Conference Coverage
13 days ago
Excipients and Intended UseTrending on Pharm Tech
FDA Commissioner Marty Makary Resigns Following Industry Pressure
Trump Planning to Oust FDA Chief Marty Makary
Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional Findings, and Documentation System Evaluation
BMS-Hengrui Pact Highlights China’s Rising Role in Drug Development
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Drug Digest

Drug Digest: Adaptive Trial Design and Regulatory Shifts in Biopharma Development
In this Drug Digest episode, Abzena’s vice president of Regulatory Strategy, Jeff Mocny, and Cellares’ director of Regulatory Affairs, Anna McMahon, examine how evolving regulatory and quality expectations are reshaping biopharmaceutical development and manufacturing.

Drug Digest: Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up
Strategic outsourcing utilizes external expertise to accelerate the biopharma pipeline, integrating specialized workflows that drive efficiency from discovery through early clinical trials.

Drug Digest: Closing the Gap in Modern Process Control and Automation for QC/QA
Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability.

Drug Digest: Strategic Alliances and Technology Integration in the Evolving Biopharma Landscape
In this episode of Drug Digest, the discussion centers around the optimization of biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

Drug Digest: Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities
In this exclusive Drug Digest video, Steve Barr from SK pharmteco and Prasad Raje from LGM Pharma explore how supply chain pressures, sustainability, and AI adoption are reshaping small molecule development and excipient use in pharma.

Drug Digest: Speed, Flexibility Top Large-Molecule Manufacturing Trends
In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.

Drug Digest: Patient Preference Drives Solid Dosage Trends
In this exclusive Drug Digest video, Adi Kaushal from Lonza summarizes the current state of the oral solid dosage market, identifies the main challenges to drug developers, explains how CDMOs are leveraging expert techniques to improve OSD bioavailability, and looks into the future of advancements in drug delivery.

Drug Digest: Keeping Pace with Progressive Technologies in Biopharma Development
This episode of Drug Digest will discuss where the significant bottlenecks are in the development and manufacturing of new molecules resulting from progressive technologies, such as AI and ML, and how best to approach these challenges.

Drug Digest: Strategic Partnerships
In this exclusive Drug Digest video interview John McQuaid from Almac Pharma Services and Sridevi Khambhampaty from Shilpa Biologics delve into the evolution of the bio/pharma outsourcing market and look at how service-providers’ strategies have adapted to meet demand.

Drug Digest: Advances in Small-Molecule Manufacturing
In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief commentaries on associated topics.
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Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Automation, isolators, and AI-driven analytics are reshaping aseptic filling while boosting sterility assurance, flexibility, and GMP compliance.

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.

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

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

Ryan Kelly, Rx360, shares how aligning quality, supply chain functions, and auditing deeper is key to pharmaceutical patient safety.

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.

Lilly expanded its Indiana manufacturing investment by $4.5 billion to support tirzepatide, oral glucagon-like peptide-1, and genetic medicines.

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

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

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

Avi Nandi, SK Pharmteco, discusses how on-site media and buffer manufacturing can simplify supply chains and de-risk cell and gene therapy production.

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 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.

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

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.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

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.

FDA approves AstraZeneca's Breztri as the first single-inhaler triple therapy for asthma in patients 12+, a new precedent for respiratory drug developers.

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.

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.

Ryan Kelly, Rx360, explains how third-party audits and integrated quality-supply chain strategies protect pharma supply chains and patient safety.

At INTERPHEX 2026, David Chau and Stuart Tindal discuss automation, single-use durability challenges, and the shift to predictive control in continuous bioprocessing.
























