z
Expediting Drug
Development Using
Artificial Intelligence
Ashley Recchione
HADM 506
z
AI and Drug
Development
Objectives:
 Understanding Artificial
Intelligence
 FDA’s role in drug
development today
 How Artificial
Intelligence is changing
lives
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
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.
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
z
z
FDA’s Strategies for Hastening Drug
Development
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
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/

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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/