from the lab to market unit 3.04 understanding biotechnology research & development
TRANSCRIPT
From the Lab to Market
Unit 3.04
Understanding Biotechnology research & Development
How a New Drug Gets to Market
Americans have access to probably the safest and most advanced pharmaceutical system in the world
The FDA is the main consumer watchdog for this system.
The FDA evaluates new drugs before they can be sold to make sure they are safe and effective for their intended use
How a New Drug Gets to Market
Development of a new drug is a lengthy process
Drug Discovery & Testing
Drug development begins in the laboratory, where scientists look for compounds that treat or prevent disease
Biopharmaceuticals are naturally occurring human proteins or modified human proteins produced from generally engineered cells grown in culture
Drug Discovery & Testing
Once a company finds a drug, it thinks is promising, it begins pre-clinical studies that test the drug on animals or in other non-human test systems
Since animals have a much shorter lifespan than humans, valuable information can be gained about a drug’s possible toxic effects over an animal’s life cycle and on its offspring
Clinical Trials
Human studies designed to distinguish a drug’s effect from other influences
If the drug appears to be safe and effective after clinical trials with several thousand subjects the company files a New Drug Application (NDA) with the FDA before the drug can go to market
Clinical Trials
Phase 1 trials: The drug is tested for its interaction with the human system,
including the way it is absorbed, distributed in the body, metabolized and excreted.
These trials usually involve normal, healthy volunteers and take about a year to complete
Clinical Trials
Phase 2 Trials: Pilot studies that begin to define the effectiveness and
safety of the drug in selected populations of patients with the disease or condition to be treated, diagnosed or prevented.
Clinical Trials
Phase 3 Trials: Expanded clinical trials intended to gather additional
evidence of effectiveness for specific indications and to better understand safety and drug-related adverse effects
Clinical Trials
Phase 4 Trials: Studies that occur after a drug has received FDA approval to
be marked.
Performed to determine the incidence of adverse reactions, to determine the long-term effect of the drug
Study a patient population not previously studied
Marketing comparisons against other products and other users
NDA Review: How Long Does This Phase Take?
NDA is a comprehensive statement with information about the drug (thousands of pages long), companies must submit three copies of the report
The FDA is 60 days to conduct a preliminary review and decide if it has enough information to proceed with the NDA review
The NDA decision making process can take anywhere from 2 months – 7years, (average is 2 years)
Post-Marketing Surveillance
Monitor the ongoing safety of marketed drugs
Accomplished by reassessing drug risks based on new data collected after the drug is marketed and by recommending new ways of trying to most appropriately manage that risk
Pharmaceutical &
Biopharmaceutical Industries
From the beginning of civilization, people have been concerned about the quality and safety of foods and medicines
Regulations of food in the United States dates from early colonial times, and one of the earliest food and drug law was enacted by the state of Massachusetts in 1785
Many tragic events and concerns about food and drug safety have led to regulations about developing and manufacturing new products/medications
What are Regulations?
General and Permanent rules issued by the various departments and agencies of the executive branch of the federal government are published in the Code of Federal Regulations
Regulations state what may or may not be done or how something must be done and are enforceable by law
Regulations are vital to ensure quality and safety of the drugs marketed in the United States