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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Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins (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 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 Briscoe<a...
Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva (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 studiesLeveraging entrepreneurial mindsets from biotech within big pharma frameworksThe promise of dried blood spots (DBS) and patient-centric samplingMentorship, curiosity, and the future of scientific leadershipHer return to Sri Lanka with KU faculty to recruit the next generation of scientistsThroughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both.Guest LinksDr. Binodh DeSilvahttps://www.linkedin.com/in/binodh-desilva/ Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ HostsDr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://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 (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 & Intro01:58 Deep Viscosity and AI in Antibody Development04:39 AI Validation and Model Reliability07:12 International Journey and Collaborative Research08:42 Future of Formulation Development10:30 AAPS NBC Experience11:30 Academic vs. Industry Career Paths12:31 Collaboration with Pharmaceutical Companies13:59 Modeling Protein Aggregation Challenges14:43 Student Engagement and Research Opportunities15:45 Expanding Applications of Machine LearningDr. Pin-Kuang Laihttps://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/DeepViscosityDr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/
The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics (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 & Intro01:10 Robert Thorne’s Reflections on the AAPS NBC conference03:14 The Professional Biotech and Pharma League05:09 A Personal Story Shared: Family Loss to Brain Cancer07:57 My Reason for Optimism Treating Brain Cancer08:50 Why Brain Metastases Remain Hard to Treat11:10 Scientific Advances in Drug Delivery for Brain Cancer12:30 Seed and Soil Concept in Oncology15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond16:49 Looking Ahead: Hope for Future Therapies21:32 Closing GratitudeDr. Robert Thornehttps://www.linkedin.com/in/robert-g-thorne/Denali Therapeutics - https://www.denalitherapeutics.com/ 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/ 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...
Inside AAPS NBC with AAPS President Dr. Russ Weiner (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 & Intro01:22 What is conference life like as AAPS President02:27 Mentoring & Fatherhood at AAPS03:54 Setting up the Meeting Season for AAPS05:43 Life back in the Rare Disease Space - a Passion10:58 The different costs of pharmaceutical & biotech research12:59 The generosity of Rare Disease Patients14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts19:57 Rare Disease conversations happening at AAPS and global reach22:37 Broad use of new technologies, including Olink24:10 Biggest change expected in Pharma in 10 yearsDr. Russ Weinerhttps://www.linkedin.com/in/russellweiner/ AAPS - https://www.aaps.org/home 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/ 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,...
Building Successful Life Science Companies with Katrina Rogers (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 Introduction03:09 Katrina’s Charity Highlight: 2nd Harvest (link below)04:04 Defining Moment in Life Science05:35 Launching a Consultancy: Overcoming Fears07:12 Leadership Lessons09:30 The Importance of Board Composition13:08 NEW NEWS: The Case for Female Founders18:04 Knowledge Gaps Between Founders and Regulators20:23 The Impact of Regulatory Changes21:32 The Direct Attack on Basic Scientific Infrastructure25:57 Understanding Market Needs29:36 The Role of Founders in Leadership and Navigating Leadership Challenges34:00 The Most Common Mistake by Biotech Founders & What To Do35:27 Katrina’s Scope & Delivering Unpleasant News36:51 NEW NEWS: Understanding Tariffs and Drug Pricing42:23 Empowering Big Ideas45:26 Overcoming Systemic Barriers47:24 Advice to My Younger Self49:38 Proposing Changes to FDA Innovation Pathways54:54 The Future of Innovation in BiotechnologyKatrina Rogershttps://www.linkedin.com/in/katrinarogers/ https://krogersconsulting.com/ Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.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 NEWSBiotech 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<a href="https://www.techtarget.com/pharmalifesciences/news/366622459/Trump-signals-shift-in-drug-import-tariff-policy" rel="noopener noreferrer"...
