At PDA Week this year, industry leaders highlighted the shift to applied AI in bio/pharma manufacturing and quality and compliance, while focusing on real-world implementation, say Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, as they share their insights from the event.
Recapping this year’s PDA Week, Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, share their insights on how AI and knowledge management are shaping the future of bio/pharma quality.
In the final part of the interview, Franco Negron, CEO, Simtra BioPharma Solutions notes the question frequently heard from sponsors and predicts where the CDMO market is heading.
Explore how strategic partnerships are reshaping bioprocessing and biopharma drug development, from early process design to scalable biologics manufacturing, with Manisha P. Desai, PhD, senior vice president, Product Development, at Bristol Myers Squibb.
In the second part of the interview, Franco Negron, CEO, Simtra BioPharma Solutions discusses the decision between insourcing manufacturing or partnering with a CDMO.
Franco Negron, CEO, Simtra BioPharma Solutions touches on rising demand for biologics and high-potency therapies and how driving early, large-scale investment in injectable manufacturing capacity keeps pace with market growth.
In the final installment of an interview with Cardinal Health’s Anna Catalanotto, she discusses how leveraging real-world evidence and advanced value-based reimbursement models can optimize clinical adoption and long-term sustainability of CGTs.
In the second half of an interview with Lonza’s Carrie Mason, Mason discusses how cross-training scientists enables scale-up of AI-enabled bioprocessing.
Sebastian Lykke Skafte Andersen, Joanna Sadowska, PhD, and Neil Sheppard, D.Phil, go behind the headlines.
Lonza’s Michael De Marco emphasizes that early tox milestones strengthen investor confidence, support funding decisions, and reduce development risk for emerging biotechs.
AI, biomarkers, and novel oncology modalities are driving evolution in biopharma pipelines, according to Nmblr CEO Janice MacLennan.
Janice MacLennan, CEO of Nmblr, notes how AI is transforming biopharma R&D and market access, forcing teams to prove value beyond science and redesign work around human strengths.
In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.
AI-driven human cell models aim to replace animal testing and deliver more accurate, data-driven insights, says iOrganBio CEO Daniel Delubac ahead of the J.P. Morgan Healthcare Conference.
In Episode 31, industry veteran Deborah Dunsire goes behind the headlines to discuss the current state of innovation and evolving drug development landscape.
Digitalization is expected to reshape bioprocessing, supply chains, and quality systems for biopharma developers amid tariffs, geopolitics, and shifting capital flows, according to BioPlan Associates’ Eric Langer.
In the biopharma industry during 2025, quality, tariffs, MFN pricing, and strategic outsourcing deals drove innovation and investment.
Autolomous and Trenchant’s partnership, begun early in 2025, addresses unmet CGT manufacturing needs, including slashing costs and cutting timelines.
In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.
Chris Spivey explains how billions wasted on flawed near-infrared glucose sensing could have been avoided.
In Episode 29, John Androsavich, Benjamin Fryer and John Wilkerson go behind the top headlines from 2025.
The discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.
ADC oncology platforms, FDA CNPV rapid review, and significant investment into US biologics manufacturing capacity led this week’s news.
News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.
In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.
Eric Hill, Chief Scientific Officer, BA Sciences, discusses the how E&L testing principles can be adapted to biologic products and the unique challenges biologic drugs face regarding E&Ls.
Government and academic leaders say that to prevent catastrophic loss of expertise and investment, coordinated policy and significant investment in workforce talent are urgently needed in the UK.
This week’s biopharma news highlights formulation stability testing, automation in analytics, and achieving regulatory compliance.
Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.
Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.
