Cell & Gene: The Podcast
By: Erin Harris
Language: en
Categories: Science, Life
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.
Episodes
The Editors' Roundtable: A 2025 Retrospective of the Life Science Industry
Jan 09, 2026We love to hear from our listeners. Send us a message.
We’re sharing this Better Biopharma episode on Cell & Gene: The Podcast because Better Biopharma is a sister show in the Life Science Connect family, and this conversation touches so many of the same challenges, pressures, and big-picture shifts our audience is thinking about right now. CGT doesn’t live in a bubble, and neither do the people building it. So we wanted to bring this wider, cross-industry conversation straight to you.
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Developing Itvisma for Broad-Range Treatment of SMA with Novartis' Dr. Norman Putzki
Jan 01, 2026We love to hear from our listeners. Send us a message.
In episode 119 of Cell & Gene The Podcast, Host Erin Harris talks to Dr. Norman Putzki, Global Head Clinical Development, Novartis, about the FDA approval of Itvisma, now the only gene replacement therapy approved for children, adolescents, and adults with spinal muscular atrophy (SMA). Dr. Putzki walks us through the six-year development journey behind the STEER and STRENGTH Phase 3 programs. And we explore what the expanded age-range label means for patients who were previously left behind, why intrathecal, fixed-dose AAV delivery represents a pivotal advance for safety...
Duration: 00:21:05Turning the Tumor Microenvironment Against Cancer with MGB's Alexander Cryer, Ph.D.
Dec 18, 2025We love to hear from our listeners. Send us a message.
In Episode 118, Host Erin Harris talks to Alexander Cryer, Ph.D., Instructor in Medicine at Mass General Brigham, about a proof of concept strategy that reprograms tumor cells with mRNA lipid nanoparticles to overactivate the cGAS-STING pathway, forcing cancer cells to produce and export large amounts of the innate immune agonist cGAMP to stimulate surrounding immune cells and drive anti-tumor immunity. Dr. Cryer explains the basic biology of cGAS-STING and how his team restored this pathway in tumor cells and leveraged intratumoral LNP delivery to overcome...
Duration: 00:16:25Building Patient-Driven Culture and Leadership Resilience in CGT with Paul Perreault
Dec 04, 2025We love to hear from our listeners. Send us a message.
On episode 117, Host Erin Harris welcomes Paul Perreault, Strategic Advisor, Board Member and former CEO of CSL, who shares insights from his decade leading the company through global expansion and the COVID-19 pandemic. Perreault highlights the importance of patient-centered culture, strategic focus, and adaptive leadership for cell and gene therapy innovators. He offers practical advice on building a values-driven culture that connects employees to patients, the importance of focusing on core competencies to attract capital, and the necessity of continuous leadership development, even advocating for mentorship...
Duration: 00:18:18Treating Inherited Retinal Disorders with Ocugen's Dr. Arun Upadhyay
Nov 20, 2025We love to hear from our listeners. Send us a message.
In episode 116 of Cell & Gene: The Podcast, Host Erin Harris talks to Dr. Arun Upadhyay, Chief Scientific officer, Head of Research and Development at Ocugen to discuss how the company’s modifier gene therapy platform is redefining treatment possibilities for inherited retinal diseases such as retinitis pigmentosa, Stargardt disease, and geographic atrophy. Dr. Upadhyay explains how Ocugen’s gene-agnostic approach differs from traditional single-gene therapies by targeting shared disease pathways to preserve photoreceptors and slow vision loss across diverse genetic mutations. He also shares key lessons lear...
Duration: 00:26:56Advancing Hematology and Cell Therapy Innovation with AstraZeneca's Aliya Omer
Nov 06, 2025We love to hear from our listeners. Send us a message.
Episode 115 of Cell & Gene: The Podcast features Host Erin Harris' talk with Aliya Omer, Vice President and Global Head of Hematology and Cell Therapy at AstraZeneca. Omer shares valuable insights from her rich experience leading cell therapy development across multiple top companies. She highlights the critical importance of collaboration by breaking down silos across research, manufacturing, regulatory, and commercial teams to deliver innovative therapies efficiently. She also discusses AZ’s diverse and ambitious cell therapy portfolio, encompassing autologous CAR-T, TCR-T, in vivo gene therapies, and regulatory T...
Duration: 00:34:02Advancing Allogeneic Cell Therapy for SCI and Blindness with Lineage's Brian Culley
Oct 23, 2025We love to hear from our listeners. Send us a message.
On episode 114 of Cell & Gene: The Podcast, Host Erin Harris talks to Brian Culley, CEO of Lineage Cell Therapeutics, about advancing cell therapy beyond oncology and into transformative treatments for conditions such as spinal cord injury and blindness. Culley shares how Lineage’s allogeneic, off-the-shelf approach, anchored by its OPC1 program, aims to replace lost or damaged cells to restore function, starting with patients who have plateaued after chronic spinal cord injury. He details the DOSED study’s innovative delivery device and thaw-and-inject formulation, both designed to s...
Duration: 00:26:23How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D.
Oct 09, 2025We love to hear from our listeners. Send us a message.
Welcome to Episode 113 of Cell & Gene: The Podcast. Host Erin Harris is joined by Thorsten Gorba, Ph.D., VP Process Development at Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing. Aspen Neuroscience stands at the forefront of integrating machine vision and AI/ML to assess induced pluripotent stem cell (iPSC) colony quality by offering a transformative approach to move beyond the subjective nature of manual evaluation. Dr. Gorba discusses how these technologies bolster reproducibility and scalability and help reduce...
Duration: 00:21:38Inside Sanofi’s Genomic Medicine Vision with Mike Quigley, Ph.D.
Sep 25, 2025We love to hear from our listeners. Send us a message.
On episode 112 of Cell & Gene: The Podcast, Michael Quigley, Ph.D., Chief Scientific Officer and Global Head of Research at Sanofi talks to Host Erin Harris about the establishment of Sanofi’s dedicated Genomic Medicine Unit (GMU). Dr. Quigley emphasizes in vivo delivery and process optimization to improve patient experience, scalability, and global access. They discuss the importance of partnerships with academia, industry, and regulators, and Dr. Quigley discusses how advances in AI are accelerating research efficiency, molecule optimization, and experimental design across Sanofi’s portfolio. He a...
Duration: 00:24:15Engineering Off-the-Shelf Cell Therapies for Cancer & Autoimmune Disease with Ernexa Therapeutics' Sanjeev Luther
Sep 11, 2025We love to hear from our listeners. Send us a message.
On episode 111 of Cell & Gene: The Podcast, Host Erin Harris talks to Ernexa Therapeutics' President and CEO, Sanjeev Luther, about how the company is advancing cell therapy innovation for cancer and autoimmune disease through engineered induced pluripotent stem cell-derived mesenchymal stem cells (iMSCs). Luther shares how Ernexa’s synthetic, standardized, off-the-shelf iMSCs are designed to overcome historic hurdles in MSC therapy, including variability, scalability, and manufacturing complexity, by leveraging master cell banks, precise gene editing, and novel product engineering. He also shares insights into the process of...
