Cell & Gene: The Podcast

Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene Nov 21, 2024

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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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Improving TCR T-Cell Persistence and Efficacy with Adaptimmune's Dennis Williams Nov 07, 2024

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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 cancer. He also highlights the unique challenges and promising outcomes associated with TCR T-cell therapies, offering a comprehensive understanding of this cutting-edge approach in cancer immunotherapy.

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Live from ARM's Meeting on the Mesa with Kiji Therapeutics' Dr. Miguel Forte Oct 24, 2024

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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, 2024

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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, including Episode 50, featuring Affini-T Therapeutics’ Co-Founder, CEO, and President Dr. Jak Knowles. Be sure to check out that episode, too.
https://www.cellandgene.com/doc/targeting-oncogenic-drivers-for-solid-tumor-cancers-with-affini-t-therapeutics-dr-jak-knowles-0001

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Optogenetics for Vision Restoration with Ray Therapeutics' Paul Bresge Sep 25, 2024

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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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A New Approach to Genome Engineering with Tessera Therapeutics' Dr. Michael Severino Sep 12, 2024

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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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Scaling Allo with Allogene Therapeutics' Dr. Zachary Roberts Aug 29, 2024

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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 versus allo," and why allogeneic is the path forward. They also discuss how and why allogeneic therapies are truly scalable.

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CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D. Aug 15, 2024

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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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Identifying Drug Development Opportunities for DMD with CureDuchenne Aug 01, 2024

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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, 2024

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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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TILs for the Treatment of Solid Tumors with KSQ Therapeutics' Micah Benson, Ph.D. Jul 04, 2024

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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, 2024

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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, 2024

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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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The Current State of the Global Regulatory Landscape with ISCT's Dr. Bambi Grilley May 28, 2024

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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, 2024

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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, 2024

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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 explains Addimmune’s lead asset, AGT103-T, which is designed to provide broad protection using silencing RNA to inhibit binding/entry of the virus, halt replication, and prevent escape.

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Inside BlueRock Therapeutics' Parkinson's Disease Trial with Dr. Ahmed Enayetallah Apr 25, 2024

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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, 2024

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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 their Cambridge, MA-based headquarters.

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Reducing Toxicities in Allogeneic Cell Therapies with Orca Bio's Dr. Scott McClellan Mar 28, 2024

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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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Inside Cellular Rejuvenation Therapies for Age-Related Diseases with Life Biosciences' Sharon Rosenzweig-Lipson, Ph.D. Mar 14, 2024

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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 Biologics to manufacture AAV for the cellular rejuvenation technology.

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The Future of Rare Diseases with The Jackson Laboratory’s Rare Disease Translational Center's Cat Lutz Feb 29, 2024

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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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Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead company's Christopher McDonald Feb 15, 2024

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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, 2024

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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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Breaking Down Solid Tumors with Triumvira Immunologics' Dr. Paul Lammers Jan 18, 2024

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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, 2024

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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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Cell Therapy For Corneal Endothelial Dystrophies With Aurion Biotech's Greg Kunst Dec 21, 2023

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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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Overcoming the Limitations of CAR T-Cell Therapy with Vittoria Bio's Nick Siciliano, Ph.D. Dec 07, 2023

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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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Gene Therapy Deals, Collaborations, & Partnerships with Astellas' Richard Wilson Nov 21, 2023

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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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The Promise of AAV Gene Therapy with REGENXBIO's Ken Mills Nov 09, 2023

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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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Inside 2023 Meeting on the Mesa with ARM's COO, Rita Johnson-Greene Oct 26, 2023

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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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The Future of Cell and Organ Transplantation in Treating T1D with Dr. Camillo Ricordi Oct 12, 2023

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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 biopreservation.

