identifying regulator 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.
Here you can download the statutes of the CIMT Regulatory Research Group.
May 8 RRG Session at 2014 CIMT Annual Meeting with John Haanen (Amsterdam, The Netherlands), Carl June (Philadelphia, USA), Matthias Renner (Langen, Germany), Cedrik Britten (Mainz, Germany) and Raj Puri (Bethesda, USA). Carl June, Matthias Renner and Raj Puri have kindly provided their meeting presentations for education purposes. Download the presentations by
"The following presentation by Dr. Raj Puri (FDA CBER OCTGT) at the Annual Meeting in 2014 can be downloaded for education purposes only. It must not be used for any commercial purposes including but not limited to endorsement of any particular product": download
May 16 RRG Session at CIMT Annual Meeting on immunomonitoring and biomarker regulation with Steffen Walter (Tübingen), Eva-Maria Jahn (Langen), Magali Gibou (Illkirch), Jan Müller-Berghaus (Langen) and Ulrich Kalinke (Hanover).
Download the presentations by
Jan Müller Berghaus
Publication on the regulation of the Actively Personalized Vaccine (APVAC) concept in Nature Biotechnology
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.
May 25 RRG session at CIMT Annual meeting on actively personalized vaccines with Cedrik Britten (CIMT RRG), Ugur Sahin (Mainz), Samir Khleif (NCI), Peter Bross (FDA CBER), Bruno Flamion (Namur/former Head of EMA SAWP). Download the presentation of Peter Bross: US regulatory considerations for the development of therapeutic cancer vaccines: an FDA reviewer’s perspective
Meeting with EMA Innovation Task Force in Jan 2012 to discuss general, preclinical, pharmaceutical and clinical aspects of Actively Personalized Vaccination (APVAC) download EMA meeting minutes
Comment on EMA Reflection Paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (jointly with CRI-CIC)
Initiated new major research project: “Individualized Immune Intervention”
RRG session at CIMT Annual Meeting on individualized immune intervention and biomarkers with Bruno Flamion (former Head of Scientific Advice Working Party, EMA)
RRG session at CIMT Annual Meeting: “Regulation – How Translation Can be Successful” with Raj K. Puri (Director Division of Cellular & Gene Therapies, FDA CBER)
Comment on EMA Draft Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Comment on EMA Concept Paper on the need to revise guideline on the evaluation of anticancer medicinal products in man (jointly with CRI-CIC)
At CIMT 2009, T. Hinz (Section Head Therapeutic Vaccines) from the Paul Ehrlich Institute (Langen, Germany) presented on´Regulatory Environment for Therapeutic Vaccines´ as part of the RRG session. You can download the presentation here.
CIMT filed an official comment on the FDA draft ´Clinical considerations for Therapeutic Cancer Vaccines´. This FDA guidance document discusses considerations common to early and late-phase clinical trials specific for therapeutic cancer vaccines.
RRG filed a comment on the implementation of the ‘Advanced Therapies’ Regulation (EC) No. 1394/2007 during the public consultation period with 198 stakeholders supporting it.
Download the RRG comment.