Clinical Research in Resource Limited Settings - Mission Impossible or Role Model for Future Drug Development?

The Swiss TPH Summer Symposium 2018 invited clinical researchers, drug development specialists and students to review and discuss future approaches to drug development. Topics included:

• Cost explosion of drug development
• Impact of GCP-guideline amendment 2016
• Conducting sponsor-investigator trials in Switzerland
• Clinical trials in low resource settings
• The Biotech approach to clinical development
• The Pharma view on clinical development
• Alternative business models and partnerships

Registration and Welcome
08.30    Registration
09:00    Welcome and Introduction, Christian Burri, Swiss TPH, Basel, Switzerland

Session 1 – Setting the Stage
Moderator: Daniel Paris, Swiss TPH, Basel, Switzerland
09:15    Cost of Development of Medicines for Neglected Diseases, Anna Doubell, Policy Cures Research, Sydney, Australia
09:45    Quality Framework for Clinical Trials, Matthias Briel, Clinical Trial Unit, Department of Clinical Research, University of Basel, Switzerland
10:15    Risk Management in Clinical Trials in Today’s ICH-GCP(R2) Framework, Ingrid Klingmann, European Forum for Good Clinical Practice, Brussels, Belgium  
10:45    Coffee Break

Session 2 – Clinical Research Worlds – Approaches and Challenges
Moderator: Wiweka Kaszubska, Medicines for Malaria Venture, Geneva, Switzerland
11:15    The Big Pharma Approach and Future Developments, Anthony Man, Novartis International AG, Basel, Switzerland
11:45    Conducting Investigator Initiated Trials in low Resource Settings – the Northern Perspective, Klaus Reither, Swiss TPH, Basel, Switzerland
12:15    Conducting Investigator Initiated Trials in low Resource Settings – the Southern Perspective, Ally Olotu, Ifakara Health Institute, Dar es Salaam, Tanzania
12:45    Lunch

Session 3 – Future Trends and Approaches
Moderator: Ingrid Klingmann, European Forum for Good Clinical Practice, Brussels, Belgium
14:00    Working in a PDP Business Model, David Reddy, Medicines for Malaria Venture, Geneva, Switzerland
14:30    The Future of Drug Development, Djordje Filipovic, Novartis International AG, Basel, Switzerland
15:00    Coffee Break

Session 4 – The Partnership Approach
Moderator: Christian Burri, Swiss TPH, Basel, Switzerland
15:30    Approaches, Success Stories and Challenges – the Industry Perspective, Luc Kuykens, Sanofi, France
16:00    Approaches, Success Stories and Challenges – the Academia Perspective, Christian Burri, Swiss TPH, Basel, Switzerland
16:30    Closing Words, Jürg Utzinger, Swiss TPH, Basel, Switzerland
17:00    Close of Day

Content: Christian Burri
Event: Joanne Blackwell