accelerating drug development through drug & companion diagnostic co-development
TRANSCRIPT
CONFIDENTIAL
Accelerating Drug Development through Drug & Companion Diagnostic Co-Development
Mark Roberts PhD Director, Diagnostics Development
Covance Central Laboratory Services
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Our Environment Today
Pressured Cycle of Dependencies
The pressures are the same across the marketplace… why are some companies succeeding while others continue to struggle?
Patients
Pharma
Sites CMOs, etc
CROs
R&D Cost Pressures
Funding Needed For Innovation
TargetScarcity
ConsumerPrice
Pressure
Regulations
Patent Cliffs
Healthcare Models
PartnershipsEmerging Markets
PricePressures
Market Realities
+
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Drugs Don’t Work for all Patients
Antidepressants
Cancer Drugs
Diabetes Drugs
Arthritis Drugs
Asthma Drugs
Source : Personalized Medicine Coalition
Estimated $350 billion wasted in 2011
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The Future Is ……… Personalized Medicine
Providing
the right treatment
for the right person
at the right time
in the right dose
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The New Drug Development Paradigm
Personalized Medicine
Companion Diagnostics are integral to the new Personalized Medicine paradigm
Personalized Medicine
Targeted Therapeutic Biomarker
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
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• 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
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CDx: Historical Perspective
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• 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
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CDx: A New Perspective
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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,”
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Drug / CDx co-development successes
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
Targets V600E mutated BRAF in advanced melanoma
Occurs is ca. 60% of mm patients
Drug and device approved together in 2011
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QUESTION:
What role do you see CROs playing in the development of companion diagnostics over the coming years?
Voice of the Client Survey : 2011
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• 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
Summary of VOC Feedback
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TodayYesterday
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Charting a New Model
Diagnostic
Devices
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Drugs & Biologics
Diagnostic
Devices
The future of Healthcare will require a new mindset:Products and industries once considered separate and distinct
move to integration
Drugs & BiologicsIntegrated with
Diagnostics
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Why Rx / CDx Co-Development?
Potential to:
enhance therapeutic efficacy
increase safety & reduce risk
Speed-up development process
improve trial design
increase commercial success
improve trial design
enhance safety profile
enhance therapeutic efficacy
accelerate trial outcome
Increase commercial success
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Hurdles Under the New Model
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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
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Global Diagnostics Market
• $ 44 billion in 2011• > 5% CAGR to $62 billion in 2016
• Largest Players
– Roche $ 7.4 billion– Siemens $ 5.2 billion – Danaher $ 4.4 billion– Abbott $ 4.3 billion
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Companion Diagnostics Market
World Companion Diagnostics Market 2010-2021 ($Billions)
(incl. the sales of testing kits and testing service revenues).
“Companion Diagnostics World Market 2011-2021”, VisionGain (2011)
1.3 1.6 1.9 2.32.8
3.44.2
5.2
6.4
7.8
9.5
11.4
0.0
2.0
4.0
6.0
8.0
10.0
12.0
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Year
Sal
es (
$B)
CAGR 21.6%
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• Nature of Diagnostic Target (biomarker)• Required Turn around Time of Result• Channel to Market• Economics
Considerations in Choice of Commercial Partner
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Rx / CDx Co-Development Value for Stakeholders
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Stake Holder Benefit
BioPharma Companies
• 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
Dx Companies
• New market opportunities• Develop new partnership with Pharma companies• Premium pricing for CDx• Increase distribution of their product
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Hurdles Under the New Model
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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
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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•Technical agility•Global reach
•Commitment to quality•Experience in Project Management
Complementing competencies•Deep technical proficiency
•Limited reach•Experience in product development
•Experience in Regulatory Submission
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CDx
Rx / CDx Co-Development
Strategic Agility• Medical Device Partner
• Technology/Platform
• Global Reach
• Intellectual Property
• Regulatory Path
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IVD
Pharma
Par
tner
ship P
artnership
Partnership
Unbiased approach enables a straightforward path to commercialization
CRO
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Technology leadership
Global Execution
Sample Handling / Storage Expertise
Regulatory Experience
Strong Commercial Partnerships
CRO Partner Expertise Required
CONFIDENTIAL
(4) Needs a partner for IVD manufacturing and global commercialization
(1) Biomarker identification & CDx development
(3) Already has an assay development/ commercialization partner
(2) Assay development and validation
(5) Requires single strategic partner with broad capabilities/expertise
Drug Development
Biomarker/CDx Development
Discovery Pre-Clinical Phase I Phase II Phase IIINDA
Submission
Biomarker Discovery & Development
CDx Assay Feasibility
CDx Development & Validation
Regulatory Submission & CDx Launch
Flexibility and access along the continuum is critical
Your Partnership Needs
CDx Development Stages
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CONFIDENTIAL
Examples of CDx Validation and Rx / CDx Co-Development
Mark Roberts PhD Director, Diagnostics Development
Covance Central Laboratory Services
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Collaboration on a CDx Clinical Validation
Clinical Candidate
Proprietary CDx
CommercialPlatform
USAEurope
Asia-PacChina
Platform expanded for global clinical studies
Collaborative assay evaluation & troubleshooting
CDx validation
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Dx Partner
Pharma Client
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Global Reach & Data Combinability
Global Consistency
1 instrument 1 technologist 1 point in time Same reagents globally
Fewer Laboratories = Higher Quality Data
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Points to consider in Rx / CDx Co-Development
• 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
Rx / CDx : A different business model
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CDx
Rx / CDx Co-Development
Strategic Agility• Medical Device Partner
• Technology/Platform
• Global Reach
• Intellectual Property
• Regulatory Path
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IVD
Pharma
Par
tner
ship P
artnership
Partnership
Unbiased approach enables a straightforward path to commercialization
CRO
CONFIDENTIAL29CONFIDENTIAL - FOR INTERNAL OR CLIENT USE ONLY
“Delivering on the promise of Personalized Medicine requires Precision Co-Development”