Alira Health’s COVID-19 Response

Just-in-time regulatory support

Our regulatory team, led by Mary McNamara-Cullinane, has been working closely with our clients and FDA on several fronts, including:

• One Emergency Use Authorization to wean patients off ventilators is pending at FDA
• Two ventilator accessory Emergency Use Authorizations
• One remote patient monitoring system Emergency Use Authorization
• Additional Emergency Use Authorizations for disinfectants and sanitizers are currently pendin

In addition, Mary is on two national task forces providing regulatory guidance for respirator and mask manufacturers.

Support across the supply chain

• Supply chain reinforcement by connecting hospitals, suppliers, and governments to critical resources, including PPE and ventilators.
• Support in establishing a PPE factory in India by connecting funding and technology with regional officials. This factory has been scaling up to produce more than 100,000 pairs of gloves and gowns.
• Collaboration with the CEO of a Massachusetts hospital to connect the hospital’s innovation center with manufacturing partners for PPE technologies.

Analysis and operational assistance

• Introductions of an N95 respirator technology to potential manufacturers and investors.
• Partnership with experienced industry professionals (who developed HIV screening protocols) to develop COVID-19 screening protocols. Looking past the current crisis, the team is also looking at how screening should be considered long-term.
• Helping a low-cost ventilator company to scale up. The company is connected with several Massachusetts universities and has seen positive clinical results.