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Fernanda Onofre, PhD, explains how the dsm-firmenich ModulaSENSE® Bitter platform and the functional application of vitamins as excipients are revolutionizing drug palatability and performance.

Andrew Chang and Steven Falcone, Novo Nordisk, explain how FDA-EU GMP mutual recognition and a robust internal signal process drive global regulatory compliance.

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

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

Christopher Lewis, Umoja Biopharma, explores how AI can streamline compliance, cut investigation time, and free skilled workers for higher-value tasks

Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks.

Terry Novak, CEO of Benuvia, explores how pharmaceutical and biotech companies can mitigate development risks and accelerate speed-to-market by prioritizing technical alignment, robust project management, and early-stage collaboration with the right CDMO partner.

Susan Schniepp, Regulatory Compliance Associates Inc., explains how flexibility, right-sized SOPs, and transparency keep compliance simple.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses siloed pharma data being a hidden risk, with AI as a possible key to connecting quality systems and seeing the full manufacturing picture.

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.

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

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.