Explore every episode of the podcast BioTalk Unzipped

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	Title	Pub. Date	Duration
	Do Clinical Trials Take Too Much Blood? Patient-Centric Sampling with Joleen White	11 Sep 2026	00:48:13
Clinical trials often collect far more blood than an assay actually needs. Dr. Joleen White asks a more disciplined question: What information is required to make a sound decision, and how little sample can be collected without compromising that decision? In this episode of BioTalk Unzipped, recorded at the 2026 AAPS National Biotechnology Conference in San Diego, Dr. Chad Briscoe sits down with Joleen to explore patient-centric sampling, dried blood microsampling, global bioanalytical capacity, and the values behind better drug development. Joleen traces her path from a childhood friendship with someone living with cystic fibrosis to a career spanning BioMarin, BMS, Biogen, EMD Serono, the Gates Medical Research Institute, and BioData Solutions. She explains why bioanalysis became her way to help patients, why she eventually moved beyond the bench, and how global health work changed the way she thinks about laboratory infrastructure and clinical-trial design. The conversation then turns practical. Joleen defines patient-centric sampling, describes the Mitra dried blood collection device, and discusses a first-in-human RSV monoclonal antibody study in which paired dried-blood and serum samples led to aligned PK conclusions. She and Chad examine regulatory acceptance, remote collection, pediatric sampling, local laboratory capacity in African countries, scientific inclusion, career choices, AI, mass-spectrometry sensitivity, and whether long-standing sample-volume and stability expectations still serve patients. Sponsors TruTechnologies provides live clinical trial execution and oversight through point-of-care data capture. Learn more: https://trutechnologies.ai/ Leucentra provides specialized IT consulting and services for life sciences and healthcare. Learn more: https://leucentra.com/ In this episode, you will hear • How a personal connection to cystic fibrosis shaped Joleen's patient-first career • Why bioanalysis connects analytical rigor to decisions about drug safety, exposure, and patient benefit • What patient-centric sampling means beyond simply collecting less blood • How dried blood microsampling can support PK, immunogenicity, and viral-neutralization assessments • What Joleen's team learned by comparing dried blood with serum in a first-in-human study • Why smaller samples and remote collection can reduce burdens on patients, caregivers, sites, and enrollment • Why sustainable global health research depends on locally led scientific and laboratory capacity • How legacy automation can slow innovation and create opportunities for newer laboratory networks • Why inclusion and access expand both the scientific workforce and the quality of science • How personal values can guide career decisions more effectively than a rigid five-year plan • Why advances in mass spectrometry should prompt a fresh look at sample volumes and stability expectations Guest and host Dr. Joleen White is a Senior Bioanalytical Consultant at BioData Solutions with more than 20 years of experience across regulated bioanalysis, ligand-binding assays, immunogenicity, cell-based assays, neutralizing-antibody assays, and data science. Connect with Joleen: https://www.linkedin.com/in/joleenwhite/ BioData Solutions: https://www.bdatasolutions.com/ Dr. Chad Briscoe is the co-host of BioTalk Unzipped and conducts this onsite conversation from AAPS NBC. Connect with Chad: https://www.linkedin.com/in/chadbriscoe/ Resources mentioned Open-access RSM01 dried blood microsampling study: https://pubmed.ncbi.nlm.nih.gov/39696004/ Patient Centric Sampling Interest Group: https://www.pcsig.org/ Follow BioTalk Unzipped Website and all episodes: https://www.biotalkunzipped.com/ YouTube: https://www.youtube.com/@BioTalkUnzipped BioTalk Unzipped unzips, unlocks, and uncovers the real stories behind medical progress.
	Why Gene Therapy Is Still So Hard to Manufacture at Scale \| Phillip Ramsey	08 Aug 2026	00:11:25
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 Sponsors Leucentra - 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 Episode Recorded 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 therapies Phillip'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 Ramsey Phillip 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 Unzipped Gregory 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.
	Her Daughter’s Brain Tumor Turned Her Into a Biotech Founder \| Tracy Ryan	20 Jul 2026	01:04:18
A mother’s search for answers to her daughter’s relentless brain tumor led her into natural killer cell biology, cancer immunotherapy, and biotech entrepreneurship. Sponsored by Leucentra, https://leucentra.com/ Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation. Tracy Ryan, co-founder of NKore BioTherapeutics and former chief communications officer, joins Gregory Austin and Dr. Chad Briscoe to explain how her daughter Sophie’s pediatric brain tumor transformed her from a parent searching for options into a cancer advocate, research fundraiser, and biotechnology founder. The conversation examines the scientific reasoning that moved Tracy from medical cannabis advocacy toward NK-cell immunotherapy. She describes an immune-system finding involving Sophie’s natural killer cells, the work of the late UCLA scientist Dr. Anahid Jewett, and the development of an experimental allogeneic NK-cell platform designed to enhance immune activity without genetic engineering. The episode also explores the practical realities of translating an early scientific hypothesis into a therapeutic program, including donor selection, cell persistence, manufacturing, treatment outside the United States, regulatory requirements, clinical evidence, and the difficulty of raising capital for an emerging cell-therapy company. At the center of the discussion is a difficult question: how do scientists, founders, regulators, and families preserve urgency when patients need better options, while still requiring the controlled evidence needed to determine whether a therapy is safe and effective? What you will learn: • How Sophie’s pediatric brain tumor changed the direction of Tracy Ryan’s life • Why natural killer cells are important in immune surveillance and cancer biology • What differentiates allogeneic NK-cell approaches from CAR-T and CAR-NK therapies • How NKore’s experimental platform was designed to activate donor-derived NK cells • Why persistence, donor biology, manufacturing, and lymphodepletion matter in cell therapy • Why early human observations must remain distinct from controlled clinical-trial evidence • How regulatory pathways and capital constraints shape whether promising science reaches patients • What parents facing pediatric cancer need from the scientific and medical community About Tracy Ryan: Tracy Ryan is a pediatric cancer advocate, entrepreneur, public speaker, and biotechnology co-founder. She formerly served as chief communications officer of NKore BioTherapeutics. Her daughter Sophie was diagnosed with a brain tumor during infancy, leading Tracy and her family into more than a decade of advocacy, research support, fundraising, and therapeutic exploration. Tracy and her husband also established Saving Sophie to support pediatric cancer research and help families pursue care. Their family’s experience with medical cannabis was featured in the documentary Weed the People. Connect with Tracy Ryan: https://www.linkedin.com/in/tracyryan23/ Connect with Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Connect with Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Watch more BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped/videos Visit BioTalk Unzipped: https://www.biotalkunzipped.com Learn more about NKore BioTherapeutics: https://www.nkore.com Support Saving Sophie: https://www.savingsophie.org This episode is brought to you by founding sponsor Lucentra. Lucentra provides information technology consulting for life science and healthcare organizations, helping teams modernize infrastructure, strengthen security, and build scalable technology environments that support scientific innovation. Subscribe to BioTalk Unzipped for conversations with the scientists, founders, regulators, and business leaders shaping the future of medicine. Medical and scientific disclaimer: This conversation is provided for educational and informational purposes only. It does not constitute medical advice, diagnosis, or treatment guidance. The therapies and outcomes discussed may be investigational, preliminary, or based on individual experience. Early observations do not establish safety or efficacy. Patients and caregivers should consult qualified healthcare professionals before making medical decisions. #CancerImmunotherapy #NKCells #PediatricCancer
	The Future of Oncology Drug Development \| Dr. Lakshmi Amaravadi	11 Jun 2026	00:29:41
Oncology drug development is becoming more complex, and bioanalysis can no longer be treated as simple drug measurement. Sponsored by Leucentra, https://leucentra.com/ Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation. In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe speak with Dr. Lakshmi Amaravadi, Head of Oncology Bioanalysis at AstraZeneca, live from AAPS PharmSci 360 in San Antonio. Dr. Amaravadi unpacks why biomarker validation is not one-size-fits-all, how context of use should guide scientific decision making, and why fit-for-purpose validation matters in modern oncology drug development. The conversation explores: 00:00 Why oncology bioanalysis is becoming more complex 02:12 FDA biomarker validation guidance and industry response 04:27 What “fit for purpose” means in practice 06:38 PK assay validation vs biomarker assay validation 07:52 What drives Dr. Amaravadi’s work in translational science 10:48 Why validation is not a checkbox exercise 12:19 Advice for young scientists entering bioanalysis 15:12 Why oncology drug development is uniquely complex 18:17 ADCs, bispecifics, T-cell engagers, and conditional T-cell engagers 19:38 Why bioanalysis now requires understanding biology 20:46 Dr. Amaravadi’s path from molecular biology to bioanalysis 24:34 Critical reagent management in complex oncology assays 26:42 Validation, qualification, and context of use 29:03 Final thoughts from AAPS PharmSci 360 This episode is especially relevant for scientists, bioanalytical leaders, translational researchers, clinical pharmacologists, oncology development teams, biomarker scientists, and anyone working at the intersection of drug development, assay validation, and precision medicine. Dr. Amaravadi discusses how oncology programs now involve ADCs, bispecifics, T-cell engagers, conditional T-cell engagers, complex linkers, multiple measurable species, immunogenicity considerations, and biomarker strategies that require deeper biological understanding. As she explains in the episode, the future of oncology bioanalysis is not simply measuring what is present. It is understanding what the measurement means in the context of the biology and the development decision. Follow BioTalk Unzipped for conversations with leaders in biotech, pharma, bioanalysis, clinical development, translational science, regulatory strategy, and the future of medicine. Guest Dr. Lakshmi Amaravadi https://www.linkedin.com/in/lakshmi-amaravadi/ Hosts Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Sponsor: Leucentra Related Links Celerion https://www.celerion.com/
	Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker	25 Apr 2026	00:50:37
Can artificial intelligence help make cancer therapies safer, more targeted, and more effective? In this episode of BioTalk Unzipped, Gregory Austin sits down with Dr. Daniel Reker, Assistant Professor at Duke University, for a wide-ranging conversation on active machine learning, nanomedicine, drug delivery, and the future of AI in biomedical research. This episode is brought to you by Leucentra. Inspired by Science Empowered by IT https://leucentra.com/ Dr. Reker works at the intersection of AI, chemistry, biomedical engineering, pharmacology, and molecular medicine. His lab develops computational and experimental approaches to better understand small molecules, nanoformulations, and drug delivery systems. The conversation explores how machine learning can support drug discovery and development, especially in areas where datasets are small and the biology is complex. Dr. Reker explains why nanoformulations may be able to improve targeted drug delivery, reduce toxicity, and potentially revive therapeutic agents that previously failed because of safety or tolerability issues. Gregory and Dr. Reker also discuss explainable AI, the risks of black box thinking, AI bias, predictive modeling, FDA considerations, non-animal models, and the responsible use of AI in education and science. Topics include: • Active machine learning in drug discovery • AI and nanomedicine • Cancer therapy and targeted drug delivery • How nanoformulations may reduce toxicity • Small datasets in biomedical AI • Explainable AI and scientific trust • AI bias and model limitations • Regulatory implications for predictive models • The role of AI in education and cognitive development • The future of integrated data in drug development Guest bio: Dr. Daniel Reker is an Assistant Professor at Duke University. His research focuses on computational and experimental approaches to molecular medicine, including active machine learning, drug delivery, nanoformulations, small molecules, and translational pharmacology. He was named to Forbes 30 Under 30 Europe in Science and Healthcare. Guest contact: Dr. Daniel Reker Email: daniel.reker@duke.edu LinkedIn: https://www.linkedin.com/in/danielreker/ Duke website: https://rekerlab.pratt.duke.edu/ Connect with BioTalk Unzipped: Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ BioTalk Unzipped uncovers the stories behind medical progress through conversations with innovators across biotech, pharma, medtech, bioanalysis, clinical research, regulatory science, and drug development.
