The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.

In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.

Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.

Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.

The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.

Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.

Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.

Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.

The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.

Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.

Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.

Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.

Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.

Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.

Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.

FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.

Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.

Vibha Jawa, PhD, chief scientific officer at EpiVax, discusses the limitations of current preclinical testing approaches and how new approach methodologies can strengthen drug development.

Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.

Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.

Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.

Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.

The new initiative aims to apply traceable AI and science to expand care worldwide by translating discovery into tools that accelerate drug development.

Sanjay Konagurthu, PhD, senior director, Science and Innovation at Thermo Fisher Scientific, provides an update on the progress of AI and machine learning used in drug delivery.

Stephanie Johnson, Pfizer, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track.

Stephanie Johnson, Pfizer, discusses how platform formulations moved 2 Pfizer protein programs to IND in 8 months by redistributing, not removing risk.

Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.