Emerging Developments and
Your Future in Pathology
Jared N. Schwartz, MD, PhD, FCAP
President, College of American Pathologists
Presbyterian Health
Charlotte, NC
John Winbern Turner, MD, FCAP
Johnston-Willis Hospital
Richmond, VA
Emerging Developments and Your
Future in Pathology
• What is happening in healthcare?
• How will that affect your career as a pathologist?
• What are the emerging technologies?
• What can you do to better prepare yourself?
• What is the College doing to help you along the
way?
Prediction is
difficult, especially
about the future
Niels Bohr, 1885-1962
Traditional trial-and-error method of
care is no longer acceptable
Patient
presents with
symptoms
Doctor makes a “most
likely” diagnosis, may
order tests to confirm,
and prescribes a
treatment plan (usually
drugs and/or surgery)
Doctor revises
treatment plan
Weight & age
may affect drug
selection &
dosage or other
intervention
Plan works
or doesn’t
work, +/side effects?
Treatment
plan success
The occasional result: sub-optimal treatment, prolonged
periods of trial and error, medical noncompliance, and
increased cost—factors that can increase patient
morbidity and mortality
In spite of all the money and effort devoted
to biomedical research, the outcomes are
not very satisfying
• Over 60% of patients diagnosed with Type II diabetes
have blood sugars that exceed the recommended target
level
• Only 17% of patients with heart disease ever reach the
national guidelines treatment goals for cholesterol
management
• Among patients diagnosed with depression, only half
report a 50% improvement in symptoms after using
antidepressant medications
– 32% of patients who received a placebo also experienced a 50%
improvement in symptoms!
Patient response rates to a major drug
in selected categories of therapy
Category of Disease
Analgesics for pain (Cox-2 inhibitors)
Asthma
Cardiac Arrythmias
Schizophrenia
Migraine (acute)
Migraine (prophylaxis)
Rheumatoid Arthritis
Osteoporosis
HCV
Alzheimer’s Disease
Oncology
Source: Physicians’ Desk Reference
% who respond
to therapy
80%
60%
60%
60%
52%
50%
50%
48%
47%
30%
25%
What does the consumer want?
• High quality
• Reasonable cost
• Delivery as fast as
possible
• Minimal inconvenience
• Access to care with the latest technology
• Reduced risk
• Confidence and trust
…and they are being ‘educated’ by the
media
What does the patient’s
treating physician want?
Help!
• Fast and accurate results
• Understandable and
useful information
• Direction on therapy
• Low costs--may not be as
important
Market demand and emerging technologies
are accelerating the shift to “Precision”
medicine
• Provision of care for diseases which can be
precisely diagnosed and subsequently treated
with predictably effective rules-based therapies
– Precision technologies driving the disruption of existing
healthcare business models
– Precise diagnosis must precede predictably
effective therapy
• Requires technology progress on two fronts
– Understanding the cause of disease
– Ability to detect those casual factors
Patient
presents with
symptoms
Doctor makes a “most
likely” diagnosis, may
order tests to confirm,
and prescribes a
treatment plan (usually
drugs and/or surgery)
Doctor revises
treatment plan
Source: Christensen/Hwang
Weight & age may
affect drug
selection &
dosage or other
intervention
Plan works or
doesn’t work,
+/- side
effects?
