1 copyright 2008 genoptix, inc. mike nerenberg, md cto & sr. vp business development genoptix,...
Post on 28-Dec-2015
215 Views
Preview:
TRANSCRIPT
1 Copyright 2008 Genoptix, Inc.
Mike Nerenberg, MDCTO & Sr. VP Business Development Genoptix, Inc.
B.A. University of Chicago M.D. Yale University School of Medicine UCSD Executive Program for Scientists and Engineers
Residency in internal medicine, University of Pennsylvania. Medical staff fellow, NCI 1984 - 1987 Postdoctoral fellowship, the Scripps Research Institute.
Faculty member, The Scripps Research Institute 1989 – 1996
Senior director at Nanogen 1996 – 1999
President and CTO, Molecular Reflections, Inc. 2000 – 2003
Medical director at Genoptix 2004 - 2006Vice president, business development and medical affairs
2006 - 2008
2 Copyright 2008 Genoptix, Inc.
2000
Delivering Personalized And Comprehensive Diagnostic Services To Community-based Hematologists And Oncologists
And Providing Customizable BioPharma Services to Biotech And Pharmaceutical Companies.
Delivering Personalized And Comprehensive Diagnostic Services To Community-based Hematologists And Oncologists
And Providing Customizable BioPharma Services to Biotech And Pharmaceutical Companies.
Located in Carlsbad:
Approximately 100,000 total sq. ft. in two facilities,
corporate headquarters and diagnostic laboratories
(1) As ranked on the 2008 Deloitte Technology Fast 500, a ranking of the 500 fastest-growing technology, media, telecommunications and life sciences companies in North America.
Ranked as the 9th fastest-growing
technology company in North
America (1)
2008
Genoptix At-A-Glance
Founded to develop high-speed optical technologies for cellular analysis
Transformed as a specialized,
differentiated laboratory service
provider
2004 Q4 2007
GXDX IPO
Turn profitable
Q1 2007
2009 SABPA Science & Technology Forum VII
Biomarker, Pharmacogenomics and Personalized Medicine
March 21, 2009Practical Aspects of Adoption of Personalized Medicine (PM) in Oncology
Mike Nerenberg, MDCTO & Sr. VP Business Development Genoptix, Inc.
4 Copyright 2008 Genoptix, Inc.
Paradigm for Personalized Therapy using Targeted Agents
Goal: the right drug to the right patient
StepsUnderstand mechanism of patient’s disease
Categorize (diagnosis)
Assign Disease Modifiers (prognosis)
Discover Therapy Modifiers (prediction)
Select targeted therapy based on above
Initiate therapy
Monitor response
Change therapy
Monitor response
5 Copyright 2008 Genoptix, Inc.
This Approach has Been Around for a Long Time
Targeted therapy Circa 20 CE-
Toxins are the target
6 Copyright 2008 Genoptix, Inc.
Medical Progress from Better TechnologyPersonalized Targeted Therapy Circa 1100
Target expanded
to
Bad Humors
7 Copyright 2008 Genoptix, Inc.
Conversion of Practitioners to Newer Technology can be Challenging
Target:
Toxins and
Bad Humor
8 Copyright 2008 Genoptix, Inc.
With Time- Better Agents and better knowledge of Mechanisms: Rapid Response to TKI in NSCLC Patients with EGFR Mutation
Hypothesis: EGFR mutation leads to modified ATP binding pocket and activates anti-apoptotic pathway.
Improved stability for binding of ATP and Gefitinib
Before After
9 Copyright 2008 Genoptix, Inc.
The Foundation: Understand Mechanism of Disease in Patient
Accurate Diagnosis with Prognostic ModifiersGreatly Aided by Molecular Tests
10 Copyright 2008 Genoptix, Inc.
Acute Myeloid Leukemia Approach: Circa 1980
Diagnosis Diagnostic Treatment
Pre - Leukemia Morphology Transfusion
Acute Myeloid Leukemia
Simple ChemoRx or transplant (if young)
