DARPA-SN-20-42 FINAL.pdf

Special Notice (SN) DARPA-SN-20-42: ADvanced Acclimation and Protection Tool for Environmental Readiness (ADAPTER) Proposers Day DATE: April 15, 2020 LOCATION: Webinar REGISTRATION DEADLINE: Registration ends on Friday, April 10, 2020, at 12:00 PM ET or until webinar capacity is reached, whichever comes first.

REGISTRATION WEBSITE: TECHNICAL POC: Dr. Paul Sheehan, DARPA/BTO EMAIL: DARPA-SN-20-42@darpa.mil

The Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA) is hosting a Proposers Day for the potential proposer community in support of a planned Broad Agency Announcement (BAA) for the ADAPTER Program. The Proposers Day will be held on April 15, 2020 from 11:00 AM to 1:30 PM ET via Webinar. Advance registration is required.

Note, all times listed in this announcement and on the registration website are Eastern Time.

The goals of the Proposers Day include:

1. Introducing the science and technology community (industry, academia, and government) to the ADAPTER program vision and goals;

2. Explaining the mechanics of a DARPA program in general and the objectives and milestones of this program in particular.

3. Facilitating interaction between investigators that may have capabilities to develop elements of interest and relevance to ADAPTER goals; and

4. Encouraging and promote teaming arrangements among organizations that have the necessary expertise, facilities and capabilities to meet research objectives established by the ADAPTER program.

The Proposers Day will include overview presentations by DARPA personnel and potential government partners; an information session during which government personnel will respond to questions posed by participants, and short sidebars with DARPA personnel for discussion of any proprietary information that participants would not want to disclose in the other open sessions.

Sidebars will be on a first-come, first-serve basis until time constraints are reached. Proposing teams should be multidisciplinary with expertise in synthetic biology, commensal organisms, gene and protein expression systems, immunogenicity, metabolomics, bioelectronic carrier engineering, control theory, infectious disease or sleep management, and medical device development. Proposing teams are strongly encouraged to include expertise across fields, as well as with industry partners familiar with FDA or equivalent regulatory approvals.

Attendance at this event is not a requirement for submission of a proposal or selection for funding.

Information relayed during the Proposers Day will be made available on the BTO section of the DARPA Opportunities page: http://www.darpa.mil/work-with-us/opportunities.

ADAPTER Program Overview:

The ADAPTER program will develop a travel adapter for the human body, an implantable or ingestible bioelectronic carrier that contains therapeutic cellular factories and biomolecules which can provide warfighters control over their own physiology. The integrated system will house multiple capabilities that typically require lengthy preparation or cold chains such as instant antibiotic production, in vivo toxin removal from ingested resources, and enhanced warfighter acclimation to jet lag or shift lag. It will alleviate operational limitations imposed by human physiology for two high-priority military needs: (1) entraining the sleep cycle, either to a new time zone or back to a normal sleep pattern after night missions and (2) eliminating bacteria that cause traveler’s diarrhea from contaminated food and water, a perennial challenge for militaries noted as far back as the Peloponnesian War. ADAPTER will provide a transient, non-genetic means of extending and enhancing warfighter readiness.

TA1: Accurate Therapies - Current implantable drug delivery systems can be limited in that the pre-packaged drugs are necessarily finite in quantity and must be stabilizable. To overcome these limitations, the developed systems must produce and deliver at least one therapy in vivo, necessitating accuracy in both the biological (TA1) and bioelectronic components (TA2). Example delivery mechanisms for the biological component, the living chassis, include bacterial or mammalian cells engineered to release an active biomolecule or, alternatively, release of the engineered cells directly to perform a function such as attacking pathogens. Physiologically relevant quantities must be delivered at precise time points and with necessary speed. Additionally, interventions and therapies must be accurate, reliable, and cease on demand. As mentioned above, to rapidly meet the milestones and metrics for the ADAPTER program, performers should leverage known strategies, solutions, and molecules. Any proposed therapy should have a published basis:

new mechanistic or exploratory studies are not of interest. Finally, while in vivo production of therapies is required, the direct release of stored biomolecules from the system is allowed in order to augment therapy, trigger a kill switch, or otherwise assist in meeting the milestones.