	Why Haven’t We Cured Cancer Yet? \| Dr. Bob Liu Explains	19 Mar 2026	01:00:16
Why haven’t we cured cancer yet? A Genentech scientist explains the real reason. In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Bob Liu, Senior Principal Scientist at Genentech Roche, to unpack one of the most important and misunderstood questions in modern medicine. This is a rigorous, scientifically grounded conversation on cancer biology, immunotherapy, and the real constraints shaping oncology drug development today. Dr. Liu brings over a decade of experience across antibody drug conjugates (ADCs), bispecific antibodies, and CAR-T therapies, offering a rare, insider perspective on why a universal cure remains elusive and where meaningful progress is actually being made. Thanks to our Founding Sponsor: LEUCENTRA: Helping teams evaluate, implement, and get real value from IT solutions that support innovation, not slow it down. https://leucentra.com/ What You’ll Learn Why cancer is not one disease, but more than 200 biologically distinct conditions What “curing cancer” actually means in clinical oncology How immunotherapies like checkpoint inhibitors and CAR-T are changing outcomes The biological limits of eliminating every cancer cell How tumors evade immune detection and adapt over time Why only about 20% of patients respond to immuno-oncology therapies The role of biomarkers, molecular profiling, and precision medicine Why early detection remains one of the biggest unsolved challenges The economic and regulatory pressures shaping next-generation therapies Key Insight Cancer is not simply something to eliminate. It is a dynamic, adaptive system evolving within the human body. The future of oncology is not just eradication, but control, personalization, and intelligent engagement of the immune system. Notable Quotes “Cancer is a collection of more than 200 diseases, each requiring its own specific approach.” “The cure for some cancers is within reach, but for many others, early detection remains the critical challenge.” “Our immune system is constantly surveilling. The key is learning how to harness it effectively.” Timestamps 00:00 – Introduction 02:42 – Bob’s passion - AACR 04:28 – Why we haven’t cured cancer 07:09 – Defining a cancer cure 10:26 – Cancer classification and molecular signatures 14:16 – Methylation profiling in diagnosis 17:22 – Patient resources and navigation 21:14 – FDA shifts toward randomized trials for CAR-T 24:15 – Cost and access challenges 26:33 – Cancer vs cardiovascular disease progress 33:39 – The challenge of early detection 37:48 – Biomarker limitations 39:14 – Immune system dynamics in cancer 45:19 – Bioanalytical challenges in modern therapies 51:08 – Progress and future outlook About the Guest Dr. Bob Liu is a Senior Principal Scientist at Genentech Roche specializing in bioanalytical sciences and immunogenicity assessment for advanced oncology therapies, including T-cell bispecifics and CAR-T. Resources & Links FDA to tighten approval requirements for CAR-T therapies https://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-cel American Association for Cancer Research (AACR) https://www.aacr.org/ National Cancer Institute – Molecular diagnostics and biomarkers https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis Pattern recognition technologies in diagnostics https://toby.health Connect Dr. Bob Liu https://www.linkedin.com/in/bob-liu-42b8b278/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Final Thought The path to curing cancer is not a single breakthrough. It is a long, complex progression of scientific advances, better diagnostics, and deeper biological understanding. The progress is real. But the work is far from finished.
	The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney	16 Feb 2026	00:52:45
Recorded October 31, 2025 In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Kate Neville, immunologist turned seasoned biotech patent attorney at Marshall, Gerstein & Borun, to unpack one of the most misunderstood and mission-critical areas of life sciences: intellectual property. If you are a biotech founder, scientist, executive, or investor, this conversation is essential listening. We explore what patent prosecution really means, when startups should begin thinking about IP protection, how “freedom to operate” can determine commercial viability, and how emerging AI tools are reshaping the patent landscape. Dr. Neville brings 25+ years of experience guiding university spin-outs, biotech startups, and global pharmaceutical companies through complex patent strategy. She has helped secure patents for FDA-approved drugs and offers a rare dual perspective as both scientist and attorney. In This Episode We Discuss: • The difference between patent prosecution and patent litigation • Why it is never too early for biotech startups to think about IP • The U.S. one-year grace period vs. Europe’s stricter disclosure rules • What “Freedom to Operate” really means for commercialization • Antibody patents, CDR regions, and the doctrine of equivalents • How premature disclosure can impact global patent strategy • The real-world back-and-forth of patent office “office actions” • AI-assisted prior art search at the USPTO — opportunity or risk? • How funding cycles influence patent filing decisions • Women in biotech leadership and venture funding disparities • The most rewarding part of protecting life-changing therapies We also break down the USPTO’s new AI pilot programs designed to modernize patent examination and discuss how artificial intelligence may impact biotech patenting over the next several years. Why This Matters Intellectual property is often the single most valuable asset in a biotech company. Strong IP strategy can unlock funding, partnerships, and market exclusivity. Weak or mistimed IP decisions can permanently limit global opportunity. For founders and scientists: timing, geography, and disclosure discipline matter more than most people realize. About Our Guest Dr. Kate Neville Partner, Marshall, Gerstein & Borun PhD in Immunology, JD LinkedIn: https://www.linkedin.com/in/kate-neville-phd/ Firm Bio: https://www.marshallip.com/katherine-l-neville-ph-d/ Charity Highlight: Girls on the Run Chicago An organization building confidence and resilience in young girls through mentorship and athletic achievement. https://www.girlsontherun.org/ Hosts Dr. Chad Briscoe Bioanalytical Scientific Leader https://www.linkedin.com/in/chadbriscoe/ Gregory Austin Director, Business Development \| Bioanalysis https://www.linkedin.com/in/gregoryaustin1/ If you enjoyed this episode, subscribe to BioTalk Unzipped on Apple Podcasts, Spotify, or your preferred platform and share with a colleague in biotech, pharma, or life sciences innovation.
	Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins	22 Dec 2025	00:49:00
In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe sit down with Glafabra CEO: Dr. Chris Hopkins, geneticist, biochemist, and biotech entrepreneur, to explore the science and strategy behind next generation cell-based gene therapies for rare diseases. With more than 25 years of experience spanning gene augmentation, rare disease biology, CRISPR licensing, and biotech formation, Dr. Hopkins shares how autologous, ex vivo engineered cell therapies may overcome key limitations of current enzyme replacement and viral gene therapies, particularly for Fabry disease. The conversation dives deep into: • How lentiviral gene augmentation in patient derived cells enables sustained enzyme production • Why redosing matters and where one time AAV therapies fall short • The scientific rationale for early intervention, including potential newborn treatment • Differences between autologous and emerging allogeneic approaches • Regulatory pathways for rare disease therapies and recent FDA developments • The role of non animal models in translational research • Montana’s early access therapy law and its broader implications • Building biotech platforms amid a challenging funding environment Topics include cell based gene therapy, Fabry disease, lentiviral vectors, stem cell engineering, rare disease drug development, regulatory science, and translational medicine. Subscribe to BioTalk Unzipped for in depth conversations with the scientists and leaders shaping the future of biomedical innovation. 00:00 - Intro 00:53 – Welcome to BioTalk Unzipped, Guest intro: Dr. Chris Hopkins 02:10 – Guest charity: Environmental Defense Fund 03:12 – His journey into rare-disease therapeutics and Glafabra 05:58 – Discovering a new enzyme-deficiency therapy 06:39 – Current standard of care 07:42 – How the new autologous cell therapy works 09:40 – Treating patients earlier (even newborns) 10:33 – Emerging therapies - AAV gene therapy vs. cell-based therapy 12:16 – Long-term results & repeat dosing 14:30 – Future plans: T-cells & allogeneic approaches *18:08 – New News: FDA resubmission for rare disease* 20:00 – Navigating FDA pathways 22:06 – Non-animal testing & alternative models 25:50 – Montana’s early-access therapy law & medical tourism 29:03 – Could other states follow? 31:31 – Biotech’s current funding challenges *33:46 – New News: Gene therapy trial saves 4-year-old* 37:09 – Long-term vision for expanding therapies 39:53 – Personal segment: outdoor life & skiing 44:43 – Guest question on international trade Dr. Christopher Hopkins https://www.linkedin.com/in/christopherehopkins/ Glafabra - https://www.glafabra.com/ Environmental Defense Fund - https://www.edf.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Articles: US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-asks-stealth-biotherapeutics-resubmit-application-rare-genetic-condition-2025-05-29/ Gene therapy trial saves boy, 4, from 'death sentence' https://www.thetimes.com/uk/healthcare/article/gene-therapy-trial-great-ormond-street-70l2sgqw Montana, revolutionary law passed: unlimited research for longevity https://en.ilsole24ore.com/art/montana-approved-revolutionary-law-researching-longevity-without-limits-AHmDI7BB?refresh_ce=1 *Key Takeaways1. A new cell therapy could replace lifelong enzyme treatments for Fabry patients.2. Unlike gene therapy, this treatment can be redosed* — no one-and-done limit.3. Early intervention, even in newborns, may become possible.4. Montana’s new law could open a fast lane for experimental therapies in the U.S.5. Despite a tough funding climate, breakthroughs show gene-edited cell therapies are reshaping the future. #CellTherapy #GeneEditing #RareDisease #BiotechInnovation #GeneticMedicine #HealthcareFuture #MedicalBreakthrough #CellBasedGeneTherapy #RareDisease #FabryDisease #GeneAugmentation #LentiviralVectors #Biotech #TranslationalScience #GeneticMedicine #BioTalkUnzipped https://youtu.be/VcPXZmK-XU8**
	Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva	23 Oct 2025	00:31:28
In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Binodh DeSilva, Senior Vice President of Bioanalysis at Ultragenyx Pharmaceutical, to explore the science and soul behind rare-disease drug development. From her early days studying electrochemistry at the University of Kansas to leading cutting-edge bioanalytical programs at Ultragenyx, Dr. DeSilva shares how curiosity and community shaped her four-decade career. She discusses the profound responsibility of working with limited, often irreplaceable patient samples with care. A special thanks to AAPS (https://www.aaps.org/) for their help and support of this episode. The conversation dives into: Balancing rigor and agility in small-population clinical studies Leveraging entrepreneurial mindsets from biotech within big pharma frameworks The promise of dried blood spots (DBS) and patient-centric sampling Mentorship, curiosity, and the future of scientific leadership Her return to Sri Lanka with KU faculty to recruit the next generation of scientists Throughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both. Guest Links Dr. Binodh DeSilva *https://www.linkedin.com/in/binodh-desilva/* Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ Hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.
