BioTalk Unzipped

Why is gene therapy still so difficult to manufacture at scale after decades of progress?Phillip Ramsey, Chief Technical Officer at Sangamo Therapeutics, joins BioTalk Unzipped for a candid conversation about one of the central challenges facing advanced therapies: turning extraordinary science into reproducible, scalable medicines.Thank You to Our SponsorsLeucentra - https://leucentra.com/Inspired by Science. Empowered by IT. Leucentra provides specialized IT consulting and services for life sciences and healthcare, helping organizations use technology more effectively to support innovation.TruTechnologies - https://trutechnologies.ai/Clinical Trial Execution, Live. TruTechnologies provides live clinical trial execution technology that gives sponsors greater visibility into protocol activities, samples, and study data as they happen.About This EpisodeRecorded onsite at the AAPS National Biotechnology Conference in Boston, Phillip explains why gene therapy manufacturing has not yet reached the maturity of monoclonal antibody production.As technologies have evolved across retroviral vectors, lentiviral vectors, adenovirus, AAV, lipid nanoparticles, and other advanced modalities, development teams have repeatedly been required to rethink fundamental manufacturing and analytical questions.Phillip discusses why analytics are critical, why experience across multiple manufacturing lots and products matters, and why there simply is no shortcut to developing the scientific knowledge necessary to manufacture advanced therapies reliably.He also reflects on the uncertainty of biotechnology.Early in his career, Phillip was walking down a hallway when his CFO asked if he had cashed his paycheck.When he said no, she told him not to.It's a remarkable story that captures something rarely discussed about biotechnology: behind transformative science are people willing to operate through considerable uncertainty while trying to build something that has never existed before.Gregory and Phillip Discuss• Viral vector manufacturing and scale-up• Why analytics are essential to gene therapy development• AAV manufacturing challenges• Lentiviral vectors and other evolving delivery technologies• Lipid nanoparticles and changes in advanced therapy manufacturing• Why gene therapy cannot simply adopt the established monoclonal antibody manufacturing playbook• Building process knowledge across lots and products• Career resilience in biotechnology• Progress across AAV, CAR-T, and other advanced therapies• Gene therapy affordability• The importance of therapeutic durability• Outcomes-based payment models for advanced therapiesPhillip's message for scientists and industry leaders is straightforward: don't assume the manufacturing problem has already been solved simply because a technology has existed for decades.The field is still evolving, and some knowledge cannot be shortcut.About Phillip RamseyPhillip Ramsey is Chief Technical Officer at Sangamo Therapeutics and brings more than 35 years of experience across biotechnology and pharmaceutical manufacturing, technical development, operations, quality, and advanced therapies.Connect with Phillip Ramsey:https://www.linkedin.com/in/phillip-ramsey-a2074711/Sangamo Therapeutics:https://www.sangamo.com/Connect With BioTalk UnzippedGregory Austin on LinkedIn:https://www.linkedin.com/in/gregoryaustin1/Dr. Chad Briscoe on LinkedIn:https://www.linkedin.com/in/chadbriscoe/BioTalk Unzipped:https://www.biotalkunzipped.com/BioTalk Unzipped unzips, unlocks, and uncovers the stories behind medical progress through conversations with scientists, executives, entrepreneurs, and innovators advancing biotechnology, pharmaceuticals, and medical technology.Recorded onsite at the AAPS National Biotechnology Conference in Boston.Special thanks to AAPS and Rebecca Stauffer for supporting the BioTalk Unzipped interview series.

