Podcasts about Cell therapy

We love to hear from our listeners. Send us a message.In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company's evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases. Altman highlights BioCardia's CardiAMP program, a precision medicine approach that pre-screens patients based on their cell profiles to improve trial outcomes and reduce costs. He explains why no cardiac cell therapy has yet received FDA approval, citing challenges in delivery, immune rejection, and arrhythmia risks. Altman outlines BioCardia's near-term roadmap, including regulatory submissions in the U.S. and Japan and the launch of a second trial focused on patients most likely to benefit.Subscribe to the podcast!Apple | Spotify | YouTube

We're online with Daniela Marino, CEO and co-founder of one of the best companies in Europe for tissue therapeutics, CUTISS.We discussed the story behind CUTISS and its current series C fundraising. We also discussed cell therapy in general and why kids are good at preventing burnout.---This episode is sponsored by CUTISS, the only TechBio company in the advanced clinical stage of developing skin tissue therapies. Learn how you can support CUTISS on its path to Series C success: https://bit.ly/flotbio-cutiss---⭐️ ABOUT THE SPEAKERIn 2023, Daniela Marino was named as one of the 30 Rising Leaders in the healthcare industry, thanks to the impact of CUTISS, the company she co-founded as a spin-off from the University of Zurich. Here, she and her team have made waves for people suffering from severe skin injuries and defects through regenerative medicine, tissue engineering, and skin pigmentation.

Are TCR-NK treatments the next big thing in cell therapies for cancer patients?As biotechs and pharma companies continue to innovate to address patient needs in oncology, T-cell receptor therapies, or TCR-Ts, are attracting significant interest and investment. There are already some promising results for TCR-Ts tackling solid tumors – but one Norwegian biotech is taking a slightly different track.This week, we sit down with Namir Hassan, CEO of Zelluna, a company with a mission to eliminate solid cancers by pioneering the development of T cell receptor guided natural killer, or TCR-NK, cell therapies.01:45                      Introducing Namir Hassan03:37                      Working at Immunocore04:40                      Lessons learned06:56                      Joining Zelluna as CSO08:44                      Becoming Zelluna CEO10:20                      Taking a biotech company public12:54                      TCR-T and TCR-NK therapies15:30                      Targets for TCR-NK therapies16:38                      Comparing TCR-NK to alternatives20:16                      Early success21:58                      An off-the-shelf-solution for cancer patients24:16                      Manufacturing and scaling25:13                      Partnering with top pharma, accelerating innovation27:05                      Milestones ahead for Zelluna28:52                      The landscape of TCR therapies in oncology31:38                      A final wordInterested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletterTo dive deeper into the topic: Future of cancer treatment: what will therapy look like in 2034?Trends in cancer therapeutics to look forward to in 2025Oncology R&D trends and breakthrough innovations

The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat looms

Tired of treating symptoms?Dive into the future of medicine with Dr. Panos Chrysanthopoulos (CDO at Morphocell Technologies and co-founder and director of weCANdev Consulting Group Inc. in Canada)! Discover how iPSCs create personalized CAR-T cell therapies for chronic liver failure and explore the potential to phase out diseases like leukemia within the next 5-10 years.Join us as we explore:CRISPR-Cas9: The DNA scissors rewriting the rules of medicine.iPSCs (Induced Pluripotent Stem Cells): The key to personalized, regenerative therapies.CAR-T Cell Therapy: Tailored immune responses to fight cancer.Quality by Design (QbD): Guaranteeing the safety and efficacy of next-gen treatments.Ethical considerations and equitable access: Navigating the future of gene editing responsibly.Don't forget to leave us a review and follow us on Spotify, LinkedIn, X, TikTok, and YouTube (Giota Pimenidou). Visit our website at www.global-greek-influence.com for more engaging content!

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Jason C. Foster, Chief Executive Officer and Executive Director at Ori Biotech. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Jason, covering: How being frustrated by big company life led to the development of a business unit within Reckitt Benckiser that went on to be valued at $1bn The story of how a spin-out went on to list on the LSE with a cool $3.5bn market cap Taking his skills and experience before making 18+ healthcare start-up investments,... determined to add value beyond the cash Being wowed by the potential of CGTs and building the business he always wanted to work for in Ori The mission is to build enabling technology for power cell therapy companies and cut down the manufacturing costs by at least 50% to improve accessibility and affordability. Jason has held leading roles in consulting, healthcare and technology companies for over 20 years in the US, UK and Europe. He is CEO and Executive Director for Ori Biotech, a cell and gene therapy manufacturing technology start-up with offices in London and New Jersey. He raised a $100M Series B funding round in December 2022. Jason also serves as a Non-Executive Director of London-based health tech start-ups gripAble and Credentially and Auxita Pty, an Australian healthcare data platform. As the Managing Director of Health Equity Consulting, he has advised PE/VC funds, family offices, accelerators and healthTech start-ups.   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Let's Talk Quality, Hemish speaks with Jose Caraballo, a biotech leader with over 30 years of experience in process engineering, manufacturing science, and quality leadership.Jose started his career in process engineering, optimizing yields and scaling up production. Over time, he made a deliberate shift into quality leadership, recognizing that understanding the external side of the business - suppliers, regulators, and customers, was just as important as technical expertise.Now, as a VP of Quality at Kite Pharma, a leader in cell therapy manufacturing, Jose is deeply involved in shaping the future of quality in biotech and remains passionate about driving innovation and leadership in the biotech space. In this conversation we cover:✅ The shift from compliance-focused quality to strategic quality leadership✅ Why quality is a company-wide responsibility, not just a QA function✅ How moving from technical roles to quality leadership can accelerate career growth✅ The importance of curiosity and adaptability in biotech✅ How CGT is changing expectations for speed, risk management, and patient impact✅ The role of automation and AI in quality systems✅ Lessons from moving into senior leadership and managing teams effectively✅ What biotech companies need to focus on to embed quality culture at every levelJose's career journey is a great example of how technical expertise, business strategy, and leadership all come together to drive impact in biotech.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.AstraZeneca has recently made a significant investment of up to $1 billion in cell therapy through the acquisition of esobiotec. This move is part of AstraZeneca's larger strategy to expand in the cell therapy space, positioning itself to be a major player in the market. Dyne is also looking to file for accelerated approval for its Duchenne exon skipping oligomer, while Taiho Pharmaceutical has acquired ADC partner Araris for up to $1.1 billion. Alnylam is expected to enter the transthyretin amyloid cardiomyopathy market, which is projected to reach $11.2 billion by 2030.Sino Biological has developed reagents for the 2025-2026 influenza vaccine strains, offering a range of recombinant proteins for vaccine development. The pharmaceutical industry is seeing significant activity in various therapy areas, with companies making strategic investments and advancements in research and development.Alnylam is awaiting approval for their drug Amvuttra in the transthyretin amyloid cardiomyopathy market, which is currently dominated by Pfizer and BridgeBio. The obesity drug market is becoming increasingly competitive, with companies focusing on overall health benefits rather than just weight loss. Biopharma companies are now exploring the use of CAR T cell therapies for autoimmune disorders, with several readouts expected this year. Ionis and Ultragenyx are competing to develop treatments for Angelman syndrome, while Neuren is trying to catch up.Overall health outcomes are becoming more important in the obesity drug market, with successful studies in therapeutic areas like cardiovascular and sleep apnea providing a market advantage. Other news includes flu vaccine recommendations from the FDA and updates on drugs for alcohol use disorder, plaque psoriasis, breast cancer, and weight loss. The biopharma industry continues to evolve, with readers encouraged to provide suggestions for future coverage topics.

