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Personalized Medicine and Companion Diagnostics 10-02-2012 Youssef Khayali Head of Applied Science, Molecular

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Personalized Medicine and Companion Diagnostics 10-02-2012 Youssef Khayali Head of Applied Science, Molecular & Tissue Diagnostics Roche Diagnostics Netherlands – PowerPoint PPT presentation

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Title: Personalized Medicine and Companion Diagnostics 10-02-2012 Youssef Khayali Head of Applied Science, Molecular


1
Personalized Medicine and Companion
Diagnostics10-02-2012Youssef KhayaliHead of
Applied Science, Molecular Tissue
DiagnosticsRoche Diagnostics Netherlands
2
RocheWe innovate healthcare
  • Scienceis the fundamental prerequisite for
    making a real difference in patients health and
    quality of life.

Dr. Severin Schwan, Roche CEO
3
Evolution of MedicineProgress in therapy driven
by new technologies
Evolution of Medicine
Evolution of Technologies
4
Roche Group - VisionInnovative medically
differentiated products
Vision Personalized healthcare to increase
efficacy, safety and cost-effectiveness of
treatment.
Focus Medically differentiated products and
services that lead to tangible improvements in
health, quality of life and survival.
5
Improve Medical ValueAddress unmet needs
Fulfillment drivers
6
Systems to Clinical ValueUnique capabilities to
generate medical value
7
Diagnostic Testing TodaySources of variability
in the testing process
Platform
Non-validated instrument software
Manual data analysis (subjective evaluation)
Test Assay
Non-validated quality control test methods
Lack of clinical validation
Laboratory
Improper training
Use of non-validated sample preparation
Specimen Selection
Inadequate tumor cell content
Non-standardized macro-dissection procedures
Medical Oncologist
Understanding the clinical utility of a test
Ability to recommend the right test to the laboratory
8
Companion Diagnostics developmentReduce
possibility of any mistake within the system
A true companion diagnostic program
Pharma
PC / Phase I
Phase II
Phase III
NDA
IVD
Diagnostics
GMP
Final assay
Prototype
Biomarker
Software ( analysis / reporting)
Hardware
Sample preparation
Any mistake in a system-component will delay
both the Diagnostic and Pharma regulatory process
9
Roche provides medically essential information
Across the cancer care continuum
Melanoma
Breast cancer
Colon cancer
Lung cancer
Prostate cancer
Cervical cancer
PSA1/fPSA
HPV2
Screening
CEA1
NSE, CEA4
PSA/fPSA1
S1006
Cytokeratin5/6
p16
CYFRA 21-14
Melan A6
E-Cadherin
CA 19.9
Cytokeratin34bE12
Ki67
Diagnosis
HMB 456
CA 15.3
CDX2
TTF1, p63, Napsin A
p63
MITF
CEA
Cytokeratin5/6
Tyrosinase

proGRP4
ER/PR1
MMR genes(MLH1, MSH2, MSH6,PmS2)1
Classification
HER21
KRAS3
Ki67
PSA/fPSA1
CA 15.31
CEA1
NSE, CEA4
Surveillance
CEA1
CA 19.9
CYFRA21-14
Prognosis/ Prediction
ER/PR1
KRAS3
EGFR5
HER21
KRAS3
BRAF7
EGFR5
ER/PR1
Treatment decision

HER21
c-Met

MUC-1
CA 15.31
CEA1
PSA/fPSA1
NSE, CEA4
S1006
HPV2
Monitoring
CYFRA 21-14
CEA1
CA 19.9
ECL cobas e 602 (8000 series), cobas e 601 (6000
series), cobas e 411 (4000 series), Molecular
Analytics E170, Elecsys 2010 IHC/ISH BenchMark
(Ventana), RT-PCR cobas 4800 system
Tests in development
1Sturgeon CM et al. Clin Chem 2008 54e11-79
2Wright Jr et al. Am J Obstet Gynecol 2007
346-355 3NCCN Clinical practice guidelines in
oncology, colon cancer, v2, 2012 4Stieber P et
al. NACB guidelines lung cancer. Available
fromhttp//www. aacc.org/SiteCollectionDocuments
/NACB/LMPG/tumor/chp3p_lung.pdf 5NCCN Clinical
practice guidelines in oncology, non-small cell
lung cancer, v2, 2012 6Garbe C et al. Eur J
Cancer 2010 46270-83 7NCCN Clinical practice
guidelines in oncology, melanoma, v3, 2012.
10
The VANTAGE Workflow System A simple, yet
empowering, patient-focused IT solution
Establishes complete chain of custody Brings all
Ventana automated platforms together
Real-time insight to manage workflow Identifies
opportunities for improvement in quality,
staffing and efficiency
Digital pathology Integrates with Virtuoso Image
Management Software and Bioimagene scanners for
seamless sharing of slide data
Helps ensure patient safety Eliminates data
re-entry, re-labelling, and labelling errors
11
Integrated IT solutionsOur vision - the patient
report
  • This same day patient report will contain
  • Multiparameter, multiplex results detailing
    morphology, phenotype and genotype
  • Integrating findings from pathology, radiology,
    surgery and oncology
  • Full definition of all therapeutic targets
  • Results communicated by a multitasking
    pathologist who serves as
  • Diagnostician
  • Lab director
  • Information integrator

12
We Innovate Healthcare
13
Personalized Healthcare betekenis nu en in de
toekomst
  • Eveline Loriaux, Director Corporate Affairs
    Communications, Roche Nederland Woerden
  • 10 februari 2012

