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Workshop Agenda

August 19-21, 2015
Cheung Kung Hai Conference Centre, G/F,
William MW Mong Block, 21 Sassoon Road
Lecture Theatre 4
Hong Kong

The U.S. Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine will serve as the secretariat for an independent global commission that will conduct a study to recommend an effective global architecture for recognizing and mitigating the threat of epidemic infectious diseases. The Commission will receive input from four IOM workshops on governance for global health, financing response to pandemic threats, resilient health systems, and research and development of medical products, which will be coordinated.

This workshop will inform the Commission prior to the final release of its report by providing 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, and
• potential strategies to address impediments to the research or development processes.

The workshop will focus on strategies to facilitate the development of medical products, including therapeutics, vaccines, diagnostics, and personal protective equipment. Key areas for consideration 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.

The workshop is co-hosted by The University of Hong Kong and will be held on August 19-21, 2015. Participants will be invited from around the world to engage in dialogue and identify potential avenues for collaboration.

DAY 1

SESSION 1: INCENTIVES AND DEVELOPMENT MODELS

Objectives:

• Review existing incentives, business models, and partnership approaches that support the research and development of medical products for emerging infectious diseases.
• Identify shortcomings in existing regulatory and financial incentives, and highlight promising ideas for improvements that can help advance the development of medical products for emerging infectious diseases.
• Discuss challenges to building and sustaining more effective business models and public–private partnerships; explore promising approaches and identify key attributes of a well-working collaborative approach.

Moderator: Tachi Yamada, Frazier Life Sciences

SESSION 2: SCIENCE AND REGULATORY CONVERGENCE AND CAPACITY

Objectives:

• Review and characterize the needs and gaps in current scientific tools, technologies, and capacities to develop and evaluate products.
• Highlight promising common platforms to enable nimble and rapid development and evaluation of products.
• Discuss whether and how discordant regulatory specifications hinder efficient development and evaluation of medical products, and possible approaches for convergence.
• Characterize the critical needs of country regulatory authorities in times of public health emergency and discuss potential strategies regulators and international organizations can take to help address these needs.
• Discuss potential strategies for encouraging the sharing of knowledge, clinical, and clinical trial data to speed clinical assessment of investigational products for emerging infectious disease.

Moderator: Maria Freire, Foundation for the National Institutes of Health (NIH)

DAY 2

SESSION 3: CLINICAL ASSESSMENT

Objectives:

• Examine barriers to the clinical assessment of the safety and efficacy of investigational medical products in communities experiencing a public health emergency from an emerging infectious disease.
• Discuss a framework for determining when investigational products should be subjected to controlled clinical assessment and when they should be used more broadly under other mechanisms.
• Describe responsible and adaptive clinical trial designs that could be developed for use in times of public health emergencies and discuss ethical considerations associated with the possible options.
• Consider ethical and methodological standards that may be used to determine optimal trial designs for assessing the readiness of investigational medical products prior to broader deployment during public health emergency.
• Highlight strategies for engaging communities during times of public health emergency to determine how and when to undertake controlled clinical assessment and, where trials are used, to facilitate rapid and fair enrollment in trials for investigational products.

Moderator: Maria Freire, Foundation for the NIH

SESSION 4: MANUFACTURING, STOCKPILING, AND DEPLOYMENT

Objectives:

• Characterize the needs and gaps in current manufacturing, stockpiling, and supply chain mechanisms for medical product development and deployment during public health emergencies.
• Highlight promising approaches for delivery and deployment of products that are manufactured outside of an affected region during public health emergencies.

• Discuss the ethical considerations of different manufacturing approaches and deployment capabilities.

Moderator: Tachi Yamada, Frazier Life Sciences

DAY 3 (HALF DAY)

SESSION 5: TOP PRIORITIES FOR FACILITATING MEDICAL PRODUCT RESEARCH AND DEVELOPMENT

Objectives:

• Examine the ethical and practical considerations for setting priorities to facilitate medical product research, development, and availability.

• Discuss potential strategies for developing a structure and process to select priorities for medical product research, development, and availability.
• Discuss potential strategies for encouraging collaboration and information sharing among private companies to speed research and development for top priorities.
• Explore how to align regulatory considerations, development milestones, and financing models for designated top priorities.

Moderators: Maria Freire, Foundation for the NIH, and Tachi Yamada, Frazier Life Sciences

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