On May 10, 2012, a group of representatives from ICRC-Weyer GmbH attended a colloquium on regulatory requirements for the development of cell-based medicine which took place at Beuth University in Berlin, Germany (Clinical Trial Management Colloquium). “This was a good chance for CROs, Beuth University Berlin and industrial partners to share their experiences with each other.” says J. Daniel Weyer, a Managing Director at ICRC-Weyer GmbH. “One of the most interesting contributions at the event was the keynote speech by Dr. Gudrun Tiedemann, CEO at Advanced Therapies Partners GmbH in Rostock, Germany, who gave an overview on new regulations in the field of Advanced Therapy Medicinal Products (ATMP).”
Oncology and cardiology trials are still dominant:
ICRC-Weyer has already been providing independent monitoring services for several clinical trials in the field of stem cells. “So it was very important for us to learn, listen and engage with others in this field and understand the latest trends. Oncology and cardiology are still the most important areas in which we conduct studies, but we believe that clinical trials in the field of regenerative medicine will become more prevalent and we want to be active in delivering these studies as well.” says Mr. Weyer.
Stem cells, somatic cells, biomaterials, tissue are used in the regenerative medicine to regenerate or replace diseased tissue. Cell-based and tissue-based products called ATMP are regulated by regulation 1394/2007/EG, which came into force in 2009. A centralized procedure for approval of ATMP and a manufacturing license for ATMP are required.
Mr. Weyer continues: “If ATMP fulfill the conditions of a so-called ‘hospital exemption’, they would be released from the approval and manufacturing license which we believe would result in greater innovation. This exemption will be managed in a flexible manner in Germany within the established legal framework making it easier for smaller companies and hospitals to establish their products and procedures, however only on a limited scale. Clinical trials and a centralized authorization procedure would be required, if the use of the Advanced Therapy Medicinal Product’s is to be increased significantly.”
Personalized Therapy can help save patients’ lives:
A trend toward ‘personalized therapy’ can also be observed in oncology. The more precise a drug can be matched to a patient, the higher the chances to treat cancer more effectively. In addition, you may save some patients during the trials, reducing the need for current ineffective treatments with their possible side effects. By testing for specific biomarkers conclusions can be drawn about individual responses. In order to find out such correlations, investigator-
ICRC-Weyer is an established all-phase contract research organization (CRO) based in Berlin, Germany. The company was founded in 1993 by Prof. Dr. Geerd Weyer and offers services ranging from pre-clinical through to phase IV clinical trials. ICRC-Weyer provides complete turnkey solutions including data management, monitoring and medical review services for all stages of the clinical development process.
ICRC-Weyer has special expertise in Advanced Therapies, Nutrition, CDISC Data Standards and Medical Review.
Johann Daniel Weyer
Boelschestrasse 2, 12587 Berlin, Germany
Phone: +49 30 403937-0