Articles

Machine learning tools are now moving from concept to validated applications, driving transformative shifts in bioanalysis, preclinical testing, and formulation optimization across the industry.

FAQ: Key AI Applications in Drug Development

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

Industry Expert Panel Weighs CNPV Benefits, Risks, and Readiness: Part I

Videos

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

PharmTech Weekly News Roundup — Week of November 17, 2025

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

Ready or Not: Biopharma Alignment for CNPV’s Rapid Review

FAQ: Everything to Know About Excipients in the Digital Era

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Anita Michael is RCA’s Executive Pharma Compliance Expert & Principal Consultant. She has 24+ years of global regulatory and quality experience, including 16 years direct FDA experience operating globally as their Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. Anita has excellent interpersonal, empathetic communication and client management skills that enable her to skillfully coach and collaborate with clients at the highest levels of an organization and prepare them for successful FDA inspections (ANDA/NDA/BLA/PMA Pre-Approvals) and global regulatory and quality assurance audits across Biotech, Biologics, Sterile Operations, Drug Substances, and 503A/B. She has been Keynote Speaker for the Pharma Industry and internally to the FDA throughout her career.

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. 

Audits, Inspections, and CDMOs

Feliza Mirasol is the science editor for 

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

Molecular Dynamics and Quantum Calculations: AAPS Thermo Fisher Interview, Part Two

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

The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program

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

Leveraging AI/ML to Reduce Risk in Drug Development: Part One

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.