Commercialization Flashcards Preview

Drug Discovery > Commercialization > Flashcards

Flashcards in Commercialization Deck (41):
1

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

True

2

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

True

3

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

1st regulatory approval -> patent expiration

4

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

Time to IND submission

5

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

6

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

Patents and Trademarks

7

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

Post-approval commitments

8

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

One Phase 2 & one Phase 3 study

9

What is the main objective of the drug commercialization stage?

Maximize overall profitability of the marketed drug

10

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

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

11

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

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

12

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

13

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

 

True

14

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

15

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

post-approval capital investments

16

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

20 years

17

What is the overall goal of drug commercialization?

Maximize profitability of approved drug

18

Key commercial metrics

Time of 1st market introduction

% sales growth

Profit breakeven

Time-to-peak

19

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

20

4 measures to maximize profitability

Fulfill post-approval commitments

Increase global sales & revenue

Reduce product costs & operational costs

Extend patent protection

21

PSP

Stands for Commercial Product Strategic Plan

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

22

IP

Intellectual Property

Different types: Patents, Trademarks, Copyright, Trade Secrets

23

IP has value only if:

underlying work is being developed & commercialized

24

Patents

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

25

Copyrights

Authors and artists

Concerned with unique artistic expression

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

26

Trade secrets

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

27

Trademarks

Brand names, logos used in commerce identifying origin of goods

NEXAVAR

HUCAL

28

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

29

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

30

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

31

What are programs in drug commercialization?

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

32

Differentiation

  • What drug product features?
  • What drug features are critical?
  • What drug features do customers want?

33

Competition

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

34

Gloacl marketing is responsible for:

Sales & market share growth

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

35

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

36

Marketing in drug development

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

37

Marketing in Drug Commercialization

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

38

Patent expirations:

 

Revenue losses due to key patent expirations

39

Generic Process is mainly -

CMC: 3-6 years, $4m

40

RITUXAN Biosimilar

REDITUX

41