Accelerated Development Pathways for Biopharmaceuticals: Will Your CMC Package Be Submission Ready?

In recent years, both the US and the EU have streamlined their
regulatory oversight and approval processes to allow for the
expedited review and approval of biopharmaceuticals. Those
pathways compress the clinical development and review timelines
by allowing for approvals based on surrogate endpoints
as well as faster review of submitted applications. But those
accelerated pathways offer no relief in the required content of
the CMC (Chemistry, Manufacturing & Controls) Section. Further,
the trend of midsize and larger biopharmaceutical companies
to in-license assets from smaller companies much later
in development (i.e., at or near Proof of Concept instead of at
Demonstration of Safety in Humans) is causing CMC activities to
be the rate-limiting factor for Regulatory Submissions. We will
discuss actions companies can take earlier in the development
cycle to ensure that CMC does not become rate-limiting as the
fi ling deadline approaches. Key considerations in the selection
and oversight of Contract Development & Manufacturing Organizations
(CDMOs), input from whom is especially critical for
CMC filings by smaller companies, will also be covered.