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Mining Social Media for Adverse Event Surveillance

Solicitation Number: FDABAA-12-00118
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services
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FDABAA-12-00118
:
Award
:
September 14, 2012
:
HHSF223201210217C
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$800,612.00
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Epidemico LLC
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013392598
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306 Dartmouth Street
Boston , Massachusetts 02116
United States
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Added: May 23, 2012 11:11 am
Broad Agency Announcement

Food and Drug Administration (FDA) solicitation for research and development to support regulatory science and innovation. FDA anticipates that research and development activities awarded under this BAA will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation.
Added: Mar 07, 2013 3:14 pm

The purpose of this amendment is to announce the FDA's Industry Day for the Broad Agency Announcement (BAA) on March 25, 2013. Please see the attachment for further details.

Added: Mar 08, 2013 3:24 pm

The purpose of this amendment is to make some adjustments to the Industry Day attachment.  The following adjustments are hereby made to the Agenda:


Dr. Peggy Miller will present in place of Jeanne Anson

The registration deadline shall be extended to March 21, 2013

Please see the attached amendment for the revised Industry Day agenda.

Added: Mar 23, 2013 11:36 am
The objective of this project is to utilize mass cytometry to map immune responses in humans and animals that result from various stimuli (including biothreat agents and candidate medical countermeasures or MCMs). The human and animal responses will be compared and the resulting data will be made available to the community through an open-access resource. It is
anticipated that this work may enhance the understanding of the diversity of immune responses elicited by these stimuli both within and across species. Specifically, the project provides a potential means to better understand the potential mechanism(s) of toxicity of biothreat agents, identify off target effects of candidate countermeasures, the mechanism(s) of action for candidate MCMs, and the comparability of these responses in animals and man. This data will be critical for not only facilitating interpretability of animal data but will provide novel and unprecedented potential to assess toxicity and off target effects. In addition the incorporation of studies with biothreat agents may provide new insight into pathogenesis and identify biomarkers as well as
providing data that may assist in interpreting studies in animals to support countermeasures being advanced under the Animal Rule. Importantly, many MCMs will or are pursuing licensure through the Animal Rule. The Animal Rule requires "a reasonably well understood pathophysiological mechanism for the toxicity of the chemical, biological, radiological, or nuclear substance and its amelioration or prevention by the product as well as a demonstration of
effectiveness in one or more species expected to react with a response predictive for humans". This project could provide an additional pathway to generating the necessary data to meet this regulatory standard.
Added: Mar 23, 2013 11:43 am
The unique properties of nanomaterials allow them to be used as a platform for nanodiagnostic products, in drug delivery and in nanotherapies. These unique properties may give rise to unexpected biological interactions or reactions. How to effectively predict and assess the interactions of nanomaterials with biological systems is a key outcome of the research in this proposal. Key objectives of this project include: synthesis and characterization of graphene-based nanomaterials physiochemical properties; identification of methods to assess and quantify exposure to nanoparticles at cellular level; and assess biological toxicity in vitro.
Added: Mar 23, 2013 11:49 am
The objective of this project is to assess the usefulness of unstructured social media data mining from a variety of sources in FDA pharmacovigilance efforts. This effort is intended to develop and/or adapt from existing technologies, the data acquisition and storage technology, the appropriate mapping strategies from layperson free-text to standard dictionaries, the appropriate data curation algorithms (automated and manual), the appropriate machine learning algorithms, the analysis and presentation of the data mining results, and the correlation of the data mining results with validation sources.
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Broad Agency Announcement

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Broad Agency Announcement
Posted Date:
May 23, 2012
Description: Announcement

Amendment 1

Type:
Mod/Amendment
Posted Date:
January 4, 2013
Amendment_1.pdf (58.90 Kb)
Description: Amendment to add Research Area No. 8

Amendment 2

Type:
Mod/Amendment
Posted Date:
January 25, 2013
Amendment_2.pdf (16.52 Kb)
Description: Amendment to add to Part I: Research Area of Interest No. 5 titled, “Harness Diverse Data through Information Sciences to Improve Health Outcomes.”

Amendment 3

Type:
Mod/Amendment
Posted Date:
March 7, 2013
Description: BAA Industry Day.

Amendment 4

Type:
Mod/Amendment
Posted Date:
March 8, 2013
Description: Industry Day Agenda with revisions.
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5630 Fishers Lane, Room 2129
Rockville, Maryland 20857-0001
:
Sean Wybenga
Phone: 301-827-6761
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,
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