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Вміст надано BioTalk Unzipped. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією BioTalk Unzipped або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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Ep. 47 – Ticketing Chaos Explained: Bots, Brokers & Bold Claims with Joel Schwartz What do Donald Trump, Kid Rock, and a 200% ticket guarantee have in common? They’re all part of the chaotic, misunderstood world of live event ticketing—and veteran ticket broker, founding member of the National Association of Ticket Brokers (NATB) and attorney, Joel Schwartz is here to discuss the current executive order and how it affects ticket brokers and fans. In this high-impact episode, we sit down with one of the original voices in ticket resale to break down what’s really driving the headlines. From political theater to pricing transparency, Schwartz shares insider stories from decades in the game—starting with Lions games in the '70s and stretching all the way to Super Bowl holdbacks, Taylor Swift meltdowns, and FTC policy shifts. In this episode, you'll learn: Why bots aren’t the real problem—and who actually is How “dynamic pricing” impact fans, travel planners, and the entire resale market What the new executive orders and pricing laws could mean for concerts, sports, and festivals How fans, brokers, and platforms can navigate an increasingly complex and competitive marketplace Whether you're a travel professional, ticketing insider, or just a fan tired of hidden fees and vanishing inventory, this episode delivers clarity, context, and a dose of hard truth. Follow us at @Tix2TravelPod on all platforms and subscribe wherever you get your podcasts. www.tttpod.com www.xpotravel.com…
BioTalk Unzipped
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Вміст надано BioTalk Unzipped. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією BioTalk Unzipped або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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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Вміст надано BioTalk Unzipped. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією BioTalk Unzipped або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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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BioTalk Unzipped

In this powerful episode (#35) of BioTalk Unzipped , recorded live at the AAPS NBC conference in Boston, Gregory Austin engages in a deep conversation with a leading Neuroscientist, Dr. Robert Thorne, Denali Fellow at Denali Therapeutics, for an intimate and scientific deep dive into the evolving world of brain cancer treatment and CNS drug delivery. Both Gregory and Dr. Thorne share personal stories of losing family members to brain metastases, weaving in the emotional 'why' behind their professional paths. Dr. Thorne highlights the complexities of the blood-brain barrier, the heterogeneity of brain metastases, and cutting-edge delivery technologies—including focused ultrasound and molecular engineering approaches. The conversation also touches on pediatric brain tumors like diffuse midline glioma (DIPG), emerging research in lysosomal storage diseases, and the collaborative spirit driving innovation in neuroscience today. This is more than a technical discussion—it’s a human story about grief, hope, and the relentless pursuit of better outcomes for patients with brain diseases. 00:00 Preview & Intro 01:10 Robert Thorne’s Reflections on the AAPS NBC conference 03:14 The Professional Biotech and Pharma League 05:09 A Personal Story Shared: Family Loss to Brain Cancer 07:57 My Reason for Optimism Treating Brain Cancer 08:50 Why Brain Metastases Remain Hard to Treat 11:10 Scientific Advances in Drug Delivery for Brain Cancer 12:30 Seed and Soil Concept in Oncology 15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond 16:49 Looking Ahead: Hope for Future Therapies 21:32 Closing Gratitude Dr. Robert Thorne https://www.linkedin.com/in/robert-g-thorne/ Denali Therapeutics - https://www.denalitherapeutics.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Key Takeaways: Personal Connection Fuels Professional Passion: Both Gregory and Dr. Thorne were driven into the life sciences field by family experiences with brain tumors. The Blood-Brain Barrier (BBB) Remains a Major Challenge: Brain metastases from cancers like melanoma, lung, and breast cancer still present difficult delivery barriers for therapies. Heterogeneity in Brain Mets: Different metastases within the same patient can have vastly different BBB permeability, requiring multifaceted delivery strategies. Emerging Drug Delivery Innovations: Focused ultrasound, engineered biologics, and Denali’s own delivery platforms are all promising ways to improve CNS drug penetration. Pediatric Brain Cancers Present a Unique Set of Challenges: Diseases like diffuse midline glioma (DIPG) remain largely untreatable, but learnings from lysosomal storage disorders may translate in the future. The Power of Community in Science: The conference setting highlights how collaboration and diverse perspectives drive breakthroughs in bioanalysis and drug development.…
In this special episode (#34) of BioTalk Unzipped , recorded live at the AAPS NBC conference in Boston, Gregory Austin and Dr. Chad Briscoe sit down with AAPS President Dr. Russ Weiner for an unfiltered look inside AAPS NBC, at the state of rare disease research, the evolution of therapeutic modalities, and the human stories that drive scientific innovation. From navigating the emotional weight of personal loss to watching his son experience the field firsthand, Russ shares not only his scientific insights but the heart behind his leadership. The conversation spans topics like the rising promise of AI diagnostics, challenges with biomarker sampling logistics, the role of CROs in rare disease trials, and the future of autologous vs. allogeneic therapies. Dr. Weiner also offers an inspiring vision of industry collaboration, sharing how organizations like AAPS are becoming conduits for progress across low- and middle-income countries, underrepresented diseases, and emerging biotechnologies. Whether you're in the lab, the boardroom, or on the frontlines of clinical trials, this episode will reignite your sense of purpose in this field. 00:00 Preview & Intro 01:22 What is conference life like as AAPS President 02:27 Mentoring & Fatherhood at AAPS 03:54 Setting up the Meeting Season for AAPS 05:43 Life back in the Rare Disease Space - a Passion 10:58 The different costs of pharmaceutical & biotech research 12:59 The generosity of Rare Disease Patients 14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts 19:57 Rare Disease conversations happening at AAPS and global reach 22:37 Broad use of new technologies, including Olink 24:10 Biggest change expected in Pharma in 10 years Dr. Russ Weiner https://www.linkedin.com/in/russellweiner/ AAPS - https://www.aaps.org/home Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Takeaways: Treating rare diseases early is not only life-saving—it’s economically sound. Gene and cell therapies may carry high price tags, but they dramatically reduce long-term costs. The diagnostic delay for rare diseases—often 4 to 7 years—remains one of the biggest barriers to treatment. AI-powered diagnostics and data integration could change that. Dr. Russ Weiner shares how personal loss fueled his career in science and how mentoring the next generation, including his son, brings it full circle. The shift toward allogeneic cell therapies and in vivo CAR-T treatments will be key to driving down costs and increasing global accessibility. CROs must evolve: future-ready organizations will localize biomarker analysis and forge relationships with rare disease investigators to improve site performance. Technologies like Olink are revolutionizing biomarker discovery, enabling cost-effective, high-resolution multiplexing that was previously out of reach. Spatial imaging, AI pathology, and facial-recognition-based diagnosis are the next wave of precision medicine. Quotes “Treating rare disease isn’t just compassionate—it’s a smart investment. Do the math, and curing someone can be far cheaper than managing chronic care for a lifetime.” “You can’t say it’s not in your backyard when that backyard becomes yours the moment you're on the same plane.” (on global health and infectious disease risk) “Some of the most generous people in clinical research are rare disease patients. They fight so no one else has to.” “It took me six months to even scratch the surface of this portfolio—rare disease isn’t just rare, it’s overwhelmingly complex.”…
