Artificial Intelligence and Expediting Drug Development
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This document discusses how artificial intelligence can expedite drug development. It begins by defining artificial intelligence and describing the FDA's role in overseeing the drug development process through five phases. It then explains how the FDA works to hasten drug development. Currently, drug approval takes an average of 10-12 years and causes many deaths from delayed treatments. However, with AI, approval could take less than a year by analyzing large patient databases and better predicting drug safety and efficacy before human testing. In the end, AI has the potential to significantly reduce drug development times and save many lives.
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You wonder what that implies about how long you will live and what that means for your grandmother, who is 82 and in good health.
Vignette 3
You hear on the news the gruesome description of a shark attack on a young boy from another state and decide to keep your son away from the beach.
While playing at a friend’s house, your son nearly drowns after falling into the backyard pool.
You ask why so many people think that drowning in a backyard pool is unusual when it is far more common than shark attacks.
Vignette 4
“Balancing the harms and benefits is essential to making decisions,” your clinician says.
The treatment you are considering has an 80% chance of working, but there is also a 20% chance of side effects.
“What do I need to consider when balancing the harms and the benefits?” you ask.
Vignette 5
You are faced with a decision to have a medical procedure.
One physician tells you there’s no other choice and you must undergo the procedure, another tells you about the harms and benefits and advises you to go ahead and the third lays out the options and tells you it’s your decision.
Why are there such different approaches to making decisions these days?
Questions-to-Ask (1)
What is the scope of health communications?
Where does public health data come from?
How is public health information compiled to measure the health of a population?
How can we evaluate the quality of the presentation of health information?
What factors affect how we perceive public health information?
Questions-to-Ask (2)
What type of information needs to be combined to make health decisions?
What other data needs to be included in decision making?
How do we utilize information to make health decisions?
How can we use health information to make healthcare decisions?
Table 3-1 The 6 Ss of Quantitative Sources of Public Health Data (1/3)Type
ExamplesUsesAdvantages/
DisadvantagesSingle case or small seriesC.
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Madhu k s
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This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
The one thing I'd fix
When the author was a young doctor, they were fascinated by research and discovering new drugs, and their goal was to stop cancer. Understanding how cells divide normally and abnormally is key to beating cancer. Cancer is complex with over 100 types and numerous causes. Efforts to develop new drugs have high failure rates. New collaborations across organizations may help cure cancer through a collective effort and looking deeper into cancer's complex pathways. Early cancer detection is important as tumor size and cell number increases exponentially with later detection. Molecular imaging shows promise for improved and earlier tumor detection and characterization to guide more effective, personalized cancer treatment.
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Ana Mingorance crdn summit 2017
This document discusses empowering patients to take a more active role in drug discovery and development. It notes that for many rare diseases, the science is incomplete and drug development is slow. However, patient organizations are already leading many scientific and medical advances. The document advocates for a more collaborative approach where patients work with researchers and companies. It presents examples where patient groups have helped identify new patients, generated data to help trials, and invested in research. It argues that patients need more access to tools and technologies to drive diagnosis and drug development themselves for ultra-rare diseases. An envisioned "23andMe of drug development" could help facilitate this.
FDA’s drug review process
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
MNI Orphan Disease Scenario in India
India has a large population affected by orphan diseases, around 72 million people. While some premier medical institutions provide diagnostic facilities, more involvement is needed from the state government to address unmet needs. There is no standard definition for orphan diseases in India, but they are generally considered rare diseases that affect 1 in 5,000 people or less. Many international researchers see Indian physicians as having expertise in diagnosing orphan diseases. Patient associations partner with academic institutions and work to educate people about orphan diseases.
USFDA
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
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Artificial Intelligence and Expediting Drug Development
- 1. z Expediting Drug Development Using Artificial Intelligence Ashley Recchione HADM 506
- 2. z AI and Drug Development Objectives: Understanding Artificial Intelligence FDA’s role in drug development today How Artificial Intelligence is changing lives
- 3. z What is Artificial Intelligence and the FDA? the theory and development of computer systems able to perform tasks that normally require human intelligence, such as visual perception, speech recognition, decision- making, and translation between
- 4. z Who is the FDA? The Food and Drug Administration 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.
- 5. z FDA’s Phases of the Drug Developme nt Process Phase 1: Discovery Phase 2: Pre-Clinical Research Phase 3: Clinical Research Phase 4: FDA Drug Review Phase 5: Post-Market Drug Safety Monitoring
- 6. z
- 7. z FDA’s Strategies for Hastening Drug Development
- 8. z Evolution of Healthcare Without AI Average approval time of 10-12 years More than 25,000 deaths due to delay of cancer treatments annually. Use of paper records and human testing for treatment solutions Harmful drugs make it to shelves, causing death or deformity With AI Average approval time of less than 1 year Reduction in deaths due to delayed death by more than 50% Large databases to withhold patient information and genotype With a better forecasting ability, the drugs development can be halted or modified prior to human harm
- 9. z References https://www.fda.gov/ForPatients/Approvals/Fast/ucm20041766.h tm https://www.pfizer.com/science/clinical-trials/trial-data-and- results https://www.bio.org/sites/default/files/Clinical%20Development% 20Success%20Rates%202006-2015%20- %20BIO,%20Biomedtracker,%20Amplion%202016.pdf https://pharmaphorum.com/views-and-analysis/ai-blockchain- big-data-can-reduce-drug-development-costs/