DARPA-SN-24-55.pdf

Special Notice (SN) DARPA-SN-24-55: Hermes Industry Day

DATE: April 8, 2024 LOCATION: Arlington, VA with Webinar Option

REGISTRATION DEADLINE:

In person: April 3, 2024 at 4:00 PM ET Webinar: April 4, 2024 at 4:00 PM ET

REGISTRATION WEBSITE: https://events.sa-meetings.com/HermesIndustryDay TECHNICAL POC: Dr. Shannon Greene Email: HermesBAA@darpa.mil

The Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA) is hosting an Industry Day for the potential proposer community in support of a planned Broad Agency Announcement (BAA) for the Hermes program. The Hermes program aims to develop systemic drug delivery vehicles capable of transporting therapeutic cargo intracellularly with minimal side effects. The Industry Day will be held on April 8, 2024 from 9:00 AM to 5:00 PM ET in Arlington, VA. The event will also be webcast for those who would like to participate remotely. Advance registration is required. Note: all times listed in this announcement and on the registration website are Eastern Time.

The Industry Day goals include:

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

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

3. Encourage and promote teaming arrangements among organizations that have the relevant expertise, research facilities, and capabilities for executing research and development responsive to the Hermes program goals.

The Industry Day will include brief overview presentations by government personnel as well as an information session to respond to questions from participants.

Attendance at this event is not a requirement for submission of a proposal or selection for funding. Information relayed during the Industry Day will be made available on the BTO section of the DARPA Opportunities page: http://www.darpa.mil/work-with-us/opportunities.

To maximize the pool of innovative proposal concepts, DARPA strongly encourages participation by non-traditional performers (e.g., small businesses, academic and research institutions, and first-time Government contractors).

DARPA anticipates releasing the Draft Hermes BAA in March 2024 and Final Hermes BAA in April 2024. When released, the Draft and Final BAAs will be available on https://sam.gov/ and http://www.grants.gov/. Following Industry Day, DARPA will post the presented materials and the list of Frequently Asked Questions (FAQ) to the Opportunities page at DARPA’s website.

https://events.sa-meetings.com/HermesIndustryDay mailto:HermesBAA@darpa.mil http://www.darpa.mil/work-with-us/opportunities https://sam.gov/ http://www.grants.gov/

Hermes Program Overview:

The goal of the Hermes program is to overcome the challenges associated with broad, intracellular delivery of biologics based therapeutic cargo to diverse cell and tissue types by developing new delivery platforms that provide systemic distribution with minimal side effects.

Hermes will address the following drug delivery challenges: (1) developing nonimmunogenic novel platforms and formulations capable of encapsulating large, complex cargos; and (2) effective distribution to and activity in multiple cell and tissue types concurrently. The Hermes program will produce flexible platforms capable of delivering diverse types of therapeutic cargo to multiple cell and tissue types to counter any biothreat. Next generation delivery platforms developed during the program should offer unprecedented efficiency with minimal toxicity and immunogenicity. Delivery platforms must be capable of delivering nucleic acids, but approaches that are also compatible with proteins, small molecules, and/or combinations of these cargos are strongly preferred.

Areas of interest for the Hermes program include:

A drug delivery platform capable of broad, systemic distribution to and transfection of multiple cell and tissue types concurrently.

A comprehensive discovery pipeline including appropriate reporter systems for assessing biodistribution, endosomal escape, and functional expression of therapeutic cargo.

Detailed methods and approaches to evaluate immunogenicity and toxicity of formulated delivery platforms, along with approaches to mitigate toxicity.

Ability of drug delivery platform to achieve program metrics and compatibility with scalable, current Good Manufacturing Practice (cGMP) manufacturing.

Areas that do not align with the goals of the Hermes program include:

Approaches that include human subjects research.

Final delivery modalities that rely on intravenous administration. Proposals that incorporate intravenous administration as a comparator method or development model are allowed, but DARPA is primarily interested in delivery modalities that would enable field forward capabilities.

Immunostimulatory or immunogenic approaches.

Approaches that only incrementally improve on the current state of the art of nucleic acid delivery.

Delivery platforms that, with further development, are not capable of packaging nucleic acids greater than 5kb.

Tissue/cell type specific delivery platforms that cannot be co-formulated/co-administered into a single product.

