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by BioTalk Unzipped
Gregory Austin and Dr. Chad Briscoe unzip, unlock, and uncover, the Stories Behind Medical Progress by sharing the latest and greatest advances in biopharmaceuticals and medical technologies in a fun, entertaining, and enlightening interview format. We bring on innovative leaders across the life sciences. The format is like a conversation you might overhear at the bar or at dinner after a day of great life science talks at a conference, engaging and accessible.
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- 1 weeks ago48 min
Do Clinical Trials Take Too Much Blood? Patient-Centric Sampling with Joleen White
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.SponsorsTruTechnologies 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 expectationsGuest and hostDr. 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 mentionedOpen-access RSM01 dried blood microsampling study:https://pubmed.ncbi.nlm.nih.gov/39696004/Patient Centric Sampling Interest Group:https://www.pcsig.org/Follow BioTalk UnzippedWebsite and all episodes: https://www.biotalkunzipped.com/YouTube: https://www.youtube.com/@BioTalkUnzippedBioTalk Unzipped unzips, unlocks, and uncovers the real stories behind medical progress.
- Aug 8, 202611 min
Why Gene Therapy Is Still So Hard to Manufacture at Scale | Phillip Ramsey
Why is gene therapy still so difficult to manufacture at scale after decades of progress?Phillip Ramsey, Chief Technical Officer at Sangamo Therapeutics, joins BioTalk Unzipped for a candid conversation about one of the central challenges facing advanced therapies: turning extraordinary science into reproducible, scalable medicines.Thank You to Our SponsorsLeucentra - https://leucentra.com/Inspired by Science. Empowered by IT. Leucentra provides specialized IT consulting and services for life sciences and healthcare, helping organizations use technology more effectively to support innovation.TruTechnologies - https://trutechnologies.ai/Clinical Trial Execution, Live. TruTechnologies provides live clinical trial execution technology that gives sponsors greater visibility into protocol activities, samples, and study data as they happen.About This EpisodeRecorded onsite at the AAPS National Biotechnology Conference in Boston, Phillip explains why gene therapy manufacturing has not yet reached the maturity of monoclonal antibody production.As technologies have evolved across retroviral vectors, lentiviral vectors, adenovirus, AAV, lipid nanoparticles, and other advanced modalities, development teams have repeatedly been required to rethink fundamental manufacturing and analytical questions.Phillip discusses why analytics are critical, why experience across multiple manufacturing lots and products matters, and why there simply is no shortcut to developing the scientific knowledge necessary to manufacture advanced therapies reliably.He also reflects on the uncertainty of biotechnology.Early in his career, Phillip was walking down a hallway when his CFO asked if he had cashed his paycheck.When he said no, she told him not to.It's a remarkable story that captures something rarely discussed about biotechnology: behind transformative science are people willing to operate through considerable uncertainty while trying to build something that has never existed before.Gregory and Phillip Discuss• Viral vector manufacturing and scale-up• Why analytics are essential to gene therapy development• AAV manufacturing challenges• Lentiviral vectors and other evolving delivery technologies• Lipid nanoparticles and changes in advanced therapy manufacturing• Why gene therapy cannot simply adopt the established monoclonal antibody manufacturing playbook• Building process knowledge across lots and products• Career resilience in biotechnology• Progress across AAV, CAR-T, and other advanced therapies• Gene therapy affordability• The importance of therapeutic durability• Outcomes-based payment models for advanced therapiesPhillip's message for scientists and industry leaders is straightforward: don't assume the manufacturing problem has already been solved simply because a technology has existed for decades.The field is still evolving, and some knowledge cannot be shortcut.About Phillip RamseyPhillip Ramsey is Chief Technical Officer at Sangamo Therapeutics and brings more than 35 years of experience across biotechnology and pharmaceutical manufacturing, technical development, operations, quality, and advanced therapies.Connect with Phillip Ramsey:https://www.linkedin.com/in/phillip-ramsey-a2074711/Sangamo Therapeutics:https://www.sangamo.com/Connect With BioTalk UnzippedGregory Austin on LinkedIn:https://www.linkedin.com/in/gregoryaustin1/Dr. Chad Briscoe on LinkedIn:https://www.linkedin.com/in/chadbriscoe/BioTalk Unzipped:https://www.biotalkunzipped.com/BioTalk Unzipped unzips, unlocks, and uncovers the stories behind medical progress through conversations with scientists, executives, entrepreneurs, and innovators advancing biotechnology, pharmaceuticals, and medical technology.Recorded onsite at the AAPS National Biotechnology Conference in Boston.Special thanks to AAPS and Rebecca Stauffer for supporting the BioTalk Unzipped interview series.
- Jul 20, 20261h 4m
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/ 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 communityAbout 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/videosVisit BioTalk Unzipped: https://www.biotalkunzipped.comLearn more about NKore BioTherapeutics: https://www.nkore.comSupport Saving Sophie:<a href
- Jun 11, 202629 min
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/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 complex02:12 FDA biomarker validation guidance and industry response04:27 What “fit for purpose” means in practice06:38 PK assay validation vs biomarker assay validation07:52 What drives Dr. Amaravadi’s work in translational science10:48 Why validation is not a checkbox exercise12:19 Advice for young scientists entering bioanalysis15:12 Why oncology drug development is uniquely complex18:17 ADCs, bispecifics, T-cell engagers, and conditional T-cell engagers19:38 Why bioanalysis now requires understanding biology20:46 Dr. Amaravadi’s path from molecular biology to bioanalysis24:34 Critical reagent management in complex oncology assays26:42 Validation, qualification, and context of use29:03 Final thoughts from AAPS PharmSci 360This 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.GuestDr. Lakshmi Amaravadihttps://www.linkedin.com/in/lakshmi-amaravadi/HostsGregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/Sponsor: LeucentraRelated LinksCelerionhttps://www.celerion.com/
- Apr 25, 202650 min
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 IThttps://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 developmentGuest 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 RekerEmail: daniel.reker@duke.eduLinkedIn: https://www.linkedin.com/in/danielreker/Duke website: https://rekerlab.pratt.duke.edu/Connect with BioTalk Unzipped:Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/Dr. Chad Briscoehttps://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.
- Mar 19, 20261h 0m
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/ 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/<
- Feb 16, 202652 min
The Intersection of Biotech, Patent Law, and AI with Dr. Kate Neville, IP Attorney
Recorded October 31, 2025In 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 therapiesWe 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 MattersIntellectual 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 GuestDr. Kate NevillePartner, Marshall, Gerstein & BorunPhD in Immunology, JDLinkedIn: 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 ChicagoAn organization building confidence and resilience in young girls through mentorship and athletic achievement.https://www.girlsontherun.org/HostsDr. Chad BriscoeBioanalytical Scientific Leaderhttps://www.linkedin.com/in/chadbriscoe/Gregory AustinDirector, Business Development | Bioanalysishttps://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.
- Dec 22, 202549 min
Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins
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/healthc
About BioTalk Unzipped
Gregory Austin and Dr. Chad Briscoe unzip, unlock, and uncover, the Stories Behind Medical Progress by sharing the latest and greatest advances in biopharmaceuticals and medical technologies in a fun, entertaining, and enlightening interview format. We bring on innovative leaders across the life sciences. The format is like a conversation you might overhear at the bar or at dinner after a day of great life science talks at a conference, engaging and accessible.
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