<a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new">We love to hear from our listeners. Send us a message.</a>In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George  A. &quot;Doc&quot;  Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, particularly around technology transfer, process reproducibility, and regulatory readiness, emphasizing the need for early collaboration between research and GMP teams. Their conversation also explores rigorous approaches to chain of identity and custody, the importance of extensive simulation runs to ensure robustness, the unique sensitivities of manufacturing cells for neurological applications, and more.Subscribe to the podcast! <a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'>Apple</a>  |  <a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'>Spotify</a> |  <a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'>YouTube</a>Visit my website: <a href='https://www.cellandgene.com/'>Cell &amp; Gene</a>Connect with me on <a href='https://www.linkedin.com/in/erinharris/'>LinkedIn</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new"&gt;We love to hear from our listeners. Send us a message.&lt;/a&gt;&lt;/p&gt;&lt;p&gt;In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George  A. &amp;quot;Doc&amp;quot;  Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, particularly around technology transfer, process reproducibility, and regulatory readiness, emphasizing the need for early collaboration between research and GMP teams. Their conversation also explores rigorous approaches to chain of identity and custody, the importance of extensive simulation runs to ensure robustness, the unique sensitivities of manufacturing cells for neurological applications, and more.&lt;/p&gt;&lt;p&gt;Subscribe to the podcast!&lt;br/&gt;&lt;a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'&gt;&lt;b&gt;Apple&lt;/b&gt;&lt;/a&gt;&lt;b&gt;  |  &lt;/b&gt;&lt;a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'&gt;&lt;b&gt;Spotify&lt;/b&gt;&lt;/a&gt;&lt;b&gt; |  &lt;/b&gt;&lt;a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'&gt;&lt;b&gt;YouTube&lt;/b&gt;&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Visit my website: &lt;a href='https://www.cellandgene.com/'&gt;Cell &amp;amp; Gene&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Connect with me on &lt;a href='https://www.linkedin.com/in/erinharris/'&gt;LinkedIn&lt;/a&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message. In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George  A. "Doc"  Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, pa...

Building Integrated cGMP Systems for Autologous Cell Therapies with MassGen's Tatyana Matveeva, Ph.D.

<a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new">We love to hear from our listeners. Send us a message.</a>On Episode 127 of Cell &amp; Gene: The Podcast, Carlos Buesa, Ph.D., Founder and Chairman of the Board at Oryzon talks to Host Erin Harris about how targeting LSD1 is unlocking new treatment approaches across oncology, CNS disorders, and sickle cell disease, with promising early clinical data and a strategy grounded in precision epigenetics.Subscribe to the podcast! <a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'>Apple</a>  |  <a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'>Spotify</a> |  <a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'>YouTube</a>Visit my website: <a href='https://www.cellandgene.com/'>Cell &amp; Gene</a>Connect with me on <a href='https://www.linkedin.com/in/erinharris/'>LinkedIn</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new"&gt;We love to hear from our listeners. Send us a message.&lt;/a&gt;&lt;/p&gt;&lt;p&gt;On Episode 127 of Cell &amp;amp; Gene: The Podcast, Carlos Buesa, Ph.D., Founder and Chairman of the Board at Oryzon talks to Host Erin Harris about how targeting LSD1 is unlocking new treatment approaches across oncology, CNS disorders, and sickle cell disease, with promising early clinical data and a strategy grounded in precision epigenetics.&lt;/p&gt;&lt;p&gt;Subscribe to the podcast!&lt;br/&gt;&lt;a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'&gt;&lt;b&gt;Apple&lt;/b&gt;&lt;/a&gt;&lt;b&gt;  |  &lt;/b&gt;&lt;a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'&gt;&lt;b&gt;Spotify&lt;/b&gt;&lt;/a&gt;&lt;b&gt; |  &lt;/b&gt;&lt;a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'&gt;&lt;b&gt;YouTube&lt;/b&gt;&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Visit my website: &lt;a href='https://www.cellandgene.com/'&gt;Cell &amp;amp; Gene&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Connect with me on &lt;a href='https://www.linkedin.com/in/erinharris/'&gt;LinkedIn&lt;/a&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message. On Episode 127 of Cell &amp; Gene: The Podcast, Carlos Buesa, Ph.D., Founder and Chairman of the Board at Oryzon talks to Host Erin Harris about how targeting LSD1 is unlocking new treatment approaches across oncology, CNS disorders, and sickle cell disease, with promising early clinical data and a strategy grounded in precision epigenetics. Subscribe to the podcast! Apple  |  Spotify |  YouTube Visit my website: Cell &amp;...