11 Copyright 2008 Genoptix, Inc.
Modern Approach to Characterization of Acute Myeloid Leukemias
AML with t(8;21)(q22;q22), RUNX1-RUNX1T1 (CBFA/ETO)
AML with inv(16)(p13q22) or t(16;16)(p13;q22), CBFB-MYH11
APL with t(15;17)(q22;q11-12), PML-RARA
AML with t(9;11)(p22;q23), MLLT3-MLL and other balanced translocations of 11q23 (MLL)
AML with t(1;22)(p13;q13), RBM15-MKL1
AML with t(9;22)(q34;q11), BCR-ABL1
AML with normal cytogenetics and cytoplasmic/mutated NPM
AML with mutation of CEBPA
AML following a myelodysplastic syndrome
AML with multilineage dysplasia
AML with MDS-related cytogenetic abnormalities
Therapy-related AML, myelodysplastic syndromes and myelodysplastic/ myeloproliferative neoplasms
AML not otherwise categorized
2008 WHO Classifications Therapies
• Highly Targeted
• Myelotarg
• Retinoic Acid Arsenic Trioxide
• Less Specific
• Etoposide
• Teniposide
• Mitoxantrone
• Idarubicin
• Carboplatin
• Adriamycin
• Ara-C
• Daunorubicin
• BM Transplant
MyeloidStem Cell
LymphoidStem Cell
Immature Basophil
Immature Eosinophil
Basophil Eosinophil Neutrophil Monocyte
N. Band
N. Metamyelocyte
N. Myelocyte
N. Promyelocyte
Myeloblast
ImmatureMonocyte
Platelets Erythrocyte
Polychromatic Erythrocyte
OrthochromaticNormoblast
PolychromaticNormoblast
BasophilicNormoblast
Pronormoblast
Lymphocyte
Megakaryocyte
MyeloidStem CellMyeloid
Stem CellLymphoidStem CellLymphoidStem Cell
Immature Basophil
Immature Basophil
Immature EosinophilImmature Eosinophil
BasophilBasophil EosinophilEosinophil NeutrophilNeutrophil MonocyteMonocyte
N. BandN. Band
N. MetamyelocyteN. Metamyelocyte
N. MyelocyteN. Myelocyte
N. PromyelocyteN. Promyelocyte
MyeloblastMyeloblast
ImmatureMonocyteImmatureMonocyte
PlateletsPlatelets ErythrocyteErythrocyte
Polychromatic Erythrocyte
Polychromatic Erythrocyte
OrthochromaticNormoblast
OrthochromaticNormoblast
PolychromaticNormoblast
PolychromaticNormoblast
BasophilicNormoblastBasophilicNormoblast
PronormoblastPronormoblast
LymphocyteLymphocyte
MegakaryocyteMegakaryocyte
Undifferentiated Leukemia
Undifferentiated A.L.L.
A.L.L.
B-A.L.L.
C.L.L.
M.D.S.
A.M.L.-M7A.M.L.-M5B
C.M.L./C.G.L.
A.M.L.-M3
HypereosinophilicSyndrome
A.M.L.-M1, M2, M4, M5
Undifferentiated A.M.L.
BasophilicLeukemia
Multiple Myeloma
© 2004 SFSU Instructional Technology
A.M.L. M6
Pure erythro-leukemia
T-A.L.L.
N.H.L.
M.D.S.
M.P.D.
12 Copyright 2008 Genoptix, Inc.
Breast Cancer: Circa 1980
Diagnosis Diagnostic Treatment
Carcinoma in situ Excision Biopsy
Localized Morphology Mastectomy
Metastatic Mastectomy + Simple ChemoRx/Radiation
13 Copyright 2008 Genoptix, Inc.
Modern Approaches to Characterization of Breast CA
Morphology
Primary
Sentinel Nodes
Immunohistochemistry
Single Markers:
ER/PR/Her2/neu
BRCA I/II status
Multigene profiles:
Risk score by multigene profile
Luminal A/B, Normal, Basal
Blood tests
Serum Markers
Circulating Tumor Cells
Highly Targeted Transtuzumab
Lapatinib
Tamoxifen
Aromatase Inhibitor
Less Specific Capecitabine
Paclitaxel/ Vinorelbine
Gemcitabine
Anthracycline
Cyclophosphamide
Radiation Rx
Mastectomy/ Oophorectomy
Diagnostics Therapeutics
14 Copyright 2008 Genoptix, Inc.
Challenges to the Practicing Oncologist: Community-Based with Limited Access to Specialty Dx
