Access over 400 key business questions you should consider when developing your diagnostic strategy

The aim of key business questions is to establish a robust checklist to ensure that therapy teams go through a comprehensive assessment of all the relevant parameters before making decisions about diagnostic strategies. You can access them below. Use the filters below to see the key business questions that are applicable to your sector, functional area and/or phase.

 

Sector
Functional Area
Phase
Results UserType FunctionalAreaType Phase
Can we benefit from a competitor’s efforts around Dx or Rx awareness, education, marketing and communications? Diagnostic Marketing Biomarker Discovery and Foundation Strategy
Can we benefit from a competitor’s efforts around Dx or Rx awareness, education, marketing and communications? Pharma Marketing Phase IIb Decision Point
Can we benefit from a competitor’s efforts around Dx or Rx awareness, education, marketing and communications? Pharma Marketing No Phase
Can we benefit from a competitor’s efforts around Dx or Rx awareness, education, marketing and communications? Pharma Marketing Pre Clinical
What additional claims for the Rx might be supported/effected by use of the Dx post-launch and is there opportunity for more optimal share through Dx intervention in Phase IV? Pharma Overview PhaseIV Market Use
How might a Dx strategy be used to change normal generic erosion curves and lifecycle revenues? Pharma Overview PhaseIV Market Use
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Overview PhaseIV Market Use
What additional claims for the Rx might be supported/effected by use of the Dx post-launch and is there opportunity for more optimal share through Dx intervention in Phase IV? Pharma Strategy PhaseIV Market Use
Can we tie Rx to Dx technology via IP? Pharma Adoption PhaseIV Market Use
How can clinical strategy support test adoption by providing hands-on use? Pharma Clinical PhaseIV Market Use
Are we actioning the KPIs we need that will help us to analyse, report back and optimize our marketing program for the Dx? Pharma Marketing PhaseIV Market Use
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Pharma Financial PhaseIV Market Use
What should the lab order form look like and can the laboratory electronically report the result back to the physician’s office? Pharma Laboratories PhaseIV Market Use
How might lab service help differentiate our Rx and improve market share? Pharma Laboratories PhaseIV Market Use
Have we built in expectations for a test lifecycle critical to market development? Pharma Laboratories PhaseIV Market Use
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Access PhaseIV Market Use
Are we ready to implement any post-marketing requirements for a Dx? Pharma Regulatory PhaseIV Market Use
Have we prepared for a potential Rx label change any time before, during or post-launch? Pharma Regulatory PhaseIV Market Use
What does the Dx business case look like? Diagnostic Partnering Biomarker Discovery and Foundation Strategy
How do we engage our partner? Diagnostic Partnering Biomarker Discovery and Foundation Strategy
Have we created a Product Specification Document (PSD) with enough detail for prospective partners to submit proposals? Diagnostic Partnering Biomarker Discovery and Foundation Strategy
Do we have an objective process for the selection of development and commercialization partner(s)? Diagnostic Partnering Biomarker Discovery and Foundation Strategy
When is the right time to start planning our Dx strategy? Diagnostic Overview No Phase
Given the specific challenges in the particular disease’s patient journey, what are the essential requirements for our Dx (eg, accessibility, low cost, non-invasiveness, etc.)? Diagnostic Overview No Phase
Does the Dx provide a proprietary position for the Rx or create a new market space? Diagnostic Overview No Phase
Will the market-ready Dx be same as that used in the Phase III clinical studies? Diagnostic Overview No Phase
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Overview No Phase
How might PM strategy impact our therapy positioning? Diagnostic Strategy No Phase
How can diagnostic tests change the patient journey to optimize appropriate use of a therapy? Diagnostic Strategy No Phase
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Diagnostic Strategy No Phase
Does the Dx provide a proprietary position for the Rx or create a new market space? Diagnostic Strategy No Phase
What is the sample type needed for the assay? Diagnostic Adoption No Phase
Will the Dx result likely be generated using a single measurement or will it be generated from a number of determinations using an algorithm? Diagnostic Adoption No Phase
Does our choice of marker and instrument platform restrict our Dx commercialization options? Diagnostic Adoption No Phase
Can we tie Rx to Dx technology via IP? Diagnostic Adoption No Phase
Will the new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? Diagnostic Clinical No Phase
Will the interpretation of the Dx result likely be well-defined and unambiguous, or require subjective interpretation by the operating or the requesting physician? Diagnostic Clinical No Phase
How novel is the biomarker and is there a lot of information about it available to the physician? Diagnostic Clinical No Phase
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical No Phase
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Diagnostic Marketing No Phase
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Diagnostic Marketing No Phase
Can we leverage superior laboratory service to improve Dx market share? Diagnostic Marketing No Phase
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling No Phase
How might PM impact our pricing strategy and ROI? Diagnostic Financial No Phase
What are the costs and benefits of moving forward with our Dx strategy? Diagnostic Financial No Phase
How many tests might be ordered each year at peak adoption and have we done a forecast projection? Diagnostic Financial No Phase
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Diagnostic Financial No Phase
Will the laboratory take complete charge of billing for the test? Diagnostic Laboratories No Phase
Which laboratories should be in the laboratory network? Diagnostic Laboratories No Phase
Is the test financially attractive to the laboratory? Diagnostic Laboratories No Phase
Have we built in expectations for a test lifecycle critical to market development? Diagnostic Laboratories No Phase
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Access No Phase
What is the cost of the Dx relative to avoided healthcare cost? Diagnostic Access No Phase
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access No Phase
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Diagnostic Access No Phase
Have we planned for the evolution of regulatory requirements? Diagnostic Regulatory No Phase
Will the Dx test be used to identify patients who have significant adverse reaction to the administered Rx? Diagnostic Regulatory No Phase
Do we need to engage external Dx regulatory expertise? Diagnostic Regulatory No Phase
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Diagnostic Regulatory No Phase
Have we planned for the evolution of regulatory requirements? Diagnostic Regulatory Biomarker Discovery and Foundation Strategy
Do we need to engage external Dx regulatory expertise? Diagnostic Regulatory Biomarker Discovery and Foundation Strategy
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Diagnostic Regulatory Biomarker Discovery and Foundation Strategy
How do we choose the right partner and have we established a criteria list for partner selection? Diagnostic Partnering No Phase
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Partnering No Phase
Do we have a plan for coordinated dialogues with our partner? Diagnostic Partnering No Phase
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Diagnostic Partnering No Phase
What partnering issues need to be considered and how can we partner effectively with Dx and lab companies? Pharma Partnering No Phase
Should we work with separate partners for the scientific and the commercial development of our Dx? Pharma Partnering No Phase
How do we engage our partner? Pharma Partnering No Phase
Do we have an objective process for the selection of development and commercialization partner(s)? Pharma Partnering No Phase
Will the market-ready Dx be same as that used in the Phase III clinical studies? Pharma Regulatory No Phase
Should we make the Dx commercially available before, at or post-therapy launch? Pharma Regulatory No Phase
Does the Indication for Use for the Dx support our overall Rx positioning and strategy? Pharma Regulatory No Phase
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? Pharma Regulatory No Phase
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle No Phase
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Pharma Access No Phase
What is the cost of the Dx relative to avoided healthcare cost? Pharma Access No Phase
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Access No Phase
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Access No Phase
How many laboratories will be able to offer the companion diagnostic test? Pharma Laboratories No Phase
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Pharma Laboratories No Phase
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Laboratories No Phase
What level of investment will be needed to execute our Dx strategy? Pharma Financial No Phase
What are the costs and benefits of moving forward with our Dx strategy? Pharma Financial No Phase
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Pharma Financial No Phase
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling No Phase
What market research do we need and how is Dx-based market research different? Pharma Marketing No Phase
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Pharma Marketing No Phase
How might another pharma’s drug plus therapy change the position of or interrupt our Dx plan? Pharma Marketing No Phase
How interdependent do we need or want the Rx and Dx positionings to be? Pharma Marketing No Phase
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? Pharma Marketing No Phase
Will the new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? Pharma Clinical No Phase
