Emerging Developments and Your Future in Pathology

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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

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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?

3
Prediction is difficult, especially about the
future
Niels Bohr, 1885-1962
4
Traditional trial-and-error method of care is no
longer acceptable
Weight age may affect drug selection dosage
or other intervention
Doctor makes a most likely diagnosis, may order
tests to confirm, and prescribes a treatment plan
(usually drugs and/or surgery)
Patient presents with symptoms
Plan works or doesnt work, /- side effects?
Treatment plan success
Doctor revises treatment plan
The occasional result sub-optimal treatment,
prolonged periods of trial and error, medical
noncompliance, and increased costfactors that
can increase patient morbidity and mortality
5
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!

6
Patient response rates to a major drug in
selected categories of therapy
Source Physicians Desk Reference
7
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

8
and they are being educated by the media
9
What does the patients treating physician want?

• Help!
• Fast and accurate results
• Understandable and useful information
• Direction on therapy
• Low costs--may not be as important

10
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

Source Christensen/Hwang
11
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

12
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
Source Christensen/Hwang
13
Today, Cancer is experiencing a similar shift
toward precision medicine
Farber develops 1st chemotherapy for leukemia
Novartis launches Gleevec, the 1st molecular
targeted drug, to treat myeloid leukemia
2 types leukemia lymphoma
1920
1930
1940
1950
1960
1970
1980
1990
2000
2010
Disease of the blood
38 types of leukemia 51 types of lymphoma
3 types of leukemia (acute, chronic, preleukemia)
and 2 types of lymphoma (indolent, aggressive)
Source Mara Aspinall, Genzyme
14
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

15
Diagnostic tests and data integration are the
critical links to the success of
personalized medicine
16
Industry recognizes the opportunity and are
willing to work with anyone
Are diagnostics the new wonder drug on Wall
Street?
17
What kinds of emerging technologies will impact
my future practice?
18
Practice of medicine is moving from the treatment
of illness to the aggressive promotion of wellness
19
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
20
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
Molecular Diagnostics
and biomarkers will be a primary tool
21
Compression of the biomarker development timeline
is accelerating progress
1977 FDA approves PSA for patients already
diagnosed
2002-04 Period and retrospective analyses on
survival
2007 220 therapeutics emerging 100 in Phase
II 20 on market
Preclinical exploratory
Clinical assay validation
Retrospective longitudinal
Prospective screening
Cancer control
1996-7 4 new chemical entity therapeutics
approved for prostate cancer
1994 PSA approved as predictive indicator
PSA Biomarker development 30 years
Source Bartsch, et al, IBM (Imaging) Biomarker
Summit III, Jan 2007
22
Circulating Tumor CellsWhat is the impact of CTC
assays on pathology?

• 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

Technology Curve CTC Assay
3 Consensus Adopters
5 Late Adopters
4 Cautious Adopters
2 Early Adopters
0 Pre-Clinical
1 Innovators
Probability of Adoption into Clinical Use
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

23
Impact may be dramaticor not
CTC Assays for Therapy Monitoring OP Test
Volumes, US Market
Potential Impact by Indication
Tests (Thousands)
35 30 25 20 15 10 5 0
2006
2008
2012
2010
2016
2014

• Current utilization almost exclusively limited to
  research
• As clinical benefits are established, utilization
  will grow significantly

Source Sg2 Analysis, 2007
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Screening Virtual Colonoscopy What is the impact
of Screening VC on pathology?

• Technology Overview
• 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

Technology Curve Screening VC
3 Consensus Adopters
5 Late Adopters
4 Cautious Adopters
2 Early Adopters
0 Pre-Clinical
1 Innovators
Probability of Adoption into Clinical Use

• Expected rate of adoption Moderate
• Barriers Public preference Paymentmust be
  driven by provider
• Accelerators Publicity for screening, public
  preference

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Destructive or positive impact?
Growth in Virtual and Optical Colonoscopy, US
Market
Total Colonoscopies (Virtual Optical) University
of Wisconsin
of Procedures
of Procedures (Millions)
3000 2500 2000 1500 1000 500 0
9 8 7 6 5 4 3 2 1 0
Optical Colonoscopy (Screening)
Virtual
Optical
-9
Optical Colonoscopy (Therapeutic)
59
200
Virtual Colonoscopy (Screening)
2006
2008
2012
2010
2016
2014

• VC will increase colorectal cancer screening and
  therapeutic volumes
• Pathology volumes for colon biopsy will mirror
  therapeutic colonoscopy volumes

