Nonclinical Tools in Drug Development

Wednesday, March 26, 2025
03/26/25 11:00 AM 03/26/25 1:00 PM America/New_York Nonclinical Tools in Drug Development This program will bring together regulators, industry, innovators, associations, and non-profits to discuss the issues limiting the development and utilization of nonclinical tools in medicines development. Speakers will set the stage on nonclinical lexicon and definitions and present on what has been achieved in the nonclinical space thus far, including reduced utilization of animal testing. Speakers will then discuss challenges faced in implementing tools, which would improve the predictability of clinical outcomes and lessen the resource intensiveness of current clinical processes. Last, speakers will consider what steps need to be taken to further use of nonclinical tools, such as global harmonization and updates to regulatory processes and requirements. Additional background on the importance and value of accelerating the development of nonclinical tools is highlighted in this article, <a aria-label="Link TCEM and NAMs: An Innovation Superhighway for Drug Development" id="menur1e9a" href="https://www.fdli.org/2025/01/tcem-and-nams-an-innovation-superhighway-for-drug-development/" rel="noreferrer noopener" target="_blank" title="https://www.fdli.org/2025/01/tcem-and-nams-an-innovation-superhighway-for-drug-development/">TCEM and NAMs: An Innovation Superhighway for Drug Development</a>. Featured speaker: Andrew von Eschenbach, MD, President, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration. Speakers:<ul><li>Maria Apostolaros, Deputy Vice President, Science and Regulatory Advocacy, PhRMA</li><li>Rhiannon David, Director, Microphysiological Systems in Clinical Pharmacology and Safety Sciences, AstraZeneca</li><li>Steven Hoffmann, Vice President, Science Partnerships, Translational Science, Foundation for the National Institutes of Health</li><li>Frederic Christian Pipp, Global Animal Welfare Officer EMEA/APAC, Corporate Sustainability, Quality, Trade Compliance | Animal Affairs, Merck Group</li><li>Amanda Roache, Deputy Vice President, Science and Regulatory Advocacy, PhRMA</li></ul> Please join us on Wednesday, March 26, 2025.  11 AM to 1 PM Eastern Time (4:00-6:00PM CET) This is a virtual event. To register, please click <a href="https://healthmanagement.zoom.us/j/92721130981?pwd=4kGnDnwn1p1ENaMndpc3zPp0NirjLg.2KWkaNxCxmxCvb68" target="_blank">HERE</a>.  A password to enter the event will be provided in your confirmation email message.  If you have any questions, please reach out to Laura Brown at <a href="mailto:laura.brown@leavittpartners.com">laura.brown@leavittpartners.com</a> Virtual Event Current Challenges and the Path Forward sshonk@healthmanagement.com false MM/DD/YYYY

Registration ended Mar 26, 2025

Virtual Event

This program will bring together regulators, industry, innovators, associations, and non-profits to discuss the issues limiting the development and utilization of nonclinical tools in medicines development. Speakers will set the stage on nonclinical lexicon and definitions and present on what has been achieved in the nonclinical space thus far, including reduced utilization of animal testing. Speakers will then discuss challenges faced in implementing tools, which would improve the predictability of clinical outcomes and lessen the resource intensiveness of current clinical processes. Last, speakers will consider what steps need to be taken to further use of nonclinical tools, such as global harmonization and updates to regulatory processes and requirements.

Additional background on the importance and value of accelerating the development of nonclinical tools is highlighted in this article, TCEM and NAMs: An Innovation Superhighway for Drug Development.

Featured speaker: Andrew von Eschenbach, MD, President, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration.

Speakers:

Maria Apostolaros, Deputy Vice President, Science and Regulatory Advocacy, PhRMA
Rhiannon David, Director, Microphysiological Systems in Clinical Pharmacology and Safety Sciences, AstraZeneca
Steven Hoffmann, Vice President, Science Partnerships, Translational Science, Foundation for the National Institutes of Health
Frederic Christian Pipp, Global Animal Welfare Officer EMEA/APAC, Corporate Sustainability, Quality, Trade Compliance | Animal Affairs, Merck Group
Amanda Roache, Deputy Vice President, Science and Regulatory Advocacy, PhRMA

Please join us on Wednesday, March 26, 2025.
11 AM to 1 PM Eastern Time (4:00-6:00PM CET)

This is a virtual event. To register, please click HERE.
A password to enter the event will be provided in your confirmation email message.

