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nist-gov/www.nist.gov/mml/bbd/day-1-gene-delivery-systems-public-workshop
Scott Williams 4063bef310 Initital commit.
2025-03-05 18:59:57 +00:00

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<h3 class="text-align-center"><span><span><span><span>Wednesday, November 1, 2023 – 8:30 am to 5:00 pm ET</span></span></span></span><br>
<br>
Agenda</h3>
<p>&nbsp;</p>
<table>
<tbody>
<tr>
<td><strong>Time (ET)</strong></td>
<td><strong>Topics</strong></td>
</tr>
<tr>
<td>
<p><span><span><span>8:30&nbsp;– 8:45 am&nbsp;</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Welcome &amp; Opening Remarks</strong></span></span></span></p>
<ul>
<li><span><span><span><strong>Charles Romine, </strong>Associate Director for Laboratory Programs (NIST)</span></span></span></li>
<li><span><span><span><strong>Heather Lombardi,</strong> Director, Office of Cellular Therapy and Human Tissue, Office of Therapeutic&nbsp;Products, CBER (FDA)</span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>8:45&nbsp;– 9:35 am</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Workshop Overview</strong></span></span></span></p>
<ul>
<li><span><span><span>"NIST Role in Standards for Emerging Biotechnology and advanced therapy" – <strong>Sheng Lin-Gibson</strong> (NIST)</span></span></span></li>
<li>“Standards Recognition Program for Regenerative Medicine Therapies”<span><span><span> – <strong>Judy Arcidiacono</strong> (FDA)</span></span></span></li>
<li><span><span><span>“Regulatory perspective: CMC considerations for viral vectors” – <strong>Anurag Sharma </strong>(FDA)</span></span></span></li>
<li><span><span><span>"NIST efforts on Gene Delivery Systems and ISO standards" – <strong>Ed Kwee </strong>(NIST)</span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>9:35&nbsp;– 10:05 am<strong> </strong></span></span></span></p>
<p>&nbsp;</p>
</td>
<td>
<p><span><span><span><strong>Complementary Programs</strong></span></span></span></p>
<ul>
<li><span><span><span>“Accelerating Medicines Partnership Program – Bespoke Gene Therapy Consortium”&nbsp;–&nbsp;<strong>Courtney Silverthorn</strong> (FNIH)</span></span></span></li>
<li><span><span><span>“NIIMBL Program in Viral Vector Manufacturing and Analytics”&nbsp;–&nbsp;<strong>Kelvin Lee</strong> (NIIMBL)</span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>10:05&nbsp;– 10:20 am</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Break</strong></span></span></span></p>
</td>
</tr>
<tr>
<td>
<p><span><span><span>10:20&nbsp;– 11:35 am</span></span></span></p>
<p>&nbsp;</p>
</td>
<td>
<p><span><span><span><strong>Common challenges and difference of gene delivery systems and ongoing efforts</strong></span></span></span></p>
<ul>
<li><span><span><span><span>“Enabling Affordable and Accessible Advanced Medicines”&nbsp;</span>–&nbsp;<strong>Boro Dropulic </strong>(Caring Cross)</span></span></span></li>
<li><span><span><span>“Common Analytical Challenges with Adeno Associated Virus Mediated Gene Therapy” - <strong>Will Fountain</strong> (Andelyn Bioscience)</span></span></span></li>
<li><span><span><span>“</span></span></span><span><span><span>Analytical Challenges Associated with Lipid Nanoparticle mediated Gene Delivery and Gene Editing”</span></span></span> <span><span><span>–&nbsp;<strong>Carl Co </strong>(Arbor Bio)</span></span></span></li>
<li>“Extracellular Vesicles (EVs) as a Novel Drug Delivery Platform"<span><span><span>&nbsp;–&nbsp;<strong>Haiying Zhang</strong> (Weill Cornell Medical)</span></span></span></li>
<li><span><span><span>“<span>Analytical challenges for adenovirus-based vectors<em>”</em></span> – <strong>Nancy Sajjadi</strong> (Sajjadi Consulting)</span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>11:35 am – 12:00 pm&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Panel Discussion</strong><em> – commonalities and differences</em></span></span></span></p>