Where will investment in key test drivers be best to ensure we deliver against our target forecast? Pharma Clinical No Phase
How can clinical strategy support test adoption by brand momentum and how tightly linked are the Dx and Rx in marketing to the physician? Pharma Clinical No Phase
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Pharma Clinical No Phase
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Clinical No Phase
What is the sample type needed for the assay? Pharma Adoption No Phase
Will there be enough responder patients to validate the biomarker? Pharma Adoption No Phase
How will the platform choice affect test adoption? Pharma Adoption No Phase
Does our choice of marker and instrument platform restrict our Dx commercialization options? Pharma Adoption No Phase
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Adoption No Phase
Is the Dx strategy for this Rx best served by one or multiple partners? Pharma Strategy No Phase
Where in the patient pathway do we need to introduce testing to drive the optimum number of the right patients towards our therapy? Pharma Strategy No Phase
Does the Dx provide a proprietary position for the Rx or create a new market space? Pharma Strategy No Phase
Can we use Dx/CoDx to change treatment paradigm pre-launch of the Rx? Pharma Strategy No Phase
When is the right time to start planning our Dx strategy? Pharma Strategy No Phase
Will we expect our Dx partner to manage the laboratory network? Pharma Overview No Phase
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Overview No Phase
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Overview No Phase
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? Pharma Overview No Phase
When is the right time to start planning our Dx strategy? Pharma Overview No Phase
Have we built in expectations for a test lifecycle critical to market development? Diagnostic Overview Commercial Management
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Diagnostic Overview Commercial Management
Can we tie Rx to Dx technology via IP? Diagnostic Overview Commercial Management
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Overview Commercial Management
How will the sequence of testing technology impact the brand? Diagnostic Adoption Commercial Management
Have we got any evidence to predict likely adoption of this test? Diagnostic Adoption Commercial Management
Will the Dx test integrate easily with existing clinical practice? Diagnostic Adoption Commercial Management
Will the Dx test integrate easily with existing clinical practice? Diagnostic Clinical Commercial Management
How can clinical strategy support test adoption by providing hands-on use? Diagnostic Clinical Commercial Management
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Adoption Commercial Management
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical Commercial Management
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Diagnostic Marketing Commercial Management
What is the appropriate Rx and Dx marketing spend split to optimize ROI? Diagnostic Marketing Commercial Management
Can the laboratory result be sent electronically to the physician’s office? Diagnostic Laboratories Commercial Management
What should the lab order form look like and can the laboratory electronically report the result back to the physician’s office? Diagnostic Laboratories Commercial Management
How might lab service help differentiate our Dx and improve market share? Diagnostic Laboratories Commercial Management
How long must physicians wait to receive the result? Diagnostic Laboratories Commercial Management
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Access Commercial Management
What are the regional variations in the US in management of reimbursement? Diagnostic Access Commercial Management
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access Commercial Management
How do we manage our partner? Diagnostic Partnering Commercial Management
How do we manage our partner? Diagnostic Partnering File and Global Rollout
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Partnering File and Global Rollout
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Partnering Commercial Management
Do we have a plan for coordinated dialogues with our partner? Diagnostic Partnering Commercial Management
Do we have a plan for coordinated dialogues with our partner? Diagnostic Partnering File and Global Rollout
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Access File and Global Rollout
What are the regional variations in the US in management of reimbursement? Diagnostic Access File and Global Rollout
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access File and Global Rollout
What should the lab order form look like and can the laboratory electronically report the result back to the physician’s office? Diagnostic Laboratories File and Global Rollout
How might lab service help differentiate our Dx and improve market share? Diagnostic Laboratories File and Global Rollout
How long must physicians wait to receive the result? Diagnostic Laboratories File and Global Rollout
Is there financial benefit for a therapy in introducing a multi-test strategy which brings more patients into the treatment pool? Diagnostic Financial Commercial Management
Is there financial benefit for a therapy in introducing a multi-test strategy which brings more patients into the treatment pool? Diagnostic Financial File and Global Rollout
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Diagnostic Financial Commercial Management
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Diagnostic Financial File and Global Rollout
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Diagnostic Marketing File and Global Rollout
Have we mapped out how a market conversion could occur in a solely PM marketplace like oncology? Diagnostic Marketing File and Global Rollout
How will the sequence of testing technology impact the brand? Diagnostic Clinical File and Global Rollout
Have we got any evidence to predict likely adoption of this test? Diagnostic Clinical File and Global Rollout
Will the Dx test integrate easily with existing clinical practice? Diagnostic Clinical File and Global Rollout
How can clinical strategy support test adoption by providing hands-on use? Diagnostic Adoption File and Global Rollout
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Adoption File and Global Rollout
How can clinical strategy support test adoption by providing hands-on use? Diagnostic Clinical File and Global Rollout
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical File and Global Rollout
Can we tie Rx to Dx technology via IP? Diagnostic Adoption File and Global Rollout
Has the drug owner planned in detail for a diagnostic strategy and managed its execution? Diagnostic Strategy Commercial Management
Has the drug owner planned in detail for a diagnostic strategy and managed its execution? Diagnostic Strategy File and Global Rollout
How will the sequence of testing technology impact the brand? Diagnostic Overview File and Global Rollout
Have we got any evidence to predict likely adoption of this test? Diagnostic Overview File and Global Rollout
Will the Dx test easily integrate with existing clinical practice? Diagnostic Overview File and Global Rollout
Will the interpretation of the Dx result likely be well-defined and unambiguous, or require subjective interpretation by the operating or the requesting physician? Diagnostic Overview File and Global Rollout
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Overview File and Global Rollout
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Overview File and Global Rollout
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Diagnostic Overview Validation Trials and Market Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Overview Validation Trials and Market Development
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Overview Validation Trials and Market Development
Can we tie Rx to Dx technology via IP? Diagnostic Overview Validation Trials and Market Development
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Overview Validation Trials and Market Development
How many patients never enter the decision process and can we reach them through diagnostic strategy? Diagnostic Strategy Validation Trials and Market Development
Can we tie Rx to Dx technology via IP? Diagnostic Adoption Validation Trials and Market Development
How will the sequence of testing technology impact the brand? Diagnostic Clinical Validation Trials and Market Development
Have we got any evidence to predict likely adoption of this test? Diagnostic Clinical Validation Trials and Market Development
Will the Dx test integrate easily with existing clinical practice? Diagnostic Clinical Validation Trials and Market Development
How can clinical strategy support test adoption by providing hands-on use? Diagnostic Clinical Validation Trials and Market Development
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical Validation Trials and Market Development
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Diagnostic Marketing Validation Trials and Market Development
To what extent are consumers aware that their symptoms or risk factors may constitute a condition or disease? Diagnostic Marketing Validation Trials and Market Development
Will the laboratory take complete charge of billing for the test? Diagnostic Laboratories Validation Trials and Market Development
What should the lab order form look like and can the laboratory electronically report the result back to the physician’s office? Diagnostic Laboratories Validation Trials and Market Development
How long must the physicians wait to receive the result? Diagnostic Laboratories Validation Trials and Market Development
Have we built in expectations for a test lifecycle critical to market development? Diagnostic Laboratories Validation Trials and Market Development
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Diagnostic Laboratories Validation Trials and Market Development
Is there financial benefit for a therapy in introducing a multi-test strategy which brings more patients into the treatment pool? Diagnostic Financial Validation Trials and Market Development
How might PM impact our pricing strategy and ROI? Diagnostic Financial Validation Trials and Market Development