In this episode, we explore the groundbreaking role of T-cell immunology in early disease detection and innovative immunotherapy treatments with Dr. Nigel McCracken, Chief Operating Officer at Virax Biolabs. With over 25 years of experience in oncology and infectious disease research, Dr. McCracken shares his insights on how T-cell diagnostics are reshaping the landscape of immune health. Virax Biolabs is leading the charge in diagnostic testing and personalized medicine, leveraging state-of-the-art biotechnology to combat chronic inflammation, immune dysfunction, and post-viral conditions. Their pioneering work in adaptive immunity is driving advancements in vaccineresearch and autoimmune disorders, offering new hope for patients worldwide. Before joining Virax, Dr. McCracken played key roles in companies like BerGenBio ASA and NuCana PLC, spearheading oncology research, companion diagnostics, and next-generation therapeutic strategies. Tune in now to discover: The critical role of T-cells in the fight against chronic illness. How immune system dysfunction contributes to conditions like long COVID and post-viral syndrome. The evolving future of medical diagnostics, immune health, and public health. What makes T-cell therapy a game-changer in immunotherapy and inflammation awareness. Follow Dr. McCracken's latest work at Virax Biolabs to stay at the forefront of immune system health innovation! Episode also available on Apple Podcasts: https://apple.co/38oMlMr

"The first decision I had to make when I joined was whether to continue this anito-cel progam that now looks to be potentially best-in-class in myeloma," Rami Elghandour, CEO of Arcellx, shares with Bloomberg Intelligence analyst Sam Fazeli. The company embodies the dream of biotech investors -- raising a small amount of capital while on the cusp of getting a drug to market with a highly credible partner. Arcellx and Gilead aim to take on the leader in multiple myeloma, Johnson & Johnson, targeting its engineered T-cell therapy (CAR-T) Carvykti with their own unique CAR-T, anito-cel. The discussion covers topics from the company's inception to Elghandour's journey through healthcare and how it has a real chance of launching a product after raising just $240 million. Oh, and Spider Man makes a cameo appearance too. See omnystudio.com/listener for privacy information.

This week on Let's Talk Quality, we sat down with Andrea Karpinecz, VP of Quality Control at Iovance Biotherapeutics, to discuss what it takes to build a successful QC career, scale teams for commercialization, and thrive in a high-pressure environment.Andrea has been in cell therapy for 16+ years, playing a pivotal role in bringing multiple therapies to market - including some of the first commercially approved CAR-T and TIL therapies. She's seen firsthand what it takes to move from the bench to executive leadership and shares key insights for QC professionals who want to grow their careers but aren't sure where to start.

Join us for an insightful episode as we sit down with Mark Tomishima, Senior Vice President at BlueRock Therapeutics, to explore the latest advancements in regenerative medicine. Mark shares his experiences leading genome engineering and stem cell research, discusses key challenges in cell therapy development, and offers valuable career advice for aspiring scientists. Don't miss this deep dive into the cutting-edge work being done at BlueRock Therapeutics to revolutionize the future of medicine! Hosted by Sophia Deng.

ATMPs, gene therapies, and cancer breakthroughs are here—but outdated regulations, high costs, and logistical bottlenecks are blocking access. What needs to change for hospitals to deliver these cures to patients who need them most?

In this week's episode we'll learn more about the significance of hypercalcemia in monoclonal gammopathy of undetermined significance, the role of neutrophil gelatinase-associated lipocalin in hemostasis, and the feasibility of combining CD19-targeted NK- or T-cell therapy with anti-CD19 monoclonal antibodies.Featured Articles:Approaching Hypercalcemia in Gammopathy of Undetermined Significance: Insights from the iStopMM study Deficiency of neutrophil gelatinase-associated lipocalin elicits Hemophilia-like bleeding and clotting disorder Anti-CD19 antibody cotreatment enhances serial killing activity of anti-CD19 CAR-T/-NK cells and reduces trogocytosis 

Send us a textThe intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products.In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence.Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform can process multiple patient doses simultaneously, enabling treatment for 30 patients in parallel within just 1,000 square feet of clean room space. This innovative method drastically reduces clean room requirements by about 95% and facility sizes by approximately 50%, significantly cutting costs associated with building and operating large-scale facilities.As Jason emphasized, this shift not only accelerates access to groundbreaking therapies but also provides a sustainable model for scaling cell therapy production.Key Points to Remember:Integrated Approach: Scientists should look beyond their specialized areas and understand the requirements of subsequent bioprocessing stages to maximize patient impact.Technological Evolution: Advancing distributed manufacturing and enhancing in-line analytics are essential steps to revolutionize the biotech landscape.Commercial Viability: Prioritizing commercial feasibility alongside safety and efficacy in preclinical development can prevent costly late-stage setbacks.This episode of the Smart Biotech Scientist underscores the complexities and transformative potential of cell therapy manufacturing. As the industry continues to innovate, integrating commercial viability, flexibility, and advanced manufacturing solutions will be critical. By breaking down silos and fostering collaboration, we can accelerate the development of life-saving therapies—ensuring they reach patients faster and more efficiently.Connect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textOne of the most urgent challenges in modern medicine is making cell and gene therapies widely accessible. These therapies, while groundbreaking in their safety and efficacy, often fall short when it comes to reaching patients. The reasons are manifold—high manufacturing costs, logistical complexities, and inefficiencies in the production pipeline.We're joined by Jason Foster, CEO and Executive Director of Ori Biotech, a company that's revolutionizing cell and gene therapy manufacturing through automation and innovative approaches.Jason sheds light on the technical bottlenecks that limit patient access to life-saving therapies and discusses how an integrated, holistic view of the development chain could make a significant difference. From the complexities of centralized manufacturing and the interconnectedness of the supply chain, to specific technical solutions Ori Biotech has developed, we explore the multi-faceted issues and potential solutions in making these advanced therapies more reachable.Here are three key takeaways from our conversation:Holistic Development Chain: Jason emphasizes the importance of integrating all stakeholders in the development chain, ensuring everyone understands what happens before and what needs to happen next to improve the overall process.Technical Bottlenecks & Solutions: We delved into various technical bottlenecks, including centralized manufacturing and logistical complexities. Jason highlighted how Ori Biotech is addressing these issues through automation and reducing manual labor, which can cut manufacturing costs by 50%.Impact on Accessibility: It's alarming that only 3-5% of patients who need CAR-T therapies have access to them. Jason's mission with Ori Biotech is to transform this narrative by enabling widespread access to these life-saving therapies through innovative manufacturing solutions.As cell and gene therapies stand poised to revolutionize cancer and rare disease treatment, the focus must shift toward overcoming manufacturing constraints. By integrating automation and aiming for decentralized models, companies like Ori Biotech offer a glimpse into a future where these revolutionary treatments are accessible to all who need them.Fascinated by Cell Therapy? Hear from top experts in these two episodes!Episodes 11 and 12: From Lab to Patient: Steve Oh's Guide to Mastering Cell Therapy Process DevelopmentEpisodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin KawamataConnect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

In this episode of Data in Biotech, Ross sits down with Dipen Sangurdekar, VP of Data Sciences at KSQ Therapeutics, to discuss the role of data-driven approaches in therapeutic design and development. The conversation explores the intersection of computational biology, machine learning, and bioinformatics in advancing personalized medicine and improving patient outcomes. Dipen shares his journey in the industry, emphasizing the importance of integrating data science with biological research and the challenges associated with working in the rapidly evolving field of cell therapies. From hypothesis-driven research to leveraging multimodal data for actionable insights, this episode explores the nuances of using statistical methods and AI to enhance drug development. Key Takeaways: Successful data science in therapeutics requires a deep understanding of both statistical methods and biological processes.High-dimensional but low-sample-size data demands a guided hypothesis-driven approach to avoid false positives.Data integration and collaboration between computational and biological teams are critical for generating meaningful insights.Emerging AI and machine learning tools are enhancing productivity but must be carefully applied in therapeutic research.Picking a problem you're passionate about and going deep into it is crucial for long-term success in the field. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyFind out more about KSQ Therapeutics Connect with Dipen on LinkedIn Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!

