Chapter 4 - Discovery
Chapter 4 - learning about Drug Discovery. Part 4 in your quest for knowledge.
- 1.What does NCE stand for? (exact spelling/wording for credit)
- 2.What is a "lead" compound?
- A.
Another term for active pharmaceutical ingredient
- B.
A compound that exhibits certain properties that suggest its value as a starting point for drug discovery
- C.
A compound that is known to possess certain properties that suggest its value in clinical trials
- D.
A compound made of lead, or, in latin, plumbum, atomic #82
- 3.When does true proof of concept (evidence that the drug is beneficial for the purpose being analyzed) occurs?
- A.
Pre-clinical.
- B.
Early Phase 1
- C.
Early Phase 2
- D.
In the discovery phase
- 4.What future advances may lead to increased effiency with regards to identifying promising lead compounds?
- A.
A shift to fully automated R&D efforts
- B.
A shift to gene and protien based targeting
- C.
A shift to greater focus on isomers and alternative formulations of current blockbuster compounds
- D.
Reverting back to manually determing the crystalline structures of lead compounds.
- 5.Discovery functions are aligned with ______________.Groups involved with discovery efforts are usually organized by ____________, and subdivided by __________.
- A.
Therapeutic area, major process stages, scientific specialty
- B.
Major process stages, scientific specialty, therapeutic area
- C.
Scientific specialty, therapeutic area, major process stages
- 6.What does NME stand for? (exact spelling/wording for credit)
- 7.The journey of drug discovery begins with isolation of a ___________ and progresses to perfection of a ________.
- A.
Disease, drug
- B.
Target, lead compound
- C.
Disease, lead compound
- D.
Target, active ingredient
- 8.Discovery begins with the selction of a disease and a target. The target may be _________ in the market or completely ___________.
- A.
In a new therapeutic area, or, a different class of drug entirely
- B.
An isomer, or, a generic equivalent
- C.
Previously established, or, new/innovative
- D.
A bullleye or an X
- 9.Why is the discovery phase so important in controlling costs?
- A.
This is where pharma companies identify promising compounds to be developed.
- B.
This is where pharma companies identify less than promising coumpounds and eliminate them from cost-intensive development
- C.
This is where drugs are discovered and is the basis for creating cash flow for the company as a whole.
- D.
It isn't a factor in controlling costs.
- 10.How have certain facets of compound indetification been expedited in the modern day?
- A.
The research teams have been diversified to bring input in from more types of scientists.
- B.
The R&D teams have become more effective at manually identifying promising early stage compounds
- C.
Researchers now use computer-based simulation and analysis to identify promising early stage compounds
- D.
People are smarter now than they used to be.
- 11.What is the mission of drug discovery?
- A.
To understand how a drug reacts on the body
- B.
To determine the level at which the drug is toxic to create a safety threshold for patients using the drug.
- C.
To improve the functioning of systems in the body by creating drugs that specifically target foreign antibodies.
- D.
To understand the processes associated with a disease and to identigy a drug that can intervene in those processes
- 12.In vitro testing is _____________, while in vivo testing is _____________
- A.
Harmful to the testing subject, not harmful to the testing subject
- B.
Not harmful to the testing subject, harmful to the testing subject
- C.
The testing in live animals, the testing of live tissue (from human or animal organs) in the lab
- D.
The testing of live tissue (from human or animal organs) in the lab, the testing in live animals
- 13.Later-stage discovery involves:
- A.
Discovering lead compounds at a later stage.
- B.
Optimization of a set of molecules that appear to influence the target.
- C.
Optimization of a target that shows promise.
- D.
Discovering a secondary useage of a set of molecules/compounds during the optimization period.
- 14.Why do target profiles often get revised?
- A.
In the event a secondary indication is discovered, it is necessary for the target profile to take into account the new usage.
- B.
As time goes by, more data becomes available and it is necessary to revise the target profile to align with the new data.
- C.
Because researchers realize that they were wrong in the first place.
- D.
Side effects often occur in the discovery testing phase and it becomes evident that the drug is not an ideal candidate for a lead compound.
- 15.Why might a company elect not to continue to the development phase with a promising compound?
- A.
Because it didnt reserve the patent in time so it would be a waste of money to develop the compound.
- B.
Because the side effects outweight the benefits.
- C.
Because it would be too expensive to develop the compound to a useable formulation.
- D.
Because it does not align with the strategic goals of the company; and it becomes an outlicensing candidate.
- 16.Lead optimization is:
- A.
The selection of the candidate with the most potential from the lead series/selecting a lead series out of a number of different compounds
- B.
Optimizing the set of molecules/compound in order to indentify their potential.
- C.
The minor modifications made to a team of sled dogs when a new team takes the lead at the Iditarod.
- 17.Why do Marketing and Discovery work so closely together?
- A.
To develop marketing strategies based on the lead series the Discovery team has synthesized.
- B.
To develop lead compounds that are based on the strategic goals of the company.
- C.
To maintain a strong and clear messaging from discovery through to production.
- D.
Come on, Beckett, they don't work closely together at all. Stop trying to trick me.
- 18.What is typically the primary research focus of R&D scientists?
- A.
There is no focus, they're out to discover anything and everything.
- B.
Focus is based on commercial imperative or a commitment to leveraging previously acquired intel.
- C.
The focus is based on establishing generic bioequivalence.
- D.
The primary focus is on the therapeutic area in which the pharma company competes.
- 19.At what point does the Discovery group apply for a patent?
- A.
On day 1.
- B.
When the lead compound(s) is/are identified.
- C.
When the compound(s) begin/s to show promise
- D.
When the full spectrum analysis con the compound/s has been conducted
- 20.What is pharmacogenomics?
- A.
The study of gnomes involved with the illicit drug trade.
- B.
The study of the pharmacology of genes.
- C.
The study of the influence a cocktail of drugs on the entire genomic structure
- D.
The study of genes and their relationship to drug action
- 21.Lead optimization includes all BUT:
- A.
Testing of preliminary safety
- B.
Pharmacology
- C.
Pharmacokinetics
- D.
Pharmacodynamics
- E.
In vitro and in vivo testing
- 22.Once the target is identified, the ideal target product profile:
- A.
Has both a high efficacy and level of side effects
- B.
Optimally will combine high efficacy with a more favorable side effect profile
- C.
Does not need to take into account the level of side effects if the condition is less serious
- D.
Is a trade off between safety and efficacy.
- 23.True or False: Companies to not typically patent supporting research or manufacturing technologies.
- A.
True
- B.
False
- 24.If you are a BDM, please describe in a short paragraph how you would use the information you learned in this chapter in a sales meeting. What key concepts would you use to sell M Squared?If you are a CSM, please describe how you would use the information learned in this chapter to identify a good consultant and pitch the opportunity to them.If you are in Operations, you already do enough hard work. Please write "I am Operations. Hear me roar".
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