Duration: 00:20:58What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago
Aug 29, 2025We love to hear from our listeners. Send us a message.
This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development. From the impact of leadership changes and evolving policy directives to the role of funding allocations and public health priorities, Drago sheds light on what CGT developers and sponsors should be watching most closely. She explores regulatory...
Duration: 00:23:15Inside CRISPR-GPT with Yuanhao Qu
Aug 28, 2025We love to hear from our listeners. Send us a message.
In this episode of Cell & Gene Podcast episode, Host Erin Harris talks to Stanford School of Medicine Ph.D. student, Yuanhao Qu, about his work developing CRISPR-GPT, an AI-driven multi-agent system designed to automate genetic experimental design and data analysis, making CRISPR experiments more efficient and accessible, even for non-experts. Qu explains how CRISPR-GPT addresses key challenges such as guide design, delivery methods, off-target prediction, and protocol generation, and shares how collaborations with Princeton helped shape the tool’s architecture and evaluation. Qu also discusses Biomni, a...
Duration: 00:20:16Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D.
Aug 22, 2025We love to hear from our listeners. Send us a message.
This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy. Dr. Grilley shares her wealth of experience and unique perspective on the most pressing barriers to accessing...
Duration: 00:45:40Defining Product Roles and Navigating FDA Approval with Monika Swietlicka
Aug 15, 2025We love to hear from our listeners. Send us a message.
Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and gene therapies. Their conversation covers the importance of defining a therapy’s intended role (curative, chronic, or adjunctive) early in development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes th...
Duration: 00:38:30Advancing Gene Therapy for FTD with Passage Bio's Dr. Will Chou
Aug 14, 2025We love to hear from our listeners. Send us a message.
In Episode 109 of Cell & Gene: The Podcast, Host Erin Harris talks to Will Chou, M.D., CEO of Passage Bio about the promise and challenges of developing gene therapies for frontotemporal dementia (FTD), a neurodegenerative disease with strong genetic underpinnings. Dr. Chou discusses the biological basis of FTD and the complex scientific, manufacturing, and regulatory hurdles that come with targeting the brain. They discuss the latest interim results from the upliFT-D study of Passage Bio’s PBFT02, including safety and tolerability findings, dose cohort comparisons, and th...
Duration: 00:24:15FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt
Aug 08, 2025We love to hear from our listeners. Send us a message.
This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the importance of early and continuous engagement with regulatory authorities, especially through structured meetings like INTERACT and pre-IND sessions. Harris and Spratt cover CMC readiness, filing for RMAT/CIT, BLA approvals and regulatory expectations, and more.
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Navigating the Journey to Safer Stem Cell Therapies with Orca Bio's Nate Fernhoff
Jul 31, 2025We love to hear from our listeners. Send us a message.
Cell & Gene: The Podcast Host, Erin Harris, talks to Orca Bio CEO and Co-Founder Nathaniel Fernhoff as he recounts the company’s origins and evolution, tracing its roots to pioneering stem cell research at Stanford University and Dr. Irv Weissman's lab. Seeking to create safer, more effective cures for blood cancers such as AML, ALL, and MDS, Orca Bio developed high-precision cell therapies that utilize purified regulatory T cells and stem cells to minimize complications, such as graft-versus-host disease. Orca Bio spun out of academia to es...
Duration: 00:33:17Rethinking Large Animal Models in Gene Therapy with Novartis' Ralf Schmid, Ph.D.
Jul 17, 2025We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Ralf Schmid, Ph.D., Associate Director of Preclinical Research at Novartis Biomedical Research, about the evolving use of large animal models in gene therapy development. Dr. Schmid discusses the current reliance on non-human primates (NHPs), their growing logistical and ethical challenges, and the emerging interest in alternatives like genetically engineered pigs and sheep. He outlines key considerations around safety, biodistribution, and immunogenicity that still necessitate large-animal testin —particularly for CNS-targeted AAV therapies — and emph...
Duration: 00:24:49Gene Therapy for Inherited Retinal Diseases with Opus Genetics' Dr. George Magrath
Jul 03, 2025We love to hear from our listeners. Send us a message.
In this episode of Cell & Gene: The Podcast, George Magrath, CEO of Opus Genetics, shares with Host, Erin Harris, how the company is advancing gene therapies for inherited retinal diseases (IRDs), with a focus on LCA5, a rare and severe form of childhood blindness. Built on the foundational science of Dr. Jean Bennett and leveraging the legacy of Luxturna, Magrath shares how Opus is developing subretinal AAV-based therapies targeting seven distinct mutations. He also explains why gene therapy is particularly well-suited to IRDs, shares compelling early...
Duration: 00:20:13Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews
Jun 19, 2025We love to hear from our listeners. Send us a message.
In this episode of Cell & Gene: The Podcast, Host Erin Harris interviews Dr. Gloria Matthews, Chief Medical Officer of Aegle Therapeutics, a clinical-stage regenerative medicine company focused on developing therapies for rare and severe dermatologic and immunologic disorders. Dr. Matthews explains how Aegle is pioneering the use of extracellular vesicles (EVs) derived from mesenchymal stem cells, which offer advantages over traditional cell-based therapies. Their discussion highlights Aegle's lead product, AGLE-102 as well as the regulatory and manufacturing challenges of scaling EV-based therapies. They cover the broader...
Duration: 00:15:58Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka
Jun 05, 2025We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris welcomes Monika Swietlicka, Principal, Regulatory Strategy at Halloran Consulting Group to discuss the key regulatory challenges facing cell and gene therapy companies. Swietlicka highlights manufacturing complexity and clinical trial design limitations. On gene editing, she notes that the FDA is focused on off-target effects and demands robust data, including functional validation. She emphasizes the importance of early definition of critical quality attributes and a strong comparability strategy to ensure product consistency. She also underscores the...
Duration: 00:24:46Harnessing AI and Synthetic Biology for Cell Therapies with Generate:Biomedicines' Dr. Alex Snyder
May 22, 2025We love to hear from our listeners. Send us a message.
Host Erin Harris talks to Generate:Biomedicines' EVP of R&D, Dr. Alex Snyder about the convergence of AI, machine learning (ML), and synthetic biology in the development of next-generation therapies. They cover how AI is transforming drug discovery by enabling the rapid design and optimization of therapeutic candidates, particularly in complex fields like immuno-oncology and cell therapy. Dr. Snyder shares how that in the context of CAR-T therapies, AI-driven approaches are used to design and refine each component of the CAR construct. And, Dr. Snyder...
Duration: 00:19:28Redefining Heart Failure Treatment with Precision Autologous Cell Therapy with BioCardia's Peter Altman, Ph.D.
May 08, 2025We love to hear from our listeners. Send us a message.
In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company’s evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases. Altman highlights BioCardia’s CardiAMP program, a precision medicine approach that pre-screens patients based on their cell profiles to improve trial outcomes and reduce costs. He explains why no cardiac cell therapy has yet received FDA approval, citing challenges in d...
Duration: 00:17:54CRI’s Response to NIH Cuts with Alicia Zhou, Ph.D.
Apr 24, 2025We love to hear from our listeners. Send us a message.
