Quality Alchemist (品質煉金術師): Regenerative Medicine 101 Webinar - Information for Patients, Caregivers & Advocates

2021年11月17日星期三

Regenerative Medicine 101 Webinar - Information for Patients, Caregivers & Advocates

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 21^st 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.