Paracelsus Medical University and Celericon Therapeutics: “Repair of the currently unrepairable
Sabine Ritzinger, Paracelsus Medical University
December 11, 2018
Paracelsus Medical University (PMU) is an institution organized as a private foundation with locations in Salzburg, Austria and Nuremberg, Germany. Teaching, research, and patient care – these are the three pillars on which the university was founded in 2002, and which continue to have the highest priority.
With 22 university institutes, four research centres and six research programs, it was possible to build, together with the Salzburg University Hospitals, a first-class educational offering and excellent research program at the Salzburg location. In February 2014, the Paracelsus Medical University built, in cooperation with the Nuremberg Hospital, a second location in Nuremberg.
A focus on international networking in both study and research is a key feature of Paracelsus Medical University. The cosmopolitan nature of the university is clear in a number of ways: for example through intensive competence exchange top of the class networks – in particular with other European countries and the United States – and the consistent support of foreign language competency for students. Passing the USMLE Step 1 exam (United States Medical Licensing Exam) is mandatory in the fourth year of study. This clearly expressed international mind-set has proven to be extremely attractive for students, teachers, researchers, and employees.
In addition, the long and intensive cooperation between the Natural Science Faculty of Salzburg University is noteworthy, as well as the cooperation between the Salzburg University Hospital and about 25 teaching hospitals in Austria and neighbouring countries. At the Nuremberg campus, Paracelsus University cooperates with the Nuremberg Hospital and Georg Simon Ohm Technical University. International partners include the Mayo Medical School/Mayo Clinic (USA), Yale University (USA), Harvard University (USA), University of Milan (Italy), Capital Medical University (China), University of Cambridge (Great Britain), and Brock University (Canada).
Demonstrative of its strong research arm, Paracelsus Medical University of Salzburg is especially proud of Celericon Therapeutics. In 2018, PMU founded “Celericon Therapeutics GmbH”. Celericon develops allogeneic off-the-shelf biopharmaceuticals based on multipotent stromal cell (MSC) – derived exosomes (small Extracellular Vesicles or EVs). Proof-of-Concept studies revealed the striking regenerative capacity of EVs using relevant animal models. Since 2016, a total of six controlled, independent small animal studies have been conducted demonstrating the efficacy of Celericon´s EV-based, GMP-compliant therapeutic EV preparations. Treatment with human MSC-derived EVs loaded onto a degradable collagen scaffold resulted in the accelerated formation of bone tissue in a rat femur critical size defect model.
Celericon´s EV preparations also exert beneficial effects on the regeneration of tendon-to-bone insertions, thus extending the potential range of therapeutic applications to clinical indications such as rotator cuff tears, humerus fractures, Achilles tendon-related pathologies, as well as delayed or non-unions. These pathologies represent some of the most frequent orthopedic indications worldwide and healing times for these injuries are generally long, painful, and often results in unsatisfactory outcomes. Current activities of Celericon focus on the implementation of scalable manufacturing processes that facilitate the cost-of-goods calculations for future industrial-scale EV manufacturing to engage in clinical trials and to obtain a market authorization for the product. Intellectual property for both manufacturing and application of therapeutically active EVs directed towards bone and tendon regeneration have been registered early in 2017.
Following a thorough evaluation of the successfully completed preclinical studies and the IP portfolio, Paracelsus Medical University decided to establish Celericon Therapeutics in order to advance further cooperation with partners and investors. Unique to a European academic institution, the university maintains its own, fully accredited GMP laboratory. The project was initiated in 2016 at the Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS) of the PMU as a result of the close cooperation between Mr. Mario Gimona, head of stem cell and EV manufacturing at the GMP laboratory, and Mr. Andreas Traweger, Professor for Regenerative Biology.
“At PMU we have all the necessary components to establish and develop a successful biotechnology company: an experienced and dedicated scientific team, a state-of-the-art GMP infrastructure and our motivated clinical partners in Salzburg, for execution of the necessary clinical studies”, says Michael Stergar, CEO of the newly founded Celericon Therapeutics GmbH.
For more information about Paracelsus Medical University , please contact us here.
