Christopher Cole

Jaenisch, Muraru, and Pandey debate whether AI "slop" is infiltrating pharma SOPs and deviation reports and who should catch it first.

PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.

FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.

At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.

Richard Jaenisch, Open Biopharma breaks down AI's real limits in drug discovery, agent security risks, and what workforce readiness looks like by 2028.

In this episode, we discuss AI drug discovery hype, agent security risks, and why pharma's AI workforce bets remain unproven.

FDA approves Moderna's mFlusiva, the first mRNA flu vaccine, testing the platform's manufacturing case amid federal funding cuts.

OSTP's July 2026 report to Trump diagnoses U.S. science slowdown and pushes deregulation, new funding models, reshoring, and AI-driven "Genesis Mission."

Pharma manufacturing and development experts reassess their 2026 predictions for the industry and look ahead to the second half of the year.

Six months in, pharma manufacturing and development experts reassess their 2026 outlooks and predict what comes next.

Richard Jaenisch surveys pharma's biggest recent AI deals with Chris Cole in part one of a two-part breakdown of the major moves.

Arcana Life Sciences' Remco Munnik revisits his 2026 predictions on EU regulatory reform, AI adoption, and data governance, and previews pharma's biggest challenges for H2 2026.

CAI's Jon Thompson explains how digital twins cut cleanroom rework by up to 50% and pressure excursion investigation time by up to 70%.

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations.

At CPHI Americas, Delaware governor Matt Meyer outlined the state's biopharma vision: fostering workforce talent, industry collaboration, and regulatory speed to market.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Bryan Poltilove discusses how distributed, point-of-care manufacturing is reshaping biopharma supply chains and cutting carbon footprints.

Mihaela Simianu and Austin Caudle join the show to discuss how digital container twins can improve pharma manufacturing, validation, and risk reduction.

George Kwiecinski, Global Key Solutions Corp, breaks down GMP inspection risks, global supply chain compliance, and AI's growing role in FDA regulatory scrutiny.

Todd Vaughn and Christa Myers of CRB discuss how robotics are reshaping aseptic pharmaceutical manufacturing, improving efficiency, repeatability, and compliance while demanding new operator skills and capital investment.

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up modeling to AI integration and virtual inspections.

Todd Vaughn and Christa Myers discuss how Robotics are reshaping aseptic pharmaceutical manufacturing by improving efficiency, repeatability, and compliance while demanding new operator skills.

Stuart Tindal and David Chau discuss spectroscopic sensor selection for continuous bioprocessing and how industry collaboration drives shared innovation.

At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption.

At INTERPHEX 2026, Bryan Poltilove highlights a novel technology as a promising point-of-use media manufacturing approach with major sustainability and logistical benefits.

At INTERPHEX 2026, George Kwiecinski examines FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

At INTERPHEX 2026, MasterControl CEO Dave Edwards details how AI tools are boosting efficiency and compliance in pharma quality and manufacturing without replacing human oversight.

At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.