BPS 2110 QUESTIONS WITH VERIFIED ANSWERS
What are drugs? - Answers - chemical substances used in the treatment, prevention or diagnosis of
disease
What are the different categories of drugs? - Answers - biologics & small molecules
How are biologics manufactured? - Answers - using living organisms
How are small molecules manufactured? - Answers - primarily through chemical synthesis
The pharmaceutical industry is one of the most highly _____ sectors. - Answers - regulated
The pharmaceutical industry is research-_____ & high _____. - Answers - intensive, risk
What are "ethical" innovator pharmaceutical companies and what do they do? - Answers - companies that
invest heavily in research - discover and develop new molecular entities
What are 3 examples of "ethical" innovator pharmaceutical companies? - Answers - Merck, Pfizer,
Astrazeneca
What are generic pharmaceutical companies? - Answers - companies that do limited research - they enter
the market after patent expiry or through patent challenges
What are 3 examples of generic pharmaceutical companies? - Answers - Teva, Sandoz, Apotex
What are biotech companies? - Answers - companies that exploit academic discoveries - heavy
investment in research
What are 3 examples of biotech companies? - Answers - Moderna, Amgen, BioNTech
What are contract research organizations (CROs)? - Answers - companies that provide specialized
services for the pharmaceutical industry
What specialized services do CROs provide for the pharmaceutical industry? - Answers - biological
testing, specialty chemical synthesis, specialty manufacturing, conduct clinical trials
What are 3 examples of CROs? - Answers - Paraza Pharma, Altasciences, Covance
What data does the Compendium of Pharmaceuticals and Specialties contain? - Answers - data on
molecular entities
What is a molecular entity? - Answers - pure active ingredient
What is a product? - Answers - formulation that contains the molecular entity
What is the total R&D spending per year? How much on biologics? Small molecules? - Answers - >$50
billion
40%
60%
, What is the typical drug project progression? - Answers - 1. Idea/target identification
2. Discovery
3. Preclinical development (research)
4. Clinical development (trials)
5. Market and post-market
On average, how long does a NME take? - Answers - 12 years
How many years of research does it take to identify a drug candidate? - Answers - 1-3
What is an Investigational New Drug (IND)? - Answers - First regulatory checkpoint - application to the
FDA for clinical trial approval
What does an IND include? - Answers - pharmacology and toxicity data in animals, information on the
manufacturing process, & clinical protocols and investigator info
What is a New Drug Application (NDA)? - Answers - application to the FDA for market approval
What is included in an NDA? - Answers - safety of the drug, efficacy of the drug, appropriate labelling, &
manufacturing methods
What is an Abbreviated New Drug Application (ANDA)? - Answers - application submitted for FDA
approval for the generic drug to enter the market
What is included in the project initiation of drug discovery? - Answers - market analysis, competitive
assessment, & research analysis
What is researched during market analysis? - Answers - number and type of potential customers, nature
of the disease, & current treatments
What type of conditions do top selling drugs target? - Answers - chronic
What is researched during competitive assessment? - Answers - what competitors are doing, timing of
market entry/profitability (1st makes most revenue), & advantages and disadvantages
What questions are asked in a feasibility study? - Answers - 1. is the disease well understood?
2. is the mechanism of the disease understood?
3. are biochemical tools available?
4. are there existing drugs?
