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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-N-0001]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public workshop.

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                           ( print page 79380)                        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.                           ( print page 79381)                        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