Biomarkers

Question 1

Biomarker

Answer 1

A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention
Eg. Bp and Hb levels

Question 2

Usefule biomarker factors

Answer 2

-Informs risk/benefict ratio when there is a decision to be made
-Does so in a better/faster/earlier/cheaper way than existing approaches
-Generally applicable: sample and technology must be availible/accessible

Question 3

% ineffective SSRI

Answer 3

8%

Question 4

% ineffective Asthma

Answer 4

40%

Question 5

% ineffective DIabetes

Answer 5

43%

Question 6

%Rheumatoid arthritis

Answer 6

50%

Question 7

% Alzeimer’s disease

Answer 7

70%

Question 8

% Cancer

Answer 8

75%

Question 9

Questions that can be addressed by biomarkers

Answer 9

-Have I got cancer: Early detection
-What type of cancer have I got and what is my prognosis: Test (ER-, Pr-, Her2-)
-What treatment is best for me: (tamoxifen)
-Is my treatment working
-Will my cancer come back: Recurrence and possibility of other cancer

Question 10

Key advantages of biomarkers

Answer 10

-Early detection of disease
-Drug Development
-Assay development

Question 11

How can BM help save more lives from cancer

Answer 11

Most cancer diagnosied when 1-4cm in size
-By this time it may have metasized
-To reduce cancer-specifc mortality, we need effective biomarkers for:
-Risk Assesment
-Early detection
-Therapy

Question 12

Factors for diagnostic kit

Answer 12

-Easy to use in clinical setting
-Cost effective
-Proven results
-Samples: Blood, serum, urine, etc. (prostagin antigen (PCA3))

Question 13

HER2 biomarker disease + Drug

Answer 13

Breast cancer
Herceptin

Question 14

Estrogen and progesterone receptors

Answer 14

Breast acncer
Tamoxifen

Question 15

HER2 acronym

Answer 15

Human Epidermal growth factor Receptor 2

Question 16

Major functions of biomarkers (different types of biomarkers)

Answer 16

Is the therapy hitting the target: Pharmacodynaimc (PD) markers
Is there a response to the therapy: Efficacy markers
Will there be a response to the therapy: Patient stratification and patient selection biomarkers
Is there or will there be toxicity for the therapy: Toxicity biomarkers

Question 17

Why are new biomarkers needed

Answer 17

-False positives
-Cannot differentiate between stages of disease
-Not universal (CA 125 is expressed in 50-60% of patients during early stages of ovarian cancer)

Question 18

Bottle-neck in biomarker development

Answer 18

Quality samples
validation
Only 100 BM used in clinic out of 150,000

Question 19

Why is discovery of useful BM difficult

Answer 19

-Biology: most of genetic changes from malignant tumors are unknown
-Need for infrastructural support
-Need for collaboration among stakeholders: Basic scientists, Clinicians, Public Health proffesionals, Informaticians and Bionformaticians, advocates, Funding organistations, Regulatory authorities

Question 20

What is needed to discover and use more biomarkers

Answer 20

-Collaborations between Academic institutions and industries (both pharma and diagnostic)
-Input from regulation experts
-Repositories of quality samples
-More funds to promote biomarker research at an academic level

Question 21

Benefits of biomarkers for all stakeholders

Answer 21

-Patients: Increased effectiveness of therapies
-Doctors: Increased safety in treatment decisions
-Healthcare providers: better outcomes for less cost
-Pharma companies: Regulatory approval and competitive advantage
-Diagnostic companies: New market opportunities