In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research. Dr. Zhou highlights CRI’s focus on funding early-stage science and clinical trials to move immunotherapy toward curing all cancers. She covers the serious implications of recent U.S. Government funding cuts, including NIH budget freezes and...
Duration: 00:38:12Rethinking CGT Biotech Growth & Investment with Audrey Greenberg
Apr 10, 2025We love to hear from our listeners. Send us a message.
On the 100th episode of Cell & Gene: The Podcast, Host, Erin Harris, sits down with Audrey Greenberg, Founder and CEO of AG Capital Advisors. Audrey is the award-winning executive, board director, and strategic advisor with a proven track record of launching, scaling, and successfully exiting multi-billion-dollar ventures. They explore the biggest challenges and opportunities facing CGT biotech leaders today; the funding crisis in biotech, the evolving investment landscape, and whether the traditional VC-driven model is still sustainable. They also examine what it really takes to scale...
Duration: 00:28:15Advancing Retinal Gene Therapy with Atsena Therapeutics' Dr. Kenji Fujita
Mar 27, 2025We love to hear from our listeners. Send us a message.
In this episode of Cell & Gene: The Podcast, Host Erin Harris dives into the world of retinal gene therapy with Kenji Fujita, M.D., Chief Medical Officer of Atsena Therapeutics. Atsena develops treatments for inherited retinal diseases, including X-linked retinoschisis (XLRS), a rare genetic condition that currently has no FDA-approved therapy. They talk through the impact of XLRS on patients, the challenges of gene delivery to the retina, and how Atsena’s AAV vector technology is designed to overcome these hurdles. They also discuss the significance of...
Duration: 00:14:53Harnessing the Power of Cord Blood Tregs with Cellenkos' Dr. Simrit Parmar
Mar 13, 2025We love to hear from our listeners. Send us a message.
In this episode, Host Erin Harris sits down with Dr. Simrit Parmar, Founder of Cellenkos, to explore how the company is pioneering umbilical cord blood-derived Regulatory T cell (Treg) cell therapies for autoimmune and inflammatory diseases. Dr. Parmar shares the vision behind Cellenkos, the advantages of cord blood-derived Tregs over other sources, and how their CRANE technology platform enhances precision in targeting diseases. They also discuss key findings from their Phase 1b trial for CK0804, the challenges of scaling up off-the-shelf Treg therapies, and what’s ne...
Duration: 00:34:57CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D.
Feb 27, 2025We love to hear from our listeners. Send us a message.
Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.
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Inside Gene Therapies for Cardiac Care with Tenaya Therapeutics' Faraz Ali
Feb 13, 2025We love to hear from our listeners. Send us a message.
In this episode, Erin Harris sits down with Faraz Ali, CEO of Tenaya Therapeutics, to explore the cutting-edge world of gene therapies for heart diseases. As Tenaya makes significant strides in developing innovative treatments, Ali shares insights on Tenaya's gene therapy platform, their in-house manufacturing capabilities, and the potential impact of their therapies on prevalent heart conditions. They also discuss the complexities of commercializing gene therapies, industry-wide developments, and Tenaya's roadmap for 2025. This conversation offers a unique glimpse into the future of cardiac care and the...
Duration: 00:35:38The Future of Adenovector-Based Therapies with Precigen's Helen Sabzevari, Ph.D.
Jan 30, 2025We love to hear from our listeners. Send us a message.
Helen Sabzevari, Ph.D., President and CEO of Precigen, joins Host, Erin Harris to discuss how the company utilizes gorilla adenovirus vectors. These vectors offer significant advantages in delivering large genetic payloads, a crucial factor in developing effective gene therapies. Sabzevari also discusses Precigen's recent BLA submission for PRGN-2012, which includes Phase 1/2 pivotal study results where over 50% of patients achieved Complete Response and more than 85% experienced decreased surgical interventions.
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The Future of NK Cell Therapy for Autoimmune Disease with Artiva Biotherapeutics' Christopher Horan
Jan 16, 2025We love to hear from our listeners. Send us a message.
Christopher Horan, Chief Technical Operations Officer, Artiva Biotherapeutics joins Cell & Gene: The Podcast Host, Erin Harris, to discuss the advantages natural killer (NK) cells have offer over T cells in terms of safety and efficacy for autoimmune disease. They take a deep dive into the key factors that make NK cells promising for ‘off-the-shelf’ cell therapy products. They cover Artiva's "manufacturing first" approach to enabling scalable NK cell production, and much more.
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Lessons in Automation with Roswell Park Comprehensive Cancer Center's Christopher Choi, Ph.D.
Jan 02, 2025We love to hear from our listeners. Send us a message.
Cell & Gene: The Podcast Host Erin Harris talks to Christopher Choi, Ph.D., MBA, SVP Industry Partnership, Director of GMP and Cell Manufacturing Facility, and Associate Professor of Oncology at Roswell Park Comprehensive Cancer Center about the Center's Buffalo, NY-based cell and gene therapy hub slated to open in early 2025. They cover the increasingly important role of automation and digital technologies in CGT manufacturing. Choi also offers his advice to new and emerging CGT biotechs on how to correctly tackle manufacturing as they begin their product...
Duration: 00:14:49Can Gene Therapy Be the Solution for CHF with AskBio's Dr. Lothar Roessig
Dec 19, 2024We love to hear from our listeners. Send us a message.
Cell & Gene: The Podcast Host Erin Harris talks to Lothar Roessig, M.D., SVP, Integrated Product Team Lead, Congestive Heart Failure at Asklepios BioPharmaceutical, Inc. (AskBio) about the biggest challenges in developing gene therapies for cardiovascular diseases, specifically congestive heart failure (CHF). They discuss AB-1002, the gene therapy the company is developing for the treatment of CHF and why a gene therapy approach is significantly different from traditional therapies.
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Inside a Dopamine-Restoring Cell Therapy for PD with BlueRock Therapeutics' Dr. Amit Rahkit
Dec 05, 2024We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris, invites BlueRock Therapeutics' Dr. Amit Rhakit to take a deep dive into therapy options for Parkinson's disease (PD). They discuss how BlueRock's bemdaneprocel's mechanism of action differs from traditional PD treatments. They cover the limitations of current PD medications, how cell therapies might offer a different approach to long-term symptom management, and how BlueRock is doing traditional dopamine replacement therapy differently.
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Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene
Nov 21, 2024We love to hear from our listeners. Send us a message.
Rita Johnson-Greene, COO at Alliance for Regenerative Medicine (ARM) joined Cell & Gene: The Podcast Host, Erin Harris, on site during 2024 Meeting on the Mesa to record their discussion. Johnson-Greene shared information about the Joint Clinical Assessment (JCA) in Europe and its potential impact on cell and gene therapies, how globalization impacts patient access, an update on ARM's Grow Internship Program, as well as a few key takeaways from the event that sector professionals can anticipate impacting the CGTs in the next 12 months and beyond.
