Does Personalized Medicine Fit? | Diaceutics

Does Personalized Medicine Fit?


This case study is based on a patent-applied-for technique that generates, for a given drug, a numerical index relating to various aspects of suitability for a personalized (test-based) marketing strategy. This index is then compared to values derived both from drugs which are currently marketed using a personalized strategy and those that are not, to indicate whether the drug in question may benefit from a personalized marketing strategy. It will help you understand:
  • How companion diagnostic strategies can help to competitively reshape therapy markets.
  • The way one-size-fits-all therapies compete with targeted therapies in the marketplace under unanticipated rules.
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1: Case Summary

This case will help you understand:

How companion diagnostic strategies can help to competitively reshape therapy markets.

The way one-size-fits-all therapies compete with targeted therapies in the marketplace under unanticipated rules.

Key messages:

Research of analogous therapy markets suggests that associated companion diagnostic strategies can also serve to competitively reshape overall therapy areas.

Oncology, infectious disease and cardiovascular markets are at various stages of a shift towards therapy targeting. Targeted therapies will eventually be competing against each other for similar, disparate or overlapping niche markets.

Key actions:

Understand where and how personalized medicine provides opportunities to reshape the therapy market.

Revise and standardise Dx planning and strategy development.

Consider using the Options for Test index (OFTi) to provide a standardized and rapid way to assess a personalized medicine fit across a therapy pipeline.

2: When Does Personalized Medicine Fit?

So What?

Research of analogous therapy markets suggests that associated companion diagnostic strategies can also serve to competitively reshape overall therapy areas.

Oncology, infectious disease and cardiovascular markets are at various stages of a shift towards therapy targeting. Targeted therapies will eventually be competing against each other for similar, disparate or overlapping niche markets.

Commentary

To date, personalized medicine strategies have typically only been implemented in scenarios where identification of a specific biomarker association to ensure efficacy or avoid adverse events is proved out during Phase 2/3 clinical studies to justify development of a companion diagnostic, along with a therapy, in anticipation of launch.


A direct example of this view is that a team may launch a one-size-fits-all therapy into a market to compete against a targeted therapy, without the tools to consider this changed market and its unanticipated rules.

3: Benefits of a More Structured Process

So What?

By formalising the scope of the personalized medicine lens through which therapy strategies are considered, pharma will be better able to interrogate the pipeline in a standardized routine way.

Commentary

Ideally, development teams throughout the life cycle of any therapy, either targeted or one-size-fits-all, should be able to interrogate their therapy area in a structured way to ask, “Under what circumstances do I consider whether this therapy should follow a targeted or a one-size-fits-all commercialization strategy.” Realistically, this interrogation is only useful if it can be undertaken within the relevant time horizon to potentially allow the development or repositioning of a diagnostic with the therapy.

4: Validated Approach

So What?

A validated worktool can be used to help interrogate the therapy pipeline.

Commentary

Diaceutics developed the Options for Test index (OFTi) to provide a standardized and rapid way to assess a personalized medicine fit across a therapy pipeline.  It uses case-based reasoning of 39 therapies to determine the most critical choice factors influencing a fit/non fit with a personalized medicine strategy.

OFTi combines a quantitative algorithm with a stepped process creating a decision analysis support tool for pharmaceutical R&D teams wishing to standardize and record the genesis of their investments in personalized healthcare.

Running the OFTi support tool results in a final cumulative weighted ratio used to compare the team’s therapy against other drugs in the therapy area to date, both targeted and one-size-fits-all. This allows the team to benchmark its therapy against known and possible competitors to assess the potential and competitive advantage of proceeding as a one-size-fits-all or a targeted therapy.

5: Key Messages

Key messages:

Research of analogous therapy markets suggests that associated companion diagnostic strategies can also serve to competitively reshape overall therapy areas.

Oncology, infectious disease and cardiovascular markets are at various stages of a shift towards therapy targeting. Targeted therapies will eventually be competing against each other for similar, disparate or overlapping niche markets.

Key actions:

Understand where and how personalized medicine provides opportunities to reshape the therapy market.

Revise and standardise Dx planning and strategy development.

Consider using the Options for Test index (OFTi) to provide a standardized and rapid way to assess a personalized medicine fit across a therapy pipeline.

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