Treatment
plan success
Precision medicine is not new; consider
the history of infectious disease therapy
• Earliest categorization schemes: immorality, weakness
of faith
• Unsanitary conditions in the city
• Exposure to affected individuals; contact with certain
insects and animals
• Microscopes and various staining techniques
– Identification of microbes that caused disease with overlapping
symptoms offering clues to the aggressiveness and spread of
disease and the prognosis
– Tailored antibiotic therapy based on the species of organism
– Molecular subtype and resistance profile of the involved strain
It took centuries of significant events to
get us to this point
The cost of diagnosing and
treating infectious diseases
has declined 5% per year
since 1940
1670
1720
Leeuwenhoek observes
“little animals” under
microscope
Source: Christensen/Hwang
Lister adopts antiseptic
technique in surgery
Semmelweis proposes
handwashing to prevent
spread of disease
1770
1820
Koch proves Germ
Theory with discovery
of B. anthracis
1870
Pasteur explores Germ
Theory of Disease
Jenner administers
smallpox vaccine
Ehrlich introduces the acidfast staining technique
1920
Reed proves
mosquitoes are vector
for yellow fever
Fleming discovers
Penicillin
Today, Cancer is experiencing a similar
shift toward precision medicine
2 types: leukemia
& lymphoma
1920
1930
1940
Disease of
the blood
Source: Mara Aspinall, Genzyme
Farber develops
1st chemotherapy
for leukemia
1950
1960
Novartis launches Gleevec, the
1st molecular targeted drug, to
treat myeloid leukemia
1970
1980
3 types of leukemia (acute,
chronic, preleukemia) and 2
types of lymphoma (indolent,
aggressive)
1990
2000
38 types of
leukemia; 51 types
of lymphoma
2010
Precision medicine implies
personalization and all its benefits
• Diagnosis predicting risk of
disease
• Determining whether a treatment
is working
• Monitoring healthy people to
detect early signs of disease
• Producing safer drugs by
predicting potential for adverse
effects earlier
• Targeting groups of people most likely to benefit from a drug, while
keeping its use from those who may be harmed by it
• Producing better medical products
• Ready access to information
• Decreasing health care costs
Diagnostic tests and data
integration are the critical
links to the success of
personalized medicine
Industry recognizes the opportunity and are
willing to work with anyone
Are diagnostics the
new wonder drug
on Wall Street?
What kinds of emerging
technologies will impact my
future practice?
DISTRIBUTED HIGH-THROUGHPUT ANALYTICS
REVOLUTIONARY TECHNOLOGIES
Practice of medicine is moving from the treatment
of illness to the aggressive promotion of wellness
PERSONALIZED HEALTHCARE
Automated
systems
Lifetime Treatment
PrePre-symptomatic Treatment
CACA-diagnosis
TRANSITIONAL MEDICINE
Molecular Medicine
Information
Correlation
Genetic Predisposition Testing
HEALTHCARE
TODAY
Clinical Genomics
Digital Imaging
1st generation
diagnostics
Episodic Treatment
Electronic Health
Record
Nonspecific
(treat symptoms)
Organized
(error-reduction)
EVOLUTIONARY PRACTICES
DATA & SYSTEMS INTEGRATION
SOURCE: IBM LIFE SCIENCES SOLUTIONS
Moving from the
treatment of illness
to the aggressive
promotion of
wellness
Artificial Expert System
Personalized
(disease prevention)
IVDs will become increasingly vital
components of the health care system
• High value Dx provide critical information to help
physicians make clinically relevant decisions
• Molecular Dx and AP are fastest growing segments
– AP market is growing at 15% CAGR and moving towards
automation and digitalization
– Continued growth of Pap is likely to slow down when MDx
assays start gaining acceptance
• Other high growth segments
– ICH, ISH and special stains
– Digital pathology
– Tissue microarrays
Source: Scientia
Molecular diagnostics is at the core of
the personalized medicine vision
Diseases will be diagnosed
long before the patient
begins to manifest any
evidence using traditional
tools
…and biomarkers will
be a primary tool
Signs & Symptoms
Molecular
Diagnostics
In vitro
Laboratory
Tests
In vivo
Imaging
Techniques
Compression of the biomarker development
timeline is accelerating progress
1977: FDA approves
PSA for patients
already diagnosed
Preclinical
exploratory
2002-04: Period and
retrospective
analyses on survival
Clinical assay
& validation
Retros
pectiv
e
longitu
dinal
1996-7: 4 new chemical
entity therapeutics
approved for prostate
cancer
2007: “220 therapeutics
emerging”; 100 in Phase II;
20 on market
Prospe
ctive
screen
ing
Cancer
control
1994: PSA approved
as predictive indicator
PSA Biomarker development: 30 years
Source: Bartsch, et al, IBM (Imaging)
Biomarker Summit III, Jan 2007
Circulating Tumor Cells
Technology Overview
•
•
•
•
•
Potentially powerful predictors of
progression-free survival
Assays count rare events – epithelial
tumor cells in the peripheral
bloodstream and compare to
established frequency profiles
May predict treatment response more
quickly than usual clinical practice with
radiologic imaging (2-3 days vs 2-3
months), allowing rapid therapy
modification
FDA-approved for patients with
metastatic breast cancer; tool for
predicting progression-free and overall
survival, monitoring disease progression
Ongoing research evaluating efficacy for
other tumor types
Probability of Adoption into Clinical Use
What is the impact of CTC assays on pathology?
