Assistant Secretary for Preparedness and Response

Description

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (DHHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. The BARDA maintains business partnerships by means of grants, cooperative agreements, and contracts with the public and private sectors, domestically and internationally. The BARDA recognizes that a critical gap has long existed in the biomanufacturing and vaccine production capabilities and the influenza pandemic preparedness of many developing nations. In an effort to mitigate the global shortage of influenza vaccines, increase global pandemic preparedness, the BARDA has developed an international influenza vaccine capacity building program. That is, collaborations exist between the BARDA and the World Health Organization (WHO), as well as between the BARDA and the Program for Appropriate Technologies in Health (PATH) for the development of influenza vaccine production facilities in developing nations. In FY 2006-2008, with a total of $24.4 million provided to the World Health Organization programs, the BARDA has supported the accelerated development and production of H5N1 influenza vaccine for humans in Vietnam, Thailand, Indonesia, India, Mexico and Brazil, and will support Korea, Egypt, Romania and Serbia. The BARDA funding addresses global and specific country needs for training, laboratory equipment, manufacturing process development, development and validation of product release assay methods, clinical sample analysis, pilot lots, scale-up development for vaccine manufacturing, vaccine production equipment, and eventual commercial scale manufacturing of H5N1 vaccines for clinical trials and pandemic usage.The WHO and the PATH represent important stakeholders in the identification of developing nations with viable vaccine manufacturing capabilities and in providing those institutions with technical guidance and support. The BARDA also recognizes many of the challenges the developing world faces in improving their influenza vaccine manufacturing capacity. Through the international influenza capacity building program the BARDA seeks to support the increased availability of influenza vaccines by stimulating influenza vaccine manufacturing infrastructure development by institutions in developing nations as they build sustainable programs for seasonal influenza vaccines, pre-pandemic, and pandemic influenza vaccines to prevent Avian H5N1 or other influenza virus infections posing threats to humans. A significant limitation in the countries/ institutions supported by the BARDA/WHO/ PATH cooperative agreements is that they currently lack and do not have access to training programs for the staff of their facilities. In order to effectively develop the vaccine manufacturing infrastructure it is important to ensure that the workforce operating vaccine production facilities becomes well trained, technically proficient, and capable of sustaining those operations. That is, in addition to the actual construction and development of viable vaccine production facilities, the development of the workforce intended to staff those facilities is essential to achieving the ultimate goals of the BARDA international influenza capacity building program. Via this FOA, the BARDA is offering the opportunity to train and develop a cadre of well-qualified, technically proficient industry professionals, whom will originate from the BARDA stakeholder institutions served and supported by the cooperative agreements that the BARDA has established with WHO and PATH. The BARDA has recognized these institutions as having biomanufacturing and/or vaccine production capabilities and seeks to fully develop them into viable vaccine production entities. Through investment in the training and workforce development of the BARDA/ WHO/ PATH supported foreign institutions, it is the expectation of the BARDA that upon completion of these trainings that the selected student trainees will be better equipped to provide operational support in improving, starting, and sustaining vaccine production capacity at their home institutions. This notice announces the intent of the BARDA to obligate approximately $2 million (US Dollars) in Fiscal Year (FY) 2010 funds via cooperative agreement awards to an applicant(s) with biomanufacturing training capabilities. This will provide additional support for the international development of human influenza vaccine candidates and influenza vaccine manufacturing infrastructure capacity building in countries where resources for vaccine acquisition and production may be limited. This cooperative agreement award will be used:1) To provide a cooperative agreement(s) to up to eight (8) entities capable of providing operational biomanufacturing training facilities reflective of current industry trends and/ or capable of providing subject matter experts/ instructors to teach critical biomanufacturing principles and practices at institutions supported by the BARDA/ the WHO/ and the PATH program to build influenza vaccine manufacturing capacity . 2) To provide short-courses with customized curriculum to meet the needs of culturally and academically diverse students (biomanufacturing industry professionals) representing the stakeholder institutions currently supported by the BARDA/ WHO/ PATH international influenza vaccine capacity building program. 3) To provide practical, hands-on training in biomanufacturing topics to students whom will staff the vaccine production entities for which they will be chosen from and/ or represent at the time of application and upon the completion of the training course.

Who can apply

• Unrestricted

Contact

Dwayne Myal <br/>Project Officer <br/>Phone 202-205-3966
dwayne.myal@hhs.gov