Early engagement with regulatory agencies is key to therapeutic developmentBy Samantha Black, PhD, ScienceBoard editor in chief
October 20, 2021
ScienceBoard.net spoke with Lane following the session about how manufacturers of novel, advanced therapeutics can collaborate with regulatory agencies. Lane explained that the regulatory agencies are encouraging companies to take advantage of early interactions with these bodies. For instance, organizations can engage via interact meetings and preinvestigational new drug meetings to successfully navigate the regulatory approval pathway.
Lane also explained how Biopharma Excellence is helping the cell and gene therapy industry. The group offers focused expertise in biopharmaceutical products coupled with a "bench-to-bedside" approach. Biopharma Excellence offers guidance on multiple aspects of therapeutic development including but not limited to science, manufacturing, regulatory, and economic facets.
PharmaLex officially debuted Biopharma Excellence at the meeting.
Learn more by watching the video below.