細胞療法・遺伝子治療薬

Your partner in developing cell, gene and other advanced therapies

Access multi-disciplinary, multi-modality experience to support your unique studies.

Get a patient-centric approach to optimize the development of your product.

Rely on our team to navigate complex logistics and implement practical solutions.

Fortrea's Cell and Gene Therapy team brings dedicated cell and gene expertise for emerging target indications. With our multi-disciplinary operational, medical, and regulatory experience, we can provide comprehensive, strategic insights to enable efficient, cost-effective development of your therapeutic and reduce risk across critical milestones.

By integrating critical services within a single global organization, we can amplify your clinical trial approaches, streamline complex processes and minimize risk. We are committed to helping you transform the future of healthcare by bringing promising cell and gene therapies to more patients.

Experience matters when choosing a partner

ぜひご相談ください

過去 5 年間の実績

当社は、開発における CRO パートナーとして、バイオテクノロジー企業や製薬会社のお客様に選ばれています。

150+

studies

1,449

施設

15,845

患者様

Advance your cell therapy studies

At Fortrea, we’ve seen the cell therapy field evolve and have played a significant role in its development by supporting and designing dozens of cell therapy programs, including all 6 FDA-approved CAR T-cell therapies.

Learn about our cell therapy experience ›

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.

Learn about our gene therapy experience ›

Focus on oncology in cell and gene therapy development

From targeted therapies and immunotherapies to advanced cell and gene therapies, our subject matter experts have helped develop biomarker-driven strategies to bring precision medicines to market.

Learn about our oncology experience in cell and gene therapies ›

Get the latest cell and gene therapy updates

We're sharing our latest news, events, and publications.

ウェビナー
 Exploring Applications of CAR-T Therapy Outside Oncology: Strategies for Applying Lessons Learned (60 min)
View webinar about Exploring Applications of CAR-T Therapy Outside Oncology: Strategies for Applying Lessons Learned (60 min)
ホワイトペーパー
 De-risking the patient journey in cell therapies: six key considerations
ホワイトペーパーを読む about De-risking the patient journey in cell therapies: six key considerations
記事
 細胞療法・遺伝子治療の最前線
Read the article 細胞療法・遺伝子治療の最前線について
資料
 Clinical development solutions for cell and gene therapy
Read the info sheet about Clinical development solutions for cell and gene therapy
ホワイトペーパー
 Examining the role of genetic counselors to promote patient centricity in cell and gene therapy clinical trials
Read the white paper about Examining the role of genetic counselors to promote patient centricity in cell and gene therapy clinical trials
ホワイトペーパー
 Combined advanced therapy medicinal products: European regulatory requirements, pathways and processes
Read the white paper about Combined advanced therapy medicinal products: European regulatory requirements, pathways and processes

We’re here to seamlessly deliver your next cell or gene therapy trial

お客様のチームの一員として、当社は以下の内容を提供することができます：

  • Experience with multiple modalities
    • CAR-T and AAV
    • Other viral and non-viral delivery systems (e.g., adenovirus, LNP)
    • Cell therapies (immune cell/stem cell, autologous/allogeneic, modified/non-modified)
    • Gene editing (e.g., CRISPR, meganucleases)
    • Advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms

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

    • プロトコルの開発
    • Long-term follow-up (LTFU)
    • Development of companion diagnostics
    • Global regulatory requirements
    • 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:

    • Providing logistics support for autologous CAR-T cell therapies
    • Navigating site selection, activation, and overall study setup
    • Defining regulatory and GMO pathways timelines along with approvals
    • 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 Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Oncology members provide targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.

複雑で斬新な臨床試験に向け、機敏なパートナーとして貢献します

Let our multidisciplinary experts put their insights and experience to work to advance your program. 当社とともに、お客様の可能性を成功へと導き、まだ満たされていない差し迫った医療ニーズに一石を投じましょう。

当社の関連専門分野をご覧ください。

 

希少疾患 小児科 オンコロジー 当社チーム（RAPT）

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