Navigating Challenges in Drug Discovery with Dr. Alfred Botchway (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 Botchwayhttps://www.linkedin.com/in/alfred-botchway-41b01a6/CEO of Attentive Science: https://www.attentivescience.com/ 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/ 00:00 Introduction to BioTalk Unzipped02:32 Dr. Alfred Botchway's Journey in Biomedical Science03:48 Challenges Founding and Growing Xenometrics07:30 Starting Attentive Science: A New Venture09:37 Love of the Work - Variations10:26 The Role of AI in Non-Clinical Safety Assessments13:04 The Three Rs: Replace, Reduce, Refine, and AI15:46 Regulatory Standards and Good Laboratory Practices20:42 New News! - Research on Anxiety and Drug Discovery27:07 Cortical Stimulation and Stress Management27:45 Bridging Academia and Industry29:26 Engaging the Next Generation in Science32:42 The Value of Vocational Training in Science34:47 Community Involvement and Giving Back37:00 Cultural Influences on Leadership42:39 Global Expansion and Strategic Goals48:41 Innovations in Sample Collection for Clinical TrialsDigital Twin Episodes reference with Tomas Helikar:Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikarhttps://youtu.be/jTM_Zlt3wxU Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikarhttps://youtu.be/NM5X0jTd6UA
2024 Year In Review: BioTalk Unzipped (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 Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ TakeawaysEvery 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.KeywordsBioTalk, 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 (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 Unzipped02:01 Celebrating Women in Pharmaceutical Sciences03:21 The Importance of STEAM Education04:09 Personal Journeys into Science08:02 Exciting Projects and Discoveries13:52 Challenges in CMC for Cell and Gene Therapies18:51 Innovations in Chiral Bioanalysis22:46 NEW NEWS! - New ADC Approved28:33 Exploring Combination Therapies in Cancer Treatment32:26 Empowering Women in Pharmaceutical Sciences37:30 Mentorship and Community Engagement45:18 The Role of Allyship in Science47:19 Breaking Barriers and Challenging Stereotypes54:15 Engaging Diverse Voices in Discussions56:49 Creating Inclusive Spaces for Feedback & Speaking Up01:01:15 Avoiding Assumptions in Professional Settings01:02:04 Setting Boundaries for Work-Life Balance01:05:24 Measuring Success in Life01:07:06 Connecting and Networking EffectivelyDr. Ines Santoshttps://www.linkedin.com/in/insantos/ Dr. Julia Sablehttps://www.linkedin.com/in/julia-sable-5b794385/ STEAMparkhttps://www.steampark.org/ WIPS in AAPShttps://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - <a href="https://www.celerion.com/" rel="noopener noreferrer"...
Are AI Doctors coming soon? A Discussion about AI in Medical Devices. - with Dr. Alex Friedman (01:10:29)
In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device. Chapters02:26 Introduction to BioTalk Unzipped03:40 Charity Spotlight: Americares05:01 Dr. Alex Friedman's Career Journey11:52 The Regulatory Landscape of Medical Device Classifications18:52 Regulatory Gameshow!: Classifying Medical Devices22:28 AI Enabled Software as a Medical Device: An Overview 25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike30:31 The Evolution of Wearable Health Technology41:17 Liability and Risk in Medical Device Development43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare47:13 Self Updating AI Doctors?? - The Future of AI in Public Health49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box56:27 New News!! - The Intersection of AI, Regulation, and Innovation01:07:28 Measuring Success in Life and WorkHOW TO REACH US:Alex Friedmanhttps://www.linkedin.com/in/alexfriedman/ Alex’s Charity: Americareshttps://www.americares.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device datahttps://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTechhttps://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersectMentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/ HIT-IQ - <a href="https://www.hitiq.com/smart-mouthguard" rel="noopener noreferrer"...
Collaborating for Innovation: Biopharma Success with Dr. Nathan Teuscher (00:31:39)
In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology), which aims to educate listeners on clinical pharmacology and related topics.Chapters00:51 The Changing Landscape of Pharmaceuticals03:49 Virtual Clinical Trials and Patient Engagement08:06 Optimizing Drug Dosage in Oncology10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy14:26 The Complexities of Cell Therapy17:33 Navigating Immunocompromised States in Treatment20:09 Advice to Young Scientists in Biopharma 23:04 Defining Success in Life and Career24:47 The Purpose and Impact of Nathan's Podcast, Clinical PharmacologyHOW TO REACH US:Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Email: nathan@aplosanalytics.comNathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40)https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacologyPodcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / TakeawaysNathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.Virtual clinical...
The Future of Pharmacometrics with Dr. Nathan Teuscher (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.Chapters00:00 Episode Preview00:55 Introduction to BioTalk Unzipped02:06 Charity Spotlight: Light of the World04:51 Nathan Teuscher's Career Journey07:34 Differentiating AI Types in Life Science12:41 Challenges with Large Language Models15:39 Rethinking Reporting in Pharma17:56 The Future of AI and Analytics in Pharma?18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies23:05 Leveraging Data, AI, and APIs in 3 Dimensions26:22 NEW NEWS! - Gene Editing Breakthroughs in MedicineHow to reach us:Light the World Charity - Church of Jesus Christ Latter Day Saintshttps://www.churchofjesuschrist.org/comeuntochrist/light-the-world Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Nathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://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 Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites"We don't need to write reports anymore."TakeawaysNathan Teuscher has over 20 years of experience in clinical pharmacology and...
