Danielle M.J. Curfs, PhD
CEO Medace
CEO Medace
Ms. Curfs studied Environmental Health Sciences and holds a PhD in Toxicology and Cardiovascular Diseases. She continued as a postdoctoral research fellow in a public private partnership between the former pharmaceutical company Organon, Maastricht University and the Dutch government, setting up high-throughput screening methods. In 2009, she transferred to Royal DSM and started working as a project manager in the public-private BioMedical Materials Program, managing a project portfolio of M€50 in the fields of cardiovascular, nephrology and drug delivery. In 2014, she switched to DSM’s Innovation Center as the program director of DSM’s global competence program Health. Simultaneously she was involved in setting up the public-private Institute for Science and Technology (InSciTe).
As of 2016, she dedicates her time on developing a matrix concept to accelerate (bio)medical innovations towards market and patient. This matrix concept is the foundation of Medace: a full service company that trains and guides its customers (being academics or entrepreneurs), in an ISO-certified work-learning environment, how to set up and develop the technical dossier needed for clinical validation whilst producing their clinical grade product.
Sales, Marketing & General Business Management Professional with 20 years’ experience in the Life Science & Biomedical Research industry.
Background as Master in biochemistry. Working with early stage companies and academic groups to bring proven concepts to the patient studies. Currently focusing on GMP and ISO-certified Manufacturing Facilities to help accelerate the growth of Medical Devices, ATMPs and Regenerative Medicine companies.
Throughout his entire career Kurt has always delivered above average growth, often 5 to 10% higher than company and industry growth.
Specialties: Market Development, Marketing, Business development, Real Estate development for innovative companies, Coaching and People Management, General Management
Jean Blom is accountable for the daily quality assurance activities as Medace’s Quality Management Representative for the certified ISO 13485 QMS of its Maastricht facility. He provides the strategy regarding Medace’s medical device clients, stepping into planning, coordination, and execution of quality support activities where necessary. He also serves as the principal expert regarding quality requirements as defined by standards and regulations such as the EU’s MDR.
Jean has over 11 years of experience in the Medical Device industry; from the hands-on quality and regulatory activities in start-up MyDiagnostick, through the quality coordination and system compliance architecture aspects of established business D.O.R.C. who had an extremely wide and varied product portfolio, to the accredited certification activities of ISO 13485. This is enhanced by his knowledge from the time in his master’s in international business Managerial Decision-Making and Control (formerly Controlling). In that time he became Lead Auditor and Audit Programme Manager, managed ISO 13485 remediation, scope extension and full-scope MDSAP implementation projects, and became Technical Expert. That combined experience is also employed to train others in advanced quality aspects and to evaluate the adherence of personnel to a QMS as internal or supplier auditors.
Jean enjoys ballroom dancing, reading, riding his Honda CB650R, and playing Dungeons and Dragons.
Coaching and mentoring comes naturally to Jean, where he takes the path of teaching things slowly so you can learn to do them smoothly. He enjoys the excellent alignment of his character in this with Medace’s mission of working together to enable learning, which accelerates successful innovative Medtech.
Jessica Gerards is specialized in the area of Regenerative Medicine development, with the focus on ATMP. Jessica ensures compliance with international quality to accelerate the development of her clients’ products towards patients.
Jessica graduated from Zuyd Hogeschool with a Bachelor degree in Applied Sciences (Biomedical). As an intern she gained experience with techniques like flow cytometry, confocal microscopy and cell culture. Her motivation to contribute to people’s quality of life combined with her general interest in regulatory issues led to her passion to work in the field of Quality.
In 2018 Jessica started working as a Quality Officer within Chemelot InSciTe to support clients in the field of Medical Devices and ATMPs with the development of their quality management system. Jessica became Interim QA Manager in 2019 which raised her managerial responsibilities. She also successfully prepared and executed the transfer of the ISO 13485 Certification to the newly built biomedical facility of Medace in Maastricht.
Jessica provides clients with the tools needed to manage their own quality systems in the maze of regulatory and quality issues.
‘ I am proud to be working at Medace as the company is unique in the service that we provide. We are front runners which makes it a dynamic and challenging place to work.’
