2021 LS&HC Horizons - Flipbook - Page 22
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Hogan Lovells
Precision and Regenerative Medicine
Cell, tissue, and gene therapies
We continue to see considerable interest
in the field of cell, tissue, and gene therapy
(CTGT) from our clients, spurred in recent
years by FDA’s approval of the first cellbased gene therapy products and FDA’s
framework for encouraging the development
of regenerative medicines. The products range
from highly complex gene editing therapies to
minimally manipulated transplanted human
tissues. While CTGT represents an emerging
opportunity for our clients, CTGT products
also pose significant regulatory issues, as the
novel technologies of CTGT products challenge
traditional FDA paradigms. The regulatory
issues faced by our CTGT clients span a
number of areas, including manufacturing,
reimbursement, and clinical trial design.
FDA has committed to providing information
to sponsors to assist with CTGT product
development, releasing about 15 CTGT
guidances in the last five years. These
include guidances on CTGT product
development for specific types of diseases,
including hemophilia, rare diseases, and
retinal disorders. They also have clarified the
criteria for transplanted human cell and tissue
products that qualify to be regulated solely
under the authority of section 361 of the Public
Health Service Act, and that consequently
are eligible to be commercialized without
premarket FDA review.
We expect FDA’s commitment to CTGT
product development to continue. Indeed, in
the first month of 2021, we have already seen
FDA issue guidances on CTGT manufacturing
considerations during the COVID-19 public
health emergency, and on CTGT product
development for neurodegenerative disorders.
FDA’s agenda of planned guidances for 2021
also lists at least seven additional guidances on
CTGT topics.
A consistent message from FDA is the
importance of meeting early with FDA in
CTGT product development. Hogan Lovells
has been assisting clients with such early
strategic interactions, including those through
INTERACT meetings. We expect continued
interest from clients in the field of CTGT over
the coming year.
Mike Druckman
Partner, Washington, D.C.
mike.druckman@hoganlovells.com
Bert Lao
Senior Associate, Los Angeles
bert.lao@hoganlovells.com