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment.01:20 Introduction to BioTalk Unzipped02:01 Celebrating Women in Pharmaceutical Sciences03:21 The Importance of STEAM Education04:09 Personal Journeys into Science08:02 Exciting Projects and Discoveries13:52 Challenges in CMC for Cell and Gene Therapies18:51 Innovations in Chiral Bioanalysis22:46 NEW NEWS! - New ADC Approved28:33 Exploring Combination Therapies in Cancer Treatment32:26 Empowering Women in Pharmaceutical Sciences37:30 Mentorship and Community Engagement45:18 The Role of Allyship in Science47:19 Breaking Barriers and Challenging Stereotypes54:15 Engaging Diverse Voices in Discussions56:49 Creating Inclusive Spaces for Feedback & Speaking Up01:01:15 Avoiding Assumptions in Professional Settings01:02:04 Setting Boundaries for Work-Life Balance01:05:24 Measuring Success in Life01:07:06 Connecting and Networking EffectivelyDr. Ines Santoshttps://www.linkedin.com/in/insantos/ Dr. Julia Sablehttps://www.linkedin.com/in/julia-sable-5b794385/ STEAMparkhttps://www.steampark.org/ WIPS in AAPShttps://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Story: In Fierce Pharma - Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphomahttps://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma Journal Article mentioned:Emerging applications of quantitative supercritical fluid chromatography-tandem mass spectrometry for chiral bioanalysishttps://www.sciencedirect.com/science/article/abs/pii/S0021967325000767 Sound Bites"We want to build our next generation.""We all want the same result.""You have to have a level of extrovert.""If you see something, say something.""Take action this year."Image Credits:AAPS & WIPS logos: https://www.aaps.org/ KeywordsBioTalk, pharmaceutical sciences, women in science, CMC challenges, chiral bioanalysis, CAR-T therapies, STEAM education, innovations in medicine, healthcare advancements, biotechnology, cancer treatment, CAR T therapy, women in science, mentorship, allyship, pharmaceutical sciences, community engagement, combination therapies, empowerment, gender equality, engagement, feedback, inclusivity, allyship, professional development, work-life balance, success, networking#pharmaceutical #women #womenempowerment #science #drugdevelopment #biotech #biopharma #mentor #mentorship #AAPS #WIPS

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a clinical pharmacology and pharmacometrics expert with more than 20 years of experience in drug development.Nathan brings a clear, practical perspective on one of the most important questions in biopharma: how do we choose the right dose for the right patient, especially in complex areas like oncology and cell therapy?The conversation explores the changing landscape of pharmaceutical development, including virtual clinical trials, patient engagement, clinical pharmacology, pharmacometrics, oncology dose optimization, and the importance of collaboration across scientific disciplines.Nathan discusses why dose selection is not just a technical detail. It can shape safety, efficacy, patient experience, regulatory strategy, and ultimately whether a therapy succeeds. The episode also touches on FDA’s Project Optimus, the evolving expectations around oncology dosing, and the challenge of treating immunocompromised patients in areas such as cell therapy.The discussion also highlights how technology, data, and AI may help improve clinical trial design and patient selection, while still requiring thoughtful ethical judgment and scientific discipline.Nathan also shares advice for young scientists entering biopharma, including the importance of listening first, learning across disciplines, and approaching scientific collaboration with humility and curiosity.The episode closes with Nathan’s reflections on success, purpose, and his own Clinical Pharmacology Podcast, which helps educate listeners on clinical pharmacology, pharmacometrics, and drug development topics.In this episodeGregory, Chad, and Nathan discuss:The changing landscape of pharmaceuticalsVirtual clinical trials and patient engagementHow pharmacometrics supports better dose selectionWhy oncology dosing is evolvingFDA’s Project Optimus and its impact on cancer drug developmentChallenges in cell therapy developmentTreating immunocompromised patientsThe role of collaboration in scientific progressAdvice for young scientists in biopharmaNathan’s Clinical Pharmacology PodcastFeatured guestDr. Nathan Teuscher is a clinical pharmacology and pharmacometrics expert, founder of Aplos Analytics, and host of the Clinical Pharmacology Podcast.Nathan Teuscher: https://www.linkedin.com/in/nathanteuscher/Aplos Analytics: https://aplosanalytics.com/Email: [email protected] Pharmacology Podcast: https://teuschersolutions.com/Spotify: https://creators.spotify.com/pod/show/clinical-pharmacologyApple Podcasts: https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234Collaboration with BioTalk Unzipped, Ep. 40: https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951New News storyAfter two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy: https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblastConnect with BioTalk UnzippedAll BioTalk Unzipped Episodes: https://www.youtube.com/@BioTalkUnzipped/videosDr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/Celerion: https://www.celerion.com/Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/BioTalk Unzipped on LinkedIn: https://www.linkedin.com/company/biotalk-unzippedKey themesClinical pharmacology and pharmacometrics are central to smarter drug development because they help teams understand exposure, response, variability, safety, and dose optimization.In oncology, the field is moving beyond the assumption that the highest tolerated dose is automatically the best dose. Better dosing decisions can improve tolerability, patient experience, and development strategy.Virtual trials and digital tools may help reduce patient burden and increase access, but they must be designed with scientific rigor and ethical responsibility.Cell therapy presents unique challenges because patient immune status, disease severity, treatment history, and biology can all affect outcomes.Collaboration is not just a professional virtue. In modern drug development, it is a scientific necessity.Sound bites“If you want to be successful, seek first to understand, then be understood.”“If you’re looking to help people and in collaboration, you’ll be successful.”“Success in life is the happiness of loved ones around you.”KeywordsBioTalk Unzipped, Nathan Teuscher, clinical pharmacology, pharmacometrics, drug development, dose optimization, oncology dosing, Project Optimus, virtual clinical trials, patient engagement, clinical research, cell therapy, Mesoblast, FDA approval, immunocompromised patients, biopharma collaboration, pharmaceutical development, clinical trial innovation, AI in pharma, data science in drug development, precision medicine, personalized medicine, Clinical Pharmacology Podcast, Aplos Analytics