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In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg Sep 28, 2023

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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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Inside Genome Editing with CBER's Dr. Peter Marks Sep 14, 2023

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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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The Future of CAR-T with Bristol Myers Squibb's Lynelle Hoch Aug 31, 2023

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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, 2023

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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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Focus Areas For Cell Therapy With Bristol Myers Squibb's Stephan Krause, Ph.D. Aug 03, 2023

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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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The Intersection Of RNA, AI, And Synthetic Biology With Shape Therapeutics' Dr. Francois Vigneault Jul 20, 2023

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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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Inside Prime Editing with Prime Medicine's Dr. Andrew Anzalone Jul 06, 2023

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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, 2023

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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, 2023

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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 tumor cancer treatment, the biggest yet solvable hurdles facing the sector today, and much more.

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Targeting Oncogenic Drivers for Solid Tumor Cancers with Affini-T Therapeutics' Dr. Jak Knowles May 25, 2023

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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, 2023

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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, 2023

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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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The Near-Term Future of Exosome Science with Capricor Therapeutics' Dr. Linda Marbán Apr 13, 2023

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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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Inside the World's First-Ever Allogeneic Approval with Atara Biotherapeutics' Pascal Touchon Mar 30, 2023

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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, 2023

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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, 2023

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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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The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier Feb 16, 2023

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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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2023 Market Outlook with AdBio and ISCT's Miguel Forte Feb 02, 2023

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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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CMC and Scale Up with Mustang Bio's Robert Sexton Jan 19, 2023

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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, 2023

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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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Inside NK and Macrophage Cellular Immunotherapies with Shoreline Biosciences CSO Dr. Robert Hollingsworth Dec 22, 2022

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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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The Future of iPSCs with BlueRock Therapeutics' CEO Seth Ettenberg Dec 08, 2022

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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, 2022

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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, 2022

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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, 2022

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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, 2022

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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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Inside RNAi with Arrowhead Pharmaceuticals' Javier San Martin Sep 29, 2022

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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, 2022

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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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Commercialization Learnings with Novartis Gene Therapies' President Chris Fox Sep 01, 2022

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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 commercialize a therapy.

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A Stem Cell-Derived Treatment for T1D Aug 18, 2022

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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, 2022

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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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An Interview with Dr. Carl June Jul 21, 2022

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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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Inside Gamma Delta T Cells with TC BioPharm’s CEO, Bryan Kobel Jul 07, 2022

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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, 2022

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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, 2022

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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 role evolving in the near term. He also explains what size CGT companies will benefit most from these new hybrid roles.
Cell & Gene: The Podcast is produced by Cell & Gene in partnership with Applied Biosystems by Thermo Fisher Scientific.

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Moving to an Allogeneic RNA Cell Therapy Program with Cartesian Therapeutics' Dr. Metin Kurtoglu May 26, 2022

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Dr. Metin Kurtoglu, COO at Cartesian Therapeutics, explains the clinical-stage biotech's autologous RNA cell therapies, Descartes-08 for Myasthenia Gravis and Descartes-11 for multiple myeloma. He also explains Descartes-25, their allogeneic RNA cell therapy and the reasons for the move to "off-the-shelf," and why the future of RNA cell therapy is not confined to rare and fatal diseases. We also discuss post-care for patients having received infusions.

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Gene Therapy's Commercial Manufacturing Issues with Encoded Therapeutics' Andy Stober May 12, 2022

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Encoded Therapeutics' Chief Manufacturing Officer Andy Stober explains the unique commercial manufacturing issues in gene therapy and how to address them. Stober also shares some of the lessons he's learned, which may educate the next generation of gene therapy scientists to accelerate future manufacturing success. We also talk about what developers need to consider regarding the ethical responsibilities in gene therapy.

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Inside CAR-T Therapy For Ovarian Cancer with Anixa Biosciences' Amit Kumar, Ph.D. Apr 28, 2022

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Amit Kumar, Ph.D., President and CEO at Anixa Biosciences details the company’s progress on its Phase 1 trial for ovarian cancer. We also discuss why the company’s ovarian cancer program is integral for initial proof of concept for other solid tumor indications. He covers why CAR-T therapy uses an existing hormone/hormone receptor relationship to create a targeted approach to treat ovarian cancer. Dr. Kumar shares how the field of cell therapy may evolve in the short term, and much more.

