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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. Emerging Developments and Your Future in Pathology.

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emerging developments and your future in pathology

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 pathology2
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?
traditional trial and error method of care is no longer acceptable
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 doesn’t 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 cost—factors that can increase patient morbidity and mortality

slide5
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
Patient response rates to a major drug in selected categories of therapy

Source: Physicians’ Desk Reference

what does the consumer want
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
slide9
Help!
  • Fast and accurate results
  • Understandable and useful information
  • Direction on therapy
  • Low costs--may not be as important

What does the patient’s treating physician want?

market demand and emerging technologies are accelerating the shift to precision medicine
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

precision medicine is not new consider the history of infectious disease therapy
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

Lister adopts antiseptic technique in surgery

Koch proves Germ Theory with discovery of B. anthracis

Semmelweis proposes handwashing to prevent spread of disease

1670

1720

1770

1820

1870

1920

Reed proves mosquitoes are vector for yellow fever

Pasteur explores Germ Theory of Disease

Leeuwenhoek observes “little animals” under microscope

Ehrlich introduces the acid-fast staining technique

Jenner administers smallpox vaccine

Fleming discovers Penicillin

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

today cancer is experiencing a similar shift toward precision medicine
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

precision medicine implies personalization and all its benefits
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
slide15

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
Industry recognizes the opportunity and are willing to work with anyone

Are diagnostics the new wonder drug on Wall Street?

slide18
Practice of medicine is moving from the treatment of illness to the aggressive promotion of wellness
ivds will become increasingly vital components of the health care system
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

Signs & Symptoms

In vivo Imaging Techniques

In vitro Laboratory Tests

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

compression of the biomarker development timeline is accelerating progress
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

circulating tumor cells what 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

Circulating Tumor CellsWhat is the impact of CTC assays on pathology?

Technology Curve:

CTC Assay

3

Consensus Adopters

4

Cautious Adopters

5

Late

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
impact may be dramatic or not
Impact may be dramatic…or 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

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
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

Screening Virtual Colonoscopy What is the impact of Screening VC on pathology?

Technology Curve:

Screening VC

3

Consensus Adopters

4

Cautious Adopters

5

Late

Adopters

2

Early

Adopters

0

Pre-Clinical

1

Innovators

Probability of Adoption into Clinical Use

  • Expected rate of adoption: Moderate
  • Barriers: Public preference; Payment—must be driven by provider
  • Accelerators: Publicity for screening, public preference
destructive or positive impact

Q1 ‘04

Q2 ‘04

Q3 ‘04

Q4 ’04

Q1 ‘05

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

2010

2012

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

what is virtual microscopy
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 can’t just be about making pretty pictures!

it s just a matter of time

40-sec

20x scan

20-sec

20x scan

20-second

40x multi-angle scan

Imaging

Multispectral imaging

Rapid

secondary consultations

Subspecialist

work flow

triage

Applications

Computer-aided detection

Computer-aided diagnosis

100 Terabytes

Petabytes

100 Petabytes

Enterprise image management

Storage

Pathology PACS

2017

2007

2012

It’s just a matter of time

* Source: Sg2 T3 Virtual Slide Imaging

slide29

Imaging

Gene Expression

Pharmacogenomics

Biomarkers

Traditional

Pathology

Pathologist

Prognosis & Treatment

The value of traditional pathology has not diminished.

It simply will no longer be sufficient.

Predisposition, Signs, Symptoms

each pathologist and organization has a place on the technology adoption curve
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

Early Adopters

target

target

Cautious Adopters

Cautious Adopters

Target

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

Innovators

target

target

sunset of their careers

sunset of their careers

for foundation grants

for foundation grants

1

1

2

2

3

3

4

4

5

5

we re interested in your thoughts
We’re 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 doesn’t? 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?
we re interested in your thoughts33
We’re 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?
but i am just a resident

But I am just a resident…

…words from the newly experienced

but i m just a resident
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
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
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
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

in early practice
In early practice
  • Re-learn skills of systems-based knowledge and challenge peers
  • “Keep your head up” for additional challenges/ opportunities
slide41

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
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
Pathology will assume a critical role in health care delivery

Special Edition

  • 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

Pathologists

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

CAP is ready to pursue a transformational role for the specialty and pathologists
while maintaining a solid foundation the cap is pursuing change
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
slide46
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
slide47
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

CAP Institute will deliver multifaceted leading-edge programs that provide you what they WANT today and what you will NEED in the future
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

Education combined with the standards, best practice and policy to support pathology
and a solid foundation to ensure we can do everything we want to accomplish
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
‘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
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.

LQI-21

Chair: E. Randy Eckert, MD, FCAP

what is pathology and the cap s role in the new world of personalized healthcare
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

Personalized Medicine

Chair: Louis Wright, MD, FCAP

will the future ehr adequately address our needs and the value of the information we provide
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

will we be prepared to harness the influx of emerging technologies affecting today s practice
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.

Technology Assessment

Chair: Greg J. Davis, MD, FCAP

slide55
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
slide56

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
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

R&D

2nd-generation products

Technology Trigger

slide58

For emerging technologies with the most significant impact and probability of adoption, what should the CAP do?

and if it s the real deal
…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
slide60

Advocacy/Policy

Information, Education & Tools

Standards/Best Practices

Financial Stability & Growth

CAP’s strategy addresses the essential components to ensure the continued relevance and strength of our specialty in the dynamic world of medicine

engage the change integrate new concepts and technologies
Engage the change—integrate new concepts and technologies

Consensus Adopters

Consensus Adopters

Primary target for education

Primary target for education

and accreditation products

and accreditation products

Early Adopters

Early Adopters

target

target

Cautious Adopters

Cautious Adopters

Target

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

Innovators

target

target

sunset of their careers

sunset of their careers

Where do you intend to be?

for foundation grants

for foundation grants

1

1

2

2

3

3

4

4

5

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

Re-assess your tool kit—all diagnostic tools are available to you
slide63

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

~ Thomas Edison

futurescape 2008 transforming pathology emerging technology driving practice innovation
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