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Duration: 00:21:39Improving TCR T-Cell Persistence and Efficacy with Adaptimmune's Dennis Williams
Nov 07, 2024We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Dennis Williams, Senior Vice President of Late Stage Development at Adaptimmune. Williams shares valuable insights into the groundbreaking world of TCR T-cell therapies, with a particular focus on the TECELRA trial. The trial led to the FDA approval of Tecelra, marking a significant milestone as the first engineered T-cell therapy for solid tumors. Williams delves into the complexities of developing this innovative treatment for synovial sarcoma, a rare and aggressive form of soft-tissue...
Duration: 00:20:52Live from ARM's Meeting on the Mesa with Kiji Therapeutics' Dr. Miguel Forte
Oct 24, 2024We love to hear from our listeners. Send us a message.
This episode of Cell & Gene: The Podcast was recorded on site during ARM's 2024 Meeting on the Mesa in Phoenix. Tune in to hear Host Erin Harris talk to Miguel Forte, M.D., Ph.D., CEO of Kiji Therapeutics, President of ISCT, and Executive Committee Member of ARM about Kiji's clinical plan and why iPSC-MSC therapy for inflammatory diseases shows great promise. They also cover this year's conference and what to expect during and after the event.
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Pioneering Next-Gen TCR Therapies in Solid Tumors with Neogene Therapeutics’ Carsten Linnemann, Ph.D.
Oct 10, 2024We love to hear from our listeners. Send us a message.
Carsten Linnemann, Ph.D., CEO of Neogene Therapeutics and Head of Oncology Cell Therapy Clinical Development, AstraZeneca joins Cell & Gene: The Podcast’s Erin Harris to discuss T-cell receptor (TCR) therapies for solid cancers. They talk through key challenges and opportunities in developing TCR therapies targeting neoantigens as well as the potential benefits of TCR-T therapies for cancer treatment. Linnemann shares his thoughts on the future landscape of cell therapy in oncology and beyond. Previous episodes of Cell & Gene: The Podcast have focused on TCR therapies, in...
Duration: 00:14:18Optogenetics for Vision Restoration with Ray Therapeutics' Paul Bresge
Sep 25, 2024We love to hear from our listeners. Send us a message.
Ray Therapeutics' Co-Founder and CEO, Paul Bresge, joins Host Erin Harris to talk about optogenetics and how the company’s optogenetics approach differs from other gene therapies on the market developed to restore vision in retinal diseases like retinitis pigmentosa.
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Duration: 00:22:00A New Approach to Genome Engineering with Tessera Therapeutics' Dr. Michael Severino
Sep 12, 2024We love to hear from our listeners. Send us a message.
Tessera Therapeutics' CEO, Dr. Michael Severino, joins Host Erin Harris to discuss Gene Writing, the biotech's genome engineering technology that writes therapeutic messages into the genome to treat diseases at their source. Severino discusses why delivery has always been a challenge for gene editing technologies and why Gene Writing is different when it comes to efficient delivery.
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Duration: 00:28:06Scaling Allo with Allogene Therapeutics' Dr. Zachary Roberts
Aug 29, 2024We love to hear from our listeners. Send us a message.
Allogene Therapeutics' EVP of R&D and CMO, Dr. Zachary Roberts, penned an original article for Cell & Gene titled, The Path Forward for CLL is Allogeneic. In his article, Dr. Roberts explains that chronic lymphocytic leukemia (CLL) is the most common leukemia in the U.S. And that while CLL remains a disease that is managed, it is not one that is often cured. In this episode, Host Erin Harris follows up Roberts' article with in-depth questions around existing issues with current CAR T approaches, "auto...
Duration: 00:25:13CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D.
Aug 15, 2024We love to hear from our listeners. Send us a message.
Applications (BLAs) of recent approvals and complete responses for novel products or rare diseases as well as BLAs currently under review. Benton shares information about FDA Draft Gudiances, including Platform Technology Designation Program for Drug Development: Guidance for Industry. She also provides a regulatory outlook for CGT developers.
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Duration: 00:27:58Identifying Drug Development Opportunities for DMD with CureDuchenne
Aug 01, 2024We love to hear from our listeners. Send us a message.
Debra Miller, CEO and Founder and Dr. Michael Kelly, Chief Scientific Officer at CureDuchenne talk to Host Erin Harris about the FDA approval for the expansion to the label indication for ELEVIDYS from Sarepta Therapeutics as well as how CureDuchenne works with various biotechs developing gene therapies for Duchenne muscular dystrophy (DMD). Miller and Kelly also share their advice and recommendations for companies developing drugs for DMD - while much progress has been made, more innovation is needed.
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Tackling "The Delivery Problem" of Gene Editing-Based Medicines with Mammoth Biosciences' Lucas Harrington
Jul 18, 2024We love to hear from our listeners. Send us a message.
Lucas Harrington, Co-Founder and Chief Scientific Officer of Mammoth Biosciences, joins Erin Harris to shed light on the biotech's proprietary ultracompact CRISPR systems to develop potential long-term curative therapies for patients with life-threatening and debilitating diseases. They discuss why in vivo delivery continues to be a bottleneck against the clinical advancement of gene-editing-based medicines and what ultracompact CRISPR systems are designed to do.
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Duration: 00:21:01TILs for the Treatment of Solid Tumors with KSQ Therapeutics' Micah Benson, Ph.D.
Jul 04, 2024We love to hear from our listeners. Send us a message.
KSQ Therapeutics' CSO, Micah Benson, Ph.D., joins Erin Harris to discuss how Tumor-Infiltrating Lymphocytes (TILs) as a treatment modality have the potential to treat a variety of solid tumor types. Benson explains KSQ's Phase 1/2 clinical study, KSQ-001EX, which consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing. In addition to solid tumors, Benson also addresses the therapeutic potential for autoimmune disease.
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Synthetic Biology and Programmable mRNA with Strand Therapeutics' Jake Becraft
Jun 20, 2024We love to hear from our listeners. Send us a message.
Strand Therapeutics' CEO and Co-Founder Jake Becraft joins Erin Harris to discuss genetic regulation and how the company's programmable mRNA constructs combine genes for self-replication derived from RNA viruses with genetically programmed logic circuits that control the location, timing, and intensity of expression of therapeutic proteins within the patient’s body, enabling precise and controlled delivery. They also cover the role synthetic biology plays to genetically program mRNA to deliver therapies.
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Developing an mRNA Therapy for DMD with Elixirgen Therapeutics' Aki Ko
Jun 06, 2024We love to hear from our listeners. Send us a message.
Elixirgen Therapeutics' Aki Ko joins Erin Harris to detail the company's Bobcat mRNA therapeutic and how it differs from traditional exon-skipping drugs and AAV-microdystrophin in treating DMD. Regarding delivery, Ko explains the advantage of the mRNA approach over the AAV approach.
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Duration: 00:14:52The Current State of the Global Regulatory Landscape with ISCT's Dr. Bambi Grilley
May 28, 2024We love to hear from our listeners. Send us a message.
Dr. Bambi Grilley is Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine AND she is Chief Regulatory Officer at ISCT. Dr. Grilley talks to us about her role as CRO at ISCT and the global regulatory landscape for cell and gene therapies. She takes a deep dive into the pediatric patient journey, and she shares her expectations for ISCT 2024 Vancouver.
