Susan Haigney

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

Winners in 8 categories were announced at ISPE’s Europe Annual Conference.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

Ranjit Deshmukh, Principal, BiologixCMC, discusses how contract manufacturers can optimize their processes and plan for the future by optimizing facility design.

Rohan Kumar, laboratory analyst at CS Analytical, discusses how sustainability in pharmaceutical packaging can be improved.

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.

In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient.

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions.

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

The agency has issued a draft qualification opinion on a new preclinical research methodology.

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

This week, three core themes have emerged: the digital transformation of quality systems through AI and hybrid cloud architectures; the pursuit of supply chain resilience via onshoring and advanced mapping; and a regulatory push toward real-time data and flexible approval pathways.

Tony Lakavage, USP, outlines pharma disruptions, pricing shifts, supply chain risks. As well as greening standards to build a resilient supply chain.

In this episode of Ask the Expert, Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Quality control for pharmaceuticals is evolving with the assistance of digital tools, sustainability practices, and a push to move manufacturing onshore.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses how IRA negotiations, Most Favored Nation pricing, US manufacturing push, and new FDA biosimilar guidance are reshaping the industry.

Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses drug supply chain vulnerabilities tied to China dependence, urging resilience through mapping, nearshoring, and manufacturing reform.

Industry experts explain how incorporating sustainability into the early development phase creates greener pharmaceutical manufacturing.

This week, the industry experienced accelerated digital transformation, regulatory evolution, and a strategic shift toward complex, patient-centric modalities.

The two companies have entered into a licensing agreement to commercialize biosimilars in Latin America.

The 2mg/kg every-4-weeks dosing regimen for pegunigalsidase alfa in adults with Fabry disease who are stable with an enzyme replacement therapy has been approved in Europe.

Developments across the sector highlight a period of rapid acceleration and structural modernization.

The companies have extended a commercial supply partnership for the manufacture of Sohonos (palovarotene), which is a treatment for the ultra-rare disease, fibrodysplasia ossificans progressiva.

Elisabeth Gardiner, PhD, CSO of Tevard Biosciences, explains some of the challenges associated with the development of treatments for rare diseases.

Industry experts discuss the benefits of utilizing contract development and contract research organizations in drug discovery and development.

PharmTech spoke with Andrew Mitchell, associate vice president of Business Development at BioVectra, about which 2025 trends will continue to impact the pharma industry and how CDMOs can offer solutions.

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval.

Dr. Jennifer Levin Carter, CEO and founder of Medzown, shares her experience as a CEO in the biotech industry and gives insights on how women can succeed in the pharmaceutical industry.

Márcio Temtem, Hovione, discusses how to tackle pharma complexity via regional growth in the US, Ireland, and Portugal, using digital tools to accelerate development.