In this powerful episode of BioTalk Unzipped , Gregory Austin and Dr. Chad Briscoe sit down with Katrina Rogers, a 25-year life sciences veteran, biotech equity advocate, and founder of Evergreen Bioscience Innovation and Katrina Rogers Consulting. Katrina shares her compelling journey from Pfizer to pioneering innovation ecosystems and mentoring underrepresented biotech founders. They unpack the role of board governance, the funding gap for female founders, and how "showing your science" is critical for regulatory success. Katrina also warns of dangerous gaps in understanding between regulators and innovators and why we must protect our basic science infrastructure. If you've ever dreamed of launching a breakthrough therapy, leading a biotech, or making your idea count, this episode is for you. 00:00 Episode Preview & BioTalk Unzipped Introduction 03:09 Katrina’s Charity Highlight: 2nd Harvest (link below) 04:04 Defining Moment in Life Science 05:35 Launching a Consultancy: Overcoming Fears 07:12 Leadership Lessons 09:30 The Importance of Board Composition 13:08 NEW NEWS: The Case for Female Founders 18:04 Knowledge Gaps Between Founders and Regulators 20:23 The Impact of Regulatory Changes 21:32 The Direct Attack on Basic Scientific Infrastructure 25:57 Understanding Market Needs 29:36 The Role of Founders in Leadership and Navigating Leadership Challenges 34:00 The Most Common Mistake by Biotech Founders & What To Do 35:27 Katrina’s Scope & Delivering Unpleasant News 36:51 NEW NEWS: Understanding Tariffs and Drug Pricing 42:23 Empowering Big Ideas 45:26 Overcoming Systemic Barriers 47:24 Advice to My Younger Self 49:38 Proposing Changes to FDA Innovation Pathways 54:54 The Future of Innovation in Biotechnology Katrina Rogers https://www.linkedin.com/in/katrinarogers/ https://krogersconsulting.com/ Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ NEW NEWS Biotech a Bright Spot for Female Founders Amid DEI Pullback, https://www.biospace.com/business/biotech-a-bright-spot-for-female-founders-amid-dei-pullback?utm_source=chatgpt.com Trump signals shift in drug import tariff policy https://www.techtarget.com/pharmalifesciences/news/366622459/Trump-signals-shift-in-drug-import-tariff-policy Quotables "The world needs your big idea." "Build trust and that will engender loyalty." "You need to have a board already established." "Show them your science." "Be Specific and people can be incredibly generous with their time." "Tariffs are incredibly blunt economic instruments." "You should at least try to get it out there." "Our culture has expectations that limit us." "You have to drive that vision." “Stop playing small - you’re meant for more.” “Put the Visionaries with the Doers and you’re unstoppable!” Takeaways Founders should evaluate their board members early in the process. Female founders are underrepresented but show higher returns on investment. Understanding customer needs is crucial for product development. Regulatory changes can create knowledge gaps for founders. Basic science is essential for innovation in drug development. Leadership challenges often stem from board dynamics. Problem-solving tools can help founders navigate challenges. The most common mistake is not doing enough discovery research. Building a network is crucial for early-stage entrepreneurs. People are generous with their time if you’re super specific about your need! Delivering unpleasant news is part of being a problem solver. Tariffs can disrupt supply chains and raise drug prices. Leadership roles require proactive vision and engagement. Cultural expectations can limit innovation and self-worth. Anyone can be an innovator with the right support. The skilled technical workforce is vital for future innovation. Passion drives significant advancements in biotechnology.…
In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alfred Botchway, CEO of Attentive Science, to discuss his journey in biomedical science and the groundbreaking work being done at the intersection of AI, non-clinical safety, and drug discovery. Dr. Botchway shares his insights on the role of AI in refining toxicology studies, how stress impacts human health, and his experience founding companies like Xenometrics and Attentive Science. The conversation dives deep into the complexities of Good Laboratory Practices (GLP), the importance of regulatory standards, and the exciting research happening in anxiety and PTSD treatments. Dr. Botchway also discusses the future of biomedical research, the need for greater collaboration between academia and industry, and how innovations in sample collection are transforming clinical trials. Whether you’re interested in AI, biomedical innovation, or the future of drug discovery, this episode offers valuable insights from a leader shaping the industry. Don’t forget to subscribe and let us know your thoughts in the comments below! Dr. Alfred Botchway https://www.linkedin.com/in/alfred-botchway-41b01a6/ CEO of Attentive Science: https://www.attentivescience.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ 00:00 Introduction to BioTalk Unzipped 02:32 Dr. Alfred Botchway's Journey in Biomedical Science 03:48 Challenges Founding and Growing Xenometrics 07:30 Starting Attentive Science: A New Venture 09:37 Love of the Work - Variations 10:26 The Role of AI in Non-Clinical Safety Assessments 13:04 The Three Rs: Replace, Reduce, Refine, and AI 15:46 Regulatory Standards and Good Laboratory Practices 20:42 New News! - Research on Anxiety and Drug Discovery 27:07 Cortical Stimulation and Stress Management 27:45 Bridging Academia and Industry 29:26 Engaging the Next Generation in Science 32:42 The Value of Vocational Training in Science 34:47 Community Involvement and Giving Back 37:00 Cultural Influences on Leadership 42:39 Global Expansion and Strategic Goals 48:41 Innovations in Sample Collection for Clinical Trials Digital Twin Episodes reference with Tomas Helikar: Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar https://youtu.be/jTM_Zlt3wxU Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar https://youtu.be/NM5X0jTd6UA…
In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations. Thanks to CREO Consulting for hosting this episode! https://creoconsulting.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ Takeaways Every sample is a person, a patient, a loved one. Embrace the fear, take more risks. The importance of human connection in drug development. AI is becoming integral in drug discovery and development. Successful individuals often wish they had taken more risks. Leadership in the industry is about raising others up. Mentorship plays a crucial role in professional growth. Personal growth can come from listening and engaging with others. Innovative approaches are essential in addressing industry challenges. Keywords BioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights…
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BioTalk Unzipped

1 Women in Pharmaceutical Sciences and their Allies with Dr. Ines Santos and Dr. Julie Sable 1:11:01
