Mara G. Aspinall President Genzyme Genetics · PDF file12.10.2006 · Mara G....
Transcript of Mara G. Aspinall President Genzyme Genetics · PDF file12.10.2006 · Mara G....
The Health Industry Forum
October 12, 2006
Mara G. AspinallPresidentGenzyme Genetics
Themes for today
Diagnostics (both genetic and non-genetic) to play larger role in the future
Evolving toward sustainable business models
Policy decisions needed today to support innovation and improved outcomes
Diagnostics: Key to unlocking the power of genome dataDiagnostics: Key to unlocking the power of genome data
Source: Lab Industry Strategic Outlook 2005; Frost & Sullivan
Testing segment
Drugs of abuse
Routine
Revenues, 2003
28.5
Cytology 1.3
0.9
Anatomic pathology 5.8
Esoteric 3.7
14
9
$ Billions %
71
3
2
Growth, 2001- 2003% CAGR
5
12
(5)
7
15
Requires board-certified pathologist. Includes complex cancer diagnostics
Too complex & low volume for most hospitals, physician offices and routine independent labs
Description
Predominantly urine tests required by employers
Relatively simple and common tests
Predominantly Pap testing
Total 40.2 100 8
Genetic testing accounted for ~$1.2 billion in 2003
Diagnostics: Genetic testing accounts for ~3% of Dx industryDiagnostics: Genetic testing accounts for ~3% of Dx industry
U.S. Laboratory Industry, 2001 2003 Segments including genetic testing
Source: Frost & Sullivan
Infectious disease
Pharmacogenetic testing
Prenatal & newborn screening
Predictive testing
Diagnostics: Genetic testing spans multiple disease areasDiagnostics: Genetic testing spans multiple disease areas
U.S. genetic testing market, 2003100% = $1.2 billion
6%7%
25%63%
Diagnostics: Valuable information at modest cost
Source: Lab Industry Strategic Outlook 2005; AdvaMed
Rx & Dx as components of national healthcare spending, 2000 2003$ billions
$122
$33 $40$48
$184
$280
2000 2003 2006E
CMS Clinical Laboratory Fees in real terms, 1984 2004Index: 1984 = $1.00
$1.00
$0.75
1984 2004
15% CAGR
7% CAGR
Testing is 70% of decisions
Therapeutics
Diagnostics
Diagnostics: Genetic testing provides tools to personalize treatmentDiagnostics: Genetic testing provides tools to personalize treatment
What is the most accurate diagnosis?
How severe is their disease?
Are they at risk for disease?
Diagnosis &Stratification
What Rx is appropriate for this patient?
What drug will they respond to?
Will they have an adverse reaction?
Drug selection
Clinical decision being made Examples Dx-Rx
BCR-Abl Gleevec
ER/PR Tamoxifen
5Q deletion - Revlimid
1
HER2 expression Herceptin
EGFR expression Erbitux
EGFR mutation Tarceva, Iressa
BCR-Abl mutation Gleevec
What dose is appropriate for this patient? UGT1A1 polymorphism Camptosar
CYP450 polymorphism Multiple
Dose selection
Is this patient responding to therapy? BCR-Abl RT-PCR Gleevec
CLL MRD Campath
Patient monitoring
2
3
4
Feb. 2005 PriceWaterhouseCoopers report titled Personalized Medicine: the Emerging Pharmacogenomics Revolution Nov. 2005 Thomas Weisel Partners report titled Beneficiaries of Personalized Medicine and Market UpdatePharmacogenetics and the concept of individualized medicine published in The Pharmacogenomics Journal (Vol 6, Pg 16-21).Molecular Diagnostics and Personalized Medicine 2003, Drug & Market Development August 2003
Need for Change:Strong case for personalized medicineNeed for Change:Strong case for personalized medicine
50% of drugs not efficacious as prescribed
FDA interested in biomarkers and diagnostic algorithms
US diagnostics spending decreased since 1984
Adverse drug reactions 6th leading cause of death
US drug spending $250+B per year and growing fast
Building the Case for Personalized
Medicine
Successful when it leads to innovation and
improves standard of
care.
Fails when we settle for Trial
and ErrorMedicine as the
standard of care.