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Dr. Bruce Levine on ISCT and the Future of CAR-T
May 23, 2024We love to hear from our listeners. Send us a message.
In anticipation of ISCT 2024 in Vancouver, Canada, Dr. Bruce Levine is back on Cell & Gene: The Podcast to share information about the event as well as his expertise on the future of CAR-T therapy for solid tumors, autoimmune disease, and more. He talks about his time and learnings as President Elect, President, and Immediate Past President of ISCT. He covers Cellicon Valley and Philadelphia's success as on-going CGT hub, and much more.
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CGTs for HIV Suppression with Addimmune's Dr. Marcus Conant
May 09, 2024We love to hear from our listeners. Send us a message.
Dr. Marcus Conant is CMO at Addimmune, a biotech startup developing a cell therapy for HIV that spun out of cell and gene therapy biotech American Gene Technologies (AGT). He spent his career on the front lines of HIV treatment and research and remains an advocate for the HIV patient. He formed the Kaposi’s Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. On this episode, Dr. Conant shares they why behind cell and gene therapy to treat HIV, and he ex...
Duration: 00:18:51Inside BlueRock Therapeutics' Parkinson's Disease Trial with Dr. Ahmed Enayetallah
Apr 25, 2024We love to hear from our listeners. Send us a message.
BlueRock Therapeutics' SVP Head of Development, Dr. Ahmed Enayetallah, joins Cell & Gene: The Podcast Host, Erin Harris, to discuss the company's phase I clinical trial for Parkinson’s disease, which continues to show positive trends at 18 months. They cover the important role induced pluripotent stem cells' (iPSCs) play in the trial, and they also discuss the company's investigational cell therapy, bemdaneprocel.
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Reducing the Disease Burden of AML with Vor Bio's Dr. Robert Ang
Apr 11, 2024We love to hear from our listeners. Send us a message.
In 2021 on Episode 13, Vor Bio’s President and CEO, Dr. Robert Ang shared data about the company’s lead engineered hematopoietic cell (eHSC) product candidate. Dr. Ang is back to talk to Cell & Gene: The Podcast Host, Erin Harris, about how Vor has treated 8 patients demonstrating clinical proof of concept and is also in the clinic with a CAR-T that could be used in combination with shielded stem cell transplants. They also talk through Vor’s decision to build an internal cell therapy manufacturing facility co-located with t...
Duration: 00:23:08Reducing Toxicities in Allogeneic Cell Therapies with Orca Bio's Dr. Scott McClellan
Mar 28, 2024We love to hear from our listeners. Send us a message.
Orca Bio's CMO, Dr. Scott McClellan, joins Erin Harris on this episode of Cell & Gene: The Podcast to discuss how and why toxicities continue to stymie allogeneic cell therapies. They cover Orca Bio's plan to potentially lowering the risk of GvHD as well as Orca-T, the investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies.
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Duration: 00:19:37Inside Cellular Rejuvenation Therapies for Age-Related Diseases with Life Biosciences' Sharon Rosenzweig-Lipson, Ph.D.
Mar 14, 2024We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Life Biosciences' CSO, Sharon Rosenzweig-Lipson, Ph.D., about the Boston-based biotech's cellular rejuvenation therapies for the treatment of age-related diseases. They cover Life Biosciences' lead program, a gene therapy called OSK that is being advanced in two optic neuropathies – a rare eye disease of aging called non-arteritic anterior ischemic optic neuropathy (NAION) and glaucoma. They also cover they why behind gene therapy as a modality, as well as Life Biosciences' partnership with Forge Bi...
Duration: 00:17:17The Future of Rare Diseases with The Jackson Laboratory’s Rare Disease Translational Center's Cat Lutz
Feb 29, 2024We love to hear from our listeners. Send us a message.
Rare Disease Day is February 29, 2024, and in honor of this important day, Cell & Gene: The Podcast Host Erin Harris sits down with Jackson Laboratory’s (JAX) Rare Disease Translational Center (RDTC)'s VP, Cat Lutz. They discuss RDTC's mission, the specific qualifications that make up a rare disease, how the study of rare diseases can potentially advance progress in common diseases, and much more.
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Duration: 00:27:31Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead company's Christopher McDonald
Feb 15, 2024We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Christopher McDonald, Global Head of Technical Operations at Kite, a Gilead company, talks to Host Erin Harris about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. They talk through the most significant steps Kite took to reach this approval, lessons learned from having worked with the FDA, scaling up technologies for cell therapy manufacturing, and more.
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Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng.
Feb 01, 2024We love to hear from our listeners. Send us a message.
The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She details how manufacturers can get ahead of addressing time to treatment issues typically experienced at launch. They cover obtaining adequate investment dollars, and much more.
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Duration: 00:37:17Breaking Down Solid Tumors with Triumvira Immunologics' Dr. Paul Lammers
Jan 18, 2024We love to hear from our listeners. Send us a message.
Paul Lammers, M.D., M.Sc., CEO of Triumvira Immunologics joins Cell & Gene: The Podcast to talk to Host Erin Harris about TAC, the company's proprietary T cell Antigen Coupler, which has both autologous and allogeneic approaches. They also discuss targeting relapsed or refractory HER2-positive solid tumors and CLDN18.2-positive solid tumors. And they cover a realistic outlook on the evolution of cancer treatment.
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4 Keys to Allo in 2024 with Poseida Therapeutics' Kristin Yarema, Ph.D.
Jan 04, 2024We love to hear from our listeners. Send us a message.
Kristin Yarema, Ph.D., CEO, Poseida Therapeutics sits down with Cell & Gene: The Podcast Host Erin Harris to discuss four of the biggest challenges the CGT sector faces when it comes to the development of off-the-shelf therapies. Kristin shares how 2024 might see some real progress in allogeneic therapies.
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Duration: 00:31:59Cell Therapy For Corneal Endothelial Dystrophies With Aurion Biotech's Greg Kunst
Dec 21, 2023We love to hear from our listeners. Send us a message.
For this third and final episode recorded at ARM's 2023 Meeting on the Mesa, Cell & Gene: The Podcast Host, Erin Harris, sat down with Greg Kunst, president, CEO, and Board member at Aurion Biotech. Listen in as they discuss the cell therapy used to treat corneal endothelial disease and how Greg navigated the event as a first-timer attending Meeting on the Mesa.
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Duration: 00:13:41Overcoming the Limitations of CAR T-Cell Therapy with Vittoria Bio's Nick Siciliano, Ph.D.
Dec 07, 2023We love to hear from our listeners. Send us a message.
Vittoria Biotherapeutics’ CEO, Nick Siciliano, joins Erin Harris on this episode of Cell & Gene: The Podcast to discuss the company's mission to expand the applications for CAR-based therapeutics by employing novel cell engineering and gene editing technologies.
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Duration: 00:17:23Gene Therapy Deals, Collaborations, & Partnerships with Astellas' Richard Wilson
Nov 21, 2023We love to hear from our listeners. Send us a message.