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In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment. 01:20 Introduction to BioTalk Unzipped 02:01 Celebrating Women in Pharmaceutical Sciences 03:21 The Importance of STEAM Education 04:09 Personal Journeys into Science 08:02 Exciting Projects and Discoveries 13:52 Challenges in CMC for Cell and Gene Therapies 18:51 Innovations in Chiral Bioanalysis 22:46 NEW NEWS! - New ADC Approved 28:33 Exploring Combination Therapies in Cancer Treatment 32:26 Empowering Women in Pharmaceutical Sciences 37:30 Mentorship and Community Engagement 45:18 The Role of Allyship in Science 47:19 Breaking Barriers and Challenging Stereotypes 54:15 Engaging Diverse Voices in Discussions 56:49 Creating Inclusive Spaces for Feedback & Speaking Up 01:01:15 Avoiding Assumptions in Professional Settings 01:02:04 Setting Boundaries for Work-Life Balance 01:05:24 Measuring Success in Life 01:07:06 Connecting and Networking Effectively Dr. Ines Santos https://www.linkedin.com/in/insantos/ Dr. Julia Sable https://www.linkedin.com/in/julia-sable-5b794385/ STEAMpark https://www.steampark.org/ WIPS in AAPS https://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Story: In Fierce Pharma - Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphoma https://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma Journal Article mentioned: Emerging applications of quantitative supercritical fluid chromatography-tandem mass spectrometry for chiral bioanalysis https://www.sciencedirect.com/science/article/abs/pii/S0021967325000767 Sound Bites "We want to build our next generation." "We all want the same result." "You have to have a level of extrovert." "If you see something, say something." "Take action this year." Image Credits: AAPS & WIPS logos: https://www.aaps.org/ Keywords BioTalk, pharmaceutical sciences, women in science, CMC challenges, chiral bioanalysis, CAR-T therapies, STEAM education, innovations in medicine, healthcare advancements, biotechnology, cancer treatment, CAR T therapy, women in science, mentorship, allyship, pharmaceutical sciences, community engagement, combination therapies, empowerment, gender equality, engagement, feedback, inclusivity, allyship, professional development, work-life balance, success, networking #pharmaceutical #women #womenempowerment #science #drugdevelopment #biotech #biopharma #mentor #mentorship #AAPS #WIPS…
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BioTalk Unzipped

1 Are AI Doctors coming soon? A Discussion about AI in Medical Devices. - with Dr. Alex Friedman 1:10:29
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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. Chapters 02:26 Introduction to BioTalk Unzipped 03:40 Charity Spotlight: Americares 05:01 Dr. Alex Friedman's Career Journey 11:52 The Regulatory Landscape of Medical Device Classifications 18:52 Regulatory Gameshow!: Classifying Medical Devices 22:28 AI Enabled Software as a Medical Device: An Overview 25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike 30:31 The Evolution of Wearable Health Technology 41:17 Liability and Risk in Medical Device Development 43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare 47:13 Self Updating AI Doctors?? - The Future of AI in Public Health 49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box 56:27 New News!! - The Intersection of AI, Regulation, and Innovation 01:07:28 Measuring Success in Life and Work HOW TO REACH US: Alex Friedman https://www.linkedin.com/in/alexfriedman/ Alex’s Charity: Americares https://www.americares.org/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device data https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424 New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect Mentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/ HIT-IQ - https://www.hitiq.com/smart-mouthguard Prevent Biometrics - https://preventbiometrics.com/ IDX-DR - Diagnosing Software https://www.healthvisors.com/en/idx-dr/ Sound Bites "The common thread is the science." "Regulatory has to catch up." "You can't sell snake oil." "It's a multidisciplinary effort." "Software as a medical device is a hot thing." Image Credits: Aliens - https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/ https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/ keywords medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs…
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. Chapters 00:51 The Changing Landscape of Pharmaceuticals 03:49 Virtual Clinical Trials and Patient Engagement 08:06 Optimizing Drug Dosage in Oncology 10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy 14:26 The Complexities of Cell Therapy 17:33 Navigating Immunocompromised States in Treatment 20:09 Advice to Young Scientists in Biopharma 23:04 Defining Success in Life and Career 24:47 The Purpose and Impact of Nathan's Podcast, Clinical Pharmacology HOW TO REACH US: Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Email: nathan@aplosanalytics.com Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacology Podcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234 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 / Takeaways Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. Virtual clinical trials can enhance patient engagement and diversity in research. Finding the right dosage is a critical challenge in drug development. Project Optimus aims to redefine oncology drug development practices. AI and data analysis can help identify ideal candidates for clinical trials. Ethical considerations are paramount in the use of patient data for research. The right dose for each patient varies significantly. Understanding individual immune system capacities is crucial in treatment. Collaboration is key to success in the scientific community. Success is measured by the happiness of loved ones. Finding joy in helping others is essential for career fulfillment. Podcasts serve as valuable educational resources. Engaging with diverse disciplines enhances scientific understanding. Sound Bites “If you want to be successful, seek first to understand, then be understood.” “If you’re looking to help people and in collaboration, you’ll be successful.” “Success in life is the happiness of loved ones around you.” New News Story: After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast keywords BioTalk, pharmacology, AI in pharma, drug development, Nathan Teuscher, pharmacometrics, virtual clinical trials, clinical research, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare…
In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants. Chapters 00:00 Episode Preview 00:55 Introduction to BioTalk Unzipped 02:06 Charity Spotlight: Light of the World 04:51 Nathan Teuscher's Career Journey 07:34 Differentiating AI Types in Life Science 12:41 Challenges with Large Language Models 15:39 Rethinking Reporting in Pharma 17:56 The Future of AI and Analytics in Pharma? 18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies 23:05 Leveraging Data, AI, and APIs in 3 Dimensions 26:22 NEW NEWS! - Gene Editing Breakthroughs in Medicine How to reach us: Light the World Charity - Church of Jesus Christ Latter Day Saints https://www.churchofjesuschrist.org/comeuntochrist/light-the-world Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites "We don't need to write reports anymore." Takeaways Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. Light the World charity offers unique giving machines for donations. AI can automate repetitive tasks in drug development, freeing up human capital for innovation. There are two types of AI: large language models and automated data analysis. Large language models can be unreliable in scientific contexts. Pharmaceutical companies spend significant resources on report writing, which may not add value. Small companies can leverage APIs to access standardized calculations and data analysis. The pharmaceutical industry is often insular, limiting the potential of AI. AI could potentially eliminate the need for extensive written reports in drug development. Collaboration and data sharing are crucial for advancing AI in the pharmaceutical industry. Leveraging data effectively requires combining various data sets and tools. The evolution of AI tools is crucial for navigating new technologies. Gene editing represents a significant breakthrough in organ transplantation. New News Story: A woman in the US is the third person to receive a gene-edited pig kidney https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/ Image Credits Pig Kidney, https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants Keywords BioTalk, pharmacology, AI in pharma, drug development, pharmacometrics, software development, clinical research, Light the World, charity, data analysis, AI tools, gene editing, kidney transplant, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare…
