CONTACTS 

SUBJECTS
Cancer Biomarker Research Interview Doctor Anna Barker Deputy Direct

0503 -
0503 -    ..
0504 - Summary/Objective
0505 -
050501 - Follow up ref SDS 2 GJ5M.
050502 -
050503 - Doctor Barker with NCI, ref SDS 0 H65N, and Doctor Woodcock at FDA
050504 - were interviewed today on advances in biomarkers that improve health
050505 - care for cancer patients.  Faster, cheaper care will help reduce costs
050506 - and improve prospects as the numer of cancer cases increases over the
050507 - next 10 years or so due to aging population. ref SDS 0 TG6O  Biomarker
050508 - technology uses proteins that associate with cancer cells. ref SDS 0
050509 - RX4L  Improvements in biomarkers, including PET scan image methods,
050510 - ref SDS 0 PL5I, will enable early detection of cancer for timely,
050511 - targeted treatment to prevent cancer from spreading. ref SDS 0 PK7G
050512 - Currently, only 9 of 1261 biomarkers identified for cancer have been
050513 - approved. ref SDS 0 3O6O  Federal agencies have teamed up to reduce
050514 - the time and cost getting more biomarkers approved for treating
050515 - patients. ref SDS 0 TD9K  NCI sponsors research to discover more of
050516 - the 100,000 to 1,000,000 potential biomarkers to discover and treat
050517 - cancer. ref SDS 0 TR7I
050518 -
050519 -        [On 070329 Millie's CA 15-3 cancer marker effective guide on
050520 -        response to treatment. ref SDS 3 GJ5M
050522 -         ..
050523 -        [On 080221 Millie reports her story in relation to an article
050524 -        on another woman fighting against rising health care costs to
050525 -        get treatment for IBC on clinical trial. ref SDS 4 E75J
050526 -
050527 -
050528 -
050530 -  ..
0506 -
0507 -
0508 - Progress
0509 -
050901 - Doctor Barker Dep Dir National Cancer Institute (NCI)
050902 - Biomarker Technology Advancing Detection and Treatment of Cancer
050903 -
050904 - This evening the Jim Lehrer Newshour broadcast an interview of Doctor
050905 - Anna Barker, Deputy Director, National Cancer Institute (NCI).
050906 - ref OF 1 0001  There is an extended interview file on the Internet
050907 - at....
050909 -               ..
050910 -              http://www.pbs.org/newshour/bb/health/jan-june07/cancerbarker_03-28.html
050912 -  ..
050913 - Interviewing Doctor Barker supplements extended interview with Doctor
050914 - Janet Woodcook, Chief Medical Officer FDA, shown below. ref SDS 0 ZG9O
050915 -
050916 -
050917 -
050918 -
0510 -

SUBJECTS
Cancer 560K Die Annually 1.5 Million Diagnosed Demand Rising Cancer

1003 -
100401 -     ..
100402 -    Malthusian Demographic Dilemma Endless Demand New Treatments
100403 -    1 of 3 Americans Get Cancer 560K Die 1.5 Million Diagnosed Annually
100404 -    560K Die from Cancer Annually 1.5 Million Diagnosed Demographic Dilemma
100405 -    Cancer Treatment Demand Rising Aging Population Demographic Dilemma
100406 -
100408 -  ..
100409 - Aging population increases cancer cases.  Older people living longer
100410 - with good medical care suffer increasing infirmaties that require new
100411 - treatments, reviewed previously on 020221. ref SDS 1 Y27F  This
100412 - Malthusian demographic dilemma seems evident in the interview today...
100413 -
100414 -            DR.  BARKER:  ...cancer will take the lives of 1,500 people
100415 -            today; 560,000 people will die from this disease this year;
100416 -            and nearly 1.5 million people will receive a diagnosis of
100417 -            cancer this year.  That's really - those statistics are
100418 -            really daunting, but if you look forward into the future,
100419 -            and not that far into the future, 12, 15 years even, we
100420 -            could see an increase of cancer approaching 50 percent in
100421 -            some estimates, certainly in the 30 percent range, and from
100422 -            30 to 50 percent means an enormous number of increase in
100423 -            cancer cases. ref OF 1 CH4N
100425 -             ..
100426 -            So today about one out of three Americans can expect to get
100427 -            cancer.  And if you look at the aging of the population,
100428 -            the number of cancer cases will increase significantly.
100429 -            ref OF 1 EC8J
100431 -  ..
100432 - Biomarkers, like CA 15-3 that aids Millie's treatment, illustrate
100433 - dilemma.  Researches estimate 100,000 to 1,000,000 cancer markers need
100434 - to be discoved and deployed.  So far, 1261 have beed identified, and
100435 - FDA has approved 9 for patient care, ref SDS 0 3O6O, in part because
100436 - approval takes 10 years and a billion dollars. ref SDS 0 TD5L
100437 -
100438 -            [On 080221 Millie reports her story in relation to an
100439 -            article on another woman fighting against rising health
100440 -            care costs to get treatment for IBC on clinical trial.
100441 -            ref SDS 4 E75J
100443 -             ..
100444 -            [On 100510 1118 costs of cancer care double past 20 years,
100445 -            ref SDS 5 P45I, because of aging population. ref SDS 5 S53P
100446 -
100447 -
100448 -
100449 -
100450 -
100451 -
1005 -

