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