	Unlocking Antibody Development with AI with Dr. Pin-Kuang Lai	12 Sep 2025	00:17:52
In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe interview Asst. Professor Pin-Kuang Lai from Stevens Institute of Technology about his keynote speech at AAPS NBC 2025 and the intersection of AI and molecular engineering, particularly in predicting the viscosity of monoclonal antibodies. They discuss the challenges of high concentration formulations, the importance of AI validation, and the future of formulation development. Lai shares insights from his international research journey and collaborations with pharmaceutical companies, as well as opportunities for students interested in this field. 00:00 Preview & Intro 01:58 Deep Viscosity and AI in Antibody Development 04:39 AI Validation and Model Reliability 07:12 International Journey and Collaborative Research 08:42 Future of Formulation Development 10:30 AAPS NBC Experience 11:30 Academic vs. Industry Career Paths 12:31 Collaboration with Pharmaceutical Companies 13:59 Modeling Protein Aggregation Challenges 14:43 Student Engagement and Research Opportunities 15:45 Expanding Applications of Machine Learning Dr. Pin-Kuang Lai https://www.linkedin.com/in/pin-kuang-lai/ Stevens Institute of Technology - https://www.stevens.edu/ Dr. Lai’s Publications - https://www.linkedin.com/in/pin-kuang-lai/details/publications/ The DeepViscosity Model - https://devpred.onrender.com/DeepViscosity Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/
	The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics	03 Jul 2025	00:22:17
In this powerful episode (#35) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin engages in a deep conversation with a leading Neuroscientist, Dr. Robert Thorne, Denali Fellow at Denali Therapeutics, for an intimate and scientific deep dive into the evolving world of brain cancer treatment and CNS drug delivery. Both Gregory and Dr. Thorne share personal stories of losing family members to brain metastases, weaving in the emotional 'why' behind their professional paths. Dr. Thorne highlights the complexities of the blood-brain barrier, the heterogeneity of brain metastases, and cutting-edge delivery technologies—including focused ultrasound and molecular engineering approaches. The conversation also touches on pediatric brain tumors like diffuse midline glioma (DIPG), emerging research in lysosomal storage diseases, and the collaborative spirit driving innovation in neuroscience today. This is more than a technical discussion—it’s a human story about grief, hope, and the relentless pursuit of better outcomes for patients with brain diseases. 00:00 Preview & Intro 01:10 Robert Thorne’s Reflections on the AAPS NBC conference 03:14 The Professional Biotech and Pharma League 05:09 A Personal Story Shared: Family Loss to Brain Cancer 07:57 My Reason for Optimism Treating Brain Cancer 08:50 Why Brain Metastases Remain Hard to Treat 11:10 Scientific Advances in Drug Delivery for Brain Cancer 12:30 Seed and Soil Concept in Oncology 15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond 16:49 Looking Ahead: Hope for Future Therapies 21:32 Closing Gratitude Dr. Robert Thorne https://www.linkedin.com/in/robert-g-thorne/ Denali Therapeutics - https://www.denalitherapeutics.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Key Takeaways: Personal Connection Fuels Professional Passion: Both Gregory and Dr. Thorne were driven into the life sciences field by family experiences with brain tumors. The Blood-Brain Barrier (BBB) Remains a Major Challenge: Brain metastases from cancers like melanoma, lung, and breast cancer still present difficult delivery barriers for therapies. Heterogeneity in Brain Mets: Different metastases within the same patient can have vastly different BBB permeability, requiring multifaceted delivery strategies. Emerging Drug Delivery Innovations: Focused ultrasound, engineered biologics, and Denali’s own delivery platforms are all promising ways to improve CNS drug penetration. Pediatric Brain Cancers Present a Unique Set of Challenges: Diseases like diffuse midline glioma (DIPG) remain largely untreatable, but learnings from lysosomal storage disorders may translate in the future. The Power of Community in Science: The conference setting highlights how collaboration and diverse perspectives drive breakthroughs in bioanalysis and drug development.
	Inside AAPS NBC with AAPS President Dr. Russ Weiner	08 Jun 2025	00:28:24
In this special episode (#34) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin and Dr. Chad Briscoe sit down with AAPS President Dr. Russ Weiner for an unfiltered look inside AAPS NBC, at the state of rare disease research, the evolution of therapeutic modalities, and the human stories that drive scientific innovation. From navigating the emotional weight of personal loss to watching his son experience the field firsthand, Russ shares not only his scientific insights but the heart behind his leadership. The conversation spans topics like the rising promise of AI diagnostics, challenges with biomarker sampling logistics, the role of CROs in rare disease trials, and the future of autologous vs. allogeneic therapies. Dr. Weiner also offers an inspiring vision of industry collaboration, sharing how organizations like AAPS are becoming conduits for progress across low- and middle-income countries, underrepresented diseases, and emerging biotechnologies. Whether you're in the lab, the boardroom, or on the frontlines of clinical trials, this episode will reignite your sense of purpose in this field. 00:00 Preview & Intro 01:22 What is conference life like as AAPS President 02:27 Mentoring & Fatherhood at AAPS 03:54 Setting up the Meeting Season for AAPS 05:43 Life back in the Rare Disease Space - a Passion 10:58 The different costs of pharmaceutical & biotech research 12:59 The generosity of Rare Disease Patients 14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts 19:57 Rare Disease conversations happening at AAPS and global reach 22:37 Broad use of new technologies, including Olink 24:10 Biggest change expected in Pharma in 10 years Dr. Russ Weiner https://www.linkedin.com/in/russellweiner/ AAPS - https://www.aaps.org/home Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Takeaways: Treating rare diseases early is not only life-saving—it’s economically sound. Gene and cell therapies may carry high price tags, but they dramatically reduce long-term costs. The diagnostic delay for rare diseases—often 4 to 7 years—remains one of the biggest barriers to treatment. AI-powered diagnostics and data integration could change that. Dr. Russ Weiner shares how personal loss fueled his career in science and how mentoring the next generation, including his son, brings it full circle. The shift toward allogeneic cell therapies and in vivo CAR-T treatments will be key to driving down costs and increasing global accessibility. CROs must evolve: future-ready organizations will localize biomarker analysis and forge relationships with rare disease investigators to improve site performance. Technologies like Olink are revolutionizing biomarker discovery, enabling cost-effective, high-resolution multiplexing that was previously out of reach. Spatial imaging, AI pathology, and facial-recognition-based diagnosis are the next wave of precision medicine. Quotes “Treating rare disease isn’t just compassionate—it’s a smart investment. Do the math, and curing someone can be far cheaper than managing chronic care for a lifetime.” “You can’t say it’s not in your backyard when that backyard becomes yours the moment you're on the same plane.” *(on global health and infectious disease risk)* “Some of the most generous people in clinical research are rare disease patients. They fight so no one else has to.” “It took me six months to even scratch the surface of this portfolio—rare disease isn’t just rare, it’s overwhelmingly complex.”
	Building Successful Life Science Companies with Katrina Rogers	12 May 2025	00:59:53
In this powerful episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Katrina Rogers, a 25-year life sciences veteran, biotech equity advocate, and founder of Evergreen Bioscience Innovation and Katrina Rogers Consulting. Katrina shares her compelling journey from Pfizer to pioneering innovation ecosystems and mentoring underrepresented biotech founders. They unpack the role of board governance, the funding gap for female founders, and how "showing your science" is critical for regulatory success. Katrina also warns of dangerous gaps in understanding between regulators and innovators and why we must protect our basic science infrastructure. If you've ever dreamed of launching a breakthrough therapy, leading a biotech, or making your idea count, this episode is for you. 00:00 Episode Preview & BioTalk Unzipped Introduction 03:09 Katrina’s Charity Highlight: 2nd Harvest (link below) 04:04 Defining Moment in Life Science 05:35 Launching a Consultancy: Overcoming Fears 07:12 Leadership Lessons 09:30 The Importance of Board Composition 13:08 NEW NEWS: The Case for Female Founders 18:04 Knowledge Gaps Between Founders and Regulators 20:23 The Impact of Regulatory Changes 21:32 The Direct Attack on Basic Scientific Infrastructure 25:57 Understanding Market Needs 29:36 The Role of Founders in Leadership and Navigating Leadership Challenges 34:00 The Most Common Mistake by Biotech Founders & What To Do 35:27 Katrina’s Scope & Delivering Unpleasant News 36:51 NEW NEWS: Understanding Tariffs and Drug Pricing 42:23 Empowering Big Ideas 45:26 Overcoming Systemic Barriers 47:24 Advice to My Younger Self 49:38 Proposing Changes to FDA Innovation Pathways 54:54 The Future of Innovation in Biotechnology Katrina Rogers https://www.linkedin.com/in/katrinarogers/ https://krogersconsulting.com/ Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ NEW NEWS Biotech a Bright Spot for Female Founders Amid DEI Pullback, https://www.biospace.com/business/biotech-a-bright-spot-for-female-founders-amid-dei-pullback?utm_source=chatgpt.com Trump signals shift in drug import tariff policy https://www.techtarget.com/pharmalifesciences/news/366622459/Trump-signals-shift-in-drug-import-tariff-policy Quotables "The world needs your big idea." "Build trust and that will engender loyalty." "You need to have a board already established." "Show them your science." "Be Specific and people can be incredibly generous with their time." "Tariffs are incredibly blunt economic instruments." "You should at least try to get it out there." "Our culture has expectations that limit us." "You have to drive that vision." “Stop playing small - you’re meant for more.” “Put the Visionaries with the Doers and you’re unstoppable!” Takeaways Founders should evaluate their board members early in the process. Female founders are underrepresented but show higher returns on investment. Understanding customer needs is crucial for product development. Regulatory changes can create knowledge gaps for founders. Basic science is essential for innovation in drug development. Leadership challenges often stem from board dynamics. Problem-solving tools can help founders navigate challenges. The most common mistake is not doing enough discovery research. Building a network is crucial for early-stage entrepreneurs. People are generous with their time if you’re super specific about your need! Delivering unpleasant news is part of being a problem solver. Tariffs can disrupt supply chains and raise drug prices. Leadership roles require proactive vision and engagement. Cultural expectations can limit innovation and self-worth. Anyone can be an innovator with the right support. The skilled technical workforce is vital for future innovation. Passion drives significant advancements in biotechnology.
