Funding-DEVELOPMENT
OF THERAPEUTICS FOR BIODEFENSE; November 4, 2010
Description
The
National Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), of the Department of Health and Human Services (HHS)
supports research related to the basic understanding of microbiology and
immunology leading to the development of vaccines, therapeutics, and medical
diagnostics for the prevention, treatment, and diagnosis of infectious and
immune-mediated diseases. The NIAID Division of Microbiology and Infectious
Diseases has a requirement for advancing the development of new medical
countermeasures against the biological agents that are most likely to be used
in a terror attack on civilian populations.
This
Broad Agency Announcement (BAA) specifically focuses on supporting the
development of promising biodefense therapeutic
candidates/products or lead series with broad spectrum activity. The research
and development activities supported through this BAA will allow candidate
therapeutic countermeasures to progress through the product development
pipeline toward licensure. The eventual goal is to enable the U.S. Government
to stockpile these medical countermeasures to protect the American public.
Broad
spectrum activity is a characteristic that enables a particular product to
mitigate biological threats across a wide range or class of agents. There are a
number of traditional threats for which effective treatments are either
non-existent, of limited usefulness, or vulnerable to both naturally emerging
and intentionally engineered antibacterial and antiviral resistance. A limited
number of anti-infectives with broad spectrum
activity directed at common, invariable, and essential components of different
classes of microbes could potentially be effective against both traditional and
non-traditional threats. This approach would allow a small number of drugs to
replace dozens of pathogen-specific drugs for emergency use. Additionally,
strategies to overcome bacterial and viral drug resistance could extend the
clinical utility of existing broad spectrum anti-infectives
and have immediate benefits. Moreover, broad spectrum treatments directed
towards host targets or human immunological responses to infection have the
potential to be effective against one or more diseases. For instance, targeting
host receptors and cellular processes to treat infections and/or cellular
intoxication can directly prevent or treat diseases. As well, targeting immune
response mechanisms may be an effective way to reduce morbidity and mortality
by controlling the host responses that contribute to disease or by
non-specifically activating the host's natural immune defenses to induce a
faster, more potent protective response. These approaches could provide
clinical utility when used alone or in combination with conventional anti-infectives.
Broad
spectrum therapeutics supported under this BAA are specified as the following
classes:
• Broad spectrum anti-bacterial: Therapeutic with activity against more than
one of the NIAID Category A, B and C bacterial threat agent AND including at
least one of the following bacterial pathogens: Bacillus anthracis,
Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazeki.
• Broad spectrum anti-viral: Therapeutic with activity against more than one of
the NIAID Category A, B and C viral threat agent AND including at least one of
the following viral pathogens: Ebola virus, Marburg virus, Junin
virus, Variola major, Dengue virus, Venezuelan
encephalitis virus, Western Equine encephalitis virus, Eastern Equine
encephalitis virus and human influenza virus.
•
Host-directed broad spectrum therapeutic: Therapeutic directed at a host
response thereby reduces morbidity and mortality from exposure/infection and is
effective against more than one of the NIAID Category A, B and C bacterial or
viral threat AND including at least one of the following bacterial and viral
pathogens: Bacillus anthracis, Francisella
tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, Rickettsia prowazeki, Ebola
virus, Marburg virus, Junin virus, Variola major, Dengue virus, Venezuelan Encephalitis virus,
Western Equine Encephalitis virus, Eastern Equine Encephalitis virus and human
influenza virus.
•
Broad spectrum anti-toxins: Therapeutics with activity against more than one of
the following toxins or activity against multiple serotypes of one of these
toxins: Botulinum neurotoxin, Staphylococcus enterotoxin B, Epsilon toxin of Clostridium perfringens, and ricin toxin.
Offerors shall propose a well-defined product
development path that must enable and include the completion of a Phase 1
clinical trial prior to or within a 5-year contract period of performance. The
performance of studies in vertebrate animals and clinical studies must be
consistent with all applicable Federal regulations and the DMID, NIAID, and NIH
policies and guidelines for the conduct and oversight
of research in vertebrate animals and human subjects. This solicitation will also
support post-Phase 1 product development activities which are enabling for a
biologic license application (BLA) or a new drug application (NDA), including:
• Manufacturing scale-up leading to consistency lot manufacturing.
• Phase 2 clinical trials.
• Animal studies leading to pivotal animal efficacy studies required to support
licensure under the U.S. Food and Drug Administration (FDA) "Animal
Rule" (New Drug and Biological Drug Products; Evidence Needed to
Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not
Ethical or Feasible: http://www.fda.gov/cber/rules/humeffic.htm).
Plans
for advancing therapeutic candidates/products or lead series through the
product development path shall be proposed, implemented and funded in stages
with specific decision gates and well-defined criteria for determining the
merit and feasibility of advancing to the next stage. Offerors
may submit proposals for more than one therapeutic candidate/product or lead
series; however, a separate Technical and Business Proposal is required for
each therapeutic candidate/product or lead series. If a single therapeutic
candidate/product or lead series is being proposed for activity against more
than one of the selected pathogens within the scope of this BAA, only a single
Technical and Business Proposal is required.
Offerors are encouraged to apply state-of-art and
innovative technological approaches and platforms in the development of the
proposed broad spectrum therapeutics. State-of-art and innovative technological
approaches refer to capabilities, such as temperature stabilization or delivery
method, that can be engineered into a wide array of existing and candidate
products to enhance the product performance. Technological platforms, on the
other hand, are standardized methods that can be used to significantly reduce
the time and cost required to bring medical countermeasures to market.
It
is anticipated that multiple cost reimbursement type contracts will be awarded
on or about July 29, 2011. The length of the project proposed by the offeror, should be consistent with the nature and
complexity of the proposed research, but should not exceed 5 years.
The NIAID estimates that one to three contracts may be issued for a total cost
of up to $17 million per year. However, it is anticipated that the total cost
for the award(s) may vary depending upon the scope of the project and the
technical objectives of the award(s).
All
responsible sources may submit a proposal which shall be considered by the
Agency. This BAA will be available electronically on/about June 25, 2010, and
may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice
does not commit the Government to award a contract. No collect calls will be
accepted. No facsimile transmissions will be accepted.
Announcement
Number:
BAA-NIAID-DMID-NIHAI2010097
Closing
Date:
Nov 04, 2010 4:00 pm Eastern
Link
to Full Announcement
https://www.fbo.gov/?s=opportunity&mode=form&id=0886faeed14f8027eb553fb27c4be605&tab=core&_cview=0
Contact
Information
Harry
L Brubaker,
Contract
Specialist
Phone:
301-496-0612
Fax:
301-480-4675
Yvette
R Brown,
Contracting
Officer
Phone:
301-496-0612
Fax:
301-480-4675