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Diagnostic Financial Validation Trials and Market Development
What are the regional variations in the US in management of reimbursement? Diagnostic Access Validation Trials and Market Development
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access Validation Trials and Market Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Partnering Validation Trials and Market Development
How do we manage our partner? Diagnostic Partnering Commencing Test Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Partnering Commencing Test Development
Do we have a plan for coordinated dialogues with our partner? Diagnostic Partnering Commencing Test Development
Have we planned for the post-marketing requirements of a Dx? Diagnostic Regulatory Commercial Management
Have we planned for the post-marketing requirements of a Dx? Diagnostic Regulatory File and Global Rollout
Have we planned for the post-marketing requirements of a Dx? Diagnostic Regulatory Validation Trials and Market Development
Have we planned for the post-marketing requirements of a Dx? Diagnostic Regulatory Commencing Test Development
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Diagnostic Regulatory Commencing Test Development
What are the regional variations in the US in management of reimbursement? Diagnostic Access Commencing Test Development
In the EU, will we need to subsidize testing and, if so, what is our funding exit strategy? Diagnostic Access Commencing Test Development
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access Commencing Test Development
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Diagnostic Access Commencing Test Development
Which laboratories should be in the laboratory network? Diagnostic Laboratories Commencing Test Development
How might lab service help differentiate our Dx and improve market share? Diagnostic Laboratories Commencing Test Development
Have we built in expectations for a test lifecycle critical to market development? Diagnostic Laboratories Commencing Test Development
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Diagnostic Laboratories Commencing Test Development
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Diagnostic Laboratories Commencing Test Development
What is the financial influence on our ROI in PM of an earlier Dx launch? Diagnostic Financial Commencing Test Development
How might PM impact our pricing strategy and ROI? Diagnostic Financial Commencing Test Development
What is the optimal environment for launch and what gaps need to be filled? Diagnostic Financial Commencing Test Development
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Diagnostic Financial Commencing Test Development
What is the Dx brand vision and how closely do we want to link the Rx and Dx brands? Diagnostic Marketing Commencing Test Development
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Diagnostic Marketing Commencing Test Development
Do we have different DTC opportunities in Dx that can impact uptake and share for an Rx? To what extent are consumers aware that their symptoms or risk factors may constitute a condition or disease? What stimulates a patient to seek treatment or present to a physician? Diagnostic Marketing Commencing Test Development
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription, based on a positive test result? Diagnostic Marketing Commencing Test Development
Will the interpretation of the Dx result likely be well-defined and unambiguous, or require subjective interpretation by the operating or the requesting physician? Diagnostic Clinical Commencing Test Development
How novel is the biomarker, is there a lot of information about it available to the physician and what market development education is needed to ensure awareness? Diagnostic Clinical Commencing Test Development
How can clinical strategy support test adoption by providing hands-on use? Diagnostic Clinical Commencing Test Development
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical Commencing Test Development
How will the platform choice affect test adoption? Diagnostic Adoption Commencing Test Development
Can we tie Rx to Dx technology via IP? Diagnostic Adoption Commencing Test Development
Given the specific challenges in the particular disease’s patient journey, what are the essential requirements for our Dx (eg, accessibility, low cost, non-invasiveness, etc.)? Diagnostic Strategy Commencing Test Development
Can we use Dx/CoDx to change treatment paradigm pre-launch of Rx? Diagnostic Strategy Commencing Test Development
Where in the patient pathway do we need to introduce testing to drive the optimum number of the right patients towards a therapy? Diagnostic Strategy Commencing Test Development
How many patients never enter the decision process and can we reach them through diagnostic strategy? Diagnostic Strategy Commencing Test Development
Who are the additional decision-makers in a Dx sale and whose responsibility is it to educate them? Diagnostic Overview Commencing Test Development
Has the appropriate Dx marketing spend been forecast? Diagnostic Overview Commencing Test Development
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Overview Commencing Test Development
Will the Rx/Dx physician adopter types overlap? Diagnostic Overview Commencing Test Development
Will the laboratory take complete charge of billing for the test? Diagnostic Overview Commencing Test Development
Will there be enough responder patients to validate the biomarker? Diagnostic Overview Proof of Concept Trials
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Overview Proof of Concept Trials
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Diagnostic Overview Proof of Concept Trials
Are the marker(s) and/or platform, or the clinical application of the Dx covered by patents or other IP protection, and do we have sufficient freedom to operate? Diagnostic Overview Proof of Concept Trials
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Diagnostic Overview Proof of Concept Trials
How is the patient diagnosed, by whom and with what tools, and what technical advances and tools can be anticipated and/or shaped by us? Diagnostic Strategy Proof of Concept Trials
Where should Dx be used – POC home, POC physician’s office or the lab? Diagnostic Strategy Proof of Concept Trials
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Diagnostic Strategy Proof of Concept Trials
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Diagnostic Strategy Proof of Concept Trials
Are there potential severe adverse events for the compound in specific populations? Diagnostic Strategy Proof of Concept Trials
Will the sample be available on diagnosis or just before treatment? Diagnostic Adoption Proof of Concept Trials
What level of validation is required for the biomarker and where is it done? Diagnostic Adoption Proof of Concept Trials
Have we selected the instrument platform to be used to run the Dx test? Diagnostic Adoption Proof of Concept Trials
Are there enough responder patients to validate the test kit? Diagnostic Adoption Proof of Concept Trials
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Diagnostic Adoption Proof of Concept Trials
To what extent are physicians aware of the disease, its prevalence and impact? Diagnostic Clinical Proof of Concept Trials
How can clinical strategy support test adoption by brand momentum and how tightly linked are the Dx and Rx in marketing to the physician? Diagnostic Clinical Proof of Concept Trials
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Diagnostic Clinical Proof of Concept Trials
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Diagnostic Clinical Proof of Concept Trials
What market research do we need and how is Dx-based market research different? Diagnostic Marketing Proof of Concept Trials
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Diagnostic Marketing Proof of Concept Trials
In what ways could the biomarker and/or Dx intervention provide sustainable competitive advantage? Diagnostic Marketing Proof of Concept Trials
Has the appropriate Dx marketing spend been forecast? Diagnostic Marketing Proof of Concept Trials
Can we leverage superior laboratory service to improve Dx market share? Diagnostic Marketing Proof of Concept Trials
What is the financial influence on our ROI in PM of an earlier Dx launch? Diagnostic Financial Proof of Concept Trials
What level of investment will be needed to execute our Dx strategy? Diagnostic Financial Proof of Concept Trials
What are the costs and benefits of moving forward with our Dx strategy? Diagnostic Financial Proof of Concept Trials
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Diagnostic Financial Proof of Concept Trials
Which laboratories should be in the laboratory network? Diagnostic Laboratories Proof of Concept Trials
Is the preferred Dx platform commercially available at reference labs or specialty labs and how globally available is/are the platform(s) envisaged to be used for the test delivery? Diagnostic Laboratories Proof of Concept Trials
Have we built in expectations for a test lifecycle critical to market development? Diagnostic Laboratories Proof of Concept Trials
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Diagnostic Laboratories Proof of Concept Trials
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Diagnostic Laboratories Proof of Concept Trials
What are the early reads on market access strategy and what will payers think and do? Diagnostic Access Proof of Concept Trials
In the EU, will we need to subsidize testing and, if so, what is our funding exit strategy? Diagnostic Access Proof of Concept Trials
Do we need to take steps with our partner to resource the access burden on physicians? Diagnostic Access Proof of Concept Trials
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Diagnostic Access Proof of Concept Trials
Will the Dx test be used to identify patients who have significant adverse reaction to the administered Rx? Diagnostic Regulatory Proof of Concept Trials
In which territories will a related Rx be marketed and do we have an understanding of the Dx regulatory requirements for these territories? Diagnostic Regulatory Proof of Concept Trials
What clinical endpoints do we target and what are the studies needed which include the biomarker? Diagnostic Regulatory Proof of Concept Trials
