[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79379-79381]
From the Federal Register Online via the Government Printing 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: jonathan.sackner-bernstein@fda.hhs.gov; 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 (jschimmenti@sainc.com).
    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]
BILLING CODE 4160-01-P