	Navigating Challenges in Drug Discovery with Dr. Alfred Botchway	07 Apr 2025	00:51:52
In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alfred Botchway, CEO of Attentive Science, to discuss his journey in biomedical science and the groundbreaking work being done at the intersection of AI, non-clinical safety, and drug discovery. Dr. Botchway shares his insights on the role of AI in refining toxicology studies, how stress impacts human health, and his experience founding companies like Xenometrics and Attentive Science. The conversation dives deep into the complexities of Good Laboratory Practices (GLP), the importance of regulatory standards, and the exciting research happening in anxiety and PTSD treatments. Dr. Botchway also discusses the future of biomedical research, the need for greater collaboration between academia and industry, and how innovations in sample collection are transforming clinical trials. Whether you’re interested in AI, biomedical innovation, or the future of drug discovery, this episode offers valuable insights from a leader shaping the industry. Don’t forget to subscribe and let us know your thoughts in the comments below! Dr. Alfred Botchway https://www.linkedin.com/in/alfred-botchway-41b01a6/ CEO of Attentive Science: https://www.attentivescience.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ 00:00 Introduction to BioTalk Unzipped 02:32 Dr. Alfred Botchway's Journey in Biomedical Science 03:48 Challenges Founding and Growing Xenometrics 07:30 Starting Attentive Science: A New Venture 09:37 Love of the Work - Variations 10:26 The Role of AI in Non-Clinical Safety Assessments 13:04 The Three Rs: Replace, Reduce, Refine, and AI 15:46 Regulatory Standards and Good Laboratory Practices 20:42 New News! - Research on Anxiety and Drug Discovery 27:07 Cortical Stimulation and Stress Management 27:45 Bridging Academia and Industry 29:26 Engaging the Next Generation in Science 32:42 The Value of Vocational Training in Science 34:47 Community Involvement and Giving Back 37:00 Cultural Influences on Leadership 42:39 Global Expansion and Strategic Goals 48:41 Innovations in Sample Collection for Clinical Trials Digital Twin Episodes reference with Tomas Helikar: Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar https://youtu.be/jTM_Zlt3wxU Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar https://youtu.be/NM5X0jTd6UA
	2024 Year In Review: BioTalk Unzipped	17 Mar 2025	00:41:57
In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations. Thanks to CREO Consulting for hosting this episode! https://creoconsulting.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Takeaways Every sample is a person, a patient, a loved one. Embrace the fear, take more risks. The importance of human connection in drug development. AI is becoming integral in drug discovery and development. Successful individuals often wish they had taken more risks. Leadership in the industry is about raising others up. Mentorship plays a crucial role in professional growth. Personal growth can come from listening and engaging with others. Innovative approaches are essential in addressing industry challenges. Keywords BioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights
	Women in Pharmaceutical Sciences and their Allies with Dr. Ines Santos and Dr. Julie Sable	03 Mar 2025	01:11:01
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 Unzipped 02:01 Celebrating Women in Pharmaceutical Sciences 03:21 The Importance of STEAM Education 04:09 Personal Journeys into Science 08:02 Exciting Projects and Discoveries 13:52 Challenges in CMC for Cell and Gene Therapies 18:51 Innovations in Chiral Bioanalysis 22:46 NEW NEWS! - New ADC Approved 28:33 Exploring Combination Therapies in Cancer Treatment 32:26 Empowering Women in Pharmaceutical Sciences 37:30 Mentorship and Community Engagement 45:18 The Role of Allyship in Science 47:19 Breaking Barriers and Challenging Stereotypes 54:15 Engaging Diverse Voices in Discussions 56:49 Creating Inclusive Spaces for Feedback & Speaking Up 01:01:15 Avoiding Assumptions in Professional Settings 01:02:04 Setting Boundaries for Work-Life Balance 01:05:24 Measuring Success in Life 01:07:06 Connecting and Networking Effectively Dr. Ines Santos https://www.linkedin.com/in/insantos/ Dr. Julia Sable https://www.linkedin.com/in/julia-sable-5b794385/ STEAMpark https://www.steampark.org/ WIPS in AAPS https://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://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 lymphoma https://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 bioanalysis https://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/ Keywords BioTalk, 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
	Can AI Become Your Doctor? FDA Regulation, Medical Devices & the Future of Healthcare	03 Feb 2025	01:09:00
Could artificial intelligence become your doctor someday? In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alex Friedman, a regulatory affairs expert with deep experience in medical devices, FDA submissions, quality systems, and AI-enabled Software as a Medical Device. Alex helps unpack one of the most important questions in healthcare innovation: when does software become a regulated medical device, and what happens when AI begins influencing clinical decisions? The conversation moves from classic medical device classifications to 510(k) submissions, De Novo pathways, wearable health technology, clinical decision support software, adaptive AI, liability risk, and the future of “doctor-in-a-box” tools for underserved communities. This episode is especially relevant for medical device developers, digital health founders, regulatory affairs professionals, biotech leaders, clinicians, investors, and anyone trying to understand how AI will be safely integrated into healthcare. Alex explains why regulatory strategy is not just bureaucracy. It is a public health safeguard designed to protect patients, validate claims, and prevent companies from selling unproven technology into high-stakes clinical environments. As he puts it in the episode, “You can’t sell snake oil.” In this episode How FDA classifies medical devices by risk Why many Class II devices follow the 510(k) pathway What “substantial equivalence” means When software becomes a medical device Why AI-enabled software raises new regulatory questions How wearable technology may change cardiovascular monitoring Why medical claims create liability risk What makes adaptive AI especially difficult to regulate How FDA may approach predetermined change control plans Why inclusive training data matters for AI in healthcare How AI tools could improve care access in underserved communities Featured guest Dr. Alex Friedman is a bioengineer and regulatory affairs professional with more than a decade of experience in medical devices, quality systems, FDA submissions, and regulatory strategy. His work includes AI-enabled hospital software, clinical decision support, and Software as a Medical Device. Connect with Alex Friedman: https://www.linkedin.com/in/alexfriedman/ Charity spotlight Alex selected Americares, a nonprofit organization that delivers emergency medical aid and health programs to people affected by poverty and disaster. Learn more: https://www.americares.org/ Links and resources All BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped/videos BioTalk Unzipped LinkedIn: https://www.linkedin.com/company/biotalk-unzipped Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Mentioned in the episode Antshrike cardiac health app from Before Health Intelligence: https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424 Fierce MedTech 2025 forecast on AI, regulators, and government: https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect SISU Sense concussion mouthguard: https://www.sisuguard.com/sisusense/ HITIQ smart mouthguard: https://www.hitiq.com/smart-mouthguard Prevent Biometrics: https://preventbiometrics.com/ IDX-DR diagnostic software: https://www.healthvisors.com/en/idx-dr/
	The Future of Dosing: Pharmacometrics, Oncology & Virtual Trials with Dr. Nathan Teuscher	20 Jan 2025	00:31:39
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 episode Gregory, Chad, and Nathan discuss: The changing landscape of pharmaceuticals Virtual clinical trials and patient engagement How pharmacometrics supports better dose selection Why oncology dosing is evolving FDA’s Project Optimus and its impact on cancer drug development Challenges in cell therapy development Treating immunocompromised patients The role of collaboration in scientific progress Advice for young scientists in biopharma Nathan’s Clinical Pharmacology Podcast Featured guest Dr. 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: nathan@aplosanalytics.com Clinical Pharmacology Podcast: https://teuschersolutions.com/ Spotify: https://creators.spotify.com/pod/show/clinical-pharmacology Apple Podcasts: https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234 Collaboration with BioTalk Unzipped, Ep. 40: https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 New News story After 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-mesoblast Connect with BioTalk Unzipped All BioTalk Unzipped Episodes: https://www.youtube.com/@BioTalkUnzipped/videos Dr. 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-unzipped Key themes Clinical 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.” Keywords BioTalk 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
	The Future of Pharmacometrics with Dr. Nathan Teuscher	06 Jan 2025	00:33:15
In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants. Chapters 00:00 Episode Preview 00:55 Introduction to BioTalk Unzipped 02:06 Charity Spotlight: Light of the World 04:51 Nathan Teuscher's Career Journey 07:34 Differentiating AI Types in Life Science 12:41 Challenges with Large Language Models 15:39 Rethinking Reporting in Pharma 17:56 The Future of AI and Analytics in Pharma? 18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies 23:05 Leveraging Data, AI, and APIs in 3 Dimensions 26:22 NEW NEWS! - Gene Editing Breakthroughs in Medicine How to reach us: Light the World Charity - Church of Jesus Christ Latter Day Saints https://www.churchofjesuschrist.org/comeuntochrist/light-the-world Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites "We don't need to write reports anymore." Takeaways Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. Light the World charity offers unique giving machines for donations. AI can automate repetitive tasks in drug development, freeing up human capital for innovation. There are two types of AI: large language models and automated data analysis. Large language models can be unreliable in scientific contexts. Pharmaceutical companies spend significant resources on report writing, which may not add value. Small companies can leverage APIs to access standardized calculations and data analysis. The pharmaceutical industry is often insular, limiting the potential of AI. AI could potentially eliminate the need for extensive written reports in drug development. Collaboration and data sharing are crucial for advancing AI in the pharmaceutical industry. Leveraging data effectively requires combining various data sets and tools. The evolution of AI tools is crucial for navigating new technologies. Gene editing represents a significant breakthrough in organ transplantation. New News Story: A woman in the US is the third person to receive a gene-edited pig kidney https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/ Image Credits Pig Kidney, https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants Keywords BioTalk, pharmacology, AI in pharma, drug development, pharmacometrics, software development, clinical research, Light the World, charity, data analysis, AI tools, gene editing, kidney transplant, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare
	Will FDA’s New LDT Rule Slow Drug Development? with Dr. Mark Arnold	30 Dec 2024	00:29:49
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/ How to reach us: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ Mark Arnold https://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Image Credits AAPS
	Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar	16 Dec 2024	00:37:38
BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe engage with Dr. Tomas Helikar in an exciting discussion on the future of AI, digital twins, and personalized medicine. From mathematical models and immune system simulations to groundbreaking collaborations with the Department of Defense, this episode uncovers how digital twins have the potential to transform drug discovery and clinical trials. Don’t miss insights on the ethical challenges of data privacy, the promise of animal digital twins, and the latest AI breakthroughs like MIT’s Sparrow algorithm! Chapters 01:00 How the mathematical models work. Normalization and Scaling in Computational Biology 07:55 Focus on the Immune System and Organ Models 09:05 Collaboration with the Department of Defense 11:03 Drug Discovery and Digital Twins 13:43 NEW NEWS! - AI in Drug Discovery: The MIT Sparrow Algorithm 17:51 Future of Digital Twins in Clinical Trials 18:59 Personalized Medicine and Individualized Treatments 23:33 The Potential of Animal Digital Twins 24:59 Building a Research Infrastructure for Digital Twins 26:03 Privacy and Ownership of Digital Twin Data 30:14 Encouraging Publication and Literature Engagement How to reach us: Tomas Helikar https://www.linkedin.com/in/tomashelikar/ X - https://x.com/tomashelikar Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites "Publications are the currency in academia." New News Story: MIT’s SPARROW Redefines Drug Discovery With Smart Synthesis https://scitechdaily.com/mits-sparrow-redefines-drug-discovery-with-smart-synthesis/ Image Credits MIT Molecule, https://news.mit.edu/topic/algorithms?page=2
	Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar	02 Dec 2024	00:32:29
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. Chapters 00:00 Introduction to BioTalk Unzipped 01:50 Meet Dr. Tomas Helikar 04:34 The Journey into Systems Biology 10:03 Understanding Digital Twins in Immunology 14:19 The Importance of Personalized Medicine 17:20 Digital Twin Research Funding and Its Impact 18:38 The Role of Digital Twins in Disease Management 21:11 Digital Twin Efforts for Organ Transplants 24:05 Computational Challenges in Modeling 26:36 Mathematical Models in Biological Research 28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody Collaboration How to reach us: Tomas Helikar https://www.linkedin.com/in/tomashelikar/ X - https://x.com/tomashelikar Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Charity Mentioned: https://saintpeterlincoln.com/school FOLLOW ► LinkedIn: https://www.linkedin.com/company/biotalk-unzipped Twitter: https://x.com/BiotalkUnzipped Instagram: https://www.instagram.com/biotalkunzipped/ Takeaways Dr. 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 Collaboration https://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/ Image Credits Signal 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-2023 https://hcc.unl.edu/office-locations
	How AI is Transforming Drug Development: Reflections from AAPS - PharmSci 360 with Dr. Mark Arnold	18 Nov 2024	00:36:11
Dr. Mark Arnold, a distinguished bioanalytical thought leader with an impressive track record in supporting drug development programs. Mark is the Owner and Principal at Bioanalytical Solution Integration, where he provides strategic counsel on complex bioanalytical assays and regulatory compliance. With over 35 years of experience, including leadership roles at BMS and Labcorp, Mark has become a key figure in the biotech and pharma industries. He is also an AAPS Fellow and a founder of the Global Bioanalysis Consortium. 01:05 - Career Reflections and Contributions to Drug Development 05:28 - Understanding the Integration of Drug Development 09:30 - What Would You Change? Embracing Career Risks in Pharma 11:32 - Navigating Career Paths: Small vs. Large Companies 16:09 - NEW NEWS! - Can Electrical Fields Disrupt Cancer? 23:28 - The Role of AI in Drug Development 31:13 - Encouraging Innovation in a Regulated Industry Follow Mark, Chad and Gregory: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ Mark Arnold - https://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/ Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / BioTalk Unzipped on LinkedIn - https://www.linkedin.com/company/biotalk-unzipped/ New News Story: Novocure wins FDA approval for electric field device in lung cancer https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997 Two articles on finding 1000’s of dark matter RNA viruses: https://www.fiercebiotech.com/research/deep-learning-ai-model-scans-dark-matter-genomic-data-and-finds-70000-never-seen-rna https://www.nature.com/articles/d41586-024-03320-6 Image Credits Novocure images courtesy of Novocure: www.novocure.com
	Biotech Funding Trends and the Rise of Digital Twinning with CEO Scott Ogle	21 Oct 2024	00:29:40
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. Chapters 1:09 - Comparison of the Banking Industry to the Pharma Industry 5:18 - Data Integrity, Same For Decentralized Trials? 8:33 - Biotech Funding Trends 11:18 - NEW NEWS! – Digital Twinning in Clinical Trials 16:15 - What Advice Would You Give to Your Younger Self? 20:57 - Mentorship and Its Impact, How it Shaped Scott 23:45 - Balancing Work and Personal Life 24:32 - The Inflation Reduction Act and Innovation Takeaways The 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 AI https://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/ TruLab - https://trulab.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Digital Twinning - Credit Getty Images Simulation - Credit: andrush / Adobe Stock Tomáš Helikar - https://www.linkedin.com/in/tomashelikar/ Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600 Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/
	Technology Meets Purpose: Transforming Clinical Trials with CEO Scott Ogle	01 Oct 2024	00:33:37
Summary In this 22nd episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Scott Ogle, CEO of TruTechnologies, discussing his journey from finance to the pharmaceutical industry, the impact of personal experiences on innovation, and the importance of technology in clinical trials. They explore how to hire the best employees in this climate, the significance of company culture, and the influence of family on business perspectives. Chapters 00:00 Introduction to BioTalk Unzipped 03:15 The Impact of Personal Experience on Innovation 08:47 TruLab's Technology and Its Role in Clinical Trials 14:33 The Importance of Sample Management and the Genesis of TruLab 20:33 NEW NEWS! – The Future of Cancer Treatments 23:34 Hiring Patterns and the value of Company Culture Takeaways Scott Ogle's personal experience with his father's illness inspired the creation of TruLab. TruLab focuses on eliminating inefficiencies in clinical trial sample management. The importance of having fun in one's career for productivity and happiness. Hiring for energy and cultural fit is crucial for company success. More young people out of college actually prefer working in the office, so it’s a hiring advantage. Sound Bites “Entrepreneurs get excited about their solution but can forget about what problem they’re solving.” "We need to iterate on technology in clinical trials." “20-25% of biological samples get tossed out.” "You can't coach energy in a candidate." “Company values. Senior leadership must beat it like a drum.” “Interviewing candidates on company values is your North Star.” “Go by what people do, not by what they say.” “Hallway meetings, that’s where stuff gets done.” New News Story: ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells https://www.nature.com/articles/s43018-024-00821-1 How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/ TruTechnologies - https://trutechnologies.ai/ Leukemia & Lymphoma Society - https://www.lls.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Keywords: Scott Ogle, TruLab, clinical trial technology, biotech innovation, sample management in clinical trials, hiring for company culture, company values in leadership, finance to pharma journey, revolutionizing clinical trials, impact of personal experience on innovation, biotechnology leadership, clinical trial inefficiencies, cancer treatment news, digital transformation in pharma, family influence in business, company culture in biotech, pharmaceutical funding challenges, ISB 2001 trispecific T cell engager. Tags: #ScottOgle, #TruLab, #ClinicalTrials, #Biotech, #PharmaInnovation, #Sample Management, #Company Culture, #Hiring Tips, #BiotechLeadership, #PharmaTechnology, #CancerTreatment, #PersonalInnovation, #BiotechFunding, #LeadershipInPharma, #BusinessLeadership, #PharmaceuticalIndustry.