Rewriting Disease Biology Through LSD1 Inhibition with Oryzon's Carlos Buesa, Ph.D.

<a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new">We love to hear from our listeners. Send us a message.</a>On episode 126 of Cell &amp; Gene: The Podcast, Host Erin Harris welcomes Catriona Jamieson, M.D., Ph.D, Director of the UC San Diego Sanford Stem Cell Institute and Professor of Medicine at the School of Medicine. They explore how shifting the medical mindset from “common horses” to rare “zebras” is unlocking earlier detection and more effective treatment of diseases like myelofibrosis. Dr. Jamieson explains how subtle, often overlooked symptoms can mask serious underlying conditions, and how advances in genomic testing are enabling clinicians to identify disease-driving mutations sooner. They cover groundbreaking progress in targeted therapies, which aim to stop cancer progression and overcome treatment resistance. Subscribe to the podcast! <a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'>Apple</a>  |  <a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'>Spotify</a> |  <a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'>YouTube</a>Visit my website: <a href='https://www.cellandgene.com/'>Cell &amp; Gene</a>Connect with me on <a href='https://www.linkedin.com/in/erinharris/'>LinkedIn</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new"&gt;We love to hear from our listeners. Send us a message.&lt;/a&gt;&lt;/p&gt;&lt;p&gt;On episode 126 of Cell &amp;amp; Gene: The Podcast, Host Erin Harris welcomes Catriona Jamieson, M.D., Ph.D, Director of the UC San Diego Sanford Stem Cell Institute and Professor of Medicine at the School of Medicine. They explore how shifting the medical mindset from “common horses” to rare “zebras” is unlocking earlier detection and more effective treatment of diseases like myelofibrosis. Dr. Jamieson explains how subtle, often overlooked symptoms can mask serious underlying conditions, and how advances in genomic testing are enabling clinicians to identify disease-driving mutations sooner. They cover groundbreaking progress in targeted therapies, which aim to stop cancer progression and overcome treatment resistance. &lt;/p&gt;&lt;p&gt;Subscribe to the podcast!&lt;br/&gt;&lt;a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'&gt;&lt;b&gt;Apple&lt;/b&gt;&lt;/a&gt;&lt;b&gt;  |  &lt;/b&gt;&lt;a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'&gt;&lt;b&gt;Spotify&lt;/b&gt;&lt;/a&gt;&lt;b&gt; |  &lt;/b&gt;&lt;a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'&gt;&lt;b&gt;YouTube&lt;/b&gt;&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Visit my website: &lt;a href='https://www.cellandgene.com/'&gt;Cell &amp;amp; Gene&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Connect with me on &lt;a href='https://www.linkedin.com/in/erinharris/'&gt;LinkedIn&lt;/a&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message. On episode 126 of Cell &amp; Gene: The Podcast, Host Erin Harris welcomes Catriona Jamieson, M.D., Ph.D, Director of the UC San Diego Sanford Stem Cell Institute and Professor of Medicine at the School of Medicine. They explore how shifting the medical mindset from “common horses” to rare “zebras” is unlocking earlier detection and more effective treatment of diseases like myelofibrosis. Dr. Jamieson explains how subtle, often overlooked ...

Advancing Early Detection in Rare Cancers with Catriona Jamieson, M.D., Ph.D.

<a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new">We love to hear from our listeners. Send us a message.</a>On episode 125 of Cell &amp; Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group&apos;s Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach. They also explore what this means for developers, from platform strategies and global regulatory divergence to the growing role of patient advocacy and the need for early, integrated planning.Subscribe to the podcast! <a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'>Apple</a>  |  <a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'>Spotify</a> |  <a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'>YouTube</a>Visit my website: <a href='https://www.cellandgene.com/'>Cell &amp; Gene</a>Connect with me on <a href='https://www.linkedin.com/in/erinharris/'>LinkedIn</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new"&gt;We love to hear from our listeners. Send us a message.&lt;/a&gt;&lt;/p&gt;&lt;p&gt;On episode 125 of Cell &amp;amp; Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group&amp;apos;s Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach. They also explore what this means for developers, from platform strategies and global regulatory divergence to the growing role of patient advocacy and the need for early, integrated planning.&lt;/p&gt;&lt;p&gt;Subscribe to the podcast!&lt;br/&gt;&lt;a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'&gt;&lt;b&gt;Apple&lt;/b&gt;&lt;/a&gt;&lt;b&gt;  |  &lt;/b&gt;&lt;a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'&gt;&lt;b&gt;Spotify&lt;/b&gt;&lt;/a&gt;&lt;b&gt; |  &lt;/b&gt;&lt;a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'&gt;&lt;b&gt;YouTube&lt;/b&gt;&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Visit my website: &lt;a href='https://www.cellandgene.com/'&gt;Cell &amp;amp; Gene&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Connect with me on &lt;a href='https://www.linkedin.com/in/erinharris/'&gt;LinkedIn&lt;/a&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message. On episode 125 of Cell &amp; Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach. They also explore what this means for developers, from platform strategies and global regulatory divergence to the growing role of patient advocacy and...

Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka

<a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new">We love to hear from our listeners. Send us a message.</a>On episode 124 of Cell &amp; Gene: The Podcast, Aurora Therapeutics&apos; CEO Dr. Edward Kaye discusses the company’s strategy for translating CRISPR gene editing into scalable, commercially viable medicines for rare diseases. Aurora is initially targeting phenylketonuria (PKU) using a platform approach that leverages shared components, such as lipid nanoparticles and base editors, while customizing guide RNAs for specific mutations. Dr. Kaye explains how trials, regulatory flexibility, and optimized manufacturing could make it possible to treat many genetic variants efficiently and cost-effectively. Ultimately, Aurora aims to build a repeatable model that expands gene editing access to larger rare-disease populations while keeping patients at the center of development.Subscribe to the podcast! <a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'>Apple</a>  |  <a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'>Spotify</a> |  <a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'>YouTube</a>Visit my website: <a href='https://www.cellandgene.com/'>Cell &amp; Gene</a>Connect with me on <a href='https://www.linkedin.com/in/erinharris/'>LinkedIn</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1810482/fan_mail/new"&gt;We love to hear from our listeners. Send us a message.&lt;/a&gt;&lt;/p&gt;&lt;p&gt;On episode 124 of Cell &amp;amp; Gene: The Podcast, Aurora Therapeutics&amp;apos; CEO Dr. Edward Kaye discusses the company’s strategy for translating CRISPR gene editing into scalable, commercially viable medicines for rare diseases. Aurora is initially targeting phenylketonuria (PKU) using a platform approach that leverages shared components, such as lipid nanoparticles and base editors, while customizing guide RNAs for specific mutations. Dr. Kaye explains how trials, regulatory flexibility, and optimized manufacturing could make it possible to treat many genetic variants efficiently and cost-effectively. Ultimately, Aurora aims to build a repeatable model that expands gene editing access to larger rare-disease populations while keeping patients at the center of development.&lt;/p&gt;&lt;p&gt;Subscribe to the podcast!&lt;br/&gt;&lt;a href='https://podcasts.apple.com/us/podcast/cell-gene-the-podcast/id1574496063'&gt;&lt;b&gt;Apple&lt;/b&gt;&lt;/a&gt;&lt;b&gt;  |  &lt;/b&gt;&lt;a href='https://open.spotify.com/show/78NSjRuHndVhI5VHWWAMya'&gt;&lt;b&gt;Spotify&lt;/b&gt;&lt;/a&gt;&lt;b&gt; |  &lt;/b&gt;&lt;a href='https://music.youtube.com/playlist?list=PLFXsCNKV78rWyuxay7hXQFo0rVyAXAdwX'&gt;&lt;b&gt;YouTube&lt;/b&gt;&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Visit my website: &lt;a href='https://www.cellandgene.com/'&gt;Cell &amp;amp; Gene&lt;/a&gt;&lt;/p&gt;&lt;p&gt;Connect with me on &lt;a href='https://www.linkedin.com/in/erinharris/'&gt;LinkedIn&lt;/a&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message. On episode 124 of Cell &amp; Gene: The Podcast, Aurora Therapeutics' CEO Dr. Edward Kaye discusses the company’s strategy for translating CRISPR gene editing into scalable, commercially viable medicines for rare diseases. Aurora is initially targeting phenylketonuria (PKU) using a platform approach that leverages shared components, such as lipid nanoparticles and base editors, while customizing guide RNAs for specific mutations. Dr. Kaye ...

Scaling CRISPR for Rare Disease with Aurora Therapeutics' Dr. Edward Kaye

Cell & Gene, the most valuable online resource for delivering in-depth content from authoritative authors and sources to professionals in the CGT sector, introduces Cell & Gene: The Podcast. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to industry and academic leaders about their current initiatives and how they are moving the sector forward.

Cell & Gene: The Podcast

Details

Recent Episodes