14
The basis of Personalized HealthcarePatient
variability leading to differential response to
treatment
Variability is the law of life, and as no two
faces are the same, so no two bodies are alike,
and no two individuals react alike and behave
alike under the abnormal conditions which we know
as disease.
Sir William Osler, Regius Professor of
Medicine 1849 - 1919
Osler was pathologist, physician, educator,
bibliophile, historian, author and one of the
founding fathers of Johns Hopkins Hospital,
Baltimore.
15
Roche Group Strategic FrameworkOverview
Group Business Model (What we do) Group Management Model(How we manage)
Our Focus Fitting treatments to patients Our People Integrity. Courage. Passion.
Our Distinctiveness Excellence in science Our Decision Making Accountable and transparent
Our Delivery Value for all stakeholders Our Structure Built for innovation
16
Roche Mission
  • Our aim as a leading healthcare company is to
    create, produce and market innovative solutions
    of high quality for unmet medical needs.
  • Our products and services help to prevent,
    diagnose and treat diseases, thus enhancing
    peoples health and quality of life.
  • We do this in a responsible and ethical manner
    and with a commitment to sustainable development
    respecting the needs of the individual, the
    society and the environment.

17
More than 114 years of RocheHistorical timeline
Personalized Healthcare
Strategic Transition - focus on Pharmaceuticals
Diagnostics
Sales in 2009 49051 million CHF
Ventana
Chugai
Disetronic
Boehringer Mannheim
Spin off Fragrances Flavours Sale OTCSale
Vitamins Fine Chemicals
Genentech
Diagnostics
starts in the seventies
LimitedCompany
Fragrances Flavours
International expansion
Founding
Diversification
18
Components of PHCKey steps to bringing new value
to the practice of medicine
  • Understand heterogeneity of diseases
  • Discover and develop relevant biomarkers
  • Stratify patients with diagnostic tests
  • Build evidence for better benefit-risk ratio

19
PHC benefits all stakeholders in healthcare
Physicians Providers ? Maximum benefit ?
Minimum toxicity
Patients ? Best treatment
PHC
Regulators Policy Makers ? Increased efficacy
safety
Payers Reimbursers ? Efficient use of
healthcare budgets
20
Roche Group what makes us distinctive
Optimally positioned for the future
  • Combined strengths of Pharmaceuticals and
    Diagnostics
  • Synergies in research, development and marketing
  • Unique global network of alliances
  • Pioneering personalized medicine

Earlydetection
Prevention
Diagnose
Therapy
Therapy monitoring
21
Roche PHC in PracticeWell known examples
Oncology Treatment for patients
identified to have HER2 over-expression in breast
cancer BRAF by melanoma. 50 express this
mutation, target for specific therapy
EGFR by lung cancer. 40 of patients benefit
from specific therapy Virology
Hepatits C infection measuring viral load before
and during treatment and Identification of viral
subtypes to guide treatment duration
Diagnosis Identification of infections
with human papilloma virus strains which may
cause cervical neoplasia
22
Personalized Healthcare is a reality
todaySignificant progress in 2011
APPROVED
FILED
TO FILE IN 2012
Zelboraf Metastatic Melanoma BRAF V600 Mutation
In Ph III
Ph III
Ph III decision in 2012
Mericitabine and danoprevir Hepatitis C HCV
viral load, genotype
Lebrikizumab Severe uncontrolled
asthma Periostin level
MetMAb NSCLC Met Status
Approved in the US, positive CHMP opinion in EU
23
Six drug candidates developed as personalised
therapies
T-DM1 Metastatic breast cancer (HER-2 expression
level)
MetMAb1 Non-small cell lung cancer (MET status)
Pertuzumab  Metastatic breast cancer (HER-2/3
expression level)
Lebrikizumab1 Asthma (periostin level)
RG71281 Hepatitis C (HCV viral load, genotype) 
RG7204 Metastatic melanoma (BRAF V600E mutation)
1 LIP decision made, phase III start pending
24
Pipeline projects companion diagnostic
toolsJoint Pharma and Diagnostics programs
Oncology
Roche Pharma targeting multiple pathways
Molecular Tests for assessing presence of
mutations offers opportunities to tailor treatment
Pipeline Drug Biomarker Pipeline Assay
RG7204 BRAF Inh/PLX4032 RG7167 MEK Inh/CIF BRAF cobas 4800 BRAF V600E test
RG7112 MDM2 Antagonist p53 AmpliChip p53 array
RG7112 MDM2 Antagonist MDM2 cobas MDM2 expression assay
Tarceva EGFR TheraScreen EGFR mutation test
RG7167 MEK Inh/CIF KRAS TheraScreen KRAS mutation test
RG1273 Pertuzumab RG3502 T-DM1 Her 1, 2, 3 AREG, BTC cobas 4800 HER Family expression assay
RG7321 PI3K Inh RG7422 PI3K Inh PIK3CA PCR PIK3CA mutations FISH PIK3CA copy number assay
List not exhaustive
25
Issues to be addressedPHC and the (Dutch)
healthcare system
  • Design pre-clinical and clinical research
  • Reimbursement / funding therapy and companion
    diagnostics
  • Trend towards centralization of patient care
  • Alignment with diagnostic testing?
  • Re-allocation of hospital budgets?
  • Compatible ICT platforms for data storage and
    data exchange
  • Ownership tissue

26
We Innovate Healthcare
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