BAN 2.0 Proposers' Day 30Aug2023.pptx

BARDA Accelerator Network Proposers’ Day Ashim Subedee, Connie Song, Manbir Singh, Mary Larkin, Matthew McCord Division of Research, Innovation, and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS)

August 30, 2023

This event is being recorded. Any discussions may be made publicly available.

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Welcome Zoom Webinar Housekeeping This event is being recorded and we plans to make both the pre-submitted and live questions and response publicly available after the event.

In the event zoom crashes… How to have a great experience at this event Use the Q&A function at the bottom of your screen Note that if we do not respond to your question live today, you can reach out to us at BAN_Inquiries@hhs.gov Introductions

Agenda

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ASPR’s mission: Assist the country in preparing for, responding to, and recovering from public health emergencies and disasters.

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Slide x | ASPR’s Purpose

The Administration for Strategic Preparedness and Response serves as the lead federal health agency responsible for helping communities prepare for, respond to, and recover from disasters and emergencies affecting our nation’s health care systems.

We accomplish this in several ways, including:

developing, stockpiling, and distributing response tools against multiple threats;

sending clinical response teams to places in times of crisis; and ensuring our healthcare and public health partners have the knowledge and tools they need to navigate today’s health care security threats.

The work that ASPR does is more important than ever.

We are living in an increasingly interconnected world where diseases and other threats can travel quickly, unnoticed for days. In addition, infectious disease outbreaks are becoming more frequent and natural disasters more deadly as a result of the increasing changes to our climate.

To keep up with the evolving threat landscape, ASPR must remain nimble and ever vigilant.

This presentation lays out ASPR’s strategic goals and programs and reflects the approach we will take to help the country prepare for, respond to, and recover from whatever comes next—no matter what that might be.

The BARDA Model

BARDA develops and makes available medical countermeasures (MCMs) by forming unique public-private partnerships to drive innovation off the bench to the patient to save lives.

Promote innovation Cutting edge expertise Multi-year funding Facilitate partnerships Flexible, nimble authorities

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ASPR cleared slide

BARDA Strategic Plan 2022-2026

Rapidly develop safe, effective medical countermeasures accessible to all Americans Maintain a sustainable, mission-ready preparedness posture Leverage mechanisms to foster flexible partnerships Build and support a world class workforce

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BARDA Strategic plan recently released- there are 4 main pillars to the plan, rapid/safe MCMs, readiness, leveraging flexible partnerships and workforce development

BARDA

ACCELERATOR

NETWORK

BARDA is seeking partners for the BARDA Acceleration Network 2.0!

Seeking execution partners for the BARDA Accelerator Network

Note: We are not currently looking for startups to engage with the program (but we certainly hope to soon).

BARDA ACCELERATOR NETWORK

Technology Sourcing

Outreach, Events & Networking

Wrap Around Support

Market Research

Launched in 2018 in partnership with 8 organizations, and expanded to 13 organizations in 2019, the current BARDA Accelerator Network has been successful in supporting the health security innovation ecosystem and medical countermeasures development by:

• Cultivating a community of those advancing the commercialization of health security innovations.

• Identifying and fostering innovations.

• Providing wraparound services such as startup-focused curriculum, technical and business mentorship, access to facilities and incubator spaces, and integration services to organizations aligned with the BARDA’s mission

• Supporting health security companies in the BARDA mission space as they navigate research, development, and regulatory pathways

Main goals Geographical reach and collaborate with various pockets of innovation around the country for the following:

Technology Sourcing Outreach, Events, and Networking Wrap Around Accelerator Support – running the programs they were already running Market Research

Because this was a 5-year program, as such we are now looking to launch the BARDA Accelerator Network 2.0

BARDA ACCELERATOR NETWORK 2.0

Accelerator Hubs to be funded $1.5M BARDA Funding per year per hub (10-year OTA) $500M OTA Ceiling Per Hub

Wraparound Accelerator Support Services

Development, Evaluation, and Validation Services

Rapid Response Capability

HUB TECHNOLOGY FOCUS AREAS

Diagnostics and Medical Devices (Sep. 15, 20231)

Therapeutics and Vaccines (Oct. 2, 20231)

Enabling Technologies (Oct. 2, 20231)

Digital Health Tools (Jan. 12, 20241)

Special Populations (Jan. 12, 20241) 1Submissions are due at 12:00PM ET on the due dates listed

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Based on the lessons learned from the current BARDA Accelerator Network and the COVID-19 pandemic regarding the importance of having agile and scalable mechanisms to support innovation, we are seeking partners for the next iteration of the BARDA Accelerator Network (BAN 2.0) to further optimize and enhance the services provided by the Accelerator Network. BARDA aims to further enhance the global health security innovation ecosystem, optimize startup acceleration and wraparound services, and ultimately develop the Accelerator Network as a scalable infrastructure for product development and commercialization by supporting active product development and validation capabilities during regular operations as well as during a rapid response scenario, such as a public health emergency.