In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients. Chapters 00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 360 03:45 Samaritan's Purse Charity and Community Impact 05:16 Most impactful talk at AAPS? 11:50 Comparative Analysis of FDA and EU Regulations 17:37 The Drive Behind Bioanalytical Work 22:24 NEW NEWS! - Innovations in RNA Editing and Bioanalysis Takeaways The FDA's new rules on lab-developed tests could delay biomarker utilization in clinical trials. Community support through charities like Samaritan's Purse is crucial during crises. The importance of collaboration in advancing drug development and bioanalytical methods. Innovations in RNA editing present new bioanalytical challenges. The drive to help patients is a key motivator for professionals in the field. Sound Bites "I worked on that drug and there's a clear benefit." "It's getting that new therapy to a patient." "This is going to change and potentially delay biomarkers." New News Story: Wave sees RNA editing validation in early trial results ◦ https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/ How to reach us: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ Mark Arnold https://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits AAPS…
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…
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Dr. Tomas Helikar, a leading researcher in bioinformatics and systems biology, delves into groundbreaking work on developing a personalized immune digital twin, which aims to revolutionize the understanding and treatment of immune-related diseases. Chapters 00:00 Introduction to BioTalk Unzipped 01:50 Meet Dr. Tomas Helikar 04:34 The Journey into Systems Biology 10:03 Understanding Digital Twins in Immunology 14:19 The Importance of Personalized Medicine 17:20 Digital Twin Research Funding and Its Impact 18:38 The Role of Digital Twins in Disease Management 21:11 Digital Twin Efforts for Organ Transplants 24:05 Computational Challenges in Modeling 26:36 Mathematical Models in Biological Research 28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody Collaboration How to reach us: Tomas Helikar https://www.linkedin.com/in/tomashelikar/ X - https://x.com/tomashelikar Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Charity Mentioned: https://saintpeterlincoln.com/school FOLLOW ► LinkedIn: https://www.linkedin.com/company/biotalk-unzipped Twitter: https://x.com/BiotalkUnzipped Instagram: https://www.instagram.com/biotalkunzipped/ Takeaways Dr. Helikar's research focuses on the immune system's network and disease. Systems biology integrates computer science and biology for better understanding. Digital twins can provide personalized models for immune system analysis. Your digital twin model could tell you how you might respond to a particular disease and if you really need to go to the hospital. The immune digital twin reflects an individual's unique immune baseline. Research funding is crucial for advancing innovative medical technologies. Personalized medicine can improve public health outcomes significantly. Computational power is essential for processing complex biological data. Mathematical models are vital for simulating biological processes. Digital twins can enhance drug discovery and clinical trial efficiency. Sound Bites "The immune system is a network of networks." “Each of our immune system baselines are different.” "We need to build out this multi-scale model." New News Story: Supplier-Turned-Partner: Twist Joins Absci in AI Antibody Collaboration https://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/ Image Credits Signal Transduction, www.scientificanimations.com - http://www.scientificanimations.com/wiki-images/ Computational Model, https://computationstructures.org/notes/models/notes.html Holland computer center, https://newsroom.unl.edu/announce/cse/16380/90600 https://news.unl.edu/article/husker-football-game-day-information-announced-for-2023 https://hcc.unl.edu/office-locations…
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1 How AI is Transforming Drug Development: Reflections from AAPS - PharmSci 360 with Dr. Mark Arnold 36:11
Dr. Mark Arnold, a distinguished bioanalytical thought leader with an impressive track record in supporting drug development programs. Mark is the Owner and Principal at Bioanalytical Solution Integration, where he provides strategic counsel on complex bioanalytical assays and regulatory compliance. With over 35 years of experience, including leadership roles at BMS and Labcorp, Mark has become a key figure in the biotech and pharma industries. He is also an AAPS Fellow and a founder of the Global Bioanalysis Consortium. 01:05 - Career Reflections and Contributions to Drug Development 05:28 - Understanding the Integration of Drug Development 09:30 - What Would You Change? Embracing Career Risks in Pharma 11:32 - Navigating Career Paths: Small vs. Large Companies 16:09 - NEW NEWS! - Can Electrical Fields Disrupt Cancer? 23:28 - The Role of AI in Drug Development 31:13 - Encouraging Innovation in a Regulated Industry Follow Mark, Chad and Gregory: Please donate to: Samaritan’s Purse https://www.samaritanspurse.org/ Mark Arnold - https://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/ Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / BioTalk Unzipped on LinkedIn - https://www.linkedin.com/company/biotalk-unzipped/ New News Story: Novocure wins FDA approval for electric field device in lung cancer https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997 Two articles on finding 1000’s of dark matter RNA viruses: https://www.fiercebiotech.com/research/deep-learning-ai-model-scans-dark-matter-genomic-data-and-finds-70000-never-seen-rna https://www.nature.com/articles/d41586-024-03320-6 Image Credits Novocure images courtesy of Novocure: www.novocure.com…
