Engagement with the FDA on Premarket Submissions and Inspections by Yuan Fang
Yuan Fang, PhD MBA P.Eng RAC
Yuan Fang, PhD MBA P.Eng RAC
The Centre for Bioengineering and Biotechnology is pleased to present the innovative work of Professor Alexander Wong.
COVID-19 has brought disease and mortality at levels not seen from a respiratory virus for over 100 years. Immune responses to this virus, which can infect several different tissues, are poorly understood, including the role of antibodies in resolving the infection. In March 2020, we reoriented our lab to develop Enzyme-Linked ImmunoSorbent Assays (ELISA) for human antibody isotypes IgM, IgG and IgA produced in response to the SARS-CoV-2 spike protein. To date we have analyzed samples from 114 patients, including both PCR positive and PCR negative individuals.
Brendan will discuss his research on the innovation processes of Grand River Hospital, Kids Ability, and Schlegel Villages as well as provide an introduction to the concept of open-innovation, specifically in healthcare.
He will also provide an overview of a Workplace Innovation Program that uses a similar innovation management model to CREATE. As part of that program, they use a needs “Needs Finding and Assessment” process to help teams identify the most valuable and viable opportunities for new products and services.
Rohan Shanbhag, VP of ML and AI Strategy, will be discussing how Achu Health has developed a personalized health and wellness platform driven by a proprietary machine learning algorithm on-device that uses passively collected biometric data from wearables to predict the onset of illness before symptoms appear. Achu Health aims to assess the scientific rigour of its technology to ensure that the evaluation can be backed by Health Science professionals in providing meaningful value to the end user.
Mr. Jeffrey Wong of Golwing WLG answers your questions regarding Biotechnology, Intellectual Property and the pathway to Patent.
The efficacy of skilled practice in promoting beneficial brain reorganization to affect functional recovery has long been appreciated. However, current best practices to stroke rehabilitation are labour intensive and characterized by variable levels of functional recovery. In many cases, recovery of function in the stroke-affected limb is incomplete.
Speaker: Abdul Khalfan CQE, SSGB
Principal, Quality Assurance & Reliability Engineering Consulting Services
The central theme of ‘Basic Concepts of Quality’ is to imbed the fundamentals of ‘Quality’ concepts in everyday work life and in their interactions with the society at large.
Speaker: Carla Girolametto, Director of Innovation, Research and Clinical Trials at Grand River Hospital.
This talk will focus on Ethics and Regulatory aspects of conducting research in a clinical setting with the involvement of Human Participants: An interactive case study.
The efficacy of skilled practice in promoting beneficial brain reorganization to affect functional recovery has long been appreciated. However, current best practices to stroke rehabilitation are labour intensive and characterized by variable levels of functional recovery. In many cases, recovery of function in the stroke-affected limb is incomplete.