Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Topic

Videos

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

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

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

Biocon launches two FDA-approved interchangeable denosumab biosimilars in the US, targeting osteoporosis and bone metastasis in a $5B market.

FDA-Designated Denosumab Biosimilars Enter US Market

Gina Marsee is the Director, Compendial Compliance and Advocacy at Merck located in West Point, PA, USA. She holds a bachelor’s degree in Chemistry & Biology from the University of Tennessee and has worked in the pharmaceutical industry for 30+ years holding various leadership roles within Quality, Compliance, and Regulatory Affairs.

Katherine Ulman is the owner and Primary for KLU Consulting, LLC.She retired from Dow Corning Corporation after more than 40 years of employment.While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.

Joseph Zeleznik is Technical Director, North America for IMCD US and is also a member of IPEC-Americas’ Executive Committee, currently serving as Immediate Past Chair.

Candy Reynolds Cummings spent 15 years at GlaxoSmithKline starting as an analytical chemist and working up to QA Validation Manager in the OTC area (specifically oral care). Currently working at Evonik as the Regulatory and Product Stewardship Manager supporting the business line Silica for regulations in US, Canada, and Mexico.

Corporate Regulatory Affairs, ROQUETTE AMERICAS, INC.
Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products.She is currently President of the IPEC Federation and the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization.

Bob Sulouff is Sr. Manager Regulatory Affairs, Health & Pharma Solutions, ROQUETTE Americas. Bob has over 25 years’ experience in Regulatory Affairs and Quality, primarily focused on excipients. He is a member of Roquette’s Health and Pharma Solutions Regulatory team, where he advocates for value added pharma regulatory solutions.

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

This article details what co-processed excipients are and how they are made.

Co-Processed Excipients: Practical Engineered Solutions for Modern Pharmaceutical Challenges

Gene therapy AFTX-201 advances into multinational clinical trials, targeting the genetic root cause of BAG3-associated dilated cardiomyopathy with an engineered capsid.

How Engineered Capsids Are Changing Cardiac Gene Therapy

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

PharmTech Weekly Roundup - April 3, 2026

Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.

New Data Ranks Oral Obesity Drugs on Weight Loss Performance

Senior Content Associate For Pharmaceutical Commerce

The FDA approves orforglipron (Foundayo), the first oral, non-peptide GLP-1 for obesity, the fastest NME approval under the new CNPV program.

FDA's 50-Day NME Approval Changes Drug Development Rules

Lilly acquires Centessa for $6.3B, gaining an orexin receptor agonist pipeline targeting narcolepsy and other sleep-wake disorders.