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Drug Commercialization Coursera Quiz Answer
Pharmacoeconomics in Drug Development Quiz
1. Which is an appropriate outcome for a Cost Utility study?
- Quality of adjusted life years
- Duration of an illness
- Natural units
- Equal outcomes
2. Which of the following is not a type of pharmacoeconomic analysis?
- Cost effectiveness
- Cost usefulness
- Cost minimization
- Cost benefit
3. 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.
4. In which quadrant are you most likely to see pharmacoeconomic analyses done?
5. In countries where it is require, failing to submit your pharmacoeconomic guidelines may allow you to be __________, but not _____________.
- approved, reimbursed
- reimbursed, approved
6. Which three were listed as types of outcomes one can consider for pharmacoeconomic analyses?
7. Which are examples of indirect economic costs? (choose 2)
- nursing time
- lost productivity of provider
- lost productivity of patient
Intellectual Property Strategy & BioSimilars Quiz
1. Which of the following applies to the America Invents Act?
- Legalize generic competition for a drug
- Patent applications to a “first to invent”
- Patent applications to a “first to file”
- University grants nonexclusive license to government
2. 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
3. All of the following are challenges to biosimilar drug development in the United States EXCEPT?
- Violation of intellectual property rights
- Concern for public safety
- Lack of company interest
- Novel regulatory framework
4. Which of these does the FDA NOT regulate?
5. Which of these was named as being the “best” pharmaceutical patent you can get?
- Formulation patent
- Product by Process Patent
- Process Patent
- Composition of Matter Patent
6. What does a “method of use” patent allow you do?
- Protect use of drug for other specific diseases (than the primary use)
- Protect the chemical process for development
- Protect the various different delivery mechanisms
Marketing Pharmaceuticals & Biotechnology Drugs Quiz
1. All of the following are common violations of prescription drug advertising EXCEPT:
- Misleading drug comparison
- Promoting off label or unapproved use
- Overstating the effectiveness
- Only include information supported by clinical trials
2. The new marketing models need to focus on:
- Pharmacoeconomic Outcome trials before, during and after launch Only include information supported by clinical trials
- Profiling patients, payers, physicians, and government
- Exclusive concentration of drug attributes
- Convenience on the customer’s time
3. Addressing payors effectively include all of the following EXCEPT:
- Understanding the funding flows for the disease area
- Less investment in outcome trials
- Identify the decision makers controlling funds
- Adapting product development based on decision making criteria
4. Why do drugs never get launched in Portugal or France first?
- Because they have the lowest pricing
- Because marketing is very complex
- Because they are very small markets
5. These characteristics define which kind of market:
generics minimally differentiated other than by price
payers have great stake in prescribing conditions
6. Recently we’ve seen a shift in focus for the market (in the US) from ________ to ___________
- specialists, general practitioners
- general practitioners, specialists
7. In the US generics represent a large percentage of overall prescriptions. What percentage of overall dollar spent do they represent?
- About half
Managed Markets and Sales Strategy Quiz
1. All of the following are appropriate sales targeting factors for identifying key physician targets EXCEPT:
- Relationship with company
- Accessibility of the drug
- Colleague influence
- Payment to prescribers
2. Tier 1 formulary coverage applies to which of the following?
- Biologics & Specialty Medications
- Preferred Brand Name Pharmaceuticals
- Non preferred Brand Name Pharmaceuticals
3. Which of the following is NOT considered a relevant product value proposition?
- Approval of a “me-too” drug
- Oral route of drug administration
- Favorable safety profile
- Demonstration of cost effectiveness
4. 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
5. 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?
Strategic Alliance & M+A in Pharma, Biotech & Academia
1. What are biodollars?
- The currency of a deal between pharma and biotech
- The currency of a deal between industry and pharma or biotech
- The total dollar value of a deal if all milestones are met
2. True or False: Since 2010 the number and overall monetary value of deals in the pharmaceutical arena have been increasing.
3. The models of university/industry collaboration described were: (choose 4)
- minilabs bio cluster
- fee-for-service agreement
- unrestricted research support & master agreement
- research relationship with single investigator
- swap alliances
4. Recently, what percent of revenue of big pharma companies came from drugs developed elsewhere (e.g. not directly from that company)?
5. Dr. Ettouati identified what as the most important key to successful alliances?
- Alignment of goals
- Agreed upon termination plan
- Chemistry between people involved
- Determination of scope of collaboration
1. The three types of business models covered in the lecture were which?
- Over the Counter
2. True or False: A company would likely choose to follow a single business model.
3. LOE stands for
- Loss of exclusivity
- Level of effort
- Licensing of effectiveness
4. 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
5. The three options mentioned for refueling the pipeline are:
- Company Acquisition
- Generic Development
- In-House R&D
6. True or False: NPV includes both past and future costs
7. What are three things mentioned that need to be considered in addition to NPV?
- Innovator market valuation
- Balancing of portfolio between early and late-stage projects
- Commercial risk (how accurate are sales forecasts)
- Company strategic fit
Academic Industry partnership “Various models, Various outcomes” Quiz
1. Collaborations with pharma and academics require agreement on the following?
- Ownership of intellectual property
- All stated responses are correct
2. All of the following are common models used between academics and industry EXCEPT
- Mergers and acquisitions
- Research support
- Fee for service
- Expert key opinion leader relationship
3. All of the following are key factors for successful collaboration between academics and industry EXCEPT:
- Undefined project termination guidelines
- Reasonable timelines and deliverables
- Communication between both parties
- Well defined research plan
From Start up to Success in Biotech Quiz
1. Which of the following would not be an ideal financing option for a new drug discovery, biotech company?
- “Angel’ investors
- Crowd sourcing from general public
- Venture capital investors
- Reverse merger into a public shell
2. All of the following are key factors of developing a success biotech company EXCEPT?
- Good scientific and management team
- Strong intellectual property portfolio
- Large infrastructure and extensive workforce
- Sufficient assess to capital
3. Which of the following has the LOWEST transition probability between phases of drug development?
- New Drug Application Submission to Approval
- Phase 1 to 2
- Phase 2 to 3
- Phase 3 to New Drug Application Submission
4. What percent of discovery compounds make it to phase 1 trials?
- About 20%
- About 40%
- About 60%
5. Which were some of the key lessons learned in the startup to success story? (choose 3)
- Be focussed & move quickly
- Look carefully for new technologies
- Being scientifically curious pays off
- Focus on targets with high phase 3 success rates
- Build a strong commercial story
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