Hans Henskens is supporting our clients in releasing their final product as QP (Qualified Person), ensuring that the product is safe to use and meets all required specifications. Next to this he supports the rest of the Quality Assurance teams of Medace and her clients in maintaining the Medace Quality Management System according to the current legislation and standards. Hans provides expert support and implementation guidance on tailor-made documentation while our customers are developing their Advanced Therapy Medicinal Products (ATMPs) at Medace enabling them to obtain their own manufacturing license and perform clinical trials with their products.
Hans initially got his teacher training degree in Tilburg, after this he broadened his experience in Molecular (cell) Biology by earning his master’s degree in molecular biology in Nijmegen and subsequent doctorate from the Free University of Amsterdam. After his PhD he has gained extensive experience in the innovative pharmaceutical industry, more specifically within Quality Assurance and Quality Control. His first role as QP was for generic medication but thereafter he managed several QA/QA departments besides his QP responsibility. At the beginning of his career, he gained much experience during his 10-year employment at Synthon, an innovative Biopharmaceutical Company. Later he acquired extensive experience in the field of ATMPs as QP of PharmaCell and subsequently Lonza Netherlands, a Cell and gene therapy CMO. After his time at Lonza he was employed Chief Quality Officer / QP for Glycostem Therapeutics, an innovative company developing stem cell-derived Natural Killer cells for an allogenic cell therapy product as s a medicinal asset in the fight against cancer. Throughout his working life, he has ensured that these companies passed various authority inspections.
Hans values the combination of several innovative emerging Biotech companies, enabling synergy and accelerated development. ‘’It’s highly motivating to work in the Medace ecosystem and being able to support multiple development trajectories at the same time to achieve our joined objectives.’’
Youri van de Beek is responsible for maintaining and improving the Quality Management System on a daily basis. Youri assists projects and clients within Medace by reviewing and updating documentation and completing technical files from a quality point of view.
Youri studied Laboratory Technique at the Vista College and spent his internships at the Uniklinik in Aachen and the Zuyderland hospital in Heerlen. In 2018 Youri started working for the Chemelot Institute for Science and Technology. Being involved in the quality team of their biomedical facility, Youri and his team members made a natural transfer to Medace at the end of 2019. At Medace he is now active as a full-fledged QA Officer by supporting implementation of guidelines and regulations.
Youri also provides introductory training for clients’ team members who will be working within the facility. ‘I enjoy working in a small team that still manages to do so much. Being a part of that and supporting others pushes me to develop into a Quality Officer that is able to support multiple projects and companies at the same time.’
Chris Duxbury makes sure that all the facilities and technical aspects in the Medace facilities run smoothly. Combining both his scientific expertise and projectmanagement skills, Chris has made a great effort in the design and development of the medical device and ATMP cleanroom facilities at Medace, in which he applied best practices seen in earlier developed facilities.
Chris studied at the University of Nottingham where he gained a PhD in Chemistry. He moved to the Netherlands and held post-doctoral fellowships within the field of polymer chemistry at Royal DSM. After these fellowships he started working at DSM’s materials research department with a focus on the biomedical business unit. In 2015 he took up the responsibility to design, build and subsequently manage the biomedical facility of the public-private Institute for Science and Technology in Geleen (InSciTe). Parallel to these activities Chris played an important role in the process of obtaining ISO 13485 certification for InSciTe’s Biomedical Program.
Chris lives close to the facility in Maastricht and enjoys his daily bike ride from home to work. “ It’s a joy to be working in this vibrating heart of the medical hub in Maastricht, with so many different people with so many different expertises. We can really make things happen here.“
Dyanne takes care of Medace's financial administration and guarantees timely payment of obligations and accurate reporting to management.
Dyanne graduated from the HBO Business Economics in Sittard. Immediately after her studies she started working at DSM where she worked for 26 years as a financial controller in various departments and projects. Then she started working for knowledge institute Chemelot InSciTe in April 2018.
She enjoys the interaction with all the diverse companies working at Medace.
'I am proud to be able to add a little value to this promising company in this beautiful working environment.’
Denise is one of the Biotech Associates within Medace. Together with the Operations team she is responsible for maintaining the facility, providing training, and assisting clients in their daily operations, mainly focusing on the aspects of Quality Control and GMP production processes in the cleanrooms.