Source Sg2 Analysis, 2007
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What is virtual microscopy?
Mid-1700s Cuff-style microscope 1st to provide
ease of use and accurate focusing mechanisms
1595 1st Compound Microscope
1998 State of the art contains accessories for
DIC, fluorescence, polarized light, phase
contrast, and photomicrography
1680s English Tripod Microscope
1899 Ernst Leitz Compound Binocular Microscope
It has taken us 500 years to get to this
point It cant just be about making pretty
pictures!
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Digitalization offers both advantages and
challenges
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Its just a matter of time
Source Sg2 T3 Virtual Slide Imaging
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Prognosis Treatment
The value of traditional pathology has not
diminished. It simply will no longer be
sufficient.
Predisposition, Signs, Symptoms
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Each pathologist and organization has a place on
the Technology Adoption Curve
Consensus Adopters

Consensus Adopters

Primary target for education
Primary target for education
and accreditation products
and accreditation products
Early Adopters

target
Early Adopters

target
Cautious Adopters

Target
Cautious Adopters

Target
for leadership and
for leadership and
for technology education
for technology education
resource committees
resource committees
Where is the specialty of pathology?
Late Adopters

Late Adopters

Members at the
Members at the
Innovators

target
Innovators

target
sunset of their careers
sunset of their careers
for foundation grants
for foundation grants
1
2
3
4
5
1
2
3
4
5
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What does this mean for you?
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Were interested in your thoughts

• In 5 years, what will be your primary role as a
  clinician? How about 10 years?
• What technology would you like for your program
  to teach but it doesnt? Why?
• What current technologies in pathology could be
  absorbed by other specialties and what
  technologies could pathology absorb?
• How does the concept of personalized medicine
  affect pathology?

33
Were interested in your thoughts

• How can the testing and certification programs in
  pathology training be re-oriented to the changing
  field of medicine?
• What is the real difference between clinical and
  anatomic pathology anyway?
• 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?
• How do other specialists view pathologists, and
  does that perception need improvement?

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But I am just a resident

• words from the newly experienced

35
But Im 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?

36
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
37
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)

38
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

PATHOLOGISTS WANTED
39
In early practice

• Re-learn skills of systems-based knowledge and
  challenge peers
• Keep your head up for additional challenges/
  opportunities

40
Will you experience frustration as you launch
into your new career?
41
Yesbut CAP is implementing strategies to ensure
you have the tools, education and advocacy
necessary for a successful, relevant career in
pathology
42
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.

43
Pathology will assume a critical role in health
care delivery
Special Edition
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

44
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

45
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

46
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

47
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

48
Education combined with the standards, best
practice and policy to support pathology

• CAP Laboratory Quality Patient Safety Center
• 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

• 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

49
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.

50
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 dont fit
• Develop high-level Institute plan for Board
  review in May
• Launch Institute at CAP 08
• Initiate Center plans
• Ensure integration of Big Things

51
What happens if, and when CLIA 88 is finally
cracked open?
LQI-21

• 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
52
What is pathology and the CAPs role in the new
world of personalized healthcare?
Personalized Medicine

• 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
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Will the future EHR adequately address our needs
and the value of the information we provide?
Diagnostic Intelligence Health IT

• 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

Integrating the information about patients, and
their body tissue and fluids, that is necessary
for diagnosis, assessing prognosis and defining
treatment alternatives
54
Will we be prepared to harness the influx of
emerging technologies affecting todays practice?
Technology Assessment

• 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
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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

56
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
57
TAC will focus on emerging technologies as they
move through the Hype Cycle
On the Rise
At the Peak
Sliding into the Trough
Climbing the Slope
1st generation products, high price, lots of
customization needed
Negative press begins
Consolidation failures
Entering the Plateau
Mass media hype begins
High-growth adoption starts--20 of target
audience has or is adopting the technology
No working products
2nd/3rd rounds of VC funding
Lab prototypes
Less than 5 adoption
Startup companies, 1st round of VC funding
3rd generation products, out of the box
RD
2nd-generation products
Technology Trigger
58
For emerging technologies with the most
significant impact and probability of adoption,
what should the CAP do?
59
and if its 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
  analyzedoperations 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

60
CAPs strategy addresses the essential components
to ensure the continued relevance and strength of
our specialty in the dynamic world of medicine
61
Engage the changeintegrate new concepts and
technologies
Consensus Adopters

Consensus Adopters

Primary target for education
Primary target for education
and accreditation products
and accreditation products
Early Adopters

target
Early Adopters

target
Cautious Adopters

Target
Cautious Adopters

Target
for leadership and
for leadership and
for technology education
for technology education
resource committees
resource committees
Late Adopters

Late Adopters

Members at the
Members at the
Innovators

target
Innovators

target
sunset of their careers
sunset of their careers
Where do you intend to be?
for foundation grants
for foundation grants
1
2
3
4
5
1
2
3
4
5
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Re-assess your tool kitall 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

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The three great essentials to achieve anything
worth while are, first, hard work second,
stick-to-itiveness third, common sense.

• Thomas Edison

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Futurescape 2008Transforming 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
Westin O'Hare June 6-8, 2008