After severe wounding, human skin fails to regenerate and physiologically heals by scar formation. Worldwide, millions of people suffer from severe skin defects or diseases requiring surgical interventions to restore skin function.
Existing therapies frequently leave these patients with permanent, painful, disfiguring, and debilitating scars. Scars may impair movement and growth, and often require several follow-up surgeries, intense homecare and psychosocial rehabilitation. Severe skin defects significantly affect quality of life in a long term, along with the economic burden for the health-care system. Human skin is composed of an outer epidermis, a dermis and a hypodermis. The components of the dermis control and regulate scarring. Today, standard of care consists in harvesting a thin layer of healthy patient’s skin, which contains the epidermis but only remnants of the dermis. Since sufficient dermis is missing, these grafts often develop into scars. Furthermore, in severe cases, where most of the skin has been destroyed (e.g. burns), the shortage of healthy skin represents a real clinical challenge.
In 2001 a team of the University-Children’s Hospital Zurich led by Professor Reichmann pursued the vision of bio-engineering personalized dermo-epidermal skin grafts, using patients’ own cells. One of the developed products, denovoSkin, is the result of fifteen years of research. A first-in-man safety study was completed with denovoSkin with very promising results. denovoSkin has obtained Orphan Drug Designation for a treatment of burns (by Swissmedic, EMA, and FDA). With the support of the regenerative medicine technology platform of Wyss Zurich the team will now proceed with product development, testing denovoSkin’s efficacy in pivotal phase II multicentric studies and prepare for market authorization in terms of regulatory and reimbursement activities.
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Tissue Biology Research Unit, University Children’s Hospital Zurich
University Children’s Hospital
Dutch Burn Center
University Hospital Zurich
University Hospital Birmingham
Voisin Life Science Consulting
Co-Project Leader and Clinical Trial Manager
Fabienne Hartmann-Fritsch joined the Wyss Zurich in October 2016. She is responsible for the project leadership and the clinical trial management for the clinical trials with the personalized skin graft “denovoSkin”. In addition, she actively supports the GMP-production of the skin grafts. Fabienne Hartmann-Fritsch received her M.Sc. in Microbiology and Immunology from the ETH Zurich in 2008 and her Ph.D. in Biology from the University of Zurich in 2013. During her postdoctoral studies at the Tissue Biology Research Unit of the University Children’s Hospital Zurich she specialized on GMP-production of human skin grafts as well as on clinical trial management and regulatory affairs.
Co-Project Leader and Business Developer
Daniela Marino is responsible for the development of personalized skin grafts for the treatment of skin defects. Daniela Marino received her M.Sc. in Biotechnologies from the University of Milan in 2005 and her Ph.D. from the Institute of Pharmacological Sciences of ETH Zurich in 2009. During her postdoctoral studies at the Tissue Biology Research Unit in Zurich, she specialized in tissue engineering of skin, and also gained expertise in project management, product development, clinical trials and regulatory affairs. She is a co-founder of the UZH spin-off CUTISS AG, awarded with the Venture Best Business Plan prize in 2015. Her professional mission is to finally provide a real solution to patients suffering from skin defects.
GMP Production Technician
Lukas Erni joined the Wyss Zurich in October 2016 and is responsible for the manufacturing of cell-based skin substitutes under GMP-conditions for clinical trials and the continuing improvement of the production process. He was educated as a Laboratory Technician EFZ in Biology at Novartis in parallel with the professional maturity (BMS). In March 2016, Lukas Erni joined the Tissue Biology Research Unit of the University Children’s Hospital Zurich where he was responsible for the GMP-production of skin grafts. Lukas Erni has several years of pharmaceutical industry experience.
GMP Production Technician
Valérie Lutz joined the Wyss Zurich in January 2017 as GMP Production Technician for the denovoSkin project. She is responsible for the manufacturing of autologous skin-grafts under GMP-conditions. Valérie Lutz received her M.Sc. in Biomedical Sciences from the University of Bern in 2016. Prior to joining Wyss Zurich, she worked temporarily at the University Hospital of Bern at the Center for Laboratory Medicine where she was, among other things, responsible for the cell culture of fibroblasts.
Head of GMP Production
Monia Saglini joined Wyss Zurich in October 2016 as Head of GMP Production for the denovoSkin project. She is responsible for the GMP-compliant production of autologous bioengineered skin grafts for clinical trials. Monia Saglini received her M.Sc. in Molecular Biology from the University of Basel in 2013. In the same year, she joined the Tissue Biology Research Unit (University Children’s Hospital Zurich), where she was responsible for the translation and establishment of the production process in the clean room facility of the Wyss Zurich and then the production of autologous bioengineered skin grafts (denovoDerm and denovoSkin) for Phase 1 clinical trials. During this time, Monia Saglini completed several GMP- and GCP-training and she gained expertise on production processes, process and method validations as well as equipment qualifications.