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1. Allogeneic RNA Cell Therapy Program With Cartesian Therapeutics' Dr. Metin Kurtoglu 5/26/2022

   Cartesian Therapeutics’ Dr. Metin Kurtoglu joins Cell & Gene: The Podcast to explain their autologous RNA cell therapies, Descartes-08 for Myasthenia Gravis and Descartes-11 for multiple myeloma. He also sheds light on Descartes-25, their allogeneic RNA cell therapy, and the reasons for the move to "off-the-shelf.” Hear why the future of RNA cell therapy is not confined to rare and fatal diseases and subscribe so you never miss an episode!

2. What's Next For COVID Vaccines: Tonix Pharmaceuticals' Seth Lederman, M.D. 5/22/2022

   As COVID-19 cases climb yet again, Tonix Pharmaceuticals Chairman and CEO Seth Lederman, M.D. shares his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants and grab its share of the highly competitive, and highly lucrative, vaccine market.

3. Running Interference: RNAi With Silence Therapeutics' Craig Tooman 5/15/2022

   Fresh on the heels of his appointment as President & CEO at Silence Therapeutics, Craig Tooman joins the Business of Biotech to share how he applies his finance-minded leadership to steward the advance of a pipeline of RNAi gene silencing candidates spanning indications from hematology to cardiovascular disease to rare diseases. 

4. New ICH Q14 Guidance Applies QbD To Analytical Procedures 5/13/2022

   ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

5. Gene Therapy's Commercial Manufacturing Issues with Encoded Therapeutics' Andy Stober 5/11/2022

   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.

6. Live Biologics & The Microbiome With 4D pharma's Duncan Peyton 5/8/2022

   4D pharma's flagship early-stage clinical candidates are live biotherapeutics, a relatively new class of biologics that seek to impact disease state by modulating the microbiome. CEO Duncan Peyton is leading the effort to understand how the health of the microbiome relates to a wide range of diseases, including immuno-oncology, central nervous system disorders, respiratory disease, auto immune indications, and gastro intestinal disease. 4D pharma is even working on a live biotherapeutic vaccine platform. Join Duncan on this episode of the Business of Biotech as we discuss this new frontier of therapeutic exploration.

7. Gene Tx For Renal Disease With Purespring CEO Richard Francis 5/1/2022

   Under the leadership of CEO Richard Francis, Purespring Therapeutics is operating with the audacious goal to take its therapeutics all the way to the commercial finish line. On this episode of the Business of Biotech, Francis offers a transparent look at the company’s growth strategy and the progress it’s achieved to date.

8. Inside CAR-T Therapy For Ovarian Cancer with Anixa Biosciences' Amit Kumar, Ph.D. 4/27/2022

   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.

9. BIOVIA Discoverant For Process Development And Manufacturing 4/25/2022

   BIOVIA Discoverant for process development and manufacturing is a validation-ready solution for process and quality data access, aggregation, contextualization, analysis and reporting.

10. Fighting Blindness & Funding The Fight With Opus Genetics' Ben Yerxa, CEO 4/24/2022

    Opus Genetics is an early-stage gene therapy company launched just last year and in unique fashion on the back of the patient advocacy group the Retinal Degeneration Fund. Already, its pipeline has developed into three candidates, the lead among them addressing Leber congenital amaurosis. Opus CEO Ben Yerxa, Ph.D. serves in triplicate as CEO at the RD Fund, Foundation Fighting Blindness, and Opus Genetics. His plate is full, but he's a man on a mission. On this episode of the Business of Biotech, Dr. Yerxa shares his story, that of Opus Genetics' unique approach to addressing inherited retinal diseases, and how the company is addressing current funding, development, and capacity challenges in the cell & gene manufacturing space.