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30 Cards in this Set

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What are some factors that influence medicine response?
Diagnosis, compliance, genetic differences among patients, interactions with concomitant drugs, dosage...
What is polymorphism?
The inheritance of genes in different forms
different DNA sequences
What is personalized medicine?
Drugs tailored to the needs of an individual, as determined by an individuals genetic profile.
What is a gene chip?
A microarray that allows for testing 300,000 to 500,000 SNPs at a time.
WTF is Warfarin?
*Discovered 60 years ago and one of the most widely prescribed drugs in the world
*Initially marketed as a pesticide against rats
*Intended to prevent and treat thromboembolisms, Afib, recurrent stroke, DVT, pulmonary embolism, heart valve prosthesis
*Multi-source anticoagulant
*1, 2, 2.5, 3, 4, 5, 6, 7.5 and 10 mg tablet strengths
*Significant increase in Rx’s over past 10 years especially in the elderly
What did the FDA suggest testing for before prescribing warfarin?
Variations in the CYP2C9 and VKORC1
What are two common examples of personalized medicine?
Gleevec and Herceptin
What are possible fears of personalized medicine?
Payers:Adds to My Cost Without Return
Treating Physicians:Too Prescriptive for Me
Patients:Will I Be Denied Access to New Drugs?
Regulators:How Do We Handle New Complexities?
Pharma:Reduces My Market
Pathologists:Reduces My Market
Diagnostics:More Tests With Poor Reimbursement
What did Diamond vs. Chakrabarty determine?
A live, human-made micro-organism is patentable subject matter under [Title 35 U.S.C.] 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.
certain genetic material is subject to patent protection
What is a gene patent?
A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims
What are some patent requirements?
Patentable subject matter (§101)
Utility (§101, 112)
Novelty (§102)
Non-obviousness (§103)
What patent did Myriad have that allowed them to sue U. Penn?
BRCA1/2
What did Judge Sweet do in February 2010?
Invalidated 7 patents related to BRCA1 and BRCA2
What is a single gene disorder?
Caused by a single gene. Examples include sickle cell, tay sachs, and cystic fibrosis.
What is a chromosome disorder?
Caused by an excess or deficiency of the genes. Down syndrome is caused by an extra copy of a chromosome, but no individual gene on the chromosome is abnormal.
What is a multifactorial inheritance disorder?
A disorder caused by a combination of small variations in genes. Heart disease, most cancers and Alzheimer's disease are examples.
What is gene therapy?
Gene therapy is the insertion of gene(s) into an individual's cells and tissues to treat a disease in which a defective mutant gene is replaced with a functional one.
What is a vector?
A gene delivery tool that allows for the gene to be inserted into the cell.
What is a virus?
A subcellular parasite with genes of DNA or RNA. Replicates inside the host cell upon which it relies for energy and protein synthesis.
What is the most common gene therapy vector?
viruses
What are potential problems associated with utilizing viruses as gene therapy vectors?
Toxicity, immune and inflammatory problems.
Prediction

—Lee M. Silver (Princeton University)
Some time in the distant future, human beings will diverge into two species, the GeneRich and the Naturals. Naturals will have the standard set of 46 chromosomes while the GeneRich will have an extra pair specially designed to receive additional gene-packs at each new generation. With 48 chromosomes and thousands of additional genes, the Generich will be, indeed, on their way to diverging from the Naturals.
What was the first recombinant protein drug approved by the FDA?
Human insulin
What is an antibody?
A protein produced to tag invasive microbes for destruction.
What are the two parts of the immune system?
Innate: General response to anything other than self (tears, skin, etc)
Adaptive: Specific counter-assault against a "Known foreign" invader. Specific defenses are those that give us immunity to certain diseases.
(T-cells, B-cells, antibodies)
What is an antigen?
Anything viewed by the body as "Not self"
Antigens resemble what letter?
They look like the letter "Y"
Problems with polyclonal antisera?
Lack of reproducibility, complex mixture, and immunogenicity
Whatsa monoclonal antibody?
Individual B cell is cloned and cultured.
Secreted antibodies are collected
from culture media
What is the main problem with mAbs?
Mice antibodies are seen as foreign, and the human patient mounts an immune response against them.