Appendix A

Workshop Agenda

PREPARING THE FUTURE WORKFORCE IN DRUG RESEARCH & DEVELOPMENT—A WORKSHOP

National Academies Building, 2101 Constitution Avenue N.W.
Washington, DC 20418

DAY 1: MONDAY, OCTOBER 16, 2023

SESSION I – FUTURE STATE OF THE CLINICAL TRIALS WORKFORCE

Session Objectives:

• Identify what types of expertise are needed and what disciplines should be included to achieve the aspirations for a transformed clinical trials enterprise in 2030 and enable a more person-centered, culturally aware workforce that can better support the evolving needs of drug R&D.
• Consider key elements/guiding principles for establishing a more self-sustaining and inclusive workforce system.

Discussion Questions:

• What types of existing clinical trials training and expertise will become even more critical 10 years from now?
• What new types of clinical trials expertise/disciplines/training will be needed to achieve a 2030 vision of the future?
• What are some key considerations/guiding principles for enabling a more sustainable future clinical trials workforce?
• What are some key considerations/guiding principles for enabling a more inclusive future clinical trials workforce?

SESSION II – CURRENT STATE OF THE CLINICAL TRIALS WORKFORCE

Session Objectives:

• Consider the traditional roles and expertise required at each stage of drug development and how these roles have changed over time.
• Examine the current landscape of U.S. academic, government, industry, and professional society training programs for preparing the next generation of clinical trials researchers and clinicians.
• Consider critical gaps and anticipated needs for the 2030 clinical trials enterprise workforce.

Discussion Questions:

• What are the traditional roles and expertise required at different stages of drug development, and how have these roles evolved over the last 10 years (e.g., in response to technological advancements and changing priorities)?

• What are the strengths and limitations of current clinical trials training programs—are they equipped to prepare the next generation of researchers and clinicians given the evolving landscape? If not, why not?
• What are the critical gaps in training/expertise and anticipated needs for the 2030 clinical trials enterprise workforce?

SESSION III – OVERCOMING BARRIERS TO PROGRESS

Session Objectives:

• Discuss approaches to removing barriers and achieving a more person-centered, culturally aware drug R&D workforce.
• Share lessons learned based on current efforts and consider what practices/approaches can be more broadly applied.

Discussion Questions:

• What are the main barriers/challenges when it comes to the development of a more person-centered and culturally aware workforce, and how can these barriers be effectively dismantled?
• What practices/approaches have current efforts/programs taken to address these barriers?
• What practices/approaches could be more broadly applied?

SESSION IV – BREAKOUT DISCUSSION: ENVISIONING THE FUTURE LANDSCAPE

Session Objectives:

• Consider practical approaches for engaging and preparing a more diverse person-centered drug R&D workforce, particularly at the clinician/principal investigator level.
• Explore ways to integrate key elements/guiding principles for establishing a more sustainable and inclusive workforce system.

Breakout Session Topics (Role/Discipline):

• Investigator Physician
• Community Engagement
• Study Coordinator
• Precision Medicine
• AI/Machine Learning

Breakout Questions:

• What is the anticipated capability and capacity for this role/discipline to meet the needs of a 2030 clinical trials enterprise?
• What elements/programs/policies should be put in place to support this career path or area in a way that is more person-centered and inclusive?
• What key elements or guiding principles should be considered to sustainably support/enable this career path or area?
• What are 1–3 short-term (i.e., within the next 5 years), tangible, and measurable milestones for assessing progress toward that goal?

Breakout Session Leaders:

DAY 2: TUESDAY, OCTOBER 17, 2023

SESSION V – SCALING AND SUSTAINABILITY OF WORKFORCE PROGRAMS

Session Objectives:

• Explore ways that stakeholders can better prepare the next-generation workforce, including opportunities to develop career paths and incentives for academics, primary care, and community-based practitioners.
• Consider opportunities/policies to accelerate and scale up efforts to develop and support a more person-centered, culturally aware drug R&D workforce.

Discussion Questions:

• How can academia, industry, and government better collaborate to create clear and attractive career paths for individuals interested in pursuing drug research and development, particularly for those from diverse backgrounds?
• In scaling up efforts, what types of opportunities/policies can accelerate the development and support for a more person-centered, culturally aware drug R&D workforce?

SESSION VI – BREAKOUT DISCUSSION: WHAT NEEDS TO BE DONE AND WHO CAN DO IT?

Session Objectives:

• Consider priority areas to be addressed to support and sustain workforce programs/efforts.
• Consider who would/should benefit from initiatives and future training programs.
• Discuss roles/responsibilities for different stakeholders to support and enable a more person-centered, culturally aware workforce.

Breakout Session Topics (Stakeholder/Sector):

• Government
• Industry
• Academia
• Nonprofit

Breakout Questions:

• What are the specific roles/responsibilities for this stakeholder/sector to support and enable a more person-centered, culturally aware workforce?
• What are the essential priority areas that should be addressed by this stakeholder/sector to ensure long-term sustainability of workforce programs?
• How can this stakeholder/sector better collaborate with others to achieve these efforts?
• What are some next steps that you and your organization could do toward furthering the points above?

Breakout Session Leaders:

SESSION VII – POLICIES FOR WORKFORCE SUSTAINABILITY AND FUTURE-PROOFING

Session Objectives:

• Explore policies and procedures that could be implemented to ensure a more person-centered, culturally aware drug R&D workforce in 2030.
• Consider guiding principles for different stakeholders to support and enable a more person-centered, culturally aware drug R&D workforce.

Discussion Questions:

• What policies and procedures should different stakeholders (government/industry/academia/non-profits) consider to better support sustainable career development programs and continuous training/learning for different roles/disciplines?
• What are some lessons learned/guiding principles that different stakeholders should consider that would support a more person-centered and culturally aware clinical trials workforce?

SESSION VIII – A PATH FORWARD

Session Objectives:

• Consider near-term and longer-term approaches to achieve a more person-centered, culturally aware drug R&D workforce.
• Discuss how success and failure could be measured.
• Consider practical next step opportunities.

Discussion Questions:

• What are 2–3 key considerations/priority goals that should be met over the next 5–10 years to ensure the workforce can meet the needs of the 2030 clinical trials enterprise?
• How can different stakeholders (e.g., government, industry, nonprofits) best strike a balance between filling immediate workforce needs and laying the groundwork for workforce development in the long term?
• What is going well and what needs to change in terms of policy/investment/career development programs?
• What are some practical next steps different stakeholders should take now to support the 2030 workforce (i.e., who needs to do what by when)?

This page intentionally left blank.