SUBJECTS
Mortality Cancer Decreases Early Diagnosis Detection Treatment Impro

1603 -
160401 -     ..
160402 -    Mortality Rates Cancer Decrease Early Diagnosis Better Treatment
160403 -
160404 -    American Cancer Society published report that mortality from
160405 -    cancer is decreasing.
160406 -
160407 -            DR.  BARKER: ... it's a combination of ...earlier
160408 -            detection... some of the biomarkers ...are being used
160409 -            effectively.  And... better treatment... you get better
160410 -            survival. ref OF 1 Y45K, and ref OF 1 X46K
160411 -
160412 -
160413 -
160414 -
1605 -

SUBJECTS
Biomarker Definition Cancer Marker Changes Genes Genetic Mutations N

1903 -
190401 -     ..
190402 -    Biomarker Definition Purpose Doctor Barker NCI
190403 -    Early Detection Targeted Treatment Enabled by Biomarkers
190404 -
190405 -
190406 -            DR.  BARKER: a biomarker measures the change in a normal
190407 -            cellular process, or a malignant or cancer cell process.
190408 -            Sometimes to measure changes following treatment.
190409 -            Biomarkers can be changes in genes, changes in proteins,
190410 -            some combination thereof.  It can even be imaging, for
190411 -            example.  Images can qualify as biomarkers if it's
190412 -            measuring changes in a specific organ or a specific
190413 -            process. ref OF 1 Y49K
190415 -  ..
190416 - Doctor Woodcock discusses proteins that associate with cancer to
190417 - provide effective biomarkers. ref SDS 0 5J45
190418 -
190420 -             ..
190421 -            Biomarker goals are early detection, ref SDS 0 PC6G, and
190422 -            timely, targeted treatment, ref SDS 0 5J97, to prevent
190423 -            cancer spreading to a point that cannot be cured, and early
190424 -            detection of effective treatment, so that ineffective
190425 -            treatment can be changed in time to prevent spread of
190426 -            disease, ref OF 1 X46K, and to detect recurrent disease to
190427 -            begin treatment early enough to extend quality of life.
190428 -            ref OF 1 SH7M
190430 -  ..
190431 - An example using biomarkers to support patient care occurred on 070301
190432 - when CA 15-3 indicated response to treatment.  This helped the doctor
190433 - avoid changing and effective treatment, even though clinical
190434 - examination found possible expanding cancer. ref SDS 2 M645
190435 -
190436 -
190437 -
190438 -
190439 -
190440 -
1905 -

SUBJECTS
The Cancer Genome Atlas (TCGA) Cancer Genome Atlas (TCGA)

2103 -
210401 -     ..
210402 -    Biomarker Projects Discovery Development Deployment
210403 -
210404 -    Follow up ref SDS 0 DP4O.
210405 -
210406 -        NCI Projects Discovering Biomarker Opportunities
210408 -             ..
210409 -            The Cancer Genome Atlas (TCGA)
210410 -
210411 -            TCGA is a $100M, 3-year pilot project.  NCI has teamed up
210412 -            with the National Human Genome Research Institute to try to
210413 -            discover all the genetic changes in cancer.  We're starting
210414 -            with three cancers and that's gliomas, or brain tumors,
210415 -            ovarian cancer, and lung cancer.  That's a very big project
210416 -            to see if it's scalable - can we do this for all cancer.
210417 -            ref OF 1 DR4J
210419 -             ..
210420 -            Cancer is the disease of gene changes.  Our challenge is to
210421 -            find all those genetic changes, and separate the signal,
210422 -            from the noise, because there are a lot of genetic changes
210423 -            that won't have much to do with cancer. ref OF 1 OL6F
210424 -
210425 -
210426 -
2105 -