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? Diagnostic Regulatory Proof of Concept Trials
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Diagnostic Regulatory Proof of Concept Trials
Should we work with separate partners for the scientific and the commercial development of our Dx? Diagnostic Partnering Proof of Concept Trials
How do we manage our partner? Diagnostic Partnering Proof of Concept Trials
Do we have an objective process for the selection of commercialization partner(s)? Diagnostic Partnering Proof of Concept Trials
Do we have a plan for coordinated dialogues with our partner? Diagnostic Partnering Proof of Concept Trials
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Diagnostic Partnering Proof of Concept Trials
What partnering issues need to be considered and how can we partner effectively with Dx and lab companies? Diagnostic Partnering Assay Development
How do we manage our partner? Diagnostic Partnering Assay Development
Do we have the expertise to undertake due diligence on candidate develoment and commercialization partners? Diagnostic Partnering Assay Development
Do we have an objective process for the selection of development and commercialization partner(s)? Diagnostic Partnering Assay Development
Will the market-ready Dx be same as that used in the Phase III clinical studies? Diagnostic Regulatory Assay Development
Will the Clinical Trial Assay (CTA) Dx test be analytically validated prior to its use in the pivotal Phase III clinical studies? Diagnostic Regulatory Assay Development
Have we planned for the evolution of regulatory requirements? Diagnostic Regulatory Assay Development
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? Diagnostic Regulatory Assay Development
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Diagnostic Regulatory Assay Development
What is the estimated total cost of diagnostic testing to payers in the US and all key markets? Diagnostic Access Assay Development
In the US, is it likely that existing CPT codes can be used or will a new code be required? Diagnostic Access Assay Development
How will the positioning of the test influence the reimbursement formulary for an Rx? Diagnostic Access Assay Development
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Diagnostic Access Assay Development
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Diagnostic Access Assay Development
Which laboratories should be in the laboratory network? Diagnostic Laboratories Assay Development
How many laboratories will be able to offer the companion diagnostic test? Diagnostic Laboratories Assay Development
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Diagnostic Laboratories Assay Development
Will the Dx shaping drive significant volume? Diagnostic Financial Assay Development
What level of investment will be needed to execute our Dx strategy? Diagnostic Financial Assay Development
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Diagnostic Financial Assay Development
Will the Dx shaping drive significant volume? Diagnostic Financial Assay Development
Has the appropriate Dx marketing spend been forecast? Diagnostic Marketing Assay Development
Will a new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? Diagnostic Clinical Assay Development
How novel is the biomarker and is there a lot of information about it available to the physician? Diagnostic Clinical Assay Development
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? Diagnostic Clinical Assay Development
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Diagnostic Clinical Assay Development
What is the sample type needed for the assay? Diagnostic Adoption Assay Development
Does our choice of marker and instrument platform restrict our Dx commercialization options? Diagnostic Adoption Assay Development
Have we selected the instrument platform to be used to run the Dx test? Diagnostic Adoption Assay Development
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Diagnostic Adoption Assay Development
When is the right time to start planning our Dx strategy? Diagnostic Strategy Assay Development
Where should Dx be used – POC home, POC physician’s office or the lab? Diagnostic Strategy Assay Development
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Diagnostic Strategy Assay Development
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Diagnostic Strategy Assay Development
Are there potential severe adverse events for the compound in specific populations? Diagnostic Strategy Assay Development
Does our choice of marker and instrument platform restrict our Dx commercialization options? Diagnostic Overview Assay Development
Could we see opportunities to introduce a novel access and reimbursement approach, combining Rx and Dx into a comprehensive package? Diagnostic Overview Assay Development
Can the drug diagnostic biomarker eliminate the incidence of serious adverse events? Diagnostic Overview Assay Development
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Diagnostic Overview Assay Development
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Diagnostic Overview Assay Development
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Commercial Management
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling File and Global Rollout
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Validation Trials and Market Development
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Commencing Test Development
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Proof of Concept Trials
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Assay Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Commercial Management
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle File and Global Rollout
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Validation Trials and Market Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Commencing Test Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Proof of Concept Trials
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Assay Development
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle Biomarker Discovery and Foundation Strategy
Have we built in expectations for a test lifecycle critical to market and technology developments? Diagnostic Lifecycle No Phase
What is the cost of the Dx relative to avoided healthcare cost? Diagnostic Access Biomarker Discovery and Foundation Strategy
How do payers affect diagnosis, treatment, brand choice and fulfillment? Will there be out of pocket costs or opportunities? Diagnostic Access Biomarker Discovery and Foundation Strategy
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Diagnostic Access Biomarker Discovery and Foundation Strategy
Is the test financially attractive to the laboratory? Diagnostic Laboratories Biomarker Discovery and Foundation Strategy
Which laboratories should be in the laboratory network? Diagnostic Laboratories Biomarker Discovery and Foundation Strategy
How many laboratories will be able to offer the companion diagnostic test? Diagnostic Laboratories Biomarker Discovery and Foundation Strategy
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? Diagnostic Laboratories Biomarker Discovery and Foundation Strategy
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Diagnostic Laboratories Biomarker Discovery and Foundation Strategy
Will the Dx shaping drive significant volume? Diagnostic Financial Biomarker Discovery and Foundation Strategy
What level of investment will be needed to execute our Dx strategy? Diagnostic Financial Biomarker Discovery and Foundation Strategy
What are the costs and benefits of moving forward with our Dx strategy? Diagnostic Financial Biomarker Discovery and Foundation Strategy
How dependent will our therapy’s commercial ambition be on a redesigned diagnostic environment, what is the optimal environment for launch and what gaps need to be filled? Diagnostic Financial Biomarker Discovery and Foundation Strategy
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Diagnostic Financial Biomarker Discovery and Foundation Strategy
Does PM enable us to explore a different sales model with integrated healthcare systems? Diagnostic Selling Biomarker Discovery and Foundation Strategy
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Diagnostic Marketing Biomarker Discovery and Foundation Strategy
How might another pharma’s drug plus therapy change the position of or interrupt our Dx plan? Diagnostic Marketing Biomarker Discovery and Foundation Strategy
Can we leverage superior laboratory service to improve Dx market share? Diagnostic Marketing Biomarker Discovery and Foundation Strategy
Where and how many patients fall out of the patient journey and how does this impact the buying process? Diagnostic Clinical Biomarker Discovery and Foundation Strategy
How novel is the biomarker, is there a lot of information about it available to the physician and what market development education is needed to ensure awareness? Diagnostic Clinical Biomarker Discovery and Foundation Strategy
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? Diagnostic Clinical Biomarker Discovery and Foundation Strategy
Will there be enough responder patients to validate the biomarker? Diagnostic Adoption Biomarker Discovery and Foundation Strategy
What is the sample type needed for the assay? Diagnostic Adoption Biomarker Discovery and Foundation Strategy
Does our choice of marker and instrument platform restrict our Dx commercialization options? Diagnostic Adoption Biomarker Discovery and Foundation Strategy
Can we tie Rx to Dx technology via IP? Diagnostic Adoption Biomarker Discovery and Foundation Strategy
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Diagnostic Adoption Biomarker Discovery and Foundation Strategy
Where should Dx be used – POC home, POC physician’s office or the lab? Diagnostic Strategy Biomarker Discovery and Foundation Strategy
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Diagnostic Strategy Biomarker Discovery and Foundation Strategy
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Diagnostic Strategy Biomarker Discovery and Foundation Strategy
Can a Dx modify the buying process and how will that affect Rx? Diagnostic Strategy Biomarker Discovery and Foundation Strategy
Are there potential severe adverse events for the compound in specific populations? Diagnostic Strategy Biomarker Discovery and Foundation Strategy