Need for Change:Current system - Cycle of trial and errorNeed for Change:Current system - Cycle of trial and error
Need for Change:Current System Intervention is often lateNeed for Change:Current System Intervention is often late
Health Care Cost vs. Disease Progression
Dis
ease
Bur
den
Baseline Risk
EarliestMolecular DetectionInitiating
Symptoms
Earliest Clinical
Detection
Typical Current
Intervention
Time
Cost / 1/R
eversibility
Source: Model by Ralph Snyderman, Duke University
Increase inantibiotic use Increase in
resistant strains
Ineffective empirictherapy
increased morbidity more antibiotics
Increased healthcare resource use
Limited treatment alternatives
more antibiotics increased
mortality
Increasedhospitalization
more antibiotics
Estimated unnecessarycost of resistance =
$4B annually
Source: McKinnon, Academy for Infection Management, February 2004
Need for Change: Costs to the system without personalized treatmentNeed for Change: Costs to the system without personalized treatment
Combining Testing with Treatment
A More Direct Answer
Observation Test Action Predictable Response
Need for Change: Breaking the cycle The new traditional medicineNeed for Change: Breaking the cycle The new traditional medicine
Disease1 Year
Survival5 Year
Survival
Lung cancer (small cell-non small cell) 36-41%
Colorectal cancer 60% 39%
Chronic myeloid leukemia (CML) 73% 37%
Heart failure (male-female) 76-72% 41-55%
End stage renal disease 78% 38%
6-13%
12005 USRDS Annual Data Report2 Levy, et. al., Long-term trends in the incidence and survival from heart failure, NEJM, 2002; 347(18):1397-4023Cancer Perspectives U.S., 2004 Fourth Edition, DaVinci Healthcare Partners; NCI SEER data, average across all stages at Dx
Need for Change:Patients dont have time for trial & errorNeed for Change:Patients dont have time for trial & error
93% 80%
Need for Change:Payors wasting money on drugs that are not workingNeed for Change:Payors wasting money on drugs that are not working
Drug ClassFrequency of
Absent or Incomplete
Efficacy (%)1
Total Market Size
Cost to the Health Care System of Ineffective Therapy
Angiotensin-converting enzyme (ACE) inhibitors
10-30
15-25
20-50
30-70
40-70
$390M-$1.2B
Beta blockers
$3.9B2 (2003)
$ 2.3B2 (2003)
$11.7B3 (2003)
$12.6B4 (2004)
$345M-575M
Anti-depressants $2.3B-$5.8B
Statins $3.8B-$8.8B
Beta agonists $1.4B5 (2004) $560M-$1B
1 Ross JS & Ginsburg GS, Am J Clin Pathol 2003;119:26-362 Datamonitor, August 1, 20053 Global Industry Analysts, October 10, 20044 Carnegie Research5 Specialty Pharmaceutical Pulse, SG Cowen, October 2005
Past Macro Level Diagnostic Testing Disease defined by location and size Tests differentiated disease from non-
disease
Today Molecular Diagnostic and Prognostic Testing
Disease defined by individual biology/DNA Tests to subcategorize disease and:
predict outcomes of specific Rx screen for adverse events monitor disease
Tomorrow Predictive Testing Predictive testing for development of
common diseases Disruptive technologies
Why Now: Testing technology has improvedWhy Now: Testing technology has improved
Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EJ, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2002, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2002/, based on Nov 2004 SEER data submission, posted to the SEER web site 2005.
Why Now:Disease better understood, segmented, & personalizedWhy Now:Disease better understood, segmented, & personalized
60 Years Ago
Leukemia or Lymphoma50 Years Ago
Chronic LeukemiaAcute LeukemiaPreleukemia
Indolent LymphomaAggressive Lymphoma
70 Years Ago
Disease of the Blood
Today
38 Leukemia types identified:Acute myeloid leukemia (12 types)Acute lymphoblastic leukemia (2 types)Acute promyelocytic leukemia (2 types)Acute monocytic leukemia (2 types)Acute erythroid leukemia (2 types)Acute megakaryoblastic leukemiaAcute myelomonocytic leukemia (2 types)Chronic myeloid leukemiaChronic myeloproliferative disorders (5 types)Myelodysplastic syndromes (6 types)Mixed myeloproliferative/myelodysplastic syndromes (3 types)
51 Lymphomas identified:Mature B-cell lymphomas (14 types)Mature T-cell lymphomas (15 types)Plasma cell neoplasm (3 types)Immature (precursor) lymphomas (2 types)Hodgkins lymphoma (5 types)Immunodeficiency associated lymphomas (5 types)Other hematolymphoid neoplasms (7 types)
5 yearSurvival
~ 0%
70%
Why Now: Targeted Rx will drive growth of companion DxWhy Now: Targeted Rx will drive growth of companion Dx
Projected impact of targeted therapies on genetic testing*
2 to 4 per year
Today 2010 2010 2015
Stage of Rx development
Percent Rx with predictive biomarker
Time to market
Phase III
~10%
Zero to 4 years
Projected joint Rx/Dx launches
6 to 9 per year
Phase I