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Pivoting to Allogeneic CAR-T Therapies with Celyad Oncology’s CMO, Dr. Charlie Morris Apr 14, 2022

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Celyad Oncology’s CMO, Dr. Charlie Morris, shares the benefits and challenges of the allogeneic approach versus the autologous approach and why a non-gene edited shRNA approach may result in better efficacy and safety for CAR-T therapies.

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Rocket Pharmaceuticals' CEO Dr. Gaurav Shah on FDA's Clinical Holds on Gene Therapy Trials Mar 31, 2022

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Rocket Pharmaceuticals CEO Dr. Gaurav Shah offers his take on why gene therapy developers have been plagued by clinical holds, whether the FDA’s AAV-focused CTGTAC meeting's takeaways will hold up throughout 2022, and more.

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Inside Solid Tumor Therapies with BlueSphere Bio’s CEO Dr. David Apelian Mar 17, 2022

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BlueSphere Bio's CEO Dr. David Apelian explains the difficulties associated with treating solid tumor cancers as well as what the CGT sector needs to get right in the short term and why.

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Restoration of Immune Balance with Anish Suri, Ph.D., President and CSO at Cue Biopharma Mar 03, 2022

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Cue Biopharma's Anish Suri, Ph.D., explains why the clinical-stage biopharma is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body to transform the treatment of cancer.

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REGENXBIO's Nina Hunter, Ph.D. Details the Accelerated Approval Pathway for Gene Therapies Feb 17, 2022

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REGENXBIO's VP of Regulatory and Science Policy, Nina Hunter, Ph.D., shares potential solutions to gene therapies' regulatory roadblocks and why the accelerated approval pathway is so pertinent.

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Selecta Biosciences' Dr. Carsten Brunn on Gene Therapy with AAV Vectors Feb 03, 2022

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Selecta Biosciences' President and CEO Dr. Carsten Brunn details the company's ImmTOR platform, which can mitigate unwanted immune responses that cause immune-related toxicities that impose significant treatment challenges with current therapies.

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Cellevolve Bio's Dr. Derrell Porter on the Need for Diversity and Inclusion in Biotech Jan 20, 2022

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Cellevolve Bio's founder and CEO. Dr. Derrell Porter shares his experience with starting up a cell therapy company and why we, as an industry, need to advocate for more Black leaders and leaders of color in the biotech industry.

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RNA's Advantages Over Other Cell Therapies with Cartesian's CSO Jan 06, 2022

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Dr. Michael Singer, CSO at Cartesian Therapeutics, details why RNA has advantages over other cell therapies, the company's three RNA trials, and the therapeutic benefit of multiple modifications.

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Vor Biopharma's CEO on Genome Engineering of Hematopoietic Stem Cells Dec 22, 2021

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Vor Biopharma's CEO Dr. Robert Ang explains the company's lead engineered hematopoietic cell (eHSC) product candidate, genome engineering of HSCs, and the cell manufacturing process needed to leverage genome engineering technologies for the cells they're creating.

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AVROBIO on Patient Advocacy's Role in Clinical Trial Development & Recruitment Dec 09, 2021

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Fernanda Copeland, Global Head, Patient Advocacy & Engagement at AVROBIO, explains how to incorporate community education, patient feedback, and more to improve clinical trial development and recruitment.

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Understanding CAR-M Technology with Carisma Therapeutics' Dr. Debora Barton Nov 24, 2021

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Carisma Therapeutics’ Dr. Barton breaks down the latest in CAR-M technology as well as the company's Phase 1 First-in-Human Study of Adenovirally Transduced Anti-HER2 CAR Macrophages in Subjects with HER2 Overexpressing Solid Tumors.

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Inside the Gene Therapy for Coronary Artery Disease with XyloCor Therapeutics' Albert Gianchetti Nov 11, 2021

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XyloCor Therapeutics' EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial for coronary artery disease — the most common type of heart disease — with gene therapy at its center.

