LS&HC Horizons 2023 - Flipbook - Page 6
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Precision and Regenerative Medicine
6
Bumps on the fast track
Innovative medicines such as cell, tissue,
and gene therapies (CTGT) often derive
from complex biological products subject
to variability and complex manufacturing
processes. While these therapies may avail of
FDA’s expedited development programs where
intended to address unmet medical needs,
developers often face challenges in expediting
development and scaling up manufacturing
activities to align with associated accelerated
clinical timelines.
Marketing applications for products in
expedited development programs need to meet
FDA’s exacting approval standards, including
compliance with current good manufacturing
practice (CGMP) and product quality. To
facilitate expedited Chemistry, Manufacturing,
and Controls (CMC) development, additional
interactions with, and assistance from,
FDA can help to resolve such issues earlier.
Accordingly, starting in April 2023, FDA will
be implementing a CMC Development and
Readiness Pilot (CDRP) program to facilitate
CMC readiness for selected products with
accelerated clinical development timelines.
Lowell M. Zeta
Partner, Washington, D.C.
Under the CDRP, FDA will provide productspecific CMC advice early in product
development so that the clinical benefits
of earlier patient access to these products can
be realized.
Relatedly, complex biological products often
face major manufacturing challenges in
scale-up or otherwise transferring materials
beyond their initial pre-clinical scale usage
demands. These issues can often be addressed,
or even avoided, by focusing on scalability
at an early stage. For example, developers
can prioritize standardizing protocols,
preparing for technology transfer to a
contract manufacturer in keeping with CGMP
compliance, as well as exploring advanced
manufacturing technologies such as continuous
processes at an early stage. Preparation is key
to avoiding surprises that may come up in the
FDA review process and cause delays.
Visit our website to
learn more about our
Cell, Tissue, and Gene
Therapies work.
