Companion Diagnostics and Biomarker Development (PH169)

Partnership Strategies and Benchmarks
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Published 2012
113 Pages
400+ Metrics
90+ Charts and Diagrams

Navigate Companion Diagnostic Development

As the life sciences industry adjusts to the current patent cliff and an increasingly payer-driven environment, specialized medicine is emerging as a critical asset in clinical development strategy. Biomarkers and companion diagnostics (CDx) offer companies the ability to target a subset of patients for testing — unleashing the potential for greater efficacy, accelerated regulatory approval and better reimbursement.

Companion diagnostics are not suitable for every product, however. The decision to embark on a CDx program is a complex one involving a pharmaceutical company’s resources and its clinical goals. Top-performing companies prepare for success by developing consistent criteria and protocol that lead to thoughtful partner selection and follow-through — ensuring a smooth co-development timeline under budget.

Clarify your decision making with this report’s in-depth data benchmarks and best practices from leading global life sciences firms. Fresh first-hand insights from pharma, biotech and diagnostic development firms will expand your understanding of companion diagnostics strategy, timing, resources, partnership leadership and test preferences.


Top Reasons to Buy this Report

Create an Effective Strategic Plan: See how other companies approach companion diagnostics, learning how they analyze the different factors that impact their go/no-go decisions and select the actual tests. The report also explores what is done in-house versus handled at diagnostics companies as you peruse real-company staffing data and budget ranges from across the life sciences.

Align Drug and Diagnostic Regulatory Timelines: Running a clinical trial in and of itself is hard; adding a diagnostic’s development at the same time is even more challenging, but essential. See detailed timeline breakdowns by development stage to keep products on track.

Master Partner Selection, Coordination, and Partnership Management: The right partner can mean the difference between lucrative results and disappointing outcomes. Learn who’s involved in partner selection — and the six (6) critical factors companies consider — and who leads the partnership at different points in product development. The report also identifies red flags foreshadowing potential partnership problems and includes best practices for strengthening communication between both sides. Along the way, discover how some companies rate six major diagnostics firms on specific tests.

Track Therapeutic Area Data: Get a firm handle on companion diagnostics activity in five prominent therapeutic areas (oncology, CNS, cardiovascular, inflammation and virology). Each snapshot shows the percentage of the company’s pipeline with a biomarker/CDx program, type of program, and program goals.

Companion Diagnostic Metrics and Benchmarks


Chapter 1: CDx Strategy, Timing and Resources

Chapter Benefits

  • Get real-company perspectives on CDx benefits, uses and limitations.
  • Explore ratings and analysis of five (5) key criteria that influence go/no-go decisions.
  • Choose the right test — see what factors companies use to select tests, based on specific criteria (e.g., speed, reliability, cost)
  • Learn what is usually done in house versus with a partner’s capabilities.
  • Align drug and CDx development timing with regulatory approval processes.
  • Benchmark CDx costs and personnel using budget ranges and staffing data.

Chapter Data

35 charts focused on these topics:

  • Importance of different criteria in deciding to develop a companion diagnostic
  • Key decision criteria, including responder identification in early-stage and late-stage trials, the existence of a charter to develop CDx for all new molecular entities, and goals to developing new indications or rescue failed programs
  • Rating selection criteria for the development of CDx tests
  • Level of in-house development
  • Assays developed by in-house teams
  • Drug development phase in which companies begin CDx development
  • Percentage of companies involved in CDx during product development:
  • Likelihood to initiate a biomarker program in order to develop a CLIA/CAP in vitro diagnostic (IVD) during drug phases
  • Likelihood to have a dedicated budget for development of CLIA/CAP in vitro diagnostic during drug phases
  • Cost to develop a CDX program, by company size
  • FTEs involved in CDx

Chapter 2: CDx Partnerships: Selection, Involvement and Leadership

Chapter Benefits

  • Explore the benefits of different types of CDx firms to determine your company needs, and examine criteria ratings of different CDx capabilities.
  • Discover what qualities companies consider when they select a partner.
  • Learn who should be involved in CDx program due diligence.
  • Prevent common partnership problems, and strengthen communication.
  • See who’s leading partnerships, and establish leadership at each product development phase.
  • Explore real-company rankings of six major diagnostics companies’ abilities.

Chapter Data

40 charts focused on these topics:

  • Preference for full-service diagnostics partners
  • Ratings for 13 key criteria for CDx partner selection
  • Lead CDx decision maker during product development phases
  • Rankings of major service labs’ and in vitro diagnostics manufacturers’ CDx capabilities
  • DNA nucleic acid tests preferred partners
  • RNA nucleic acid tests preferred partners
  • Immunoassays preferred partners
  • Point-of-care tests preferred partners
  • Multiplexed platform tests preferred partners
  • Microassay tests preferred partners
  • Array CGH tests preferred partners
  • Sequencing tests preferred partners
  • Global analysis & IT solutions preferred partners
  • Single-cell (rare cell) analysis preferred partners
  • Microfluidic tests preferred partners
  • Molecular imaging preferred partners
  • IHC/ISH tests preferred partners

Chapter 3: Therapeutic Area Snapshots

Chapter Benefits

  • Get a quick overview of CDx activity in five major therapeutic areas.
  • See relevant companion diagnostic/biomarker data for each TA at a glance.

