Biopharma’s Big Inflection Point: There’s never been a better time to innovate with next-generation medicine
by Christian K. Schneider, MD
In all of the years I have been tracking and helping to drive...
How to create a smart integrated drug development plan including considerations for cell and gene therapies
by Diane Seimetz
An integrated drug development plan is a critical tool for the efficient and effective progression...
Risk Management Plans for ATMPs
by Maria Schacker
ATMPs are a relatively novel class of medicinal products with anew and very unique set...
Neutralizing Antibody Assay Development – a key consideration for immunogenicity packages
by Jennifer Sales
Neutralising Antibodies, or NAbs, are a subclass of Anti-Drug Antibodies that may be formed during...
Better late than never? What developers of SARS-CoV-2 vaccines in early-to -late-stage development should consider
by Michael Pfleiderer, Ilona Baraniak and Ciaran Greene
Unfortunately, as of today the ongoing pandemic is still far...
Wake up the Sleeping Beauty – Transposons in gene therapy: How do they compare to other genome modifying tools?
by Ewa Janosz
Gene therapy is currently a quickly developing field. Except from commonly known viral vectors and...