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

Her Daughter’s Brain Tumor Turned Her Into a Biotech Founder | Tracy Ryan

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/ [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/?utm_source=chatgpt.comhttps://www.linkedin.com/in/tracyryan23/ [https://www.linkedin.com/in/tracyryan23/?utm_source=chatgpt.com] Connect with Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/] Connect with Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/] Watch more BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped/videoshttps://www.youtube.com/@BioTalkUnzipped/videos [https://www.youtube.com/@BioTalkUnzipped/videos] Visit BioTalk Unzipped: https://www.biotalkunzipped.comhttps://www.biotalkunzipped.com [https://www.biotalkunzipped.com] Learn more about NKore BioTherapeutics: https://www.nkore.comhttps://www.nkore.com [https://www.nkore.com] Support Saving Sophie: https://www.savingsophie.orghttps://www.savingsophie.org [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

Oncology drug development is becoming more complex, and bioanalysis can no longer be treated as simple drug measurement. Sponsored by Leucentra, https://leucentra.com/ [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/ [https://www.linkedin.com/in/lakshmi-amaravadi/] Hosts Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/] Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/] Sponsor: Leucentra Related Links Celerion https://www.celerion.com/ [https://www.celerion.com/]

Active Machine Learning for Drug Discovery & Nanomedicine with Dr. Daniel Reker

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/ [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/ [https://www.linkedin.com/in/danielreker/] Duke website: https://rekerlab.pratt.duke.edu/ [https://rekerlab.pratt.duke.edu/] Connect with BioTalk Unzipped: Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/] Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [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

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/ [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 [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/ [https://www.aacr.org/] National Cancer Institute – Molecular diagnostics and biomarkers https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis [https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis] Pattern recognition technologies in diagnostics https://toby.health [https://toby.health] CONNECT Dr. Bob Liu https://www.linkedin.com/in/bob-liu-42b8b278/ [https://www.linkedin.com/in/bob-liu-42b8b278/] Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/] Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [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

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/ [https://www.linkedin.com/in/kate-neville-phd/] Firm Bio: https://www.marshallip.com/katherine-l-neville-ph-d/ [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/ [https://www.girlsontherun.org/] HOSTS Dr. Chad Briscoe Bioanalytical Scientific Leader https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/] Gregory Austin Director, Business Development | Bioanalysis https://www.linkedin.com/in/gregoryaustin1/ [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.