Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

Videos

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

Manufacturing Intelligence: AI Integration in Pharmaceutical Lifecycle Management

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

PharmTech Weekly Roundup - April 10, 2026

Articles

New PRAC safety data link cenobamate to rare severe liver injury, prompting updated monitoring requirements and revised product labeling for prescribers.

What PRAC's Flagging of Cenobamate Means for Drug Regulation

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

How AI Is Transforming Biopharma Quality and Compliance

Frank Balonis is chief information security officer and senior VP of operations and support at 

, with more than 20 years of experience in IT support and services. Since joining Kiteworks in 2003, Frank has overseen technical support, customer success, corporate IT, security and compliance, collaborating with product and engineering teams. He holds a Certified Information Systems Security Professional (CISSP) certification and served in the U.S. Navy. He can be reached at fbalonis@kiteworks.com.

Modernizing technology is urgent as legacy web forms expose pharma companies to breaches averaging $5.1 Million

Hidden Liability: Why Legacy Web Forms Put Life Sciences Organizations at Critical Risk

BMS and Oxford BioTherapeutics partner to develop tumour-selective T-cell engagers, signalling pharma's growing reliance on specialist discovery platforms.

How Pharma Is Outsourcing Oncology Target Discovery in 2026

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

Susan Schniepp discusses how AI and digital twins speed up pharma batch release and detect data integrity issues while maintaining human oversight.

Managing Deviations Between Humans and Digital Twin Data

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

FDA Approves First Generic Dapagliflozin Tablets

Wilber Cruz is senior QC Microbiology manager at Abzena.

Wilbur Hightower is senior director, head of Site Quality at Abzena.

Vaishali Shah is previously head of Site Quality at Abzena.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Building a Future-Ready Contamination Control Strategy with Microbiology Testing

Joseph Zeleznik is technical product director, IMCD US

Sydney Badger is a Technical Development Manager at IMCD. With over seven years of experience in the pharmaceutical excipient industry, Sydney has a strong background in oral solid dosage forms and formulation development. Leveraging her previous experience as an R&D formulator, she brings application-oriented technical expertise to her current role.

Dr. Manish Ghimire is the Director of Technical Development – North America at IMCD. Manish brings over 20 years of experience in pharmaceutical R&D and technical marketing, with deep expertise in solid dosage forms and advanced formulation strategies. He is a recognized thought leader known for translating complex scientific concepts into practical, commercially relevant solutions.

Understanding how factors such as excipient choice affect nitrosamine formation is essential to developing safer, lower-risk pharmaceutical formulations.

News