Welcome International Society for CNS Clinical Trials and - - PowerPoint PPT Presentation

2017 Autumn Conference, with ECNP Joint Day

31 August – 2 September 2017 Paris, France

Welcome

International Society for CNS Clinical Trials and Methodology

Mission Statement

The International Society for CNS Clinical Trials and Methodology (ISCTM) is a multi-disciplinary independent organization, devoted to promoting advances that address strategic clinical, regulatory, methodological and policy challenges that arise in the development and use of CNS therapeutic

• agents. This work is accomplished through

partnership with persons in academia, industry, government, policy-making, and the public.

• Improving the lives of our patients through

excellent science

• Many stakeholders

– Patients, Clinicians, Investigators, Statisticians, Regulators, Policy-makers, Public

• International
• Non-commercial, non-promotional
• Pre-competitive and/or collaborative
• Active participation is strongly encouraged

Principles

Implementing the Vision

Semi-annual meetings / Consensus Meetings Working groups Publications / Comments on Draft Guidelines Website – Meeting presentation videos and slides

14th Annual Meeting

20-22 February 2018

Topics – Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint – Use of FDA Schizophrenia NDA Databases an Exemplar to Improve RCT Efficiency; Can the Model Be Extended? – Methodological Challenges Related to Rare and Orphan Disease Drug Development – Innovative Approaches for Identifying Enduring and Meaningful Outcomes in Parkinson’s Disease Clinical Trials (with Michael J Fox Foundation)

Become involved

• Ways to become involved

– Submit topic ideas – Submit Working Group/Workshop topics – Submit Consensus Group topics

• Advise of interest in serving on committees

– Will be reconstituted in the spring – These are actual working committees! (Submit interest to Carlotta McKee via email, attach CV)

Platinum Janssen Pfizer

Gold Bracket Lundbeck

Thanks to ISCTM Corporate Members

Thanks to ISCTM Corporate Members Silver AbbVie Boehringer Ingelheim Mallinckrodt Otsuka Sunovion Takeda

Thanks to ISCTM Corporate Members

Bronze Acadia Alkermes Allergan ERG Consulting INC Research Intra-Cellular Therapies NeuroCog Trials Pierre Fabre

2017 Autumn Conference

Thanks to those who have traveled from US / Asia to Paris Welcome Celso Arango, ECNP President