BioTalk Unzipped

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Binodh DeSilva, Senior Vice President of Bioanalysis at Ultragenyx Pharmaceutical, to explore the science and soul behind rare-disease drug development.From her early days studying electrochemistry at the University of Kansas to leading cutting-edge bioanalytical programs at Ultragenyx, Dr. DeSilva shares how curiosity and community shaped her four-decade career. She discusses the profound responsibility of working with limited, often irreplaceable patient samples with care.A special thanks to AAPS (https://www.aaps.org/) for their help and support of this episode.The conversation dives into:Balancing rigor and agility in small-population clinical studiesLeveraging entrepreneurial mindsets from biotech within big pharma frameworksThe promise of dried blood spots (DBS) and patient-centric samplingMentorship, curiosity, and the future of scientific leadershipHer return to Sri Lanka with KU faculty to recruit the next generation of scientistsThroughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both.Guest LinksDr. Binodh DeSilvahttps://www.linkedin.com/in/binodh-desilva/ Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ HostsDr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe interview Asst. Professor Pin-Kuang Lai from Stevens Institute of Technology about his keynote speech at AAPS NBC 2025 and the intersection of AI and molecular engineering, particularly in predicting the viscosity of monoclonal antibodies. They discuss the challenges of high concentration formulations, the importance of AI validation, and the future of formulation development. Lai shares insights from his international research journey and collaborations with pharmaceutical companies, as well as opportunities for students interested in this field.00:00 Preview & Intro01:58 Deep Viscosity and AI in Antibody Development04:39 AI Validation and Model Reliability07:12 International Journey and Collaborative Research08:42 Future of Formulation Development10:30 AAPS NBC Experience11:30 Academic vs. Industry Career Paths12:31 Collaboration with Pharmaceutical Companies13:59 Modeling Protein Aggregation Challenges14:43 Student Engagement and Research Opportunities15:45 Expanding Applications of Machine LearningDr. Pin-Kuang Laihttps://www.linkedin.com/in/pin-kuang-lai/ Stevens Institute of Technology - https://www.stevens.edu/ Dr. Lai’s Publications - https://www.linkedin.com/in/pin-kuang-lai/details/publications/ The DeepViscosity Model - https://devpred.onrender.com/DeepViscosityDr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/

In this powerful episode (#35) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin engages in a deep conversation with a leading Neuroscientist, Dr. Robert Thorne, Denali Fellow at Denali Therapeutics, for an intimate and scientific deep dive into the evolving world of brain cancer treatment and CNS drug delivery. Both Gregory and Dr. Thorne share personal stories of losing family members to brain metastases, weaving in the emotional 'why' behind their professional paths.Dr. Thorne highlights the complexities of the blood-brain barrier, the heterogeneity of brain metastases, and cutting-edge delivery technologies—including focused ultrasound and molecular engineering approaches. The conversation also touches on pediatric brain tumors like diffuse midline glioma (DIPG), emerging research in lysosomal storage diseases, and the collaborative spirit driving innovation in neuroscience today.This is more than a technical discussion—it’s a human story about grief, hope, and the relentless pursuit of better outcomes for patients with brain diseases.00:00 Preview & Intro01:10 Robert Thorne’s Reflections on the AAPS NBC conference03:14 The Professional Biotech and Pharma League05:09 A Personal Story Shared: Family Loss to Brain Cancer07:57 My Reason for Optimism Treating Brain Cancer08:50 Why Brain Metastases Remain Hard to Treat11:10 Scientific Advances in Drug Delivery for Brain Cancer12:30 Seed and Soil Concept in Oncology15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond16:49 Looking Ahead: Hope for Future Therapies21:32 Closing GratitudeDr. Robert Thornehttps://www.linkedin.com/in/robert-g-thorne/Denali Therapeutics - https://www.denalitherapeutics.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  Key Takeaways:Personal Connection Fuels Professional Passion: Both Gregory and Dr. Thorne were driven into the life sciences field by family experiences with brain tumors.The Blood-Brain Barrier (BBB) Remains a Major Challenge: Brain metastases from cancers like melanoma, lung, and breast cancer still present difficult delivery barriers for therapies.Heterogeneity in Brain Mets: Different metastases within the same patient can have vastly different BBB permeability, requiring multifaceted delivery strategies.Emerging Drug Delivery Innovations: Focused ultrasound, engineered biologics, and Denali’s own delivery platforms are all promising ways to improve CNS drug penetration.Pediatric Brain Cancers Present a Unique Set of Challenges: Diseases like diffuse midline glioma (DIPG) remain largely untreatable, but learnings from lysosomal storage disorders may translate in the future.The...

