GM4: College of American Pathologists – Debra Leonard

Teri Manolio:
And first is Debra Leonard from the College of American Pathologists. Debra Leonard:
Well, thank you for inviting us to participate in this conference. We’re very excited, and
I was a little daunted when I got this list of topics that we were supposed to cover so
I will try to — I targeted my talk simply to address the questions that were asked.
And so we will look at the first two together: member needs assessments completed or planned,
and state of genomic science and practice by members. We are toward the end of a five-year process
of what we call the Pathology Transformation Process, which was driven by changing pathologist
demographics, as well as health care delivery reform and genomics. Those were kind of the
three major driving forces of this. In 2010 we did a member survey of genetic/genomic
knowledge, and we were rather pleased to find that, you know, 61 percent of people, pathologists,
practicing pathologists, and this is a thousand of our 17,000 practicing pathologists, were
familiar with whole genome sequencing or analysis, which we were very surprised to find. Now,
we did not test them, so we don’t know what they mean by familiar, but — and then we
also asked about gene panel tests and single gene tests, and, of course, the familiarity
went up. So from 2009 to 2012, we basically defined
the pathology transformation strategy, which I think any practice subspecialty you could
take this and just change pathology to pediatrics, or medicine, or whatever. Enable our members
to control their professional economic destinies. Focus our support on pathology practices,
because, classically, the College of American Pathologists had been focused on the individual
pathologists, so it’s just a technical point. And help them create greater value, especially
in embedding new genomics and informatics capabilities in their work, get paid for this
in the context of coordinated care. So it’s a very simple strategy. And we are going to implement a multi-year
series of initiatives starting this year and moving forward. And one of the aspects is
to take the analysis that we’ve already done and develop a specific genomics strategy,
or genomic medicine strategy of what initiatives are going to have the greatest impact in helping
pathologists move toward the practice of genomic medicine. So we were next asked to talk about the short-
and long-term pace of change in genomics use. So in pathology practice, we are currently
standardly doing single or few mutation or single gene pathogen detections, or a few
genes. But we are moving to incorporating next-gen sequencing, basically, or genomic
analysis into our practices, doing predominately gene panels or exome sequencing. Right now,
research — this slide may be rapidly becoming dated, but genome and transcriptome sequencing,
we are beginning to think about doing clinically, but pretty much remain in the realm of research.
And we feel like all of the research will build back flow [spelled phonetically] to
help us understand the clinical usefulness of the sequencing that we are doing over time.
So this is what we call genomic analysis by next-gen sequencing. So what you need to understand about pathology
or molecular pathology tests is that not all molecular pathology tests can move over into
next-gen sequencing platforms. So we do a lot of tests: HIV viral loads, CMV/EVV viral
loads, bone marrow engraftment analysis. Those will have to stay on their current platforms
and can’t really be done by next-gen sequencing. But there are a lot of genetic and cancer-related
tests that are better done by next-gen sequencing either as gene panels, and that would be for
cancer or specific inherited disorders where you know the sets of genes used for that or
causative of that disease, or exome sequencing, also for cancer or for unidentified inherited
disorders, exome or genome. So we, in the process of doing this transformative
strategy investigation, looked at the early adopters of genome/exome sequencing or gene
panels, next-gen sequencing technology in clinical laboratories. And there was quite
a rise in the number of laboratories doing this. And this is in 2011, just when the MiSeq
and Ion Torrent smaller instruments became available, which are really the game changers. So I will go very rapidly through this, that
the first genome was done on ABI sequencers, which cost a lot of money, moving into next-gen
sequencing mostly in research but it was an instrument that cost $750,000, and it had
a one-week data processing time — I mean, data generation time. But the MiSeq and Ion
Torrent basically are in a clinically-relevant price range and a clinically-relevant turnaround
time. So this is what is the game changer for us. And we’re moving on to an ion proton
and other instruments that will have clinically-relevant costs and turnaround times. So we are seeing
much, much greater adoption of next-gen sequencing technologies, predominately for gene panels
in clinical laboratories. So the current plans to address genomics literacy
by the College, and I am going to talk about different categories of initiatives, and one
is assuring the quality of the genomic tests that are being performed because the College
also is an accrediting body for clinical laboratories under — with deemed status under CLIA. And
so we have developed an NGS inspection checklist series of questions that address both the
wet bench aspects of generating the data as well as the bioinformatics pipeline. And it
[inaudible] dominantly on proper validation and documentation, and applies to any instruments
or tests being done by next-gen sequencing technology. And those became available on
July 2012, and we are updating those this year in 2013. CAP also has a proficiency testing program
that we offer to laboratories and so we are looking at how you do proficiency testing
for next-gen sequencing based tests. We are going to use highly characterized genomes,
and I can go into detail about how we are characterizing those. And then each laboratory
would perform their [inaudible] on those — a characterized genome or more sent to them,
and it will assess both the sequence data generation and bioinformatics processes. We also have developed what we call Resource
Guides. And we actually have four Resource Guides. There are two related to genomics.
