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
Copyrights
Authors and artists
Concerned with unique artistic expression
Provides right to reproduce, perform, distribute,, display, make derivative work
Trade secrets
protected know-how & information with economic vale only if kept secret
Trademarks
Brand names, logos used in commerce identifying origin of goods
NEXAVAR
HUCAL
What does the Project Manager own?
The process to achieve business results
- Planning, organizing, directing and controlling of company resources (people, $, infrastructure, assets) for a project that has been established to achieve specific corporate business objectives
What’s a project?
- Specific objective (tied to business goals)
- Completed within defined specification
- Defined starting and finishing dates
- Constrained by limited resources & funding
- Consumes resources (people, $, infrastructure
- Performed by people
What’s a program?
- Specific objective (tied to business goals)
- Completed within defined specification
- Defined starting and finish dates
- Constrained by limited resources & funding
- Consumes resources (people, $, infrastructure)
- Performed by people
What are programs in drug commercialization?
- Post-approval commitments
- Global sales & revenue growth
- Product cost reductions
- Operational cost reductions
- Patent protection & extension
Differentiation
- What drug product features?
- What drug features are critical?
- What drug features do customers want?
Competition
- What competing drugs on the market?
- What drug features do these have?
- Are these what customers want?
Gloacl marketing is responsible for:
Sales & market share growth
- Fulfill post-approval commitments
- Increase global sales& revenue
- Reduce product & operational costs
- Extend patent protection
Marketing in Drug Discovery
- Drug Candidate features & attributes
- Market Research on features & attributes
- Indication, markets, market segments, target customers, reimbursement potential
- Commercial $ value: drug candidate
Marketing in drug development
- Drug Candidate features & attributes
- Detailed Market Research
- Detailed: Indication, market segments, target customers, pricing & reimbursement
- Commercial $ value: Drug label claims
Marketing in Drug Commercialization
- Commercial Product Strategic Plan (PSP)
- Drug Product Life Cycle Management
- Increase sales, revenue, and market share
Patent expirations:
Revenue losses due to key patent expirations
Generic Process is mainly -
CMC: 3-6 years, $4m
RITUXAN Biosimilar
REDITUX
