Susan Haigney

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.

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.

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.

The industry is feeling the push to modernize facilities and manufacturing processes.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

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.