	Mentoring in Pharmaceutical Science with Dr. Jim Shen	29 Sep 2024	00:35:08
Mentoring in Pharmaceutical Science with Dr. Jim Shen Summary In 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. Chapters 01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis 04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference 05:10 - Early Career in Bioanalysis 07:35 - The Importance of Mentorship and Dealing With Adversaries 17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy 24:55 - Personal Interests: Photography and Gaming Takeaways Dr. 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 others Build a network of champions, allies, and sponsors Be open to new career opportunities and emerging fields Maintain integrity and transparency in scientific research Explore different hobbies and interests outside of work Sound 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 therapy https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/ How to reach us: Dr. Jim Shen https://www.linkedin.com/in/jimxshen/ Bristol Myers Squibb - https://www.bms.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Travis 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_OD8vogDFQAAAAAdAAAAABB2 https://www.te-university.com/posts https://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839 https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.html https://www.newheightshow.com/ https://www.aol.com/fans-think-moment-travis-kelce-185629668.html World of Warcraft Guilds https://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/ Infrared Photography: Jim Shen Keywords Pharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis
	Great Advances in Cancer Research with Dr. Jim Shen	01 Sep 2024	00:37:19
In this episode (EP20) 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. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry. Chapters 01:15 - Introduction, Background, and Passion for The American Cancer Society 03:46 - Advancements in Cancer Therapies, Opdualag 08:03 - From Small Molecule to Large to Hybrid 12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy 18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis 27:00 - The Integration of AI and Mechanistic Modeling in Drug Development 34:30 - Navigating the Complexities of Regulatory Submissions Takeaways Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes. The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential. Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision. Dr. 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. Sound Bites "Advancements in cancer therapies have revolutionized the treatment landscape." "Antibody drug conjugates are one of the most exciting and interesting types of molecules." "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy." New News Story: Startup Halda raises $126M to advance new type of targeted cancer therapy https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/ How to reach us: American Cancer Society https://www.cancer.org/ Dr. Jim Shen https://www.linkedin.com/in/jimxshen/ Bristol Myers Squibb - https://www.bms.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Images ADC Mechanism of Action https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953 https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441 Keywords Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science
	The Future of Hybrid Healthcare \| Chuck Piccirillo	15 Aug 2024	00:39:32
Patients increasingly expect healthcare to work the way the rest of their lives work: flexibly, digitally, and around their individual needs. Chuck Piccirillo returns to BioTalk Unzipped to explore how healthcare organizations can build more adaptive patient journeys without losing the human connection that remains essential to care. Chuck explains why different patients, therapies, and diseases require different engagement models and why digital health platforms need to be adaptable rather than static. The conversation examines the growing demand for hybrid healthcare, combining virtual and in-person interactions, and the emergence of virtual-health models in Europe. In New News, the group explores ion channels and why these microscopic cellular structures continue attracting significant interest as targets for new medicines. From there, Gregory, Chad, and Chuck move into the economics of drug development and the realities of building a life-sciences company. Chuck offers lessons on leadership, persistence, incremental progress, and why face-to-face human interaction still matters even in increasingly digital organizations. The episode concludes with practical advice for entrepreneurs trying to build businesses in life sciences, where scientific ambition has to coexist with capital constraints, regulatory requirements, execution, and patience. Chapters 00:17 - Adapting to what is unique about each patient journey 07:08 - The push toward hybrid healthcare and greater flexibility 09:20 - The emergence of virtual health, particularly in Europe 14:02 - New News: Why ion channels are a goldmine for new medicines 19:23 - The financial side of drug development 21:50 - Leadership, incremental progress, in-person interaction, and hard lessons 30:58 - Advice for entrepreneurs in life sciences Key ideas Digital patient experiences should adapt to the patient and therapy rather than forcing every patient into the same process. Hybrid healthcare can combine the convenience of technology with necessary in-person care. Remote monitoring and virtual interactions may reduce some burdens on patients and healthcare providers. Ion channels continue to represent an important area of therapeutic research. Persistence and incremental progress are fundamental to entrepreneurship. Technology does not eliminate the value of real human relationships. Crohn’s & Colitis Foundation https://www.crohnscolitisfoundation.org/ Connect with Chuck Piccirillo Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/ Zealic Health http://www.zealichealth.com Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News These microscopic tunnels are a goldmine for new medicines: https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/ Keywords patient journey, hybrid healthcare, virtual health, ion channels, drug development, life sciences entrepreneurship, remote patient monitoring, decentralized clinical trials, digital health, leadership #HealthcareInnovation #VirtualHealth #DrugDevelopment #LifeSciences #DigitalHealth #IonChannels #ClinicalTrials #Leadership #Biotechnology
	Genetic Diagnostics and the Rise of Student CEOs \| Dr. Jonathan Hill	04 Aug 2024	00:33:17
Could future physicians combine a patient’s genome with artificial intelligence to make faster, more precise diagnoses? Dr. Jonathon Hill returns to BioTalk Unzipped to discuss the convergence of genetics, AI, diagnostics, entrepreneurship, higher education, and biotechnology. Jonathon explains an unusual partnership between academia and industry that allows students to build projects with genuine commercial potential, sometimes moving from student researcher to company founder at an exceptionally young age. The conversation then explores how AI could influence genomic medicine and future diagnosis. Jonathon challenges the traditional trial-and-error model of medicine and considers what could become possible as genetic information and computational tools improve. In New News, the group discusses Lumicell’s fluorescence-guided technology for identifying residual breast-cancer tissue during surgery and what improved visualization could mean for patients. Jonathon also offers advice to students interested in genetics and biotechnology, emphasizing laboratory experience, curiosity, and a willingness to take intelligent risks. The episode closes with a candid look at the regulatory hurdles facing biotechnology companies and a broader question confronting higher education: how can universities give students enough real-world value to justify the growing cost of a degree? Chapters 01:01 - Balancing life as a professor while running a laboratory 02:00 - The unique partnership between university and industry 03:55 - Why more students are pursuing entrepreneurship after college 06:31 - How AI may affect genetics research, biotechnology, and future diagnosis 12:58 - New News: Lumicell’s breakthrough in residual breast-cancer imaging 16:10 - Dr. Hill’s passions inside and outside his professional life 17:37 - Advice for young scientists and aspiring biotechnology entrepreneurs 21:00 - Bioinnovation, scientific business training, and concerns about the cost of higher education 28:48 - Regulatory hurdles and progress for Wasatch and its DNA research Connect with Dr. Jonathon Hill Dr. Jonathon Hill https://www.linkedin.com/in/jonathon-t-hill/ Wasatch Labs https://www.wasatchbiolabs.com/ Rainforest Trust https://www.rainforesttrust.org/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News FDA approval of Lumicell’s fluorescent system for highlighting residual breast cancer: https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer Image credits Gattaca: https://www.justwatch.com/us/movie/gattaca Lumicell: https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer Laser Focus World: https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care Vimeo: https://vimeo.com/807609920 Keywords genetics, nanopore sequencing, AI diagnosis, personalized medicine, biotechnology entrepreneurship, precision medicine, fluorescence imaging, breast cancer, genomic medicine #genetics #AI #personalizedmedicine #biotechnology #breastcancer #diagnostics
	How AI Is Helping Diagnose Disease \| Chuck Piccirillo	02 Aug 2024	00:38:04
Technology can make healthcare more sophisticated. The harder question is whether it actually makes healthcare better for the patient. Chuck Piccirillo, CEO of Zealic Health, joins BioTalk Unzipped to discuss patient-centered digital health, entrepreneurship, artificial intelligence, regulation, and the personal experience that helped shape his career. Chuck shares his experience living with colitis and how it influenced his desire to improve healthcare from the patient’s perspective. He explains how Zealic Health approaches digital platforms intended to create more individualized care experiences. The conversation then turns unexpectedly geopolitical. Chuck describes how the war in Ukraine affected his organization and how the company worked to relocate employees to Poland. In New News, the discussion tackles the FDA’s final rule involving laboratory-developed tests and the debate surrounding regulation of LDTs as medical devices. Gregory, Chad, and Chuck examine the difficult balance between protecting patients and creating regulatory uncertainty that may complicate innovation. The episode closes with AI and diagnostics. Where can artificial intelligence genuinely improve medical decision-making, and where does marketing run ahead of evidence? The larger question is not whether AI will enter healthcare. It is how healthcare can use it responsibly while keeping clinicians and patients at the center. Chapters 01:33 - Introduction and background 04:03 - The Crohn’s & Colitis Foundation and Chuck’s experience with colitis 07:49 - Patient-centric healthcare and Zealic Health 13:26 - Plan B: Moving operations from Ukraine to Poland 20:02 - New News: The controversy surrounding LDTs as medical devices 27:20 - Healthcare regulation and its implications for AI 30:07 - How AI can assist medical diagnosis Crohn’s & Colitis Foundation https://www.crohnscolitisfoundation.org/ Connect with Chuck Piccirillo Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/ Zealic Health http://www.zealichealth.com Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News House committee tells FDA to suspend lab-developed test rule: https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/ Image credits Crohn’s & Colitis Foundation: https://www.crohnscolitisfoundation.org/ FDA/LDT: https://x.com/FDADeviceInfo/status/1784965525522493657 U.S. Capitol: https://worldstrides.com/blog/2013/07/u-s-capitol/ Healthcare costs: https://www.freepik.com/photos/increasing-costs Cancer patient: https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm Computer-aided diagnosis: https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/ Keywords digital health, patient engagement, patient-centric healthcare, artificial intelligence, AI diagnostics, laboratory-developed tests, FDA regulation, decentralized clinical trials, healthcare technology #BioTalkUnzipped #DigitalHealth #AIinHealthcare #FDA #PatientCare #Biotechnology #MedicalDevice
	Reptiles, Toxicology, and the Future of Cell and Gene Therapy \| Dr. Andy Vick	15 Jul 2024	00:38:01
