Cell and Gene Therapy

When you’re developing a cell therapy or gene therapy, you need a CRO who not only has experience with your modality but is also flexible, adaptable, and capable of keeping up with this evolving area of research.

For your cell therapy or gene therapy, partner with Worldwide.

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Learn more about our cell and gene services

Every cell therapy and gene therapy program is different.

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We know that all trials are different. But with cell and gene therapy programs, that’s even more true. That’s why our Cell & Gene Therapy Hub is committed to providing you with a customized team to tackle your specific scientific, regulatory, medical, and operational needs.

Advancing Cell and Gene Therapies: Expertise and Patient-Centered Solutions

Your Worldwide team has built their careers in developing complex cell and gene therapy programs across North America and Europe, and their experience spans all phases, many rare and non-rare indications, and all major treatment modalities. We are committed to following through on timelines and providing patient-focused solutions to build a collaborative partnership that improves outcomes for patients and families.

We specialize in providing end-to-end solutions for adult and pediatric cell and gene therapy programs, leveraging:

Early strategic and scientific consulting ahead of trial for program success
Partnerships with global investigators, sites, and providers
Our integrated team for seamless trial execution
Comprehensive global and local regulatory support

Every study we support draws on our individual and corporate experience in cell and gene therapy programs across the following therapeutic areas and modalities:

Gene Modified Cell Therapy

Chrimeric Antigen Recepter T-Cells (CAR-T)
T-Cell Reception Engineered (TCR)

Cell Therapy

Autologous Hematopoietic Stem Cells (HSCs)
Health economics/PRO portfolio planning
Autologous Mesenchymal Bone Marrow Stromal Cells
Natural Killer (NK) Cells

Gene Therapy

Adeno-associated virus (AAV) vectored in vivo Gene Therapy
Adenovirus-vectored in vivo Gene Therapy
Plasmid DNA

RNA Therapy

Anti-sense oligonucleotides (ASOs)
siRNA and sRNA

Gene Editing

Autologous Gene Edited Hematopoietic Progenitor Cells (HCPs)
In-vivo Gene Editing

Looking for more information about our capabilities?

Therapeutic Areas of Expertise

Immune-mediated Inflammatory Disease

Oncology

Hematology

Neurology

Metabolic

Cardiovascular

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Cell and gene therapy studies supported by our strategic and scientific leads

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Average years of cell and gene therapy experience across our strategic and scientific leads

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Publications and presentations on cell and gene therapy by our strategic and scientific leads

Your cell and gene programs deserve a personalized approach.

Early engagement support for collaborative development

We specialize in providing early engagement and consulting services for truly collaborative development. As our partner, you’ll have access to our therapeutic strategy leads, scientific solutions team, regulatory experts, clinical research methodology expertise, and more. With these resources, you can progress with confidence.

Global and local regulatory support

Our team of regulatory experts has supported diverse cell and gene therapy programs across North America and Europe. Our global and local regulatory experts maintain a strong understanding of regulatory pathways in their area and can support you with local agency engagement.

One united team for seamless trial execution

Our cell and gene therapy offerings bring together an integrated team of specialists from across the globe. From our regulatory support to our strategy leads and CRAs, your Worldwide team has a history of delivering cell and gene studies and is united in offering one seamless trial delivery. Whether you are launching a new program or nearing commercialization, we take an integrated and flexible approach to your trial.

Trusted relationships with industry stakeholders

We partner with global sites and providers to optimize your trial. Our site relationships provide protocol reviews and investigator feedback and help fulfill your enrollment needs. Whether you opt to employ our logistics coordinator, our provider partnerships, or partner on a customized approach, you can trust your study’s requirements will be carefully orchestrated.

“At Worldwide, we take a true team approach to make your program an operational and strategic success. Along with my global colleagues, I’m committed to working closely with you to deliver that full, end-to-end personalized solution.”

Amy Raymond, Executive Director Therapeutic Strategy Lead, Cellular and Genetic Medicines

Meet Amy