Approaches that are not amenable to cGMP regulations enforced by the U.S. Food and

Drug Administration.

Teaming DARPA highly encourages teaming and suggests that attendees mediate the active formation of teams with the necessary expertise in advance of, or during, Industry Day. Industry Day registrants may choose to participate in either, none or both of the following options:

1. Attendee List (Publicly available): The registration website will ask registrants to indicate whether they approve publication of their contact information (name, organization, email address). If approved, participant contact information (name, organization, email address) will be included (1) on an Industry Day Registration list on the Industry Day website; (2) on an Industry Day Attendee List published on the BTO Opportunities website; and (3) distributed via e-mail.

2. Proposer Profile List (Limited distribution): Interested parties shall submit a one-page profile consisting of their 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. These profiles will be distributed via e-mail to all registrants following the event.

Presentations Interested, in-person, attendees are invited to present a brief one-slide PowerPoint summary of their organization’s focus and capabilities (see Attachment 1). These will be presented during 3-minute “lightning” presentations at Industry Day. Presentations consisting of multiple slides will not be granted a time slot.

Attendees may also choose to present a poster (Attachment 1) describing their research interests that will be available for viewing and interaction for the duration of Industry Day. Those interested may submit both a lightning talk and a poster.

Lightning talk and/or poster submissions will be accepted on a first-come, first-serve basis until time constraints (lightning talks) or physical capacity (posters) is reached. Attendees selected for lightning talks are highly encouraged to attend in person.

Profiles, presentations, and posters must be emailed to HermesBAA@darpa.mil no later than 4:00 PM ET on April 3, 2024. Specific content, communications, networking, and team formation are the sole responsibility of the participants. Neither DARPA nor the DoD endorses the documents submitted, nor does DARPA or DoD exercise any responsibility for improper dissemination of information provided in profiles, presentations, or posters.

Sidebars There will be an opportunity to meet individually with the Program Manager, Dr. Shannon Greene. Requests must be received no later than the registration deadline date. Individual meetings will be scheduled on a first-come, first-served, and space-available basis and limited to three (3) people per institution. Sidebar Meetings will be available for in-person attendees only.

Registration Information The Hermes Industry Day will be held on April 8, 2024 from 9:00 am to 5:00 pm. in Arlington, VA. There is no registration fee for the Industry Day meeting or webcast.

Registration opens: As of publication of this announcement.

Registration website: https://events.sa-meetings.com/HermesIndustryDay mailto:HermesBAA@darpa.mil https://events.sa-meetings.com/HermesIndustryDay

Registration closes (in person attendance): April 3, 2024 at 4:00 PM ET, or when capacity is reached, whichever comes first.

Registration closes (webinar): April 4, 2024 at 4:00 PM ET, or when capacity is reached, whichever comes first.

Advance registration via the above website is required for attending the Industry Day in person and for receiving access to the webcast. The advance registration requirement applies to every individual intending to view the webcast alone or as part of a group. Due to the limitations of the conference facility space, in-person attendance is restricted to the first 100 registrants with a maximum of three (3) individuals from any one organization and no more than two (2) representatives per division/department of that organization. Interested parties are encouraged to coordinate attendance internally within their organizations prior to registration.

Registrants in excess of the maximum capacity limitations will be automatically registered for the webcast. Registration received in excess of 350 individuals for ZoomGov may be added to a waitlist for the webinar. If slots become available due to cancellations, the slots may be filled on a first come, first served basis from the waitlist.

Eligibility Industry Days are only open to registered potential proposers, i.e., the events are closed to the general public and media. For this particular program, Industry Day registration is open to potential proposers who are U.S. citizens, U.S. permanent residents, and foreign nationals.

All registrants who are not U.S. citizens must complete and submit either a DARPA Form 60 (U.S. Permanent Resident and Foreign National Visit Request – e.g., industry or academia) or an Official Visit Request (foreign government personnel, only) through the U.S. Embassy based in Washington, DC, no later than April 1, 2024 at 4pm ET. Form 60 submission instructions are provided on the registration website and in the registration confirmation email. Contact your Embassy staff for assistance in submitting the Official Visit Request. Upon entry to the physical meeting, all attendees must present valid, Government-issued photo identification.

Disclaimers and Important Notes 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.