Strategic Initiatives

SITC Biotech Initiative

Launched in 2023 with a vision of accelerating the approval of 100 novel immuno-oncology agents in the next 10 years, the SITC Biotech Committee is leading six strategic pillars to support the entire IO biotech ecosystem. With 2024 FDA IO Approvals and 2025 PDUFA Dates, the community is on its way to achieving 100 novel IO agents approved in the next decade. 
Organizations within the IO biotech ecosystem that share SITC’s vision for 100 novel IO agents approved by 2034, can join the movement by becoming a member of the SITC Biotech Community.

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SITC Biotech Strategic Meeting at the NYSE

Friday, June 27, 2025, from 8 A.M.–2:25 P.M. ET

This exclusive event brought together experts, investors, and biotech innovators to discuss the future of T-cell engagers, China’s impact on IO clinical research, and strategic pathways for novel immunotherapy advancements. The program began with an analysis of IPO trends, followed by panel discussions on the current state and future potential of T Cell Engagers, Bi-specifics & CAR-T therapies. Part two of the program focused on China's impact on biotech, addressing innovative approaches to biologics beyond "Me Too" products. 

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Leveraging Essential Biomarkers Manuscript

SITC convened a group of experts in IO to discuss strategies to leverage biomarkers in the enrichment of early-phase trials with patients best suited for response. This panel of experts have proposed the framework for a biomarker-based enrichment strategy which incorporates the collaboration of multi-omics, improved understanding of the tumor microenvironment, novel informative biomarkers, adaptive trial designs, and standardized pathology. 

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Crisis in Clinical Research

The SITC Crisis in Clinical Research Virtual Summit was a successful initial step in addressing the crisis in clinical research that brought oncologists, administrators, the NCI, the FDA, pharmaceutical companies, contract research organizations, and other major oncology professional organizations together to further delineate the current staffing and administrative issues for oncology clinical trials. The group also considered alternative clinical trials administrative models to reduce the current burden.

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Essential Biomarkers

Recognizing the major developments in clinical oncology over the last twelve years and the value of standardized datasets, The Society for Immunotherapy of Cancer (SITC) is working to provide data- and consensus-based recommendations for biomarker studies in early-phase immunotherapy clinical trials. SITC has developed and disseminated a commentary and consensus-level manuscript in the Journal for ImmunoTherapy of Cancer (JITC) and plans to update the manuscript as evidence and applicable laboratory protocols for new validated biomarkers become available.

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Expanding Access to Cellular and Bispecific Therapies

At the SITC ACCC Expanding Access to Cellular and Bispecific Therapies workshop, SITC and ACCC gathered experts tasked with providing recommendations for centers interested in opening cellular therapy and bispecific programs. Through group discussion, the workshop came to consensus on a number of recommendations that address three distinct categories. These recommendations are detailed as actions suggested to be taken prior/while opening a program.

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IO Resistance Initiative

SITC's Immunotherapy Resistance Committee convenes stakeholders from across the field of immunotherapy to help develop unified definitions of immunotherapy resistance in order to support future drug development.

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IO Surrogate Endpoints Initiative

On April 5, 2024, the Society for Immunotherapy of Cancer (SITC) held a closed-door summit on novel surrogate endpoints in order to advance the field of immunotherapy. The goal of this closed-door workshop was to engage experts across the field of immunotherapy to discuss the science behind surrogate endpoints and identify potential endpoints worth pursuing.

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Release Criteria Initiative

On December 12, 2023, The Society for Immunotherapy of Cancer (SITC) convened cellular therapy experts with representation from major academic centers, industry, and the regulatory agencies to dive deeper into the topic of release criteria for cellular therapies, and provide recommendations to the field on their application, usefulness, and role in the regulatory process.

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