Explore every episode of the podcast Cell & Gene: The Podcast
| Title | Pub. Date | Duration | |
|---|---|---|---|
| A New Approach to Genome Engineering with Tessera Therapeutics' Dr. Michael Severino | 12 Sep 2024 | 00:28:06 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Scaling Allo with Allogene Therapeutics' Dr. Zachary Roberts | 29 Aug 2024 | 00:25:13 | |
We 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 versus allo," and why allogeneic is the path forward. They also discuss how and why allogeneic therapies are truly scalable. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| CGTs for HIV Suppression with Addimmune's Dr. Marcus Conant | 09 May 2024 | 00:18:51 | |
We 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 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside BlueRock Therapeutics' Parkinson's Disease Trial with Dr. Ahmed Enayetallah | 25 Apr 2024 | 00:29:39 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Reducing the Disease Burden of AML with Vor Bio's Dr. Robert Ang | 11 Apr 2024 | 00:23:08 | |
We 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 their Cambridge, MA-based headquarters. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Reducing Toxicities in Allogeneic Cell Therapies with Orca Bio's Dr. Scott McClellan | 28 Mar 2024 | 00:19:37 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside Cellular Rejuvenation Therapies for Age-Related Diseases with Life Biosciences' Sharon Rosenzweig-Lipson, Ph.D. | 14 Mar 2024 | 00:17:17 | |
We 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 Biologics to manufacture AAV for the cellular rejuvenation technology. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Future of Rare Diseases with The Jackson Laboratory’s Rare Disease Translational Center's Cat Lutz | 29 Feb 2024 | 00:27:31 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead company's Christopher McDonald | 15 Feb 2024 | 00:20:48 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng. | 01 Feb 2024 | 00:37:17 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Breaking Down Solid Tumors with Triumvira Immunologics' Dr. Paul Lammers | 18 Jan 2024 | 00:21:33 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| 4 Keys to Allo in 2024 with Poseida Therapeutics' Kristin Yarema, Ph.D. | 04 Jan 2024 | 00:31:59 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D. | 15 Aug 2024 | 00:27:58 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Cell Therapy For Corneal Endothelial Dystrophies With Aurion Biotech's Greg Kunst | 21 Dec 2023 | 00:13:41 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Overcoming the Limitations of CAR T-Cell Therapy with Vittoria Bio's Nick Siciliano, Ph.D. | 07 Dec 2023 | 00:17:23 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Gene Therapy Deals, Collaborations, & Partnerships with Astellas' Richard Wilson | 21 Nov 2023 | 00:25:02 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Promise of AAV Gene Therapy with REGENXBIO's Ken Mills | 09 Nov 2023 | 00:28:34 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside 2023 Meeting on the Mesa with ARM's COO, Rita Johnson-Greene | 26 Oct 2023 | 00:16:33 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Future of Cell and Organ Transplantation in Treating T1D with Dr. Camillo Ricordi | 12 Oct 2023 | 00:18:15 | |
We 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 biopreservation. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg | 28 Sep 2023 | 00:30:37 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside Genome Editing with CBER's Dr. Peter Marks | 14 Sep 2023 | 00:25:17 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Future of CAR-T with Bristol Myers Squibb's Lynelle Hoch | 31 Aug 2023 | 00:25:53 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Promise of Genome Editing with Caribou Biosciences' Rachel Haurwitz, Ph.D. | 17 Aug 2023 | 00:23:21 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Identifying Drug Development Opportunities for DMD with CureDuchenne | 01 Aug 2024 | 00:29:55 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Focus Areas For Cell Therapy With Bristol Myers Squibb's Stephan Krause, Ph.D. | 03 Aug 2023 | 00:19:29 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Intersection Of RNA, AI, And Synthetic Biology With Shape Therapeutics' Dr. Francois Vigneault | 20 Jul 2023 | 00:29:17 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside Prime Editing with Prime Medicine's Dr. Andrew Anzalone | 06 Jul 2023 | 00:24:34 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Navigating CMC Challenges with Parenteral Drug Association's Glenn Wright | 22 Jun 2023 | 00:24:55 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| An Interview with Dr. Usman "Oz" Azam | 08 Jun 2023 | 00:27:37 | |
We 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 tumor cancer treatment, the biggest yet solvable hurdles facing the sector today, and much more. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Targeting Oncogenic Drivers for Solid Tumor Cancers with Affini-T Therapeutics' Dr. Jak Knowles | 25 May 2023 | 00:23:45 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| TJU's Jefferson Institute for Bioprocessing's Impact on CGT with Parviz Shamlou | 11 May 2023 | 00:42:20 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Computational Biology's Role In Gene Therapy With Kriya Therapeutics' Dr. Shankar Ramaswamy | 27 Apr 2023 | 00:31:57 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Near-Term Future of Exosome Science with Capricor Therapeutics' Dr. Linda Marbán | 13 Apr 2023 | 00:28:17 | |
We 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). Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside the World's First-Ever Allogeneic Approval with Atara Biotherapeutics' Pascal Touchon | 30 Mar 2023 | 00:40:51 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Tackling "The Delivery Problem" of Gene Editing-Based Medicines with Mammoth Biosciences' Lucas Harrington | 18 Jul 2024 | 00:21:01 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Potential of RNA Exon Editing with Ascidian Therapeutics' Romesh Subramanian, Ph.D. | 16 Mar 2023 | 00:20:40 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Automating Processes to Scale CGT Manufacturing with PA Consulting's Paolo Siciliano | 02 Mar 2023 | 00:31:52 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier | 16 Feb 2023 | 00:21:42 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| 2023 Market Outlook with AdBio and ISCT's Miguel Forte | 02 Feb 2023 | 00:26:34 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| CMC and Scale Up with Mustang Bio's Robert Sexton | 19 Jan 2023 | 00:36:05 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| An Interview with Dr. Peter Marks | 05 Jan 2023 | 00:28:34 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside NK and Macrophage Cellular Immunotherapies with Shoreline Biosciences CSO Dr. Robert Hollingsworth | 22 Dec 2022 | 00:26:58 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| The Future of iPSCs with BlueRock Therapeutics' CEO Seth Ettenberg | 08 Dec 2022 | 00:28:35 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Manufacturing at the Point of Care with Orgenesis' CEO Vered Caplan | 24 Nov 2022 | 00:36:45 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Capstan Therapeutics' CEO Laura Shawver on In Vivo Cell Engineering | 10 Nov 2022 | 00:40:25 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| TILs for the Treatment of Solid Tumors with KSQ Therapeutics' Micah Benson, Ph.D. | 04 Jul 2024 | 00:35:30 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| PepGen's SVP Head Of Clinical Development On Delivery Of Oligonucleotide Therapies | 27 Oct 2022 | 00:30:46 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| BridgeBio's Chief Regulatory Affairs Officer Adora Ndu on PDUFA VII Reauthorization | 13 Oct 2022 | 00:28:12 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Inside RNAi with Arrowhead Pharmaceuticals' Javier San Martin | 29 Sep 2022 | 00:32:58 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||
| Planning For Manufacturing Capacity With Kite Pharma's Will Junker | 15 Sep 2022 | 00:22:49 | |
We 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. Subscribe to the podcast! Visit my website: Cell & Gene Connect with me on LinkedIn | |||