Independent expert reports on dementia drug development and regulation

Raj Long, Senior Regulatory Officer at the Bill and Melinda Gates Foundation and independent expert, has produced an executive summary outlining her recommendations to address the current state of dementia drug development. Focusing on the steps that would help overcome the current challenges, the executive summary will be part of a report due to be published in April 2015. The report forms part of the ambition to help drive towards the G8 dementia summit’s goal of a cure or disease modifying therapy for dementia by 2025.

Raj Long is presenting her findings at the World Health Organization’s First Global Ministerial Conference on Global Action Against Dementia on 16 March 2015. The recommendations made in the executive summary are directed at governments and regulatory agencies, but also scientists, clinicians, patients and carers. The recommendations set out the need to:

  • learn from attrition analysis and reconsider molecules previously rejected by pharmaceutical developers, if the science could be viewed differently
  • support the regulators who have identified and agreed a way forward on six areas of work throughout 2015, notably in relation to clinical trial efficiency, modelling and extrapolation and composite endpoints – see the MHRA section of GOV.UK for more details
  • co-ordinate existing pathways that are conducive to current gaps in science within existing laws and procedures that can be achieved in the context of different regulatory pathways
  • spearhead adaptive clinical development by focusing on accelerated regulatory pathways for dementia medicines
  • employ a sensitive and patient centric approach to risk-benefit ratio, learning from other diseases like HIV, oncology and rheumatoid arthritis and assessing applicability to dementia
  • create a multilateral advisory platform of regulators and research experts who can leverage and integrate the outcome of the above recommendations for dementia drug development

Read the executive summary