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EP-23. In the second half of this compelling conversation on BioTalk Unzipped , Gregory Austin and Dr. Chad Briscoe continue their deep dive with Scott Ogle, CEO of TruLab. They explore the surprising parallels between the banking and pharma industries, the game-changing role of digital twinning in clinical trials, and the biotech funding landscape. Scott also shares his thoughts on leadership, mentorship, and the impact of the Inflation Reduction Act on pharma innovation. This episode offers listeners valuable insights into the future of drug development and the challenges of balancing professional and personal life in a fast-paced industry. Chapters 1:09 - Comparison of the Banking Industry to the Pharma Industry 5:18 - Data Integrity, Same For Decentralized Trials? 8:33 - Biotech Funding Trends 11:18 - NEW NEWS! – Digital Twinning in Clinical Trials 16:15 - What Advice Would You Give to Your Younger Self? 20:57 - Mentorship and Its Impact, How it Shaped Scott 23:45 - Balancing Work and Personal Life 24:32 - The Inflation Reduction Act and Innovation Takeaways The regulatory environment in pharma can slow down innovation. Digital twinning in clinical trials could revolutionize drug development. Family influences play a significant role in shaping business perspectives. The need for a strong company culture to maintain values during growth. Biotech funding trends are influenced by macroeconomic factors like interest rates. The importance of mentorship in professional development. Sound Bites “The similarities between the banking industry and the pharma industry is eerily similar.” “Quality is really what we do.” “Being quality is core to software.” “It’s really clear people care more about their money than they do their healthcare.” “Biotech and large pharma seem to balance each other out.” “The career for you is at the intersection of what you are good at and what you like to do.” “If you’re good at something and you like to do it, it fuels your energy to keep getting better.” “Enjoy the impact in what you’re doing and accomplishing!” New News Story: Digital “Twinning”: Clinical Trials Powered by AI https://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/ TruLab - https://trulab.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Digital Twinning - Credit Getty Images Simulation - Credit: andrush / Adobe Stock Tomáš Helikar - https://www.linkedin.com/in/tomashelikar/ Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600 Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/…
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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 to pharma journey, revolutionizing clinical trials, impact of personal experience on innovation, biotechnology leadership, clinical trial inefficiencies, cancer treatment news, digital transformation in pharma, family influence in business, company culture in biotech, pharmaceutical funding challenges, ISB 2001 trispecific T cell engager. Tags: #ScottOgle, #TruLab, #ClinicalTrials, #Biotech, #PharmaInnovation, #Sample Management, #Company Culture, #Hiring Tips, #BiotechLeadership, #PharmaTechnology, #CancerTreatment, #PersonalInnovation, #BiotechFunding, #LeadershipInPharma, #BusinessLeadership, #PharmaceuticalIndustry.…
Mentoring in Pharmaceutical Science with Dr. Jim Shen Summary In Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography. Chapters 01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis 04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference 05:10 - Early Career in Bioanalysis 07:35 - The Importance of Mentorship and Dealing With Adversaries 17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy 24:55 - Personal Interests: Photography and Gaming Takeaways Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans. Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of others Build a network of champions, allies, and sponsors Be open to new career opportunities and emerging fields Maintain integrity and transparency in scientific research Explore different hobbies and interests outside of work Sound Bites “Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.” “EQ is so important in being successful in your larger pharmaceutical company.” “I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.” “And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.” New News Story: Following FDA rejection, a journal retracts papers on MDMA-assisted therapy https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/ How to reach us: Dr. Jim Shen https://www.linkedin.com/in/jimxshen/ Bristol Myers Squibb - https://www.bms.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Travis Kelce: https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DQY8xlVldVp8&psig=AOvVaw2yCKg3oh923dt0beIIR8w3&ust=1726284386832000&source=images&cd=vfe&opi=89978449&ved=0CBcQjhxqFwoTCICN_OD8vogDFQAAAAAdAAAAABB2 https://www.te-university.com/posts https://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839 https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.html https://www.newheightshow.com/ https://www.aol.com/fans-think-moment-travis-kelce-185629668.html World of Warcraft Guilds https://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/ Infrared Photography: Jim Shen Keywords Pharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis…
In this episode (EP20) of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the Executive Director and Head of Regulated Bioanalysis Operations at BMS. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry. Chapters 01:15 - Introduction, Background, and Passion for The American Cancer Society 03:46 - Advancements in Cancer Therapies, Opdualag 08:03 - From Small Molecule to Large to Hybrid 12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy 18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis 27:00 - The Integration of AI and Mechanistic Modeling in Drug Development 34:30 - Navigating the Complexities of Regulatory Submissions Takeaways Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes. The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential. Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision. Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans. Sound Bites "Advancements in cancer therapies have revolutionized the treatment landscape." "Antibody drug conjugates are one of the most exciting and interesting types of molecules." "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy." New News Story: Startup Halda raises $126M to advance new type of targeted cancer therapy https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/ How to reach us: American Cancer Society https://www.cancer.org/ Dr. Jim Shen https://www.linkedin.com/in/jimxshen/ Bristol Myers Squibb - https://www.bms.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Images ADC Mechanism of Action https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953 https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441 Keywords Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science…
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 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 Patient Journey, Hybrid Healthcare Solutions, Drug Development Finance, Leadership in Life Sciences, Entrepreneurship in Life Sciences, Remote Patient Monitoring, Decentralized Clinical Trials, Healthcare Technology Integration, Digital Patient Experience, Clinical Software Adaptability, Pragmatic Innovation, Persistence in Entrepreneurship, Leadership #HealthcareInnovation #VirtualHealth #DrugDevelopment #LifeSciences #Entrepreneurship #DigitalHealth #HybridHealthcare #IonChannels #PatientCare #RemoteMonitoring #ClinicalTrials #Leadership #HealthTech #PragmaticInnovation #Persistence #pharmaceutical #biotech #science #CEO…
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 https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Gattaca https://www.justwatch.com/us/movie/gattaca Lumicell Fluorescent System https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care https://vimeo.com/807609920 https://healthandpharma.net/fda-approves-imaging-tumor-detection-breast-cancer-surgeries#google_vignette Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA…
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/ ECI - https://eci-rx.com / Image credits: https://www.crohnscolitisfoundation.org/ LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657 Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/ Cost, https://www.freepik.com/photos/increasing-costs Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/ #BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice…
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 https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids How to reach us: Dr. Andy Vick https://www.linkedin.com/in/andy-vick-4467189/ Attralus: https://www.attralus.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image credits: Pharmacognosy - https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy #biotechnology #science #research #toxicology #reptiles #academia #cellgenetherapy #AAPS…
