In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop (2023)

Chapter: Appendix B: Workshop Task and Agenda

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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Appendix B

Workshop Task and Agenda

WORKSHOP TASK

A planning committee of the National Academies of Sciences, Engineering, and Medicine will convene a public workshop exploring scientific, ethical, and regulatory implications associated with the research and development of in vitro–derived human gametes. Potential topics will explore

  1. The current state of the science for in vitro derivation of male and female gametes from embryonic or induced pluripotent stem cells, including achievements with other mammalian species, roadblocks that remain to producing human gametes, and near-term prospects for overcoming remaining scientific and technical barriers.
  2. The extent to which in vitro–derived human gametes could offer new options or potentially address unmet needs for both laboratory research and for reproductive medicine.
  3. The ethical or social issues that would be raised by development or potential use of in vitro–derived human gametes.
  4. How research and potential reproductive use of in vitro–derived human gametes would be addressed by current regulation and whether existing regulatory approaches address the issues discussed during the workshop.

The public workshop will feature invited presentations and discussions. The planning committee will organize the workshop, select and invite

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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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speakers and discussants, and moderate the discussions. A workshop proceedings will be prepared by a designated rapporteur based on the information gathered and discussions held during the workshop, in accordance with National Academies policies and procedures.

WORKSHOP AGENDA

APRIL 19, 2023

Session 1: Opening Session

Objectives
  1. Introduce the workshop topic and rationale.
  2. Understand how research advances with induced pluripotent stem cells (iPSCs) are driving innovation in reproductive medicine.
  3. Highlight perspectives on the potential impact of IVG on different communities and affected stakeholders.
9:15amWelcome and Introduction
Eli Y. Adashi(Brown University) Workshop Chair (virtual)
9:30amCurrent State of the Science for Early Human Stem Cell Transitions
Ali Brivanlou(Rockefeller University) (virtual)
9:50amDiscussion
10:00amNeeds and Concerns in Human Biology and Reproductive Medicine
Session Introduction
Susan Crockin(O’Neill Institute, Georgetown Law) Moderator
10:05amPotential Impacts for Stakeholders and Society
Joel Michael Reynolds(Georgetown University)
Andrea Braverman(Thomas Jefferson University) (virtual)
Katherine Kraschel(Yale Law School)
10:30amDiscussion
10:50amBreak
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Session 2: State of the Science

Objectives
  1. Provide a high-level overview of human germ cell development.
  2. Present the current state of science for IVG, including research achievements with other mammalian species and roadblocks for achieving in vitro derivation of human gametes.
  3. Highlight near-term prospects for overcoming remaining scientific and technical barriers.

Session 2a: Context and Background

11:10amSession Introduction
Amander Clark(University of California, Los Angeles) and
Kotaro Sasaki(University of Pennsylvania) Moderators
11:15amHuman Germ Cell Development
Azim Surani(Cambridge University and The Gurdon Institute) (virtual)
11:30amDiscussion

Session 2b: The Oogenesis Pathway

11:40amStem Cell–Derived Ovarian Germ Cells: The Rodent Paradigm
Katsuhiko Hayashi(Kyushu University, Japan)
11:55amStem Cell–Derived Ovarian Germ Cells: The Primate and Human Paradigm
Mitinori Saitou(Kyoto University, Japan) (virtual)
12:10pmThe Importance of Meiosis
Paula Cohen(Cornell University)
12:25pmDiscussion
12:50pmLunch
Page 126 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Session 2c: The Spermatogenesis Pathway

1:50pmStem Cell–Derived Testicular Germ Cells: The Primate and Human Paradigm
Kotaro Sasaki(University of Pennsylvania) Moderator
2:05pmSpermatogonial Stem Cell Transplantation
Kyle Orwig(University of Pittsburgh Medical Center)
2:20pmThe Importance of Epigenetic Resetting in Germ Cells
Petra Hajkova(Imperial College, London)
2:35pmGermline Mutation and Variation: Considerations for IVG
Anne Goriely(Oxford University)
2:50pmDiscussion
3:15pmBreak

Session 3: Implications of IVG If It Were in Clinical Practice

Objectives
  1. Explore how IVG technology could potentially impact fertility care.
  2. Examine how IVG technology could intersect with currently available methods of assisted reproductive technology.
  3. Highlight how IVG’s potential path to clinical practice may differ between countries according to political, cultural, and religious contexts.
3:35pmSession Introduction
Hugh Taylor(Yale University) Moderator
3:40pmClinical Considerations
Gamal Serour(Al Azhar University, Egypt) (virtual)
Paula Amato(Oregon Health and Sciences University)
4:20pmDiscussion
4:50pmConcluding Remarks from Day 1
Susan Crockin(O’Neill Institute, Georgetown Law)
Page 127 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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5:00-6:30pmReception (National Academies’ Keck Center Atrium, Washington, DC)

APRIL 20, 2023

9:30amWelcome and Orientation to Day 2
Hugh Taylor(Yale University)

