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Drug Discovery > Commercialization > Flashcards

Commercialization Flashcards

1
Q

NEXAVAR Target label indication statement guided the planning of Phase 3 for registration

A

True

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2
Q

NEXAVAR’s target Product Profile (TPP) is a key document summarizing NEXAVAR’s critical scientific, medical, regulatory and commerical success criteria

A

True

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3
Q

How is the drug commercialization stage defined (start -> end)?

A

1st regulatory approval -> patent expiration

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4
Q

Which of the following metrics is NOT a key commercial metric?

A

Time to IND submission

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5
Q

What Program Management parameters are used to analyze drug commercialization programs, and make them comparable to each other for decision-making?

A
  • Scope
  • Time
  • Costs & resources
  • Risks & uncertainties
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6
Q

What combination of IP types is most evident (mostly used) in the R&D-based biosciences industry?

A

Patents and Trademarks

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7
Q

Which of the following commercialization activities are short-term, and are mostly realized suring the introduction phase of drug commercialization?

A

Post-approval commitments

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8
Q

NEXAVAR initial regulatory approval was based on how many clinical studies?

A

One Phase 2 & one Phase 3 study

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9
Q

What is the main objective of the drug commercialization stage?

A

Maximize overall profitability of the marketed drug

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10
Q

What is not the role of Program Management in the Commercialization stage?

A

Setting & deciding on commercial objectives incl. sales and growth targets

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11
Q

What are the key characteristics of patentability applied in the biosciences industry?

A
  • Novelty
  • Usefulness
  • Non-obviousness
  • Adequately described to public @ filing
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12
Q

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

A

Increase global sales & revenue AND reduce product & process-related costs

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13
Q

Activities to reduce drug product- and process related (operational) costs are best organized as programs?

A

True

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14
Q

Which life cycle management program to increase drug sales, revenue and market share has the highest level of success?

A

Geographical expansion of drug in approved clinical indication

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15
Q

What is most likely NOT considered by drug companies once they decide on a drug price?

A

post-approval capital investments

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16
Q

What is the time span between the beginning of development to the end of commercialization?

A

20 years

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17
Q

What is the overall goal of drug commercialization?

A

Maximize profitability of approved drug

18
Q

Key commercial metrics

A

Time of 1st market introduction

% sales growth

Profit breakeven

Time-to-peak

19
Q

Major commercialization milestones

A
  • 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
20
Q

4 measures to maximize profitability

A

Fulfill post-approval commitments

Increase global sales & revenue

Reduce product costs & operational costs

Extend patent protection

21
Q

PSP

A

Stands for Commercial Product Strategic Plan

  • Defined at EOP2 and prior to P3 registration studies
  • Defined key commercial metrics
22
Q

IP

A

Intellectual Property

Different types: Patents, Trademarks, Copyright, Trade Secrets

23
Q

IP has value only if:

A

underlying work is being developed & commercialized

24
Q

Patents

A

Protect ideas, discoveries, inventions, methods, data, designs, or practical implementations of algorithms

25
Q

Copyrights

A

Authors and artists

Concerned with unique artistic expression

Provides right to reproduce, perform, distribute,, display, make derivative work

26
Q

Trade secrets

A

protected know-how & information with economic vale only if kept secret

27
Q

Trademarks

A

Brand names, logos used in commerce identifying origin of goods

NEXAVAR

HUCAL

28
Q

What does the Project Manager own?

A

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
29
Q

What’s a project?

A
  • 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
30
Q

What’s a program?

A
  • 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
31
Q

What are programs in drug commercialization?

A
  • Post-approval commitments
  • Global sales & revenue growth
  • Product cost reductions
  • Operational cost reductions
  • Patent protection & extension
32
Q

Differentiation

A
  • What drug product features?
  • What drug features are critical?
  • What drug features do customers want?
33
Q

Competition

A
  • What competing drugs on the market?
  • What drug features do these have?
  • Are these what customers want?
34
Q

Gloacl marketing is responsible for:

A

Sales & market share growth

  • Fulfill post-approval commitments
  • Increase global sales& revenue
  • Reduce product & operational costs
  • Extend patent protection
35
Q

Marketing in Drug Discovery

A
  • Drug Candidate features & attributes
  • Market Research on features & attributes
  • Indication, markets, market segments, target customers, reimbursement potential
  • Commercial $ value: drug candidate
36
Q

Marketing in drug development

A
  • Drug Candidate features & attributes
  • Detailed Market Research
  • Detailed: Indication, market segments, target customers, pricing & reimbursement
  • Commercial $ value: Drug label claims
37
Q

Marketing in Drug Commercialization

A
  • Commercial Product Strategic Plan (PSP)
  • Drug Product Life Cycle Management
  • Increase sales, revenue, and market share
38
Q

Patent expirations:

A

Revenue losses due to key patent expirations

39
Q

Generic Process is mainly -

A

CMC: 3-6 years, $4m

40
Q

RITUXAN Biosimilar

A

REDITUX

41
Q
A

Drug Discovery (3 decks)

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