What can reptile venom teach us about medicine, and what separates merely good scientific work from truly great work? Dr. Andy Vick returns to BioTalk Unzipped for a conversation that moves from drug development and toxicology into reptiles, academia, gene therapy, professional development, and the extraordinary possibilities opening up across modern medicine. Andy shares the discoveries and industry changes that have surprised him over the course of his career, including how dramatically some areas of cancer treatment have changed. Then science meets one of his personal passions: reptiles. Andy describes his rare reptile collection and his work educating future toxicologists about venom and its potential pharmaceutical applications. The discussion moves into Andy’s role as an adjunct professor at The Ohio State University and his work connecting academic research, students, and industry. In New News, Gregory, Chad, and Andy discuss gene therapy used to restore hearing in children with mutations affecting otoferlin. The story opens a broader discussion about the extraordinary therapeutic potential of cell and gene therapy as well as the safety and tolerability questions researchers still need to answer. Andy closes by discussing the role organizations such as AAPS play in scientific collaboration, networking, mentorship, and professional growth. Chapters 00:21 - Surprises throughout Dr. Vick’s career 02:24 - The cyclical nature of technology 03:30 - Exploring the pharmaceutical potential of venom 05:35 - Improvements in cancer and other diseases over the past 30 years 10:13 - Educating future toxicologists about reptiles and pharmaceuticals 15:45 - Andrew Vick’s role as an adjunct professor at The Ohio State University 21:21 - New News: Restoring hearing in children through gene therapy 27:27 - The impact of professional organizations such as AAPS Selected quotes“It’s probably a good 10 years from the glimmer in a biochemist’s eyes to on the market.”“There’s a logarithmic difference between great and good.”“Just use your imagination on a way to tackle a disease and then find a way.”“Cell and gene therapy opens the door to a whole different category of opportunities.”Connect with Dr. Andy Vick Dr. Andy Vick https://www.linkedin.com/in/andy-vick-4467189/ Attralus Therapeutics https://www.attralus.com/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Regeneron gene therapy restores hearing in two children: https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids Image credit Pharmacognosy: https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy Keywords toxicology, reptiles, venom, drug discovery, drug development, gene therapy, hearing loss, academia, AAPS, cell and gene therapy, biotechnology #biotechnology #toxicology #genetherapy #hearingloss #AAPS #science
	Amyloidosis, Drug Safety, and a New Therapeutic Hope \| Dr. Andy Vick	01 Jul 2024	00:40:52
Drug development is ultimately a balancing act: can a therapy create meaningful benefit without introducing unacceptable risk? Dr. Andy Vick joins BioTalk Unzipped to discuss systemic amyloidosis, therapeutic antibodies, diagnostics, toxicology, rare disease research, and the transition from CRO life into biotechnology. Andy explains the biology of systemic amyloidosis and describes Attralus Therapeutics’ approach to developing biologic therapeutics and diagnostics aimed at amyloid disease. The conversation provides an accessible introduction to toxicology and why safety evaluation is fundamental to drug development. Andy also discusses one of the recurring challenges in rare disease research: finding animal models that adequately represent human disease. He then reflects on moving from a contract research organization into a smaller biotechnology company and what changes, and what stays remarkably similar, when scientists move between CROs, pharmaceutical companies, and biotech. New News takes the discussion into cancer immunology with an experimental mRNA-based approach to glioblastoma. The technology packages tumor-specific RNA inside lipid nanoparticles with the goal of generating a strong immune response against the cancer. It is a conversation that spans fundamental drug safety, rare disease biology, career transitions, and some of the most ambitious approaches being investigated in oncology. Chapters 02:22 - Dr. Vick’s charity work in Brazil 06:30 - Introduction to Attralus Therapeutics 07:41 - Developing treatments for systemic amyloidosis 10:35 - The role of toxicology in drug discovery and development 16:38 - Using animal models to study amyloidosis 22:06 - The history of Attralus and Dr. Vick’s transition from CRO to biotech 32:45 - New News: Promising results from an mRNA-based brain-cancer vaccine Connect with Dr. Andy Vick Dr. Andy Vick https://www.linkedin.com/in/andy-vick-4467189/ Attralus Therapeutics https://www.attralus.com/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Glioblastoma vaccine turns brain tumors from “cold” to “hot” in humans and dogs: https://www.fiercebiotech.com/research/glioblastoma-vaccine-turns-brain-tumors-cold-hot-humans-and-dogs Media credits Pilot image: https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY University of Florida: https://www.clickorlando.com/news/florida/2024/03/11/university-of-florida-axes-diversity-and-inclusion-office-under-gop-led-law-aimed-at-ridding-similar-programs/ Music: “CLARITY,” Mifune Music provided by Slip.stream: https://slip.stream https://get.slip.stream/KFCilm Keywords systemic amyloidosis, therapeutic antibodies, toxicology, drug discovery, rare disease, biotechnology, diagnostics, glioblastoma, mRNA vaccine, lipid nanoparticles #biotechnology #toxicology #glioblastoma #braincancer #amyloidosis #drugdevelopment
	A New Path to Earlier Alzheimer’s Detection \| Dr. Jonathan Hill	01 Jun 2024	00:30:25
What if scientists could read DNA differently, uncover biological signals earlier, and eventually diagnose disease before symptoms become obvious? Dr. Jonathon Hill joins BioTalk Unzipped to explore nanopore sequencing, genetics, epigenetics, artificial intelligence, addiction research, fertility, and the search for earlier biomarkers of Alzheimer’s disease. Jonathon explains how nanopore sequencing works and why the ability to analyze native DNA and RNA can provide researchers with information extending beyond the underlying genetic sequence. His scientific interests also connect with a deeply personal passion for biodiversity. Jonathon describes his time in Brazil and his dream of establishing a nanopore sequencing laboratory in the Amazon to study its extraordinary biological diversity. The conversation then turns toward AI and genetics, including research into the genetic underpinnings of tobacco addiction. Jonathon discusses both the potential of AI to accelerate biological discovery and the risks of treating opaque models as scientific explanations. Later, he explains work involving cell-free DNA and fertility before discussing one of the most consequential areas of his research: DNA methylation signatures that may eventually contribute to earlier detection of Alzheimer’s disease. It is a fascinating look at what becomes possible when genomics, computation, and molecular biology begin converging. Chapters 00:00 - Introduction 02:51 - Donation to Rainforest Trust and Jonathon’s time in Brazil 06:37 - How nanopore sequencing works 12:45 - New News: AI and the genetic code of tobacco addiction 15:20 - Using AI in nanopore sequencing at Wasatch Labs and Diagnostics 21:14 - Finding cell-free DNA for fertility treatments 22:56 - Breakthrough: Finding early biomarkers for Alzheimer’s disease Selected quotes“Biology is not rocket science, it’s much harder.”“Better diagnosis comes better treatment.”Connect with Dr. Jonathon Hill Dr. Jonathon Hill https://www.linkedin.com/in/jonathon-t-hill/ Wasatch Labs https://www.wasatchbiolabs.com/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Breaking the Genetic Code of Tobacco Addiction: https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/ Additional resources and image credits Rainforest Trust: https://www.rainforesttrust.org/ EnviroBuild / Rainforest Trust: https://www.envirobuild.com/blog/rainforest-trust Fire Sponge: https://stock.adobe.com/ Oxford Nanopore Technologies, How Nanopore Sequencing Works: https://www.youtube.com/watch?v=RcP85JHLmnI Keywords nanopore sequencing, genomics, epigenetics, DNA methylation, Alzheimer’s disease, AI, genetic research, tobacco addiction, biomarkers #nanopore #genetics #epigenetics #AI #Alzheimers #DNA #biotechnology
	AI, Pharma, and the Future of Patient Care \| Jason Burke	15 May 2024	00:35:59
What happens when AI begins designing drugs, healthcare data becomes a strategic asset, and software starts changing faster than companies can adapt? Jason Burke returns to BioTalk Unzipped to explore the intersection of artificial intelligence, biotechnology, healthcare, entrepreneurship, and technology strategy. Jason explains the distinctive approach of the Duke program and the value of exposing students to real-world healthcare datasets rather than purely academic exercises. The conversation then turns to AI-generated drug discovery and what these technologies could mean for pharmaceutical companies, biotechnology startups, investors, and patients. Jason also explains how he assesses emerging technologies by looking beyond technical capability to questions of business value, intellectual property, scalability, and practical adoption. Gregory, Chad, and Jason then tackle a deeper structural problem: pharmaceutical companies develop products for healthcare systems, yet the two sectors do not always interact as closely as they should. They examine the complexity facing physicians and ask whether life-sciences companies may increasingly need to think not merely as product developers, but as providers of services and solutions. Finally, the science gets wonderfully unconventional as Jason takes us into amateur radio, including bouncing radio signals off the Moon. Chapters 00:29 - The unique approach of the Duke program 05:14 - New News: AI-generated drug discovery 09:33 - Assessing technologies for companies and patients 11:52 - Why unique intellectual property matters 12:35 - The future of AI and software 13:36 - Data as a commodity 15:10 - Innovation curves, technology, and how AI may compress them 16:41 - Using AI in everyday life 19:04 - Why were search-engine companies late to the generative-AI game? 20:05 - New forms of software and digital experiences 22:53 - The future relationship between healthcare and pharma 25:08 - The difficulty of practicing medicine in complex environments and implementing precision medicine 29:03 - Jason’s interest in amateur radio and the ham-radio community 31:39 - Bouncing a radio signal off the Moon and sending email over radio waves Connect with Jason Burke Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. https://www.creoinc.net/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ #AI #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences
	Organoids, AI, and the Future of Healthcare \| Jason Burke	01 May 2024	00:34:40
Miniature organs grown from cells. Artificial intelligence making increasingly complex healthcare decisions. Quantum computing. FDA-regulated data systems. Science fiction is becoming remarkably close to scientific reality. Jason Burke joins BioTalk Unzipped for a wide-ranging discussion of emerging technologies and how they could change drug discovery, clinical research, precision medicine, and healthcare. The conversation begins with organoids, three-dimensional cell structures designed to reproduce important characteristics of human organs. Gregory, Chad, and Jason discuss their applications in research as well as the ethical questions that become particularly interesting when brain organoids enter the conversation. Jason then explains his background and discusses the technologies he believes could materially transform clinical research. The discussion moves into AI, data science, precision medicine, and quantum computing before addressing a challenge every organization eventually confronts: implementing powerful new technologies without sacrificing data integrity, regulatory compliance, or sound strategy. The episode concludes with discussion of FDA expectations, 21 CFR Part 11, and why successful digital transformation requires more than simply adopting the newest technology. Chapters 01:14 - Introduction to BioTalk Unzipped 03:30 - New News: Organoids and their applications 04:45 - Ethical questions surrounding brain organoids and biological computing 06:31 - Organoids in drug-discovery research and brain interfaces 08:59 - Brain training and neuroplasticity 10:51 - The impact of AI and data science in healthcare 11:18 - Jason’s background and emerging technologies transforming clinical research 13:43 - AI in precision medicine, quantum computing, and business growth 24:15 - FDA IT strategy and the challenges of implementing AI 26:32 - Technology strategy, prioritization, data integrity, and 21 CFR Part 11 Connect with Jason Burke Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. https://www.creoinc.net/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News The many uses of mini-organs: https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/ Image credits Brain illustration: https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs UFO: https://www.pinterest.com/pin/swampthingy--675891856570360044/ #Organoids #AI #QuantumComputing #HealthcareInnovation #DrugDiscovery #ClinicalResearch
	Melanoma Breakthroughs and the Promise of Curative Therapy \| Scott Schliebner	15 Apr 2024	00:36:44