Richard Wilson, Senior Vice President, Primary Focus Lead, Genetic Regulation at Astellas sat down with Cell & Gene: The Podcast's Erin Harris at ARM's 2023 Meeting on the Mesa to discuss the gene therapy deal making landscape as well as Astellas' recent deals and collaborations. They also discussed Astellas' strategic approach since having acquired Audentes back in 2020.
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Duration: 00:25:02The Promise of AAV Gene Therapy with REGENXBIO's Ken Mills
Nov 09, 2023We love to hear from our listeners. Send us a message.
Ken Mills, CEO, President, and Director at REGENXBIO joins Erin Harris for this episode of Cell & Gene: The Podcast to discuss the company's progress with its Phase I/II Affinity Duchenne trial of RGX-202 for the treatment of Duchenne Muscular Dystrophy. They discuss the future of AAV gene therapy as well as achieving scalability with consistent yield and product purity in gene therapy manufacturing.
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Duration: 00:28:34Inside 2023 Meeting on the Mesa with ARM's COO, Rita Johnson-Greene
Oct 26, 2023We love to hear from our listeners. Send us a message.
Alliance for Regenerative Medicine's COO, Rita Johnson-Greene, joined Cell & Gene: The Podcast host, Erin Harris, in person at the 2023 Meeting on the Mesa to discuss this year's event. Johnson-Greene also shared what's ahead for 2024 as the event heads to a new location. They discussed major topics and trends at the event as well as ARM's GROW internship program.
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<... Duration: 00:16:33The Future of Cell and Organ Transplantation in Treating T1D with Dr. Camillo Ricordi
Oct 12, 2023We love to hear from our listeners. Send us a message.
A pioneer and an icon in diabetes research, Camillo Ricordi, M.D., is the Professor of Surgery, Director of Cell Transplant Center and Director Emeritus of the Diabetes Research Institute at the University of Miami Miller School of Medicine, Florida (UM-DRI). He joins Cell & Gene: The Podcast's Erin Harris to discuss the biggest and most troubling challenges facing the treatment of Type 1 Diabetes (T1D). They also discuss the future of cell and organ transplantation in treating T1D as well as the latest innovations in...
Duration: 00:18:15In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg
Sep 28, 2023We love to hear from our listeners. Send us a message.
Umoja Biopharma's CEO, Andy Scharenberg, M.D., joins Cell & Gene: The Podcast's Erin Harris to discuss the evolution of allogeneic, in vivo CAR-T cell therapeutics. They discuss The Climb, or The Colorado Laboratory and Innovation Manufacturing Building, which is Umoja’s lentiviral vector development and manufacturing facility. They also cover recent progress in lentiviral vector manufacturing.
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Duration: 00:30:37Inside Genome Editing with CBER's Dr. Peter Marks
Sep 14, 2023We love to hear from our listeners. Send us a message.
The FDA's Center for Biologics Evaluation and Research (CBER)'s Dr. Peter Marks makes his second appearance on Cell & Gene: The Podcast. This time Dr. Marks talks to Host, Erin Harris, about base editing and prime editing and their potential to meet unmet medical need. They discuss what clinical holds say about the FDA’s views on gene editing. They also discuss heritable genome editing.
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Duration: 00:25:17The Future of CAR-T with Bristol Myers Squibb's Lynelle Hoch
Aug 31, 2023We love to hear from our listeners. Send us a message.
As SVP Cell Therapy Franchise Lead at Bristol Myers Squibb, Lynelle Hoch leads her team to bring more curative cell-based therapies to patients. She joins Cell & Gene: The Podcast's Host, Erin Harris, to discuss the near-term future of CAR-T. They also take a deep dive into the various innovations and patient access progress being made in both solid tumors and hematologic malignancies in the CGT sector at large as well as at Bristol Myers Squibb.
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The Promise of Genome Editing with Caribou Biosciences' Rachel Haurwitz, Ph.D.
Aug 17, 2023We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Rachel Haurwitz, Ph.D., CEO at Caribou Biosciences joins Host Erin Harris to discuss the evolution of genome editing, its present state, as well as its undeniable potential. They also discuss Caribou's chRDNA genome editing technology and how it differs from CRISPR-Cas9.
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Duration: 00:23:21Focus Areas For Cell Therapy With Bristol Myers Squibb's Stephan Krause, Ph.D.
Aug 03, 2023We love to hear from our listeners. Send us a message.
In June 2023, PDA held its Advanced Therapy Medicinal Products Conference in Baltimore, MD. At the conference, Stephan Krause, Ph.D., Executive Director, AS&T, CT Global Quality at Bristol Myers Squibb, sat down with Cell & Gene: The Podcast Host Erin Harris to discuss the event's major themes and topics as well his focus areas for cell therapy in 2023 and beyond.
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Duration: 00:19:29The Intersection Of RNA, AI, And Synthetic Biology With Shape Therapeutics' Dr. Francois Vigneault
Jul 20, 2023We love to hear from our listeners. Send us a message.
Dr. Francois Vigneault, Co-Founder, President, and CEO at Shape Therapeutics joins Cell & Gene: The Podcast's Erin Harris to discuss how RNA technologies are shaping the future of gene therapy. They also discuss AI's role in gene therapy as well as the how the CGT sector is benefiting from RNA, AI, and synthetic biology.
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Duration: 00:29:17Inside Prime Editing with Prime Medicine's Dr. Andrew Anzalone
Jul 06, 2023We love to hear from our listeners. Send us a message.
Dr. Andrew Anzalone, Head of the Prime Editing Platform and Scientific Co-Founder of Prime Medicine joins Cell & Gene: The Podcast to talk with Host Erin Harris about prime editing - what it is and why it is a major technological advancement in gene editing. Anzalone explains why prime editing has a broad applicability for different tissue and cell types to be used in different therapeutic applications.
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Navigating CMC Challenges with Parenteral Drug Association's Glenn Wright
Jun 22, 2023We love to hear from our listeners. Send us a message.
Glenn Wright, President and CEO of Parenteral Drug Association (PDA), sat down with Cell & Gene: The Podcast's Erin Harris at the 2023 PDA ATMP conference to discuss not only the conference's theme, “Navigating Through CMC Challenges,” but also Wright's take on CGT manufacturing strategy based on his years in industry. Wright shares his insight on the past, present, and future of the cell and gene therapy space.
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An Interview with Dr. Usman "Oz" Azam
Jun 08, 2023We love to hear from our listeners. Send us a message.
Dr. Usman "Oz" Azam is CEO of Inspirna now but has spent much of his career in the cell and gene therapy space dedicating years as Novartis’ Global Head of Cell & Gene Therapy, President and CEO of Tmunity Therapeutics, and more. Given Oz’s tenure in cell and gene therapy space, I invited him to Cell & Gene: The Podcast to get his valuable take on the state of the space. During our discussion, we cover best practices in engaging with the FDA, the potential in solid tumo...
Duration: 00:27:37Targeting Oncogenic Drivers for Solid Tumor Cancers with Affini-T Therapeutics' Dr. Jak Knowles
May 25, 2023We love to hear from our listeners. Send us a message.
