Basic Research Research conducted to increase fundamental knowledge. Research conducted to increase fundamental knowledge. Provides building blocks for.

Basic ResearchBasic Research Research conducted to Research conducted to

increase fundamental increase fundamental knowledge.knowledge.

Provides building blocks Provides building blocks for all types of research.for all types of research.

Not directed toward Not directed toward solving any particular solving any particular problem.problem.

Basic ResearchBasic Research A teacher assigning A teacher assigning

her students to her students to write a research write a research paper on paper on Alzheimer’s disease. Alzheimer’s disease.

Mice being deprived Mice being deprived of sleep as part of a of sleep as part of a research study.research study.

A new disease in A new disease in Africa would prompt Africa would prompt us to do basic us to do basic research in America.research in America. Basic = gathering information

Applied ResearchApplied Research Directed toward specific objectives – Directed toward specific objectives –

for example, development of a new for example, development of a new drug, treatment, or surgical drug, treatment, or surgical procedure.procedure.

Conducted MOSTLY with animals.Conducted MOSTLY with animals. Can be non-animal methods Can be non-animal methods

(computer models or tissue cultures), (computer models or tissue cultures), and humans.and humans.

Clinical ResearchClinical Research1.1. 1. Used when other 1. Used when other

forms of research forms of research have taken place.have taken place.

2. Used to test potential 2. Used to test potential drugs & treatments in drugs & treatments in humans.humans.

3. Builds on what is done 3. Builds on what is done in basic & applied in basic & applied stages. stages.

Broad variety of activities & areas Broad variety of activities & areas of study.of study.

Human clinical trails-leukemia, Human clinical trails-leukemia, cancers, AIDS & many other cancers, AIDS & many other diseases. Some people are paid diseases. Some people are paid if willing to participate. if willing to participate.

Psychosocial & behavioral Psychosocial & behavioral researchresearch

Disease control research.Disease control research.Humans are mainly used when Humans are mainly used when

testing drugs.testing drugs.

Medical ResearchMedical Research Clinical Research occurs in Clinical Research occurs in

the the last stage last stage of medical of medical research.research.

Biomedical Research Biomedical Research MethodsMethods

Chemical, mechanical, mathematical, Chemical, mechanical, mathematical, and computer simulations.and computer simulations.

Strengths of modelsStrengths of models Computer simulations increases Computer simulations increases

speedspeed & & efficiencyefficiency of existing data. of existing data. It provides a method of not using It provides a method of not using animals.animals.

Limitations of modelsLimitations of models

Can not replace Can not replace laboratory testing.laboratory testing.

In vitro tests In vitro tests “In glass”“In glass” – – takes place in an artificial takes place in an artificial environment. environment. (Laboratory)(Laboratory)

Strengths of vitro Strengths of vitro studiesstudies

Critical to the study of Critical to the study of a microorganism like a a microorganism like a virus…which can only virus…which can only grow in living cells. grow in living cells.

LimitationsLimitations of in vitro of in vitro studiesstudies

Cultures Cultures cannot tell us cannot tell us how a how a substance substance affects a affects a complex complex animal system.animal system.

Non-human modelsNon-human models Animals provide the best known Animals provide the best known

surrogate for humans in the lab.surrogate for humans in the lab.

Similarities between animals and Similarities between animals and humans outweigh differences. humans outweigh differences.

Share the same structures (cells, Share the same structures (cells, tissues, organs) as humans.tissues, organs) as humans.

The use of animals is governed by The use of animals is governed by federalfederal regulations. regulations.

Clinical TrialsClinical Trials Phase 1 - first stage of human testing,

typically enroll fewer than 100 volunteers.

These studies are primarily concerned with assessing risks and side effects associated with a drug.

Phase II trialsPhase II trials Enroll up to a few hundred volunteers with Enroll up to a few hundred volunteers with

the condition the drug is designed to the condition the drug is designed to treat. treat.

Focus is on determining the best dose of a Focus is on determining the best dose of a drug. drug.

Scientists also watch for signs of Scientists also watch for signs of effectiveness. effectiveness.

Phase III trialsPhase III trials Enroll several Enroll several

hundred to hundred to thousands of thousands of volunteers - volunteers - multiple study multiple study sites nationwide. sites nationwide.

Provide the chief Provide the chief evidence for safety evidence for safety and effectiveness and effectiveness that the FDA will that the FDA will consider in consider in deciding whether deciding whether to approve a drug.to approve a drug.

Phase IV trialsPhase IV trials

The trial sponsor The trial sponsor must monitor the must monitor the health of individuals health of individuals taking the drug to taking the drug to gain further insight gain further insight into its long-term into its long-term safety and safety and effectiveness and the effectiveness and the best way to use it.best way to use it.

