PharmaPerspectiveonCDx. DrGillian Ellison

Transcription

1 PharmaPerspectiveonCDx DrGillian Ellison

2 Pharma Perspective Need for CDx Partnering with Dx company Co- development Launch readiness & LCM

3 Need for CDx Drug development Drug development is a challenging and competitive business Drugs don t tend to work in all patients Cost of new medicines keeps rising Patient stratification needs to be considered

4 Need for CDx The need for CDx Pros Competitive edge Better for patients Faster drug approval Smaller studies More acceptable to payors Required Required by regulators- efficacy/safety Cons Smaller patient market Less profit Need for Dx for trials and sales Extra regulatory processes Extra cost of development Every situation will be different

5 Need for CDx Increase in Precision Medicines 28% of the novel new drugs approved by the FDA in 2015 are personalised medicines 35% of the novel new oncology drugs approved by the FDA in 2015 are personalised medicines Corporate/file/2015_Progress_Report_PM_at_FDA1.pdf

6 Partnering with Dx company Partnering with a Dx Company Drug approval Drug sales Pharma are not Dx experts May need different Dx for different medicines

7 Partnering with Dx company The Selection Process Multidisciplinary Team Drug development project leads Technical experts Search for Dx companies Shortlisting Request for information- questionnaire Visit(s) Regulatory Scoring matrix Commercial function Business development/alliance management Decision

8 Partnering with Dx company Partner Selection Criteria What criteria could be used to help select the best Dx partner?

9 Partnering with Dx company Examples of criteria Expertise in required Dx Technology Previous experience with the Dx company Dx regulatory expertise Global reach Financial stability Cost IP (eg gene) Kit Existing test Gut feeling/unknown factor Time to delivery Same company Compliance/ethics Weighted criteria: critical to nice to have

10 Co- development Co- development Process Rx Patent life Pre- clinical Clinical Phase I Clinical Phase II Clinical Phase III / Registration studies Regulatory approval Possible need for patient stratification determined Small studies- need unknown Case for CDx may be made- Investment decision Need CDx- NOW CDx required- NOW Dx Drug may fail Drug may fail Drug may fail Not approved Feasibility studies Prototype assays/product development Analytical validation Clinical validation/utility Regulatory approval

11 Co- development Pharma are aware of the time constraints Start researching for suitable Dx companies Collect samples- biobanking Biomarker testing If possible use commercial tests for biomarker analysis on studies Interim analysis on ongoing studies Method comparison studies

12 Co- development Expectations of the Dx Partner During Development Good communication on progress and issues Dx partner will be the Dx expert Dx partner will determine how to develop the required test Meet timelines Stick to budget Attend joint regulatory meetings Open to audit/inspection Allow regular QC of clinical data- can be early warning of many issues Provide training on Dx test

13 Co- development Working with your partner We speak different languages eg Test sensitivity Sensitivity measures the proportion of positives that are correctly identified as such (e.g., the percentage of sick people who are correctly identified as having the condition) Not- an amount that can be detected- Limit of Detection Important when defining test specification

14 Co- development Beyond Funding Pharma will have resources beyond just funding Disease area expertise Access to technologies Samples- knowledge of issues, access to biobanks, known variants/positives/negatives Biomarker testing expertise

15 Launch readiness & LCM Launch Readiness & Life Cycle Management Big change in Dx requirements Dx now required to sell the drug Testing rates Increased testing required Testing globally Increase in testing labs Different country requirements Cost of testing Samples Test reimbursement Clinical pathway/patient journey Clinical studies Year 1 Year 2

16 Launch readiness & LCM Pharma activities to enable testing to treat Education of the health care providers on WHY the need for testing Education on HOW to test May engage with other Dx companies to increase testing options Training field force on Dx Develop testing pathways May pay for testing Dx studies

17 Launch readiness & LCM Comes with risks Competitors use your Dx initiatives But no Dx = no prescriptions

18 Launch readiness & LCM Expectations of the Dx Partner Post- approval Help with training- labs, pharma field force Supply and support tests as long as they are needed Early warning if Dx to be withdrawn

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