Technology Curve:
CTC Assay
3
4
2
0
1
Consensus
Cautious
Early
PreInnovators
Adopters Adopters Adopters
Clinical
5
Late
Adopters
Other
Metastatic Breast Cancer
• Expected rate of adoption: Slow
• Barriers: Only clinical evidence is in therapy
monitoring for metastatic breast cancer
• Accelerators: FDA approval of additional
applications/tumor types
Impact may be dramatic…or not
CTC Assays for Therapy Monitoring
OP Test Volumes, US Market *
Potential Impact by Indication
Impact
Timing
Screening

N/A
Diagnosis
& Staging

2014
Treatment
Planning

2010
Therapy
Monitoring

2008
 High
 Medium
 Low
Tests (Thousands)
35
30
25
20
15
10
5
0
2006 2008 2010 2012 2014 2016
• Current utilization almost
exclusively limited to research
• As clinical benefits are
established, utilization will grow
significantly
* Source: Sg2 Analysis, 2007
Screening Virtual Colonoscopy
What is the impact of Screening VC on pathology?
•
•
•
•
VC uses CT technology as an
alternative to optical screening
colonoscopy
VC digitally reconstructs the CT
image into 2D and 3D pictures of
colonic luminal surfaces
(achievable, manipulatable, post
procedure review)
Early studies indicate VC offers
sensitivity and specificity similar to
OC; VC does not require sedation
Patients with suspicious VC exams
immediately referred for an optical
colonscopy, often on same day, for
possible biopsy and/or polyp
excision
Probability of Adoption into Clinical Use
Technology Overview
Technology Curve:
Screening VC
3
4
2
0
1
Consensus
Cautious
Early
PreInnovators
Adopters Adopters Adopters
Clinical
5
Late
Adopters
• Expected rate of adoption: Moderate
• Barriers: Public preference; Payment—must
be driven by provider
• Accelerators: Publicity for screening, public
preference
Destructive or positive impact?
Growth in Virtual and Optical
Colonoscopy, US Market *
Total Colonoscopies (Virtual & Optical)
University of Wisconsin *
# of Procedures (Millions)
9
Optical Colonoscopy
(Screening)
8
-9%
7
6
Optical Colonoscopy
(Therapeutic)
5
4
+59%
>200%
3
Virtual Colonoscopy
2
(Screening)
1
0
2006
2008
2010
2012
2014 2016
• VC will increase colorectal
cancer screening and
therapeutic volumes
• Pathology volumes for colon
biopsy will mirror therapeutic
colonoscopy volumes
* Source: Sg2 Analysis, 2007
# of Procedures
3000
Virtual
2500
Optical
2000
1500
1000
500
0
Q1 ‘04 Q2 ‘04 Q3 ‘04 Q4 ’04 Q1 ‘05
UW Clinical Experience Year 1
VC patients referred for OC (size ≥ 10 mm)
4%
VC patients who would be referred if all patients
with lesions ≥ 6 mm were sent for an OC
11%
Patients in VC study
1,110
What is virtual microscopy?
