Drug Regulation Flashcards
Overview from bench to bedside
Discovery of new molecules –> Patent –> Health Canada (pre-clinical and clinical testing leading to NOC and product monograph)–> CADTH (clinical data and economic data leading to drug coverage recommendation)–> Providers/pharmacies (Generics and dispensing) –> Patients
Key goals of investigative toxicology drug discovery and development
Target selection and hit identification –> Lead identification and optimization –> Non-clinical development –> Clinical development
Patent process (5 steps)
- Get ready to apply: Determine the type of protection needed and determine if the invention is patentable, cost, patent type
- File the application: Prepare the application, provisional or non-provisional, and submit the application with all the required parts, pre-prosecution
- Application prosecution
- Receive your patent: If the requirements are met, you receive a notice of allowance
- Maintain legal protection of your patent: Pay the maintenance fee and check the status (3.5, 7.5, and 11.5 years for utility patent)
Provisional vs Non-provisional application
Provisional application: quick and inexpensive way to establish a filing date that can be claimed in a later non-provisional application. It will not lead to patents by itself; you have 12 months from the provisional filing date to file the non-provisional application.
Non-provisional application: Examined by a patent examiner and may be issued as a patent if requirements are met.
Utility patent
Covers the creation of a new or improved product, process, or machine
What is a notice of compliance
NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the food and drug regulation
What are the phases of clinical research
The drug-development process will proceed through all phases over many years.
Phase 1: Screening for safety
Phase 2: Establishing the testing protocol
Phase 3: Final testing
Phase 4: Post-approval studies
Describe the number of people involved in each phase of clinical research
1: 0-80
2: 100-300
3: 1000-3000
4: general population
Before pharmaceutical companies start clinical trials, they conduct extensive _______
pre-clinical studies
What are evolving FDA mechanisms for accelerating the clinical trial?
Fast track and goes straight from bench to bedside
What is compassionate use (right to try)? What are the requirements?
Bypasses phases 2 and 3 of the clinical trials
Requirements are constantly evolving. Exact pre-requisites are not exactly clear and may vary from case to case
What is the common stem cell clinic approach
Avoids the clinical trials approval process entirely
Traditional drug discovery versus drug repurposing
Traditional: time-consuming, financially a burden
Drug repurposing: years can be cut down from the typical drug discovery cycle. Abolish the steps needed for FDA approval
How does FDA approval affect drug repurposing? Effects?
Phase I of trials can be eliminated
Saves time, effort, and money.
What are the challenges of data-driven artificial intelligence modeling in modern, computer-aided drug discovery
As model reliability and predictivity increases, data sparsity and variety decrease
What is the CADTH
Canadian agency for drugs and technologies in Health
Provides research and analysis to healthcare decision-makers
Established in 1989 and before 2006 were known as CCOHTA
Medicare on a national level was facilitated by who?
John Diefenbaker and Emmett Hall
What was the canada health act? What is the primary objective
Canada’s federal legislation for publicly funded health care insurance
Primary objective: “to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers.”
The CHA aims to ensure that all eligible residents of Canada have reasonable access to insured health services on a prepaid basis, without direct charges at the point of service for such services
Five principles of medicare
Public administration
Accessibility
Comprehensiveness
Universality
Portability
Issues facing the Canadian health care system
Rising prices: partly a function of technological advances
inequality: Social determinants of health, racism and ageism
aging demographic: Fewer HC workers to care for more patients
What are the social determinants of health? Examples:
The social determinants of health (SDH) are the non-medical factors that influence health outcomes.
Conditions in which people are born, grow, work, live, and age.
The wider set of forces and systems shape the conditions of daily life.
the lower the socioeconomic position, the worse the health
Income
education
unemployment
job insecurity
working life conditions
food insecurity
housing
Childhood development
What is structural conflict?
Structural conflict : The structural determinants affect whether the resources necessary for health are distributed equally in society, or whether they are unjustly distributed according to race, gender, social class, geography, sexual identity, or other socially defined groups of people
How do social determinants affect health?
Research shows that social determinants can be more important than health care or lifestyle choices in influencing health
Addressing SDH is fundamental for improving health and reducing longstanding inequities in health
What are commercial determinants of health? How does the private sector influence us?
Commercial determinants of health are the private-sector activities that affect people’s health, directly or indirectly, positively or negatively.
The private sector influences the social, physical and cultural environments through business actions and societal engagements
What risk factors do commercial determinants affect
Wide range includign smoking, air pollution, alcohol use, etc…
Who is affected by commercial determinants of health
Commercial determinants of health affect everyone, but young people are especially at risk, and unhealthy commodities worsen pre-existing economic, social and racial inequities
Social determinant vs commercial determinant
- The social determinants of health are the conditions in which people are born, grow, work, live, and age, the systems put in place to deal with illness, and the broader set of forces and systems shaping the conditions of daily life. These forces and systems include economic policies and systems, development agendas, social norms, social policies and political systems. Social determinants of health matter because addressing them helps prevent illness and promotes healthy lives and societal equity.
- Commercial determinants of health are key social determinants and refer to the conditions, actions and omissions by commercial actors that affect health. Commercial determinants arise in the context of the provision of goods or services for payment and include commercial activities and the environment in which commerce takes place. They can have beneficial or detrimental impacts on health
What are new initiatives in HC
AI: efficiency through machine learning
TeleHealth: Increasing access/reducing inequality
Analytics: Using evidence in a different way
Devices: Devices
Robotics: Companions and precision