This includes providing hands-on support in GMP production and QC processes (e.g. carrying out aseptic manufacturing procedures, write and review quality documentation, validation of QC protocols). And work with the quality and operations team to develop quality control methods, initiation and follow-up of deviations, CAPAs and changes.
She recently graduated from the Maastricht University with a Master of Science degree in Biomedical Sciences, specialized in Inflammation and Pathophysiology. Before starting her MSc degree, Denise had gained experience as a jr. quality assurance officer at Lonza. During her MSc she did an internship at the department of Radiotherapy at Maastricht University in which she studied the effect of Sertraline on radiotherapy resistance in Non-Small Cell Lung Cancer. Denise gained extensive experience in techniques like Flow Cytometry, Cell culture, and qPCR.
Denise enjoys working at Medace for its unique concept and the opportunity to work in an environment with highly-motivated experts and cutting-edge innovations. ‘’I like to contribute to bridging the gap between research and the clinic and help to bring biomedical innovations to the patient.’’
Frans is one of the Biotech Associates at Medace. Together with the rest of the Operations team he is responsible for maintaining the facility, providing training, and assisting clients in their daily development and manufacturing operations. Besides that, he also is a great aid in creating in-depth strategies to overcome Research & Development obstacles that arise in the biomedical domain.
Frans studied at the University of Technology in Eindhoven, where he obtained a Master of Science degree in Biomedical Engineering. He gained expertise both in the Biomaterials and Cell-Matrix Interactions area, gathering knowledge on what make up the building blocks of a biomaterial, and comprehending the interaction between such biomaterial and biological elements.
During his graduation project he studied the development of an adhesive supramolecular hydrogel and a supramolecular electrospun patch for the treatment of myocardial infarction. He combined this with more fundamental research on the influence of substrate stiffness and curvature on the behavior of fibroblasts. This was followed by an internship at STENTiT, in Eindhoven where he assisted in the development of a biodegradable stent.Frans continued his career at STENTiT as an R&D Engineer after obtaining his MSc degree. Frans has extensive experience in chemical, mechanical and biological manufacturing and analytical techniques such as electrospinning, tensile testing, confocal and scanning electron microscopy, cell culturing and immunofluorescence, among others.
Frans appreciates working at Medace because the close cooperation within the team gives him insights into all aspects that advance the company. Secondly he truly enjoys the opportunity to work with a wide variety of biomedical entrepreneurs and innovations.
Linda is responsible for supporting clients regarding the matters related to the regulatory compliance of their product and product development. This is achieved by advising, reviewing and teaching within client-focused projects, and by improvement and updates of the Medace QMS used for clients.
Linda graduated as BSc from Hogeschool Rotterdam as a biomedical research technician. She started her career at IsoTis BV where she worked on skin and bone tissue engineering. Her experience continued at the University of Utrecht, where she worked at the department of Immunology as technician in a project of the Dutch Asthma Fund. After the project ended, Linda decided to return to a company setting and did research at start-up Progentix Orthobiology BV (now known as Kuros Biosciences BV). In this job Linda performed tasks such as setting up an ordering system, histology, pre-clinical studies, shelf-life studies and coordinating clinical trials. During this time she got acquainted with the field of regulatory affairs, and after more than 10 years in research, she moved to D.O.R.C. to enhance her career in regulatory affairs of medical devices. At D.O.R.C. she was responsible for the regulatory side of product development and product changes, as well as regulatory intelligence, CE certification and 510(k) clearances, technical file maintenance of ophthalmic surgery devices ranging from class I to class IIb, from reusable to sterile, from short-term use to implantable and active devices with software.
At Medace Linda hopes to combine the experiences gained at start-up companies with her laboratory background and wide knowledge of medical device regulatory affairs to advise and teach other medical device start-ups and help them get their product to market in an efficient and compliant way.
Michał Ferens is currently working as Business Developer at Medace B.V. and seeking partnerships with academic groups and (bio)medical startups willing to bring their innovative therapies to patients.