Affini-T Therapeutics combines a validated TCR discovery platform with synthetic biology switches to attack tumor biology at its root cause. Co-Founder, CEO, and President Dr. Jak Knowles joins Cell & Gene: The Podcast Host Erin Harris to discuss how the company engineers immune cells to target oncogenic driver mutations, such as KRAS, the most prevalent oncogenic driver mutation in solid tumors, to minimize potential tumor escape mechanisms.
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TJU's Jefferson Institute for Bioprocessing's Impact on CGT with Parviz Shamlou
May 11, 2023We love to hear from our listeners. Send us a message.
Parviz Shamlou, Vice President and Executive Director at Thomas Jefferson University joins Cell & Gene: The Podcast to talk to Host Erin Harris about Jefferson Institute for Bioprocessing (JIB), the full-service development and training organization specializing in biopharmaceuticals and biologics. Shamlou explains how JIB will move forward cell and gene therapies as well as JIB’s partnership with NIBRT (National Institute for Bioprocessing Research & Training), and much more.
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Computational Biology's Role In Gene Therapy With Kriya Therapeutics' Dr. Shankar Ramaswamy
Apr 27, 2023We love to hear from our listeners. Send us a message.
Shankar Ramaswamy, M.D., CEO & Co-Founder, Kriya Therapeutics joins Cell & Gene: The Podcast's Erin Harris for a discussion on the evolving role computational biology plays in gene therapy development. They also discuss the company's lessons learned from building its own North Carolina-based in-house manufacturing facility as well as Ramaswamy's insight on the future of gene therapy.
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Duration: 00:31:57The Near-Term Future of Exosome Science with Capricor Therapeutics' Dr. Linda Marbán
Apr 13, 2023We love to hear from our listeners. Send us a message.
Dr. Linda Marbán, Ph.D., CEO of Capricor Therapeutics, a clinical-stage biotech focused on the development of cell and exosome-based therapeutics for the treatment and prevention of serious diseases, joins Cell & Gene: The Podcast's Erin Harris to discuss the current state and the near-term future of exosomes. Marbán discusses Capricor’s exosome program and the company’s proprietary allogeneic cardiosphere-derived cells (CDCs) and engineered exosomes. She also covers the company's HOPE clinical trial series' progress to treat Duchenne muscular dystrophy (DMD).
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Duration: 00:28:17Inside the World's First-Ever Allogeneic Approval with Atara Biotherapeutics' Pascal Touchon
Mar 30, 2023We love to hear from our listeners. Send us a message.
In December 2022, Atara Biotherapeutics’ Ebvallo received European Commission approval as the first-ever therapy for adults and children with EBV+ PTLD. The ground-breaking approval represents the first approval of an allogeneic T-cell immunotherapy ever, globally. Atara Bio's CEO, Pascal Touchon, talks to Cell & Gene: The Podcast's Erin Harris about the biopharma's path to regulatory approval, commercialization plans for Ebvallo, an in-depth look at EBV+ PTLD, the connection between EBV and serious diseases like multiple sclerosis (MS), and much more.
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The Potential of RNA Exon Editing with Ascidian Therapeutics' Romesh Subramanian, Ph.D.
Mar 16, 2023We love to hear from our listeners. Send us a message.
Cell & Gene: The Podcast Host, Erin Harris, welcomes Romesh Subramanian, Ph.D., CEO of Ascidian Therapeutics, a Boston-based biotech focused on rewriting RNA to the pod. During the episode, Subramanian defines RNA exon editing, and they discuss the differences between RNA exon editing and gene editing. With current programs in ophthalmology, neurological and neuromuscular disorders, as well as rare diseases, Subramanian explains the overwhelming potential of RNA exon editing.
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Automating Processes to Scale CGT Manufacturing with PA Consulting's Paolo Siciliano
Mar 02, 2023We love to hear from our listeners. Send us a message.
When it comes to manufacturing, many cell and gene therapy companies struggle to automate the diverse processes needed to scale manufacturing. London-based PA Consulting's Associate Partner, Paolo Siciliano, talks to Cell & Gene: The Podcast's Erin Harris about how lean, small biotechs with limited resources and limited funds can strive for automation success. They also discuss what cell and gene therapy companies should do today to address tomorrow’s scalability challenges and what the long-term effects on the business may be from such upfront work.
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Duration: 00:31:52The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier
Feb 16, 2023We love to hear from our listeners. Send us a message.
On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Andy Ramelmeir, EVP Head of Technical Operations at Sangamo Therapeutics, a biotech based in Brisbane, California that applies cell and gene therapy to combat Hemophilia A and other genetic diseases. Ramelmeir explains the why behind the company's decision to build its own Phase 1/2 cGMP AAV in-house facility. He also talks broadly about manufacturing cell and gene therapies and the potential and realistic solutions to needed to drive down manufacturing costs.
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Duration: 00:21:422023 Market Outlook with AdBio and ISCT's Miguel Forte
Feb 02, 2023We love to hear from our listeners. Send us a message.
Miguel Forte is Entrepreneur in Residence at AdBio, a VC firm based in France, and President Elect of ISCT. Forte and Cell & Gene: The Podcast host, Erin Harris, break down market outlook perspective for the cell and gene therapy space. He provides valuable tips to employ when seeking VC partnership, and he covers ISCT's primary focus areas and what to expect from ISCT 2023 Paris.
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Duration: 00:26:34CMC and Scale Up with Mustang Bio's Robert Sexton
Jan 19, 2023We love to hear from our listeners. Send us a message.
MustangBio's Robert Sexton, VP Program and Alliance Leadership, explains the why behind the need for this role in any CGT company. Having worked for Novartis, Sanofi, Legend Biotech, and more, with responsibilities having included quality, operations, and order management, Sexton is currently responsible for aspects of CMC. As such, he addresses the industry's top CMC challenges as well as sound advice for future scale up.
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An Interview with Dr. Peter Marks
Jan 05, 2023We love to hear from our listeners. Send us a message.
Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) sits down with Cell & Gene: The Podcast host Erin Harris to discuss the most anticipated areas of innovation in clinical development, and he offers recommendations to companies in their engagement with the FDA in order to make manufacturing more streamlined and cost effective. Dr. Marks also provides advice to listeners about how and when to engage with CBER, and much more.
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Duration: 00:28:34Inside NK and Macrophage Cellular Immunotherapies with Shoreline Biosciences CSO Dr. Robert Hollingsworth
Dec 22, 2022We love to hear from our listeners. Send us a message.
Shoreline Biosciences' Chief Scientific Officer Dr. Robert Hollingsworth shares his insight on intelligently designed allogeneic off-the-shelf, standardized, and targeted iPSC-derived natural killers (NK) and macrophage cellular immunotherapies. He explains the company's preclinical testing on a potential NK cell therapy for acute myeloid leukemia. We discuss how the field recognizes the importance of off-the-shelf NK cell therapy not only for cost reduction but also for improving safety measures. As such, Dr. Hollingsworth talks through why NK cells necessary to move immunotherapies forward.
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Duration: 00:26:58The Future of iPSCs with BlueRock Therapeutics' CEO Seth Ettenberg
Dec 08, 2022We love to hear from our listeners. Send us a message.
