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Hall Plan

Hallenplan Biomedica 2017

Day 1 // Session 2, Senaatszaal

Regenerative Medicine

Prof. Dr. Carlijn Bouten

Prof. Dr. Carlijn Bouten (Chairman)

Eindhoven University of Technology, NL

Professor of Cell-Matrix Interaction

Curriculum vitae

Carlijn Bouten is full professor of Cell-Matrix Interaction in Cardiovascular Regeneration in the Department of Biomedical Engineering of the Eindhoven University of Technology (TU/e). Her research concentrates on new engineering approaches to regenerate the tissues of the human heart. A particular example is the development of a synthetic, bio-degradable heart valve prosthesis that ‘seduces’ the body to create a new, living heart valve at the site of implantation. The research is performed in close collaboration with material scientists, life scientists, and clinicians, and mainly executed within public-private partnerships.

Prof Bouten is theme-leader ‘Regenerative Medicine’ of the strategic area Health at TU/e and jointly established CREATE, the Center for Regenerative Engineering at Eindhoven. She is recipient of the prestigious Aspasia and VICI career development awards of the Dutch National Science Foundation. She is founding fellow of the European Alliance for Medical and Biological Engineering and Science (EAMBES), member of the board of directors of the Heart Valve Society, and member of AcademiaNet for Outstanding Female Scientists and Scholars in Europe.

Prof. Marianne van der Steen

13:30 - REGMED XB: Innovative collaborations in regenerative medicine to solve chronic diseases

Prof. Marianne van der Steen

Maastricht University, NL

Professor of Entrepreneurship in Healthcare

Curriculum vitae

Marianne van der Steen is Professor of Entrepreneurship in Healthcare at the Faculty of Health, Medicine and Life Sciences, Maastricht University (MERLN). Marianne is the director of REGMED XB. Marianne is the founding director of several global accelerator programs for life sciences start-up companies, such as the Global Scale-Up Program, Global Investor Forum and MBI Life Sciences and Health.  At MERLN, Marianne is responsible for biomedical entrepreneurship from the lab to a spin-off company. Her research focus is on biomedical entrepreneurship, specifically on the growth of ventures & transformation of venture management teams. Marianne van der Steen holds a PhD in innovation economics (1999). Since 2006, she has been involved as consultant, business developer and coach in life sciences start-ups in the Netherlands and Belgium.

Abstract

The presentation will address emerging collaborations in regenerative medicine (RM) that will result in faster and better solutions for patients with chronic diseases. RM is an interdisciplinary and translational field that requires clinical application and critical mass. This implies that a focused approach and close collaborations between top scientists, physicians, entrepreneurs, health foundations and patients, and public organizations is a necessity to result in effective and affordable patient solutions. The speaker will introduce REGMED XB and and address innovations in RM from the perspective of an emerging RM entrepreneurial ecosystem of REGMED XB.
RegMedXB - Regenerative Medicine Crossing Borders - is an extensive new virtual institute of Dutch and Flemish public (universities and governments) and private (health foundations and companies) partners, joining forces to speed up the development of regenerative medicine innovations for patients with chronic diseases. Since 2017, RegMedXB's world class scientists, specialist physicians and entrepreneurs are developing regenerative solutions in organ diseases (e.g. kidney and diabetes), musculoskeletal disease (e.g. osteoarthritis) and cardiovascular disease. The aim is a structural cooperation with a projected budget of 250 million euros for the first 10 years.

