About RRG

Founded in 2008, the CIMT Regulatory Research Group is an independent group of experts focusing on regulatory aspects of drug development:

  • identifying regulatory challenges posed by emerging immunotherapies

  • developing new regulatory concepts to facilitate clinical testing of innovative immunotherapies

  • facilitating discussion between all groups relevant for the translation of scientific knowledge from bench to bedside

The group is open to any expert committed to contributing to the RRG goals. All RRG activities are intended to support the scientific or medical progress in the field of immunotherapy. Independency and transparency are basic principles on which all RRG activities are based. The group discusses the generic principles and publicly available information on national and international laws, directives and regulations influencing the development of immunotherapy. All relevant activities of the group are made publicly available.

Regulatory Research at CIMT Annual Meeting

In 2023, the CIMT-RRG organized a special session on trial enrollment for innovatice personalized immunotherapies as part of the 20th CIMT Annual Meeting.

Chairs: Cedrik Britten (Immatics, Tübingen, Germany), Stefan Fröhling (German Cancer Research Center DKFZ and NCT Heidelberg, Heidelberg, Germany)

Speakers:

  • Koustubh Ranade (Immunocore, Rockville, United States of America)

    "Tebentafusp-a gp100 directed TCR-CD3 bispecific for the treatment of metastatic uveal melanoma"

  • Hilke Zander (Paul-Ehrlich-Institut, Langen, Germany)

    "Evolving regulatory framework for IVDs and CDxs (IVDR)"

  • Miriam Meyer (Immatics, Tübingen, Germany)

    “HLA genotyping for T-cell therapy"

  • Lisa McShane (National Institutes of Health, National Cancer Institute, United States of America)"Genomic screening for actionable genomic alterations - experience from NCI precision medicine platform trials"

  • Stefan Fröhling (German Cancer Research Center DKFZ and NCT Heidelberg, Heidelberg, Germany)

  • "RNA sequencing to facilitate patient enrollment into biomarker-guided clinical trias"

CIMT-RRG Publications

Britten CM, Singh-Jasuja H, Flamion B, Hoos A, Huber C, Kallen K-J, Khleif SN, Kreiter S, Nielsen M, Rammensee H-G, Sahin U, Hinz T, Kalinke U (2013): The regulatory landscape for actively personalized cancer immunotherapies, Nature Biotechnology 31 (10), 880-882. doi 10.1038/nbt.2708.

Hinz T, Kallen K, Britten CM, Flamion B, Granzer U, Hoos A, Huber C, Khleif S, Kreiter S, Rammensee HG, Sahin U, Singh-Jasuja H, Türeci Ö15, Kalinke U. The European Regulatory Environment of RNA-Based Vaccines. Methods in Molecular Biology. 2017. Volume 1499. pp 203-222

CIMT-RRG Statutes

Here you can download the statutes of the CIMT Regulatory Research Group.