Partnering with Diagnostic Companies | Diaceutics

Partnering with Diagnostic Companies


This case study focuses on partnerships with diagnostics companies and why they need to be clearly defined. It outlines the core principles of partnering in the diagnostic space, highlighting the partner selection process steps and timelines that can enable an optimal CDx strategy. It will help you understand:
  • That partnerships with diagnostic companies are not as simple to set up and manage as they seem
  • While much of the CDx strategic and tactical plan can and should be executed by the diagnostic partner, pharma must maintain the role of strategic architect
  • The core principles of partnering in the diagnostic space and the partner selection process steps and timelines
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Table Of Contents

1: Case Summary2: Partnerships with Diagnostic Companies May Not Be as Simple to Set Up and Manage as they Seem3: A Clearly Defined Partnering Process Helps to Avoid Potential Future Challenges4: A Suboptimally Planned and Executed CDx Strategy Can Impact on Novel Drug Uptake5: Pfizer's Failure to Manage its Partnership Meant FDA Approval for the Trofile Test was Never Sought6: Pharma R&D and Commercial Teams Both Need to Buy In to a Dx Partnership …7: … As Lack of a Commercial Buy-In to a Dx Alliance Can Lead to Serious Strategic Misalignment8: Different Models Pursued to Ensure Pharma Access to Critical CDx Capabilities9: Novartis’s Genoptix Offers Lab Services for Routine Testing and Dx Development10: Genoptix' CLIA-Certified Labs Provide Pharma with Full CDx Development Services...11: … Embedded in a Global Network of Partner Labs and Distribution Depots …12: … Offering Collaboration Models From Fee-for-Service to Strategic Partnerships …13: … All the Way from Assay Development to Rx / Dx Co-Approval14: Pfizer's In-House CLIA-Certified Lab Supports Clinical and Preclinical Development15: Early Partnership Between Pfizer and Abbott Enabled Aligned Development of Rx and Dx 16: Abbott Vysis ALK CDx: a New Benchmark for Co-Developed Tests?17: However, Pfizer’s Choice of FISH for its ALK CDx is Considered 'Technically Challenging and Costly'18: Consequently, Pfizer Also Partnered with Roche’s Ventana to Develop a More Adoption-Friendly IHC CDx19: Ventana’s IHC ALK CDx for Xalkori Received Approval in China in September 201320: Contract Research Organizations Providing CDx Capabilities in Development21: CLIA-Certified Since 2011, Covance Genomics Lab Offers State-of-the-Art Dx Services for Drug Development22: Labceutics Provides Fully Integrated Personalized Medicine Laboratory Partnerships23: Labceutics' Clients Gain Access to Specialist Resources to Execute Seamless Testing Programs in the EU and Beyond24: Key Messages

1: Case Summary

This case will help you understand:

That partnerships with diagnostic companies are not as simple to set up and manage as they seem.

While much of the CDx strategic and tactical plan can and should be executed by the diagnostic partner, pharma must maintain the role of strategic architect.

The core principles of partnering in the diagnostic space and the partner selection process steps and timelines.

Key messages:

Partnerships with diagnostic companies are not as simple to set up and manage as they seem.

A clearly-defined partnering process will allow you to avoid potential challenges going forward. 

A suboptimally planned and executed diagnostic strategy can have a big impact on novel drug uptake.

Key actions:

Understand and clearly define the partnering process.

Know your needs to create an efficient diagnostic market for the therapy.

2: Partnerships with Diagnostic Companies May Not Be as Simple to Set Up and Manage as they Seem

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So What?

Problems with a partner usually occur because the pharmaceutical company is not specific about its requirements or because those requirements change over time.

3: A Clearly Defined Partnering Process Helps to Avoid Potential Future Challenges

 

So What?

Start by 'knowing your total needs' to create an efficient diagnostic market for your therapy. Then shortlist and engage the partner or partners most likely to help you meet those needs.

4: A Suboptimally Planned and Executed CDx Strategy Can Impact on Novel Drug Uptake

Example: Pfizer’s Selzentry and Monogram Biosciences' Trofile Dx

5: Pfizer's Failure to Manage its Partnership Meant FDA Approval for the Trofile Test was Never Sought

Example: Pfizer’s Selzentry and Monogram Biosciences’ Trofile Dx

 


 

 

So What?

An expensive, inconvenient testing approach contributed substantially to a disappointing Selzentry market performance.

6: Pharma R&D and Commercial Teams Both Need to Buy In to a Dx Partnership …

Example: Sanofi-Aventis’ Lovenox and PharmaNetics' ENOX Dx

7: … As Lack of a Commercial Buy-In to a Dx Alliance Can Lead to Serious Strategic Misalignment

 

 

So What?

Sanofi-Aventis did not follow the closely aligned Rx/Dx strategy and decided to promote the drug's use without the need to test. Consequently, PharmaNetics sued Sanofi-Aventis for false and misleading promotion.

