Commercialization Flashcards
NEXAVAR Target label indication statement guided the planning of Phase 3 for registration
True
NEXAVAR’s target Product Profile (TPP) is a key document summarizing NEXAVAR’s critical scientific, medical, regulatory and commerical success criteria
True
How is the drug commercialization stage defined (start -> end)?
1st regulatory approval -> patent expiration
Which of the following metrics is NOT a key commercial metric?
Time to IND submission
What Program Management parameters are used to analyze drug commercialization programs, and make them comparable to each other for decision-making?
- Scope
- Time
- Costs & resources
- Risks & uncertainties
What combination of IP types is most evident (mostly used) in the R&D-based biosciences industry?
Patents and Trademarks
Which of the following commercialization activities are short-term, and are mostly realized suring the introduction phase of drug commercialization?
Post-approval commitments
NEXAVAR initial regulatory approval was based on how many clinical studies?
One Phase 2 & one Phase 3 study
What is the main objective of the drug commercialization stage?
Maximize overall profitability of the marketed drug
What is not the role of Program Management in the Commercialization stage?
Setting & deciding on commercial objectives incl. sales and growth targets
What are the key characteristics of patentability applied in the biosciences industry?
- Novelty
- Usefulness
- Non-obviousness
- Adequately described to public @ filing
Which of the following combinations of commercialization activities describes critical trade-off decisions which need to be made during the growth phase of drug commercialization
Increase global sales & revenue AND reduce product & process-related costs
Activities to reduce drug product- and process related (operational) costs are best organized as programs?
True
Which life cycle management program to increase drug sales, revenue and market share has the highest level of success?
Geographical expansion of drug in approved clinical indication
What is most likely NOT considered by drug companies once they decide on a drug price?
post-approval capital investments
What is the time span between the beginning of development to the end of commercialization?
20 years
What is the overall goal of drug commercialization?
Maximize profitability of approved drug
Key commercial metrics
Time of 1st market introduction
% sales growth
Profit breakeven
Time-to-peak
Major commercialization milestones
- Regulatory approval (NDA, BLA, MAA, JNDA)
- First launch in major geography
- Regulatory submissions: Emerging Markets
- Regulatory approvals in emerging markets
- Annual % sales growth targets achieved
- Global peak revenues achieved
- First Patent Expiration in Major Geography
4 measures to maximize profitability
Fulfill post-approval commitments
Increase global sales & revenue
Reduce product costs & operational costs
Extend patent protection
PSP
Stands for Commercial Product Strategic Plan
- Defined at EOP2 and prior to P3 registration studies
- Defined key commercial metrics
IP
Intellectual Property
Different types: Patents, Trademarks, Copyright, Trade Secrets
IP has value only if:
underlying work is being developed & commercialized
Patents
Protect ideas, discoveries, inventions, methods, data, designs, or practical implementations of algorithms