Insights from AAPS PharmSci 360 Live with Dr. Mark Arnold (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. Chapters00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 36003:45 Samaritan's Purse Charity and Community Impact05:16 Most impactful talk at AAPS?11:50 Comparative Analysis of FDA and EU Regulations17:37 The Drive Behind Bioanalytical Work22:24 NEW NEWS! - Innovations in RNA Editing and BioanalysisTakeawaysThe 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 Pursehttps://www.samaritanspurse.org/ Mark Arnoldhttps://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image CreditsAAPS
Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar (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 (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:
...
How AI is Transforming Drug Development: Reflections from AAPS - PharmSci 360 with Dr. Mark Arnold (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: <a href="http://www.novocure.com"...
Biotech Funding Trends and the Rise of Digital Twinning with CEO Scott Ogle (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 /
Technology Meets Purpose: Transforming Clinical Trials at TruLab with CEO Scott Ogle (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 TrueLab, 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/
TruLab - https://trulab.com/
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...
Mentoring in Pharmaceutical Science with Dr. Jim Shen (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 - <a...
Great Advances in Cancer Research with Dr. Jim Shen (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
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The Future of Hybrid Healthcare: Insights from Zealic CEO Chuck Piccirillo (00:39:32)
In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Zealic CEO, Chuck Piccirillo. They delve into the unique challenges of the patient journey and the increasing demand for hybrid healthcare solutions that offer more flexibility. The discussion highlights the rise of virtual health, particularly in Europe, and introduces exciting developments in ion channels as a goldmine for new medicines. They also explore the financial intricacies of drug development, the importance of leadership through incremental steps, the value of in-person interactions, and hard-earned lessons in the industry. Finally, Chuck offers invaluable advice for entrepreneurs in the life sciences sector.
Chapters
00:17 - Adapting to what is unique in the patient journey.
07:08 - Push for hybrid solutions - more flexibility.
09:20 - Virtual health is emerging, especially in Europe.
14:02 - New News! - Ion Channels are a goldmine for new medicines
19:23 - The Financial Side of Drug Development
21:50 - Leadership - Incremental Steps, the Value of In-Person Interactions, Learning Hard Lessons
30:58 - Advice For Entrepreneurs in Life Science
Takeaways
Building blocks to build the digital patient experience, then tweak it to the individual drug and form a complex digital and personal adaptive health journey.
The healthcare industry needs to find a balance between safety and innovation to ensure patients have access to the best possible care. Remote patient monitoring and decentralized clinical trials are crucial in improving patient engagement and outcomes in the healthcare industry.
Virtual visits and technology integration can enhance patient engagement and make healthcare more accessible.
While there has been an increase in decentralized trials, the focus is currently on commercial solutions due to the crowded nature of the clinical trial technology space.
Virtual health and routine monitoring have the potential to alleviate the burden on healthcare providers and improve patient care.
Ion channel research holds promise for developing new medicines and treatments for various conditions.
Incremental progress and persistence are key in entrepreneurship and leadership.
Sound Bites
(regarding adaptability in clinical software) “Imagine if LinkedIn only every 6 months. How engaging would that be?”
"And it would actually integrate with like Uber, for example, and help them get a ride if they had to go to the doctor and actually, and all of that is based on these building blocks that we're able to assemble and then press a button."
“I think everybody wants whatever aspect of life nowadays to be hybrid anything.”
“It’s why we always talk about pragmatic innovation.”
“Persistence in the face of opposition of all sorts.”
New News Story: These microscopic tunnels are a goldmine for new medicines
https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/
How to reach us:
Crohn's & Colitis Foundation
https://www.crohnscolitisfoundation.org/
Chuck Piccirillo
https://www.linkedin.com/in/cpiccirillo/
Zealic Health - http://www.zealichealth.com
Dr. Chad Briscoe
<a...
Genetic Diagnostics & Student CEOs with Dr. Jonathon Hill (00:33:17)
Summary
In this conversation, Dr. Jonathon Hill discusses the unique partnership between his lab and the university, which allows students to become entrepreneurs, develop their own projects, and become the CEO. Dr. Hill discusses the potential for AI to better diagnose disease based on the individual’s genome. He also talks about Lumicell's fluorescent system for highlighting residual breast cancer tissue and the importance of genetic diagnostics in personalized medicine. Dr. Hill shares his advice for students interested in genetics and biotechnology research, emphasizing the value of research experience and taking risks. He also discusses the challenges of regulatory pathways in the biotech industry.
Takeaways
The unique partnership between academic institutions and companies can provide students with opportunities to develop their own ideas and become entrepreneurs, fostering innovation and impact in the biotechnology industry.
