RRG

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

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.

Statutes

Members

Ulrich Kalinke
Chairman, Twincore, Hanover
Harpreet Singh
Co-chair, immatics, Tübingen
Ugur Sahin
TRON, Mainz
Christoph Huber
CIMT, Mainz
Thomas Hinz
PEI, Langen
Kajo Kallen
CureVac, Tübingen
Cedrik Britten
Glaxo Smith Kline, UK
Sebastian Kreiter
TRON, Mainz
Ulrich Granzer
Granzer Consulting, Munich
Samir Khleif
Georgia Health Sciences University Cancer Center, USA
Bruno Flamion
University of Namur, Belgium

Activities

2014

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

Matthias Renner
Carl June
John Haanen

"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

2013

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
Magali Gibou
Eva-Maria Jahn
Jan Müller Berghaus
Steffen Walter


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.

2012

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




2011

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)

2010

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)

2009

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.

FDA draft document (FDA-2009-D-0427)
RRG comment
Visit the FDA site for the FDA draft guideline document.
Read all comments on this guideline

2008

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.

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