SUBJECTS
Clinical Proteomics Technology Initiative Biomarker Projects NIC FDA

2303 -
230401 -             ..
230402 -            Clinical Proteomics Technology Initiative
230403 -
230404 -            When mutations occur or changes occur in genes, those get
230405 -            translated into proteins, which will be there in much
230406 -            larger numbers in terms of changes than genes.  The
230407 -            Clinical Proteomics Technology Initiative is trying to
230408 -            bring some standardization to the discovery of proteins so
230409 -            they can be used as biomarkers. ref OF 1 FQ8N
230411 -             ..
230412 -            We're working on mass spectrometry to measure changes in
230413 -            proteins, just to create the reagents, so that we have
230414 -            common sets of reagents that all scientists can use.
230415 -            ref OF 1 2S4F
230417 -             ..
230418 -            Reagents will be antibodies, or parts of antibodies,
230419 -            because most of the proteins that we have used to date
230420 -            actually have to be developed by isolating them, finding
230421 -            them, and testing for them using antibodies.  Antibodies
230422 -            are your body's response to an antigen or a foreign
230423 -            protein, or a self-protein.  We are going to create sets of
230424 -            reagents or sets of antibodies, or parts of antibodies that
230425 -            the entire community can access, and then protocols for how
230426 -            to do this, and how to get reproducible results.
230427 -            ref OF 1 JU4L
230429 -             ..
230430 -            We believe there could be anywhere from 100,000 to a
230431 -            million different proteins that might be important in
230432 -            cancer, and published literature from scientists shows a
230433 -            little over 1,200 proteins that have been discovered and
230434 -            seem to be linked to cancer, so far, indicating a lot of
230435 -            work. ref OF 1 NX5O
230437 -  ..
230438 - Doctor Woodcock explains that only 9 of 1261 proteins currently
230439 - identified for cancer biomarkers have been approved by the FDA.
230440 - ref SDS 0 3O6O   Since Doctor Barker explains that FDA approval for
230441 - new drugs takes about 10 years and a billion dollars, making
230442 - meaningful progress toward using 100,000 - 1,000,000 potential cancer
230443 - biomarkers appears extremely challenging. ref SDS 0 TD5L
230444 -
230445 -
230446 -
230447 -
230448 -
2305 -

SUBJECTS
Validation Biomarkers Early Detection Research Network Biomarkers Re

2503 -
250401 -         ..
250402 -        Projects in Development of Biomarkers
250404 -             ..
250405 -            Validation of Biomarkers
250406 -            Early detection research network
250407 -
250408 -            The goal is to validate biomarkers in patients.  It is a
250409 -            very rigorous process.  It's very hard to qualify your
250410 -            biomarker for the early detection research network.  You
250411 -            have to go through a lot of hurdles because it's a very
250412 -            expensive process to put this biomarker into the clinic.
250413 -            ref OF 1 P73O
250415 -  ..
250416 - Early diagnosis of cancer meets objectives of biomarkers, per above.
250417 - ref SDS 0 PK7G
250418 -
250419 -
250420 -
250421 -
2505 -

SUBJECTS
Interagency Oncology Task Force Oncology Biomarker Qualification Ini

2803 -
280401 -             ..
280402 -            Interagency Oncology Task Force
280403 -            Oncology Biomarker Qualification Initiative
280404 -
280405 -            NCI has been working with the FDA and the Center for
280406 -            Medicare/Medicaid Services (CMS) over the last five years
280407 -            to establish guidance on trials for biomarkers.  The
280408 -            Interagency Oncology Task Force has developed the Oncology
280409 -            Biomarker Qualification Initiative where NCI, FDA, and CMS
280410 -            have have designed two trials to measure the impact of
280411 -            biomarkers. ref OF 1 GN6N
280413 -             ..
280414 -            The first one is in non-Hodgkin's lymphoma, and the second
280415 -            one is in lung cancer.  Both of them actually are going to
280416 -            get underway probably here in the next two months.
280417 -            ref OF 1 UP3N
280419 -  ..
280420 - Doctor Woodcock explains that the Center for Medicare and Medicade
280421 - agency particpates in the biomarker project to facilitate approval of
280422 - payment for new technologies that are eventually produced and
280423 - prescribed by doctors to treat patients. ref SDS 0 YU3F
280424 -
280425 -
280426 -
280427 -
280428 -
2805 -

