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  • The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi

    The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi
    2026/06/11

    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/
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    30 分
  • Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker

    Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker
    2026/04/25

    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.
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    51 分
  • Why Haven’t We Cured Cancer Yet? | Dr. Bob Liu Explains

    Why Haven’t We Cured Cancer Yet? | Dr. Bob Liu Explains
    2026/03/19
    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 LearnWhy cancer is not one disease, but more than 200 biologically distinct conditionsWhat “curing cancer” actually means in clinical oncologyHow immunotherapies like checkpoint inhibitors and CAR-T are changing outcomesThe biological limits of eliminating every cancer cellHow tumors evade immune detection and adapt over timeWhy only about 20% of patients respond to immuno-oncology therapiesThe role of biomarkers, molecular profiling, and precision medicineWhy early detection remains one of the biggest unsolved challengesThe economic and regulatory pressures shaping next-generation therapiesKey InsightCancer 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.”Timestamps00:00 – Introduction02:42 – Bob’s passion - AACR04:28 – Why we haven’t cured cancer07:09 – Defining a cancer cure10:26 – Cancer classification and molecular signatures14:16 – Methylation profiling in diagnosis17:22 – Patient resources and navigation21:14 – FDA shifts toward randomized trials for CAR-T24:15 – Cost and access challenges26:33 – Cancer vs cardiovascular disease progress33:39 – The challenge of early detection37:48 – Biomarker limitations39:14 – Immune system dynamics in cancer45:19 – Bioanalytical challenges in modern therapies51:08 – Progress and future outlookAbout the GuestDr. 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 & LinksFDA to tighten approval requirements for CAR-T therapieshttps://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-celAmerican Association for Cancer Research (AACR)https://www.aacr.org/National Cancer Institute – Molecular diagnostics and biomarkershttps://www.cancer.gov/about-cancer/diagnosis-staging/diagnosisPattern recognition technologies in diagnosticshttps://toby.healthConnectDr. Bob Liuhttps://www.linkedin.com/in/bob-liu-42b8b278/Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Final ThoughtThe 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.
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    1 時間
  • The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney

    The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney
    2026/02/16

    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.
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    53 分
  • Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins

    Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins
    2025/12/22
    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 environmentTopics 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 - Intro00:53 – Welcome to BioTalk Unzipped, Guest intro: Dr. Chris Hopkins02:10 – Guest charity: Environmental Defense Fund03:12 – His journey into rare-disease therapeutics and Glafabra05:58 – Discovering a new enzyme-deficiency therapy 06:39 – Current standard of care 07:42 – How the new autologous cell therapy works09:40 – Treating patients earlier (even newborns)10:33 – Emerging therapies - AAV gene therapy vs. cell-based therapy12:16 – Long-term results & repeat dosing14:30 – Future plans: T-cells & allogeneic approaches18:08 – New News: FDA resubmission for rare disease20:00 – Navigating FDA pathways22:06 – Non-animal testing & alternative models25:50 – Montana’s early-access therapy law & medical tourism29:03 – Could other states follow?31:31 – Biotech’s current funding challenges33:46 – New News: Gene therapy trial saves 4-year-old37:09 – Long-term vision for expanding therapies39:53 – Personal segment: outdoor life & skiing44:43 – Guest question on international trade Dr. Christopher Hopkinshttps://www.linkedin.com/in/christopherehopkins/ Glafabra - https://www.glafabra.com/ Environmental Defense Fund - https://www.edf.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/Celerion - https://www.celerion.com/Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Celerion - https://www.celerion.com/New News Articles:US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapyhttps://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-70l2sgqwMontana, revolutionary law passed: unlimited research for longevityhttps://en.ilsole24ore.com/art/montana-approved-revolutionary-law-researching-longevity-without-limits-AHmDI7BB?refresh_ce=1Key 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 #BioTalkUnzippedhttps://youtu.be/VcPXZmK-XU8
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    49 分
  • Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva

    Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva
    2025/10/23

    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.
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    31 分
  • Unlocking Antibody Development with AI with Dr. Pin-Kuang Lai

    Unlocking Antibody Development with AI with Dr. Pin-Kuang Lai
    2025/09/12

    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/
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    18 分
  • The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics

    The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics
    2025/07/03

    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.
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    22 分