There is a Genomic Analysis Resource Guide and a Molecular Diagnosis Resource Guide.
So some pathologists need to get up to speed with the now routine molecular testing. But
then there is also one for Genomic Analysis. And here you can see the table of contents
— I won’t read through it — of the Genomic Analysis Resource Guide. But there are pearls
from early adopters, there is technology information. We do it by — we have information for different
types of testing being done, standards and accreditation, and in 2013, we are going to
be adding a bioinformatics section to this Resource Guide. So many pathologists have
given us very positive feedback that these are very, very useful to them. Education realm, we had 37 molecular or genomic
courses at CAP ’12. I know relative to ASHG every single one of their courses is related
to genetics or genomics, but this is a big change for the College. And there is a range
of topics, some involving next-gen sequencing, but others molecular testing, molecular hematopaths
[spelled phonetically], molecular microbiology. So we have to consider the molecular and genomics
of all kinds of applications, from inherited disorders to cancers to infectious diseases
and pharmacogenetics. We also have three pharmacogenomics online
courses and other — we have a total of 16 online courses that pathologists can use for
CME or SAMs. SAMs is what we — it’s the continuing education for reaccreditation at the 10-year
period. And out of the committee that I run we also have a webinar series that’s been
going on for three years. And it focuses in three areas: genomic testing, around next-gen
sequencing of panels, exomes, or genomes; molecular pathology testing, so, you know,
not next-gen; and then organ-based molecular pathology, which predominately focuses on
cancer. And these webinars have reached — more than 4,500 CAP members have attended one or
more webinars. And so we’re having a pretty significant impact in reaching pathologists
with the webinar series. And these are some of the upcoming topics:
Molecular Microbiology in Community-Based Practice, Pathologist’s Role in Breast Cancer
Diagnosis. You can see many of them are — we always have a talk on DNA Day that is available
nationally, but it’s done at the College of American Pathologists headquarters in Chicago. And we are also providing tools for practicing
pathologists. We call these SPECS; don’t ask how that happened. But they’re short presentations
on emerging concepts. And what they are, are short PowerPoint presentations of five to
10 slides that can be used to describe testing that is relevant and impacts patient care
directly now. And they are not branded with CAP logos or anything. They are to be used
by the practicing pathologist, and we also provide key references because some practicing
pathologists actually do not have easy access to PubMed, believe it or not. And so they
can customize these for their local conferences, tumor boards, or to talk with their hospital
administrators. And we are tracking the use, and we are providing updated materials, so
when you download, you have to register that you are getting this. And then as we update
the information, we would push out the updated information to anyone who’s already downloaded
previous versions of these. And so we have five of these in existence.
Our plan is to develop two more and update these: one on the workup of colorectal cancers,
so that’s somatic mutations; and then inherited colorectal cancer, metastatic melanoma, BRAF
testing in thyroid cancer, and workup of polycythemia and thrombocytosis, JAK2. So what’s the process for genomics practice
guidelines development for diagnosis and treatment? We have what we call the CAP Pathology and
Laboratory Quality Center to ensure that they’re — so, basically, this is our area of the
College that develops guidelines, uses evidence to support development of practice guidelines
and protocols, and we usually are doing that development in the context of a multidisciplinary
approach, working with either specialists from other subspecialty areas or other professional
organizations. And it facilitates the coordination of the consensus activities in the absence
of evidence-based practice guidelines. And so this is the process we — ideas for
guidelines that are needed are submitted, and so we select the ones we are going to
work on, and so we develop the scope and form the work group, do the research and literature
reviews, solicit and develop the guidelines, solicit public comments, complete recommendations,
review and approve, publish and implement. And then we haven’t yet quite figured out
the process for maintaining. Well, actually we do, I mean, because we have some guidelines
that are out. So there are two guidelines developed in collaboration with ASCO around
breast cancer testing. We have one in press around the selection of lung cancer patients
for EGFR and ALK tyrosine kinase inhibitors, and two more that are in development around
acute leukemia and colorectal cancer. What you can see from this is that, for pathologists,
the reality is we make our money around surgical pathology practice. And so the cancer genomics
is much more important and sellable to practicing pathologists than is inherited disorders that
we don’t have a lot of familiarity with. But we are trying to impact that. So activities by associated specialty boards
to include genomics and certification processes. Our residency training program requirements
currently require one to three months of training in molecular pathology, not necessarily specifying
genomics. So those centers that have training programs that are incorporating next-gen sequencing
and genomic testing into their molecular pathology laboratories are providing that as part of
their training. Others that don’t have it are not. So there aren’t any specific requirements
for genomics, per se. The American Board of Pathology includes molecular
knowledge. We refer to it as molecular pathology knowledge. Seven to 9 percent of the AP exam
is based on molecular pathology, and 10 to 15 percent of the CP. So that’s anatomic pathology
and clinical pathology. We are the only specialty that has two primary board certifications.