The informant's microphone picked up the din of the busy beachfront restaurant. Sheriff's deputies were stationed in a covert van nearby. They had a camera trained on one of the large windows, focusing on the target's hands passing an envelope of money to the informant. Still clear enough over the customer's chatter, the informant asked when he wanted it done. “Yesterday” was the response…*** LISTENER CAUTION IS ADVISED *** This episode was researched and written by Eileen Macfarlane.Edited by Joel Porter at Dot Dot Dot Productions.Script editing, additional writing, illustrations and production direction by Rosanna FittonNarration, additional audio editing, script editing, and production direction by Benjamin Fitton.To get early ad-free access, including Season 1, sign up for They Walk Among PLUS, available from Patreon or Apple Podcasts.More information and episode references can be found on our website https://theywalkamonguspodcast.comMUSIC: Sabotage by Cody Martin Darker Days by Alternate Endings Far From Home by Cody Martin Illusion by Cody Martin Playing Games by Cody Martin A Construct by Falls Moonbeam by Falls Fractured Light by Stephen Keech Fleet Street by Stephen Keech Glass Houses by Third Age Bingdu by Kevin Graham Liminal by Chelsea McGough Blackstone by Lincoln Davis Stratos by Lone Canyon Life Giving by Moments Cocoon Of Light by Phillip Mount Blinding Light by Salon Dijon Distances by Salon Dijon Harboring by Salon Dijon The Matter At Hand by Salon Dijon Worth by Shimmer Stasis Interrupted by Dresden, the Flamingo Winds Of Change by Four Trees SOCIAL MEDIA: https://linktr.ee/TheyWalkAmongUsSupport this show http://supporter.acast.com/theywalkamongus. Hosted on Acast. See acast.com/privacy for more information.

In today's episode, we talk with Krista Wood, a registered nurse with the Cell Therapy and Transplant Program at Victoria General Hospital in Halifax, Nova Scotia (Canada). Krista shares her invaluable insights and experiences working with patients dealing with chronic graft-versus-host disease (GVHD), a common complication following stem cell transplants. Our discussion delves into the importance of communication, post-transplant care, and finding joy and purpose during survivorship.Krista emphasizes that early detection and treatment of GVHD are critical. She encourages patients to report any changes, no matter how minor they may seem, and reassures them that healthcare teams are there to help. This open communication is vital, as post-transplant life can be overwhelming with fears of relapse or complications. Ensuring patients have direct access to their care team can ease their anxieties and foster trust.Routine health checks, like blood work and pulmonary function tests, play a crucial role in monitoring potential complications. Krista explains the importance of tracking liver enzymes, bone density, and lung function to catch and address issues early. She underscores that post-transplant care goes beyond the transplant itself, extending to overall health maintenance, including routine screenings like mammograms, dental care, and colorectal exams.Reconnecting with life post-transplant is another important theme. Krista encourages patients to rediscover the activities they loved before their illness, whether it's returning to work, volunteering, or pursuing hobbies. Work and social engagement provide purpose and can aid emotional recovery. For those who can't return to work, finding alternative ways to contribute, such as volunteering with organizations like the Leukemia & Lymphoma Society or HealthTree, can offer fulfillment and connection. (Note: the National Bone Marrow Transplant Link (nbmtLINK) has a peer mentor program as well, email info@nbmtlink.org if you'd like to be a peer or need a peer mentor. )Preparing for transplant and understanding GVHD beforehand is crucial. While some patients prefer to know everything, others may only want the basics. Krista and her team provide consistent education in manageable increments to help patients absorb key information. She explains factors that increase the risk of GVHD, such as donor characteristics and patient preconditioning, and stresses the importance of entering the transplant process in the best possible physical shape.Krista also highlights the importance of addressing sensitive topics like sexual health, which many patients are reluctant to discuss. She brings up these issues proactively, ensuring patients feel supported and have access to necessary resources.Finally, Krista shares stories of hope, including patients who, despite long-term challenges, have regained a sense of normalcy and fulfillment. She reminds us that while every patient's journey is unique, resilience and adaptation are common threads in their recovery.This episode is a testament to the critical role nurses like Krista play in guiding patients through this complex medical journey, offering care, education, and encouragement every step of the way.More:Leukemia & Lymphoma Society: https://www.lls.orgHealthTree Foundation: https://www.healthtree.orgGVHD Alliance: https://www.gvhdalliance.orgLink to LLS free Nutrition Consultations: https://www.lls.org/managing-your-cancer/food-and-nutritionThank you to our sponsors. This season is supported by a healthcare contribution from Sanofi  https://www.sanofi.com/ National Bone Marrow Transplant Link - (800) LINK-BMT, or (800) 546-5268.nbmtLINK Website: https://www.nbmtlink.org/nbmtLINK Facebook Page: https://www.facebook.com/nbmtLINKFollow the nbmtLINK on Instagram! https://www.instagram.com/nbmtlink/The nbmtLINK YouTube Page can be found by clicking here.To participate in the GVHD Mosaic, click here: https://amp.livemosaics.com/gvhd

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna has received nearly $600 million in funding from HHS for mRNA-based bird flu vaccines, with the goal of having these vaccines ready before potential human outbreaks. As 2025 begins, there is a predicted shift towards investments in immunology, inflammation, obesity, neuromuscular, kidney, and cardiovascular diseases. Sage is suing partner Biogen after an unsolicited takeover offer, and Astrazeneca and Daiichi Sankyo's ADC has won its first approval despite mixed data. Analysts and biotech executives also highlight a pivot towards cell therapy for autoimmune diseases and continued interest in next-generation obesity drugs.Analysts and biotech executives predict a focus on immunology, inflammation, obesity, neuromuscular, kidney, and cardiovascular diseases in 2025. Cell therapy is shifting towards autoimmune diseases. Key stories include setbacks for the Astrazeneca/Daiichi Sankyo antibody-drug conjugate, new treatments for celiac disease gaining traction, and advancements in reframing multiple myeloma from fatal to treatable. Novo Nordisk's high-dose Wegovy shows increased weight loss in a Phase III trial, AstraZeneca receives full FDA approval for a lymphoma treatment, and Pfizer is optimistic about an obesity pill. Johnson & Johnson makes a major neuro play with a $14.6 billion buyout.