What happens when a treatment has the potential to cure disease rather than manage it for years? Scott Schliebner returns to BioTalk Unzipped for a deeper discussion of rare disease clinical trials, gene therapy, cell therapy, cancer treatment, and one of the most difficult questions in modern medicine: how should potentially curative therapies be valued and made accessible? Scott first expands on the operational complexity of rare disease studies, including patient recruitment, multidisciplinary care, and the importance of collaboration among stakeholders. The conversation then examines how AI might help identify patients and analyze increasingly complex clinical datasets. A major focus is the FDA approval of Iovance’s Amtagvi, discussed in the episode as the first T-cell therapy approved for a solid tumor. Scott, Gregory, and Chad examine what progress in melanoma might mean for the broader effort to bring cell therapies into solid tumors. That leads to a larger discussion about gene and cell therapy economics. If a therapy can eliminate years of ongoing medical treatment, what should it cost? How should healthcare systems weigh upfront expense against long-term health and economic benefit? The episode concludes with practical career advice for both early-career and experienced clinical-development professionals. Chapters 00:21 - A collaborative approach to rare disease trials 03:32 - The role of AI in rare disease trials 06:11 - Success stories in rare disease development 11:34 - Expanding gene therapy to target multiple genes 16:56 - New News: FDA approval of Iovance's Amtagvi and the melanoma breakthrough 19:27 - Targeting solid tumors with cell therapy and expanding its potential 20:23 - How curative therapies could affect quality of life and healthcare costs 21:11 - Pricing and ethical challenges surrounding advanced therapies 22:37 - Lessons from curative treatments for hepatitis C 23:25 - The high bar for clinical development and regulatory standards 24:05 - Pricing considerations across cancer types and the possibility of cost-effective treatments 27:45 - Advice for young professionals entering clinical drug development 31:49 - Advice for established clinical professionals 33:21 - Scott’s hobbies and interests Rare Givers Learn more or donate: https://www.raregivers.global/ Connect with Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News FDA approves first T-cell therapy for a solid tumor: https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor Image credits Iovance: https://www.iovance.com/ FDA approval: https://www.tipranks.com/news/iovance-nasdaqiova-fda-approves-cell-therapy-stock-gains Amtagvi: https://www.amtagvi.com/ #melanoma #raredisease #celltherapy #genetherapy #clinicaltrials #science
	AI in Rare Disease Trials \| Scott Schliebner	01 Apr 2024	00:36:12
Rare disease clinical trials present a problem unlike almost anything else in drug development: how do you run a rigorous trial when the patients you need may be exceptionally difficult to find? Scott Schliebner joins BioTalk Unzipped to explore rare disease development, clinical research, artificial intelligence, and the operational realities of building organizations across international boundaries. The episode begins with a discussion of Rare Givers, an organization supporting caregivers in the rare disease community. Scott then explains what led him into clinical research before the conversation turns to the Epitomee weight-loss capsule and the changing landscape of obesity treatment. From there, Scott shares lessons from building North American infrastructure for a European MedTech-focused CRO, including the cultural differences that can influence how global teams work together. The discussion then moves into AI and machine learning. Rather than treating AI as a buzzword, Scott, Gregory, and Chad examine practical applications across clinical trials, patient recruitment, data analysis, quality, and regulatory compliance. Finally, Scott breaks down why rare disease trials are so challenging and why successful development often requires collaboration among patients, caregivers, investigators, sponsors, and other stakeholders. Chapters 00:53 - Introduction and charity donation to Rare Givers 02:30 - The mission of Rare Givers 04:08 - What inspired Scott to enter clinical research 06:12 - New News: The Epitomee weight-loss capsule 11:25 - Epitomee, targeted weight-loss approaches, and competition with Wegovy 14:05 - Building North American infrastructure for a European MedTech-focused CRO 16:35 - Cultural differences when doing business across countries 23:53 - AI, machine learning, and generative AI in clinical trials, drug development, FDA compliance, and quality 30:13 - Understanding rare disease trials and overcoming their unique challenges 33:12 - Is it a zebra or a horse? Key takeaways Rare disease trials often require unusually sophisticated patient-identification and recruitment strategies. Caregivers are an essential part of the rare disease ecosystem. AI may improve patient recruitment, data analysis, and other areas of clinical research, but implementation must be thoughtful. Building international clinical-development organizations requires understanding cultural as well as operational differences. Rare Givers Learn more or donate: https://www.raregivers.global/ Connect with Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Epitomee announces filing of a novel weight-loss capsule for FDA clearance: https://www.prnewswire.com/news-releases/epitomee-announces-the-filing-of-a-novel-weight-loss-capsule-for-fda-clearance-302081225.html NIH publication, Safety, Tolerability and Efficacy of a Novel Self-Use Biodegradable Device for Management of Obesity: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700511/ Image credit Rare Disease Day: https://www.rarediseaseday.org/event/6th-annual-rare-disease-day-virtual-race/ #clinicaltrials #raredisease #AI #drugdevelopment #biotechnology
	Leadership, Diagnostics, and Scientific Integrity \| Dr. Russell Grant	15 Mar 2024	00:43:28
How should a scientist react when confronted with a groundbreaking new publication? Dr. Russell Grant returns to BioTalk Unzipped for a conversation about scientific skepticism, leadership, mentorship, emerging technology, and the discipline required to separate compelling science from compelling headlines. Russ explains what happens in his mind when he encounters an extraordinary scientific claim and why experimental execution matters as much as the conclusion of a publication. The conversation then turns to brain-computer interfaces and Neuralink, raising larger questions about neuroscience, brain biochemistry, and how far technology may eventually take us. Russ also shares lessons from his leadership within the Triangle Area Mass Spectrometry Discussion Group, including how strong professional communities help bridge academia and industry. He discusses mentoring scientists, developing people, and keeping teams focused on scientific fundamentals while still pursuing ambitious work. And, as always on BioTalk Unzipped, we get outside the laboratory and learn more about the person behind the science. Chapters 01:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication? 07:47 - New News! 13:10 - Dr. Grant’s leadership with TAMS and why the organization has been successful 24:05 - Have the challenges facing graduate students changed over the past two decades? 26:49 - When Russ’ work led to something truly unexpected 30:56 - Leadership, career development, and developing the people you lead 35:51 - Memorable quotes and lessons 37:30 - What Russ does for fun Connect with Dr. Russell Grant Dr. Russell Grant grantr@labcorp.com https://www.linkedin.com/in/russell-grant-5144a26/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Organizations mentioned ASMS: https://www.asms.org/ MSACL: https://www.msacl.org/ ADLM: https://www.myadlm.org/ TAMS, Triangle Area Mass Spectrometry Discussion Group: https://tamsgroup.org/ New News Neuralink implants brain-computer interface in first human trial participant: https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant Image credits Clint Eastwood clip: https://www.youtube.com/watch?v=eJJXIcig2h8 Neuralink: https://dig.watch/updates/neuralinks-first-human-implant-shows-promising-results Tricorder technology: https://astrobiology.com/2023/11/tricorder-tech-that-star-trek-medical-scanner-is-getting-much-closer.html Neuralyzer: https://meninblack.fandom.com/wiki/Neuralyzer #biotechnology #diagnostics #science #innovation #leadership #pharmaceutical
	Diagnostics That Change Patient Care \| Dr. Russell Grant	01 Mar 2024	00:33:04
What happens when a scientist moves from pharmaceutical development into the world of clinical diagnostics? Dr. Russell Grant joins BioTalk Unzipped to discuss a career that has taken him from the United Kingdom to the United States, from large pharmaceutical organizations into diagnostics, and across the evolving worlds of mass spectrometry and laboratory medicine. Russ explains important differences between bioanalysis supporting clinical trials and laboratory testing used directly in patient care. He also shares his experience working through the extraordinary demands created by COVID-19 and why seemingly small improvements in laboratory efficiency can have meaningful consequences when multiplied across thousands of patients. The conversation also examines a remarkable gene therapy story involving the restoration of hearing in a child with genetic hearing loss. Beyond the technology, Russ discusses why diagnostics became such an important part of his career, the role scientific integrity plays in trustworthy research, and what concerns him about problems within scientific literature. It is a conversation about science, healthcare, professional reinvention, and the responsibility researchers have to get the science right. Topics explored Moving from the UK to the United States and from pharma to diagnostics Clinical-trial bioanalysis versus diagnostic laboratory medicine The evolving role of mass spectrometry Improving healthcare through better laboratory processes Working through the COVID-19 pandemic Gene therapy and genetic hearing loss Scientific integrity and academic fraud Why diagnostics can directly affect patient outcomes Connect with Dr. Russell Grant Dr. Russell Grant https://www.linkedin.com/in/russell-grant-5144a26/ Connect with the hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss: https://www.fiercebiotech.com/biotech/lilly-makes-waves-says-gene-therapy-restored-hearing-child-genetic-hearing-loss Image credits David Gilmour, Getty Images Sir Isaac Newton: https://en.wikipedia.org/wiki/Isaac_Newton #biotechnology #diagnostics #science #innovation #patientcare
	False Positives In The AI Explosion with Dr. Stephanie Pasas Farmer	15 Feb 2024	00:33:56
Welcome to Episode 6 of our podcast featuring Dr. Stephanie Pasas Farmer! 🎙️ Join us as we delve into the intricate world of data integrity, unveiling new software tools and the transformative impact they bring. Discover how virtual audits post-COVID, coupled with cloud security measures, are reshaping the landscape. 🔍 Explore the regulatory challenges amidst the technology and the AI explosion, with insights into the FDA's evolving role and its mission for public safety. Learn how ChatGPT transcends boundaries, from revolutionizing travel planning to enhancing workplace productivity. 💼 Delve into the nuances of ChatGPT's capabilities and limitations, navigating the fine line between its potential and pitfalls. Uncover concerns surrounding AI detectors in academia and the intricate realm of Deep Fakes. 🤖 Step into the conversational realm of ChatGPT, contrasting its prowess with conventional assistants like Alexa. Follow Dr. Stephanie Pasas Farmer's impactful journey, from combating malaria in South Africa to her unique career trajectory. 🌍 Tune in as she shares the most surprising moments of her career and imparts invaluable advice for aspiring scientists and entrepreneurs. Don't miss out on this riveting exploration of innovation, integrity, and entrepreneurship in the scientific realm! 🚀 #Science #ChatGPT #Innovation #Entrepreneurship #LifeScience #SoftwareTools #FDA #AI #CareerAdvice 01:00 - Data integrity concerns and new software tools. 05:43 - How are Regulators dealing with this technology and AI explosion? Regulatory Challenges and FDA’s Role. FDA agents speaking about AI at conferences. 10:00 - Using ChatGPT in your non-work life for things like Travel Planning. 13:15 - Using ChatGPT for Work. 14:40 - Limitations of ChatGPT. 16:19 - Concerns about False Positives for AI detectors in academics and Deep Fakes, which are so difficult to detect. 17:13 - The Conversational Nature of ChatGPT. 19:57 - Stephanie’s Work in South Africa. She helps a non-profit for malaria and unmet medical needs globally. Building out the laboratory capabilities there. . 22:22 - The most surprising thing in her career. Advice for Aspiring Scientists and Entrepreneurs. Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/ spfarmer@bdatasolutions.com Ariadne Software: https://www.ariadnesolutions.com/ BioData Solutions: https://www.bdatasolutions.com/ Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Image Credits KU basketball, stubhub, https://www.stubhub.com/kansas-jayhawks-basketball-tickets/performer/6849 BTS, https://www.teenvogue.com/story/bts-billboard-music-awards-2018 Cardi B, https://www.xxlmag.com/cardi-b-reacts-criticism-not-dropping-album-tour/ Taylor Swift, https://www.tiktok.com/discover/You-broke-my-hand-and-you-didnt-even-seems-sorry-taylor-swift Costa Rica, https://www.pixelstalk.net/ Deep fake, https://www.trymaverick.com/blog-posts/are-deep-fakes-all-evil-when-can-they-be-used-for-good Korean food, https://spoonuniversity.com/lifestyle/i-learned-the-secret-to-mastering-korean-bbq-by-growing-up-in-my-familys-restaurant Africa, https://en.wikipedia.org/wiki/Africa WRIB, https://www.wrib.org/ AAPS, https://www.aaps.org/home APA, https://www.bostonsociety.org/APA/
	How To Start A Company In Bioanalysis with Dr. Stephanie Pasas Farmer	01 Feb 2024	00:27:35