Subspecialty board certification in molecular genetic pathology is jointly by the American
Board of Pathology and the American Board of Medical Genetics. That has not yet incorporated
genomics into their requirements. But, again, most of the places that have MGP fellowships
are at academic medical centers. That’s also where the next-gen sequencing is being adopted
mostly. So many of the molecular genetic pathology fellows are being trained in next-gen sequencing
technologies. And then the College and the Association of
Pathology Chairs have actually developed a Memorandum of Understanding to work together
on pathology residency training issues including genomics, residency education, both at the
residency and the fellowship levels. And then, finally, and this is my last slide,
there is a — Richard Haspel is at Beth Israel Deaconess, Harvard, and he has been leading
an intersociety initiative, interpathology society initiative to develop a national curriculum
in cancer genomics for pathology residents. We called it TRIG. Actually, it’s not just
pathology, because the National Society for Genetic Counselors and other organizations
have also been involved in this. And so Rich just got an NCI R25 to support a five-year
project in implementing a curriculum that we have already begun to develop, but we are
going to fill it out a little bit more with three aims, is to develop the curriculum;
evaluate that, and my — University of Vermont will be one of the four training sites where
this will be tried; and then promote the national implementation of this curriculum across all
— the goal is greater than 90 percent of pathology residency training programs nationwide. So I think I answered the questions. So… Teri Manolio:
Great. Thank you very much Debra. Yeah, that was a tour de force through the many questions
that we [laughs] that we sent you. Thank you. So we have Mark Ratain, Gene, let’s see, Bill,
sorry, and then Marc. Mark Ratain:
So, Debra, I appreciate that pharmacogenomics is one of the areas in which CAP is interested,
and I — Debra Leonard:
Yeah. Mark Ratain:
— and I note on your website that you have a number of learning opportunities. And I’m
just wondering, are you partnering with any clinical pharmacology organizations to develop
these, or is this something CAP is doing on its own? Debra Leonard:
We have toxicology expertise, and because we run toxicology laboratories, and so I think
it goes along with the pharmacokinetics testing that we do, and it’s growing. So it’s a collaboration
between toxicology, which is within pathology, but not necessarily clinical pharmacology. Mark Ratain:
Yeah. Because I don’t think the lab medicine types are very involved in the cutting-edge
work that is going on. And so I would — I would encourage you to think about working
with organizations — Debra Leonard:
[affirmative] Mark Ratain:
— such as American Society for Clinical Pharmacology and Therapeutics, is one example. Debra Leonard:
Well, we clearly are highly collaborative anyway, so that’s a good suggestion. Teri Manolio:
Gene. Eugene Passamani:
Thank you for really a nice summary, Debra. A couple of questions. One is, in 2008, you
or someone said about putting this all together, and you’ve got a wonderful product. Can you
tell us a little bit about how you did that? Debra Leonard:
Painfully. [laughter] It really was the vision of the president
of the College of American Pathologists at the time, as well as several of our board
members, who really felt like we needed a process to move pathology toward what we were
then calling personalized medicine. We are now transitioning that term, because personalized
health care/personalized medicine is offensive to many physicians because we don’t go out
into the waiting room and say, “Okay, everybody with pneumonia, come into my office now.”
You know, it’s really — we personalize the care that we do now. So we prefer the term
genomic medicine or precision medicine. But genomic medicine really ties it to the genomic
information. But all that was happening, and a big uproar
within the College in 2008 because many pathologists were not incorporating genomics and even reticent
around molecular pathology, which is the single-gene testing. Genomics was kind of like the future
at that point. The future is now, [laughs] in pathology practice. So it’s — Mark Ratain:
So there was some resistance to change, I guess? Debra Leonard:
Yeah. But it became overwhelming to change. And then I actually chaired — there were
four modules that did a two-year process of looking at the economics, the demographics
of pathologists. I was doing the emerging technologies, which included not only genomics
but also in vivo microscopy and digital pathology, and then the service models for pathologists.
And those four groups then provided information, and then that became the work of the integration
team to put all that together into what we now call Pathways for Transformation. We have
a document that pathologists are actually reading and embracing because it ties in with
the ACO changes and the coordinated care models of practice in that pathologists have to be
out there; we can’t sit in our laboratories. I mean, this is becoming really personal now.