Session 4: Social, Ethical, and Legal Considerations Raised by IVG

Objectives
  1. Frame key social, ethical, and legal questions that arise when considering IVG as a potential clinical tool.
  2. Discuss issues relating to informed consent, governance, egg donation, surrogacy, and the financialization of third-party reproduction.
  3. Consider how attitudes about IVG reflect societal values about genetically related progeny, parenting, and family building.
9:40amSession Introduction
Glenn Cohen(Harvard Law School) Moderator
9:45amOpening Perspectives
Michele Goodwin(University of California, Irvine) (virtual)
Alana Cattapan(University of Waterloo, Canada)
Sonia Suter(George Washington University)
Henry (Hank) Greely(Stanford University)
10:20amDiscussion
11:00amBreak

Session 5: Equity, Access, and Cost Considerations Associated with IVG

Objectives
  1. Explore how socioeconomic and equity considerations impact who would be able to access IVG as a new and disruptive technology.
  2. Contemplate lessons from existing practices in third-party reproduction to inform an understanding of how IVG would affect the global fertility industry.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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  1. Reflect on how funding sources in public vs. private health care systems impact patient access to reproductive medicine.
11:20amSession Introduction
Ubaka Ogbogu(University of Alberta, Canada) Moderator
11:25amOpening Perspectives
Lisa Ikemoto(University of California, Davis School of Law)
Amrita Pande(University of Cape Town, South Africa)
Lorian Hardcastle(University of Calgary) (virtual)
11:50amDiscussion
12:30pmLunch

Session 6: Imagining a Potential Clinical Research Pathway for Human IVG

Objectives
  1. Outline the major scientific and ethical elements that would need to be addressed to move from the laboratory to a clinical trial.
  2. Present regulatory frameworks that could apply to IVG.
  3. Discuss lessons learned from other pluripotent stem cell therapies that have successfully moved into clinical trials.
1:30pmSession Introduction
Jeffrey Kahn(Johns Hopkins University), Moderator
1:35pmU.S. Policy and Legal Approaches
Alta Charo(University of Wisconsin-Madison) (virtual)
1:45pmAn Industry Perspective on the Potential Path to Clinical Research
Matthew Krisiloff(Conception Bio, Inc.)
1:55pmU.S. Regulatory Frameworks for a Translational Pathway from Lab to Clinical Trials for IVG
Peter Marks(U.S. Food and Drug Administration)
2:15pmDiscussion
Page 129 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Session 7: Breakout Group Discussions

2:45pmOrientation to Breakout Groups
NASEM staff, Moderators
3:00pmBreak and Move to Groups
3:20pmThree Parallel Breakout Groups with Discussion Questions
Keck 100BREAKOUT 1: Societal, Ethical, and Legal Implications of IVG
In anticipation of continued research progress, the ramifications of IVG must be proactively considered. The group will discuss the societal, ethical, and legal issues raised by its potential development and use.
Keck 101BREAKOUT 2: Impact of IVG on the Fertility Enterprise
Fertility care has become a major business enterprise worldwide. The breakout group will discuss the potential impacts of IVG on this burgeoning industry should it ever be used clinically.
Keck 103BREAKOUT 3: Translating IVG from Laboratory to Market
Emerging technologies require extensive testing and approvals before clinical use. The breakout group will discuss pathways for IVG from laboratory to any potential clinical use, including validation assays and regulatory considerations.
4:35pmBreak and Reconvene in Keck 100
4:40pmConcluding Remarks from Day 2
Ubaka Ogbogu (University of Alberta, Canada)
4:50pmAdjourn Day 2
5:00-6:30pmReception
National Academies’ Keck Center Atrium, Washington, DC
Page 130 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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APRIL 21, 2023

9:30amWelcome and Orientation to Day 3
Glenn Cohen(Harvard Law School)

Session 8: Breakout Group Report-Outs

9:45amGroup 1 Report-Out and Discussion
Katherine Kraschel(Yale Law School) (virtual)
10:10amGroup 2 Report-Out and Discussion
Amrita Pande(University of Cape Town, South Africa)
10:35amGroup 3 Report-Out and Discussion
Jeffrey Kahn(Johns Hopkins University)

Session 9: Participatory Public Engagement Around Reproductive Science Advances

Objectives
  1. Examine public attitudes, values, and perceptions around IVG.
  2. Discuss how communities with relevant lived experiences shape research agendas and ongoing technology development.
  3. Highlight best practices for effective and productive engagement between stakeholders in research, medicine, regulation, and patient advocacy.
11:00amSession Introduction
Melissa Simon(Northwestern University) Moderator (virtual)
11:05amOpening Perspectives
Erica Marsh(University of Michigan)
Hannah Landecker(University of California, Los Angeles)
Tanika Gray Valbrun(The White Dress Project)
11:30amDiscussion
12:10pmLunch
Page 131 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Session 10: Concluding Thoughts

1:00pmKey Messages from the Workshop
Amander Clark(University of California, Los Angeles)
2:10pmNext Steps
NASEM staff
2:30pmAdjourn Workshop
Eli Y. Adashi(Brown University) Workshop Chair
Page 132 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Page 128 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Page 129 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Suggested Citation: "Appendix B: Workshop Task and Agenda." National Academies of Sciences, Engineering, and Medicine. 2023. In Vitro–Derived Human Gametes as a Reproductive Technology: Scientific, Ethical, and Regulatory Implications: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27259.
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Next Chapter: Appendix C: Biographies of Speakers and Planning Committee Members
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