We’re here to seamlessly deliver your next trial

En venant nous greffer à votre équipe, nous vous offrons :

Scientific and medical expertise 

Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. For example, beyond cell and gene therapies, we've also supported advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms.

We understand how these unique treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:

  • Développement de protocoles
  • Long-term follow-up (LTFU)
  • Development of companion diagnostics
  • Global regulatory requirements for GMO and ATMP products
  • Vendor qualification
  • Medical monitoring

Global operational solutions 

The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:

  • Navigating site selection, activation, and overall study setup
  • Defining regulatory and GMO pathways timelines along with approvals
  • Assessing Biosafety Level (BSL) accreditation needed to protect workers, the environment, and the public 
  • Reducing the patient burden for LTFU studies
  • Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics

Customized training 

To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Cell and Gene Therapy Team provides targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.

Serving as your agile partner for complex and novel clinical trials

Let our multidisciplinary experts put their insights and experience to work to advance your program. Ensemble, nous œuvrerons à votre succès et mettrons au point un projet unique dans la mise au point de traitements médicaux non disponibles.

Explore our related areas of expertise. 

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