11th ExEx constraint driven innovation in medical devices

The ExEx symposium, organized by the SWAPP Task Force Medical Device (TFMD), was kindly hosted by the Swiss Integrative Center for Human Health SA (SICHH) in Fribourg on 8 March 2018. The symposium was a big success, bringing together more than 70 professionals of both Medical Devices and Medicinal Products to Fribourg. After a visit of the SICHH the symposium held in the afternoon offered a varied overview on innovations and regulatory changes in the field of medical devices. The symposium was opened by Daniela Gunz, Member of the Board, SwAPP (Bern, CH) and Jean-Marc Brunner, CEO, SICHH (Fribourg, CH).

The plenary session was opened and moderated by Marie Gaumet, member of the board, SwAPP. First key note speaker was Bradley Nelson, Professor of Robotics & Intelligent systems, Director of Multi-Scale Robotics Lab, ETHZ (Zurich, CH) who gave a wide insight into new fields of robotics and new uses of medical devices. Successful developments from bench to patients have been demonstrated. Impressive research on micro robotics were presented.

Ulla Grauschopf, Head of Device Development Europe, F. Hoffmann-La Roche Ltd (Basel, CH) followed in the key note session and detailed the collaboration between medicinal product  and medical device development within one company. Early communication and common understanding between medicinal product  and medical device departments is key for success and learnings can be made by both sides.

The key note sessions were closed by Bassil Akra, Vice-President, TÜV SÜD Product Service GmbH (Munich, D) in a talk about the European Medical Device Regulation: Timelines and Impact. He clearly showed the importance of the industry to carefully consider the new regulations and to take actions immediately in order to comply with the new regulatory demands.

 

Three workshops followed the key note speeches. Workshops with a mixed auditorium were challenging but were well conducted and excellently moderated by Eckhart Wildi, Medical & Regulatory Affairs Merz Pharma (Schweiz) AG, Dominique Pioletti, Laboratory of Biomechanical Orthopedics, EPFL, Lausanne Switzerland and Dorothee Heer, Managing Director, SwAPP.

Priscilla Brunetto R&D Project Leader, University of Fribourg (Fribourg, CH) and Vanya Loroch, CEO Loroch CTLS (Essertines-sur-Rolle, CH) presented in a first workshop how the Biomaterials used in medical devices can interact with Body Biological Barriers.

Christa Spitznagel, Sr Regulatory Affairs Manager Alpine, Allergan AG (Zurich, CH) and Ivo Schauwecker, Manager Clinical Services, AO Foundation (Zurich, CH) held the second workshop on Medicinal Products versus Medical Devices: Reaching the Market. Difference between medicinal product and medical device development were explored.

The third workshop was about Strategies in Clinical Evaluations held by Kathrin Abegg, Clinical & Regulatory Affairs Manager, ISS AG (Biel, CH) and about Person Responsible for Regulatory Compliance: Roles & Responsibilities, held by Rainer Voelksen, Co-Chair RAPS EU Advisory Committee (Geneva, CH). The two topics were ideal examples to show some of the new challenges the medical device industry is facing nowadays.

The closing remarks were performed in a very clearly manner by Michel Weber, Head Clinical Services, ISS AG (Biel, CH). He also outlined planned activities in medical devices by SwAPP.

 

SwAPP would like to thank Marie Gaumet, chair of the task force medical device and the members of the task force, Laetitia Galea, Rainer Voelksen and Michel Weber for organising the 2018 ExEx Event.

MG

22nd SwAPP/sgpm Annual Symposium Pharmaceutical Medicine “Drug Development in Special Populations”

The 22nd SwAPP/SGPM Annual Symposium was held in Zurich on 29 November 2017. More than 130 participants from pharmaceutical industry (headquarters and local affiliates), academia, authorities, ethics committees, clinical research units as well as from contract and consultancy organisations attended. The professional fields of pharmaceutical medicine most strongly represented by the audience were clinical studies, medical affairs and regulatory affairs. About a third of the audience was mixed from various other fields of pharmaceutical medicine. Once again, the symposium attracted a sizeable proportion of young professionals who attended for the first time. The overall quality of the symposium and the relevance of the topics presented were rated consistently high (between good and excellent). Credit points for continued education from SwAPP/SGPM, GSASA and SKPT were awarded.