8: Different Models Pursued to Ensure Pharma Access to Critical CDx Capabilities

9: Novartis’s Genoptix Offers Lab Services for Routine Testing and Dx Development

 

 

So What?

Genoptix's self-portrait suggests a shifting focus from clinical routine testing to pharma development support around lab and diagnostic development services.

10: Genoptix' CLIA-Certified Labs Provide Pharma with Full CDx Development Services...

11: … Embedded in a Global Network of Partner Labs and Distribution Depots …

12: … Offering Collaboration Models From Fee-for-Service to Strategic Partnerships …

13: … All the Way from Assay Development to Rx / Dx Co-Approval

14: Pfizer's In-House CLIA-Certified Lab Supports Clinical and Preclinical Development

Clinical Pharmacogenomics (PGx) Lab at Pfizer, Norwich CT …
…Clinical Laboratory Improvement Amendments (CLIA) certified in Pharmacogenomics.



…provide PGx support to multiple clinical trials and to pre­clinical PGx studies associated with drug responses or toxicities.


15: Early Partnership Between Pfizer and Abbott Enabled Aligned Development of Rx and Dx

  • Advancing a candidate companion diagnostic test through early development and into PMA-enabling late development requires close integration with the clinical development plan.
  • Similar to the sequence of decisions committing increasing resources to advance a drug candidate through the pipeline (e.g., candidate nomination for FIH study, POM, POC), development of a candidate companion diagnostic test also requires rigorous, data-driven evaluation.

16: Abbott Vysis ALK CDx: a New Benchmark for Co-Developed Tests?

Commentary

Abbott received a PMA from the FDA at the same time as Xalkori was approved, ensuring an FDA-approved test for ALK was on the market.

The co-development and co-approval processes were hailed as examples of the promise of rapid approval and definitive testing in the new era of personalized medicine.

17: However, Pfizer’s Choice of FISH for its ALK CDx is Considered 'Technically Challenging and Costly'

 
 

Although ALK FISH is clinically validated, the assay can be technically challenging and costly Therefore, other diagnostic modalities are being explored, including immunohistochemistry (IHC) and reverse transcriptase-polymerase chain reaction. This article provides an overview of the diagnostic assays available for detecting ALK rearrangement. Each assay, including ALK FISH, has its strengths and weaknesses.

 


Commentary

The debate about FISH testing versus IHC testing harkens back to the ongoing issues around the accuracy and cost-effectiveness of Her2 expression testing for Herceptin.

Test adoption rates and propensity to prescribe rate are lowered by confusion and debate around quality of testing.

18: Consequently, Pfizer Also Partnered with Roche’s Ventana to Develop a More Adoption-Friendly IHC CDx

So What?

"...a collaboration agreement with Pfizer Inc. and license agreement with Cell Signalling Technology (CST) to develop the first fully automated and standardized immunohistochemistry (INC) companion diagnostic test for ALK gene rearrangements."

Commentary

Once the Ventana IHC CDx is approved, the Abbott ALK FISH test will no longer be the only official CDx option on the market. This suggests that the agreement between Pfizer and Abbott on developing an ALK CDx was non-exclusive.

19: Ventana’s IHC ALK CDx for Xalkori Received Approval in China in September 2013

Commentary

The approval is based on a retrospective study that included 1100 Chinese subjects across three national hospitals where the Ventana assay demonstrated 99.23 per cent concordance with Abbott's Vysis ALK Break Apart FISH Probe Kit.

20: Contract Research Organizations Providing CDx Capabilities in Development

21: CLIA-Certified Since 2011, Covance Genomics Lab Offers State-of-the-Art Dx Services for Drug Development

Commentary

The laboratory is purpose-built to support genomics-based drug development with services including next generation sequencing, gene expression profiling, genome-wide genotyping, qPCR biomarker assays, microRNA profiling, targeted genotyping, tissue homogenization and nucleic acid extraction, scalable amplification protocols and computational biology and bioinformatics. Having run more than 450,000 samples to date, the laboratory provides end-to-end services for genomics-based drug development research.

22: Labceutics Provides Fully Integrated Personalized Medicine Laboratory Partnerships

So What?
Labceutics is a global laboratory network providing pharma and diagnostic companies with a fully integrated personalized medicine laboratory partner.

23: Labceutics' Clients Gain Access to Specialist Resources to Execute Seamless Testing Programs in the EU and Beyond

24: Key Messages

Key messages:

Partnerships with diagnostic companies are not as simple to set up and manage as they seem.

A clearly-defined partnering process will allow you to avoid potential challenges going forward. 

A suboptimally planned and executed diagnostic strategy can have a big impact on novel drug uptake.

Key actions:

Understand and clearly define the partnering process.

Know your needs to create an efficient diagnostic market for the therapy.

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