All Weeks Drug Commercialization Coursera Quiz Answers
The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Commercialization course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug commercialization.
This course will cover pharmacoeconomic, marketing strategy, intellectual property strategy, portfolio management, managed markets and strategic alliances. It will also have a lecture case study from startup to success.
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.
Q4. In which quadrant are you most likely to see pharmacoeconomic analyses done?
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?
Q7. Which are examples of indirect economic costs? (choose 2)
- lost productivity of provider
- lost productivity of patient
- nursing time
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?
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
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?
- About half
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
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?
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.
Q3. The models of university/industry collaboration described were: (choose 4)
- fee-for-service agreement
- unrestricted research support & master agreement
- 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)?
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
Q1. The three types of business models covered in the lecture were which?
- Over the Counter
Q2. True or False: A company would likely choose to follow a single business model.
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:
- Generic Development
- Company Acquisition
- In-House R&D
Q6. True or False: NPV includes both past and future costs
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
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?
- 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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