In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients. Chapters 00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 360 03:45 Samaritan's Purse Charity and Community Impact 05:16 Most impactful talk at AAPS? 11:50 Comparative Analysis of FDA and EU Regulations 17:37 The Drive Behind Bioanalytical Work 22:24 NEW NEWS! - Innovations in RNA Editing and Bioanalysis Takeaways ​The FDA's new rules on lab-developed tests could delay biomarker utilization in clinical trials. ​Community support through charities like Samaritan's Purse is crucial during crises. ​The importance of collaboration in advancing drug development and bioanalytical methods. ​Innovations in RNA editing present new bioanalytical challenges. ​The drive to help patients is a key motivator for professionals in the field. ​ Sound Bites ​"I worked on that drug and there's a clear benefit." ​"It's getting that new therapy to a patient." ​"This is going to change and potentially delay biomarkers." ​ New News Story: ​Wave sees RNA editing validation in early trial results ◦https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/ (https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/) How to reach us: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ (https://www.samaritanspurse.org/) Mark Arnold https://www.linkedin.com/in/markearnoldphd/ (https://www.linkedin.com/in/markearnoldphd/) Blog - https://bioanalysisandbiomarkers.blogspot.com/ (https://bioanalysisandbiomarkers.blogspot.com/) Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ (https://www.linkedin.com/in/chadbriscoe/) Celerion - https://www.celerion.com/ (https://www.celerion.com/) Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ (https://www.linkedin.com/in/gregoryaustin1/) ECI - https://eci-rx.com/ (https://eci-rx.com) / Image Credits ​AAPS

Dr. Tomas Helikar, a leading researcher in bioinformatics and systems biology, delves into groundbreaking work on developing a personalized immune digital twin, which aims to revolutionize the understanding and treatment of immune-related diseases. Chapters00:00 Introduction to BioTalk Unzipped01:50 Meet Dr. Tomas Helikar04:34 The Journey into Systems Biology10:03 Understanding Digital Twins in Immunology14:19 The Importance of Personalized Medicine17:20 Digital Twin Research Funding and Its Impact18:38 The Role of Digital Twins in Disease Management21:11 Digital Twin Efforts for Organ Transplants24:05 Computational Challenges in Modeling26:36 Mathematical Models in Biological Research28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody CollaborationHow to reach us:Tomas Helikar https://www.linkedin.com/in/tomashelikar/ X - https://x.com/tomashelikar Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Charity Mentioned: https://saintpeterlincoln.com/school FOLLOW ►LinkedIn: https://www.linkedin.com/company/biotalk-unzippedTwitter: https://x.com/BiotalkUnzippedInstagram: https://www.instagram.com/biotalkunzipped/ TakeawaysDr. Helikar's research focuses on the immune system's network and disease.Systems biology integrates computer science and biology for better understanding.Digital twins can provide personalized models for immune system analysis.Your digital twin model could tell you how you might respond to a particular disease and if you really need to go to the hospital.The immune digital twin reflects an individual's unique immune baseline.Research funding is crucial for advancing innovative medical technologies.Personalized medicine can improve public health outcomes significantly.Computational power is essential for processing complex biological data.Mathematical models are vital for simulating biological processes.Digital twins can enhance drug discovery and clinical trial efficiency.Sound Bites"The immune system is a network of networks."“Each of our immune system baselines are different.”"We need to build out this multi-scale model."New News Story: Supplier-Turned-Partner: Twist Joins Absci in AI Antibody Collaborationhttps://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/Image CreditsSignal Transduction, www.scientificanimations.com - http://www.scientificanimations.com/wiki-images/Computational Model, https://computationstructures.org/notes/models/notes.html Holland computer center, https://newsroom.unl.edu/announce/cse/16380/90600 https://news.unl.edu/article/husker-football-game-day-information-announced-for-2023https://hcc.unl.edu/office-locations