 

Thomas Szucs, ECPM, University Basel (CH), set the stage with a fascinating Introductory Talk on Small and Vulnerable Populations: Considerations for Drug Development. He differentiated between small and vulnerable, with the elderly and the geriatric populations being large and, in the case of the elderly, growing, but both populations are vulnerable and underrepresented in clinical studies, versus small, rare disease populations, which in 95% of cases do not have an approved treatment. He then outlined some clinical research tools to address the challenges of these populations.

 

This talk was followed by a session dedicated to Paedriatric Populations. Johannes van den Anker, Paediatric Pharmacology, University Children’s Hospital Basel (CH), in his talk on Pharmacological Challenges in Children, presented some impressive examples of how drug exposure varies in infants week by week with regard to age and how difficult it is to use age as a guidance for dosing. He showed a variety of biological factors that change quickly with increasing maturity and affect drug exposure in this population. Hülya Ozsahin, Clinical Reviewer, Swissmedic (Bern, CH), Critical Path Institute – Neonatology and Enpr-EMA (Representative for Swissmedic), in her presentation on Paediatric Medicines: Regulatory Issues and Insights, presented the difficulties of providing a regulatory framework for research in children and the challenges associated with pediaetric investigation plans.

 

The next session focused on the Geriatric Population. Florian von Raison, Therapeutic Area Head Neurodegenerative Diseases, Novartis (Basel, CH), Chairman Geriatric Medicine Working Party, EFGCP (Brussels, B), talked about Practical and Ethical Challenges in Clinical Trials with Geriatric Patients. He showed impressive numbers of the growing elderly population and their underrepresentation in clinical research, as well as the European efforts to improve research in the elderly with guidelines and dedicated programmes. He concluded with practical examples of how to attract and keep elderly persons in clinical studies. Roy Turner, Technical Project Leader, Idorsia Pharmaceuticals Ltd (Allschwil, CH), in his talk on Formulation and Administration of Drugs to Geriatric Patients, presented the challenges of developing dosage forms for elderly patients, factors that influence adherence and patient acceptability as well as packaging and labelling issues that affect handling and safety of the medicinal drugs.

 

The topic of Rare Diseases was covered by Robert Morgan, Head of European Regulatory Affairs Strategy, Shire (London, UK), in his presentation on Regulatory and Development Challenges of European Orphan Products, and Therese Stutz-Steiger, ProRaris (Bern, CH), with her talk on Orphan Diseases: A Patient Perspective. Robert Morgan presented the international definitions of orphan drugs and the challenges of clinical studies in rare disease. He highlighted the European regulatory incentives and the rationale behind the European regulatory framework. Therese Stutz-Steiger highlighted what the burden of a rare disease means for the patient in terms of his/her medical condition and in terms of access to medical care and social support for mastering the challenges of daily life. She concluded with a short summary about the Swiss National Rare Disease Policy.

 

The pre-lunch lecture addressing soft skills was given by Barbara Zenklusen, Culture Change/Transformation at CAS Digital Leadership, HWZ (Zurich, CH), Zenklusen Consulting (Küsnacht, CH). She presented tools on how to master change in organisations in her talk on Change and Transformation Management.

In summary, we are proud to look back on a lively, multifaceted and highly informative event.
MG/ME

4th Speed Networking Event

“Interactive, lively and enriching, these are the adjectives one could use to describe the 4th SwAPP Speed Networking Event that took place on May 2nd, 2017. This human sized event, operated by the Task Force Medical Device was kindly hosted by CPA Group SA, in Villaz-St-Pierre.

After welcome by Tony Arquisch (CPA Group), the conferences given by Dominique Piguet (Medtronic) and Stéphane  Porchet (Valtronic) were well appreciated and their high-level of expertise was fully exploited during the question and answer phase at the end of the talks.

The session dedicated to speed networking provided an opportunity for all participants to join in the exchange.

A visit to the facilities was then led by Marc Thurner (RegenHU) and Marcel Dubey (CPAutomation), both companies hosted by CPA Group SA. They gave interesting practical insights into the challenges of innovative development.

Delegates enjoyed continuing networking in a relaxed atmosphere during the closing apéro.”

MW