We love to hear from our listeners. Send us a message.Christopher Horan, Chief Technical Operations Officer, Artiva Biotherapeutics joins Cell & Gene: The Podcast Host, Erin Harris, to discuss the advantages natural killer (NK) cells have offer over T cells in terms of safety and efficacy for autoimmune disease. They take a deep dive into the key factors that make NK cells promising for ‘off-the-shelf' cell therapy products. They cover Artiva's "manufacturing first" approach to enabling scalable NK cell production, and much more.Subscribe to the podcast!Apple | Spotify | YouTube

Can cell therapy revolutionize hearing loss treatment? In this follow-up discussion, Brian Culley, CEO of Lineage Cell Therapeutics, shares exciting updates on the ReSonance™ (ANP1) program, a pioneering preclinical study exploring auditory neuron cell transplantation. Culley explains how lab-grown auditory neurons are being delivered to the inner ear to potentially restore damaged auditory pathways—a groundbreaking approach that could even complement existing treatments. In this conversation, Culley sheds light on the preclinical results, including the successful delivery of auditory neurons in animal models, and discusses the challenges and opportunities ahead as Lineage prepares for clinical trials. The discussion also touches on the broader implications of cell therapy and its potential integration into hearing care solutions. Interested in the latest in cell therapy and other cutting-edge hearing loss treatments under development? You won't want to miss out on the Hearing Therapeutics Virtual Summit. Taking place from February 4-5. Learn more and register here: https://www.accelevents.com/e/Hearing-Therapeutics-Summit For more information on the ReSonance program, visit the company's website here. Be sure to subscribe to our YouTube channel for the latest episodes each week, and follow This Week in Hearing on LinkedIn and X (formerly Twitter): https://www.linkedin.com/company/this-week-in-hearing/ https://twitter.com/WeekinHearing

Today's top stories, including a look at Jimmy Carter's legacy as the former president passed away. The impact AI is having on the workforce. Shocking revelations in the Girls Gone Wild documentary. How T-cell therapy is saving the lives of cancer patients. Food and weight loss trends in the new year. What's Trending: man takes granddaughter to father-daughter dance. A celebration of heart warming movies. Learn more about your ad choices. Visit megaphone.fm/adchoices

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Jonathan Parker, MD, PhD, an assistant professor of neurosurgery at Mayo Clinic Arizona, spoke about the emerging commotion around cell therapies as a way to treat patients with epilepsy. The discussion, which took place at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, California, covers the thought process behind this approach and why it may hold greater advantages over other traditional surgeries that result in detrimental cognitive effects. Parker, director of the Device-Based Neuroelectronics Lab, spoke on the different types of cell therapies currently in development, the limitations and challenges associated with these medications, and the need to create innovative trials to appropriately test them. Furthermore, Parker spoke on the therapeutic pipeline of cell therapies for epilepsy, including his experience leading a study site for a first-in-human trial of an investigational agent NRTX-1001, a product derived from human pluripotent stem cells. Looking for more epilepsy discussion? Check out the NeurologyLive® Epilepsy clinical focus page. Episode Breakdown: 1:00 – Idea behind cell therapy to treat epilepsy 4:05 – Current state of stem cell therapies for neurological disorders, focusing on Parkinson disease, stroke, and epilepsy 8:05 – NTE001 study of NRTX-1001, an investigational human embryonic stem cell product 11:45 – Neurology News Minute 13:50 – Unanswered questions and safety concerns with cell therapies; challenges with clinical trial design and the need for more innovative trials 17:35 – Misconceptions or gaps in understanding about cell therapies for epilepsy 20:05 – Unique challenges and potential of stem cell therapies for epilepsy, particularly in younger patients; patient motivation and hope The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here: Anavex Submits Marketing Authorization Application for Blarcamesine in Alzheimer Disease in the EU Testing Begins for RELIEV-CM2 Study of ShiraTronics Neuromodulation Device in Chronic Migraine STK-001 Gains FDA Breakthrough Designation as Potential Disease-Modifying Treatment for Dravet Syndrome Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

Sonal Gupta, MD, PhD, SVP and Head of Clinical Development at Affyimmune Therapeutics talks with host Emily Walsh Martin, PhD, to explore the challenges of cell therapy clinical trials and how to move patients quickly and thoughtfully through the steps required to receive therapy in aggressive solid tumor cancers.  But first, "we've moved straight from pumpkin spice season into ASGCT Annual Meeting registration season," as Dr. Walsh Martin says. So hop online and join ASGCT, then register and take advantage of the incredible member discounts on Annual Meeting registration. We'll see you in New Orleans, May 13-17, 2025! AnnualMeeting.ASGCT.org/register Music by: https://www.steven-obrien.net/--------------------------Bright New Morning - Steven O'Brien (Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

For more information, visit theconferenceforum.org 

We love to hear from our listeners. Send us a message.On this episode of Cell & Gene: The Podcast, Host Erin Harris, invites BlueRock Therapeutics' Dr. Amit Rhakit to take a deep dive into therapy options for Parkinson's disease (PD). They discuss how BlueRock's bemdaneprocel's mechanism of action differs from traditional PD treatments. They cover the limitations of current PD medications, how cell therapies might offer a different approach to long-term symptom management, and how BlueRock is doing traditional dopamine replacement therapy differently.Subscribe to the podcast!Apple | Spotify | YouTube

Professor Piotr Trzonkowski, CEO of PolTREG, is focused on developing cell therapies for autoimmune diseases like type-1 diabetes and multiple sclerosis using polyclonal T-regulatory cell therapy. Treg cells are key in regulating the immune system and preventing autoimmune diseases. Clinical trials are showing promise for safe and effective treatments for preventing type-1 diabetes in pre-symptomatic patients and maintaining insulin production for years after treatment in those with this form of diabetes.   Piotr explains, "My initial research subject was vaccination in the elderly, and I was looking for the reasons they did not respond to the vaccine. It was initially on the flu vaccine. The same is valuable, for example, for the COVID-19 vaccine. What we found is that elderly people do not respond to the vaccines because of the high level of accumulation of T-regulatory cells. T-regulatory cells can suppress immune responses, which is bad for the elderly." "A very simple answer would be if you compare the immune system to kind of an army. The majority of the army fights with enemies. In the case of the immune system, these enemies are bacteria and viruses that attack us, and in each and every army, there must be police who keep an eye on the soldiers. So, the soldiers really fight with the enemies and do not fight with the self-tissue." "The T-regulatory cells are a kind of military police of the immune system, which really keeps an eye on the immune system. So, the immune system fights with bacteria and virus cells and does not touch our own tissues. We call it in immunology, keeping the immune tolerance. So, proper immune tolerance is very dependent on T-regulatory cells. We say that this is an immune-dominant mechanism. T-regulatory cells are present in each and every process where the immune system responds to the bacteria. So, we successfully fight the infection, and at the same time, we do not destroy ourselves." #PolTREG #TregCells TRegulatoryCells #CellTherapy #AutoimmuneDiseases #Diabetes #Type1Diabetes poltreg.com Download the transcript here

Professor Piotr Trzonkowski, CEO of PolTREG, is focused on developing cell therapies for autoimmune diseases like type-1 diabetes and multiple sclerosis using polyclonal T-regulatory cell therapy. Treg cells are key in regulating the immune system and preventing autoimmune diseases. Clinical trials are showing promise for safe and effective treatments for preventing type-1 diabetes in pre-symptomatic patients and maintaining insulin production for years after treatment in those with this form of diabetes.   Piotr explains, "My initial research subject was vaccination in the elderly, and I was looking for the reasons they did not respond to the vaccine. It was initially on the flu vaccine. The same is valuable, for example, for the COVID-19 vaccine. What we found is that elderly people do not respond to the vaccines because of the high level of accumulation of T-regulatory cells. T-regulatory cells can suppress immune responses, which is bad for the elderly." "A very simple answer would be if you compare the immune system to kind of an army. The majority of the army fights with enemies. In the case of the immune system, these enemies are bacteria and viruses that attack us, and in each and every army, there must be police who keep an eye on the soldiers. So, the soldiers really fight with the enemies and do not fight with the self-tissue." "The T-regulatory cells are a kind of military police of the immune system, which really keeps an eye on the immune system. So, the immune system fights with bacteria and virus cells and does not touch our own tissues. We call it in immunology, keeping the immune tolerance. So, proper immune tolerance is very dependent on T-regulatory cells. We say that this is an immune-dominant mechanism. T-regulatory cells are present in each and every process where the immune system responds to the bacteria. So, we successfully fight the infection, and at the same time, we do not destroy ourselves." #PolTREG #TregCells TRegulatoryCells #CellTherapy #AutoimmuneDiseases #Diabetes #Type1Diabetes poltreg.com Listen to the podcast here