Sorry. But, you know, so it ties into a lot of different aspects of how pathology practice
has to change. And genomics is just one of those. Mark Ratain:
And your regulatory burden or need helps you get this out to people. Of all pathologists
who are practicing, how many do you think you have actually gotten to with all of this
educational stuff? Debra Leonard:
I — well, we — I don’t know. I don’t know. I do know that one of my new faculty at UVM
went to a leadership conference led by the College and came back drinking the Kool-Aid.
And I am absolutely delighted because he is going to lead in changing pathology practice
at UVM to be more the transformed model that we are looking to become. Teri Manolio:
Thanks. Bill. Bill Oetgen:
Yes. Thank you. That was really an excellent presentation. I am Bill Oetgen. I am a cardiologist
who is full time with the American College of Cardiology, as the senior vice president
for Science and Quality. And I have a question that I think my colleague, who directs our
Lifelong Learning Division, would ask, but she wasn’t able to be here. And it’s a little
bit of minutia, and that is, you mentioned that 4,500 of your CAP members had attended
the webinars over a period of several years. We think that — Debra Leonard:
That was actually just in 2011. Bill Oetgen:
Oh, just in 2011. Oh — Debra Leonard:
Yes. Bill Oetgen:
— even more impressive. We think that webinars are important and promising ways to provide
information to our members, but have not had success in those numbers ever. And so my question
is just, basically, how many members — how many CAP members are there? I’d kind of like
to get an idea of what the denominator is. Debra Leonard:
I knew somebody was going to ask me that. I know that there are supposedly around 17,000
practicing pathologists in the U.S. But I don’t know how many — Bill Oetgen:
Okay. Debra Leonard:
— are CAP members. And I must — one thing I didn’t mention about those webinars: They
are not CME, because we can’t be nimble enough and do CME. I hate to say that with the head
of ACCME sitting — you know. [laughter] But it’s very hard to do that. And we also
archive those webinars so that you can go online. So you can go on to the CAP website
and view any of those webinars over the past three years. They are — they do become dated
because they are on pretty hot topics, usually. Bill Oetgen:
Yeah. Well, that they’re not CME is even more impressive that you have those numbers of
attendees. I think that’s great. I’d like to just chat offline about — Debra Leonard:
Sure. Bill Oetgen:
— about how you’re so successful in that. Debra Leonard:
My contact information for the next seven weeks is in the bulletin. But — [laughter] — my, if you call that number or email me,
hopefully it will be forwarded, or my assistant will say where I can be located. Bill Oetgen:
Okay. Thank you. Teri Manolio:
So Marc. Marc Williams:
Yeah. It is very impressive. Because most of us have had the experience that Bill related
which we — if you build it, they won’t come. So maybe it says something about the amount
of free time pathologists have. I don’t know. [laughter] So my question is a little — Debra Leonard:
Educational energy that we have. [laughter] Marc Williams:
Yeah, there you — okay, fine. Well, you say tomato, I say tomato. So you’ve obviously been tracking the use,
which I think is great, and that’s a very useful process metric. But I was wondering
if there’s been discussion or any efforts in terms of actually measuring the impact
on practice. Have you been able to take a look and see how is this really fundamentally
changing how our members are practicing? It’s much harder to do, and I’m just curious if
there’s been discussions or attempts. Debra Leonard:
Not in a systematic way. I don’t know if the College has plans to repeat the kind of survey
that we did in 2010 to see if the kinds of things that we were asking about have changed.
But I showed one slide from the survey of the pathologists. But we actually did a survey
of other subspecialties, patients, many other people who don’t know anything about pathologists,
and it just confirmed that they don’t know anything about pathologists, and we basically
hide in a hole. And so that’s part of what we’re also trying [inaudible]. I don’t know
the way to measure that. We have gotten verbal, I mean, email and other comments back of how
individuals would incorporate this information into their practice, but not any systematic
way across all of them. Teri Manolio:
Great. Well, maybe while Robert Saul is heading up to the podium for the next talk, I might
ask Debra. I noticed your meeting topics were, you know, legion, I think, and it looked like
you had a very strong emphasis, as you said, 30-some seminars on genetics. I’m curious.
I don’t know that a lot of investigators that NHGRI supports or even some of the other institutes
who do molecular genetic type work necessarily submit to your meeting and recognize that,
you know, you don’t want to commit to the College right now or the program committee.
Would there be interest in having The Cancer Genome Atlas, or the Clinical Sequencing Exploratory
Research Centers, or other things that are supported in this space, presenting abstracts
or posters at your meetings? Debra Leonard:
The more that pathologists become aware of the other initiatives going on — and the
college does try to interact with other societies that are appropriate to whatever projects
we’re working on. So, yes, our meetings are in September usually. And so I don’t know
when abstracts are due, but sometime in early summer. And you can go on the CAP website
and find that out: It’s very easy. Teri Manolio:
Great. Thank you very much. All right, Dr. Saul for the American Academy
of Pediatrics.

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