[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79379-79381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Defense Advanced Research Projects Agency and Food and Drug
Administration Expanding In Vivo Biomarker Detection Devices Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing the following
public workshop cosponsored with the Defense Advanced Research Projects
Agency (DARPA): Expanding In Vivo Biomarker Detection Devices Workshop.
The DARPA Defense Sciences Office and the FDA Center for Devices
and Radiological Health (CDRH) are hosting a workshop to discuss
current state-of-the-art and innovative research opportunities in the
area of in vivo analytical devices capable of measuring biomarkers that
characterize normal biological processes, pathologic
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processes, and pharmacologic responses. In particular, this workshop
will focus on the technical challenges for developing implanted or
continuously applied devices capable of measuring and monitoring
clinically relevant molecular biomarkers (small molecules, proteins,
peptides, and nucleic acids) to alert the user of the need for clinical
attention and/or to inform the clinician with regard to appropriate
action.
Date and Time: The workshop will be held on February 9, 2011, from
7:30 a.m. to 5 p.m.
Location: The workshop will be held at the Executive Conference
Center at Liberty Center, 4075 Wilson Blvd., suite 350, Arlington, VA
22203.
Contact: Jonathan Sackner-Bernstein, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, rm. 5410, Silver Spring, MD 20903,
301-796-5420, e-mail: [email protected]; or Daniel
Wattendorf, Defense Advanced Research Projects Agency, 3701 North
Fairfax Dr., Arlington, VA 22203, 703-526-6630. Administrative
questions about the workshop should be directed to the attention of Ms.
Jenifer Schimmenti ([email protected]).
Registration and Requests for Presentations: Registration logistics
will be managed by DARPA according to instructions posted on their Web
site at http://www.sa-meetings.com/DARPA_FDA_Workshop (login:
DARPAFDA, password: arlington), including instructions for registration
and presentation of previous or potential research and development
capabilities consistent with the workshop goals in order to facilitate
discussions. The deadline to submit abstracts and requests for poster
presentations is listed on the DARPA Web site. After the deadline
posted, no submissions will be considered.
If you need special accommodations due to a disability, please
contact Jenifer Schimmenti (see Contact) at least 7 days in advance.
Transcripts: There will not be a transcription of this workshop.
SUPPLEMENTARY INFORMATION:
Currently available glucose monitoring systems provide the most
developed approach to continuous monitoring of a biomarker in real-
time. Despite FDA approval for human use and extensive research and
development, these monitoring systems exhibit several important
limitations including accuracy/precision, durability, adaptability, and
reliability. For example, many of these technologies are limited to
detecting one biomarker (glucose) in real-time and the approach cannot
be used for the detection of other classes of biomarkers (e.g., nucleic
acids), nor do they have the capabilities for being multiplexed.
Additionally, these technologies also require frequent secondary
testing of blood glucose levels to assure the performance and accuracy
of the device. Such technical challenges limit the ability to
conveniently monitor health status in real-time settings outside of the
patient-physician encounter. These challenges are not isolated to
implantable/applied technologies. Available in vitro tools are
primarily developed for intermittent measurements, typically within a
clinical environment, and do not account for biologic dynamics or
responses to environmental stimuli.
With accelerating advances in genomics, epigenomics,
transcriptomics, proteomics, and microbiomics, innumerable biomarkers
could be informative for the health/disease of individuals and/or
populations, particularly when considering potential exposure to
allergens, infections, and toxins. Owing to the typical paradigm for
development of diagnostic devices, these next generation class of
biomarkers that function either as a surrogate endpoint for efficacy or
an adverse response do not have their clinical utility qualified in the
real-world setting. Without a device to accurately measure predictive
biomarkers either continuously or at an acceptable interval, clinical
utility may be difficult to establish and translation to accepted
screening or diagnostic testing may be impaired. Qualification of
biomarkers that inform an individual to seek medical attention or guide
a medical provider toward an intervention or clinical decision, within
the context of an implanted/applied technology, is a priority.
DARPA and CDRH are seeking to understand challenges and develop
technological advancements necessary to enable in vivo medical devices
for biomarker detection. While glucose is a critical biomarker,
workshop interest will focus broadly on technologies for detection of
next-generation biomarkers including chemical biomarkers, proteins,
peptides, and nucleic acids. The workshop will address the challenges
for developing in vivo devices to clinically validate biomarkers for
disease screening, surveillance, prediction of therapeutic response, or
prognosis, as well as the potential for using an in vivo approach to
measure biomarkers for safety and effectiveness of a therapy
(metabolites, toxicity, or surrogate endpoints) as part of a real-time
Phase 4 postmarketing surveillance.
The workshop will not focus on the discovery or identification of
relevant biomarkers or potential surrogates. Instead, the workshop will
focus on critical topic areas and specific technical challenges related
to the development of in vivo technologies capable of biomarker
detection.
We encourage you to address the following specific technical
challenges related to development of in vivo devices:
Novel materials: Materials and chemistries that can be
safely applied for continuous in vivo detection of biomarkers, and do
not induce/stimulate a biological response (e.g., inflammation).
Device design for analytical validation: Methods for
maximizing and verifying accuracy, sensitivity, specificity,
reproducibility, and reliability of in vivo biomarker detection
methods.
Minimal invasiveness: Device delivery methods and device
size reduction, to include issues related to on-board versus external
power, communication, and processing.
Maximum duration: Operational lifetime of the implanted
device to include overcoming bio-fouling, enhanced biocompatibility,
and continuous versus periodic measurements.
Capacity to measure multiple biomarkers simultaneously.
Capacity to be rapidly adapted to measure an emerging
biomarker of concern.
Potential for using an in vivo approach to clinically
validate biomarkers for disease screening, surveillance, prediction of
therapeutic response, or prognosis.
Ideally, these challenges are within the context of the following,
as summarized in the Institute of Medicine (IOM) Evaluation of
Biomarker and Surrogate Endpoints in Chronic Disease 2010 Consensus
Report (http://books.nap.edu/openbook.php?record_id=12869):
1. Analytical validation to assure biomarker tests are reliable,
reproducible, and adequately sensitive and specific.
2. Qualification to assure the measurement methods can be
correlated to a clinical outcome of concern.
3. Utilization analysis to determine that the biomarker used to
develop the technology is appropriate.
The goals of this workshop are to define the current state-of-the-
art and innovative research opportunities and challenges in developing
such devices.
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Participants are asked to submit an abstract of no more than 250 words
to explain their research efforts and how they specifically pertain to
the objectives of the Expanding In Vivo Biomarker Detection Devices
Workshop. A workshop representative will contact participants after
abstract submission.
Dated: December 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-31811 Filed 12-17-10; 8:45 am]
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