EP-23. In the second half of this compelling conversation on BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their deep dive with Scott Ogle, CEO of TruLab. They explore the surprising parallels between the banking and pharma industries, the game-changing role of digital twinning in clinical trials, and the biotech funding landscape. Scott also shares his thoughts on leadership, mentorship, and the impact of the Inflation Reduction Act on pharma innovation. This episode offers listeners valuable insights into the future of drug development and the challenges of balancing professional and personal life in a fast-paced industry.Chapters1:09 - Comparison of the Banking Industry to the Pharma Industry5:18 - Data Integrity, Same For Decentralized Trials?8:33 - Biotech Funding Trends11:18 - NEW NEWS! – Digital Twinning in Clinical Trials16:15 - What Advice Would You Give to Your Younger Self?20:57 - Mentorship and Its Impact, How it Shaped Scott23:45 - Balancing Work and Personal Life24:32 - The Inflation Reduction Act and InnovationTakeawaysThe regulatory environment in pharma can slow down innovation.Digital twinning in clinical trials could revolutionize drug development.Family influences play a significant role in shaping business perspectives.The need for a strong company culture to maintain values during growth.Biotech funding trends are influenced by macroeconomic factors like interest rates.The importance of mentorship in professional development.Sound Bites“The similarities between the banking industry and the pharma industry is eerily similar.”“Quality is really what we do.”“Being quality is core to software.”“It’s really clear people care more about their money than they do their healthcare.”“Biotech and large pharma seem to balance each other out.”“The career for you is at the intersection of what you are good at and what you like to do.” “If you’re good at something and you like to do it, it fuels your energy to keep getting better.”“Enjoy the impact in what you’re doing and accomplishing!”New News Story: Digital “Twinning”: Clinical Trials Powered by AIhttps://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai How to reach us:Scott Oglehttps://www.linkedin.com/in/scott-ogle/ TruLab - https://trulab.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image CreditsDigital Twinning - Credit Getty ImagesSimulation - Credit: andrush / Adobe StockTomáš Helikar - https://www.linkedin.com/in/tomashelikar/ Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/

Mentoring in Pharmaceutical Science with Dr. Jim ShenSummaryIn Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography.Chapters01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference 05:10 - Early Career in Bioanalysis07:35 - The Importance of Mentorship and Dealing With Adversaries17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy24:55 - Personal Interests: Photography and GamingTakeawaysDr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of othersBuild a network of champions, allies, and sponsorsBe open to new career opportunities and emerging fieldsMaintain integrity and transparency in scientific researchExplore different hobbies and interests outside of workSound Bites“Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.”“EQ is so important in being successful in your larger pharmaceutical company.”“I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.”“And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.”New News Story: Following FDA rejection, a journal retracts papers on MDMA-assisted therapyhttps://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/ How to reach us:Dr. Jim Shenhttps://www.linkedin.com/in/jimxshen/ Bristol Myers Squibb - https://www.bms.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image CreditsTravis Kelce:https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DQY8xlVldVp8&psig=AOvVaw2yCKg3oh923dt0beIIR8w3&ust=1726284386832000&source=images&cd=vfe&opi=89978449&ved=0CBcQjhxqFwoTCICN_OD8vogDFQAAAAAdAAAAABB2https://www.te-university.com/postshttps://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.htmlhttps://www.newheightshow.com/ https://www.aol.com/fans-think-moment-travis-kelce-185629668.htmlWorld of Warcraft Guildshttps://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/ Infrared Photography: Jim ShenKeywordsPharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis