Accelerating Drug Development through Drug &
Companion Diagnostic Co-Development
Mark Roberts PhD
Director, Diagnostics De...
Our Environment Today
Pressured Cycle of Dependencies

Market Realities
Price
Pressures

Regulations

R&D Cost
Pressures

...
Drugs Don’t Work for all Patients

Antidepressants

Asthma Drugs

Arthritis Drugs

Diabetes Drugs

Cancer Drugs

Estimated...
The Future Is ……… Personalized Medicine
Providing






4

CONFIDENTIAL

the right treatment
for the right person
at t...
The New Drug Development Paradigm
Personalized Medicine
Personalized Medicine
Targeted
Therapeutic

Biomarker

Companion D...
CDx: Historical Perspective
• Many „Companion‟ Diagnostics developed after a
drug is on market
• Retrospective validation ...
CDx: A New Perspective
• Better understanding of the genetic and
polypharmacy causes of adverse reaction
• Increasing util...
FDA :Drug & CDx Co-Development

“In most circumstances, if use of an in vitro
companion diagnostic device is essential for...
Drug / CDx co-development successes
Targets V600E mutated BRAF
in advanced melanoma
Occurs is ca. 60% of mm
patients
Drug ...
Voice of the Client Survey : 2011
QUESTION:

What role do you see CROs playing in the development of
companion diagnostics...
Summary of VOC Feedback
• Clients had not considered CROs role – Dx focused
• Clients continue to define their needs (lack...
Charting a New Model
The future of Healthcare will require a new mindset:
Products and industries once considered separate...
Why Rx / CDx Co-Development?

Potential to:
enhance therapeutic
improve trial design efficacy
increase safety & reduce ris...
Hurdles Under the New Model

Understanding the
diagnostic industry

Choosing a
Diagnostics Partner

Complex Trial
Executio...
Global Diagnostics Market
• $ 44 billion in 2011
• > 5% CAGR to $62 billion in 2016

• Largest Players
–
–
–
–

Roche
Siem...
Companion Diagnostics Market
World Companion Diagnostics Market 2010-2021 ($Billions)
(incl. the sales of testing kits and...
Considerations in Choice of Commercial Partner
•
•
•
•

Nature of Diagnostic Target (biomarker)
Required Turn around Time ...
Rx / CDx Co-Development Value for Stakeholders
Stake Holder

BioPharma
Companies

Dx
Companies

18

Benefit
• Reduced Drug...
Hurdles Under the New Model

Understanding the
diagnostic industry

Choosing a
Diagnostics Partner

Complex Trial
Executio...
Leveraging Complementary Competencies
CRO

Dx Partner

Sole focus of supporting
Clinical Development

Focus on delivering ...
Rx / CDx Co-Development
Strategic Agility

Pharma

• Medical Device Partner
• Technology/Platform
• Global Reach
• Intelle...
CRO Partner Expertise Required
Technology leadership
Global Execution
Sample Handling / Storage Expertise
Regulatory Exper...
CDx Development Stages
Drug
Development

Biomarker/CDx
Development

Discovery

Pre-Clinical

Biomarker Discovery &
Develop...
Examples of CDx Validation and Rx / CDx
Co-Development
Mark Roberts PhD
Director, Diagnostics Development
Covance Central ...
Collaboration on a CDx Clinical Validation

Clinical Candidate

USA
Europe

Dx Partner

Asia-Pac
China

Pharma Client

Com...
Global Reach & Data Combinability
Global Consistency

1 instrument

1 technologist

1 point in time

Fewer Laboratories = ...
Points to consider in Rx / CDx Co-Development
Rx / CDx : A different business model

• CDx manufacturer distinct from Rx c...
Rx / CDx Co-Development
Strategic Agility

Pharma

• Medical Device Partner
• Technology/Platform
• Global Reach
• Intelle...
“Delivering on the promise of Personalized Medicine
requires Precision Co-Development”

CONFIDENTIAL - FOR INTERNAL OR CLI...
Thank You

30

CONFIDENTIAL
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Accelerating Drug Development through Drug & Companion Diagnostic Co-Development

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Accelerating Drug Development through Drug & Companion Diagnostic Co-Development

  1. 1. Accelerating Drug Development through Drug & Companion Diagnostic Co-Development Mark Roberts PhD Director, Diagnostics Development Covance Central Laboratory Services CONFIDENTIAL
  2. 2. Our Environment Today Pressured Cycle of Dependencies Market Realities Price Pressures Regulations R&D Cost Pressures Target Scarcity Healthcare Models Pharma + Sites Patients CMOs, etc CROs Partnerships Patent Cliffs Emerging Markets Consumer Price Pressure Funding Needed For Innovation The pressures are the same across the marketplace… why are some companies succeeding while others continue to struggle? 2 CONFIDENTIAL
  3. 3. Drugs Don’t Work for all Patients Antidepressants Asthma Drugs Arthritis Drugs Diabetes Drugs Cancer Drugs Estimated $350 billion wasted in 2011 Source : Personalized Medicine Coalition 3 CONFIDENTIAL
  4. 4. The Future Is ……… Personalized Medicine Providing     4 CONFIDENTIAL the right treatment for the right person at the right time in the right dose
  5. 5. The New Drug Development Paradigm Personalized Medicine Personalized Medicine Targeted Therapeutic Biomarker Companion Diagnostics are integral to the new Personalized Medicine paradigm An “in vitro” device that provides information that is essential for the safe and effective use of a corresponding therapeutic product” Source : US Food & Drug Administration CONFIDENTIAL
  6. 6. CDx: Historical Perspective • Many „Companion‟ Diagnostics developed after a drug is on market • Retrospective validation using banked samples: potential IRB / informed consent issues / new trial • Drug manufacturer unlikely to change labeling unless required to do so by FDA : may consider extra testing / expense to be a detriment to clinical use 6 CONFIDENTIAL 6
  7. 7. CDx: A New Perspective • Better understanding of the genetic and polypharmacy causes of adverse reaction • Increasing utility of pre-dosing patient stratification through understanding of „pathway‟ targets • Targeted therapy improves clinical outcome – Enhanced safety profile : and reduced liability claims? – Enhanced therapeutic efficacy • Enhanced healthcare economics 7 CONFIDENTIAL 7
  8. 8. FDA :Drug & CDx Co-Development “In most circumstances, if use of an in vitro companion diagnostic device is essential for the safe and effective use of a therapeutic product, the IVD companion diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling,” 8 CONFIDENTIAL
  9. 9. Drug / CDx co-development successes Targets V600E mutated BRAF in advanced melanoma Occurs is ca. 60% of mm patients Drug and device approved together in 2011 Targets ALK mutation in NSCLC Occurs in 4% - 5% of patients Tumor shrinkage in 83% of ALK +ve patients (4-5% of NSCLC) Drug and CDx (Abbott) launched in 2011 CONFIDENTIAL
  10. 10. Voice of the Client Survey : 2011 QUESTION: What role do you see CROs playing in the development of companion diagnostics over the coming years? 10 CONFIDENTIAL
  11. 11. Summary of VOC Feedback • Clients had not considered CROs role – Dx focused • Clients continue to define their needs (lack clarity) • Clients voiced the need for: – Capabilities: Fill the gap where clients lack ability or expertise – Flexibility: Resource flexibility under an outsource model – Integration: Providers able to integrate services are valuable – CDx vision & direction: Clients are struggling and need a partner with vision AND capabilities to guide their path forward 11 CONFIDENTIAL
  12. 12. Charting a New Model The future of Healthcare will require a new mindset: Products and industries once considered separate and distinct move to integration Today Yesterday Diagnostic Diagnostic Devices Devices Drugs & Biologics 12 Drugs & Biologics Integrated with Diagnostics CONFIDENTIAL CONFIDENTIAL
  13. 13. Why Rx / CDx Co-Development? Potential to: enhance therapeutic improve trial design efficacy increase safety & reduce risk enhance safety profile Speed-up therapeutic efficacy enhance development process improve trial design accelerate trial outcome Increase commercial success increase 13 CONFIDENTIAL
  14. 14. Hurdles Under the New Model Understanding the diagnostic industry Choosing a Diagnostics Partner Complex Trial Execution Managing the co-development process Regulatory uncertainty around CDx Intellectual property issues Success Begins with the Right Partners 14 CONFIDENTIAL
  15. 15. Global Diagnostics Market • $ 44 billion in 2011 • > 5% CAGR to $62 billion in 2016 • Largest Players – – – – Roche Siemens Danaher Abbott $ 7.4 billion $ 5.2 billion $ 4.4 billion $ 4.3 billion CONFIDENTIAL
  16. 16. Companion Diagnostics Market World Companion Diagnostics Market 2010-2021 ($Billions) (incl. the sales of testing kits and testing service revenues). 11.4 12.0 CAGR 21.6% 9.5 10.0 7.8 Sales ($B) 8.0 6.4 5.2 6.0 4.2 4.0 1.3 1.6 2010 2011 2.0 1.9 2.3 2.8 3.4 0.0 2021 2020 CONFIDENTIAL 2019 16 2018 “Companion Diagnostics World Market 2011-2021”, VisionGain (2011) 2017 2016 2015 2014 2013 2012 Year
  17. 17. Considerations in Choice of Commercial Partner • • • • Nature of Diagnostic Target (biomarker) Required Turn around Time of Result Channel to Market Economics CONFIDENTIAL
  18. 18. Rx / CDx Co-Development Value for Stakeholders Stake Holder BioPharma Companies Dx Companies 18 Benefit • Reduced Drug Development Costs • Improved safety-efficacy profile of drug • Increased cost effectiveness of drug • Accelerated regulatory approval • Competitive advantage (differentiated therapeutic) • Rescued drugs • Premium pricing for “targeted” drug • New market opportunities • Develop new partnership with Pharma companies • Premium pricing for CDx • Increase distribution of their product CONFIDENTIAL
  19. 19. Hurdles Under the New Model Understanding the diagnostic industry Choosing a Diagnostics Partner Complex Trial Execution Managing the co-development process Regulatory uncertainty around CDx Intellectual property issues Success Begins with the Right Partners 19 CONFIDENTIAL
  20. 20. Leveraging Complementary Competencies CRO Dx Partner Sole focus of supporting Clinical Development Focus on delivering innovative Dx products Experienced collaborator for novel assays, technologies and Dx devices Experienced in assay development & technology Complementing competencies Complementing competencies •Technical agility •Global reach •Commitment to quality •Experience in Project Management •Deep technical proficiency •Limited reach •Experience in product development •Experience in Regulatory Submission 20 CONFIDENTIAL
  21. 21. Rx / CDx Co-Development Strategic Agility Pharma • Medical Device Partner • Technology/Platform • Global Reach • Intellectual Property • Regulatory Path CDx IVD Partnership Unbiased approach enables a straightforward path to commercialization 21 CONFIDENTIAL CRO
  22. 22. CRO Partner Expertise Required Technology leadership Global Execution Sample Handling / Storage Expertise Regulatory Experience Strong Commercial Partnerships 22 CONFIDENTIAL
  23. 23. CDx Development Stages Drug Development Biomarker/CDx Development Discovery Pre-Clinical Biomarker Discovery & Development Phase I CDx Assay Feasibility Phase II Phase III CDx Development & Validation NDA Submission Regulatory Submission & CDx Launch Your Partnership Needs (1) Biomarker identification & CDx development (2) Assay development and validation (3) Already has an assay development/ commercialization partner (4) Needs a partner for IVD manufacturing and global commercialization (5) Requires single strategic partner with broad capabilities/expertise Flexibility and access along the continuum is critical 23 CONFIDENTIAL
  24. 24. Examples of CDx Validation and Rx / CDx Co-Development Mark Roberts PhD Director, Diagnostics Development Covance Central Laboratory Services CONFIDENTIAL
  25. 25. Collaboration on a CDx Clinical Validation Clinical Candidate USA Europe Dx Partner Asia-Pac China Pharma Client Commercial Platform Proprietary CDx Platform expanded for global clinical studies Collaborative assay evaluation & troubleshooting CDx validation 25 CONFIDENTIAL
  26. 26. Global Reach & Data Combinability Global Consistency 1 instrument 1 technologist 1 point in time Fewer Laboratories = Higher Quality Data 26 CONFIDENTIAL Same reagents globally
  27. 27. Points to consider in Rx / CDx Co-Development Rx / CDx : A different business model • CDx manufacturer distinct from Rx client • Parties may have different priorities • All parties need to be at the table • Not all assays are created equal : Assay must be very robust in order to be „plug and play‟ Development assays require more attention 27 CONFIDENTIAL
  28. 28. Rx / CDx Co-Development Strategic Agility Pharma • Medical Device Partner • Technology/Platform • Global Reach • Intellectual Property • Regulatory Path CDx IVD Partnership Unbiased approach enables a straightforward path to commercialization 28 CONFIDENTIAL CRO
  29. 29. “Delivering on the promise of Personalized Medicine requires Precision Co-Development” CONFIDENTIAL - FOR INTERNAL OR CLIENT USE ONLY 29 CONFIDENTIAL
  30. 30. Thank You 30 CONFIDENTIAL
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