In this special episode (#34) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin and Dr. Chad Briscoe sit down with AAPS President Dr. Russ Weiner for an unfiltered look inside AAPS NBC, at the state of rare disease research, the evolution of therapeutic modalities, and the human stories that drive scientific innovation.From navigating the emotional weight of personal loss to watching his son experience the field firsthand, Russ shares not only his scientific insights but the heart behind his leadership. The conversation spans topics like the rising promise of AI diagnostics, challenges with biomarker sampling logistics, the role of CROs in rare disease trials, and the future of autologous vs. allogeneic therapies.Dr. Weiner also offers an inspiring vision of industry collaboration, sharing how organizations like AAPS are becoming conduits for progress across low- and middle-income countries, underrepresented diseases, and emerging biotechnologies. Whether you're in the lab, the boardroom, or on the frontlines of clinical trials, this episode will reignite your sense of purpose in this field.00:00 Preview & Intro01:22 What is conference life like as AAPS President02:27 Mentoring & Fatherhood at AAPS03:54 Setting up the Meeting Season for AAPS05:43 Life back in the Rare Disease Space - a Passion10:58 The different costs of pharmaceutical & biotech research12:59 The generosity of Rare Disease Patients14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts19:57 Rare Disease conversations happening at AAPS and global reach22:37 Broad use of new technologies, including Olink24:10 Biggest change expected in Pharma in 10 yearsDr. Russ Weinerhttps://www.linkedin.com/in/russellweiner/ AAPS - https://www.aaps.org/home Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  Takeaways:Treating rare diseases early is not only life-saving—it’s economically sound. Gene and cell therapies may carry high price tags, but they dramatically reduce long-term costs.The diagnostic delay for rare diseases—often 4 to 7 years—remains one of the biggest barriers to treatment. AI-powered diagnostics and data integration could change that.Dr. Russ Weiner shares how personal loss fueled his career in science and how mentoring the next generation, including his son, brings it full circle.The shift toward allogeneic cell therapies and in vivo CAR-T treatments will be key to driving down costs and increasing global accessibility.CROs must evolve: future-ready organizations will localize biomarker analysis and forge relationships with rare disease investigators to improve site performance.Technologies like Olink are revolutionizing biomarker discovery, enabling cost-effective, high-resolution multiplexing that was previously out of reach.Spatial imaging,...

In this powerful episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Katrina Rogers, a 25-year life sciences veteran, biotech equity advocate, and founder of Evergreen Bioscience Innovation and Katrina Rogers Consulting. Katrina shares her compelling journey from Pfizer to pioneering innovation ecosystems and mentoring underrepresented biotech founders. They unpack the role of board governance, the funding gap for female founders, and how "showing your science" is critical for regulatory success. Katrina also warns of dangerous gaps in understanding between regulators and innovators and why we must protect our basic science infrastructure. If you've ever dreamed of launching a breakthrough therapy, leading a biotech, or making your idea count, this episode is for you.00:00 Episode Preview & BioTalk Unzipped Introduction03:09 Katrina’s Charity Highlight: 2nd Harvest (link below)04:04 Defining Moment in Life Science05:35 Launching a Consultancy: Overcoming Fears07:12 Leadership Lessons09:30 The Importance of Board Composition13:08 NEW NEWS: The Case for Female Founders18:04 Knowledge Gaps Between Founders and Regulators20:23 The Impact of Regulatory Changes21:32 The Direct Attack on Basic Scientific Infrastructure25:57 Understanding Market Needs29:36 The Role of Founders in Leadership and Navigating Leadership Challenges34:00 The Most Common Mistake by Biotech Founders & What To Do35:27 Katrina’s Scope & Delivering Unpleasant News36:51 NEW NEWS: Understanding Tariffs and Drug Pricing42:23 Empowering Big Ideas45:26 Overcoming Systemic Barriers47:24 Advice to My Younger Self49:38 Proposing Changes to FDA Innovation Pathways54:54 The Future of Innovation in BiotechnologyKatrina Rogershttps://www.linkedin.com/in/katrinarogers/ https://krogersconsulting.com/ Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  NEW NEWSBiotech a Bright Spot for Female Founders Amid DEI Pullback, https://www.biospace.com/business/biotech-a-bright-spot-for-female-founders-amid-dei-pullback?utm_source=chatgpt.com Trump signals shift in drug import tariff policy

