Susan Haigney

In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.

The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.

In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.

PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.

Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.

At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a holistic view of its chemical, physical, and biological properties.

On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.

Shilpa Pharma Lifesciences Limited will launch a new small-molecule CDMO at CPHI Milan in October.

The IMA Pharmaceutical and MedTech divisions will be highlighting the TILE-X fill-finish line, a new VPHP BioIndicator, X-PEN autoinjector platform, and a range of machines from its IMA Active, IMA Life, IMA Safe, and IMA BFB divisions at the CPHI Milan event.

Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, provides a preview of the new Sustainability Summit at CPHI Milan 2026.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss navigating CMC requirements for new modalities and AI’s involvement in CMC.

This week saw predictive modeling, microstructure intelligence, a CAR T-cell safety pause, and major licensing deals reshape pharma manufacturing.

PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about what’s new for CPHI Milan this year, including 4 new zones and a Sustainability Summit.

In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discussed how CMC review practices are evolving and what that means for manufacturing strategy.

Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.

This week’s PharmTech.com content covered AI agent authority, hold-time and nitrosamine risk frameworks, biologics formulation, 3D bioprinting, and major oncology and dealmaking news.

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopeias.

The collaboration will use Andelyn’s viral vector process to produce clinical-grade material for an upcoming gene therapy trial.

This week, a $2.3 billion manufacturing campus and a new fill-finish platform signal capacity is crucial; AI in pharma is still evolving; and CPHI Milan previews a new Sustainability Summit.

This year’s conference agenda includes more than 260 industry experts, a new Sustainability Summit, and zones targeting AI, cold chain, and labeling.

This week’s content included Moderna's mRNA flu approval, CMO governance tips, OSTP’s deregulation push, a $2 billion oncology license, and July's regulatory wrap-up.