This episode features a conversation between Dr. Timothy Cripe and Dr. Joseph Glorioso, who discuss an article published in Molecular Therapy Oncology by Dr. Glorioso and colleagues titled Oncolytic Herpes Simplex Viruses Designed for Targeted Treatment of EGFR-bearing Tumors. Join the editor-in-chief of Molecular Therapy, Dr. Roland Herzog, and ASGCT this January for the next installment of Molecular Therapy Presents: Clinical Gene and Cell Therapy. This transformative field has grown from promising experimental treatments to approved medicines for a wide range of genetic and/or acquired diseases. This virtual event is free for ASGCT members to attend and will highlight several in-depth invited reviews appearing in Molecular Therapy's Clinical Gene and Cell Therapy special issue. Attend the webinar and learn more about cutting-edge developments in the clinical space before the special issue is published in early 2025. Find Molecular Therapy Presents: Clinical Gene and Cell Therapy, and all upcoming ASGCT events at ASGCT.org/events.  In This Episode Timothy Cripe, MD, PhDEditor-in-Chief, Molecular Therapy Oncology and Professor and Chief of Hematology, Oncology, BMT at Nationwide Children's Hospital Dr. Joseph GloriosoProfessor, Department of Microbiology and Molecular Genetics and Department of Human Genetics at the University of Pittsburgh 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0.www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

You know the drill, Danny and Julius talked for way too long and now the episode is split into 2 parts! It's like the new Wicked movie! Topical, eh?First up is Danny's playlist. This playlist tells the story of Danny's youth where he grew to appreciate movies enough to want to study them in college. Of course Julius provides some excellent film criticism, particularly to a mutual favorite film from 2016, Moonlight.Songs/Movies Discussed"Bonzo Goes to Bitburg" - Ramones - from School of Rock (2003) dir. Richard Linklater"The Man in Me" - Bob Dylan - from The Big Lebowski (1998) dir. Coen BrothersKaw-liga - Hank Williams - from Moonrise Kingdom (2012) dir. Wes Anderson"Cell Therapy" - Goodie Mob - from Moonlight (2016) dir. Barry Jenkins"Beyond the Sea" - Bobby Darin - from Finding Nemo (2003) dir. Andrew Stanton & Goodfellas (1990) dir. Martin Scorcese"Me & Mr. Hohner" - Bobby DarinCheck back in next week to hear Julius's version!PlaylistsDanny: Spotify - Apple Music - YoutubeJulius: Spotify - Apple Music - YoutubeSend us a text message!You can follow us here: Instagram Twitter Tiktok Send us a message, we'd love to hear from you! Email is thegmspod at gmailLeave us a rating and review if you want to!Thanks for listening!

Synopsis: Host Rahul Chaturvedi leads an insightful conversation with Dr. Kristin Yarema, President and CEO of Poseida Therapeutics. Kristin shares the inspiring journey of her career, from her roots in science to leadership roles in big pharma, culminating in her move to biotech entrepreneurship. She reflects on pivotal experiences at Novartis and Amgen, her deep-seated passion for oncology and autoimmune diseases, and the exciting leap into the field of cell therapy. Kristin unveils Poseida's innovative genetic engineering toolkit and the company's advancements in allogeneic cell therapies, spotlighting their potential to revolutionize treatment for conditions like multiple myeloma. She delves into the challenges and opportunities within the cell therapy space, underscoring Poseida's strategic partnerships and commitment to transformative solutions. With candid reflections on the lessons learned as a first-time CEO, Kristin offers valuable insights on fostering cohesive company culture and shares career advice for aspiring biotech professionals. An essential listen for anyone drawn to biotech innovation, the future of cell therapy, and leadership strategies at the intersection of cutting-edge technology and patient care. Biography: Dr. Yarema was appointed President and Chief Executive Officer of Poseida and named to the Board of Directors in January 2024. She joined Poseida as President, Cell Therapy in April 2023, bringing extensive biopharmaceutical experience in oncology and allogeneic T cell immunotherapy. Prior to Poseida she served as Chief Commercial Officer at Atara Biotherapeutics, where she led the commercialization of EBVALLO™️, which became the world's first marketed allogeneic T cell therapy after receiving regulatory approval in Europe for the treatment of a rare lymphoma. Previously Dr. Yarema held a series of U.S. and global commercial leadership roles at Amgen, including most recently Vice President & Therapeutic Area Head for Global Product Strategy & Commercial Innovation in Hematology-Oncology. Earlier in her career, Dr. Yarema worked at Novartis and McKinsey & Company. Dr. Yarema holds a Ph.D. in Chemical Engineering from University of California, Berkeley and is a graduate of Stanford University, where she earned a B.S. in Chemical Engineering and a B.A. in English. She is an officer and member of the board of directors of the Alliance for Regenerative Medicine and serves on the board of directors of the Celiac Disease Foundation.

Retinal neurons derived from human stem cells are a promising source of replacement cells for regenerating damaged or diseased retinas. As scientists progress toward translation of cell therapies for restoring vision, they encounter challenges, including how to deliver the cells, ensure that they integrate appropriately with host tissue, and enable proper function after transplantation. In this episode, Iris Kulbatski from The Scientist spoke with Deepak Lamba, a distinguished scientist in the department of immunology and regenerative medicine at Genentech and an associate adjunct professor at the University of California, San Francisco, to learn more about how advances in cell culture models and associated technologies help researchers progress towards retinal cell therapy. The Scientist Speaks is a podcast produced by The Scientist's Creative Services Team. Our podcast is by scientists and for scientists. Once a month, we bring you the stories behind news-worthy molecular biology research. This month's episode is sponsored by Bio-Rad.

It's a new era in the fight against cancer. The disease still kills nearly 10 million people worldwide every year, but advances in genomic sequencing and artificial intelligence have ushered in a new era of research. Treatments can now be personalized to patients and someday we might even have vaccines that can prevent the disease altogether. In this episode, host Samantha Laine Perfas, cancer researcher Levi Garraway, radiologist Connie Lehman, and cell therapy expert Cathy Wu talk about how close we are to turning a corner on cancer.

