Drug Commercialization Coursera Quiz Answers

All Weeks Drug Commercialization Coursera Quiz Answers

Drug Commercialization Week 01 Quiz Answers

Pharmacoeconomics in Drug Development Quiz Answers

Q1. Which is an appropriate outcome for a Cost Utility study?

• Quality of adjusted life years
• Natural units
• Equal outcomes
• Duration of an illness

Q2. Which of the following is not a type of pharmacoeconomic analysis?

• Cost effectiveness
• Cost minimization
• Cost usefulness
• Cost benefit

Q3. TRUE/FALSE Question. Intervention Q with a benefit/cost ratio of 1.5 offers more value for money spent on an intervention than intervention R which has a 0.6 benefit/cost ratio.

• True
• False

Q4. In which quadrant are you most likely to see pharmacoeconomic analyses done?

• Top-left
• Bottom-right
• Top-right
• Bottom-left

Q5. In countries where it is require, failing to submit your pharmacoeconomic guidelines may allow you to be __________, but not _____________.

• reimbursed, approved
• approved, reimbursed

Q6. Which three were listed as types of outcomes one can consider for pharmacoeconomic analyses?

• humanistic
• clinical
• comparator
• indirect
• economic

Q7. Which are examples of indirect economic costs? (choose 2)

• lost productivity of provider
• transportation
• lost productivity of patient
• nursing time
• hospitalization

Intellectual Property Strategy & BioSimilars Quiz Answers

Q1. Which of the following applies to the America Invents Act?

• University grants nonexclusive license to government
• Patent applications to a “first to file”
• Legalize generic competition for a drug
• Patent applications to a “first to invent”

Q2. The “pay for delay” process has been applied to all of the following EXCEPT?

• Maintaining market monopoly
• Delaying generic alternative to enter the market
• Application to prescription drug user fee
• Maximizing possible sales of the brand-name drug

Q3. All of the following are challenges to biosimilar drug development in the United States EXCEPT?

• Lack of company interest
• Violation of intellectual property rights
• Concern for public safety
• Novel regulatory framework

Q4. Which of these does the FDA NOT regulate?

• pricing
• efficacy
• safety

Q5. Which of these was named as being the “best” pharmaceutical patent you can get?

• Formulation patent
• Product by Process Patent
• Composition of Matter Patent
• Process Patent

Q6. What does a “method of use” patent allow you do?

• Protect the chemical process for development
• Protect use of drug for other specific diseases (than the primary use)
• Protect the various different delivery mechanisms

Drug Commercialization Week 02 Quiz Answers

Marketing Pharmaceuticals & Biotechnology Drugs Quiz Answers

Q1. All of the following are common violations of prescription drug advertising EXCEPT:

• Only include information supported by clinical trials
• Promoting off label or unapproved use
• Overstating the effectiveness
• Misleading drug comparison

Q2. The new marketing models need to focus on:

• Exclusive concentration of drug attributes
• Profiling patients, payers, physicians, and government
• Convenience on the customer’s time
• Pharmacoeconomic Outcome trials before, during and after launch Only include information supported by clinical trials

Q3. Addressing payors effectively include all of the following EXCEPT:

• Less investment in outcome trials
• Adapting product development based on decision making criteria
• Identify the decision makers controlling funds
• Understanding the funding flows for the disease area

Q4. Why do drugs never get launched in Portugal or France first?

• Because they are very small markets
• Because they have the lowest pricing
• Because marketing is very complex

Q5. These characteristics define which kind of market:

• generics minimally differentiated other than by price
• payers have great stake in prescribing conditions

• Commodity
• Differentiated

Q6. Recently we’ve seen a shift in focus for the market (in the US) from ________ to ___________

• specialists, general practitioners
• general practitioners, specialists

Q7. In the US generics represent a large percentage of overall prescriptions. What percentage of overall dollar spent do they represent?

• Large
• About half
• Low

Managed Markets and Sales Strategy Quiz Answers

Q1. All of the following are appropriate sales targeting factors for identifying key physician targets EXCEPT:

• Payment to prescribers
• Relationship with company
• Colleague influence
• Accessibility of the drug

Q2. Tier 1 formulary coverage applies to which of the following?