Given the specific challenges in the particular disease’s patient jouney, what are the essential requirements for our Dx (eg, accessibility, low cost, non-invasiveness, etc.)? Diagnostic Overview Biomarker Discovery and Foundation Strategy
Does our choice of marker and instrument platform restrict our Dx commercialization options? Diagnostic Overview Biomarker Discovery and Foundation Strategy
Can we tie Rx and Dx technology via IP? Diagnostic Overview Biomarker Discovery and Foundation Strategy
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Diagnostic Overview Biomarker Discovery and Foundation Strategy
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Diagnostic Overview Biomarker Discovery and Foundation Strategy
What partnering issues need to be considered and how can we partner effectively with Dx and lab companies? General Partnering No Phase
How do we agree on sharing costs of development and commercialization (ie, risk sharing)? General Partnering No Phase
Do we have a plan for coordinated dialogues with our partner? General Partnering No Phase
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? General Partnering No Phase
Will the market-ready Dx be same as that used in the Phase III clinical studies? General Regulatory No Phase
In which territories will a related Rx be marketed and do we have an understanding of the Dx regulatory requirements for these territories? General Regulatory No Phase
Does the Indication for Use for the Dx support our overall Rx positioning and strategy? General Regulatory No Phase
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? General Regulatory No Phase
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? General Regulatory No Phase
Have we built in expectations for a test lifecycle critical to market and technology developments? General Lifecycle No Phase
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? General Access No Phase
What is the cost of the Dx relative to avoided healthcare cost? General Access No Phase
Do we need to take steps with our partner to resource the access burden on physicians? General Access No Phase
Could we see opportunities to introduce a novel access and reimbursement approach, combining Rx and Dx into a comprehensive package? General Access No Phase
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? General Access No Phase
Will the laboratory take complete charge of billing for the test? General Laboratories No Phase
Is the preferred Dx platform commercially available at reference labs or specialty labs and how globally available is/are the platform(s) envisaged to be used for the test delivery? General Laboratories No Phase
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? General Laboratories No Phase
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? General Laboratories No Phase
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? General Laboratories No Phase
If we are partnering externally, what is the Dx business case and who should share which costs of development and commercialization? General Financial No Phase
Will the Dx shaping drive significant volume? General Financial No Phase
What are the costs and benefits of moving forward with our Dx strategy? General Financial No Phase
How dependent will our therapy’s commercial ambition be on a redesigned diagnostic environment, what is the optimal environment for launch and what gaps need to be filled? General Financial No Phase
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? General Financial No Phase
Does PM enable us to explore a different sales model with integrated healthcare systems? General Selling No Phase
What market research do we need and how is Dx-based market research different? General Marketing No Phase
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? General Marketing No Phase
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? General Marketing No Phase
Can we leverage superior laboratory service to improve Dx market share? General Marketing No Phase
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? General Marketing No Phase
Will the new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? General Clinical No Phase
How can clinical strategy support test adoption by brand momentum and how tightly linked are the Dx and Rx in marketing to the physician? General Clinical No Phase
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? General Clinical No Phase
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? General Clinical No Phase
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? General Clinical No Phase
Will there be enough responder patients to validate the biomarker? General Adoption No Phase
Will the sample be available on diagnosis or just before treatment? General Adoption No Phase
Will the Dx result likely be generated using a single measurement or will it be generated from a number of determinations using an algorithm? General Adoption No Phase
Does our choice of marker and instrument platform restrict our Dx commercialization options? General Adoption No Phase
Are there enough responder patients to validate the test kit? General Adoption No Phase
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? General Adoption No Phase
Is the broad population efficacy of the compound likely to be superior to current therapies or only in targeted populations? General Strategy No Phase
How can diagnostic tests change the patient journey to optimize appropriate use of a therapy? General Strategy No Phase
Have we comprehensively mapped out how competitor moves or other external developments may impact our choice of Dx test and related development programs? General Strategy No Phase
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? General Strategy No Phase
Does the Dx provide a proprietary position for the Rx or create a new market space? General Strategy No Phase
Do we believe that we can drive a higher price point if we isolate the target patient population more narrowly, through a companion Dx or a related intervention? General Strategy No Phase
Are there potential severe adverse events for the compound in specific populations? General Strategy No Phase
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? General Overview No Phase
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? General Overview No Phase
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? General Overview No Phase
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Phase I FIH
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Phase IIa POC
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Phase IIb Decision Point
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Phase III Pivotal Trial
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? General Overview No Phase
How do we ensure Dx market forces work for us on Dx adoption, including profitability for all in the chain? Pharma Partnering PhaseIV Market Use
How do we manage our partner? Pharma Partnering PhaseIV Market Use
How do we ensure Dx market forces work for us on Dx adoption, including profitability for all in the chain? Pharma Partnering Launch
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Partnering Launch
Have we prepared for a potential Rx label change any time before, during or post-launch? Pharma Regulatory Launch
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Pharma Access Launch
What are the regional variations in the US in management of reimbursement? Pharma Access Launch
Do we need to take steps with our partner to resource the access burden on physicians? Pharma Access Launch
What should the lab order form look like and can the laboratory electronically report the result back to the physician’s office? Pharma Laboratories Launch
How might lab service help differentiate our Rx and improve market share? Pharma Laboratories Launch
How long must the physicians wait to receive the result? Pharma Laboratories Launch
Have we built in expectations for a test lifecycle critical to market development? Pharma Laboratories Launch
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Pharma Financial Launch
What are the KPIs we need to analyse and report back to help us optimize our marketing program for the Dx? Pharma Marketing Launch
Have we mapped out how a market conversion could occur in a solely PM marketplace like oncology? Pharma Marketing Launch
How can clinical strategy support test adoption by providing hands-on use? Pharma Clinical Launch
Will the interpretation of the Dx result likely be well defined and unambiguous, or require subjective interpretation by the operating or the requesting physician? Pharma Clinical Launch
Will the Dx test integrate easily with existing clinical practice, have we got any evidence to predict likely adoption of this test and how will the sequence of testing technology impact the brand? Pharma Clinical Launch
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Clinical Launch
Can we tie Rx to Dx technology via iP? Pharma Adoption Launch
How many patients never enter the decision process and can we reach them through diagnostic strategy? Pharma Strategy Launch
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling PhaseIV Market Use
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Launch
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling FDA/Global Regulatory Submission
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Pre Clinical
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Phase I FIH
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Phase IIa POC
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Phase IIb Decision Point
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Phase III Pivotal Trial
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle FDA/Global Regulatory Submission
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle PhaseIV Market Use
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Lifecycle Launch
How can clinical strategy support test adoption by managing physician perceptions? Pharma Overview Launch
Have we mapped out how a market conversion could occur in a solely PM marketplace like oncology? Pharma Overview Launch
Do we need to take steps with our partner to resource the access burden on physicians? Pharma Overview Launch
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Overview Launch
Will we expect our Dx partner to manage the laboratory network? Pharma Partnering FDA/Global Regulatory Submission