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 https://www.clickorlando.com/news/florida/2024/03/11/university-of-florida-axes-diversity-and-inclusion-office-under-gop-led-law-aimed-at-ridding-similar-programs/ Music Track: "CLARITY", Mifune Music provided by https://slip.stream Download / Stream: https://get.slip.stream/KFCilm Keywords Attralus Therapeutics, systemic amyloidosis, therapeutic antibodies, panamyloid reactive peptide sequence, diagnostic tool, toxicology, drug discovery, drug development, animal models, rare diseases, transition, contract research organization, CRO, biotech, pharma, motivation, quality of life, mRNA-based cancer vaccine, glioblastoma, lipid nanoparticles, immune response #biotechnology #science #research #toxicology #glioblastoma #braincancer #vaccine #amyloidosis…
A Diagnostic Breakthrough for Alzheimer’s Summary In this conversation, Dr. Jonathan Hill discusses his work in nanopore sequencing-based technology and its applications in genetic and epigenetic research. He shares his experiences working in Brazil and his passion for preserving the rainforest. The conversation also explores the use of AI in analyzing the genetic underpinnings of tobacco addiction and the potential impact on addiction treatment. Dr. Hill highlights his lab's breakthrough in identifying early biomarkers for Alzheimer's disease using DNA methylation signatures. Takeaways Nanopore sequencing is a powerful technology that allows for real-time analysis of native DNA and RNA, regardless of length, and provides valuable insights into genetic and epigenetic research. Preserving the rainforest is crucial, and initiatives like the Rainforest Trust play a vital role in protecting the biodiversity and resources found in these ecosystems. AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment. The integration of AI technologies in genetic research should be approached with caution, as the black box nature of AI can limit our understanding of the underlying biology. It is important to carefully test and explain AI models to build trust among users. The use of nanopore sequencing and DNA methylation signatures shows promise in the early detection of Alzheimer's disease, potentially allowing for personalized approaches to treatment and intervention. Sound Bites "One of my bucket list items, one of my dreams would be to set up a nanopore sequencing lab in the Amazon and just sequence that biodiversity and create that data so we could glean it for everything it's worth and learn so much about how our world works." "Nanopore sequencing is based on protein nanopores that exist in nature, and these particular nanopores can pass DNA through the pore." "AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment." “Biology is not rocket science, it’s much harder.” "Better diagnosis comes better treatment." Chapters 00:00 Introduction 02:51 Donation to the Rainforest Trust & Time in Brazil 06:37 How Nanopore Sequencing Works 12:45 New News! AI and the Genetic Code of Tobacco Addiction 15:20 Using AI in Nanopore Sequencing at Wasatch Labs and Diagnostics 21:14 Finding Cell-Free DNA for Fertility Treatments 22:56 Breakthrough - Finding Early Biomarkers for Alzheimer’s New News Article Breaking the Genetic Code of Tobacco Addiction https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/ How to reach us: Dr. Jonathan Hill https://www.linkedin.com/in/jonathon-t-hill/ Wasatch Labs: https://www.wasatchbiolabs.com/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image Credits Rainforest Trust - https://www.rainforesttrust.org/ https://www.envirobuild.com/blog/rainforest-trust Fire Sponge https://stock.adobe.com/ Amazon Photos: Shutterstock Medicine Man https://www.rollingstone.com/music/music-lists/stills-from-the-movie-medicine-man-32217/medicine-man-5-159239/ https://www.solarnavigator.net/films_movies_actors/medicine_man.htm Oxford Nanopore Technologies How nanopore sequencing works https://www.youtube.com/watch?v=RcP85JHLmnI Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA…
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BioTalk Unzipped

The AI Prescription: Revolutionizing Pharma & Patient Care with Jason Burke Summary In Episode 13, Jason Burke discusses the unique approach of the Duke program in providing real-world healthcare data to students. He also highlights the breakthrough in AI-generated drug discovery and its potential impact on investors and startups. The process of assessing technologies for companies and patients is explored, with a focus on evaluating business and technology aspects. The importance of unique intellectual property is emphasized, and the future of AI and software is discussed. The conversation concludes with insights into using AI in everyday life and the role of search engine companies in AI. In this conversation, Chad and Jason discuss the interface between pharma companies and the healthcare industry, highlighting the lack of interplay between the two. They explore the challenges faced by the healthcare industry, including the complexity of the operating environment and the limited infrastructure for research. Jason emphasizes the potential for life sciences firms to become service companies and overcome these challenges. They also delve into Jason's interest in amateur radio and the fascinating world of ham radio, where he has been learning and discovering new things. Takeaways The Duke program provides students with real-world healthcare data, giving them a unique advantage in the job market. AI-generated drug discovery has the potential to revolutionize the pharmaceutical industry and attract more investment to startups. Assessing technologies for companies and patients involves evaluating both the business and technology aspects, including intellectual property. The future of AI and software will see the emergence of new forms of experiences and collaboration between humans and machines. Search engine companies have been late to adopt AI technologies like ChatGPT, but they have already been utilizing AI in their search algorithms. \There is a need for more interplay between pharma companies and the healthcare industry to ensure better understanding of customer needs and feedback. The healthcare industry faces challenges due to the complexity of the operating environment and limited infrastructure for research. Life sciences firms have the potential to become not just product companies, but service companies and provide valuable solutions to overcome the challenges in the healthcare industry. Doctors want to help patients at the highest level possible but continually grapple with the complexity of the healthcare environment and the sheer volume of patients. Amateur radio, or ham radio, offers a fascinating world of learning and discovery, with a community of innovators constantly finding new and creative ways to use the technology. Chapters 00:29 Unique Approach in Duke Program 05:14 New News! The First AI-Generated Drug Discovery 09:33 Assessing Technologies for Companies and Patients. 11:52 The Importance of Unique Intellectual Property 12:35 The Future of AI and Software 13:36 Data as a Commodity 15:10 Innovation Curves and Technology, AI Compressing it 16:41 Using AI in Everyday Life 19:04 Why were Search Engine Companies Late to the Generative AI Game? 20:05 New Forms of Software and Experiences 22:53 The Future of Healthcare and Pharma - Enough Interfacing? 25:08 The Difficulty of Doctors in Complex Environments and Implementing Precision Medicine 29:03 Jason's Interest in Amateur Radio and Exploring the Ham Radio Community 31:39 Bouncing a Radio Signal Off the Moon & Sending Emails over Radio Waves How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. - https://www.creoinc.net/ 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/ #AI #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences…
