Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon

Cytotherapy ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 686-698 ◽  
Author(s):  
Jolene Chisholm ◽  
Crystal Ruff ◽  
Sowmya Viswanathan
Keyword(s):  
Gene Therapy ◽  
State Of Health ◽  
Current State ◽  
Health Canada

scholarly journals Preference measurement in health using experiments

2021 ◽  
Author(s):  
Peter Zweifel
Keyword(s):  
Health Care ◽  
Discrete Choice ◽  
Discrete Choice Experiments ◽  
State Of Health ◽  
Preference Measurement ◽  
Health Econ ◽  
Economic Criterion ◽  
Lay Persons ◽  
Current State ◽  
Treatment Of Diabetes

AbstractThis contribution has three objectives. First, it seeks to justify the use of the economic criterion, “Provision of health care in accordance with the preferences of current and potential patients” for guiding decisions concerning the adoption of costly innovation in health. Next, it proposes the measurement of these preferences in the guise of willingness to pay (WTP) values through Discrete Choice Experiments (DCEs). Third, it purports to examine two popular arguments against accepting lay persons´ preferences, viz. that they are unwilling or unable to express preferences with regard to health and health care, and that their preferences are unstable, depending on the current state of health. Both of these arguments are refuted by the findings of four DCEs designed to measure WTP for attributes of health insurance and of the treatment of diabetes, respectively [Zweifel in J Regul Econ 29(3): 319–332, 2006; MacNeil Vrooman and Zweifel in Eur J Health Econ 12(1): 87–95, 2011; Sennhauser and Zweifel in: Jakovlijevic M (ed.), Health Economics and Policy Challenges in Global Emerging Markets. NOVA Publishers, Hauppauge NY, 2016].

scholarly journals The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

2019 ◽  
Vol 24 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Daniel Eisenman
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Clinical Trials ◽  
The United States ◽  
Regulatory Environment ◽  
Evidence Based ◽  
Regulatory Structure ◽  
Regulatory Changes ◽  
Current State ◽  
Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

Respiratory gymnastics as a means of strengthening the health of student youth

2021 ◽  
pp. 135-137
Author(s):  
N. Shashlov
Keyword(s):  
Healthy Lifestyle ◽  
Human Life ◽  
Effective Means ◽  
Specific Effect ◽  
The Body ◽  
External Respiration ◽  
State Of Health ◽  
Critical Systems ◽  
Breathing Exercises ◽  
Current State

The article analyzes the current state of health of students of higher education institutions. The importance of breathing exercises for student youth in a pandemic is determined. The necessity of using respiratory techniques to harden the body, improve the work of the respiratory and cardiovascular systems is substantiated. It is established that breathing exercises are a system of breathing exercises and an effective means of strengthening human health. During respiratory gymnastics our body is saturated with oxygen, blood circulation improves, metabolic processes are accelerated, emotional state is stabilized, immunity is strengthened. Breathing exercises improve and activate the function of external respiration, promote its faster recovery after exercise and have a specific effect on some respiratory diseases. Health is the main value of human life, to which man himself does not pay due attention. An important preventive factor in strengthening it is a healthy lifestyle. There are basic requirements for maintaining a healthy lifestyle - physical activity, nutrition, comfortable conditions and a rational mode of work and rest, optimal exercise, abandonment of bad habits, the use of traditional and non-traditional means of health. The problem of health, especially of students, is receiving more and more attention. The state of health of students can be classified as high risk. The transition from one learning environment to another, more intensive, requires the body of the future student to pay more attention to the work of critical systems, including respiratory. There are many issues related to the formation of new approaches to health promotion.