If you have any questions, please reach out to Laura Brown at laura.brown@leavittpartners.com

Event Contact: Sarah Shonk
sshonk@healthmanagement.com

Nonclinical Tools in Drug Development

Wednesday, March 26, 2025, 11:00 AM — 1:00 PM EDT

03/26/25 11:00 AM 03/26/25 1:00 PM America/New_York Nonclinical Tools in Drug Development This program will bring together regulators, industry, innovators, associations, and non-profits to discuss the issues limiting the development and utilization of nonclinical tools in medicines development. Speakers will set the stage on nonclinical lexicon and definitions and present on what has been achieved in the nonclinical space thus far, including reduced utilization of animal testing. Speakers will then discuss challenges faced in implementing tools, which would improve the predictability of clinical outcomes and lessen the resource intensiveness of current clinical processes. Last, speakers will consider what steps need to be taken to further use of nonclinical tools, such as global harmonization and updates to regulatory processes and requirements. Additional background on the importance and value of accelerating the development of nonclinical tools is highlighted in this article, <a aria-label="Link TCEM and NAMs: An Innovation Superhighway for Drug Development" id="menur1e9a" href="https://www.fdli.org/2025/01/tcem-and-nams-an-innovation-superhighway-for-drug-development/" rel="noreferrer noopener" target="_blank" title="https://www.fdli.org/2025/01/tcem-and-nams-an-innovation-superhighway-for-drug-development/">TCEM and NAMs: An Innovation Superhighway for Drug Development</a>. Featured speaker: Andrew von Eschenbach, MD, President, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration. Speakers:<ul><li>Maria Apostolaros, Deputy Vice President, Science and Regulatory Advocacy, PhRMA</li><li>Rhiannon David, Director, Microphysiological Systems in Clinical Pharmacology and Safety Sciences, AstraZeneca</li><li>Steven Hoffmann, Vice President, Science Partnerships, Translational Science, Foundation for the National Institutes of Health</li><li>Frederic Christian Pipp, Global Animal Welfare Officer EMEA/APAC, Corporate Sustainability, Quality, Trade Compliance | Animal Affairs, Merck Group</li><li>Amanda Roache, Deputy Vice President, Science and Regulatory Advocacy, PhRMA</li></ul> Please join us on Wednesday, March 26, 2025.  11 AM to 1 PM Eastern Time (4:00-6:00PM CET) This is a virtual event. To register, please click <a href="https://healthmanagement.zoom.us/j/92721130981?pwd=4kGnDnwn1p1ENaMndpc3zPp0NirjLg.2KWkaNxCxmxCvb68" target="_blank">HERE</a>.  A password to enter the event will be provided in your confirmation email message.  If you have any questions, please reach out to Laura Brown at <a href="mailto:laura.brown@leavittpartners.com">laura.brown@leavittpartners.com</a> Virtual Event Current Challenges and the Path Forward sshonk@healthmanagement.com false MM/DD/YYYY

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Mar 26, 2025 ico

	03/26/25 11:00 AM 03/26/25 11:30 AM America/New_York Current Use and Regulations Surrounding Nonclinical Tools View session: https://hma.connect.space/accounts/events/nonclinical-tools-in-drug-development/agenda/2025-03-26#session_row_30721 <br/> Current Challenges and the Path Forward sshonk@healthmanagement.com MM/DD/YYYY 11:00 - 11:30 AM Current Use and Regulations Surrounding Nonclinical Tools
	03/26/25 11:00 AM 03/26/25 11:30 AM America/New_York Setting the Stage View session: https://hma.connect.space/accounts/events/nonclinical-tools-in-drug-development/agenda/2025-03-26#session_row_30720 <br/> <p><strong>Andrew von Eschenbach</strong>, resident, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration</p> <br> Current Challenges and the Path Forward sshonk@healthmanagement.com MM/DD/YYYY 11:00 - 11:30 AM Setting the Stage Andrew von Eschenbach, resident, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration Less Info
	03/26/25 12:00 PM 03/26/25 1:00 PM America/New_York Advancing the Science of Nonclinical Medical Product Development: Industry and Regulatory Challenges and Steps Forward View session: https://hma.connect.space/accounts/events/nonclinical-tools-in-drug-development/agenda/2025-03-26#session_row_30722 <br/> Current Challenges and the Path Forward sshonk@healthmanagement.com MM/DD/YYYY 12:00 - 1:00 PM Advancing the Science of Nonclinical Medical Product Development: Industry and Regulatory Challenges and Steps Forward