SUBJECTS
Biomarker PET FDG Scan Technology Lung Cancer Non-Hodgkins Lymphoma

3103 -
310401 -                ..
310402 -               Lung Cancer Biomarker FDG PET Technology
310403 -               PET Scan FDG Biomarker Non-Hodgkins Lymphoma Lung Cancer
310404 -               Biomarker FDG PET Non-Hodgkins Lymphoma and Lung Cancer
310405 -               FDG PET Biomarker for Non-Hodgkins Lymphoma and Lung Cancer
310406 -
310407 -               NCI is looking at FDG PET functional imaging biomarker.
310408 -               It's based on changes in the metabolism of cancer cells
310409 -               versus normal cells, measuring changes in the way
310410 -               glucose is metabolized.  We have a long history in
310411 -               non-Hodgkin's lymphoma using this biomarker.  We believe
310412 -               this is one will be reasonably straightforward to
310413 -               qualify with FDA, and we are using the same approach for
310414 -               lung cancer.  The two diseases are different, but this -
310415 -               this functional imaging should work in both of these
310416 -               trials. ref OF 1 YN4M
310417 -
310418 -
3105 -

SUBJECTS
Integrated Cancer Biology Program Systems Biology

3303 -
330401 -             ..
330402 -            Systems Biology, or
330403 -            Integrated Cancer Biology Program
330404 -
330405 -            NCI is investigating how pathways and the cells come
330406 -            together in malignant cells, and that will tell us more
330407 -            about which biomarkers might be critical, and have a bigger
330408 -            impact on the cell, for example, than some of the smaller
330409 -            regions that we're looking at. ref OF 1 W68F
330410 -
330411 -
330412 -
3305 -

SUBJECTS
Projects Delivering Biomarkers Nanotechnology

3603 -
360401 -         ..
360402 -        Projects in Delivering Biomarkers Nanotechnology
360403 -
360404 -            How are we going to deliver these protein biomarkers of
360405 -            genome biomarkers, we have a program in nanotechnology.  We
360406 -            are going to have to measure lots of things in cells.
360407 -            Nanotechnology is a science that measures at 10 angstroms.
360408 -            NCI developed a program to put lots of biomarkers onto
360409 -            platforms so that we can measure them in patients.
360410 -            ref OF 1 UC8O
360411 -
360412 -
360413 -
3605 -

SUBJECTS
Biomarkers Reduce Time Cost Developing New Drugs Currently 10 Years

4003 -
400401 -     ..
400402 -    10 Years Billion Dollars Deploy New Drugs Biomarkers
400403 -    Biomarkers May Reduce Time Cost Developing New Drugs
400404 -
400405 -    We hope biomarkers won't be as long as drug development, which now
400406 -    takes roughly 10 years, and can cost up to a billion dollars.  We
400407 -    think that biomarkers will enable that process.  It will probably
400408 -    reduce the time it requires to develop drugs as well as reduce the
400409 -    cost of developing drugs. ref OF 1 XF5F
400411 -  ..
400412 - Expending 10 years and billions of dollars explains why FDA has
400413 - approved only 9 of 1261 proteins for biomarkers to improve health care
400414 - of patients, per below. ref SDS 0 3O6O
400416 -  ..
400417 - Doctor Woodcock describes a Critical Path Initiative at the FDA to
400418 - reduce the time and cost for deployment of biomarkers and drugs to
400419 - treat patients. ref SDS 0 PT5V
400420 -
400421 -            [On 100510 1118 costs of cancer care double past 20 years,
400422 -            ref SDS 5 P45I, because of aging population. ref SDS 5 S53P
400423 -
400424 -
400425 -
400426 -
400427 -
400428 -
4005 -

SUBJECTS
Cancer Biomarker Research Interview Doctor Janet Woodcock Chief Medi

4203 -
420401 -  ..
420402 - Doctor Woodcock Chief Medical Officer Food Drug Admin (FDA)
420403 - Biomarker Technology Advancing Detection and Treatment of Cancer
420404 -
420405 - This evening the Jim Lehrer Newshour broadcast an interview of Doctor
420406 - Janet Woodcock, Chief Medical Officer, Food and Drug Administration
420407 - (FDA). ref OF 2 0001  There is an extended interview file on the
420408 - Internet at....
420409 -
420410 -               http://www.pbs.org/newshour/bb/health/jan-june07/cancerbarker_03-28.html
420412 -  ..
420413 - Interviewing Doctor Woodcock supplements extended interview with
420414 - Doctor Anna Barker, Deputy Director National Cancer Institute, shown
420415 - above. ref SDS 0 H65N
420416 -
420417 -
420418 -
420419 -
420420 -
4205 -