85% of Oncology practice is in the Community
Small practice groups- Non-Hospital-based
Limited regional access to advanced diagnostics technology
Increasing reliance on reference labs
Communication with these labs is a key problem
15 Copyright 2008 Genoptix, Inc.
Challenges to the Practicing Oncologist: Information Overload and Integration
Clinicians must select from a bewildering and constantly increasing number of diagnostic tests
By far, the single largest category of lab related error is the selection of the wrong test by the clinician
Difficult to interpret and integrate results of tests into a patient management plan
Reconcile with ever more specific therapeutic options
16 Copyright 2008 Genoptix, Inc.
Integration is key
A large menu of tests is not helpful if they are selected inappropriately or misinterpreted
Our View:
Integrated Services are required for Optimal Therapy Choice & Patient Care
17 Copyright 2008 Genoptix, Inc.
COMPASS
Report
Comprehensive And Integrated DiagnosisComprehensive And Integrated Diagnosis
Patient Bone Marrow Draw & Transport
Hem/Onc Customer
PCR
Cytogenetics/FISH
Flow & MorphologyGenoptix One Hempath One Patient One Diagnosis
18 Copyright 2008 Genoptix, Inc.
Integrated Solutions
Partner with the oncologist to insure optimal test selection for each patient
Results should be provided with the end in mind match patient to the right therapy
100% inspection for clarity, accuracy, and comprehension
19 Copyright 2008 Genoptix, Inc.
Near-term Challenges to the Lab
Variable process for State Licensures
Lack of regulatory clarity: FDA vs CLIAHome Brew
IVD MIA
ReimbursementStandard CPT Codes are relatively bad for molecular testing
State to state and company to company variation in Medicare and private insurance payment
Value Based Pricing is risky and slow
IP Barriers
Stark rules (Limit business to business relationships)
20 Copyright 2008 Genoptix, Inc.
PM Requires Enhanced Role of Clinical Lab/Pathologist
Diagnosis Prognosis
Diagnosis Prognosis Treatment
Decisions Monitor
Traditional
Expanded Role
Morphology
Flow Cytometry
Karyotyping
Protein Chemistry
FISH
PCR
Gene Expression
Clinical Sequencing
FFPE Molecular Tests
Array Technology
21 Copyright 2008 Genoptix, Inc.
COMPASS for blood and bone marrow
6-color Flow Cytometry
Histologic analysis
PCR
Cytogenetics
FISH
CLL Flow Cytometry Panel
Plasma Cell Labeling Index for MM
Quantitative PCR
Cytogenetics
FISH
CTC Assay
CTC Breast
CTC Colon
CTC Prostate
KRAS
EGFR
Comprehensive hematopathology assessment & review over time through CHART
Quantitative PCR for MRD
Flow Cytometry for MRD in CLL
Support Hem/Onc Customers In Many Patient Management DecisionsSupport Hem/Onc Customers In Many Patient Management Decisions
Diagnosis Prognosis Treatment
Decisions Monitor
22 Copyright 2008 Genoptix, Inc.
Longer-term Challenges for Lab
Information ManagementEspecially on therapeutics (pathologists not used to this)
Limited Development resourcesRandomized prospective trials outside the range of most Commercial Labs
Prioritization of adoption
Economic
23 Copyright 2008 Genoptix, Inc.
Partnering with Pharma Companies can Help
New Therapeutic Options Drive the Need for New Tests
Segments trial population and decreases risk of clinical failure Pharma
Provides insight into next generation drugs and tests Labs
Speeds up development and (hopefully) drives down cost of drug Patients
Facilitates smoother transition of new therapeutic agent/test into clinical practice Clinicians
When done in concert, everybody benefits
24 Copyright 2008 Genoptix, Inc.
Benefits of Personalized Approach- Higher Quality Patient Care
More options
More rational
Less toxicity
Less futile trials
Higher quality of life for patient
In some cases longer survival
25 Copyright 2008 Genoptix, Inc.
Near-term Challenges of Personalized Medicine
Nonlinear Physician AdoptionEspecially in Community
In the short term- Increased CostRequires greater specialized training for lab and clinician
Use more expensive drugs
Often requires more expensive tests
26 Copyright 2008 Genoptix, Inc.
Long Term Challenges
Can personalized approaches be compatible with cost controlled medicine?
Not very compatible with fully Socialized Medicine Models
Are we in a temporary disequilibrium?
What is the true value of quality of life improvement and or extended years of survival?
27 Copyright 2008 Genoptix, Inc.
How Labs Can Help in the Near-term
Set the course of therapeutics by providing a correct diagnosis
Decrease medical errors by pathologists participating in the selection and interpretation of tests
Assist with matching patients to the appropriate therapy by providing predictive tests
Accelerate availability of new therapeutics by working with Pharma
Assist with monitoring therapeutic response through molecular and cellular testing and integrated services
top related