BioPharm Videos

Speaking at AAPS PharmSci 360, Dr Stephanie Johnson, a principal formulation scientist at Pfizer, details how platform formulations save time before commitment, shift risk downstream, and what AI tools need to earn trust.

Dr Karunakar Sukuru of Catalent explains how lipid-based softgels address physiological barriers to oral peptide delivery as approvals increase.

Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team cuts monoclonal antibody costs without cutting purification steps, and why the $10-per-gram target could make antibodies viable for infectious disease and global access.

Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team is making antibody manufacturing more efficient and replacing costly raw materials to cut monoclonal antibody costs to about $10 per gram.

Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.

At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.

BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.

Emily Heffernan of Arcadis explains how facility scale, equipment, containment, and quality testing differ across ex vivo cell therapy, viral vector, and mRNA-LNP manufacturing.

Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.

Bristol Myers Squibb's Nathan Pennell explains how the MRD endpoint supports accelerated approval in multiple myeloma without changing how clinicians monitor patients.

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

Acuitas CEO Dr Thomas Madden and NanoVation co-founder and president Dr Dominik Witzigmann discuss how LNP engineering is expanding genetic medicine applications to traditionally undruggable targets.

Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.

BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.

Eron Kelly, CEO of ConcertAI, and Dr. Shaalan Beg, CMO, oncology, ConcertAI, discuss how AI can help physicians access the right information at the right time while supporting clinical trials, research, and quality initiatives.

BIIE CEO Dr Stephen Wilson explains why Basel's condensed innovation ecosystem was chosen for the institute’s translational research mission.

Experts Harpreet Singh and Steven Quay discuss FDA expedited regulatory pathways for biologics, including Fast Track, Breakthrough Therapy, RMAT, Real-Time Oncology Review, and the National Priority Voucher Pilot Program, and explain how these mechanisms can accelerate development without lowering evidentiary standards.

Mayo Clinic’s Dr Keith L. Knutson and CellxLife’s Dr. von Hofe discuss why cancer vaccines may succeed where checkpoint inhibitors fall short in 60 to 70% of patients.

Dr Eric von Hofe of CellxLife and Dr Keith L. Knutson of Mayo Clinic explain why manufacturing speed and cost will determine the scalability of personalized cancer vaccines.

AI tools that extract information from unstructured medical records could help oncology practices identify eligible clinical trial patients, surface care gaps, and compare treatment outcomes across real-world cohorts, according to Shaalan Beg and Eron Kelly of ConcertAI.

Real-time process analytics and digital manufacturing systems could generate the reliable data needed for artificial intelligence to deliver more predictive insights in biopharmaceutical manufacturing, according to Bryan Hassell, founder and CEO of Nirrin Technologies.

CellxLife CEO Dr Eric von Hofe and Mayo Clinic immunology professor Dr Keith L. Knutson explain how dendritic cell vaccines generate long-term immune memory to prevent cancer recurrence.

Cellex Life CEO Dr Eric von Hofe and Professor of Immunology at Mayo Clinic, Dr Keith L. Knutson, explain why individualized tumor profiling, not off-the-shelf targeting, is key to effective personalized cancer vaccines.