Prof. Dr. Jan de Boer

13:40 - Digitizing the interface between cells and biomaterials

Prof. Dr. Jan de Boer

Maastricht University, NL

Professor of Applied Cell Biology

Curriculum vitae

Jan de Boer is full professor of applied cell biology and chair of the Cell Biology-inspired Tissue Engineering (cBITE) department at the MERLN Institute, University of Maastricht, the Netherlands. Prof. de Boer obtained his PhD in the lab of Jan Hoeijmakers at the Erasmus MC Rotterdam in 1999 on mouse models for premature ageing, after which he worked as a postdoc at the MRC Laboratory of Molecular Biology in Cambridge, UK.
In 2002, he started as a research associate at IsoTis B.V. in Bilthoven where he focused on the use of stem cells in bone tissue engineering. In 2003, de Boer was appointed associate professor at the University of Twente. After a 12 month sabbatical at the Wyss Institute and the Broad Institute of MIT and Harvard (Boston, MA), he became full professor at MERLN in 2014.
He received a career development grant (VIDI) on the topic of vascularized bone tissue engineering, is author of >100 scientific papers, including articles in Science, Molecular Cell, J. Exp. Med., Adv. Materials and PNAS. He is former chair of the Netherlands Society of Biomaterials and Tissue Engineering, editorial board member of several journals and co-founder and CSO of the biotech company Materiomics B.V.

Abstract

Research in our laboratory is dedicated to understanding and applying basic cell biological principles in the field of biomedical engineering. The research program is characterized by a holistic approach to both discovery and application, aiming at combining high throughput technologies, computational modeling and experimental cell biology to streamline the wealth of biological knowledge to real clinical applications.

In my seminar I will present our latest work on controlling the interaction of cells with biomaterials through design of surface topography. For instance, we are interested in the bone-inducing properties of a subset of porous calcium phosphate ceramics and show how through reverse engineering, we are uncovering an interesting and complex response of cells to materials. Inspired by this, we have started to design high throughput screening strategies of biomaterials libraries, and in particular libraries of surface topographies. Using a design algorithm, we have generated numerous different patterns, which can first be reproduced on a silicon mold and then imprinted onto polymers using microfabrication. After cell seeding, we use quantitative high content imaging and machine learning algorithms to characterize the response of the cells to the thousands of different surfaces and learn more about the relation between surface topography and cell response. For instance, we have identified surfaces which stimulate osteogenic differentiation of mesenchymal stem cells and we are currently testing whether these surfaces can be applied in orthopedic surgery. The focus of my seminar will be on our effort to digitize life at the interface of biomaterials and cells through parameterization of biomaterial properties, –omics based approaches to analyse cell response and computational science to understand and design bio-active biomaterials.

Prof. Dr. Marianne Verhaar

13:50 - Renal regeneration

Prof. Dr. Marianne Verhaar

UMC Utrecht, NL

Professor of Experimental Nephrology & Head of the Nephrology and Hypertension Department

Curriculum vitae

Marianne C. Verhaar is Nephrologist and Professor of Experimental Nephrology at the University Medical Center Utrecht, the Netherlands. She is chair of the department of Nephrology and Hypertension and heads a research group in Experimental Nephrology. In 2015 she has been appointed chair of the UMC Utrecht Research Program Regenerative Medicine & Stem Cells.

Her research focuses on renal and vascular regeneration and involves translational studies from basic cell studies to animal experiments and clinical trials. General aim is to improve care for the patient with chronic kidney disease by developing new strategies to enhance protective mechanisms against microvascular dysfunction, atherosclerotic disease and chronic kidney disease, to enhance vascular and renal regeneration and to improve renal replacement therapies. Specific interests of the research group are: mechanisms underlying increased cardiovascular risk in chronic kidney disease; the relation between chronic kidney disease, microvascular dysfunction and heart failure; the role of stem and progenitor cells or cellular products in vascular and renal regeneration and their therapeutic potential in patients with cardiovascular and chronic kidney disease; development of renal organoids; development of a wearable (bio)artificial kidney.

Marianne Verhaar received several prestigious grants from the Netherlands Organisation for Scientific Research, the Dutch Heart Foundation and the Dutch kidney Foundation and participates in several large (inter)national consortia.

Mariëtte Geltink

14:00 - From photo imaging to regenerative medicines

Mariëtte Geltink

Fujifilm Manufacturing Europe B.V., NL

Manager New Business Development LS

Curriculum vitae

Mariëtte Geltink is working at Fujifilm Manufacturing Europe B.V. as Manager New Business Development Regenerative Medicines.