SUBJECTS
Biomarker Definition Cancer Marker Changes Genes Genetic Mutations N

4503 -
450401 -     ..
450402 -    Biomarker Definition Purpose Doctor Woodcock FDA
450403 -    Early Detection Targeted Treatment Enabled by Biomarkers
450404 -
450405 -    Follow up ref SDS 0 RX4L.
450406 -
450407 -            DR.  WOODCOCK:  Cancer is probably the most promising field
450408 -            right now for biomarkers, and from FDA's point of view, I
450409 -            think biomarkers are the future of medical therapy, both
450410 -            for diagnostic purposes as well as for cancer therapeutics.
450411 -            ref OF 2 5J51
450413 -             ..
450414 -            New biomarkers get to the mechanism of cancer.  They get to
450415 -            the actual causes in the cancer cells of what's gone wrong,
450416 -            why they've turned into cancer cells.  They provide a lens,
450417 -            a new way of looking at people so we could determine they
450418 -            have cancer earlier, diagnose earlier, as well as pick the
450419 -            right treatment. ref OF 2 5J61
450421 -             ..
450422 -            DR.  WOODCOCK:  Biomarkers can be turned into diagnostic
450423 -            tests, of course, and those tests can be used to either
450424 -            detect, for example in cancer, detect a tumor much earlier
450425 -            than the kind of tests we use now, or they can be used to
450426 -            direct therapy.  Or they can be used to say you are a
450427 -            patient who is at high risk for a side effect, and we
450428 -            shouldn't give you this therapy.  So biomarkers can really
450429 -            help us make treatments safer. ref OF 2 5J86
450431 -             ..
450432 -            ...diagnostic tests that doctors can use on patients,
450433 -            looking at the proteins in their body, looking at the genes
450434 -            in their cancer cells and how they've mutated, looking at
450435 -            images of their cancer in ways we've never been able to do
450436 -            before, to tell us all kinds of new information.
450437 -            ref OF 2 5J45
450438 -
450439 -
450440 -
4505 -

SUBJECTS
Critical Path Initiative (CPI) FDA Biomarkers Project

4703 -
470401 -     ..
470402 -    Biomarker Projects Discovery Development Deployment
470403 -
470404 -    Follow up ref SDS 0 TQ62.
470405 -
470406 -        FDA Projects
470408 -             ..
470409 -            Critical Path Initiative (CPI)
470410 -            FDA Approval Lengthy Expensive Process CPI Streamlines
470411 -
470412 -            DR. WOODCOCK:  The Critical Path Initiative is the track
470413 -            that a new innovation has to follow from the laboratory, to
470414 -            actually get in the hands of doctors and patients.  FDA
470415 -            strives to pull innovations along in a rigorous, safe, and
470416 -            useful way and move them faster into the hands of doctors
470417 -            and patients. ref OF 2 5J67
470419 -             ..
470420 -            DR. WOODCOCK:  Biomarkers are extremely important in the
470421 -            critical path because at every step of the way we need new
470422 -            biomarkers to predict whether or not a product is going to
470423 -            be safe enough, whether or not it's going to be effective,
470424 -            who it should be used in, and how to manufacture it
470425 -            properly.  And biomarkers play a role in all of these
470426 -            critical steps that have to be taken. ref OF 2 0A8L
470428 -  ..
470429 - This is a bit vague, like the FCS project to empower commanders and
470430 - soldiers on the battlefield with integrated force at the right place
470431 - and the right time.
470432 -
470433 -
470434 -
4705 -