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Advancing Patient Engagement with Novartis Gene Therapies' Dr. Amy Nicole Nayar Oct 28, 2021

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Dr. Amy Nicole Nayar, VP of US Patient Advocacy and Government Affairs at Novartis Gene Therapies explains what patient engagement should encompass in the cell and gene field as well as the unique challenges cell and gene therapy companies face where a patient engagement officer provides essential help.

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BridgeBio's Approach to Gene Therapy & Nearing the Clinic Oct 14, 2021

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BridgeBio's CEO of Gene Therapy, Dr. Eric David, explains the company's gene therapy programs for Canavan disease and congenital adrenal hyperplasia, their manufacturing plans, and the platform underpinning their novel approach to gene therapy.

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Inside Spark Therapeutics' Investigational SPK-8011 for Hemophilia A Sep 30, 2021

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Spark Therapeutics' Clinical Development Lead, Hematology, Dr. Tiffany Chang explains the company's data from its ongoing Phase 1/2 clinical trial of investigational SPK-8011 for hemophilia A, the largest gene therapy trial in this disease to date as well as the misconceptions and unknowns about the disease.

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Gene Therapies for Spinal Cord-Related Disorders with SwanBio's CEO Sep 16, 2021

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Karen Kozarsky, Ph.D., Co-Founder and CSO of SwanBio, explains how the company is pioneering a deep and varied pipeline of gene therapies for genetically defined neurological diseases with a focus on the spinal cord.

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Chronic Lymphocytic Leukemia: A Patient's Perspective Sep 02, 2021

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Bob Levis was diagnosed with Chronic Lymphocytic Leukemia in 2002 and was one of the early experimental trial participants at Penn Medicine for Dr. Carl June’s CAR-T therapy. Bob shares his remarkable journey with CLL as well as his important work with the CLL Society.

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State-of-the-Art GMP Manufacturing RNA Cell Therapies with Cartesian's CEO Aug 19, 2021

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Dr. Murat Kalayoglu, CEO at Cartesian Therapeutics, details the cell and gene therapy sector’s advancements in RNA cell therapy and the why behind the company's decision to build its own wholly-owned GMP manufacturing facility.

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Therapeutic Firsts and "Eds and Meds" with Penn’s Dr. Bruce Levine Aug 05, 2021

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University of Pennsylvania’s Dr. Bruce Levine explains his road to adoptive immunotherapy trials, overcoming the gap between academia and industry, and how Philadelphia earned the "Cellicon Valley" name for its continued innovation in cell and gene therapy — and more.

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Hospitals And Advanced Therapies with Penn Medicine’s Kevin Mahoney Jul 22, 2021

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In this episode of Cell & Gene: The Podcast, University of Pennsylvania Health System’s CEO Kevin Mahoney talks to Host Erin Harris about how hospital systems must evolve to meet the needs of cell and gene therapy patients as these complex therapies are commercialized. They discuss what comprises UPHS and the ongoing innovation it brings to advanced therapies as well as how the Health System stays patient-focused at all costs.

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Enzyvant's Rachelle Jacques on the Biotech’s Lead Asset Jul 08, 2021

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During this first episode of Cell & Gene: The Podcast, Host Erin Harris talks to Enzyvant’s CEO Rachelle Jacques about the biotech’s lead asset, investigational regenerative therapy RVT-802 for congenital athymia. Jacques provides an update on FDA approval and details what’s next for RVT-802. She explains tissue-based therapies — how far they’ve come and the work that’s left to be done. And, they discuss what being patient-focused means in the world of rare diseases.

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Introducing Cell & Gene: The Podcast Jun 30, 2021

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Cell & Gene, the online resource that delivers in-depth content from authoritative authors and sources to professionals in the CGT sector, is thrilled to introduce “Cell & Gene: The Podcast.” Cell and gene therapies offer huge potential to treat a wide range of diseases and their possibilities represent a new era in medicine. “Cell & Gene: The Podcast” will explore approved and pipeline therapies, new trends in manufacturing, the long, regulated road to commercialization, and everything in between. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to an industry or academic leader about their current initiatives and how they are moving the sector forward. (Music by Royalty Free Music From Bensound)

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