Welcome to the Green Rush, a weekly conversation at the intersection of cannabis, psychedelics, the capital markets, and culture, produced by KCSA Podcast Labs. Today, we have a special episode featuring our newest production, Alternatively Speaking. In our debut season, we're diving into a revolutionary concept in health span, longevity, and healthcare. We sat down with Dr. Bob Harari, a renowned biomedical scientist, surgeon, and entrepreneur. He is the Founder, Chairman, and CEO of Celularity, a biotechnology company leading the next evolution in cellular medicine. Dr. Hariri pioneered the use of stem cells to treat a range of life-threatening human diseases and continues today to make transformative contributions in the fields of immuno-oncology and cell therapeutics along with tissue engineering and functional regeneration.  Dr. Hariri is widely acknowledged for his discovery of pluripotent stem cells derived from the human placenta, and as a member of the team that discovered the physiological activities of tumor necrosis factor (TNF). He holds over 150 issued and pending patents for discoveries including placenta-derived stem cells, which Nature recognized as one of the ten most important patent estates in the field. Dr. Hariri was the founder and CEO of Anthrogenesis Corporation, and after its acquisition by Celgene Corporation, served as CEO of Celgene Cellular Therapeutics. Dr. Hariri also co-founded the genomic-based health intelligence company, Human Longevity, Inc. Podcast Highlights: Introduction & Dr. Bob Harari's Research (1:00): Dr. Harari's background and journey to longevity science. Placental Stem Cells (04:30): Advantages of using placental-derived stem cells and their ethical considerations. Universal Donor Tissue (10:05): Concept of the placenta as a universal donor tissue is explored, highlighting its potential in cellular therapies. Genetic Modification (12:40): Process of genetic modification in stem cells and their natural intelligence. Chimerism (20:35): The potential therapeutic benefits of chimerism in cellular medicine are discussed. Adult Stem Cell Banking (24:18): Cellularity's adult stem cell banking program and its value for future treatments. Future of Stem Cell Medicine (36:40): A vision of stem cell medicine in 10 years, including potential treatments for cancer, autoimmune diseases, and aging-related conditions. Social Media: Dr. Bob Hariri's Instagram: https://www.instagram.com/drbobhariri/?hl=en  Dr. Bob Hariri's LinkedIn: https://www.linkedin.com/in/bob-hariri-md-phd-3654b239/  Other Links/Mentions/Resources: Cellularity's official website: https://www.cellularity.com/  National Institutes of Health (NIH) information on stem cells: https://stemcells.nih.gov/  FDA resources: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products  Nature article on chimerism: https://www.nature.com/articles/d41586-021-01001-2  The American Society for Gene and Cell Therapy's patient education page: https://asgct.org/education  Show Credits: This episode was hosted by Lewis Goldberg of KCSA Strategic Communications.  Special thanks to our Program Director, Shea Gunther, and Executive Producer, Maria Petsanas. You can learn more about how KCSA can help your cannabis and psychedelic companies by visiting www.kcsa.com or emailing AltSpeaking@kcsa.com. You can also connect with us via our social channels: X: @KCSAPodcastLabs Instagram: @KCSAPodcastLabs LinkedIn: https://www.linkedin.com/company/kcsapodcastlabs/

Send us a textIn this insightful episode, Technical Development Leader at Flagship Pioneering Oliver Kraemer reveals why developing Advanced Therapy Medicinal Products (ATMPs) require a fundamental shift in thinking from traditional biologics development.Drawing from his extensive experience across Boehringer Ingelheim, Sanofi, and BMS, Kraemer challenges conventional wisdom about process development timing and demonstrates why early integration of process considerations is crucial for ATMP success.You will learn:Rethink Development Timing: Learn why incorporating process development earlier in ATMP programs dramatically reduces failure rates and prevents costly repetitionMaster Complexity: Understand the unique challenges of cell therapy development, including biological fitness and the critical interplay between cell lines, media, and processesNavigate Cost Implications: Discover strategies for managing the unexpectedly high development costs of ATMPs and making informed early decisions that impact commercial successReady to transform your approach to ATMP development? Join us for this must-listen episode as we demystify the path from bench to bedside in cell and gene therapy.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textIn this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering.Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about automation in cell and gene therapy while illuminating the crucial differences between biologics and ATMPs.Key Takeaways for Biotech Scientists:Discover why automation isn't the ultimate solution for advancing CGT development right now, and what this means for your process development strategyLearn how ATMP development requires a fundamental rethinking of the traditional research-to-development pipelineUnderstand the critical early-stage decisions in cell therapy development that can make or break your project timelineJoin us as Oliver shares invaluable insights from his journey from traditional biologics to cutting-edge cell therapies, including both iPSC-derived and donor-derived approaches. Whether you're a bioprocess developer, cell therapy researcher, or biotech professional, this episode offers practical wisdom for navigating the complex landscape of ATMP development.Ready to transform your understanding of cell therapy development? Listen now to gain insights that could save you months or even years in your development timeline.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

In this episode of LifeSciences 360, we dive into the fascinating world of cell and gene therapy manufacturing with Carlos Yuraszeck. With over 16 years of experience, Carlos shares his deep insights into the unique challenges, opportunities, and innovations in the field, offering a detailed look into what it takes to bring life-saving therapies to patients. We cover everything from the design of manufacturing facilities to the complexities of quality systems, patient-centric innovations, and the future of allogeneic therapies.If you're interested in the life sciences, cell and gene therapy, or just curious about cutting-edge advancements in medicine, this episode is for you!Chapters:00:00 - Intro  00:02 - Understanding Cell and Gene Therapy Facilities  00:09 - Challenges in Cell Therapy Facility Design  00:26 - Automation in Manufacturing  00:42 - Balancing Quality, Cost, and Time  00:53 - Patient-Centric Manufacturing  01:21 - Guest Introduction: Carlos Yuraszeck  02:06 - Carlos's Journey in Cell and Gene Therapy  03:21 - Unique Factors in Facility Design  04:14 - Making Facilities Operational  05:09 - Subscription Appeal  06:13 - Autologous vs. Allogeneic Cell Therapies Explained  08:13 - Adjusting Processes Based on Patient Variability  09:37 - Stem Cell Derived Therapies  10:39 - Biotech Companies: Autologous or Allogeneic?  12:07 - Strategic Decisions in Facility Design  14:50 - Phase-Appropriate Quality Systems  16:45 - Regulatory Flexibility and Urgency for Patients  18:08 - Change Control in Early vs. Late Phases  19:02 - Batch Records and Operator Judgment  20:27 - Training Focus for Different Phases  22:38 - Balancing Regulatory Requirements and Innovation  24:32 - Risk Assessment Based on Patient Needs  26:18 - The Potential of CAR T Therapies  28:05 - The Allogeneic Space and Future Prospects  31:00 - The Transformative Impact of Cell Therapy  32:22 - Carlos's Career Lessons and Fear of the Unknown  34:45 - Closing Remarks and Subscription Reminder  36:37 - Outro---

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Eisai's sales of its Alzheimer's disease therapy Leqembi have disappointed analysts, leading the company to lower its fiscal 2024 guidance. The underwhelming sales are attributed to barriers such as coverage, infusion centers, and time to diagnosis. In other news, Pfizer has made a $1 billion commitment in China to boost innovation and target the Chinese market, while AstraZeneca's China head has been taken into custody by Chinese authorities for reasons that remain unclear. There is also a dispute between Lilly and Novo over Catalent's GLP-1 work, as regulators review Novo Holdings' buyout of Catalent and the work the contract drug manufacturer may or may not be performing for Eli Lilly remains contentious.Additionally, a gene therapy webinar on successful preparation for scaling gene therapy processes is highlighted. Other news includes the impact of a Trump victory on the biopharma industry, cell therapy biotechs shifting focus to autoimmune expertise, and updates on Lilly's Q3 performance and more.

Cell therapy research and manufacturing are driving demand for automated high-throughput equipment to improve quality, reduce costs, and shorten the development cycles of innovative treatments that save lives. But what factors shape a startup's journey from the lab to commercialization?In Episode #35 of the Speed to Data podcast, Key Tech Business Development Manager Kelly Parker leads a panel of industry experts who discuss high-throughput automation in cell therapy screening and manufacturing.Daniela Hristova-Neeley, Ph.D., is a partner at the advisory firm Health Advances, where she is a leader in the diagnostics and life sciences tools practice.Blair Morad is Senior Director of Engineering at Cellino, a startup developing autonomous biomanufacturing technology for personalized cell therapies.Nova Syed is a founder and angel investor in the deep tech and healthcare sector. Most recently, Syed was the founding VP of Product at Mekonos, a developer of silicon nano-needles for cell therapies.Need to knowThree factors drive requirements in cell therapy screening:·       Customers are studying a huge variety of biological systems and drug targets. ·       Business requirements drive the need for faster and cheaper therapy development.·       Meeting regulatory standards demands high-quality, reproducible data.In manufacturing, meeting GMP makes design requirements even more complex as the product must:·       Improve flexibility and scalability.·       Improve quality control and traceability.·       Lower manufacturing costs.·       Reduce human interaction to improve efficiency and quality.The nitty-grittyGiven the many competing business, market, and regulatory requirements, the instrument design process inevitably forces developers to make tradeoffs.The panelists agreed that quality is table stakes, which means technologists and business leaders must balance time, cost, and scope.“You have to be ruthless when it comes to prioritizing your differentiator,” Hristova-Neeley said.In Morad's experience, understanding the organization's core competency is essential to focusing on the right problems.Data that made the differenceThe three panelists shared their lessons learned from hard experience in the healthcare technology business.Get early feedback from the market. “Product-market fit doesn't just happen,” Syed explains. “Unless you get feedback directly from the users and the customers, you don't have the data to iterate to the next cycle.”Hristova-Neeley agreed. “It's always important to hear what the customers have to say. Automation is certainly important, but it's not the only thing that is going to solve how we do cell therapy manufacturing or cell therapy development.”Look for outside expertise. “When you're working with the right experts,” Morad said, “they know how to ask the right questions that are helpful to move forward.” A good startup employs many intelligent people, but they won't know everything about everything. Find outside partners who have already built the assays, workflows, automation modules, and other elements outside your core competency so you can focus on your innovations.