SUBJECTS
Validation Test Biomarkers Establish Reliable Results Requires Long

5203 -
520401 -         ..
520402 -        Validation Test to Establish Reliable Results
520403 -        Time Cost Verify Safe Effective Treatments FDA Approval
520404 -        FDA Approval Takes Time and Expense Verify Safe Effective
520405 -        9 of 1261 Proteins FDA Approved for Possible 500K Biomarkers
520406 -
520407 -
520408 - Interview continues...
520409 -
520410 -            SUSAN DENTZER:  Now, only nine of 1261, or some numbers
520411 -            close to that, of proteins that have been identified as
520412 -            having links to cancer have so far been approved by FDA.
520413 -            Why is that? ref OF 2 YL4N
520415 -  ..
520416 - Doctor Barker explained the Clinical Proteomics Technology Initiative
520417 - project sponsored by NCI identifies proteins for biomarkers to detect
520418 - cancer and guide treatment. ref SDS 0 TR4J  The difference between
520419 - 1261, and current understanding of 100,000 to 1,000,000 proteins that
520420 - could identify cancer shows a lot of work will be required to apply
520421 - the potential of biomarkers.  Since only 9 of the proteins have been
520422 - approved by FDA, and since this seems to take 10 years and a billion
520423 - dollars for each approval, ref SDS 0 TD5L, this presents a significant
520424 - challenge.
520426 -  ..
520427 - Interview continues...
520428 -
520429 -            Not all associations are true predictors, and so a lot of
520430 -            scientific work has to go on clinical trials, on patient
520431 -            volunteers and so forth to determine whether or not these
520432 -            proteins really predict accurately enough some event in
520433 -            people. ref OF 2 WB5O
520435 -             ..
520436 -            A diagnostic company has to create a test kit that is
520437 -            reliable and precise so doctors and patients can rely on
520438 -            results that will make a life altering decision.
520439 -            ref OF 2 GE6K
520441 -             ..
520442 -            Biomarker qualification..... validation
520444 -             ..
520445 -            Developing a scientific idea or discovery of association,
520446 -            like a cancer biomarker, and testing for reliability is
520447 -            called validation, or biomarker qualification.  It's a very
520448 -            difficult process to gather up enough information about the
520449 -            performance of the test in a real world situation to verify
520450 -            reliability. ref OF 2 WL7N
520452 -             ..
520453 -            Clinical trials test patients who may have a disorder, and
520454 -            patients who don't have a disorder in order to see if
520455 -            testing produces accurate, consistent results.  Genetic
520456 -            variability between people causes different effects taking
520457 -            aspirin.  A lot of people are helped by aspirin, but some
520458 -            are not.  Similar variability occurs with biomarkers and
520459 -            other drugs affecting patients differently.  Therefore,
520460 -            testing must yield acceptably low numbers of false
520461 -            positives when the patient is not afflicted, and also yield
520462 -            low numbers of false negatives for patients who are
520463 -            afflicted. ref OF 2 T19I
520465 -             ..
520466 -            SUSAN DENTZER:  And because this is a long disease process
520467 -            often in cancer, you might have to follow people for years,
520468 -            correct? ref OF 2 HK4M
520470 -             ..
520471 -            DR.  WOODCOCK:  Some of the screening tests for cancer are
520472 -            the most difficult, and if you think about it, you can see
520473 -            why. ref OF 2 2L5G
520475 -             ..
520476 -            Errors occur in laboratory processes obtaining a specimen
520477 -            from the patient, incorrect handling that contaminates,
520478 -            mislabels, misdirects the specimen, technicians and
520479 -            physicians interpret, record, and distribute test results
520480 -            incorrectly. e.g., pap smear tests. ref OF 2 526G
520481 -
520482 -
520483 -
5205 -

SUBJECTS
Interagency Oncology Task Force Oncology Biomarker Qualification Ini

5503 -
550401 -             ..
550402 -            Teaming with Other Agencies Integrate Science Safety Payment
550403 -            Interagency Oncology Task Force Science Safety Payment
550404 -            Oncology Biomarker Team with Agencies Qualification Initiative
550405 -            Medicare Stakeholder Payment for Oncology Biomarker Project
550406 -
550407 -            Follow up ref SDS 0 TD9K
550408 -
550409 -            DR.  WOODCOCK:  We think this is so urgent that amongst the
550410 -            federal sector -- the Food and Drug Administration, the
550411 -            National Cancer Institute, and the Center for Medicare and
550412 -            Medicaid Services, or CMS, that we've teamed up together to
550413 -            make sure from the innovation side, the science side, which
550414 -            is NCI, the medical product development side, which is FDA,
550415 -            and then CMS, the reimbursement, that we can have a smooth
550416 -            process for biomarkers.  We call this the Oncology
550417 -            Biomarker. ref OF 2 KN6G
550419 -             ..
550420 -            SUSAN DENTZER:  And the CMS end of it is to make sure that
550421 -            at the end of the line Medicare is going to pay for these
550422 -            tests? ref OF 2 RP3L
550424 -             ..
550425 -            DR.  WOODCOCK:  Yes.  We need to make sure that not only
550426 -            are the tests developed into medical products, but there's
550427 -            enough information about them and about their value that
550428 -            CMS is able to reimburse for them. ref OF 2 O14H
550429 -
550430 -
550431 -
550432 -
550433 -
5505 -