BlueRock Therapeutics' President and CEO Seth Ettenberg, Ph.D. talks to Cell & Gene: The Podcast listeners about the company's Phase 1 Clinical Trial for Advanced Parkinson’s Disease. Ettenberg also covers the most promising therapeutic applications for iPSCs currently in development as well as the major regulatory challenges that the field faces for their clinical use. We also cover how far iPSCs have come and what future progress may entail.
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Manufacturing at the Point of Care with Orgenesis' CEO Vered Caplan
Nov 24, 2022We love to hear from our listeners. Send us a message.
Orgenesis' CEO, Vered Caplan explains the business model behind providing cell and gene therapies that may be manufactured at the point of care. She details how working with hospitals and healthcare providers to enable them to participate in CGT development on their sites and providing these therapies in-house by adapting them to closed system manufacturing rather than relying on the typical biotech model is an important step forward in CGT manufacturing.
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Capstan Therapeutics' CEO Laura Shawver on In Vivo Cell Engineering
Nov 10, 2022We love to hear from our listeners. Send us a message.
Capstan Therapeutics' CEO, Laura Shawver, Ph.D., talks us through the company's in vivo CAR therapies and what led to the in vivo cell engineering breakthrough that has been decades in the making. Shawver explains the promise of harnessing mRNA and targeted LNP delivery to train a patient’s body to make CAR-T cells in vivo. She also details best practices to garner funding and investment partnership.
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PepGen's SVP Head Of Clinical Development On Delivery Of Oligonucleotide Therapies
Oct 27, 2022We love to hear from our listeners. Send us a message.
PepGen, a Cambridge, MA-based biotech, is advancing oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases has focused on delivery. SVP Head of Clinical Development Dr. Michelle Mellion explains PepGen's trial of PGN-EDO51, the company’s lead product candidate for the treatment of DMD patients whose mutations are amenable to an exon 51 skipping approach. She also explains how the delivery of oligonucleotide therapies differ from other techniques in genetic medicine, and much more.
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BridgeBio's Chief Regulatory Affairs Officer Adora Ndu on PDUFA VII Reauthorization
Oct 13, 2022We love to hear from our listeners. Send us a message.
On the heels of Congress' reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act, BridgeBio's Chief Regulatory Affairs Officer, Adora Ndu, explains the Commitment Letter, the programs that may be rolled out under PDUFA VII, why right-sizing CBER will help the cell and gene sector going forward as well as how sponsor companies can prepare for 2023 from a regulatory perspective.
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Duration: 00:28:12Inside RNAi with Arrowhead Pharmaceuticals' Javier San Martin
Sep 29, 2022We love to hear from our listeners. Send us a message.
Arrowhead Pharmaceuticals is a biopharmaceutical company based in Pasadena, CA that develops medicines that treat intractable diseases by silencing the genes that cause them. Javier San Martin, Arrowhead's CMO, talks to Cell & Gene: The Podcast listeners about the similarities and differences between RNAi and CRISPR. He also explains the roadmap for RNAi as well as the company's pipeline development strategy, which includes pre-clinical to Phase 3 trials.
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Planning For Manufacturing Capacity With Kite Pharma's Will Junker
Sep 15, 2022We love to hear from our listeners. Send us a message.
Will Junker, Head of Manufacturing Quality at Kite Pharma, talks to Cell & Gene: The Podcast listeners about the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time-to-market. We also discuss why developing a better understanding of the vector manufacturing process is critical to bringing continuous and secure supply to market.
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Duration: 00:22:49Commercialization Learnings with Novartis Gene Therapies' President Chris Fox
Sep 01, 2022We love to hear from our listeners. Send us a message.
With 20+ gene therapy targets in Novartis Gene Therapies’ pipeline, President Chris Fox and her team are hyper-focused on newborn screenings as the pathway to helping more and more patients. The company's initial gene therapy, Zolgensma, for spinal muscular atrophy (SMA) has been approved in more than 40 regions and countries and has been used to treat more than 2,300 patients worldwide. Fox details what’s next on the commercialization front for the therapy, and she shares advice with Cell & Gene: The Podcast listeners about what it takes to comm...
Duration: 00:19:55A Stem Cell-Derived Treatment for T1D
Aug 18, 2022We love to hear from our listeners. Send us a message.
Sernova Corp. is a clinical-stage regenerative therapies company currently focused on insulin-dependent diabetes. CEO and President, Philip Toleikis, Ph.D., details the company's on-going clinical trial to treat Type 1 diabetes (T1D) as well as the very real potential to progress from simply masking symptoms to having a functional cure for T1D. Toleikis also provides his take on the near-term future of regenerative medicine.
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Best Practices for Partnering with a CDMO
Aug 04, 2022We love to hear from our listeners. Send us a message.
Emily Moran, VP of Vector Manufacturing and Avi Nandi, VP of Process Development at the Center for Breakthrough Medicines share key considerations for biotechs looking to partner with a CDMO. During this epsiode, biotechs will learn how to reduce risk, lower costs, and how to better manage expectations when it comes the biotech / CDMO relationship.
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Duration: 00:28:24An Interview with Dr. Carl June
Jul 21, 2022We love to hear from our listeners. Send us a message.
Dr. Carl June, an HIV gene therapy pioneer and the father of CAR-T cell therapy, joins Cell & Gene: The Podcast to discuss the current state of CAR-T therapy, what's on the short-term horizon for immunotherapy, on-going manufacturing capacity issues, an update on Emily Whitehead, the first child to receive CAR-T cell therapy on an experimental basis, and more.
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<... Duration: 00:27:43Inside Gamma Delta T Cells with TC BioPharm’s CEO, Bryan Kobel
Jul 07, 2022We love to hear from our listeners. Send us a message.
TC BioPharm's CEO Bryan Kobel explains gamma delta t cells (GDT) in depth as well as the advantages of using GDT cells as a cell therapy vehicle. He discusses why the publicly-traded, clinical-stage cell therapy company conducts and manages all clinical trials in house as well as the unique challenges and benefits that come along with doing so.
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Moving On from AAV with Poseida Therapeutics' CEO, Mark Gergen
Jun 23, 2022We love to hear from our listeners. Send us a message.
Poseida Therapeutics is a broad platform technology company led by CEO, Mark Gergen. During this episode, Gergen explains how and why the company is moving away from AAV delivery in favor of nanoparticle delivery. He shares some of the biggest hurdles the CGT sector faces when it comes to the development of off-the-shelf therapies as well as the manufacturing challenges Poseida has had to overcome and how they did it.
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Inside the New Hybrid Roles for Cell Therapy Clinical Trials with Immatics' Michael Mehler
Jun 09, 2022We love to hear from our listeners. Send us a message.
Autologous cell therapy clinical trials and products are very complex, and the stakeholder investment is diverse. Immatics' Director, Clinical Operations, Michael Mehler, explains why new hybrid roles operate in clinical operations, clinical supply chain, strategic operations, and medical affairs to help bridge the gap between the sponsor company and the clinical site for clinical trials in an autologous setting. Mehler talks through the main aspects of a site operations lead and why the role is imperative to commercial success as well as how he sees the...
Duration: 00:23:48