Synopsis: Rob Williamson, CEO of Triumvira, joins Biotech 2050 host, Rahul Chaturvedi, to discuss his dynamic career from economics to biotech, tackling the volatile capital markets, and navigating high-stakes decisions in cell therapy. He shares insights on therapeutic developments in cell therapy, the pressures of solid tumor research, and the evolving biotech ecosystem. A deep dive into biotech board dynamics, funding strategies, and the potential of AI in healthcare, Rob offers invaluable lessons and forward-thinking perspectives on life sciences and patient care innovation. Biography: Robert F. Williamson, III has been active in building biotechnology companies and shareholder value for over two decades. He currently is the President and COO of Triumvira Immunologics. Previously, he was the CBO of OncoMyx, an oncolytic virus company, and CEO of BioTheryX, a protein degradation therapeutics company, raising a $100M crossover round and preparing the company for an IPO. Prior to BioTheryX, Mr. Williamson served as CEO of both PharmAkea and ATXCo, oncology and fibrosis companies financed through a partnership with Celgene, until PharmAkea's acquisition by Galecto and ATXCo's acquisition by Blade Therapeutics. Prior, Mr. Williamson was CEO of Arriva Pharmaceuticals, President and COO of Eos Biotechnology, which he sold to Protein Design Labs, and COO of DoubleTwist, Inc. through its acquisition by Merck and Hitachi. Mr. Williamson also serves as a director and adviser for foundations, private, and public companies. Notably, Mr. Williamson served as an early Director of Pharmasset, Inc., where he helped finance, grow, and advance the company into the public markets and through its acquisition by Gilead in 2011 for $11 billion. Earlier, Mr. Williamson was a Partner with The Boston Consulting Group and a Research Assistant for the Federal Reserve Board. He received a BA in economics from Pomona College and an MBA from Stanford.

"It's progress we couldn't have envisioned decades ago." - Oscar “I felt interested in being part of something bigger than my practice and something that will impact even more people that I was able to in the hospital.” - Carolina Dr. Oscar Bronsther and Dr. Carolina Escobar from Interlink joined me this week to discuss the exciting and scary world of cell and gene therapy, CRISPR, and how we fund these amazing medical advances.  In addition to me attempting to act smart enough to be in the same room as these two, we covered their wholistic approach to this emerging scientific field, which promises potential cures for rare and debilitating diseases, but often comes with 7-figure price tags. The rare genetic diseases are known as “orphan diseases”, and there have been some recent incredible advances in detecting them early on in life. We talked about what this all means for individuals as well as the insurance space as a whole, and how it has the potential to increase medical costs in this country even further.  Chapters: 00:00:00 Meet Oscar and Carolina 00:09:16 Genetic Therapy Solutions for Orphan Diseases 00:14:39 Detecting and Targeting Single Gene Mutations 00:26:52 CRISPR Technology 00:30:08 Equitable Access To Gene/Cell Therapy 00:37:21 How Do We Finance This? 00:46:13 The Ethical Concerns Of Cell/Gene Therapy 00:59:45 Economic Implications of This Technology Key Links for Social: @SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFunded Listen on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02 Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286 Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/ Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/ Key Words:  Rare Diseases, Gene Therapy, CRISPR technology, CRISPR, Healthcare Skepticism, Healthcare Warranties, Medical Revolution, Healthcare Advances, Orphan Diseases, Cell Therapy, Healthcare Innovation, self funded, podcast #RareDiseases #GeneTherapy #CRISPRtechnology #CRISPR #HealthcareSkepticism #HealthcareWarranties #MedicalRevolution #HealthcareAdvances #OrphanDiseases #CellTherapy #HealthcareInnovation #selffunded #podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/spencer-harlan-smith/support

The Foundation funded Dr. David Gamm for development of the induced pluripotent stem cell approach to be used in the trial.

This episode of ASTCT Talks dives into outpatient CAR T therapy, exploring logistics, challenges, and success strategies. Host Dr. Zahra Mahmoudjafari leads a panel of experts to share insights from their innovative programs. The panel features Robb Richards, Administrative Director of Cell Therapy and Transplant at Penn Medicine; Dr. Katie Gatwood, Clinical Pharmacy Specialist at Vanderbilt University Medical Center; and Dr. Taha Al-Juhaishi, Associate Director at the University of Oklahoma's Transplant and Cell Therapy Program. Topics include outpatient program structures, toxicity management, and the evolving role of cell therapies beyond hematologic malignancies. About the Host:Dr. Zahra Mahmoudjafari is a board-certified oncology pharmacist and Clinical Pharmacy Manager in Hematologic Malignancies at the University of Kansas Cancer Center. She earned her PharmD and MBA from UMKC and focuses on clinical and operational management of cell and gene therapies. Dr. Mahmoudjafari is active in HOPA, ATOPP, and ASTCT and was honored with ASTCT's Pharmacy SIG Lifetime Achievement Award and ASCO's 40 Under 40 in Cancer Award. Meet the Panel: Robb Richards has over 20 years of oncology experience, with roles spanning private practice, IT, and leadership in healthcare systems. At Penn Medicine, he oversees CAR T therapy operations, expanding services into community hospitals. He holds degrees from Drexel University and St. Joseph's University. Dr. Katie Gatwood is a Board-Certified Oncology Pharmacist at Vanderbilt University Medical Center, where she leads the PGY2 Oncology Residency Program and chairs the ASTCT Pharmacy SIG. Her expertise spans CAR T therapy, transplant conditioning, and GVHD therapies. Dr. Gatwood is an award-winning practitioner and has authored several publications on oncology pharmacy practice. Dr. Taha Al-Juhaishi is an attending physician and clinical investigator at OU Stephenson Cancer Center, Oklahoma's only NCI-designated center. He serves as associate director of the Hematopoietic Stem Cell Transplantation and Cell Therapy program and leads several clinical trials. Dr. Al-Juhaishi trained at Weill Cornell Medicine, VCU, and MD Anderson Cancer Center. Listeners will gain valuable insights into the complexities of managing outpatient CAR T therapy and strategies to enhance patient care.