FDA Approval – Total = 11 - 12 years

FDA Review – 2 - 2 ½ years

Clinical Studies – Phase 1 – Safety studies – 1 year

Clinical Studies – Phase 2 – Effectiveness – 2 years

Clinical Studies – Phase 3 – Extensive clinical testing – 3 years

Laboratory and Animal Studies – 3 - 3 ½ years

Development of New Drug Steps

H1N1 H1N1 InfluenzaInfluenzaAka – Swine Aka – Swine FluFlu

Benefits of Biomedical Benefits of Biomedical ResearchResearch

Contributions to human healthContributions to human health

1.) Treatment for heart disease — 1.) Treatment for heart disease — heart-lung machineheart-lung machine

2.) Treatment for cancer2.) Treatment for cancer

3.) Treatment for diabetes3.) Treatment for diabetes

4.) Bone marrow transplants4.) Bone marrow transplants

5.) Early vaccines 6.) Polio vaccine 7.) Chicken pox (Varicella) 8.) Hepatitis 9.) Fluoride-many countries add to water to

decrease tooth decay. 10.) Penicillin & other

antibiotics

Some Some examples of examples of the benefits the benefits

of Biomedical of Biomedical Research…Research…

Treatment for heart diseaseTreatment for heart diseaseheart-lung machineheart-lung machine

Revolutionized Revolutionized cardiac surgery cardiac surgery 40 40 years ago.years ago.

SmallpoxSmallpox In In 19671967, the World Health , the World Health

Organization launched a global Organization launched a global campaign to eradicate Smallpox. campaign to eradicate Smallpox.

Heart DiseaseHeart Disease The reduction of The reduction of

CIGARETTE SMOKING CIGARETTE SMOKING has decreased HEART has decreased HEART disease by disease by 40%40%..

An experimental drug An experimental drug for heart disease is for heart disease is currently in Phase I currently in Phase I clinical trails. How long clinical trails. How long before it will be before it will be approved for public approved for public use? use?

2,4,8, or 11 years2,4,8, or 11 years

CANCERCANCER Cancer is the most studied in Cancer is the most studied in

biomedical research efforts.biomedical research efforts. Gene therapy for treatment si Gene therapy for treatment si

currently being researched!currently being researched!

Insulin Insulin 11STST extracted extracted

from a cow’s from a cow’s pancreas & used pancreas & used to treat a 14 year to treat a 14 year old boy in 1922. old boy in 1922. Today we Today we genetically genetically engineer insulin. engineer insulin.

BacteriaBacteria is used is used to produce to produce human insulin.human insulin.

Chicken pox (Varicella)Chicken pox (Varicella)

Is a highly contagious Is a highly contagious illness caused by primary illness caused by primary infection with infection with varicellavaricella zoster.zoster.

Today there is a vaccine Today there is a vaccine to prevent chicken pox.to prevent chicken pox.

GlucometerGlucometer A device used to measure a A device used to measure a

persons blood sugar levels. persons blood sugar levels. Today there has been developed Today there has been developed a machine that uses a machine that uses very little very little bloodblood..

Availability of VaccinesAvailability of Vaccines Why are children under 2 still not Why are children under 2 still not

vaccinated with the vaccinated with the recommended vaccines?recommended vaccines?

Fear of side effects and lack of education about diseases vaccines prevent!

Parents are not familiar with Parents are not familiar with infectious diseases and have infectious diseases and have therefore become complacent about therefore become complacent about vaccinations….problem!vaccinations….problem!

Polio vaccinePolio vaccine

The first was The first was developed by Jonas developed by Jonas Salk, first tested in Salk, first tested in 1952, and announced 1952, and announced to the world by Salk to the world by Salk on April 12, 1955. on April 12, 1955.

Dr. Albert SabinDr. Albert Sabin

Worked on a polio Worked on a polio vaccine that could be vaccine that could be administered orally. administered orally. It It was made from an was made from an attenuatedattenuated (live (live organisms) organisms) virus. virus.

Biomedical ResearchBiomedical Research Has had a profound impact on Has had a profound impact on

childhood cancer (leukemia) childhood cancer (leukemia) that, in the 1950’s, killed every that, in the 1950’s, killed every child diagnosed with it within 6 child diagnosed with it within 6 months. Survival rate is 75 % months. Survival rate is 75 % now!now!

Biomedical ResearchBiomedical Research Most commonly Most commonly

studied is cancer studied is cancer and genetic and genetic diseasesdiseases

Research on Research on tooth decay lead tooth decay lead to what element to what element being added to being added to the drinking the drinking H2O?H2O?

Alexander FlemingAlexander Fleming

Discovered the Discovered the antibiotic antibiotic

PenicillinPenicillin.. Penicillin is one of the Penicillin is one of the earliest discovered and earliest discovered and widely used antibiotic widely used antibiotic agents, derived from the agents, derived from the Penicillium mold. Penicillium mold.

AIDS research continues (Acquired AIDS research continues (Acquired Immunodeficiency Syndrome)Immunodeficiency Syndrome)

1.) Began in early 1980s1.) Began in early 1980s 2.) Caused by a virus2.) Caused by a virus 3.) HIV infection progresses to AIDS 3.) HIV infection progresses to AIDS

when immune system is impaired & when immune system is impaired & individual becomes susceptible to individual becomes susceptible to opportunistic infections. opportunistic infections.

Bodily fluidsBodily fluids Infected blood Infected blood Breast milkBreast milk

Abstaining from sex Abstaining from sex Being aware if one’s partner is infected Being aware if one’s partner is infected Using condoms.Using condoms. Sterilized needles or sharing needles Sterilized needles or sharing needles Health workers should wash hands and Health workers should wash hands and

use protective barriers, such as, gloves use protective barriers, such as, gloves and goggles when handling infected blood. and goggles when handling infected blood.

Mothers infected with HIV should not Mothers infected with HIV should not breastfeed their childbreastfeed their child..

Common sense preventive measures best way to prevent AIDS.