Workshop on Research and Development of Medical Products

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Background

Over the past decade or more, infectious disease out- breaks including those associated with Ebola, SARS, H1N1, MERS-CoV, H7N9, and Chikungunya, have demonstrated that the international community, including governmental and non-governmental entities, do not have adequate infrastructure in place to mitigate the systemic burdens that result from these large scale public health emergencies. Countless lives have been lost and billions of dollars have been spent responding to these outbreaks. These events highlighted the need for enhanced and sustainable capacity to plan for and respond to global infectious diseases, as well as an augmented framework for identifying and effectively responding to the contemporary challenges and realities that these emergencies present.

These current and past challenges support that the time is right for a comprehensive, multi-pronged, high capacity framework to ensure that the international community has the ability to quickly respond to diverse emerging infectious disease scenarios while simultaneously creating resilient and sustainable health systems.

To achieve this objective, the IOM will serve as the secretariat for an independent global commission that will assess governance options to ensure a robust response capability to emerging global health infectious disease threats; the specifications for financing such events; the characteristics of and optimum approaches to building sustainable and resilient health systems that are responsive to such threats; and the core needs and strategies to facilitate the development of medical products to prevent, diagnose, treat, and protect from such events. The Commission’s work will culminate in a report to be provided in time for consideration at the January 2016 meeting of the World Health Assembly Executive Board.

This workshop will inform the commission prior to the final release of their report by gathering diverse perspectives of informed stakeholders, characterizing needs and gaps in current approaches, documenting key successes and lessons learned, highlighting opportunities and potential approaches to improve the global system, and considering indicators and metrics that may be used to guide and assess the resilience of the global health infrastructure to future outbreaks and emergencies.

Workshop Objectives

An ad hoc committee will plan and conduct a three-day public workshop that will provide a forum for relevant stakeholders to describe and provide input on the core needs and strategies to facilitate development of medical products to prevent, diagnose, treat, and protect from emerging global infectious diseases. Speakers and workshop participants will be invited to describe and examine systems and approaches to discover and develop medical products to address emerging threats. The focus of the workshop will be on global systems and policy needs to foster communication, partnerships, and other strategies to advance medical product development. The workshop will feature invited presentations and discussions that will describe and examine:

  • the current state of approaches and infrastructure
  • barriers to effective and efficient research and development;
  • potential strategies to address impediments to the research or development processes.

This workshop will focus on strategies to facilitate the development of medical products — including therapeutics, vaccines, diagnostics, and personal protective equipment. Key areas for consideration may include: product development, clinical development, optimization for development, regulatory review standards and systems, manufacturing, legal issues, and indicators relevant to medical product research and development.

For more information, contact Michelle Mancher at mmancher@nas.edu.

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