What does the Dx business case look like? Pharma Partnering FDA/Global Regulatory Submission
How do we ensure Dx market forces work for us on Dx adoption, including profitability for all in the chain? Pharma Partnering FDA/Global Regulatory Submission
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Partnering FDA/Global Regulatory Submission
Have we planned for the post-marketing requirements of a Dx? Pharma Regulatory FDA/Global Regulatory Submission
Will we be able to robustly demonstrate the cost-effectiveness of using the test to support reimbursement discussions and other payer negotiations? Pharma Access FDA/Global Regulatory Submission
What is the estimated total cost of diagnostic testing to payers in the US and all key markets? Pharma Access FDA/Global Regulatory Submission
How will the positioning of the test influence the reimbursement formulary for an Rx? Pharma Access FDA/Global Regulatory Submission
Does PM enable us to explore a different payer model with integrated healthcare systems? Pharma Access FDA/Global Regulatory Submission
Do we need to take steps with our partner to resource the access burden on physicians? Pharma Access FDA/Global Regulatory Submission
Will the laboratory take complete charge of billing for the test? Pharma Laboratories FDA/Global Regulatory Submission
How might lab service help differentiate our Rx and improve market share? Pharma Laboratories FDA/Global Regulatory Submission
How long must physicians wait to receive the result? Pharma Laboratories FDA/Global Regulatory Submission
Have we built in expectations for a test lifecycle critical to market development? Pharma Laboratories FDA/Global Regulatory Submission
How might PM impact our Rx pricing strategy and ROI? Pharma Financial FDA/Global Regulatory Submission
How many tests might be ordered each year at peak adoption and have we done a forecast projection? Pharma Financial FDA/Global Regulatory Submission
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Pharma Financial FDA/Global Regulatory Submission
Do we have different DTC opportunities in Dx that can impact uptake and share for an Rx? Pharma Marketing FDA/Global Regulatory Submission
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? Pharma Marketing FDA/Global Regulatory Submission
Will the Dx test integrate easily with existing clinical practice, have we got any evidence to predict likely adoption of this test and how will the sequence of testing technology impact the brand? Pharma Clinical FDA/Global Regulatory Submission
How can clinical strategy support test adoption by providing hands-on use? Pharma Clinical FDA/Global Regulatory Submission
How can clinical strategy support test adoption by brand momentum and how tightly linked are the Dx and Rx in marketing to the physician? Pharma Clinical FDA/Global Regulatory Submission
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Clinical FDA/Global Regulatory Submission
Can we tie Rx to Dx technology we have via IP? Pharma Adoption FDA/Global Regulatory Submission
How will the platform choice affect test adoption? Pharma Adoption FDA/Global Regulatory Submission
Where in the patient pathway do we need to introduce testing to drive the optimum number of the right patients towards our therapy? Pharma Strategy FDA/Global Regulatory Submission
Do we, as the drug owner, need to plan a diagnostic strategy in detail and manage its execution, rather than farm it out to a Dx company, and what are the critical considerations in making this choice? Pharma Strategy FDA/Global Regulatory Submission
Does PM enable us to explore a different sales model with integrated healthcare systems? Pharma Selling Pre Clinical
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Overview FDA/Global Regulatory Submission
Do we have different DTC opportunities in Dx that can impact uptake and share for an Rx? Pharma Overview FDA/Global Regulatory Submission
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Overview FDA/Global Regulatory Submission
Will we expect our Dx partner to manage the laboratory network? Pharma Partnering Phase III Pivotal Trial
What does the Dx business case look like? Pharma Partnering Phase III Pivotal Trial
How should we align the regulatory labels for the Rx and Dx? Pharma Regulatory Phase III Pivotal Trial
Have we planned for the post-marketing requirements of a Dx? Pharma Regulatory Phase III Pivotal Trial
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Pharma Regulatory Phase III Pivotal Trial
Does PM enable us to explore a different payer model with integrated healthcare systems? Pharma Access Phase III Pivotal Trial
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Access Phase III Pivotal Trial
Will the laboratory take complete charge of billing for the test? Pharma Laboratories Phase III Pivotal Trial
What lab footprint does the therapy actually need at launch and beyond? Pharma Laboratories Phase III Pivotal Trial
How many laboratories will be able to offer the companion diagnostic test? Pharma Laboratories Phase III Pivotal Trial
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Pharma Laboratories Phase III Pivotal Trial
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Laboratories Phase III Pivotal Trial
How might PM impact our Rx pricing strategy and ROI? Pharma Financial Phase III Pivotal Trial
How does test adoption influence our investment choices? Pharma Financial Phase III Pivotal Trial
How dependent will our therapy’s commercial ambition be on a redesigned diagnostic environment, what is the optimal environment for launch and what gaps need to be filled? Pharma Financial Phase III Pivotal Trial
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Pharma Financial Phase III Pivotal Trial
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Pharma Financial Phase III Pivotal Trial
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? Pharma Marketing Phase III Pivotal Trial
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? Pharma Marketing Phase III Pivotal Trial
How novel is the biomarker and is there a lot of information about it available to the physician? Pharma Clinical Phase III Pivotal Trial
How can clinical strategy support test adoption by providing hands-on use? Pharma Clinical Phase III Pivotal Trial
How can clinical strategy support test adoption by managing physician perceptions? Pharma Clinical Phase III Pivotal Trial
How will the platform choice affect test adoption? Pharma Adoption Phase III Pivotal Trial
Can we tie Rx to Dx technology via IP? Pharma Adoption Phase III Pivotal Trial
Where in the patient pathway do we need to introduce testing to drive the optimum number of the right patients towards our therapy? Pharma Strategy Phase III Pivotal Trial
What additional claims for the Rx might be supported/effected by use of the Dx post-launch and is there opportunity for more optimal share through Dx intervention in Phase IV? Pharma Strategy Phase III Pivotal Trial
How many patients never enter the decision process and can we reach them through diagnostic strategy? Pharma Strategy Phase III Pivotal Trial
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Pharma Overview Phase III Pivotal Trial
Does PM enable us to explore a different payer model with integrated healthcare systems? Pharma Overview Phase III Pivotal Trial
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Pharma Overview Phase III Pivotal Trial
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Overview Phase III Pivotal Trial
What approaches should be in the marketing mix to optimize Dx adoption and appropriate prescription based on a positive test result? Pharma Overview Phase III Pivotal Trial
How do we agree on sharing costs of development and commercialization (ie, risk sharing)? Pharma Partnering Phase IIb Decision Point
Have we selected the most suitable collaborators/partners for the next phase of Dx development and commercialization work? Pharma Partnering Phase IIb Decision Point
Have we built in expectations for a test lifecycle critical to market and technology developments? Pharma Partnering Phase IIb Decision Point
Have we a plan for coordinated dialogues with our partner? Pharma Partnering Phase IIb Decision Point
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Pharma Partnering Phase IIb Decision Point
Will the Clinical Trial Assay (CTA) Dx test be analytically validated prior to its use in the pivotal Phase III clinical studies? Pharma Regulatory Phase IIb Decision Point
In which territories will a related Rx be marketed and do we have an understanding of the Dx regulatory requirements for these territories? Pharma Regulatory Phase IIb Decision Point
Should we make the Dx commercially available before, at or post-therapy launch? Pharma Regulatory Phase IIb Decision Point
Does the Indication for Use for the Dx support our overall Rx positioning and strategy? Pharma Regulatory Phase IIb Decision Point
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Pharma Regulatory Phase IIb Decision Point
How will the positioning of the test influence the reimbursement formulary for an Rx? Pharma Access Phase IIb Decision Point
Have we incorporated pharmacoeconomic assessment in Phase II/III? Pharma Access Phase IIb Decision Point
Does PM enable us to explore a different payer model with integrated healthcare systems? Pharma Access Phase IIb Decision Point
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Access Phase IIb Decision Point
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? Pharma Laboratories Phase IIb Decision Point
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Pharma Laboratories Phase IIb Decision Point
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Laboratories Phase IIb Decision Point
What level of investment will be needed to execute our Dx strategy? Pharma Financial Phase IIb Decision Point
What is the financial influence on our ROI in PM of an earlier Dx launch? Pharma Financial Phase IIb Decision Point
If we are partnering externally, what is the Dx business case and how can we incentivise them? Pharma Financial Phase IIb Decision Point
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Pharma Financial Phase IIb Decision Point
Have we modelled the NPV of this test based on its financial benefit to the therapy, its predicted adoption and physicians’ propensity to prescribe Rx based on a positive test result for each key region? Pharma Financial Phase IIb Decision Point
