B

Workshop Statement of Task

GLOBAL HEALTH RISK FRAMEWORK: A WORKSHOP ON RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS

An ad hoc committee will plan and conduct a 3-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 threats such as global infectious diseases. The committee will define the specific workshop topics to be addressed, develop the agenda, select and invite speakers, and moderate workshop discussions.

The overarching objectives for the workshop include

• Gathering diverse perspectives of informed stakeholders to foster constructive discussion and facilitate the formation of collaborative solutions;
• Characterizing needs and gaps in current approaches to addressing global infectious disease outbreaks and other public health threats, and describing barriers to addressing those needs;
• Highlighting opportunities and potential approaches to improve the global system for addressing emerging threats;
• Documenting key successes and lessons learned from past global infectious disease outbreaks and other public health emergencies and how they may inform preparation and response to future outbreaks and emergencies; 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.

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. Workshop discussions will describe and examine the current state of approaches and infrastructure for research and development, barriers to the effective and efficient development of medical products, and potential strategies to address impediments to the research or development processes. The scope of medical products under consideration at the workshop will include therapeutics, vaccines, diagnostics and other medical devices, and personal protective equipment. Key areas for consideration may include

• Product development: describe current product development platforms; explore science and research needs, including needs for development of appropriate and effective regulatory science and evaluation tools;
• Clinical development: discuss clinical trials approaches, including clinical trial methods and ethics considerations around enrollment and access to developing products in an emergency;
• Optimization for development: explore incentives and infrastructure for product development, and conditions and needs for effective public–private partnerships and global/intergovernmental partnerships;
• Regulatory review standards and systems: address regulatory considerations, including approaches to global regulatory harmonization and regulatory systems capacity;
• Manufacturing: describe issues pertaining to supply chain management and product quality and integrity, and deployment of medical products;
• Legal issues: highlight key legal considerations including developer/manufacturer liability, distribution/sharing of biological samples, other patent/data exclusivity considerations, and sharing of clinical and clinical trial data; and
• Indicators: explore indicators to facilitate and measure success and advances in the face of new and emerging threats.

A summary will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop.