CHARITE - Charité-Universitätsmedizin Berlin

Charité-Universitätsmedizin Berlin is the leading University Hospital in Germany and coordinating institution of JOIN4ATMP. Together with the Berlin Center for advanced therapies (BeCAT), Berlin Institute of Health (BIH) and the new National Center for Tumor Diseases (NCT) the Charité possesses excellent opportunities to transfer biomedical research into new (personalized) therapeutic approaches. Charité BIH Innovation is the joint technology transfer of the Charité and BIH and offers expertise in law and intellectual properties with a focus on ATMPs. The BIH Regulatory Office supports Research & Innovation scientists with ATMP regulatory issues.

Role within JOIN4ATMP

The Charité team, led by Prof. Annette Künkele-Langer, is responsible for the JOIN4ATMP initiative's management and scientific coordination. In WP1, this initiative aims to enhance preclinical data predictability for safety and efficacy, in which Charité will identify innovative non-animal preclinical models to forecast clinical ATMP outcomes. WP2 focuses on harmonizing GMP-compliant ATMP production in the EU, with Charité mapping requirements for manufacturing and planning an EU-wide GMP coordination platform. JOIN4ATMP aims to streamline clinical ATMP development towards marketing authorization, with Charité evaluating alternative clinical trial and approval processes in WP3. Additionally, we explore new incentives and funding strategies for ATMPs developed by academics and SMEs. To develop frameworks for value assessment and reimbursement in WP4, Charité will create an economic model tool for ATMPs to assist developers in understanding their economic value. Lastly, JOIN4ATMP seeks to raise ATMP regulatory awareness among manufacturers and acceptance among patients and healthcare professionals, with Charité providing recommendations to enhance patient involvement and public awareness in WP5.

Main contact(s)

Annette Künkele-Langer

Pediatric oncologist and coordinator of JOIN4ATMP, Team leader, WP6 leader

Stefanie Grunwald

Patent assessor, Technology Transfer focus on ATMP, Team leader

Hans-Dieter Volk

Spokesperson of the EU network RESTORE as one Partner for Join4ATMP, expert for biomarkers and preclinical testing of ATMPs, Co-lead WP1, Member Steering Committee

Gady Goldsobel

Expert in intellectual property (IP), licensing, and innovation with particular interest in health economics, Task leader

Maja Pizevska

Regulatory Specialist for ATMPs, Patient Expert, Task leader

Maria Wenzel

Legal Counsel - Expert Legal Affairs of Medical Technology Transfer, Team Member WP2 and 3

Catharina Delebinski

Team Member WP 6 and 7

Franka Klatte-Schulz

Team Member WP3, 4, 5, 6