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BioTalk Unzipped

1 Unlocking the Future of Healthcare with Organoids, AI, and Quantum Computing with Jason Burke 34:40
Summary In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11. Chapters 01:14 - Introduction to BioTalk Unzipped 03:30 - NEW NEWS: Discussion on Organoids and Their Applications 04:45 - Ethical Concerns with Brain Organoids as mini bio-computers 06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces 08:59 - The Potential of Brain Training and Neuroplasticity 10:51 - The Impact of AI and Data Sciences in Healthcare 11:18 - Jason’s Background and Emerging Technologies Transforming Clinical Research 13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth 24:15 - FDA's IT Strategy and the Challenges of Implementing AI 26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11 How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. - https://www.creoinc.net/ 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/ New News Link: The many uses of mini-organs https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/ Image Credits Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/ #HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery…
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BioTalk Unzipped

Summary In this episode, Scott Schliebner discusses the unique challenges and complexities of rare disease trials. He highlights the difficulties in recruiting patients, the multidisciplinary nature of care, and the importance of collaboration among various stakeholders. The role of AI in rare disease trials is also explored, with a focus on its potential for patient recruitment and data analysis. Scott shares success stories in the field and discusses the expanding use of gene therapy to target multiple genes. The conversation concludes with a discussion on the recent FDA approval of Iovance's Amtogvy as the first T-cell therapy for a solid tumor, Melanoma. In this conversation, Scott discusses the potential of cell therapy in targeting solid tumors, particularly melanoma. He highlights the importance of expanding the use of cell therapy to other tumor types and the potential for curative treatments. The conversation also delves into the challenges and questions surrounding pricing and ethics in the gene and cell therapy space. The impact of curative therapies on quality of life and healthcare costs is explored, along with the success of curative therapies in hepatitis C. The high bar of clinical development and regulatory standards is discussed, as well as the potential for cost-effective treatments. The conversation concludes with advice for young professionals and established clinical professionals in the field of drug development. Takeaways Cell therapy shows promise in targeting solid tumors, such as the breakthrough in melanoma treatment, and has the potential to provide curative treatments for various cancer types. The pricing and ethical considerations surrounding gene and cell therapy raise important questions about accessibility and affordability. Curative therapies have the potential to significantly improve quality of life and reduce healthcare costs by eliminating the need for long-term treatments. The success of curative therapies in hepatitis C demonstrates the potential for similar breakthroughs in other disease areas. Young professionals interested in a career in clinical drug development should seek opportunities to gain experience and consider starting in roles such as clinical research coordinators or clinical research associates. Rare Givers is a nonprofit organization that supports caregivers in the rare disease space. Chapters 00:21 - Collaborative Approach in Rare Disease Trials 3:32 - The Role of AI in Rare Disease Trials 6:11 - Success Stories in Rare Disease Trials 11:34 - Expanding Gene Therapy to Target Multiple Genes 16:56 - New News: FDA Approval of Iovance's Amtagvi, The Breakthrough of IOVANCE for Melanoma 19:27 - Targeting Solid Tumors with Cell Therapy, Expanding the Potential of Cell Therapy 20:23 - The Impact of Curative Therapies on Quality of Life and Healthcare Costs 21:11 - Challenges and Questions around Pricing and Ethics 22:37 - Cures for Hepatitis C 23:25 - The High Bar of Clinical Development and Regulatory Standards 24:05 - Pricing Considerations for Different Cancer Types, The Potential for Cost-Effective Treatments 27:45 - Advice for Young Professionals in Clinical Drug Development 31:49 - Advice for Established Clinical Professionals 33:21 - Scott's Hobbies and Interests Learn about and DONATE to Rare Givers: https://www.raregivers.global/ How to reach us: Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Link: https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor Image Credits Iovance, https://www.iovance.com/ FDA approved, https://www.tipranks.com/news/iovance-nasdaqiova-fda-approves-cell-therapy-stock-gains Amtagvi, https://www.amtagvi.com/…
Impact of AI in Rare Disease Trials with Scott Schliebner Summary In this episode, the hosts welcome Scott Schliebner as their guest and kick off with a charitable act, donating to Rare Givers. They delve into the Epitomee weight loss capsule's potential impact, then shift to discussing the challenges of establishing a North American infrastructure for a MedTech CRO, navigating cross-cultural dynamics. Later, they investigate the transformative potential of AI and machine learning in clinical trials. Scott Schliebner weighs in on the intricacies of rare disease trials, emphasizing patient recruitment hurdles, interdisciplinary care, and stakeholder collaboration. The conversation also delves into AI's role in addressing these challenges, particularly in patient recruitment and data analysis. #clinicaltrials #science #ai #raredisease #drugdevelopment Takeaways Rare Givers ( https://www.raregivers.global/ ) is a nonprofit organization that supports caregivers in the rare disease space. The Epitome weight loss capsule is an innovative medical device that tricks the body into feeling full, aiding in weight loss. Building a North American infrastructure for a MedTech CRO requires navigating cultural differences and finding key leaders who can adapt to a startup environment. AI and machine learning have the potential to transform clinical trials by improving drug discovery, analyzing large datasets, and enhancing patient retention. Chapters 00:00 - Introduction and Charity Donation - Rare Givers 02:30 - Discussion on Rare Givers 04:08 - What inspired Scott to the Clinical space 06:12 - New News: Epitomee Weight Loss Capsule 11:25 - Epitomee target drug delivery application weight loss competition with Wegovy 14:05 - Building a North American infrastructure for EU-based MedTech focused CRO 16:35 - Cultural idiosyncrasies to be aware of doing business with different countries 23:53 - The Impact of AI and Machine Learning, and generative AI in Clinical Trials, drug development, FDA compliance, and quality control 30:13 - Understanding Rare Disease Trials, and overcoming challenges 33:12 - Is it a Zebra or a Horse? DONATE to Rare Givers: https://www.raregivers.global/ How to reach us: Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Link: Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance https://www.prnewswire.com/news-releases/epitomee-announces-the-filing-of-a-novel-weight-loss-capsule-for-fda-clearance-302081225.html NIH Study publication: Safety, tolerability and efficacy of a novel self‐use biodegradable device for management of obesity https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700511/ Image Credits Zebra - https://www.rarediseaseday.org/event/6th-annual-rare-disease-day-virtual-race/…