The Rush Cell Therapy Lab provides stem cell transplants, bone marrow transplants and other advanced cell therapy treatments for patients with leukemia, lymphoma, multiple myeloma, and other hematological malignancies. In addition, the lab will soon function as a contracted manufacturing facility partner for the production and quality control and release of cell and gene therapies, representing a significant leap in decentralized hospital based cellular therapeutic manufacturing. Mahzad Akbarpour, PhD, is the Director of the Rush Cell Therapy Lab at RUSH MD Anderson Cancer Center and is also an Assistant Professor of Internal Medicine in the Division of Hematology, Oncology, and Cell Therapy. “When CAR-T cells first came on the market a few years ago, Rush was one of the first centers in the nation to provide this therapy to its patients. We've also been involved in several clinical trials to advance care and we'll soon be able to manufacture our own cells on-site.”

Today's top stories, including a federal judge unsealed new evidence in the federal election case against Trump. Power outages continue for those affected by Hurricane Helene. Information on a new bill deporting illegal immigrants convicted of sexual offenses. Groundbreaking T Cell therapy is being used to fight cancer.

Dr. Chris Heery is Chief Medical Officer at Arcellx, a company focusing on developing anito-cel, a significant advancement in CAR-T cell therapy, to treat relapsed and refractory multiple myeloma (rrMM). Multiple myeloma is a rare type of blood cancer that affects plasma cells in the bone marrow and has few treatment options. Arcellx is showing promising data from clinical trials with patients with rrMM who have failed prior therapies and have received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations from the FDA for anito-cel. Chris explains, "The company was founded based on an idea that you could take a novel protein structure and modify it to be able to bind to targets on the surface of cancer cells. And over many years of work, the founders were able to demonstrate that that was possible. Over the last three or four years, Arcellx has focused more on taking what were some of those early ideas and turning them into a product that can help patients. For these last three or four years, most of our focus has been around the lead asset that we call anito-cel that treats multiple myeloma and trying to get that product through the approval process to be able to be a commercial product that can be used for patients both in the United States and the rest of the world." "When a patient is diagnosed with multiple myeloma, in general, most patients are older. The median age of diagnosis of multiple myeloma is around 70 years old, and those plasma cells can cause damage to the normal bone marrow by crowding out the normal bone marrow."  "They can also make a lot of the protein that a normal plasma cell would make. By making a lot of that protein, those proteins can cause deposition and damage into other tissues. So, patients can arrive at the clinic with a variety of different symptoms that have to do with either decreased bone marrow activity, decreased number of normal cell populations in their blood, or damage to things like their kidneys or other end organs that you need for normal human function." #Arcellx #CellTherapy #CARTTherapy #RRMM #MultipleMyeloma #BloodCancer #Cancer #RareDisease arcellx.com Listen to the podcast here

Dr. Chris Heery is Chief Medical Officer at Arcellx, a company focusing on developing anito-cel, a significant advancement in CAR-T cell therapy, to treat relapsed and refractory multiple myeloma (rrMM). Multiple myeloma is a rare type of blood cancer that affects plasma cells in the bone marrow and has few treatment options. Arcellx is showing promising data from clinical trials with patients with rrMM who have failed prior therapies and have received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations from the FDA for anito-cel. Chris explains, "The company was founded based on an idea that you could take a novel protein structure and modify it to be able to bind to targets on the surface of cancer cells. And over many years of work, the founders were able to demonstrate that that was possible. Over the last three or four years, Arcellx has focused more on taking what were some of those early ideas and turning them into a product that can help patients. For these last three or four years, most of our focus has been around the lead asset that we call anito-cel that treats multiple myeloma and trying to get that product through the approval process to be able to be a commercial product that can be used for patients both in the United States and the rest of the world." "When a patient is diagnosed with multiple myeloma, in general, most patients are older. The median age of diagnosis of multiple myeloma is around 70 years old, and those plasma cells can cause damage to the normal bone marrow by crowding out the normal bone marrow."  "They can also make a lot of the protein that a normal plasma cell would make. By making a lot of that protein, those proteins can cause deposition and damage into other tissues. So, patients can arrive at the clinic with a variety of different symptoms that have to do with either decreased bone marrow activity, decreased number of normal cell populations in their blood, or damage to things like their kidneys or other end organs that you need for normal human function." #Arcellx #CellTherapy #CARTTherapy #RRMM #MultipleMyeloma #BloodCancer #Cancer #RareDisease arcellx.com Download the transcript here

Drs. Beverly Davidson and Bryan Simpson join Molecular Therapy EiC Dr. Roland Herzog to discuss their recent paper, Targeted long-read sequencing captures CRISPR editing and AAV integration outcomes in the brain, which was published in Molecular Therapy. ASGCT is proud to present this episode of the Molecular Therapy Podcast in partnership with our upcoming Advancing Gene and Cell Therapy for Cancer conference, which will be held on October 16 and 17 in Philadelphia and online. This landmark hybrid event brings together innovative treatment approaches and an unparalleled opportunity to immerse yourself in the latest gene and cell therapy research for cancer. Learn more and register today at ASGCT.org/Advancing. In This Episode: Dr. Roland HerzogEditor-in-Chief of Molecular Therapy and Professor of Pediatrics, Riley Children's Foundation Professor of Immunology, and Director of the Gene and Cell Therapy Program at Indiana University Dr. Beverly DavidsonChief Scientific Strategy Officer and Director of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics at Children's Hospital of Philadelphia Dr. Bryan SimpsonPreclinical Team Lead at Latus Bio 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0.www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

This Podcast offers a pathway to continuing education via this CMEfy link: https://earnc.me/07mw5v   Dr. Shikha Jain is a board-certified hematology and oncology physician on faculty at Rush University Medical Center with a focus on GI malignancies. She is an assistant professor of medicine in the Division of Hematology, Oncology and Cell Therapy and the Physician Director of Media Relations for the Rush University Cancer Center. She founded and co-chaired the inaugural Women In Medicine Symposium at Northwestern Memorial Hospital in Chicago in 2018 focused on promoting the advancement of women physicians at Northwestern. She is the co-founder and co-chair of the “Women in Medicine Summit: An Evolution in Empowerment” in Chicago. This national CME conference focuses on gender equality and finding and implementing solutions to eliminate the gap. Dr. Jain  is a member of the Women's Leadership Council at Rush and is the founder and host of the podcast “The Rush Cast.” Her clinical focus is GI oncology with a special interest in neuroendocrine tumors.  Her research interests include neuroendocrine tumors, precision oncology, immunotherapy, genomics, colorectal and pancreatic cancers, hepatocellular carcinoma and advances in cancer therapy.  She has several papers published in peer-reviewed journals.  Her research interests also include gender equity and career advancement for women and underrepresented minorities in medicine, the impact of social media on medicine. -=+=-=+=-=+= Are you a doctor struggling to provide the best care for your patients while dealing with financial and caregiving matters out of the scope of your practice? Do you find yourself scrambling to keep up with the latest resources and wish there was an easier way? Finally, our Virtual Health and Financial Conference for Caregivers is here! This conference helps you and your patients enlist the best strategies around health care resources and the best financial steps for your patients to take while navigating care. You don't have to go home feeling frustrated and helpless because you couldn't connect your patients with the best services. In just 90 minutes, our VIP Live Roundtable will answer your questions and be the lifeline that helps your patients put together an effective caregiving plan. Find out more at Jeanniedougherty.com and click on Conference for Caregivers VIP. -+=-+=-+=-+= Join the Conversation! We want to hear from you! Do you have additional thoughts about today's topic? Do you have your own Prescription for Success? Record a message on Speakpipe   Unlock Bonus content and get the shows early on our Patreon Follow us or Subscribe: Apple Podcasts | Google Podcasts | Stitcher | Amazon  | Spotify --- There's more at https://mymdcoaches.com/podcast Music by Ryan Jones. Find Ryan on Instagram at _ryjones_, Contact Ryan at ryjonesofficial@gmail.com Production assistance by Clawson Solutions Group, find them on the web at csolgroup.com