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 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 received her MSc in Microbiology and Immunology from the ETH Zurich in 2008 and her PhD 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 received her MSc in Biotechnologies from the University of Milan in 2005 and her PhD 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.
Kathi N. Mujynya
Senior Director of Operations
Kathi N. Mujynya is Senior Director of Operations of the Wyss Zurich project denovoSkin. With her expertise in cell biology and cell therapy from manufacturing to commercialization, Kathi is managing the operations activities for the manufacturing of denovoSkin (overseeing of the denovoSkin GMP team) as well as paving the road for the tech-transfer of denovoSkin from the location at Wyss Zurich to the new GMP site of the spin-off CUTISS AG. Kathi holds a Bachelor of Sciences (Neuchatel School of Health), a post-grade diploma in Management of Biotech (EPFL Lausanne), and an MBA from the University of Geneva (HEC).
Kathi can draw on the experience of many leading positions in the life-sciences industry (cellular therapy, wounds and burns) including managing GMP manufacturing and development projects in Asia, USA and CH. She also acted as a CMC expert for Swissmedic, EMA and FDA submissions all along her 20+ year’s career.
GMP Production Officer
Laura Bojsen-Møller joined the denovoSkin project at Wyss Zurich in January 2020. In her role as GMP Production Officer, she supports the Production team in the manufacturing of autologous skin grafts and the implementation of changes from the R&D phase to the production process. Laura received her Master’s degree in Biotechnology from the Technical University of Denmark in 2017 and gained experience with GMP manufacturing while working at the bioscience company Chr. Hansen.
GMP Production Officer
Selina Budinjas joined Wyss Zurich in October 2019 as GMP Production Officer for the denovoSkin project. She supports the production team in the manufacturing of autologous skin grafts for the treatment of skin defects. Selina finished her apprenticeship as a biotechnological technician at the University of Hohenheim in Stuttgart. In a company for molecular biotechnologies she gained expertise in a GMP-environment on production processes, method validations and in the development of diagnostic products. Prior to joining Wyss Zurich, Selina acquired extensive knowledge in tissue engineering of skin at the Tissue Biology Research Unit of the University Children’s Hospital Zurich.
Daniele De Nardo
Production Team Leader
Daniele De Nardo holds a Master’s degree in Biomedical Engineering from ETH with a major in Tissue Engineering (2018). During his Master’s studies he worked on the generation and refinement of a high cell density biomaterial for detrusor muscle bioengineering in the field of urology.
In October 2018, Daniele joined the R&D department of CUTISS AG as a process developer on the denovoSkin project, focusing on process improvements and denovoSkin characterization.
From 01.01.2020, Daniele was appointed Production Team Leader P007 with the task of leading manufacturing during the current clinical trial and implementing the process improvements from the R&D into the manufacturing process.
GMP Production Officer
Arina Löw joined Wyss Zurich and the denovoSkin project in January 2018. In her role as GMP Production Officer, she is responsible for the GMP-conform manufacturing of autologous skin-grafts and assists with the GCP documentation of the clinical studies. Arina received her MSc in Health Sciences and Technology with a major in Molecular Health Sciences from the ETH Zurich in 2017 and gained experience in the manufacturing process of skin substitutes during her master thesis at the Tissue Biology Research Unit of the Children’s Hospital Zurich.
Senior GMP Production Officer
Monia Saglini joined Wyss Zurich in October 2016 as Head of GMP Production for the denovoSkin project. Starting from October 2019, she took over the position of Senior GMP Production Officer within the project. Monia is responsible for the technical supervision of the GMP Production Officers during the GMP-compliant production of autologous skin grafts for Phase II clinical trials and acts as head of production deputy. Monia received her MSc 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 and then the production of autologous bioengineered skin grafts (denovoDerm and denovoSkin) for Phase I clinical trials. Monia completed several GMP- and GCP-training gaining wide expertise in the field of production processes, validations, qualifications as well as quality assurance.
GMP Production Officer
Chantal Stenger joined the denovoSkin project at Wyss Zurich in November 2017. As a GMP production officer, she supports the production team in the manufacturing of autologous skin grafts for the treatment of skin defects. Chantal received her MSc in Human Biology from the University of Zurich in 2016. Prior to joining Wyss Zurich, she worked as a scientific assistant at the Institute of Chemistry and Biotechnology at the Zurich University of Applied Sciences.