Chapter Data

5 profiles of companion diagnostics and biomarkers for these therapeutic areas:

  • Oncology
  • Central Nervous System
  • Cardiovascular
  • Inflammation
  • Virology

Each profile contains the following elements:

  • Number of products in pipeline
  • Percentage of companies and products with biomarker programs
  • Percentage of companies and products with CDx
  • Types of products with companion diagnostics (small molecule and large molecule)
  • Usage rates for retrospective and prospective trials
  • Usage rates for companion diagnostics
  • Usage rates for predictive and prognostic biomarkers

Appendix

Chapter Benefit

  • Explore a compendium of data benchmarks for companion diagnostics and biomarkers

Chapter Data

20 charts focused on these topics:

  • Companion diagnostic test preferences
  • Types of tests that are developed
  • Importance of CLIA/CAP lab ownership when selecting partners
  • Stage at which GLP manufacturing is employed (when necessary)
  • Phase in which biomarker-specific trials are initiated (when necessary)
  • Preferred types of biomarkers
  • Preferred sample types
  • Preference for single-gene vs. multi-gene analyses as CDx, by company
  • Multi-gene analyses currently in use
  • Need for multiplex platforms of protein/antibody detection by company
  • Satisfaction ratings for types of multiplex protein/antibody platforms
  • Need for oligoplex protein technologies
  • Companies that consider positive predictive value (PPV) and negative predictive value (NPV) separately when considering CDx accuracy

Companion Diagnostics Report Sample

The following excerpt is a key finding from the full report’s Executive Summary.

Develop Consistent Criteria to Select the Right Test for a Companion Diagnostics Program

After the company reviews the clinical data for a particular compound and decides to pursue a companion diagnostic, it is time to focus on the test itself. The company should evaluate a potential companion diagnostic test considering the following criteria:

  • Accuracy
  • Reliability
  • Speed
  • Cost

Ideally, the companion diagnostic test for a drug would be both extremely accurate and reliable, while requiring little time and money to develop — but in reality, these tests can be complicated. Figure E.3 [Figure appears in full report] shows the four evaluation criteria and the average importance survey respondents assigned to them, rated on a scale of 1 to 5. Not surprisingly, all four criteria earned an average rating of 4.0 or greater, indicating that they are very important when selecting a companion diagnostics test. But the two clinical criteria (accuracy and reliability) rank slightly higher than the two business development criteria (speed and cost).

Accuracy and reliability each earned an average rating of 4.6. Survey respondents agree — accuracy and reliability are at the heart of a successful companion diagnostic program. These criteria are critically important to the test selection process. The success of an entire companion diagnostic program (and maybe the drug itself) hinges on the test’s ability to accurately and reliably select patients who will respond effectively to a drug. Without these two characteristics, the test likely will not receive regulatory approval, nor will it be widely used.

The third most important criteria in selecting a companion diagnostic test is speed, earning an average rating of 4.3. It is critical because investigational compounds are on a strict development timeline of their own. If the companion diagnostic test cannot be developed quickly enough, then the drug might experience delays regulatory approval or market access and reimbursement. Because patent protection for a compound is finite, delays can be costly, so most companies would rather spend the extra money to ensure the test is developed quickly. Those additional costs can be recouped if the drug and the companion diagnostic test enter the market sooner than expected.

Cost, earning an average rating of 4.0, ranked last on the list of test selection criteria. Because all, or most, of the companion diagnostic program will be developed outside the pharmaceutical company, cost is a critical consideration when selecting a test. It should not be the only consideration, however.

Companion Diagnostics Report Sample

  The following excerpt is a key finding from the full report’s Executive Summary. Develop Consistent Criteria to Select the Right Test for a Companion Diagnostics Program After the company reviews the clinical data for a particular compound and decides to pursue a companion diagnostic, it is time to focus on the test itself.  The company should evaluate a potential companion diagnostic test considering the following criteria:
  • Accuracy
  • Reliability
  • Speed
  • Cost
Ideally, the companion diagnostic test for a drug would be both extremely accurate and reliable, while requiring little time and money to develop — but in reality, these tests can be complicated. Figure E.3 [Figure appears in full report] shows the four evaluation criteria and the average importance survey respondents assigned to them, rated on a scale of 1 to 5.  Not surprisingly, all four criteria earned an average rating of 4.0 or greater, indicating that they are very important when selecting a companion diagnostics test. But the two clinical criteria (accuracy and reliability) rank slightly higher than the two business development criteria (speed and cost). Accuracy and reliability each earned an average rating of 4.6. Survey respondents agree — accuracy and reliability are at the heart of a successful companion diagnostic program.  These criteria are critically important to the test selection process.  The success of an entire companion diagnostic program (and maybe the drug itself) hinges on the test’s ability to accurately and reliably select patients who will respond effectively to a drug.  Without these two characteristics, the test likely will not receive regulatory approval, nor will it be widely used. The third most important criteria in selecting a companion diagnostic test is speed, earning an average rating of 4.3.  It is critical because investigational compounds are on a strict development timeline of their own.  If the companion diagnostic test cannot be developed quickly enough, then the drug might experience delays regulatory approval or market access and reimbursement.  Because patent protection for a compound is finite, delays can be costly, so most companies would rather spend the extra money to ensure the test is developed quickly.  Those additional costs can be recouped if the drug and the companion diagnostic test enter the market sooner than expected. Cost, earning an average rating of 4.0, ranked last on the list of test selection criteria.  Because all, or most, of the companion diagnostic program will be developed outside the pharmaceutical company, cost is a critical consideration when selecting a test.  It should not be the only consideration, however.