When
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.<br>
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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>.<br>
<br>
Featured speaker: <strong><strong></strong>Andrew von Eschenbach,</strong> MD, President, Samaritan Health Initiatives; Urologic Oncologist and Former Director of the National Cancer Institute and Commissioner of the Food and Drug Administration.<br>
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<strong>Speakers:</strong><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>
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Please join us on Wednesday, March 26, 2025. <br>
<strong>11 AM to 1 PM Eastern Time (4:00-6:00PM CET)</strong><br>
<br>
This is a virtual event. To register, please click <a href="https://healthmanagement.zoom.us/j/92721130981?pwd=4kGnDnwn1p1ENaMndpc3zPp0NirjLg.2KWkaNxCxmxCvb68" target="_blank">HERE</a>. <br>
A password to enter the event will be provided in your confirmation email message. <br>
<br>
If you have any questions, please reach out to <strong>Laura Brown </strong>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
Mar
26
Wed, Mar 26, 2025, 11:00 AM — 1:00 PM EDT
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:
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
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