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Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

The evolution of Pace® Life Sciences from an analytical services firm to a full-service CDMO supporting the drug development lifecycle.

Discover how Piramal Pharma Solutions is innovating in integrated CDMO services, leveraging their Science Collective of experts to streamline drug substance and drug product programs from early development through commercialization.

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA.

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

Emily Schirmer, Catalent, explains how to accelerate the path to first-in-human trials as biologics pipelines grow more complex and timelines tighten.

Christian Houborg discusses how FUJIFILM Biotechnologies is helping customers navigate evolving patient demand and supply chain uncertainty.

Valerie Bandy, Tecsys, discusses how manufacturers are adopting data-driven supply chain strategies to reduce drug shortages, control costs, and get the right inventory where it's needed.

Valerie Bandy, Tecsys, shares how manufacturers can build resilient supply chains, navigate drug shortages, and better support health systems.

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Richard Sanderson of IPS discusses risk management, predictive controls, and innovation to address skilled labor shortages in pharma construction.

Leslie Weaver and George Hunt, IPS, explore how design for disassembly and lean thinking are transforming the way pharmaceutical facilities are built and scaled.

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

Maria Batalha, Valgenesis, discusses how a centralized digital platform unified drug substance data from R&D to commercial manufacturing, enabling smarter, FAIR-compliant pharma operations.

Ryan Kelly, Rx360, shares expert strategies for mapping, auditing, and protecting pharmaceutical supply chains to ensure global patient safety.

In part 3 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, talks about the collaboration between the pharma company and the excipient supplier when different routes of administration are considered for an ingredient.

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

Avi Nandi, SK Pharmteco, explores the benefits, challenges, and sustainability impact of on-site media and buffer manufacturing for cell & gene therapy.

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.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

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

Richard Sanderson, IPS, discusses pharma capital project cost pressures, bloated deliverable lists, and making the case for EPCM's end-to-end delivery model.

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.

Leslie Weaver and George Hunt, IPS, discuss early sustainability and lean alignment in pharma construction that reduce costs, absorb disruptions, and keep projects on schedule.