Lumicell's fluorescent system can help detect residual breast cancer tissue, reducing the need for additional surgeries
Genetic diagnostics will play a crucial role in personalized medicine, but there are limitations to relying solely on genetic sequencing
Navigating regulatory pathways is a challenge in the biotech industry
Sound Bites
“We like to say that we are creating CEOs in our labs … CEO at age 23.”
“When you go to the doctor, they do a guess and check model.”
“Why did you not carefully diagnose the problem and give me the right treatment the first time?”
“And medicine needs to go in the direction of AI-aided diagnosis because it's going to lower costs, make things faster and more efficient and better in the long run if we can create if we can create accurate diagnoses.”
“Typically about 50% of high school seniors indicate they will go to college. This year it’s down to 37%”
Chapters
01:01-The balance between being professor and running a lab
02:00-The unique partnership between university and industry
03:55-More students are looking to pursue entrepreneurship out of college
06:31-How will AI affect genetics research and the industry? The impact of AI in future diagnoses.
12:58-New News! Lumcell’s breakthrough in residual breast cancer imaging detection.
16:10-Dr Hill’s passions within and outside his professional life.
17:37-Advice for young scientists and budding biotech entrepreneurs.
21:00-Growth of bioinnovations and training scientific students for business success vs. backlash of the cost of education.
28:48-The regulatory hurdles and progress for Wasatch and their DNA research.
New News Article
The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftov...https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer
How to reach us:
Dr. Jonathon Hill
https://www.linkedin.com/in/jonathon-t-hill/
Wasatch Labs: https://www.wasatchbiolabs.com/
Rainforest Trust - https://www.rainforesttrust.org/
Dr. Chad Briscoe
<a...
How AI is Helping Diagnose Disease with Chuck Piccirillo (00:38:04)
Summary
In this conversation, Gregory Austin and Chad Briscoe interview Chuck Piccirillo, CEO of Zealic Health, about his experience in the healthcare industry and the focus on patient-centric solutions. Chuck shares his personal journey with colitis and how it ultimately inspired him to start Zealic Health. The company aims to provide highly patient-centric digital platforms to improve care and treatment in the healthcare industry. Chuck also shares the story of how Zealic Health adapted to the war in Ukraine and relocated their employees to Poland.
The panel tackles the tough questions around the new LDT as a Medical Device final ruling by the FDA. They then discuss how AI is helping doctors detect cancer and in making better diagnostic decisions.
Takeaways
Zealic Health focuses on providing patient-centric digital platforms to improve care and treatment in the healthcare industry.
The use of AI in healthcare can help accelerate drug development, improve diagnostics, and enhance patient engagement.
Zealic Health adapted to the war in Ukraine by relocating their employees to Poland, demonstrating their commitment to their team and their mission.
The FDA final ruling is clearly to improve safety but the confusion is in the interpretation of that ruling and
Sound Bites
“The biggest challenge is the interpretation of these (LDT) rules.”
“Typically I’m not in favor of what Congress is doing.”
“Trying to understand how we’re going to navigate the space … it’s just been confusing.”
"The FDA is trying to protect us, but they need to navigate these things and engage industry experts."
“(regarding AI) Where does marketing end and reality begin?”
"AI isn't going to say, 'We don't need the doctor, just use AI.'"
“The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.”
“The whole promise of AI is taking massive amounts of data and finding those patterns
Chapters
01:33 Introduction and Background
04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis
07:49 Patient-Centric Solutions in Healthcare and Zealic Health
13:26 Plan B - Moving offices from Ukraine to Poland
20:02 New News!! - The Controversy of LDTs Becoming Medical Devices
27:20 Implications of healthcare and regulations as it applies to AI
30:07 How AI Aids in Diagnosis
New News Story: House committee tells FDA to suspend lab developed test rule
https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/
How to reach us:
Crohn's & Colitis Foundation
https://www.crohnscolitisfoundation.org/
Chuck Piccirillo
https://www.linkedin.com/in/cpiccirillo/
Zealic Health - http://www.zealichealth.com
Dr. Chad Briscoe
https://www.linkedin.com/in/chadbriscoe/
Celerion - https://www.celerion.com/
Gregory Austin
https://www.linkedin.com/in/gregoryaustin1/ ...