🎙️ Episode 5 of BioTalk Unzipped is here! Join hosts Gregory Austin and Dr. Chad Briscoe as they chat with Dr. Stephanie Pasas Farmer, founder of Ariadne Software and BioData Solutions. Explore the origins of Stephanie's companies, and the creation of RedThread, an AI-Enabled Auditing Tool that blends human intelligence with AI. 🧠 Dive into the practical side of Stephanie's software and the ever-evolving landscape of machine learning regulations. Get a glimpse into Stephanie's perspective on machine learning vs. expert systems and the challenges of navigating this dynamic field. 🌐 Discover what lies ahead for AI in Stephanie's software and the integration of her companies. The conversation extends to QPCR Analysis, exploring the monitoring of DNA and RNA for safety and efficacy. Uncover the resurgence of PCR technology with new applications. 🔍 Join us for a casual chat packed with insights, anecdotes, and a peek into the future of bioanalysis. Tune in now and enjoy the exploration of BioTech innovation with BioTalk Unzipped! 🧬🎧 #biotechnology #AIInnovation #Podcast #pharmaceutical #science Segment list: 3:22 - Journey into Bioanalysis 7:56 - Stephanie starting her own company - Ariadne Software - the problem that inspired a company 12:44 - RedThread: An AI-Enabled Auditing Tool - human augmented intelligence 15:54 - What is the learning aspect of the software? Vigilante Computer Scientist? Regulations for machine learning. 19:04 - Machine Learning vs. Expert Systems. Machine learning analysis 20:52 - What is next for AI in Stephanie’s software and combining her companies. 22:23 - Expanding into QPCR Analysis. Monitoring DNA and RNA, safety and efficacy. 25:05 - PCR - what’s old is new again based on new applications. Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/ Ariadne Software: https://www.ariadnesolutions.com/ BioData Solutions: https://www.bdatasolutions.com/ Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Image Credits KU logo, https://www.amazon.com/Open-Road-Brands-Jayhawk-Framed/dp/B07QJ4CK32 KU banner, https://www.amazon.com/Kansas-Jayhawks-Chalk-University-College/dp/B005RON6UA
	Sickle Cell Gene Therapy: Can We Afford a Cure? \| Dr. Russ Weiner	15 Jan 2024	00:35:47
In Episode 4, (Part 2 of our conversation with Dr. Russ Weiner - a top scientific leader at Takeda), we boldly explore the Cell and Gene Therapy Industry, questioning its trajectory and potential impact on insurance companies. Shifting focus, we delve into a groundbreaking Sickle Cell Therapy breakthrough, discussing its triumphs, challenges, and the crucial aspect of affordability. Despite the hurdles faced by payers and insurance companies, we find inspiration in the thrill of witnessing healing. Discover the role of AAPS in shaping the biotech future and efforts to engage students. Episode 4 also highlights Russ’ passions, including a heartfelt case study and insights into his AAPS Presidential platform. Explore surprising career moments, the transformative power of AI, and personal aspects of Russ’ life, from scuba diving to family. The episode concludes with valuable advice on mentoring, self-worth, and navigating the intricacies of career development. Join us on BioTalk Unzipped for a captivating journey where science meets stories, leaving you enlightened and inspired. #biotechnology #AI #careerdevelopment #cellgenetherapy #science #career SEGMENTS 1:15 - Be Brutal to the Cell and Gene Therapy Industry - Where is CGT really going? Will it bankrupt insurance companies? 3:50 - Sickle Cell Therapy breakthrough, side effects, and affordability 4:22 - Difficulty for payers, insurance companies, but the thrill of people getting healed 8:20 - Role in AAPS. Bringing in students to AAPS. 10:16 - Russ’ #1 Passion and a Heartbreaking case study of a young woman. 11:06 - Russ’ #2 Passion and his AAPS Presidential platform and amazing science done outside the US 15:07 - What we need to do to help the world and realities we don’t often see 17:51 - What’s the most surprising thing in Russ’ career? 19:31 - AI changed everything 23:43 - Russ’ other passions: scuba diving and family 27:37 - Funny stories and knowing your worth 29:24 - Always mentoring and always find a mentor 31:09 - Who’s in charge of your career? 33:51 - The difference between career development and promotion How to find our guest, Dr. Russ Weiner, Head Oncology and Cell Therapy Clinical Biomarker Sciences and Operations at Takeda: https://www.linkedin.com/in/russellweiner/ Your BioTalk Unzipped Cohosts: Gregory Austin, Business Development Manager at ProPharma Group https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe, Executive Vice President of Global Bioanalytical Services at Celerion https://www.linkedin.com/in/chadbriscoe/ Image credits: Image by Tumisu from Pixabay Giphy: The Chemical Brothers; PBS Digital Studios; http://www.gizmodo.com.au/2015/07/did-an-australian-university-just-say-wi-fi-gives-you-and-your-kids-cancer/; http://dynamicoceans.tumblr.com/post/99418047836/manta-ray-glittering-in-the-sunlight-despite Photo by Andres Siimon on Unsplash Tenor AAPS Cardiac cell beating courtesy of IGI Deputy Director Bruce Conklin Liquid Diving Adventures, https://www.liquiddivingadventures.com/blog/post/2020/11/27/socorro-islands-mexico-only-by-liveaboard
	Miraculous Cures: From Hospice to Survivor with Dr. Russ Weiner	02 Jan 2024	00:36:54
In Episode 3 of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe dive deep into the world of biotech with an exclusive interview featuring the esteemed Dr. Russ Weiner. As a senior-level biopharmaceutical professional with over 30 years of hands-on experience, Dr. Weiner shares invaluable insights into pharmaceutical and biologic drug discovery/development, clinical trial conduct, and project leadership. The episode unfolds with a detailed exploration of Dr. Weiner's impressive career, starting with his journey into the industry and an incredible success story in hospice care. The conversation transitions into the dynamic changes witnessed in the past three decades, particularly the pivotal shift into biologics. Dr. Weiner's experiences with large molecules, mass spec, and the challenges faced in the evolving CRO space are discussed. Key Highlights: Podcast Episode 3 Tracks, Miraculous Cures: From Hospice to Survivor 🔬 1:36 - Russ’ Bio: Delve into the professional journey of Dr. Russ Weiner, a senior-level biopharmaceutical professional with over 30 years of hands-on experience. 🌟 4:29 - What Got You into This Industry?: Uncover the motivations and inspirations that led Dr. Weiner to a distinguished career in the biotech industry. 🏥 6:29 - Hospice Success: Explore a noteworthy success story from Dr. Weiner's career, shedding light on the impact of his work. 🔄 8:08 - Changes in the Past 30 Years: Trace the dynamic changes in the biotech industry over the last three decades, with a spotlight on the significant move into biologics. 🌐 12:30 - Biggest Challenges in Biologics: Dr. Weiner discusses the current hurdles in biologics, including pre-analytics, training, and the logistics of sample handling. 🦠 16:00 - COVID's Impact on the Process: Gain insights into how the COVID pandemic has influenced the biotech process and its day-to-day operations. 🌦️ 19:20 - Weather's Effect on Science: Explore how weather conditions can impact scientific processes in biotech. 🤝 21:30 - Improved Communication: Dr. Weiner reflects on the enhanced communication between sponsor companies, CROs, and laboratories in the biotech ecosystem. 🏗️ 24:00 - Building Labs and Transformational Leadership: Uncover what drives Dr. Weiner's role as a builder of labs and a transformational leader, emphasizing his passion for both science and leadership. 👥 26:00 - Building Cohesive Lab Teams: Gain insights into Dr. Weiner's approach to building cohesive and successful lab teams. 🌟 29:37 - Success Tips for Young Leaders: Dr. Weiner shares valuable advice for aspiring young leaders on how to achieve success in the dynamic field of biotech. 🏢 32:40 - Russ’ Career at Takeda: Explore Dr. Weiner's impactful career at Takeda Oncology, touching on his experiences in a start-up-like environment and his strategies for supporting his team. 🎙️ **Subscribe for more exclusive content and in-depth conversations in the world of biotech! 🚀 #BiotechJourney #LeadershipStories #BioTalkUnzippedPodcast #biotechnology #pharmaceutical #science #interview #hospice
	Science is Not a Conspiracy Theory	15 Dec 2023	00:26:01
Why does developing a new medicine remain so difficult, and what happens when artificial intelligence enters the equation? In Episode 2 of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe examine some of the fundamental challenges facing drug discovery and development, including the enormous scientific uncertainty involved in turning an idea into a medicine. The conversation moves into artificial intelligence and its growing role in biopharmaceutical research. Gregory and Chad explore where AI could accelerate discovery and development, but also what increased reliance on AI may mean for education, critical thinking, and the way future scientists learn. They also look beyond technology to something even more fundamental: the motivation of the scientists doing this work. What keeps people pursuing difficult scientific problems when experiments fail, companies change direction, and years of work may never become an approved therapy? Gregory concludes the episode by sharing the unconventional path that brought him into biotechnology and pharmaceuticals. This episode is designed for anyone curious about how medicines are developed, whether you work inside the industry or simply want to better understand the science shaping healthcare. Chapters 00:56 - Chad Briscoe’s take on one of the greatest challenges in drug discovery and development 05:41 - A declaration about science 10:02 - The use of AI in biopharmaceutical science 15:17 - How AI may affect education and learning 16:57 - Swifties and science 17:42 - What drives scientists working toward medical progress 20:18 - Gregory’s journey into biotech and pharma Connect with the hosts Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Resources mentioned The Boston Society / Applied Pharmaceutical Analysis: https://www.bostonsociety.org Tom Shull: https://www.linkedin.com/in/tomshull/ #biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery #research
	Biotech, Drug Development & the Stories Behind Medical Progress \| BioTalk Unzipped Trailer	28 Nov 2023	00:00:45
BioTalk Unzipped explores the science, people, breakthroughs, setbacks, and unexpected stories behind medical progress. Hosted by Gregory Austin and Dr. Chad Briscoe, the podcast brings biotechnology, pharmaceutical development, drug discovery, clinical research, and emerging medical technologies to life through candid conversations with the scientists, executives, entrepreneurs, and innovators helping move medicine forward. The idea behind BioTalk Unzipped started simply: some of the best conversations about science happen when people put down the presentations, pull up a chair, and talk openly. Think intelligent biotech conversation with the accessibility and personality of a great conversation over a drink. We explore questions such as: • How does a promising scientific idea become a medicine? • Why do drug-development programs succeed or fail? • What breakthroughs are genuinely changing healthcare? • How are AI, cell and gene therapy, precision medicine, bioanalysis, clinical research, and new technologies reshaping drug development? • What can we learn from the people behind the science? BioTalk Unzipped is scientifically credible without being inaccessible and serious about medical progress without taking itself too seriously. Watch all BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped Connect with the hosts: Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ #Biotechnology #DrugDevelopment #DrugDiscovery #ClinicalResearch #Pharmaceutical #Science #BioTalkUnzipped
	Why Biotech Companies Fail	27 Nov 2023	00:25:22
Biotechnology changes lives, but the stories behind those breakthroughs are often far more complicated than the headlines suggest. Welcome to the premiere of BioTalk Unzipped, where Gregory Austin and Dr. Chad Briscoe explore the science, people, decisions, failures, and unexpected moments behind medical progress. In this inaugural episode, Gregory and Chad introduce themselves, explain what drew them into biotechnology and pharmaceutical development, and discuss why they created a podcast designed for scientists and non-scientists alike. The conversation explores an uncomfortable reality of biotech: even companies built around talented scientists and promising ideas can fail. Gregory and Chad examine what happens when science, capital, execution, and business realities collide, and why setbacks remain an important part of innovation. Chad also shares some of the biggest surprises from his career in bioanalysis and drug development, while the conversation turns toward what young scientists and industry professionals can do to build successful careers. BioTalk Unzipped was created to make biotechnology more understandable without stripping away the complexity that makes the field so fascinating. In this episode Meet BioTalk Unzipped hosts Gregory Austin and Dr. Chad Briscoe Why biotechnology companies fail, even when the science looks promising Unexpected lessons from a career in drug development What aspiring scientists need to understand about building a career Why the human stories behind science matter Connect with the hosts Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin’s book, Stellar Resume Writing: Secrets From a Corporate Recruiter: https://www.amazon.com/dp/B07NTK6RG2 #biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery

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