Early engagement with regulatory agencies is key to therapeutic development

By Samantha Black, PhD, The Science Advisory Board editor in chief
October 20, 2021

Next-generation advanced therapies call for novel regulatory approaches, according to Mark Lane, PhD, vice president, development consulting and scientific affairs, of Biopharma Excellence by PharmaLex. Lane moderated a panel discussion titled "Innovative Regulatory Pathways for Next-Generation Treatments" at the 2021 Cell & Gene Meeting on the Mesa.

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.

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Last Updated ka 10/25/2021 1:19:47 PM