Introduction:

In an ever-evolving landscape of public health emergencies and biological threats, the importance of collaborative efforts between the public and private sectors cannot be overstated. Biomedical Advanced Research and Development Authority (BARDA), a component of the ASPR arm of U.S. Department of Health and Human Services, has emerged as a crucial player in fostering partnerships to advance the development of medical countermeasures. In this blog, we will explore how BARDA collaborates with both the private and public sectors to drive innovation and preparedness.

Some examples will be provided to illustrate the diverse partnerships BARDA has established with the private sector to drive innovation, accelerate development, and strengthen manufacturing and distribution capabilities for medical countermeasures.  The examples below are a just a partial who’s who of BARDA collaborators: our hope is that they also serve to stimulate ideas for further collaboration.

Private and Public Sector Collaboration

BARDA recognizes that effective preparedness and response require bridging the gap between the private and public sectors. It actively seeks partnerships with pharmaceutical companies, biotech firms, academia, and other stakeholders to leverage their expertise, resources, and infrastructure. By pooling together knowledge and capabilities, BARDA aims to accelerate the development and deployment of medical countermeasures, ensuring the nation’s readiness against health threats.

Johnson & Johnson (J&J)

BARDA has collaborated with Johnson & Johnson to advance the development and production of COVID-19 vaccines. Through a partnership known as “Operation Warp Speed,” BARDA provided substantial funding to support J&J’s research, development, and manufacturing efforts for their single-shot COVID-19 vaccine. This partnership enabled the accelerated development and distribution of the J&J vaccine, contributing to the global response against the COVID-19 pandemic.

Even better

The ASPR has recently (2023) launched a new tool called IBx Connect that helps industry partner with US Government to reduce supply chain vulnerabilities.  Flexibility, nimbleness and resiliency are key targets for the program, which is interested in many aspects of strategic medical countermeasures (MCMs), from drug substances and drug products to PPEs, testing and consumables.

Funding Opportunities: Catalyzing Innovation

One way BARDA facilitates private sector engagement is through funding opportunities. BARDA provides grants, contracts, and cooperative agreements to support research, development, manufacturing, and procurement activities. These funding mechanisms not only provide financial support but also foster innovation and drive the advancement of cutting-edge technologies and medical countermeasures. By partnering with BARDA, pharma companies can access valuable resources and funding that can help expedite the development of potential life-saving therapeutics, vaccines, diagnostics, and other critical medical countermeasures.

Novavax

BARDA awarded Novavax, a biotechnology company, with significant funding to support the development and manufacturing of their COVID-19 vaccine candidate. The partnership aimed to accelerate the clinical trials and manufacturing scale-up of Novavax’s vaccine, which demonstrated promising efficacy against COVID-19. This collaboration played a vital role in expanding vaccine availability and diversifying the vaccine portfolio during the pandemic.

Even better

BARDA has reopened application to their TechWatch program to fast track-track MCM development.  They emphasize strategic measures, especially (but not entirely) to address COVID-19.  From their website:

“We are particularly interested in products, technologies, and capabilities that have progressed into or beyond clinical trials, have established large-scale cGMP manufacturing capability, or utilize an approved platform. Information regarding diagnostics, therapeutics, vaccines, and other products, technologies, or capabilities relevant to respond to public health emergencies are sought.”

The application to request an evaluation and a list of requirements can be found at the link above, along with further description of the program.

Collaborative R&D Expertise

BARDA promotes collaborative research and development initiatives to address public health challenges. By forming partnerships with private sector entities, BARDA facilitates the sharing of knowledge, expertise, and data. This collaborative approach allows for the pooling of resources and the utilization of diverse perspectives to tackle complex problems.

Pharmaceutical executives can benefit from BARDA’s collaborative research and development programs by accessing valuable insights from BARDA’s network of experts and researchers. By working together with BARDA, pharma companies can leverage their own capabilities while tapping into a broader ecosystem of knowledge and experience.

Takeda

BARDA partnered with Takeda Pharmaceutical Company to support the development of plasma-derived therapies for emerging infectious diseases, including COVID-19. The collaboration aimed to accelerate the development of convalescent plasma therapies as a potential treatment option. BARDA provided funding to Takeda to support clinical trials and manufacturing scale-up, leveraging Takeda’s expertise in developing and producing plasma-derived therapies.  This isn’t the first time that BARDA has opened the doors of a US based public institution to collaboration with the global giant: BARDA awarded Takeda up to $312 M to develop a zika vaccine back in 2016.

Even better

BARDA’s CARB-X National Defense Plan for Combatting Antibiotic Resistant Bacteria is extending its’ global connections, fostering new connections aimed at the increasingly worrisome number of antibiotic-resistant bacteria that present a major strategic challenge for the US and its’ allies.  It’s scope of work is far reaching and mentions the extension of surveillance and evaluation of sources of resistance by 2023, optimization of antibiotic use in countries beyond the US, launching international antibiotic labs, and even assisting public and private sector organizations to combat antibiotic resistance.

Manufacturing and Distribution Support

BARDA’s partnerships extend beyond research and development. The agency actively supports the manufacturing and distribution of medical countermeasures. By collaborating with the private sector, BARDA aims to enhance domestic manufacturing capabilities, develop advanced manufacturing techniques, and establish robust supply chains. To that end, BARDA’s manufacturing and distribution support can be leveraged to scale up production, streamline processes, and ensure timely delivery of critical medical countermeasures. BARDA’s expertise in this area can help companies navigate regulatory requirements, optimize manufacturing practices, and address any challenges related to production and distribution.

Emergent BioSolutions

BARDA collaborated with Emergent BioSolutions to enhance domestic manufacturing capabilities for medical countermeasures, including vaccines and therapeutics. BARDA provided funding to support the expansion of Emergent BioSolutions’ manufacturing facilities and the establishment of a Center for Innovation in Advanced Development and Manufacturing. This partnership aimed to strengthen the nation’s capacity to rapidly respond to public health emergencies by scaling up the production and distribution of critical medical countermeasures.  Some of Emergent’s awards have been for its’ novel anthrax vaccine AV909, treatment for cyanide poisoning, and botulism antitoxin, to name just a few.

Conclusion

BARDA’s commitment to fostering public-private partnerships has significantly contributed to the development of medical countermeasures and strengthened the nation’s preparedness against public health emergencies. By actively engaging with the private sector, BARDA catalyzes innovation, accelerates research and development, and facilitates the manufacturing and distribution of essential medical countermeasures.

Pharmaceutical executives have a unique opportunity to collaborate with BARDA, accessing funding, expertise, and resources that can expedite the development of life-saving products. By forging partnerships with BARDA, the private sector can play a pivotal role in safeguarding public health and building a resilient healthcare system for future challenges. Together, public and private sectors can make a profound impact in protecting and improving the well-being of communities worldwide.