Niche advisory and consulting firm specializing in human blood plasma biologics. Domestic and international advisory services, contracted management, and plasma center infrastructure development. AureaVitaAdvisors.com

Established and operated plasma procurement businesses in developing countries that lacked supporting infrastructure and regulatory framework through key partnerships with local stakeholders and on-site high-performing teams that delivered exceptional results. These efforts contributed to increasing the availability of critical plasma-derived therapies in underserved regions.• Pioneered the establishment and remotely managed a plasma donor center in Monrovia, Liberia, successfully collecting, testing, and shipping anti-Ebola plasma despite a lack of infrastructure and experience in the region.• Successful in placing an unlicensed plasma center directly within the University of Massachusetts Medical School hospital to collect plasma for use in clinical trials for combating COVID-19.• Successfully conceptualized and spearheaded a comprehensive plasma collection, storage, transportation, and shipping system in Egypt, encompassing the initiation of four donor centers (with an additional six in the construction phase and site selections completed for eight more), a dedicated Learning Academy, and Plasma Logistics Center. This included assisting the government with creating necessary regulatory framework, SOP development including all donor and unit suitability criteria, HR functions including job description and organization chart development, candidate interviews, and hiring recommendations; all while being sensitive to local cultural norms and lack of infrastructure supporting the plasma industry.• Developed, implemented, and oversaw an anti-Covid collection program working closely with BARDA (Biomedical Advanced Research and Development Authority (U.S. Department of Health and Human Services)) to the point that Grifols was requested to produce additional batches of higher titer product.• Developed draft regulatory guidelines that were provided to several countries to implement and regulate a source plasma collection industry.

Various leadership positions central to driving the success of the plasma collection business. Through strategic vision, operational expertise, and dedication to excellence, the management team oversaw the expansion of the business from 14 plasma collection centers to an industry leader with over 160 centers, two central testing laboratories, two frozen plasma warehouse distribution centers, and two Academy of Plasmapheresis facilities.• Led the development and implementation of state-of-the-art standard operating procedures (SOPs) and establishment of a comprehensive quality system that created robust systems and protocols thereby significantly improving operational efficiency and regulatory compliance.• Integrated systems and operations of approximately 12 acquired companies, while evaluating and adopting multiple operational improvements from these organizations.• Obtained 510(k) clearance for two major operating software systems central to Biomat USA, Inc. plasma operations and warehouse operations including serving as chief technical consultant for the plasma operations software.• On an ad hoc, pro-bono basis, assisted several start up plasma organizations with SOP development, quality systems, operational processes/systems, and provided regulatory guidance toward successful state, Federal, and international approvals