Mid-1700s: Cuff-style
microscope; 1st to
provide ease of use
and accurate focusing
mechanisms
1595: 1st
Compound
Microscope
1680s: English
Tripod
Microscope
1899: Ernst Leitz
Compound Binocular
Microscope
1998: State of the art contains
accessories for DIC, fluorescence,
polarized light, phase contrast,
and photomicrography
It has taken us 500 years to get to this point…
It can’t just be about making pretty pictures!
Digitalization offers both
advantages and challenges
Imaging
It’s just a matter of time
40-sec
20x scan
20-sec
20x scan
20-second
40x multi-angle
scan
Applications
Multispectral imaging
Rapid
secondary
consultations
Subspecialist
work flow
triage
Computer-aided
detection
Storage
100 Terabytes
Computer-aided
diagnosis
Petabytes 100 Petabytes
Enterprise image management
Pathology PACS
2007
2012
2017
* Source: Sg2 T3 Virtual Slide Imaging
Prognosis & Treatment
Imaging
Gene Expression
Pharmacogenomics
Biomarkers
Traditional
Pathology
Predisposition,
Signs, Symptoms
The value of traditional pathology
has not diminished.
It simply will no longer be sufficient.
Each pathologist and organization has a place on
the Technology Adoption Curve
Consensus Adopters—
Primary target for education
and accreditation products
Early Adopters—target
for leadership and
resource committees
Where is the specialty of
pathology?
Innovators—target
for foundation grants
1
Cautious Adopters—Target
for technology education
2
3
4
Late Adopters—
Members at the
sunset of their careers
5
What does this mean for
you?
We’re interested in your thoughts…
1. In 5 years, what will be your primary role
as a clinician? How about 10 years?
2. What technology would you like for your
program to teach but it doesn’t? Why?
3. What current technologies in pathology
could be absorbed by other specialties and
what technologies could pathology
absorb?
4. How does the concept of personalized
medicine affect pathology?
We’re interested in your thoughts…
5. How can the testing and certification programs in
pathology training be re-oriented to the changing field of
medicine?
6. What is the real difference between clinical and
anatomic pathology anyway?
7. If your first job out of training required you to read a PET
scan, could you / would you be willing to do it and how
would you go about learning how?
8. How do other specialists view pathologists, and does
that perception need improvement?
But I am just a resident…
…words from the newly
experienced
But I’m just a resident…
Do you feel powerless as
a trainee, or are you using
your status as a crutch to
avoid challenging the
status quo?
How to prepare yourself for the
future now…
• In training
• How you choose a job or fellowship
• In early practice
But I am just a resident…
During training
• Take advantage of pioneers in your facility
• Get exposure out of your training program
• Insert yourself into the flow of patient care
(e.g. projects, sign out)
Leaving training
• Choose a job that will allow you
to pursue your learning and
practice goals
– Ask about opportunities to be
involved in new technologies and
new activities
– Find out what innovations have
recently been implemented
– Ask about decision-making
processes
– Get involved
In early practice
• Re-learn skills of systems-based knowledge
and challenge peers
• “Keep your head up” for additional challenges/
opportunities
Will you experience
frustration as you
launch into your new
career?
Yes…but CAP is implementing
strategies to ensure you have the
tools, education and advocacy
necessary for a successful, relevant
career in pathology
Vision of Pathologists
Pathologists are physicians who take an active
role in patient care, utilizing all available tools to
integrate and interpret diagnostic information to
provide an accurate diagnosis of disease.
Pathologists work closely with other members of
the medical team to assess the patient condition
and prognosis in order to determine optimum
therapy alternatives.
Pathology will assume
a critical role in health
care delivery
Pathologists
• Have a unique knowledge
of disease processes
• Are knowledge integrators
• Can get access to all the
diagnostic data necessary
• Are responsible for the
testing that is driving
therapy
CAP is ready to pursue a transformational
role for the specialty and pathologists
Mission
The CAP, the leading
organization of board-certified
pathologists, serves patients,
pathologists, and the public by
fostering and advocating
excellence in the practice of
pathology and laboratory
medicine.
