Topic

Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA

Articles

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

The Manufacturing Edge on Path to Market

Mike Hollan is an Editor for Pharm Exec. He can be reached at 

Tracking the pandemic’s influence on brand awareness and prescribing efforts in light of decline in physician visits and fewer diagnoses—and what these dynamics, still unsettled post-pandemic, might mean for future launches.

Assessing HCP-Visit Fallout: COVID’s Ultimate Impact on New Drug Entrants 

Launch of novel drug for rare neuromuscular disorder seeks to give voice to the patients.

More Than a Name: Vyvgart

Elaine Quilici is Pharmaceutical Executive's Editor-in-Chief. Email her at equilici@mjhlifesciences.com

Use against pair of pathways could pave way for standout in stocked eye disease market.

Fighting Vision Loss: Vabysmo

Michael Christel is Group Managing Editor of Pharmaceutical Executive, Pharmaceutical Commerce, and Applied Clinical Trials. He can be reached at mchristel@mjhlifesciences.com.

Tapping the potential of new market mindset in insomnia—delivering a quality next day.

A Sleeping Giant?: Quviviq 

’s 2022 summer editorial intern and is now an Assistant Editor for 

Dual-targeted injection poised to rock GLP-1 field in diabetes—and eventually weight loss.

Next-level Efficacy: Mounjaro

More favorable administration, reimbursement could separate latest PCSK9 entrant.

LDL Game Changer: Leqvio

CEO, Chairman, and Founder, NeuBase Therapeutics

Failed efforts do not overshadow field’s progress, resolve.

The Silver Lining Of Innovation in Genetic Medicine

Innovative and continuous remote patient monitoring, along with AI-based predictive analytics, are advancing progress toward replacing the one-size-fits-all, population-driven vaccination model.

Getting ‘Personal’ With Vaccine Development

The road to precision medicine as a fixture in healthcare delivery is still a journey, but recent advances and new understandings in gene profiling, biomarker development, and AI and data analytics are steadily bringing these therapies closer to the individual patient every day.

R&D/Clinical Trials