She studied Chemical Engineering at the Eindhoven University of Technology, and she did after graduation her PhD in the group „Solid state and materials chemistry“ of the Eindhoven University of Technology. In close cooperation with Philips Research Laboratories she worked on modelling of abrasive processes.

Mariëtte works for Fujifilm since 1998. She started in the photopaper factory in Tilburg, The Netherlands. After several assignments in the photographic industry, she moved end 2009 to Fujifilm’s new business development department, where she is now responsible for business development of Fujifilm’s Cellnest product in Europe.

Abstract

Due to the digitalization, there was a rapid decline in the photographic film market after the year 2000. To compensate for the loss of her traditional business Fujifilm developed many new products for other markets and industries. It is Fujifilm’s ambition to help to solve issues that affect society, such as health and environment.

Regenerative Medicines is since a few year an important focal area for Fujifilm. This started with the development of new animal-free biomaterial, which is now available under the name Cellnest. Cellnest is a recombinant peptide based on human collagen type 1. This well-defined and highly reproducible biomaterial is very suitable as cell culturing matrix in drug discovery and regenerative medicine applications.

Over the years Fujifilm has extended her activities in the field of Regenerative Medicines with the acquisition of J-Tec (Japanese Tissue Engineering Company) and CDI (Cellular Dynamics International), a US based company specialised in iPSC cell reprogramming and differentiation.

Martijn Cox

14:10 - Redefining heart valve replacement with bioabsorbable technology

Martijn Cox

Xeltis BV, NL

Co-Founder & CTO

Curriculum vitae

Martijn Cox is Co-Founder and CTO of Xeltis, a clinical-stage medical device company developing the first ever heart valves and blood vessels enabling cardiovascular restoration, through a therapeutic approach called Endogenous Tissue Restoration (ETR). Xeltis’ cardiovascular implants are made of bioabsorbable polymers based on Nobel Prize-awarded science. In 2016, Xeltis initiated the Xplore-I clinical feasibility study, providing pediatric patients with the first ever bioabsorbable pulmonary heart valves designed to allow ETR. Worldwide, around 80,000 children each year that are born with congenital heart defects that require right ventricular outflow tract (RVOT) reconstruction could benefit from this product.

Abstract

Xeltis is a clinical-stage medical device company developing the first heart valves and blood vessels enabling cardiovascular restoration, through a therapeutic approach called Endogenous Tissue Restoration (ETR). The porous structure of a Xeltis’ bioabsorbable heart valve enables cardiovascular restoration by harnessing the body’s natural healing process to pervade it with new healthy tissue once implanted. As a new healthy heart valve or blood vessel made of patient’s own tissue forms around the structure of the implant and takes over functionality, the implanted valve gets absorbed in the body. Xeltis’ cardiovascular implants are made of bioabsorbable polymers based on Nobel Prize-awarded science.

Xeltis has recently completed enrollment in a clinical trial, which is the first-ever study using synthetic bioabsorbable pulmonary heart valves to treat patients born with congenital malformations of their Right Ventricular Outflow Tract.

Jan Schrooten

14:20 - Creating a cross-border ecosystem to bring living implants to the patient

Jan Schrooten

Antleron, BE

Co-Founder & Managing Director

Curriculum vitae

Jan Schrooten is co-founder and managing director of Antleron (www.antleron.com), a nimble team that will revolutionise medicine by leading the development of next generation advanced therapies and medical devices.
Jan Schrooten also initiated and presently coordinates the Regenerative Medicine Innovation Platform (RegMed, www.regmed.be), an open and growing community across the regenerative medicine value chain to create a leading cross-border ecosystem that can drive regenerative medicine towards a real industry with clinical applications and a societal return.
Previously Jan Schrooten was senior research manager at KU Leuven (Belgium), responsible for long-term management and technology transfer of biomaterials and tissue engineering research. Scientifically he focused on translational regenerative medicine.
Jan Schrooten also holds coordinating and editorial positions. He co-edited the 2nd edition of the Elsevier ‘Tissue Engineering Handbook’, is board member of FlandersBio, the Flemish Life Science networking organisation (www.flandersbio.be), and of the Flemish Biobank Initiative (www.cmi-vzw.be). He is also co-founder and board member of the Bone4Kids charity fund (www.bone4kids.be).