• Non preferred Brand Name Pharmaceuticals
• Preferred Brand Name Pharmaceuticals
• Biologics & Specialty Medications
• Generics

Q3. Which of the following is NOT considered a relevant product value proposition?

• Demonstration of cost effectiveness
• Oral route of drug administration
• Approval of a “me-too” drug
• Favorable safety profile

Q4. Medicare was mentioned as the largest growing segment of the pharmaceutical market in the US. In 2010, there were 46 million people enrolled in Medicare. What was the estimate for 2013?

• ~50 million
• ~60 million
• ~80 million
• ~100 million

Q5. True of False: IN the 2010-2011 timeframe in the US, the % increase in prescription drug spending has higher than that of overall healthcare spending?

• False
• True

Drug Commercialization Week 03 Quiz Answers

Strategic Alliance & M+A in Pharma, Biotech & Academia Answers

Q1. What are biodollars?

• The currency of a deal between industry and pharma or biotech
• The currency of a deal between pharma and biotech
• The total dollar value of a deal if all milestones are met

Q2. True or False: Since 2010 the number and overall monetary value of deals in the pharmaceutical arena have been increasing.

• True
• False

Q3. The models of university/industry collaboration described were: (choose 4)

• fee-for-service agreement
• unrestricted research support & master agreement
• sub-licensing
• swap alliances
• research relationship with single investigator
• minilabs bio cluster

Q4. Recently, what percent of revenue of big pharma companies came from drugs developed elsewhere (e.g. not directly from that company)?

• 10%
• 20%
• 50%
• 70%
• 90%

Q5. Dr. Ettouati identified what as the most important key to successful alliances?

• Chemistry between people involved
• Agreed upon termination plan
• Determination of scope of collaboration
• Alignment of goals

Quiz Answers

Q1. The three types of business models covered in the lecture were which?

• Generic
• Over the Counter
• Innovator
• High-risk
• Low-risk

Q2. True or False: A company would likely choose to follow a single business model.

• True
• False

Q3. LOE stands for

• Loss of exclusivity
• Level of effort
• Licensing of effectiveness

Q4. Why is it important for companies to invest in both early and late-stage projects? (choose 2)

• to engage with different markets
• to manage risk
• to manage revenue pipeline

Q5. The three options mentioned for refueling the pipeline are:

• In-Licensing
• Generic Development
• Company Acquisition
• In-House R&D

Q6. True or False: NPV includes both past and future costs

• True
• False

Q7. What are three things mentioned that need to be considered in addition to NPV?

• Innovator market valuation
• Company strategic fit
• Balancing of portfolio between early and late-stage projects
• Commercial risk (how accurate are sales forecasts)

Drug Commercialization Week 04 Quiz Answers

Academic Industry partnership “Various models, Various outcomes” Quiz Answers

Q1. Collaborations with pharma and academics require agreement on the following?

• Ownership of intellectual property
• All stated responses are correct
• Budget
• Deadlines

Q2. All of the following are common models used between academics and industry EXCEPT

• Mergers and acquisitions
• Fee for service
• Research support
• Expert key opinion leader relationship

Q3. All of the following are key factors for successful collaboration between academics and industry EXCEPT:

• Well defined research plan
• Undefined project termination guidelines
• Communication between both parties
• Reasonable timelines and deliverables

From Start up to Success in Biotech Quiz Answers

Q1. Which of the following would not be an ideal financing option for a new drug discovery, biotech company?

• Venture capital investors
• Reverse merger into a public shell
• “Angel’ investors
• Crowd sourcing from general public

Q2. All of the following are key factors of developing a success biotech company EXCEPT?

• Sufficient assess to capital
• Large infrastructure and extensive workforce
• Strong intellectual property portfolio
• Good scientific and management team

Q3. Which of the following has the LOWEST transition probability between phases of drug development?

• Phase 1 to 2
• New Drug Application Submission to Approval
• Phase 3 to New Drug Application Submission
• Phase 2 to 3

Q4. What percent of discovery compounds make it to phase 1 trials?

• <10%
• About 20%
• About 40%
• About 60%

Q5. Which were some of the key lessons learned in the startup to success story? (choose 3)

• Look carefully for new technologies
• Be focussed & move quickly
• Being scientifically curious pays off
• Build a strong commercial story
• Focus on targets with high phase 3 success rates

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