Vision
The CAP is the primary driver in the
transformation of the specialty of
pathology and pathologists. As the
transformation agent, CAP will greatly
strengthen and evolve its position into:
– The leading organization guiding
pathologists
– The leader in promoting quality patient
care
– The primary resource for information
and education
– The most influential advocate for
pathologists
While maintaining a solid foundation,
the CAP is pursuing change
• Broad initiatives: The Four “Big Things”
• Laboratory Quality & Improvement for the 21st
Century (LQI-21) Ad Hoc Committee
• Technology Assessment Committee
• Personalized Medicine Committee
• Diagnostic Database Initiative
Strategic Planning identified 4 initiatives that
would contribute most significantly to the
transformation of the specialty
•
•
•
•
Institute
Laboratory Quality & Patient Safety Center
Personalized Healthcare
EBIDA
CAP Institute will deliver multifaceted leading-edge
programs that provide you what they WANT today
and what you will NEED in the future
• Programs to support MOC,
MOL and hospital privileging
• Certificate programs in
emerging technologies, organ
systems, etc.
• Practice management tools
• Research studies and
publications
• Virtual and on-site practicums
with an “Institute-approved”
curriculum
• Education programs targeting
system-based practice
• Re-training programs for
qualified individuals interested
in re-establishing active
practice status
• Guidelines for “best practice”
residency programs
• Program Director tools to
assess resident medical
knowledge and ability to apply
this knowledge
• Comprehensive branding
Education combined with the standards,
best practice and policy to support pathology
CAP Laboratory Quality &
Patient Safety Center
Personalized Healthcare
Develop and implement a
comprehensive College-wide plan to
maximize influence on the ongoing
development of public policies designed
to support current needs and the
transformation of the specialty including
a focus on personalized health care
Clearly define and develop programs
that ensure quality in Dx medicine, its
linkage with patient outcomes, and
the role of the pathologist in
improving quality and contributing to
patient care
And a solid foundation to ensure we can do
everything we want to accomplish
EBIDA from ongoing operations
To ensure that the CAP has the resources to
support the other three Big Things in addition to
our normal operations, the College intends to
maintain a positive cumulative EBIDA from
ongoing operations for every three-year rolling
period.
‘Big Thing’ plan development and
implementation has already begun
• Establish member/staff planning team(s)
• Identify strategies that help define the Big Things
• Determine current operations that already fit;
determine things that don’t fit
• Develop high-level Institute plan for Board
review in May
• Launch Institute at CAP ’08
• Initiate Center plans
• Ensure integration of ‘Big Things’
What happens if, and when CLIA ’88 is
finally cracked open?
Evaluate current and future patient safety initiatives, laboratory
oversight legislation and regulations, and other related issues in the
development of specific CAP position recommendations that give
consideration to the scientific, medical and economic implications
for patients, laboratories, pathologists, and the College.
Recommendations will be presented to the Board of Governors in
February 2009 or sooner if necessary.
Chair: E. Randy Eckert, MD, FCAP
What is pathology and the CAP’s role
in the new world of personalized
healthcare?
Initial charge: Develop a white paper to define the issues,
opportunities and challenges for the College to position the
specialty to maximize the effectiveness of its input into the
government initiative to transform the health care system
Chair: Louis Wright, MD, FCAP
Will the future EHR adequately address
our needs and the value of the
information we provide?
Integrating the
information about
patients, and their body
tissue and fluids, that is
necessary for diagnosis,
assessing prognosis
and defining treatment
alternatives
•
•
•
•
•
•
Information derived from specimens and
specimens themselves
Patient data about history and outcome
Requisitions and orders
Lab, pathology and radiology results and reports
Collections of similar, related and derivative
information used for interpretation
Knowledge integration, interpretation and
communication
Will we be prepared to harness the
influx of emerging technologies
affecting today’s practice?
To identify, evaluate, and monitor emerging technologies and to
develop and monitor processes for communication and program
development to ensure that the College is aware of and prepared
to respond to technologies that may impact upon patient care,
the specialty of Pathology and Laboratory Medicine, and the
College of American Pathologists.