Abstract

Creating a cross-border ecosystem to bring living implants to the patient
The road to sustainable medicine is complex, but feasible. Our region holds all puzzle pieces to kick-start a revolution from curative, over regenerative to preventive, and more personalised medicine. It plays a leading role in regenerative and personalised medicine research, translation, industrialisation, dissemination and clinical implementation. Part of the puzzle has already been laid out by the creation and growth of the regional RegMed community. Over the past two years RegMed evolved into a cross-border support basis with international recognition, in combination with hands-on innovation actions by and for its community members.
As one of regenerative medicine innovations medical 3D-(bio)printing holds, despite its disruptive, complex and interdisciplinary character, potential as a manufacturing technology for living implants. For it to enter our daily life in a sustainable way, the translation from lab to patient requires customisation and rethinking of existing educational, legal, ethical, regulatory and clinical frameworks. Importantly, also business models need to be innovated, as these were developed and optimised for mass produced drugs and devices, and do not support yet personalised, advanced therapies that target patient outcome based on health economics. Building this supporting framework as part of the regenerative medicine evolution starts with understanding the complexity of medical 3D-(bio)printing, including improved insights to distinguish hype from reality. From there one needs to develop a realistic translation into the clinic by engaging a cross-border, critical mass of value chain wide stakeholders.
With medical 3D-(bio)printing being a show case to map out and better understand the complexity of regenerative therapies within medical innovation, regenerative medicine can further create awareness and define its innovating needs. The supporting momentum that is regionally growing needs to be fostered by building on the existing community spirit, values and engagements. The growing regional contacts between industry, academics, hospitals, regional governments, patients and general public have the potential to create a coordinating, Euregional RegMed community that will boost cross-border innovation and will also contribute to dissemination, valorisation and training.
RegMed wants to become a leading public-private community that, by building on its regional actors, can drive regenerative medicine towards a real industry with clinical applications and a socio-economical return. In practice RegMed brings together cross-regional stakeholders to stimulate discussion and project initiation across the value chain. It focuses on multi-stakeholder co-creation, coupled to dissemination towards the general public. Within this setting, RegMed targets to become an interregional hot spot for regenerative medicine.

Alexandra Briquet

14:30 - Production of GMP - grade off the shelf mesenchymal stromal cells

Alexandra Briquet

CHU of Liège , BE

ATMPs Production Manager

Curriculum vitae

Since 2013
ATMPs Production Manager
Cell and Gene Therapy Lab (LTCG), Hematology department, CHU of Liège, Belgium.

2011-2012
Postdoctoral research: “Study of regulation of bone tissue metabolism by neuro-intestinal peptides and implication for bone cellular therapy”, Laboratory of Haematology, team of Prof. Yves Beguin
University of Liège, Belgium.

2009-2010
Postdoctoral research: “Treatment of metabolic diseases of the liver by stem cells of 
umbilical cord”, Laboratory of Haematology, team of Prof. Yves Beguin
University of Liège, Belgium.

2004 – 2009
PhD thesis in Biomedical Sciences
University of Liège, Belgium
Defended on 19th of December 2009: “In vitro study of pro-hematopoietic properties of mesenchymal stem cells”. Supervisors: Prof. André Gothot and Prof. Yves Beguin.

1999 – 2004
Graduate in Biomedical Sciences
University of Liège, Belgium

Abstract

Mesenchymal Stem/Stromal Cells (MSC) exert powerful immunomodulatory effects in addition to showing ability to multilineage differentiation and being a key element to the hematopoietic micro-environment.