Description: In Episode 8 of BioTalk Unzipped, we dive deep into the scientific mind of Dr. Russell Grant, exploring how he navigates groundbreaking publications with a healthy dose of skepticism. From microsampling blood spots to dissecting experimental execution gaps, Dr. Grant reveals his strategies for separating scientific sizzle from substance. In our latest segment of "New News," we discuss Elon Musk's Neurolink gaining FDA approval for clinical trials, sparking debates about neuroscience's role in the 21st century. With insights into the risks and rewards of understanding brain biochemistry, this episode challenges conventional thinking. Discover the secrets behind Dr. Grant’s legendary leadership with the Triangle Area Mass Spec (TAMS) group, where mentorship, empowerment, and strong networks bridge academia and industry. Uncover how Dr. Grant encourages scientists to stay focused on foundational processes while striving for brilliance in their work. From unexpected breakthroughs in sensitive testosterone measurements to fostering career development in his team, Dr. Grant shares invaluable lessons in leadership and personal growth. Tune in for memorable quotes, career insights, and a glimpse into Dr. Grant's life beyond the lab. Join us as we unzip the world of science with Dr. Russell Grant on BioTalk Unzipped! #biotechnology #diagnostics #science #innovation #leadership #pharmaceutical SEGMENTS: 1:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication? 7:47 - New News! 13:10 - Dr. Grant’s leadership with the TAMS (Triangle Area Mass Spec) group and why it’s so successful. 24:05 - Has the challenges for grad students changed in the past 2 decades? 26:49 - When Russ’ work led to something truly unexpected, 30:56 - Leadership in career development and the people they lead 35:51 - More memorable quotes 37:30 - What Russ does for fun. How to reach us: Dr. Russell Grant grantr@labcorp.com https://www.linkedin.com/in/russell-grant-5144a26/ Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Conferences mentioned: ASMS - https://www.asms.org/ MSACL - https://www.msacl.org/ ADLM - https://www.myadlm.org/ TAMS, Triangle Area Mass Spectrometry Discussion Group - https://tamsgroup.org/ New News Link: https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant Image Credits Client Eastwood, Firefox - https://www.youtube.com/watch?v=eJJXIcig2h8 Neuralink - https://dig.watch/updates/neuralinks-first-human-implant-shows-promising-results Tricorder Tech: That Star Trek Medical Scanner Is Getting Much Closer https://astrobiology.com/2023/11/tricorder-tech-that-star-trek-medical-scanner-is-getting-much-closer.html Neuralizer - https://meninblack.fandom.com/wiki/Neuralyzer…
Join us for Episode 7 of our podcast as we delve into the fascinating journey of Dr. Russell Grant, from the UK to America, navigating through large pharma to the field of diagnostics. Discover the nuances between bioanalytical approaches in clinical trials versus clinical healthcare, and Russ's insights on GLP environments. Learn how Russ tackled the challenges of COVID, and hear the incredible New News breakthrough in restoring hearing in an 11-year-old using gene therapy. Russ shares his American dream, his passion for diagnostics, and his thoughts on scientific integrity. Tune in for a captivating discussion on the critical role of diagnostics in saving lives and the pursuit of scientific excellence. #biotechnology #diagnostics #science #innovation #patientcare SEGMENTS: 1. Transitioning Across Continents: A Tale of Professional Evolution - From the UK to America, Exploring Pharma to Diagnostics. 2. Navigating Bioanalytics: Unraveling the Contrast Between Clinical Trials and Healthcare Applications, with a Focus on Mass Spec. 3. Efficiency in Action: Revolutionizing Patient Care by Shaving Seconds Off Injections, One Assay at a Time. 4. COVID Chronicles: Dr. Russel Grant's Vital Role Amidst the Pandemic's Chaos. 5. New News!: A Landmark Achievement in Gene Therapy Unveiled. 6. Crossing Borders: Dr. Russel Grant's Journey to America - Dreams, Challenges, and Triumphs. 7. Fueling Passion: Understanding Russ' Zeal for the Field of Diagnostics. 8. The Power of Diagnosis: Unveiling How Diagnostics Serve as Lifelines in Healthcare. 9. Navigating Integrity: A Candid Discussion on Scientific Literature, Academic Fraud, and the Path Forward for Scientists. Connect with: Dr. Russell Grant: https://www.linkedin.com/in/russell-grant-5144a26/ Dr. Chad Briscoe : https://www.linkedin.com/in/chadbriscoe/ Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ New News link: Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss Image Credits: David Gilmour (Getty Images) Sir Isaac Newton, https://en.wikipedia.org/wiki/Isaac_Newton…
Welcome to Episode 6 of our podcast featuring Dr. Stephanie Pasas Farmer! 🎙️ Join us as we delve into the intricate world of data integrity, unveiling new software tools and the transformative impact they bring. Discover how virtual audits post-COVID, coupled with cloud security measures, are reshaping the landscape. 🔍 Explore the regulatory challenges amidst the technology and the AI explosion, with insights into the FDA's evolving role and its mission for public safety. Learn how ChatGPT transcends boundaries, from revolutionizing travel planning to enhancing workplace productivity. 💼 Delve into the nuances of ChatGPT's capabilities and limitations, navigating the fine line between its potential and pitfalls. Uncover concerns surrounding AI detectors in academia and the intricate realm of Deep Fakes. 🤖 Step into the conversational realm of ChatGPT, contrasting its prowess with conventional assistants like Alexa. Follow Dr. Stephanie Pasas Farmer's impactful journey, from combating malaria in South Africa to her unique career trajectory. 🌍 Tune in as she shares the most surprising moments of her career and imparts invaluable advice for aspiring scientists and entrepreneurs. Don't miss out on this riveting exploration of innovation, integrity, and entrepreneurship in the scientific realm! 🚀 #Science #ChatGPT #Innovation #Entrepreneurship #LifeScience #SoftwareTools #FDA #AI #CareerAdvice 01:00 - Data integrity concerns and new software tools. 05:43 - How are Regulators dealing with this technology and AI explosion? Regulatory Challenges and FDA’s Role. FDA agents speaking about AI at conferences. 10:00 - Using ChatGPT in your non-work life for things like Travel Planning. 13:15 - Using ChatGPT for Work. 14:40 - Limitations of ChatGPT. 16:19 - Concerns about False Positives for AI detectors in academics and Deep Fakes, which are so difficult to detect. 17:13 - The Conversational Nature of ChatGPT. 19:57 - Stephanie’s Work in South Africa. She helps a non-profit for malaria and unmet medical needs globally. Building out the laboratory capabilities there. . 22:22 - The most surprising thing in her career. Advice for Aspiring Scientists and Entrepreneurs. Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/ spfarmer@bdatasolutions.com Ariadne Software: https://www.ariadnesolutions.com/ BioData Solutions: https://www.bdatasolutions.com/ Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ Image Credits KU basketball, stubhub, https://www.stubhub.com/kansas-jayhawks-basketball-tickets/performer/6849 BTS, https://www.teenvogue.com/story/bts-billboard-music-awards-2018 Cardi B, https://www.xxlmag.com/cardi-b-reacts-criticism-not-dropping-album-tour/ Taylor Swift, https://www.tiktok.com/discover/You-broke-my-hand-and-you-didnt-even-seems-sorry-taylor-swift Costa Rica, https://www.pixelstalk.net/ Deep fake, https://www.trymaverick.com/blog-posts/are-deep-fakes-all-evil-when-can-they-be-used-for-good Korean food, https://spoonuniversity.com/lifestyle/i-learned-the-secret-to-mastering-korean-bbq-by-growing-up-in-my-familys-restaurant Africa, https://en.wikipedia.org/wiki/Africa WRIB, https://www.wrib.org/ AAPS, https://www.aaps.org/home APA, https://www.bostonsociety.org/APA/…
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