Five bio/pharmaceutical industry experts discuss the impacts of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.

AI, in-silico modeling, and rational design streamline drug formulation; rapid regulatory pathways demand pre-submission perfection in quality and parallel execution.

Industry experts weigh in on the CNPV's demands for flawless CMC pre-submission, affordable pricing, expanded communication, and more.

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.

The conclusion of this interview with Sanjay Konagurthu focuses on simulations and calculations that go beyond simple screening.

FDA’s CNPV pilot aims to speed drug reviews but raises questions about safety trade-offs, resource strain, and unclear incentives for sponsors.

Sanjay Konagurthu of Thermo Fisher Scientific discusses how AI and ML can help solve the dilemma of poor solubility.

To meet rising demand, developers of precision radiopharmaceutical therapies must overcome challenges in global isotope supply and align R&D platforms with evolving FDA guidance on clinical dosimetry.

Mechanistic models and hypothesis-driven strategies generate optimized efficient solutions for drug development, says Catalent’s Nathan Bennette at AAPS PharmSci 360.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

CHMP supports an enhanced nusinersen regimen, according to Biogen, indicating possible SMA treatment shifts and international regulatory decisions.

Corey Bloom of Lonza outlines major points from his AAPS presentation, from drug delivery technology selection to the importance of CDMO partnerships.

Accelerated drug development insights using AI/digital twins, advanced bioanalysis, targeted delivery, and optimized formulation stability models.

To prevent catastrophic loss of expertise and investment, government and academic leaders say coordinated policy and significant investment in workforce talent are urgently needed in the UK.

Take our survey to voice your opinions on the bio/pharma industry impacts of the FDA Commissioner’s National Priority Vouchers program.

A worldwide, exclusive license is being granted to develop and commercialize enzyme replacement therapies using proprietary platform technology.

At AAPS PharmSci 360 2025, Elly Zhou says digital twins helped forecast the effects of drugs on human drugs via a digital control arm.

At AAPS PharmSci 360, Xialing Li, PhD, says 3D-printed budesonide tablets achieve precise, delayed delivery to the ileum for IgA nephropathy, lowering in vivo variability.

At AAPS PharmSci 360, Xuanzi Zhou says digital twins accurately predict ex vivo lung function, revealing therapeutic effects missed by conventional preclinical drug testing.

Siddhant Sojitra, Alexion, defines in an AAPS PharmSci 360 2025 presentation an agitation model to reliably test stability for early-stage biologics.

In a poster presentation at AAPS PharmSci 360, Eda Fenercioglu, a scientist at Pfizer, outlines a streamline workflow for identifying and mitigating visible particles in biologic drugs.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss some of the unique instruments used to conduct bioanalysis.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss method validation of biomarker bioanalysis.

In a poster presentation at AAPS PharmSci 360, by Dineli Ranathunga, PhD, indicates that AI/ML in-silico modeling can accelerate poorly soluble drug development.

PharmSci 360 will spotlight the economics behind AI, scale-up, and advanced modalities, addressing cost barriers that influence future drug manufacturing.

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability.

Pharmaceutical Technology® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration, ahead of AAPS PharmSci 360 to find out how bioanalysis enhances bio/pharmaceutical drug development.