NorthWest Biotherapeutics Inc (NWBO)

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Innovative Drugs for Europe - Dr. Martina Schüssler-Lenz of the Paul-Ehrlich-Institut elected as chairman of the EU Committee for Advanced Therapies

In February of this year, Dr. Martina Schüssler-Lenz, a clinical assistant to the Department of Medical Biotechnology at the Paul-Ehrlich-Institut ( PEI ), became the Chair of the Committee for Advanced Therapies at the European Medicines Agency EMA Selected.

http://www.pei.de/DE/home/de-node.html

My comment: I am sure she is very aware of DCVaxl-L and GBM trial when NWBO went through PEI evaluation for the start of the trial and granting Hospital Exemption in Germany.

Major advances in biotechnology enable the development of " Advanced Therapy Medicinal Products " ( ATMP ). These medicinal products are products in which cells or tissues are manufactured and processed using innovative methods. Thereby, gene therapy, somatic cell therapy and tissue engineering are distinguished. For this type of medicinal product, the complexity of the medicinal product makes it possible to create specific regulations harmonized at European level. In order to ensure the patency of these medicinal products at the EMA , the CAT has been established as a multidisciplinary committee, in 2009, in accordance with Regulation ( EC ) No 1394/2007, in which experts from a wide range of disciplines work together. The CAT performs, among other things, the initial assessment of the quality, safety and efficacy of ATMP and, An authorization recommendation to the EMA Committee for Medicinal Products for Human Use ( CHMP ).

Each EU Member State provides an expert as a member of the CAT . Five of these members are simultaneously members of the Committee for Human Medicinal Products ( CHMP ). Iceland and Norway each represent one member. Two members appointed by the European Commission come from the medical profession and from patient organizations.

"We are delighted that Dr. Schüssler-Lenz will be able to contribute its expertise in the field of clinical evaluation of medicinal products in combination with the expertise of the Department of Medical Biotechnology at the Paul-Ehrlich-Institut Path of admission so that new therapeutic approaches for serious diseases can find their way into medical practice " , explains Prof. Klaus Cichutek, President of the Paul-Ehrlich-Institut.

Dr. Martina Schüssler-Lenz has been a member of the CAT since 2009. After working as a specialist, she worked at Tumble Research at the Memorial Sloan Kettering Cancer Center, New York, where she was responsible for several years of clinical trials in Phase I-III in the pharmaceutical industry. At the Paul-Ehrlich-Institut, the evaluation of clinical data and scientific advice are among their tasks.

"The medicine does not stop and new, innovative therapies have to reach the patients. I am delighted that as the chairman of the CAT I can contribute to an important interface," says Martina Schüssler-Lenz.

Further information:
News of the EMA from 17.02.2017 - Martina Schüssler-Lenz elected as new chair of the Committee for Advanced Therapies
Press contact:
Paul-Ehrlich-Institute
Press office
Dr. Susanne Stöcker, Dr Corinna Volz-Zang, Brigitte Morgenroth
Paul-Ehrlich-Strasse 51-59
63225 Langen, Germany
GERMANY
Phone: [phone]
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E-mail: [e-mail]

The Paul-Ehrlich-Institut in Langen near Frankfurt am Main is a federal agency for vaccines and biomedical drugs, a federal agency in the area of ??the Federal Ministry of Health ( BMG ). It researches, evaluates and approves biomedical human medicines and immunological veterinary drugs and is responsible for approving clinical trials and pharmacovigilance - recording and assessing possible side effects.

The state batch test, scientific advice and scientific advice and inspections are among the other tasks of the institute. An essential basis for the many-sided tasks is their own experimental research in the field of biomedicine and life sciences.

The Paul-Ehrlich-Institut with its 800 members of staff also performs consulting functions in the national (federal government, Länder) and international environment (World Health Organization, European Medicines Agency, European Commission, Council of Europe and others).