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Day 1 // iSession 2:

Regulatory Affairs / ATMPs

Paul Borm

Paul Borm (Chairman)

Nano4Imaging, DE

CEO, Lector life sciences, Head of Department of Life Sciences & health

Curriculum vitae

Paul Borm is an entrepreneur in Life Sciences and Medical Technology after a 25 year academic career in Toxicology (Maastricht, Dusseldorf) with research into biomarkers of lung diseases,such as caused by ambient air pollution. His position at Zuyd Polytechnical school in Heerlen creates an ideal setting to be active in regional innovation in Life Sciences by linking product development in small and larger companies to know-how in research institutes and Universities. Nanoscience is the area that feeds his business and research activities on regional and global level. In 2011 he founded Nano4Imaging GmbH in Aachen which focuses on improvement of cardiovascular diagnosis and interventions using MRI. Nano4Imaging is performing clinical studies and market-entry of its MRI compatible guide wire.Our focus group are patients with congenital heart diseases.

Specialties: Imaging, Nanotechnology, Life Sciences, toxicology, MRI, cardiovascular diseases.

Frank Luyten

16:30 - Regulatory Affairs

Frank Luyten

KU Leuven, BE

Director Skeletal Biology & Engineering Research Center

Curriculum vitae

Frank P. Luyten, MD, PhD is board certified Rheumatologist, tenured full Professor and Head of the Division of Rheumatology at the University Hospitals Leuven; Director of the Skeletal Biology & Engineering Research Center, KU Leuven and of Prometheus, the Tissue Engineering Division of Leuven Research and Development.
Training: He obtained his MD, PhD degree and Board Certification in Rheumatology at the University of Ghent, Belgium in 1986. He spent his postdoctoral training at the National Institutes of Health in Bethesda, USA between 1986 and 1991. He became subsequently group leader at the  NIH till 1997. He joined the KU Leuven since the fall of 1997.
Research expertise: Discovery of novel molecular partners in both BMP and Wnt signalling pathways and their role in skeletal and joint biology and human arthritic diseases. Expert in regenerative medicine & tissue engineering supported by contributions in the field of cell based therapeutics for the regeneration of skeletal tissues. Clinical expertise mostly in the field of osteoarthritis and osteoporosis.
Some Senior International Activities at Present:
ERC Advanced Grant holder 2012-2017
Member of the Scientific Panel for Health, European Commission
Co-Founder, scientific and medical advisor of TiGenix (Haasrode, BE)
Member of the board of directors of PharmaCell (Maastricht, NL)
Medical and/or scientific advisor of AstraZeneca UK Limited, Stealthyx (UK),  Beta-Cell (BE)


The clinical impact of cell based therapeutic approaches for applications in the field of tissue regeneration is still limited.  Therefore,  more insight is needed on many aspects of the development of these novel cell based therapeutic medicinal products including a mechanistic understanding of cell survival, local inflammatory processes, tissue formation and tissue integration in vivo.
Manufacturing of the cell based implants and upscaling is another major challenge. In order to address this, we introduced a “developmental engineering” approach for the fabrication of clinical size products. This methodology is based on the design of sequential in vitro sub-processes corresponding to in vivo developmental stages.  They follow a gradual and coordinated progression of cell growth, differentiation and tissue assembly that leads to organization of cells into intermediate tissue forms. New enabling technologies are required to translate this into robust manufacturing  processes and include miniaturization, automation, bioreactor and biosensor technologies with online monitoring and non invasive imaging. In addition, the reduction of cost of production becomes a major goal.
Based on progress on many fronts, a  second wave of new and more rational approaches for tissue engineering  will hopefully lead to more predictable clinical outcomes.  In view of this,  a regulatory framework has been defined both in Europe and the USA in which tissue engineered products can prove their safety and effectiveness. For these products, to live up to the standards of drug development, challenges arise towards practical implementation but also to legislation and ethics.

Jürgen Scherer

Jürgen Scherer

Paul-Ehrlich-Institut, DE

Section ATMP, Tissue Preparations, Head of Section

Curriculum vitae

Dr. Jürgen Scherer studied Biology at the University of Mainz. For completing his PhD, he joined the Max-Planck-Institute for Brain Research and continued neurobiological work at the Max-Delbrück Centre for Molecular Medicine. In 1993, he joined the Paul-Ehrlich-Institut. After initially doing virological research, he then moved into regulatory business as a Deputy Head of the Section for Viral Vaccines. Since 2007 he is in his current function dealing with all regulatory aspects of ATMPs including clinical trial and marketing authorizations, at the national and the European level. Work includes also advising developers, participating in inspections and contributing to European expert bodies and committees.

Rob Ngungu

Austen BioInnovation Institute, USA

Jan Schrooten

Antleron bvba, BE

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