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alfred Botchway, CEO of Attentive Science, to discuss his journey in biomedical science and the groundbreaking work being done at the intersection of AI, non-clinical safety, and drug discovery. Dr. Botchway shares his insights on the role of AI in refining toxicology studies, how stress impacts human health, and his experience founding companies like Xenometrics and Attentive Science.The conversation dives deep into the complexities of Good Laboratory Practices (GLP), the importance of regulatory standards, and the exciting research happening in anxiety and PTSD treatments. Dr. Botchway also discusses the future of biomedical research, the need for greater collaboration between academia and industry, and how innovations in sample collection are transforming clinical trials.Whether you’re interested in AI, biomedical innovation, or the future of drug discovery, this episode offers valuable insights from a leader shaping the industry.Don’t forget to subscribe and let us know your thoughts in the comments below!Dr. Alfred Botchwayhttps://www.linkedin.com/in/alfred-botchway-41b01a6/CEO of Attentive Science: https://www.attentivescience.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/ Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/ 00:00 Introduction to BioTalk Unzipped02:32 Dr. Alfred Botchway's Journey in Biomedical Science03:48 Challenges Founding and Growing Xenometrics07:30 Starting Attentive Science: A New Venture09:37 Love of the Work - Variations10:26 The Role of AI in Non-Clinical Safety Assessments13:04 The Three Rs: Replace, Reduce, Refine, and AI15:46 Regulatory Standards and Good Laboratory Practices20:42 New News! - Research on Anxiety and Drug Discovery27:07 Cortical Stimulation and Stress Management27:45 Bridging Academia and Industry29:26 Engaging the Next Generation in Science32:42 The Value of Vocational Training in Science34:47 Community Involvement and Giving Back37:00 Cultural Influences on Leadership42:39 Global Expansion and Strategic Goals48:41 Innovations in Sample Collection for Clinical TrialsDigital Twin Episodes reference with Tomas Helikar:Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikarhttps://youtu.be/jTM_Zlt3wxU Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikarhttps://youtu.be/NM5X0jTd6UA

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations.Thanks to CREO Consulting for hosting this episode!https://creoconsulting.com/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  TakeawaysEvery sample is a person, a patient, a loved one.Embrace the fear, take more risks.The importance of human connection in drug development.AI is becoming integral in drug discovery and development.Successful individuals often wish they had taken more risks.Leadership in the industry is about raising others up.Mentorship plays a crucial role in professional growth.Personal growth can come from listening and engaging with others.Innovative approaches are essential in addressing industry challenges.KeywordsBioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment. 01:20 Introduction to BioTalk Unzipped02:01 Celebrating Women in Pharmaceutical Sciences03:21 The Importance of STEAM Education04:09 Personal Journeys into Science08:02 Exciting Projects and Discoveries13:52 Challenges in CMC for Cell and Gene Therapies18:51 Innovations in Chiral Bioanalysis22:46 NEW NEWS! - New ADC Approved28:33 Exploring Combination Therapies in Cancer Treatment32:26 Empowering Women in Pharmaceutical Sciences37:30 Mentorship and Community Engagement45:18 The Role of Allyship in Science47:19 Breaking Barriers and Challenging Stereotypes54:15 Engaging Diverse Voices in Discussions56:49 Creating Inclusive Spaces for Feedback & Speaking Up01:01:15 Avoiding Assumptions in Professional Settings01:02:04 Setting Boundaries for Work-Life Balance01:05:24 Measuring Success in Life01:07:06 Connecting and Networking EffectivelyDr. Ines Santoshttps://www.linkedin.com/in/insantos/ Dr. Julia Sablehttps://www.linkedin.com/in/julia-sable-5b794385/ STEAMparkhttps://www.steampark.org/ WIPS in AAPShttps://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 https://www.aaps.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion -

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device. Chapters02:26 Introduction to BioTalk Unzipped03:40 Charity Spotlight: Americares05:01 Dr. Alex Friedman's Career Journey11:52 The Regulatory Landscape of Medical Device Classifications18:52 Regulatory Gameshow!: Classifying Medical Devices22:28 AI Enabled Software as a Medical Device: An Overview 25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike30:31 The Evolution of Wearable Health Technology41:17 Liability and Risk in Medical Device Development43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare47:13 Self Updating AI Doctors?? - The Future of AI in Public Health49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box56:27 New News!! - The Intersection of AI, Regulation, and Innovation01:07:28 Measuring Success in Life and WorkHOW TO REACH US:Alex Friedmanhttps://www.linkedin.com/in/alexfriedman/ Alex’s Charity: Americareshttps://www.americares.org/ Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ Celerion - https://www.celerion.com/  New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device datahttps://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTechhttps://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersectMentioned in the podcast: Concussion Mouthguard Sensors: SISU Sense - https://www.sisuguard.com/sisusense/  HIT-IQ -

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology), which aims to educate listeners on clinical pharmacology and related topics.Chapters00:51 The Changing Landscape of Pharmaceuticals03:49 Virtual Clinical Trials and Patient Engagement08:06 Optimizing Drug Dosage in Oncology10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy14:26 The Complexities of Cell Therapy17:33 Navigating Immunocompromised States in Treatment20:09 Advice to Young Scientists in Biopharma 23:04 Defining Success in Life and Career24:47 The Purpose and Impact of Nathan's Podcast, Clinical PharmacologyHOW TO REACH US:Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Email: nathan@aplosanalytics.comNathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40)https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacologyPodcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / TakeawaysNathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.Virtual clinical...

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants.Chapters00:00 Episode Preview00:55 Introduction to BioTalk Unzipped02:06 Charity Spotlight: Light of the World04:51 Nathan Teuscher's Career Journey07:34 Differentiating AI Types in Life Science12:41 Challenges with Large Language Models15:39 Rethinking Reporting in Pharma17:56 The Future of AI and Analytics in Pharma?18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies23:05 Leveraging Data, AI, and APIs in 3 Dimensions26:22 NEW NEWS! - Gene Editing Breakthroughs in MedicineHow to reach us:Light the World Charity - Church of Jesus Christ Latter Day Saintshttps://www.churchofjesuschrist.org/comeuntochrist/light-the-world Nathan Teuscherhttps://www.linkedin.com/in/nathanteuscher/ Aplos Analytics - https://aplosanalytics.com/ Nathan Teuscher’s Podcast: Clinical Pharmacology Podcasthttps://teuschersolutions.com/ Collaboration with BioTalk Unzipped (Ep. 40)https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Sound Bites"We don't need to write reports anymore."TakeawaysNathan Teuscher has over 20 years of experience in clinical pharmacology and...

In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients. Chapters00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 36003:45 Samaritan's Purse Charity and Community Impact05:16 Most impactful talk at AAPS?11:50 Comparative Analysis of FDA and EU Regulations17:37 The Drive Behind Bioanalytical Work22:24 NEW NEWS! - Innovations in RNA Editing and BioanalysisTakeaways​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 Pursehttps://www.samaritanspurse.org/ Mark Arnoldhttps://www.linkedin.com/in/markearnoldphd/ Blog - https://bioanalysisandbiomarkers.blogspot.com/  Dr. Chad Briscoehttps://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austinhttps://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com / Image 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 

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:  ...

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:

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 / 

Summary In this 22nd episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Scott Ogle, CEO of TrueLab, discussing his journey from finance to the pharmaceutical industry, the impact of personal experiences on innovation, and the importance of technology in clinical trials. They explore how to hire the best employees in this climate, the significance of company culture, and the influence of family on business perspectives.  Chapters 00:00 Introduction to BioTalk Unzipped 03:15 The Impact of Personal Experience on Innovation 08:47 TruLab's Technology and Its Role in Clinical Trials 14:33 The Importance of Sample Management and the Genesis of TruLab 20:33 NEW NEWS! – The Future of Cancer Treatments 23:34 Hiring Patterns and the value of Company Culture Takeaways Scott Ogle's personal experience with his father's illness inspired the creation of TruLab. TruLab focuses on eliminating inefficiencies in clinical trial sample management. The importance of having fun in one's career for productivity and happiness. Hiring for energy and cultural fit is crucial for company success. More young people out of college actually prefer working in the office, so it’s a hiring advantage. Sound Bites “Entrepreneurs get excited about their solution but can forget about what problem they’re solving.” "We need to iterate on technology in clinical trials." “20-25% of biological samples get tossed out.” "You can't coach energy in a candidate." “Company values. Senior leadership must beat it like a drum.” “Interviewing candidates on company values is your North Star.” “Go by what people do, not by what they say.”  “Hallway meetings, that’s where stuff gets done.” New News Story:  ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells https://www.nature.com/articles/s43018-024-00821-1 How to reach us: Scott Ogle https://www.linkedin.com/in/scott-ogle/  TruLab - https://trulab.com/  Leukemia & Lymphoma Society - https://www.lls.org/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Keywords: Scott Ogle, TruLab, clinical trial technology, biotech innovation, sample management in clinical trials, hiring for company culture, company values in leadership, finance...

Mentoring in Pharmaceutical Science with Dr. Jim Shen Summary In Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography. Chapters 01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis 04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference  05:10 - Early Career in Bioanalysis 07:35 - The Importance of Mentorship and Dealing With Adversaries 17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy 24:55 - Personal Interests: Photography and Gaming Takeaways Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans. Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of others Build a network of champions, allies, and sponsors Be open to new career opportunities and emerging fields Maintain integrity and transparency in scientific research Explore different hobbies and interests outside of work Sound Bites “Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.” “EQ is so important in being successful in your larger pharmaceutical company.” “I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.” “And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.” New News Story:  Following FDA rejection, a journal retracts papers on MDMA-assisted therapy https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/  How to reach us: Dr. Jim Shen https://www.linkedin.com/in/jimxshen/  Bristol Myers Squibb - https://www.bms.com/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - a...

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 a...

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Zealic CEO, Chuck Piccirillo. They delve into the unique challenges of the patient journey and the increasing demand for hybrid healthcare solutions that offer more flexibility. The discussion highlights the rise of virtual health, particularly in Europe, and introduces exciting developments in ion channels as a goldmine for new medicines. They also explore the financial intricacies of drug development, the importance of leadership through incremental steps, the value of in-person interactions, and hard-earned lessons in the industry. Finally, Chuck offers invaluable advice for entrepreneurs in the life sciences sector. Chapters 00:17 - Adapting to what is unique in the patient journey. 07:08 - Push for hybrid solutions - more flexibility. 09:20 - Virtual health is emerging, especially in Europe. 14:02 - New News! - Ion Channels are a goldmine for new medicines 19:23 - The Financial Side of Drug Development 21:50 - Leadership - Incremental Steps, the Value of In-Person Interactions, Learning Hard Lessons 30:58 - Advice For Entrepreneurs in Life Science Takeaways Building blocks to build the digital patient experience, then tweak it to the individual drug and form a complex digital and personal adaptive health journey. The healthcare industry needs to find a balance between safety and innovation to ensure patients have access to the best possible care. Remote patient monitoring and decentralized clinical trials are crucial in improving patient engagement and outcomes in the healthcare industry. Virtual visits and technology integration can enhance patient engagement and make healthcare more accessible. While there has been an increase in decentralized trials, the focus is currently on commercial solutions due to the crowded nature of the clinical trial technology space. Virtual health and routine monitoring have the potential to alleviate the burden on healthcare providers and improve patient care. Ion channel research holds promise for developing new medicines and treatments for various conditions. Incremental progress and persistence are key in entrepreneurship and leadership. Sound Bites (regarding adaptability in clinical software) “Imagine if LinkedIn only every 6 months. How engaging would that be?” "And it would actually integrate with like Uber, for example, and help them get a ride if they had to go to the doctor and actually, and all of that is based on these building blocks that we're able to assemble and then press a button." “I think everybody wants whatever aspect of life nowadays to be hybrid anything.” “It’s why we always talk about pragmatic innovation.” “Persistence in the face of opposition of all sorts.” New News Story:  These microscopic tunnels are a goldmine for new medicines https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/  How to reach us: Crohn's & Colitis Foundation https://www.crohnscolitisfoundation.org/  Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/  Zealic Health - http://www.zealichealth.com   Dr. Chad Briscoe a...