Michał is an experienced professional in the field of Life Sciences, with over 15 years of international experience, he has worked in various areas including: R&D in Microbiology, Analytical Method Validation and Quality in Pharma and Biotech, Product Development in the field of Specialty Chemicals, After Sales and Technical Support, International Business Development and Marketing, Operations and Remote Team Management.
Michał graduated with a MSc. & Eng. in Chemistry with a specialization in Molecular Biotechnology from the Gdansk University of Technology (Poland) and he also holds a Master’s Degree in Digital Marketing (WeM_ParK | PIN, University of Florence, Italy).
Michał's hobbies include: reading, travelling, tennis, photography as well as music production.
Rianne is one of the Biotech Associates at Medace. Within the Operations team, she is responsible for the maintenance of the facility, providing training to Clients, and supporting with various clients daily operations with a primary focus on GMP production processes in the cleanrooms.
Rianne studied at Zuyd Hogeschool in Heerlen, where she obtained a Bachelor of Science degree in Applied Science, with a specialty in Biomedical Science. Her graduation internship took place at Neuroplast where she researched on the possible usage of the Monocyte Activation Test as a sterility test for their ATMP product (Advanced Therapy Medicinal product). After graduating, she joined Neuroplast as a Biotech Associate, where she got hands on experience on manufacturing an ATMP product compliant to the EU GMP regulations. She also took active participation in writing and dealing with non-conformities, corrective and preventive actions, change controls, and updating batch related/other GMP documentation. Prior to joining Medace, Rianne worked at the Central Diagnostic Lab within MUMC+ where she performed blood, urine and liquor tests and maintained the highest quality test results while working with the patient materials.
Rianne thrives in the dynamic environment at Medace, where a multitude of companies are working on innovation and development. These fuel her passion for innovation and problem-solving which she will deploy to help with the challenges the clients are facing, and contribute towards their success.
Marco is Quality Associate GMP at Medace. He supports clients with their quality-related needs, thereby aiding their company developments. A well-established Quality Management System is a prerequisite to warrant consistent manufacturing and product quality to secure patient safety.
Marco is driven by biomedical applications that could improve treatment outcomes and quality of life. After graduating the Clinical Molecular Sciences master (2010), Marco pursued unravelling cellular means that sustain therapy-thwarting features of the tumor microenvironment. Herein, the research revolved around intracellular vesicle trafficking systems called autophagy and the endo-lysosomal pathway. First as PhD student at Maastricht University and later on as post-doc at KU Leuven. In 2019, Marco started at Neuroplast in the position of Quality Control Manager. Neuroplast produced an ATMP (GMP-compliant) for treatment of traumatic spinal cord injured patients in phase 1 and phase 2 clinical studies. In this position, Marco got experienced with the requirements of GMP, running a compliant lab facility and the structured Quality Management System.
Together, this collective of experiences in academic (pre-clinical) studies and GMP-compliant manufacturing and quality control is a great foundation for his position within the Quality team at Medace. Marco is excited to provide tailored quality support to start-ups to bring the medical innovative concepts to clinical application in a compliant way.
Gert is one of the Biotech Associates within Medace. Together with the Operations team he is responsible for maintaining the facility, providing training, and assisting clients in their daily operations, mainly focusing on the aspects of tech transfer and process development for ATMPs.
Gert obtained a BSc degree in Agro- and Biotechnology at PXL Hogeschool followed up by a BSc degree in Biochemistry & Biotechnology at the University of Antwerp. He did a graduation internship at the department of experimental oncology in the Gasthuisberg campus, Leuven.
Since then, Gert has gained over 5 years of experience working in a GMP environment, starting as a QC analyst in a small molecule API production plant. Here he learnt the basics of GMP lab work, quality assurance and structure of a pharmaceutical company. The next step was moving back to the field of biotechnology and gaining a broader insight in pharmaceutical production. This was achieved by joining a pre-clinical ATMP startup and aiding in product development as well as building a QMS. In this diverse role Gert worked on various tasks including hands on experience with pre-clinical studies, aseptic manufacturing in grade-B cleanroom, handling of non-conformities, CAPAs, and change controls which resulted in a GMP certification for the company and an NK-cell culturing process with yields far exceeding competitors.
“I get energized from building efficient processes, having the opportunity at Medace to help multiple companies simultaneously to reach their goals is a perfect fit!”
