Genetic insights for biopharmaceuticals: Propelling drug candidates into therapeutic assets

whitePaper | January 24, 2022

Since early 2020, coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome.

whitePaper | January 24, 2022

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization.

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

whitePaper | January 31, 2023

The first biosimilar approved under the abbreviated pathway established by the Biologics Price Competition and Innovation Act launched in the U.S. in 2015.

whitePaper | January 7, 2022

While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the sector is healthy

whitePaper | January 23, 2023

Recruitment, retention, and diversity are critical elements of clinical trials that, if insufficient, can jeopardize successful trial completion.