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Susan Schniepp, Regulatory Compliance Associates Inc., says poor quality in pharma manufacturing is costly but catching defects early can saves millions.

Michelle Dennis at MilliporeSigma explores how biofluorescent particle counting and RFID traceability are transforming real-time environmental monitoring.

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.

Richard Jaenisch explains how digitally interactive SOPs and Human-AI Training Parallelization help build, measure, and continuously improve AI-era workforce skills.

Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental monitoring in pharma manufacturing.

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

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions.

In regard to their presentations at PDA Week 2026, Richard Jaenisch and David Jaenisch discuss balancing AI integration with human expertise, compliance, and IP protection.

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.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology advocates clinically relevant PDX models to bridge preclinical and clinical gaps for radiopharmaceutical success.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses PDX models preserving tumor architecture and heterogeneity, yielding clinically relevant data for more accurate radiopharmaceutical translation.

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

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

AI accelerates biopharma from discovery to production, cutting cycle times by up to 40%.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition.

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

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.

This week, we highlight big news from Roche, BMS, GSK, J&J, and Lilly, as well as well as key insights from industry experts.

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.

This week, we highlight AI efficiency, modular hardware, onshoring, Alzheimer's DMTs, and the impact of women in STEM leadership.

Hear from Miguel Ángel Ortega Sánchez, Corporate Industrial Director at ROIS CDMO, as he breaks down the company’s new brand, a strategic acquisition, and what these moves mean for ROIS’s future as a global leader in high-value injectables.

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.

Márcio Temtem, Hovione, discusses how his company integrates modular hardware and modeling software to accelerate pharmaceutical R&D and optimize manufacturing processes.

This week, we look at a cross-industry shift toward integrated automation, domestic resilience, and a critical focus on the human talent pipeline.

Marcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing.

Oncologist Dr. Maria de Miguel, MD, PhD, MBA, Director, Clinical Research for START Rioja, spoke with PharmTech about the importance of STEM education in early phase drug development.

Strategic outsourcing utilizes external expertise to accelerate the biopharma pipeline, integrating specialized workflows that drive efficiency from discovery through early clinical trials.