For more information about Celericon Therapeutics GmbH , please contact Michael Stergar, CEO
The Celericon team: Michael Stergar, CEO, Prof. Andreas Traweger, CSO, Mario Gimona, CSO © PMU/Ritzinger
The GMP Laboratory
Member Spotlight: Tor Vergata University Hospital and University Medicine in Italy
By Giuseppe Novelli & Tiziana Frittelli, Tor Vergata University Hospital, Rome, Italy
September 11, 2018
Health services improves with the development of research and technological innovation, as well as with the improvements in expertise of the operators of the national health system (NHS). Seventy percent of biomedical research in Italy is carried out in universities. The top universities for clinical medicine produce research in anesthesia, cardiology, general and internal medicine, gastroenterology, obstetrics, ophthalmology, radiology, and surgery. This reflects the quality of Italian medical education, highly rated at the international level. Italian doctors are increasingly recruited abroad, while our national health service (NHS) is considered among the best in the world. The Italian NHS was established in 1978, and founded on the principles of universal coverage, social financing through the use of general taxation, and non-discriminatory access to the health care services. Italian universities and their medical schools have certainly contributed to this success by coordinating and guaranteeing assistance functions together with teaching and research activities. This integration has been possible thanks to the synergy of the Schools of Medicine with the Hospital-University Companies.
The Policlinico Tor Vergata (PTV) is qualified as a "teaching hospital", representing "academic medicine" where clinical projects are integrated with interdisciplinary research programs and translational medicine. It is a reference point for assistance, teaching and research, thanks to the new and renewed relationship between the Regional Health Service (Regione Lazio) and the University of Rome Tor Vergata .
The PTV offers a culturally fertile and internationally oriented area for teachers and students. The new frontiers of biotechnology and molecular medicine impose a solid bond between biological and medical knowledge so as to make the presence of the biological and the clinical component of the Schools of Medicine and Surgery indispensable in the University Hospitals. Today, biomedical research and medical engineering constitute the fertile soil on which therapeutic and diagnostic paths are built. Technological innovation must be aimed at the economic exploitation of knowledge: only in this way it will be possible to face the increasing costs of health care. Universities should stimulate technological innovation through the activities of a "third mission", aimed at favoring the development or creation of public goods that increase the well-being of society. We have no doubt that affirming innovative or more disruptive technologies represent the main drivers for economic growth, and also attract investments. University hospitals have to guarantee high standards of interdisciplinary and inter sectoral health care and carry out biomedical and health research. Only this kind of process can favor economic development, the creation of new drugs, the development of new technologies and preventive and therapeutic strategies.
New AAHCI Steering Committee Chair and Membership
Steven A. Wartman MD, PhD
Thursday, July 7, 2016
I am pleased to announce the appointment of Dr. Nicholas Fisk, deputy vice chancellor (Research) at the University of New South Wales, as the new Chair of the AAHCI Steering Committee. Dr. Fisk assumed this role, replacing Dr. Martin Paul, President of Maastricht University, who served two terms as the inaugural Chair of the Steering Committee. Dr. Paul’s dedication and contribution to the development of AAHCI was extraordinary, and we look forward to continuing our work with him as the immediate past Chair and Ambassador of the AAHCI European Regional Office.
The AAHCI Steering Committee oversees AAHC’s international activities, including setting strategic direction priorities as well as reviewing member services, programs, and meeting themes and locations. The AAHCI Steering Committee Chair also serves as a member of the AAHC Board of Directors.
The composition of the committee reflects AAHCI’s diverse global membership. In addition to Dr. Fisk, several new members will help lead AAHCI this year:
- Michael Strong, MD, dean, Schulich School of Medicine & Dentistry, The University of Western Ontario (Canada)
- John Connell, MD, chair, NHS Tayside Board, Academic Health Science Partnership in Tayside (Scotland)
- Guo-Qiang Chen, MD, PhD, president, School of Medicine, and vice president, Shanghai Jiao Tong University (China)
- Mohamed Sayegh, MD, executive vice president for medicine and global strategy, Raja N. Khuri dean, Faculty of Medicine, American University of Beirut Medical Center (Lebanon)
Priorities for this year include guidance in the development of the AAHCI Aligned Institutional Mission (AIM) Program™ and the growth of AAHCI Regional Offices and region-specific programs and services.