What are the Dx leverage points that provide an opportunity to influence behaviour and drive growth for the Rx brand? Pharma Marketing Phase IIb Decision Point
How might another pharma’s drug plus therapy change the position of or interrupt our Dx plan? Pharma Marketing Phase IIb Decision Point
Have we considered the Dx adoption benefits of higher levels of marketing integration between Rx and Dx? Pharma Marketing Phase IIb Decision Point
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? Pharma Marketing Phase IIb Decision Point
Can we leverage superior laboratory service to improve Rx market share? Pharma Marketing Phase IIb Decision Point
How can clinical strategy support test adoption by brand momentum and how tightly linked are the Dx and Rx in marketing to the physician? Pharma Clinical Phase IIb Decision Point
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? Pharma Clinical Phase IIb Decision Point
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Pharma Clinical Phase IIb Decision Point
What is the sample type needed for the assay? Pharma Adoption Phase IIb Decision Point
Will the Dx result likely be generated using a single measurement or will it be generated from a number of determinations using an algorithm? Pharma Adoption Phase IIb Decision Point
How difficult is the sample procurement? Pharma Adoption Phase IIb Decision Point
Are there enough responder patients to validate the test kit? Pharma Adoption Phase IIb Decision Point
Can the drug diagnostic biomarker eliminate enough non-responders to significantly improve the efficacy of the compound? Pharma Strategy Phase IIb Decision Point
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Pharma Strategy Phase IIb Decision Point
Can a CoDx modify the buying process and how will that affect the Rx? Pharma Strategy Phase IIb Decision Point
Are there potential severe adverse events for the compound in specific populations? Pharma Strategy Phase IIb Decision Point
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Overview Phase IIb Decision Point
Can the drug diagnostic biomarker eliminate the incidence of serious adverse events? Pharma Overview Phase IIb Decision Point
Can a CoDx modify the buying process and how will that affect the Rx? Pharma Overview Phase IIb Decision Point
Are there enough responder patients to validate the test kit? Pharma Overview Phase IIb Decision Point
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Overview Phase IIb Decision Point
How do we agree on sharing costs of development and commercialization (ie, risk sharing)? Pharma Partnering Phase IIa POC
Do we have the expertise to undertake due diligence on candidate develoment and commercialization partners? Pharma Partnering Phase IIa POC
Have we created a Product Specification Document (PSD) with enough detail for prospective partners to submit proposals? Pharma Partnering Phase IIa POC
Do we have a plan for coordinated dialogues with our partner? Pharma Partnering Phase IIa POC
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Pharma Partnering Phase IIa POC
Which clinical endpoints do we target and what are the studies needed that include the biomarker? Pharma Regulatory Phase IIa POC
Do we have a clear understanding of the Dx regulatory process? Pharma Regulatory Phase IIa POC
Does the Indication for Use for the Dx support our overall Rx positioning and strategy? Pharma Regulatory Phase IIa POC
Do we need to engage external Dx regulatory expertise? Pharma Regulatory Phase IIa POC
Are we prepared to meet the regulatory requirements and timelines in the EU, Japan and other key markets? Pharma Regulatory Phase IIa POC
What is the cost of the Dx relative to avoided healthcare cost? Pharma Access Phase IIa POC
What are the early reads on market access strategy? What will payers think and do? Pharma Access Phase IIa POC
How do payers affect diagnosis, treatment, brand choice and fulfillment? Will there be out of pocket costs or opportunities? Pharma Access Phase IIa POC
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Access Phase IIa POC
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Access Phase IIa POC
Will the laboratory take complete charge of billing for the test? Pharma Laboratories Phase IIa POC
Is the test financially attractive to the laboratory? Pharma Laboratories Phase IIa POC
Is the preferred Dx platform commercially available at reference labs or specialty labs and how globally available is/are the platform(s) envisaged to be used for the test delivery? Pharma Laboratories Phase IIa POC
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? Pharma Laboratories Phase IIa POC
What are the costs and benefits of moving forward with our Dx strategy? Pharma Financial Phase IIa POC
If we are partnering externally, what is the Dx business case and how can we incentivise them? Pharma Financial Phase IIa POC
How might PM impact our Rx pricing strategy and ROI? Pharma Financial Phase IIa POC
How many tests might be ordered each year at peak adoption and have we done a forecast projection? Pharma Financial Phase IIa POC
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Pharma Marketing Phase IIa POC
What are the Dx leverage points that provide an opportunity to influence behaviour and drive growth for the Rx brand? Pharma Marketing Phase IIa POC
How interdependent do we need or want the Rx and Dx positionings to be? Pharma Marketing Phase IIa POC
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? Pharma Marketing Phase IIa POC
Can we leverage superior laboratory service to improve Rx market share? Pharma Marketing Phase IIa POC
Will the new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? Pharma Clinical Phase IIa POC
Where should we expand our KOL capabilities? Pharma Clinical Phase IIa POC
To what extent are physicians aware of the disease, its prevalence and impact? Pharma Clinical Phase IIa POC
How novel is the biomarker, is there a lot of information about it available to the physician and what market development education is needed to ensure awareness? Pharma Clinical Phase IIa POC
Are there any requirements from a test, or preferences regarding test features, specific to individual markets, which may slow down adoption of the test in clinical routine? Pharma Clinical Phase IIa POC
Have we developed a robust product specification document defining our requirement for the development of the commercial test? Pharma Adoption Phase IIa POC
Does our choice of marker and instrument platform restrict our Dx commercialization options? Pharma Adoption Phase IIa POC
Are there enough responder patients to validate the test kit? Pharma Adoption Phase IIa POC
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Adoption Phase IIa POC
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Pharma Strategy Phase IIa POC
Does the Dx provide a proprietary position for the Rx or create a new market space? Pharma Strategy Phase IIa POC
Do we, as the drug owner, need to plan a diagnostic strategy in detail and manage its execution, rather than farm it out to a Dx company, and what are the critical considerations in making this choice? Pharma Strategy Phase IIa POC
Can the drug diagnostic biomarker eliminate the incidence of serious adverse events? Pharma Strategy Phase IIa POC
Are there potential severe adverse events for the compound in specific populations? Pharma Strategy Phase IIa POC
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Overview Phase IIa POC
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Pharma Overview Phase IIa POC
Are there potential severe adverse events for the compound in specific populations? Pharma Overview Phase IIa POC
Are there enough responder patients to validate the test kit? Pharma Overview Phase IIa POC
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Overview Phase IIa POC
How do we manage our partner? Pharma Partnering Phase I FIH
How do we engage our partner? Pharma Partnering Phase I FIH
How do we choose the right partner and have we established a criteria list for partner selection? Pharma Partnering Phase I FIH
Do we have the expertise to undertake due diligence on candidate develoment and commercialization partners? Pharma Partnering Phase I FIH
Do we have an objective process for the selection of development and commercialization partner(s)? Pharma Partnering Phase I FIH
Should we make the Dx commercially available before, at or post-therapy launch? Pharma Regulatory Phase I FIH
Have we planned for the evolution of regulatory requirements? Pharma Regulatory Phase I FIH
Do we have a clear understanding of the Dx regulatory process? Pharma Regulatory Phase I FIH
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? Pharma Regulatory Phase I FIH
In the US, is it likely that existing CPT codes can be used or will a new code be required? Pharma Access Phase I FIH
In the EU, will we need to subsidize testing and, if so, what is our funding exit strategy? Pharma Access Phase I FIH
In Asia (outside of Japan) and other patient pay markets, will we need to subsidize testing and, if so, what is our funding exit strategy? Pharma Access Phase I FIH
Have we incorporated pharmacoeconomic assessment in Phase II/III? Pharma Access Phase I FIH
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Access Phase I FIH
Is the preferred Dx platform commercially available at reference labs or specialty labs and how globally available is/are the platform(s) envisaged to be used for the test delivery? Pharma Laboratories Phase I FIH
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? Pharma Laboratories Phase I FIH
Is the test financially attractive to the laboratory? Pharma Laboratories Phase I FIH
How can we ensure efficient transportation of the patient sample to the labs? Pharma Laboratories Phase I FIH
How does test adoption influence our investment choices? Pharma Financial Phase I FIH
Is there financial benefit for a therapy in introducing a multi-test strategy which brings more patients into the treatment pool? Pharma Financial Phase I FIH
Will the Dx shaping drive significant volume? Pharma Financial Phase I FIH
What are the costs and benefits of moving forward with our Dx strategy? Pharma Financial Phase I FIH
If the Dx or biomarker is expected to be utilized by competitors, what is our competitive strategy? Pharma Marketing Phase I FIH
