Development

Videos

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

Living Drugs for Immunotherapy (PDA/FDA Joint Regulatory Conference 2023)

Articles

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Nurix Announces Strategic Collaboration with Seagen

Feliza Mirasol is the science editor for 

Nanoparticles offer the potential for a safer, more effective method of drug delivery to the patient.

Nanoparticle Engineering in Drug Delivery Under the Microscope

There are solutions on the horizon that will help overcome the current bottlenecks and other challenges that are occurring in early drug development.

Moving Closer to Dynamic Drug Development through Automated Solutions

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

Aptamer Group and Neuro-Bio Collaborate to Develop Alzheimer’s Disease Diagnostic Test

Editor of Pharmaceutical Technology Europe

Podcasts

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

Grant Playter is the Assistant Editor for 

Outsourcing collaborations provide insight into the key drivers of market growth.

Identifying Outsourcing Marketing Trends

FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology and pharmacology research has been focused on the development of highly curated data sets and QSAR models for endpoints of regulatory interest.

New QSAR Model for Predicting Blood Brain Barrier Permeability

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

FDA’s Office of New Drugs Highlights New Research Projects for Growth 

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.



Formulation and Drug Delivery, Biologic Drugs