BioTalk Unzipped

Fail Fast, Learn Faster: Drug Development in Rare Disease with Dr. Binodh DeSilva

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/ [https://www.aaps.org/]) for their help and support of this episode. The conversation dives into: * Balancing rigor and agility in small-population clinical studies * Leveraging entrepreneurial mindsets from biotech within big pharma frameworks * The promise of dried blood spots (DBS) and patient-centric sampling * Mentorship, curiosity, and the future of scientific leadership * Her return to Sri Lanka with KU faculty to recruit the next generation of scientists Throughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both. Guest Links Dr. Binodh DeSilva https://www.linkedin.com/in/binodh-desilva/ [https://www.linkedin.com/in/binodh-desilva/] Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ [https://www.ultragenyx.com/]  Hosts Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.

Unlocking Antibody Development with AI with Dr. Pin-Kuang Lai

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 & Intro 01:58 Deep Viscosity and AI in Antibody Development 04:39 AI Validation and Model Reliability 07:12 International Journey and Collaborative Research 08:42 Future of Formulation Development 10:30 AAPS NBC Experience 11:30 Academic vs. Industry Career Paths 12:31 Collaboration with Pharmaceutical Companies 13:59 Modeling Protein Aggregation Challenges 14:43 Student Engagement and Research Opportunities 15:45 Expanding Applications of Machine Learning Dr. Pin-Kuang Lai https://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/DeepViscosity 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/

The Science and Hope of Brain Cancer with Dr. Robert Thorne, Denali Therapeutics

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/ [https://www.linkedin.com/in/robert-g-thorne/] Denali Therapeutics - https://www.denalitherapeutics.com/ [https://www.denalitherapeutics.com/]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  Celerion - https://www.celerion.com/ [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.

Inside AAPS NBC with AAPS President Dr. Russ Weiner

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/ [https://www.linkedin.com/in/russellweiner/]  AAPS - https://www.aaps.org/home [https://www.aaps.org/home]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  Celerion - https://www.celerion.com/ [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.”

Building Successful Life Science Companies with Katrina Rogers

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://www.linkedin.com/in/katrinarogers/]  https://krogersconsulting.com/ [https://krogersconsulting.com/]  Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ [https://2-harvest.org/]  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ [https://www.linkedin.com/in/chadbriscoe/]  Celerion - https://www.celerion.com/ [https://www.celerion.com/]   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ [https://www.linkedin.com/in/gregoryaustin1/]  Celerion - https://www.celerion.com/ [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 [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 [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.