These properties make these cells of great interest for clinical applications in Hematopoietic Stem Cell Transplantation (HSCT) and in immune diseases such as Graft-Versus-Host Disease (GVHD) and Crohn’s Disease (CD) but also in Solid Organ Transplantation.

MSC constitute a heterogeneous population of spindle-shaped, plastic-adherent cells isolated from various sources, such as bone marrow, adipose tissue, umbilical cord or cord blood. They can be easily isolated and expanded in vitro to reach adequate numbers for therapeutic doses. 

In the Laboratory of Cell and Gene Therapy (LTCG, Hematology department, CHU of Liège), we have set up in late 2006 a “MSC bank” based on clinical-grade expansion of MSC from BM samples obtained from healthy donors volunteers. During more than 10 years, cells have been produced according to the European Group for Blood and Marrow Transplantation (EBMT) MSC expansion consortium guidelines. 73 donors have been collected, 80 culture processes completed and 506 MSC bags produced (80 - 180 x 10e6 cells/bag).

From these, around 300 have already been infused to patients included in 6 clinical trials with MSC infusion in different settings including Hematopoietic Cell Transplantation (HCT) with myeloablative or non-myeloablative conditioning, Umbilical Cord Blood Transplantation (UCBT), prevention of rejection in solid organ transplant (liver and kidney) and auto-immune diseases (Crohn).

In the meantime, MSC have become considered as advanced therapy medicinal products (ATMP) by the European Medicines Agency (EMA), are under European Regulation N° 1394/2007 and must be produced in compliance with Good Manufacturing Practices (GMP). 

During the past 2-3 years, we’ve been busy implementing GMP standards to our production line. Major changes were applied in the following aspects: staff training and attributions, local classification, equipment, reagents type and traceability, environmental controls, Quality Controls, validation and liberation of the produced batches, quality management and documentation…..

We’ve now obtained the GMP certification for ATMP production and have initiated our first MSC production run recently. These cells will be used in a clinical trial including patients suffering from fistulas in Crohn’s disease.

Marc Simonet

14:40 - Electrospinning for regenerative medicine

Marc Simonet

IME Technologies, NL

Application Scientist

Curriculum vitae

Marc Simonet works as an electrospinning application specialist at IME Technologies. He studied Chemistry at the University of Applied Sciences, HTW Chur, Switzerland. Concomitantly, he worked at EMS-Chemie AG, Switzerland in the Materials Testing Department.
From 2003 to 2007, he was working in the Polymer Technology Group, in the Department of Materials at the Swiss Federal Institute of Technology (ETH) Zurich, with main research focus on developing and processing of bio-compatible polymers for tissue engineering applications.
To further advance the electrospinning technique he worked as a Marie Curie Fellow at the Materials Department at Queen Mary University of London (QMUL) from 2007 to 2009.
From 2009 till 2013 he was a PhD candidate in the Department of Biomedical Engineering, TU/Eindhoven, The Netherlands; adapting and applying generic electrospinning techniques focusing to create a functional in-situ heart valve scaffold.

Abstract

IME Technologies develops and implements the electrospinning process and technology needed for the development and manufacturing of electrospun medical devices of its customers. IME Technologies assist the customer where desired from the research and product development up to the manufacturing in an ISO 13485 certified cleanroom.
In the regenerative medicine field, electrospinning has gained widespread interest to produce extracellular matrix (ECM) mimicking scaffolds for tissue engineering. This technique often was and still is the preferred choice due to its capability to produce fibrous ECM lookalike scaffolds with similar nano- to micrometer length scales.
The process is highly versatile and tunable, allowing to tailor scaffold properties to fit many demands and various applications. This versatility has led to more than 37000 scientific publications and 5000 patents. Meanwhile controlling all the parameters, which create the base of this methods versatility, has proven to be a challenge holding back the development of medical electrospun products. We will show that thanks to a better understanding and tighter control on process parameters, the number of electrospun products is expected to growth and electrospinning can fulfill its great potential also for the regenerative market.

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