Chair: Greg J. Davis, MD, FCAP
TAC serves as core technology investigators and
explorers with a long term perspective,
complementing CSA committee work
• Accelerate emerging technology investigation; sift through
and prioritize
• Translate findings into knowledge and recommend action
– Collaborative relationships with sentinel industry organizations
provide knowledge emerging technologies CAP can influence
– Visit with key innovators that are “doing it” and have early
demonstrations of how new technologies can impact pathology
• Recommend technology strategy priorities
–
–
–
–
Define emerging technology strategies CAP should pursue
Recommend who should be doing what
Consider resources necessary to implement action plans
Facilitate cross council discussion on emerging technology
implications
Execute
Plan
Environment
Scan
Monitor for indication
to re-assess a
technology or
proceed to the next
step
Analyze
Watch
TAC will operationalize a
technology assessment
framework to ensure that
pathology continues to be
relevant and integral to
patient care in a changing
technological health care
environment
TAC will focus on emerging technologies as
they move through the Hype Cycle
On the
Rise
1st generation products,
high price, lots of
customization needed
Mass media hype
begins
No working products
At the Peak
Sliding into
the Trough
Climbing
the Slope
Negative
press begins
Consolidation
& failures
2nd/3rd rounds of
VC funding
High-growth adoption
starts--~20% of target
audience has or is
adopting the technology
Lab prototypes
Less than 5%
adoption
Startup companies,
1st round of VC
funding
R&D
Technology
Trigger
2nd-generation
products
3rd generation
products, out of the
box
Entering
the
Plateau
Emerging Technology Prioritization
10
For emerging technologies with
the most significant impact and
probability of adoption, what
should the CAP do?
9
8
Magnitude of Impact
7
6
5
4
3
2
1
0
0
1
2
3
4
5
6
7
Probability of Adoption
8
9
10
11
12
…and if it’s the “real deal”
• Action Item recommending completion of a detailed action plan
– Council/committee leadership/plan “ownership”
– Planning team composition (not specific individuals but rather expertise
needed)
– Specific elements that should be addressed by the plan (e.g., value to
be delivered, elements to be analyzed—operations impact, CPT codes,
education)
– General timeline for action plan execution based on TAC
characterization of impact timing
• SPC and Board approval will instigate plan development with the
appropriate expertise
• Execution and monitoring involve TAC and the “owning” Council
CAP’s strategy addresses the essential
components to ensure the continued
relevance and strength of our specialty in
the dynamic world of medicine
Advocacy/Policy
Information, Education & Tools
Standards/Best Practices
Financial Stability & Growth
Engage the change—integrate new
concepts and technologies
Consensus Adopters—
Primary target for education
and accreditation products
Early Adopters—target
for leadership and
resource committees
Innovators—target
for foundation grants
1
Cautious Adopters—Target
for technology education
Late Adopters—
Members at the
sunset of their careers
Where do you intend
to be?
2
3
4
5
Re-assess your tool kit—all diagnostic
tools are available to you
• Acknowledge market forces
driving changes in practice of
pathology
• Be life long learners
• Expand beyond the tissue on
the slide
• Market your services for
consults
– Establish and advertise an
open door policy
– Meet with your clinician peers
to review slides, case histories
and interpretations
• Expand value by influencing
prognosis and treatment
– Pursue educational
opportunities that demonstrate
integration of pathology with
the rest of the treatment plan
– Collaborate with others
providing diagnostic data
• Go see patients
– Actively participate in patient
grand rounds
– Review charts and talk to the
attending physicians
The three great essentials to
achieve anything worth while are,
first, hard work; second, stick-toitiveness; third, common sense.
~ Thomas Edison
Futurescape 2008
Transforming Pathology: Emerging
Technology Driving Practice Innovation
Learn how to harness
technology to keep your
skills and practice at the
forefront of a rapidly
advancing health care
environment