Reptiles, Treatments, and Cell-Gene Therapy with Dr. Vick (00:38:01)
Summary
Dr. Andy Vick shares some of the things that surprised him throughout his career and he discusses his passion for reptiles and his experience discussing the pharmaceutical potential of venom with future toxicologists at Ashland University. Next, Andrew Vick discusses his role as an adjunct professor at Ohio State University, his involvement in academia, and how he got into it. We discuss a story about a clinical study that restored hearing in children with gene therapy. The conversation concludes with a discussion about the impact of professional organizations like AAPS on the industry and the importance of networking and fellowship.
Takeaways
Cancer doesn’t have the same death sentence - fear factor it used to have 30+ years ago.
It takes about 10 years for a newly discovered compound to make it on the market.
Andrew Vick is passionate about reptiles and has a collection of rare reptiles. He enjoys educating others about reptiles and their pharmaceutical potential, particularly venom.
There’s a shift from small molecules to biologics in the past 5 years.
Andrew Vick visited Ashland University to discuss the pharmaceutical potential of venom with future toxicologists, combining his passion for reptiles and pharmaceutical science. Andrew Vick is an adjunct professor at Ohio State University, where he teaches in the College of Pharmacy Division of Pharmaceutical Chemistry.
His role as an adjunct professor involves giving guest lectures, providing career and professional development for students, and serving on the Dean's Corporate Council.
Andrew Vick is also involved in evaluating assets developed in academia and collaborating with industry to develop strategies for bringing products to the clinic.
We discuss a study by Regeneron that used gene therapy to restore hearing in children with mutations in the otoferlin gene.
Regarding Cell-Gene Therapy we have a lot to learn both from the positive pharmacological potential, but also from a safety and tolerability standpoint.
Professional organizations like AAPS play a crucial role in networking and fellowship, providing opportunities for collaboration and learning in the pharmaceutical industry.
Sound Bites
"I have just a passion for reptiles and have accumulated a small and pretty rare collection of reptiles from around the world."
“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.”
“AAPS is just kind of part of my DNA.”
Chapters
00:21 - Surprises in 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 In The Past 30 Years
10:13 - Educating Future Toxicologists about Reptiles and Pharmaceuticals
15:45 - Andrew Vick's Role as an Adjunct Professor at Ohio State University
21:21 - New News!! - Restoring Hearing in Children with Gene Therapy
27:27 - The Impact of Professional Organizations on the Industry, AAPS
New News Story: The 'little protein factory' that could: Regeneron gene therapy restores hearing in 2 children
<a...
Amyloidosis Exposed: New Hope with Dr. Vick (00:40:52)
Summary
Dr. Andy Vick discusses his work at Attralus Therapeutics, a biotech company focused on developing treatments for systemic amyloidosis. He explains the etiology of the disease and how Attralus is attacking it using therapeutic antibodies with a pan amyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Dr. Vick emphasizes the importance of toxicology in drug discovery and development, describing its role in evaluating the adverse side effects of drugs and ensuring safety. He also highlights the challenges of finding animal models for rare diseases like amyloidosis. In this part of the conversation, Andrew Vick discusses his transition from working in a contract research organization (CRO) to a small biotech company. He highlights the similarities and differences between working in biotech, pharma, and CROs, emphasizing the motivation to help others and improve the quality of life. The conversation then shifts to a discussion about a novel mRNA-based cancer vaccine for glioblastoma, which shows promise in early research. The vaccine wraps the RNA specific to a patient's tumor in lipid nanoparticles, stimulating a robust immune response against the cancer.
Takeaways
Attralus Therapeutics is focused on developing treatments for systemic amyloidosis using therapeutic antibodies with a panamyloid reactive peptide sequence.
The company is also developing a diagnostic tool to visualize amyloid burden in patients.
Toxicology plays a crucial role in drug discovery and development, evaluating the adverse side effects of drugs and ensuring safety.
Finding animal models for rare diseases like amyloidosis can be challenging. Andrew Vick transitioned from working in a contract research organization (CRO) to a small biotech company, highlighting the similarities and differences between the two.
The motivation to help others and improve the quality of life is a common thread in biotech, pharma, and CROs.
A novel mRNA-based cancer vaccine for glioblastoma shows promise in early research, stimulating a robust immune response against the cancer.
Sound Bites
"Attralus Therapeutics is focusing on biologic-based therapeutics and diagnostics related to amyloidosis."
"Toxicology is the science of evaluating the adverse side effects of drugs."
"Attralus Therapeutics' lead product is a therapeutic antibody with a panamyloid reactive peptide sequence."
"This novel mRNA vaccine shows promise against deadly brain cancer."
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 Studying Amyloidosis
22:06 The History of Attralus and Dr. Vick’s Transition There from CRO
32:45 New News! - Promising Results of an mRNA-Based Brain Cancer Vaccine
New News Story: 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
https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY
UF
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