European Meeting Explores Key Challenges of Academic Health Centers
Steven A. Wartman MD, PhD
Thursday, March 31, 2016
The AAHCI European Regional Office, hosted by Maastricht University in The Netherlands, held an informative roundtable discussion with 22 delegates on March 18, 2016. The delegates represented fifteen institutions from nine countries throughout Europe. Attendees had the opportunity to share with one another the critical issues they are facing in their countries and at their academic health centers, and, as always, I was struck by the recurring issues institutions face that resonate throughout Europe as well as worldwide.
Among topics raised were:
- The importance of measuring impact. We learned about the Maastricht Study ,an extensive phenotyping study focused on understanding the causes and consequences of type 2 diabetes;
- How to financially integrate in a manner that is appealing to all branches of the academic health center or system;
- The importance of harmonizing standards and practices among European countries so that educators and students can study or practice in different countries;
- Understanding new technologies and which to implement within an academic health center; and
- Driving change from the bottom up within an academic health center.
Overall, the meeting provided a unique, collegiate, atmosphere for academic health center leaders to learn from one another, make close connections with their peers, and to learn about AAHCI. At the conclusion of the meeting, attendees had the unique opportunity to visit The European Fine Art Fair (TEFAF). This extraordinary event served to bring the meeting to a close by further enhancing the cultural bonds of the attendees. This regional meeting was a highly successful model as the international branch of AAHC grows and develops further.
Helping Students to Learn with HELP
Dr. Mark JG Govers & Stefan van Aalst, Msc.
Tuesday, November 10, 2015 - Reposted: Wednesday, July 27, 2016
Maastricht University has been successful in applying problem-based learning (PBL) as its principal learning method throughout all faculties. Many think that PBL is teaching based on tutorial meetings. This is a misinterpretation, as PBL comes in different formats. The key is to organize learning as a constructive, collaborative and contextual process (see box 1 below). We developed such a PBL format by asking: ‘how can we develop an inter-active form of PBL without tutorial meetings?’ We found an answer in what we call HELP (Hear, Explore, Learn, and Propose).
How does the HELP program work? We begin with an eight-week master course on “organizational change in healthcare” that is divided into two blocks of four weeks. The first block focuses on gaining theoretical knowledge and insights. Each education day deals with a main theme via hear (introductory lecture), explore (working as a group of five students maximum on a related assignment), and learn (presenting and discussing assignment solutions within all groups). The following themes are discussed: (1) importance and difficulty of change; (2) organizational theory and professionalism; (3) change theory; and (4) leadership. The first block ends with an individual written test. The second block of four weeks focuses on all that was learned on an integral project (the propose phase) in which student groups of five act as “change consultants.” Their mission is to advise an executive board of two hospitals merging together with teachers and students acting as board members. At the end of the course, student groups present their advice to the executive board. The executive board selects a winner, and the winner receives an encouraging prize: a bottle of wine.
Over the past three years, the results were overwhelming. The course could be executed with fewer teachers; however, it asked more intense engagement from them. Students greatly appreciated this form of PBL. It offered an alternative way to gain and apply knowledge and competencies. On average, students evaluated the course with an eight out of ten – the highest score within this master program. It strengthens our belief that HELP benefits students as well as teachers.
Contact us at: firstname.lastname@example.org
Box 1: Theoretical foundation of PBL
Constructivism is a theory of knowledge claiming that individuals produce knowledge and give meaning by relating experiences with existing ideas (Hendry, Frommer & Walker, 1999; Dolmans, et al, 2005). It is essential that students are actively involved in the process of producing knowledge and give meaning to it. Teachers act as facilitators in these processes by encouraging and stimulating students to discover and grasp underlying theories, concepts, and models by themselves. By doing so, they actively construct knowledge. Besides learning as a constructive process, PBL is also collaborative and contextual. Collaborative learning implies that a group of students interact with each other to learn about a shared problem in order to be able to construct knowledge. Contextual learning implies that students are preferably exposed to, for them, relevant context and challenged with cases, problems, or assignments from multiple perspectives to stimulate construction and collaboration.
Dolmans, D. H., De Grave, W., Wolfhagen, I. H., & Van Der Vleuten, C. P. (2005). Problem‐based learning: Future challenges for educational practice and research. Medical education, 39(7), 732-741.
Hendry, G. D., Frommer, M., & Walker, R. A. (1999). Constructivism and problem‐based learning. Journal of further and higher education, 23(3), 369-371.