Looking into the future, we are seeking to take the Hub approach with the BARDA Accelerator Network 2.0 to… Provide more targeted support to companies developing health development countermeasures in the following areas of interest Support in Wraparound accelerator support, DEV, and all in all build a Rapid Response Capability

Taking a step back, 5 Hubs to start 1.5M funding per year per Hub for a 10-year period via OTA (Other Transaction Authority) Each hub will have a 500M ceiling for the period of performance

HUB KEY COMPONENTS

Wraparound Accelerator Support Services Development, Evaluation, and Validation Services Rapid Response Capability

Sourcing and supporting health security innovators, startups, and BARDA portfolio companies by providing wraparound accelerator services including entrepreneurship education and access to technical and business/commercialization expertise and resources.

Providing BARDA with product development capabilities to source, review, fund, accelerate, and perform evaluation and validation of products and technologies based on BARDA's strategic priorities.

Building a rapid emergency response mechanism to fund and accelerate product development and validation of products and technologies to support faster development and deployment.

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Want to partner with organizations that have a strong track record of supporting early-stage companies in… Along with supporting startups on their business, and commercialization strategy, we want to build a mechanism to support the technical derisking of technologies by supporting the startups with designing milestone-based project proposals and funding to perform evaluation and validation of their technologies.

Having a rapid response mechanism and infrastructure in place that can be scaled up to support faster funding and development of technologies in the event of a public health emergency.

HUB TECHNOLOGY FOCUS AREAS

Diagnostics and Medical Devices (Sep. 15, 20231) Focus on diagnostics and devices to enable pathogen-agnostic surveillance, detection, and diagnosis, especially at point-of-care and at-home settings, and innovative medical devices to improve the quality of casualty care, alert the potential of an adverse health condition, simplify collection or processing of testing samples, and protect respiratory health.

Therapeutics and Vaccines (Oct. 2, 20231) Focus on next-generation therapeutic and vaccine platforms.

Enabling Technologies (Oct. 2, 20231) Focus on drug discovery and development innovations, biomanufacturing innovations to increase speed, capacity, portability, and scalability, and innovations to improve clinical research and clinical care coordination.

Digital Health Tools (Jan. 12, 20241) Focus on the development and application of digital health tools to empower people to prepare for and respond to health security threats and improve the continuum of clinical care.

Special Populations (Jan. 12, 20241) Focus on innovations that can improve detection, diagnosis, treatment, and inform outcomes in pediatric/neonatal populations and/or immunocompromised populations and/or enable health equity solutions to traditionally underrepresented communities and low-resource settings.

1Submissions are due at 12:00PM ET on the due dates listed

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High-level focus areas, more focused goals will be designed with the funded partners of each Hub building a network that works together to support (overlap of technologies) Mention due dates for execution partners to submit proposals

Invite Connie Song to overview the submission process for the program.

SUBMISSION PROCESS

Proposal Submission Submit proposals to BAN_Inquiries@hhs.gov by the technology area-specific due date within the solicitation (solicitation Section IX).

Initial Review BARDA will review each proposal to determine whether it meets the minimum eligibility criteria (solicitation Section XI).

Proposal Evaluation BARDA will continue evaluating those proposals which adequately met the minimum eligibility criteria (solicitation Section XI).

Notification of BARDA’s Disposition of Proposal BARDA will notify all respondents whose proposals were deemed ineligible or not the most highly rated within 60 days after the respective technology area proposal due dates.

Negotiations BARDA may enter into negotiations with the respondent with the most highly rated proposal (solicitation Section XII).

Award BARDA intends to make an award within 90-120 days following the proposal due date (solicitation Section IX).

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Responses to Pre-Submitted Questions

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Questions and Responses for:

Eligibility/Requirement with Mary Larkin Accelerator Programming/ DEV Services with Manbir Singh Funding/Contracting with Connie Song

Afterward, we will respond to questions coming in live from the audience today. Reminder to post questions for the Q&A using the zoom webinar Q&A feature at the bottom of your screen

Moderated Live Q&A

Unclassified/For Public Use medicalcountermeasures.gov Portal to BARDA: Register to request a TechWatch meeting!

sam.gov/ Official announcements and info for all government contract solicitations aspr.hhs.gov/BARDA/ Program description, information, news, announcements drive.hhs.gov Learn about DRIVe, including our Accelerator Network and EZ BAA www.usajobs.gov Join the team!

@BARDA

Biomedical Advanced Research and Development Authority

@BARDAGOV

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