FDA CBER OTAT’s webinar on Regenerative Medicine 101:
Information for Patients, Caregivers & Advocates was held on 17 Nov 2021 at
12:00am (HK Time). Ms. Anne Rowzee chaired
the webinar and explained the RegenMedEd Webinar Series and its goals that to
discuss foundational information about regenerative medicine therapies,
including gene therapy and cell therapy; to explore opportunities to engage
with FDA and advance regenerative medicine research and drug development; as
well as sharing the experience from FDA, patients, advocates, researchers and
other important stakeholders.
The speaker was Mr. Wilson Bryan, MD (Director, OTAT;
CBER, FDA) and he first mentioned the mission of FDA that it is responsible for
protecting the public health by ensuring the safety, efficacy, and security of
human and veterinary drugs, biological products, and medical devices; and by ensuring
the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Then he showed the organization chart of FDA.
And then Mr. Wilson Bryan introduced the Center for
Biologicas Evaluation & Research (CBER) and its mission is to ensure the
safety , purity, potency, and effectiveness of biological products incuding vaccines,
allergenics, blood and blood products, cells, tissues, and gene therapies for
the prevention, diagnosis and treatment of human diseases, conditions, or
injury. He also described the mission of
the Office of Tissues and Advanced Therapies (OTAT) to promote the public
health through collaborative, science-based regulation of medical products. This
includes facilitating drug development and ensuring safety of individuals. OTAT’s
regulatory decisions are data-driven, impartial, and compassionate.
After that Mr. Wilson Bryan briefed different
regenerative medicine therapies (RMTs) including Gene therapies, Cell
therapies, Tissue engineering products and xeno-transplantation products. RMTs are defined in the 21st Century
Cures Act: Title III, section 3033 in 2016.
The following two diagrams showed diversity of
OTAT-regulated Products.
He also stated the role in regulating RMTs by FDA such as
regulate products over their entire lifecycle-during development and after
approval and provide oversight of clinical trials to protect patient safety and
rights.
Finally, Mr. Wilson Bryan concluding the advancing development
of RMTs from today, tomorrow and beyond.
Lastly, he also mentioned the patient engagement through
different patient input paths.
At the end, Mr. Bryan showed different helpful resources
for our further study.
Reference:
20161216:
HKSTP 2nd Hong Kong & Guangzhou International Conference on Stem Cell and
Regenerative Medicine - https://qualityalchemist.blogspot.com/2016/12/hkstp-2nd-hong-kong-guangzhou.html
20151220:
HKSTP Hong Kong & Guangzhou International Conference on Stem Cell and
Regenerative Medicine - https://qualityalchemist.blogspot.com/2015/12/hkstp-hong-kong-guangzhou-international.html
20140608:
HKU Public Lecture on Gene and Cancer & Stem Cells - https://qualityalchemist.blogspot.com/2014/06/hku-public-lecture-on-gene-and-cancer.html
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