</td>
</tr>
<tr>
<td>
<p><span><span><span>12:00&nbsp;– 1:00 pm</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Lunch Break</strong></span></span></span></p>
</td>
</tr>
<tr>
<td>
<p><span><span><span>1:00&nbsp;– 2:10 pm</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Breakout Sessions (in-person only) </strong></span></span></span></p>
<ul>
<li><span><span><span><span><span>Viral vector functional measurements</span></span></span></span></span></li>
<li><span><span><span><span><span>Viral vector physical measurements</span></span></span></span></span></li>
<li><span><span><span><span><span>Non-viral vector functional measurements</span></span></span></span></span></li>
<li><span><span><span><span>Non-viral vector physical measurements</span></span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>2:10&nbsp;– 2:30 pm</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Break</strong></span></span></span></p>
</td>
</tr>
<tr>
<td>
<p><span><span><span>2:30&nbsp;– 4:30 pm</span></span></span></p>
<p>&nbsp;</p>
</td>
<td>
<p><span><span><span><strong>New Technology Showcase (Measurements and Systems)</strong></span></span></span></p>
<ul>
<li><span><span><span><span>“NibaPlex® assay platform for AAV vector genome integrity quantification”&nbsp;</span>– <strong>David Dobnik </strong>(Niba Labs)</span></span></span></li>
<li><span><span><span><span>“Viral vector capsid characterization using mass photometry”</span> – <strong>Gabriella Kiss</strong> (Refeyn)</span></span></span></li>
<li><span><span><span><span><strong><span>“</span></strong><span>How super resolution can helps you gain better insights into your samples” &nbsp;–<strong>Ricardo Nunes Bastos</strong>&nbsp;(Oni)</span></span></span></span></span></li>
<li><span><span><span><span><span>“Image cytometry technology and applications for viral infectivity/transduction analysis” -<strong> Bo Lin</strong>&nbsp;(Revvity)</span></span></span></span></span></li>
<li><span><span><span><span>“Label-free single cell PAT precision analytics for cell and gene therapies and vaccines” -<strong> </strong></span><strong>Renee Hart </strong>(Lumacyte)</span></span></span></li>
<li>“Insights into LNP quantification and their therapeutic application”-&nbsp;<span><span><span><strong>Carsten Russ</strong> (Intellia)</span></span></span></li>
<li><span><span><span><span>“Focused ultrasound modulation of the blood-brain-barrier permeability for delivery of gene therapy to the brain”</span> - <strong>Frederic Padilla</strong> (Focused Ultrasound Foundation)</span></span></span></li>
<li><span><span><span><span>“Therapeutic Applications of Novel Q5 Exosomes”<strong> - </strong></span><strong>Javed Siddiqi</strong> (Exom BioPharma)</span></span></span></li>
</ul>
</td>
</tr>
<tr>
<td>
<p><span><span><span>4:30&nbsp;– 5:00 pm</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Closing</strong></span></span></span></p>
<ul>
<li><span><span><span>Report of breakout sessions</span></span></span></li>
<li><span><span><span>Summary with polling</span></span></span></li>
<li><span><span><span>Next Steps for NIST Gene Delivery Systems Working Group and opportunities for participation.</span></span></span></li>
</ul>
<p><span><span><span><strong>Jamie Almeida</strong> (NIST)</span></span></span></p>
</td>
</tr>
<tr>
<td>
<p><span><span><span>5:00 pm</span></span></span></p>
</td>
<td>
<p><span><span><span><strong>Adjourn </strong></span></span></span></p>
</td>
</tr>
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</table>
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<a href="/topic-terms/bioscience" hreflang="en">Bioscience</a> and <a href="/topic-terms/gene-delivery-systems" hreflang="en">Gene delivery systems</a></div>
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Created September 6, 2023, Updated December 18, 2024
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