Tuesday, Apr 27, 2021

Embrace the Challenge: How Startups Can Help Shift the Preparedness Paradigm

Gretta Blatner, MPHSpecial Assistant to the Director, Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS)

Rachel Rath, MBA, MPHDirector, BARDA Alliance, Johnson & Johnson Innovation – JLABS

Ashley Cecere, MSBiologist, Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS)

HLTH Foundation

In what the Biotechnology Innovation Organization (BIO) is calling a “monumental campaign to combat, and hopefully eradicate, COVID-19,” it’s become evident that small, creative-thinking biotech companies are needed to help lead on the frontline.1


Through our joint initiative, BLUE KNIGHT™, the Biomedical Advanced Research and Development Authority (BARDA) and Johnson & Johnson Innovation – JLABS (JLABS) are collaborating with early-stage companies with the goal of bringing leading ideas to patients. By building the Blue Knight community, we aim to be better prepared with even more deployable potential solutions when the next health threat strikes. To do so, we are challenging you, commercial innovators, to explore multi-use opportunities for your technologies that may help shift the paradigm of preparedness and rapid health threat response. 


What are Multi-Use Technologies?


Multi-use technologyI models provoke innovators to think outside the box when conceptualizing market impact. Rather than developing a narrow concept that addresses one commercial need, multi-use technologies have the potential to address multiple gaps. One of these potential utilizations may be a medical countermeasure (MCM)—a product that may be used during or in response to a potential public health threat.2 Multi-use technologies can help us move out of the “one bug-one drug” mindset3 towards nimble and more sustainable models of innovation that are capable of addressing routine health needs and have the potential to quickly adapt during a public health threat. 


The Blue Knight portfolio exemplifies the types of potential multi-use solutions we aim to support, including wearable detection devices and platform technologies that may help address emerging infectious disease needs, as well as support broader disease areas. 


Three Reasons to Consider Identifying a Multi-Use Approach 


  1. Expanded markets. Technologies that can support multiple markets are often seen as advantageous because of the potential for increased revenue and manufacturing opportunities. By broadening potential impact, your idea may appeal to a more diverse set of stakeholders, potential partners, and investors, leading to potentially greater impact for more patients. This can also allow you to diversify funding across both dilutive and non-dilutive sources. 
  2. Building trust across the healthcare spectrum. Getting your technology to market can be challenging. However, once you’ve navigated the regulatory, manufacturing, and distribution hurdles with one product and application, each subsequent utilization may face fewer barriers. You may be able to leverage and maximize your initial investment in your product by supporting additional indications for that product. Multi-use technologies can help stakeholders across the healthcare spectrum – from regulators and providers to patients – gain familiarity through commercial use of these technologies prior to use as an MCM in emergency settings. When physicians can gain experience with a technology as a standard care therapeutic first, they may have increased confidence using the therapeutic in a crisis compared to something that may be developed in a specific response to the crisis. Further, every time a technology is submitted and approved for a new use, its archive of safety and efficacy data has the opportunity to be strengthened. When it comes time to evaluate for an emergency response, this data archive can become the backing for a stronger regulatory submission. Together, the combination of engaged stakeholders, strong data, and established trust may be key for streamlined adoption.
  3. Accessing greater support. For even the most promising solutions, having a strong support network may be the most critical component in establishing market share. Developing a multi-use technology can help expand your network into the preparedness space to enhance public health security through the development of MCMs. By connecting with both private and public sector mentors, you can access new perspectives for anticipating the unexpected and navigating the expected barriers to market readiness. With preparedness solutions, developing these partnerships before the next health threat emerges may be critical. By connecting early, you may gain a better understanding of the development process and support for setting expectations while working to position your technology to help address emerging health threats.

Getting Started: Reimagining Possibilities for Your Technology


In response to the COVID-19 pandemic, we’ve seen many innovators pivoting or repurposing existing science and technologies to address MCM needs.1 In 2020, for example, Johnson & Johnson Innovation worked with over 100 global innovators to explore COVID-19 applications for their approaches.5 While pivoting can help further our repertoire of pandemic solutions, it must happen more proactively because, in emergencies, it’s often the solutions with proven efficacy and safety that can be rapidly scaled to meet new manufacturing demands and deployed in unprecedented timeframes. 


For companies already innovating with the aim to address infectious pathogens, pivoting for pandemic preparedness may not be a far stretch. For others, identifying a preparedness utility may require creativity and unorthodox thinking. 


While we need solutions for combatting specific threats, it’s also critical to develop end-to-end technologies that may be foundational for improving patient care and responsiveness across routine health challenges. One great example is the safety syringe: a high-performance, retractable needle that evolved in response to an increasing incidence of needle-stick injures among medical professionals.6 They aren’t often at the forefront when discussing the extraordinary ideas supporting our COVID-19 response, but if the manufacturing supply chain did not already exist and providers were not already trained to use them, the vaccine rollout could have looked very different.


End-to-end solutions developed years ago, like the safety syringe, are now the tools helping us cross the finish line in addressing COVID-19.


Ready to Accept the Challenge? 


Looking ahead, it may be the innovations of today that become the solutions for future threats. Blue Knight aims to shift the paradigm of health threat preparedness by developing a rich pipeline of science and technology solutions that can address the innovation gaps. Together, we hope to establish promising technologies now, so that they become the critical tools waiting in our toolbox to deploy during the health threat.


Let’s start reimagining possibilities together: sign up to meet with us




I BARDA defines multi-use products as products that demonstrate efficacy against a wide range of specified threats…, that can find durable and well-defined commercial markets and leverage market force.


References: 


  1. Biotechnology Innovation Organization. BIO COVID-19 Therapeutic Development Tracker. Available at: https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus/pipeline-tracker. Last accessed: April 2021. 
  2. U.S. FDA. What are Medical Countermeasures. Available at: https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures. Last accessed: April 2021.  
  3. U.S. HSS. 2014 Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan. Pg. 31. Available at: https://www.phe.gov/Preparedness/mcm/phemce/Documents/2014-phemce-sip.pdf. Last accessed: April 2021. 
  4. U.S. FDA. Clinical Trial Diversity. Available at: https://www.fda.gov/consumers/minority-health-and-health-equity/racial-and-ethnic-minorities-clinical-trials. Last accessed: April 2021. 
  5. Johnson & Johnson Innovation. Deals Around the World. Available at: https://jnjinnovation.com/node/video/deals-around-the-world. Last accessed: April 2021. 
  6. Biospace. Retractable Safety Syringe Market. Available at: https://www.biospace.com/article/retractable-safety-syringe-market-popularity-of-disposable-automatic-retractable-safety-syringe-is-growing/. Last accessed: April 2021. 

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