Biotechnology

2021 ◽  
pp. 112-132
Author(s):  
Qing-Ping Ma
Keyword(s):  
Gene Therapy ◽  
Energy Consumption ◽  
Biological Systems ◽  
Hereditary Diseases ◽  
Future Trends ◽  
Current State ◽  
Ore Processing ◽  
Living Organisms ◽  
High Yields ◽  
Reducing Energy

Biotechnology utilizes biological systems or living organisms to create, develop, or make products. This chapter reviews the current state of biotechnology and examines its future trends. Currently, biotechnology plays key roles in medicine, agriculture, and industry. In medicine, vaccines which still rely on biological systems for their production, are the best tools to prevent infectious diseases; antibodies and RNA/DNA probes have been crucial in detecting and treating diseases; and genetic editing and gene therapy is making it possible to treat hereditary diseases. In agriculture, biotechnology is generating crops that produce high yields and need fewer inputs, crops that need fewer applications of pesticides, and crops with enhanced nutrition profiles. In industry, biotechnology is being utilized in food processing, metal ore processing, the production of chemicals, and reducing energy consumption and pollution.

Pathway to professionalizing health leadership in Canada: The two faces of Janus

2019 ◽  
Vol 33 (1) ◽  
pp. 25-29 ◽  
Author(s):  
Graham Dickson ◽  
John Van Aerde ◽  
Bill Tholl
Keyword(s):  
Social Contract ◽  
Public Services ◽  
State Of Health ◽  
Body Of Knowledge ◽  
Current State ◽  
Health Leadership ◽  
The Future ◽  
Knowledge And Practice ◽  
Do So

This article looks at the current state of health leadership in terms of expectations for professionalism: controlled entry, exit, and licensure/certification; a social contract to provide public services for the good of Canadians; and a unique body of knowledge and practice generally accepted. Looking to the future, and using the same three criteria, a compelling case for pursuing the professionalization of health leadership is made using LEADS as a roadmap. The article also outlines how to realize the professionalization of health leadership in Canada and why it is important to do so.

Viral vectors for gene therapy: Current state and clinical perspectives

2016 ◽  
Vol 81 (7) ◽  
pp. 700-708 ◽  
Author(s):  
A. N. Lukashev ◽  
A. A. Zamyatnin
Keyword(s):  
Gene Therapy ◽  
Viral Vectors ◽  
Current State

Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon

Cytotherapy ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 699-724 ◽  
Author(s):  
Michael Mendicino ◽  
Yong Fan ◽  
Deborah Griffin ◽  
Kurt C. Gunter ◽  
Karen Nichols
Keyword(s):  
Gene Therapy ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Current State

Improving guideline-mandated care of patients with implantable cardiac defibrillators

2020 ◽  
Vol 81 (8) ◽  
pp. 1-10
Author(s):  
Daniel Garner ◽  
Matthew Blackburn ◽  
David J Wright ◽  
Archana Rao
Keyword(s):  
Cardiac Death ◽  
State Of Health ◽  
Implantable Cardiac Defibrillator ◽  
Improvement Project ◽  
Disease Trajectory ◽  
Current State ◽  
Audit Data ◽  
Cardiac Centre ◽  
Improve Patient ◽  
Implantable Cardiac Defibrillators

Background/Aims Implantable cardiac defibrillators reduce the risk of sudden cardiac death in selected patients. The value of an implantable cardiac defibrillator declines as the patient's disease progresses. Guidelines suggest that the appropriateness of maintaining implantable cardiac defibrillator therapy be regularly reviewed as part of monitoring of the patient's disease trajectory. It is recommended that implantable cardiac defibrillators are deactivated as patients approach the end of life. Patients with a better understanding of their current state of health and the role that the implantable cardiac defibrillator plays within it are more likely to make informed decisions about the timing of deactivation. Methods: A quality improvement project was undertaken on appropriate deactivation of implantable cardiac defibrillators within a large tertiary cardiac centre. This was driven by audit data showing inadequate patient communication and documentation around deactivation. Drivers for change included the introduction of electronic data records, clinical review of comorbid patients approaching elective battery change and an ongoing forum for patient and carer education. Measured outcomes included the number of deactivations performed, evidence of patient discussion and consent, and timing of deactivation of the implantable cardiac defibrillator. Results There were increased numbers of timely device deactivations undertaken following the interventions with improved documented evidence of patient discussion and consent. The educational forum was received favourably. Conclusions Focused multidisciplinary interventions can impact favourably on appropriate implantable cardiac defibrillator deactivation and improve patient engagement.

Sign in / Sign up

Export Citation Format

Share Document