We 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 f...
May 28, 2024•25 min•Ep. 77
We 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. ...
May 23, 2024•32 min•Ep. 76
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 s...
May 09, 2024•19 min•Ep. 75
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. Listen and subscribe so...
Apr 25, 2024•30 min•Ep. 74
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 ...
Apr 11, 2024•23 min•Ep. 73
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!...
Mar 28, 2024•20 min•Ep. 72
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 (N...
Mar 14, 2024•17 min•Ep. 71
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! Apple | Spotif...
Feb 29, 2024•28 min•Ep. 70
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 t...
Feb 15, 2024•21 min•Ep. 69
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 l...
Feb 01, 2024•37 min•Ep. 68
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...
Jan 18, 2024•22 min•Ep. 67
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! Apple | Spotify | YouTube...
Jan 04, 2024•32 min•Ep. 66
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! Apple | Spotify | YouTube...
Dec 21, 2023•14 min•Ep. 65
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! Apple | Spotify | YouTube...
Dec 07, 2023•17 min•Ep. 64
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! Apple | Spotify | YouTube...
Nov 21, 2023•25 min•Ep. 63
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! Apple | Spo...
Nov 09, 2023•29 min•Ep. 62
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! Apple | Spotify | YouTube...
Oct 26, 2023•17 min•Ep. 61
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 c...
Oct 12, 2023•18 min•Ep. 60
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! Apple | Spotify |...
Sep 28, 2023•31 min•Ep. 59
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! Apple | Spotify | YouTube...
Sep 14, 2023•25 min•Ep. 58
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 Myer...
Aug 31, 2023•26 min•Ep. 57
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! Apple | Spotify | YouTube...
Aug 17, 2023•23 min•Ep. 56
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! Apple | Spotify | YouTube...
Aug 03, 2023•19 min•Ep. 55
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! Apple | Spotify | YouTube...
Jul 20, 2023•29 min•Ep. 54
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! Apple | ...
Jul 06, 2023•25 min•Ep. 53
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!...
Jun 22, 2023•25 min•Ep. 52
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...
Jun 08, 2023•28 min•Ep. 51
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 mechan...
May 25, 2023•24 min•Ep. 50
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 Bioprocess...
May 11, 2023•42 min•Ep. 49
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! Apple | Spotify | YouTub...
Apr 27, 2023•32 min•Ep. 48
