Cell & Gene Therapies

Moving the Field of Cellular Therapy Forward

Advancements in cancer immunology and recent clinical experience with emerging cellular therapeutics have the potential to rapidly change cancer treatment and represents a new treatment paradigm. Friends has focused on convening experts from across healthcare sectors to design new strategies to catalyze the development of cell and gene therapies.

“The goal is to create predictably effective and predictably safe treatments that will revolutionize cancer therapies.”
Richard Klausner

In 2019, Friends partnered with the Parker Institute for Cancer Immunotherapy to launch the initiativeDesigning the Future of Cell Therapies, bringing together leaders in cancer drug development, federal health and regulatory agencies, academic research, the private sector, and patient advocates. The project focused on T-cell receptor (TCR)-based therapies, including chimeric antigen receptor (CAR) T-cell therapy, having emerged as a new paradigm for treating cancers. The expert working groups examined several challenges facing TCR-based therapies, including unique development and manufacturing needs, which require an examination of current regulatory frameworks to ensure they are aligned to facilitate rapid development, commercialization, and evolution of these safe and effective therapies.

The output of this initiative has informed regulatory guidance in immunotherapies, cell therapies, and gene therapies.

Understanding the Patient Experience

In 2020, we worked with key leaders to develop a report to address challenges associated with measuring the long-term benefits and patient experience with cell and gene therapies. This work led to the peer reviewed publication in Therapeutic Innovation & Regulatory Science linked below:

Shaping the Future of Emerging Immunotherapies and Cell Therapies

“Patients are waiting. These therapies are potentially curative. They’re important for the field.”
Ellen Sigal

As science drives towards personalized cell therapies for patients across multiple diseases, Friends will further address the changing regulatory landscape of cell, gene, and immuno-oncology therapies with leaders in cancer research and drug development.

This includes the release of a new report developed with leading experts:Harmonizing the Definition and Reported of Cytokine Release Syndrome (CRS) in Immuno-Oncology Clinical Trials.

In addition, Friends led acollaborative meeting onFebruary 11th with these same leading experts, Shaping the Future of Emerging Immunotherapies and Cell Therapies.

The focus of the report and meeting objectives include:

  • Characterize current challenges and recommendations for consistent capture of novel toxicities in early clinical development
  • Discuss current regulatory paradigms and opportunities to facilitate the development of emerging cell therapies and other complex immunotherapies
  • Discuss longitudinal data collection needs for assessing duration of benefit and toxicities
  • Discuss near-term and long-term objectives to facilitate development and sustainability of cell therapies