What market research do we need and how is Dx-based market research different? Pharma Marketing Phase I FIH
What does the competitive landscape look like for an Rx seen through the lens of the current and rapidly evolving competitive Dx market and has the future Dx landscape been predicted? Pharma Marketing Phase I FIH
Should we manage the marketing spend or leave that to a Dx partner and what is the appropriate Rx and Dx marketing spend split to optimize ROI? Pharma Marketing Phase I FIH
Will the new therapy require a change in a practice guideline for the disease and can a drug-related diagnostic biomarker help? Pharma Clinical Phase I FIH
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? Pharma Clinical Phase I FIH
How novel is the biomarker and is there a lot of information about it available to the physician? Pharma Clinical Phase I FIH
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Pharma Clinical Phase I FIH
What is the sample type needed for the assay? Pharma Adoption Phase I FIH
What level of validation is required for the biomarker and where is it done? Pharma Adoption Phase I FIH
How difficult is the sample procurement? Pharma Adoption Phase I FIH
Does our choice of marker and instrument platform restrict our Dx commercialization options? Pharma Adoption Phase I FIH
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Adoption Phase I FIH
Have we estimated the costs to develop the Dx test, obtain regulatory approval and commercialize it? Pharma Strategy Phase I FIH
Can we use Dx/CoDx to change treatment paradigm pre-launch of the Rx? Pharma Strategy Phase I FIH
Can the drug diagnostic biomarker eliminate enough non-responders to significantly improve the efficacy of the compound? Pharma Strategy Phase I FIH
Can a CoDx modify the buying process and how will that affect the Rx? Pharma Strategy Phase I FIH
Are there potential severe adverse events for the compound in specific populations? Pharma Strategy Phase I FIH
Do we believe that we can drive a higher price point if we isolate the target patient population more narrowly, through a companion Dx or a related intervention? Pharma Overview Phase I FIH
Could we see opportunities to introduce a novel access and reimbursment approach, combining Rx and Dx into a comprehensive package? Pharma Overview Phase I FIH
Can the drug diagnostic biomarker eliminate the incidence of serious adverse events? Pharma Overview Phase I FIH
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Pharma Overview Phase I FIH
Are there potential severe adverse events for the compound in specific populations? Pharma Overview Phase I FIH
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Overview Phase I FIH
Can we tie Rx to Dx technology via IP? Pharma Overview Pre Clinical
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Overview Pre Clinical
Can our Rx disproportionately benefit from a Dx or CoDx that is already on the market, even one from a competitor? Pharma Overview Pre Clinical
Beyond the currently envisaged delivery platform, could the commercial Dx test easily be designed for use on a range of routinely used instrument platforms available from test providers worldwide? Pharma Overview Pre Clinical
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Overview Pre Clinical
Should we work with separate partners for the scientific and the commercial development of our Dx? Pharma Partnering Pre Clinical
Do we have a plan for coordinated dialogues with our partner? Pharma Partnering Pre Clinical
What partnering issues need to be considered and how can we partner effectively with Dx and lab companies? Pharma Partnering Pre Clinical
Do we have the expertise to undertake due diligence on candidate develoment and commercialization partners? Pharma Partnering Pre Clinical
Can we partner with consortia in the early stages for landscape analysis in the biomarker area? Pharma Partnering Pre Clinical
Will the Dx test be used to identify patients who have significant adverse reaction to the administered Rx? Pharma Regulatory Pre Clinical
Do clinical or pre-clinical trial results exist to provide evidence that the Dx biomarker has the potential to deliver the intended clinical utility? Pharma Regulatory Pre Clinical
Will the drug biomarker need to be in the labelling of the drug? Pharma Regulatory Pre Clinical
Do we have a clear understanding of the Dx regulatory process? Pharma Regulatory Pre Clinical
Does the Indication for Use for the Dx support our overall Rx positioning and strategy? Pharma Regulatory Pre Clinical
What are the early reads on market access strategy and what will payers think and do? Pharma Access Pre Clinical
What is the cost of the Dx relative to avoided healthcare cost? Pharma Access Pre Clinical
Can the drug diagnostic biomarker improve the value of the drug to the healthcare system? Pharma Access Pre Clinical
How do payers affect diagnosis, treatment, brand choice and fulfilment? Will there be out of pocket costs or opportunities? Pharma Access Pre Clinical
Does the Dx require any new or specialist equipment/platforms to be acquired or otherwise sourced by the physician or laboratory? Pharma Laboratories Pre Clinical
Given that the Dx test would be performed on the instruments of one or more manufacturers, independently of the choice of test developer, what type of contacts with these companies make sense to initiate? Pharma Laboratories Pre Clinical
How many laboratories will be able to offer the companion diagnostic test? Pharma Laboratories Pre Clinical
How can we ensure efficient transportation of the patient sample to the labs? Pharma Laboratories Pre Clinical
Are the marker and/or platform innovative (ie, currently only used in the research setting) or established in the routine clinical setting for which they are intended? Pharma Laboratories Pre Clinical
How does propensity to prescribe (percentage of patients actually getting Rx) influence our investment choices? Pharma Financial Pre Clinical
What is the financial influence on our ROI in PM of an earlier Dx launch? Pharma Financial Pre Clinical
Is there financial benefit for a therapy in introducing a multi-test strategy which brings more patients into the treatment pool? Pharma Financial Pre Clinical
What are the costs and benefits of moving forward with our Dx strategy? Pharma Financial Pre Clinical
How dependent will our therapy’s commercial ambition be on a redesigned diagnostic environment, what is the optimal environment for launch and what gaps need to be filled? Pharma Financial Pre Clinical
What is the Dx brand vision and how closely do we want to link the Rx and Dx brands? Pharma Marketing Pre Clinical
If the Dx or biomarker is expected to be utilized by competitors, what is our competitive strategy? Pharma Marketing Pre Clinical
Have we mapped out how a market conversion could occur in a solely PM marketplace like oncology? Pharma Marketing Pre Clinical
How might competitors pre-position us using Dx and how could they help with awareness/pre-competitive partnering using Dx? Pharma Marketing Pre Clinical
How interdependent do we need or want the Rx and Dx positionings to be? Pharma Marketing Pre Clinical
Where and how many patients fall out of the patient journey and how does this impact the buying process? Pharma Clinical Pre Clinical
How novel is the biomarker, is there a lot of information about it available to the physician and what market development education is needed to ensure awareness? Pharma Clinical Pre Clinical
To what extent are physicians aware of the disease, its prevalence and impact? Pharma Clinical Pre Clinical
Have we defined the minimum (note: not maximum) clinical performance characteristics (sensitivity/specificity) required to deliver on the intended clinical use? Pharma Clinical Pre Clinical
Does the Dx test involve a procedure that is invasive, inconvenient to the patient or pose considerable risks to the patient’s health? Pharma Clinical Pre Clinical
Will there be enough responder patients to validate the biomarker? Pharma Adoption Pre Clinical
Have we developed a robust product specification document defining our requirement for the development of the commercial test? Pharma Adoption Pre Clinical
Does our choice of marker and instrument platform restrict our Dx commercialization options? Pharma Adoption Pre Clinical
Can we tie Rx to Dx technology we have via IP? Pharma Adoption Pre Clinical
Are the marker(s) and/or platform and/or the clinical application of the Dx covered by patents or other IP protection, and do they give us sufficient freedom to operate? Pharma Adoption Pre Clinical
Will the sample be available on diagnosis or just before treatment? Pharma Adoption Pre Clinical
Will the Dx result likely be generated using a single measurement or will it be generated from a number of determinations using an algorithm? Pharma Adoption Pre Clinical
How will the platform choice affect test adoption? Pharma Adoption Pre Clinical
Have we selected the instrument platform to be used to run the Dx test? Pharma Adoption Pre Clinical
Are there enough responder patients to validate the test kit? Pharma Adoption Pre Clinical
When is the right time to start planning our Dx strategy? Pharma Strategy Pre Clinical
Have we comprehensively mapped out how competitor moves or other external developments may impact our choice of Dx test and related development programs? Pharma Strategy Pre Clinical
How might PM strategy impact our therapy positioning, are competitive products being delivered for this indication and does the Dx need to include all products or just ours? Pharma Strategy Pre Clinical
How is the patient diagnosed, by whom and with what tools, and what technical advances and tools can be anticipated and/or shaped by us? Pharma Strategy Pre Clinical
Given the specific challenges in the particular disease’s patient journey, what are the essential requirements for our Dx (eg, accessibility, low cost, non-invasiveness, etc.)? Pharma Strategy Pre Clinical
How does this biomarker improve the commercial feasibility of the therapy? Pharma Strategy Pre Clinical
Have we estimated the costs to develop the Dx test, obtain regulatory approval and commercialize it? Pharma Strategy Pre Clinical
Have we clearly defined the type of marker(s) we intend to develop and commercialize? Pharma Strategy Pre Clinical