TA2: Carrier and Communication - Performers will develop innovative carriers (devices/platforms) to maintain TA1 components and, when signaled by an external device controlled by the user, activate therapies. Carriers can be ingested or implanted subcutaneously, must sustain their localization within the body throughout the duration of use, and change shape, self-orient, or otherwise open when activated to release therapies. Testing will use both realistic models, such as phantom tissues developed by the performers or others, and animal models.

Proposals for the ADAPTER program should include approaches to achieve the following:

1. Address one physiological track, either: (1) entraining the sleep cycle to a new time zone or back to a normal sleep pattern after night missions or (2) eliminating bacteria that cause traveler’s diarrhea from contaminated food and water.

2. Hierarchical control systems based on a bioelectronic “carrier” and cellular factories (engineered mammalian or bacterial cells that can deliver a defined dose or intervention in vivo) providing external control over the specified physiology.

3. Therapeutic production or intervention by the cellular factories at physiologically relevant concentrations

4. Secure communication through tissue and targeted power transfer

5. Integration of the carrier (TA2) and cellular factory (TA1) for effective in vivo interventions

6. Stabilization of engineered organisms in vivo.

TEAMING

One goal of Proposer’s Day is to encourage the formation of teams with all necessary expertise before proposal submission. Proposers Day registrants may choose to participate in either, none or both of the following options:

1. Attendee List (Limited distribution): participant contact information (name, organization, email address) will be included on a Proposers Day Attendee List distributed via e-mail to event registrants. The registration website will ask registrants to indicate whether they approve sharing of their contact information.

2. Proposer Profile List (Limited distribution): interested parties shall submit a one-page PDF profile providing contact information (name, organization, email, telephone number, mailing address and, if applicable, organization website); a brief description of their technical competencies; and, if applicable, their desired expertise from other teams/organizations (see Attachment 1 – teaming profile template).

PROFILES

Profiles must be emailed to DARPA-SN-20-34@darpa.mil no later than 12:00 PM EST on April 14, 2020. Following the deadline, a consolidated list of all profiles will be sent via email to the proposers who submitted a valid profile (following the format provided and not exceeding the single page limit). Specific content, communications, networking, and team formation are the sole responsibility of the participants. Neither DARPA nor the Department of Defense (DoD) endorses the documents submitted, nor does DARPA or DoD exercise any responsibility for improper dissemination of information provided in profiles, presentations, or posters.

Registration Information:

PLEASE NOTE: Registration closes Friday, April 10, 2020, at 12:00 PM ET

Participants must register in advance through the registration website. Registration is free but limited by the webinar capacity of 500 participants, so early registration is recommended. Interested parties are encouraged to coordinate attendance within their organizations prior to registration.

Individuals who are unable to register because the deadline has occurred or capacity has been reached will be added to a waitlist. Slots that remain open after registration closes or that become available due to cancellations will be filled on a first-come, first-served basis from the waitlist.

An online registration form and various other meeting details can be found at the registration website, https://events.sa-meetings.com/ADAPTERProposersDay

Non-US citizens are required to submit a DARPA Form 60 (U.S. Permanent Resident and Foreign National Visit Request) no later than Friday, April 10, 2020 at 12:00 PM ET. This form and submission instructions will be provided in the registration confirmation email.

Further administrative questions should be addressed to DARPA-SN-20-42@darpa.mil. Please refer to the ADAPTER Proposers Day (DARPA-SN-20-42) in all correspondence. This announcement is not a request for abstracts or proposals; any sent will be disregarded.

DARPA hosts Proposers Days to provide potential performers with information on whether and how they might respond to the Government’s research and development solicitations; and to increase efficiency in proposal preparation and evaluation. Therefore, Proposers Days are open only to potential proposers who have registered.

This SN is issued solely for information and potential new program planning purposes; the SN does not constitute a formal solicitation for proposals or proposal abstracts. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Submission is voluntary and is not required to propose to subsequent Broad Agency

Announcements (if any) or research solicitations (if any) on this topic. DARPA will not provide reimbursement for costs incurred in responding to this SN. Respondents are advised that DARPA is under no obligation to acknowledge receipt of the information received, or provide feedback to respondents with respect to any information submitted under this SN.

NO CLASSIFIED INFORMATION SHOULD BE INCLUDED IN THE SN RESPONSE.