What is researched in biochemical studies? - Answers - proof of principle, drug testing methods,
development of animal models
What methods are used to identify leads in drug discovery? - Answers - High-Throughput Screening,
natural products, rational drug design, combinatorial chemistry, de-novo design
What is High-Throughput Screening (HTS)? - Answers - Random testing for activity on a massive scale
How many compounds do typical libraries contain? - Answers - >500,000
What do compound collections include? - Answers - every compound that was ever made in the
company, compounds purchased from academic labs, and natural products
Why is it important to test a variety of compounds? - Answers - increases the chance of finding hits &
compounds in the same family will likely behave similarly, making it harder to get hits
What are drugs? - Answers - chemical substances used in the treatment, prevention or diagnosis of
disease
What are the different categories of drugs? - Answers - biologics & small molecules
How are biologics manufactured? - Answers - using living organisms
How are small molecules manufactured? - Answers - primarily through chemical synthesis
The pharmaceutical industry is one of the most highly _____ sectors. - Answers - regulated
The pharmaceutical industry is research-_____ & high _____. - Answers - intensive, risk
What are "ethical" innovator pharmaceutical companies and what do they do? - Answers - companies that
invest heavily in research - discover and develop new molecular entities
What are 3 examples of "ethical" innovator pharmaceutical companies? - Answers - Merck, Pfizer,
Astrazeneca
What are generic pharmaceutical companies? - Answers - companies that do limited research - they enter
the market after patent expiry or through patent challenges
What are 3 examples of generic pharmaceutical companies? - Answers - Teva, Sandoz, Apotex
What are biotech companies? - Answers - companies that exploit academic discoveries - heavy
investment in research
What are 3 examples of biotech companies? - Answers - Moderna, Amgen, BioNTech
What are contract research organizations (CROs)? - Answers - companies that provide specialized
services for the pharmaceutical industry
What specialized services do CROs provide for the pharmaceutical industry? - Answers - biological
testing, specialty chemical synthesis, specialty manufacturing, conduct clinical trials
What are 3 examples of CROs? - Answers - Paraza Pharma, Altasciences, Covance
What data does the Compendium of Pharmaceuticals and Specialties contain? - Answers - data on
molecular entities
What is a molecular entity? - Answers - pure active ingredient
What is a product? - Answers - formulation that contains the molecular entity
What is the total R&D spending per year? How much on biologics? Small molecules? - Answers - >$50
billion
40%
60%
, What is the typical drug project progression? - Answers - 1. Idea/target identification
2. Discovery
3. Preclinical development (research)
4. Clinical development (trials)
5. Market and post-market
On average, how long does a NME take? - Answers - 12 years
How many years of research does it take to identify a drug candidate? - Answers - 1-3
What is an Investigational New Drug (IND)? - Answers - First regulatory checkpoint - application to the
FDA for clinical trial approval
What does an IND include? - Answers - pharmacology and toxicity data in animals, information on the
manufacturing process, & clinical protocols and investigator info
What is a New Drug Application (NDA)? - Answers - application to the FDA for market approval
What is included in an NDA? - Answers - safety of the drug, efficacy of the drug, appropriate labelling, &
manufacturing methods
What is an Abbreviated New Drug Application (ANDA)? - Answers - application submitted for FDA
approval for the generic drug to enter the market
What is included in the project initiation of drug discovery? - Answers - market analysis, competitive
assessment, & research analysis
What is researched during market analysis? - Answers - number and type of potential customers, nature
of the disease, & current treatments
What type of conditions do top selling drugs target? - Answers - chronic
What is researched during competitive assessment? - Answers - what competitors are doing, timing of
market entry/profitability (1st makes most revenue), & advantages and disadvantages
What questions are asked in a feasibility study? - Answers - 1. is the disease well understood?
2. is the mechanism of the disease understood?
3. are biochemical tools available?
4. are there existing drugs?
What is researched in biochemical studies? - Answers - proof of principle, drug testing methods,
development of animal models
What methods are used to identify leads in drug discovery? - Answers - High-Throughput Screening,
natural products, rational drug design, combinatorial chemistry, de-novo design
What is High-Throughput Screening (HTS)? - Answers - Random testing for activity on a massive scale
How many compounds do typical libraries contain? - Answers - >500,000
What do compound collections include? - Answers - every compound that was ever made in the
company, compounds purchased from academic labs, and natural products
Why is it important to test a variety of compounds? - Answers - increases the chance of finding hits &
compounds in the same family will likely behave similarly, making it harder to get hits
