Paul Mozdziak

North Carolina State University's Biomanufacturing Training and Education Center (BTEC) in Raleigh, NC proposes to provide a comprehensive biomanufacturing training program to Food and Drug Administration (FDA) investigators under the auspices of the FDA Office of Regulatory Affairs. The goal of the program is to enable investigators to expand the scope of their biopharmaceutical inspections. To accomplish this goal, industry-experienced BTEC staff will design, develop, and deliver a 4-course program covering a range of biopharmaceutical topics. This program will be offered every year for five years. These courses will include Web-based training, classroom instruction and hands-on laboratory experiences at BTEC.

muscle cultures will be performed at NC State

North Carolina State University?s Biomanufacturing Training and Education Center (BTEC) proposes to provide a comprehensive biomanufacturing training program that will develop the workforce of the foreign institutions supported by the BARDA, WHO, and PATH international influenza vaccine capacity building program over a five-year period. To accomplish this goal, industry-experienced BTEC staff will design, develop, and implement a selective registration system; a comprehensive training program with significant hands-on activities in the state-of-the-art BTEC facility; and evaluation tools to measure learning during the program and application in the workplace. In the first year, the training program will be offered six times and all instruction will take place at the BTEC facility. As additional equipment and related hands-on training modules become available in years 2-5, the training program will be offered eight times each year, with basic lectured-based materials that will be delivered in a Web-based format rather than at the BTEC site. After completion of the training program, graduates will be able to write, execute, and approve procedures and batch records; write, execute, and approve validation protocols; investigate process failures, determine root cause, suggest corrective/preventative actions, and document their findings; and conduct internal audits at their institution. These activities will, in turn, help put their institution in a better position to produce sufficient quantities of safe and effective vaccines. Products of this project include training materials for Web-based, classroom, and laboratory instruction; a Web site for information and registration; assessment and evaluation tools; data generated from these tools; and semi-annual internal evaluation reports.

Primordial germ cells (PGCs) are the germline stem cells destined to give rise to eggs or sperm in the adult animal. Long term culture of primordial germ cells is possible for the domestic fowl (van de Lavoir et al., 2006, Nature). We have established lines of primordial germ cells from a strain of chicken that expresses Green Fluorescent Protein (GFP) in all tissues inducing the germ cells making the germ cells easily traced in resulting animals. These PGC lines are derived from a single blood sample taken at 55 hours of incubation and can be expanded in culture to provide millions of cells. Currently we have two male cell lines of GFP-expressing chicken PGCs. We have shown that the cultured PGCs can migrate to the gonadal anlage (germinal ridge) when injected at Stage X (unicubated) embryo or when injected directly into the blood stream at 55 hours of incubation. We have also shown that the exogenous PGCs survive throughout incubation and remain a stable population in the gonad at hatch. The next steps are to establish additional lines of GFP-PGCs and determine in collaboration with Stice and West whether they can be made resistant to NDV and to demonstrate the ability of the cultured PGCs to undergo normal spermatogenesis in the testis. Specific Aim 1. Establishment of additional lines of male GFP-expressing PGCs from chick embryos. Specific Aim 2. Test functional germline transmission of cultured GFP-expressing PGCs in male fowl

Plan of Work Overall Objective: to determine the efficiency of germline transmission of cultured avian PGCs Specific Objectives: 1) Culture of PGCs from eggs of donor line chickens to establish long-term culture. 2) Inject donor line cultured PGCs into recipient line of chick embryos and detect the presence of donor line genotype in recipient line embryos or chicks. 3) Set and hatch sufficient numbers of embryos injected with donor line PGCs to place a small flock of 30-40 hens. 4) Rear PGC-injected female chicks with male donor chicks to sexual maturity. 5) Test mate male donor roosters with PGC-injected females, set eggs and hatch chicks. 6) Analyze genotype and phenotype of offspring from test-matings.

Agricultural productivity is a foundational component of the US economy. Advances in traditional animal breeding, nutrition, and immunology have made us a worldwide leader in animal agriculture; however with the threats of global warming, globalization, and competition from countries such as China and Brazil it is imperative that we aggressively develop new technologies if we are to ensure our position of leadership. With the completion of several food-animal genomes, attention must now be placed on how to translate genomic information into practical applications. To do this, a new generation of scientists must be trained. Herein, we propose an integrated program of graduate training, research, and industry outreach designed to meet the national need for animal/poultry scientists trained in the emerging functional genomics discipline. The objectives are to: 1) attract three exceptional pre-doctoral students in the targeted area of Agricultural Genomics and Bioinformatics, emphasizing Functional Genomics of animal agriculture; 2) provide students with inter-disciplinary training, merging Functional Genomics, Bioinformatics, and Animal/Poultry Sciences; 3) provide students with significant training in online learning. We will meet these objectives by taking advantage of existing curricula and resources at NCSU. The National Needs Fellows will be recruited into the Functional Genomics graduate program, with a concerted effort to recruit students from under-represented groups by partnering with other UNC system universities. The graduates of this program will be leaders in the emerging online learning environment, developing rational pedagogies and technologies for instructional and outreach activities. These Fellows will enhance the competitiveness and sustainability of US farm communities and strengthen our capacity for international trade.

This work is a mentored career development award directed at the study of ovarian cancer in the avian (chicken) model. Ovarian cancer is a devastating disease giving rise to significant mortality and morbidity. The main determinant in survival rates is the stage of diagnosis. Currently, most women are diagnosed in the advanced stage of the disease where survival rates are less than 10 percent. Our goal is to eludicate new biomarkers for the diagnoisis of ovarian cancer in its early stage.

The objective of the proposal is to Generate Transgenic Ceratrophys Ornata Expressing a Fluorescent Protein

This study will evaluate the chemopreventive effect of CP-31398 and Progestin on the occurance of spontaneous ovarian cancer in the domestic laying hen.

The Golden LEAF Biomanufacturing Training & Education Center (BTEC) at North Carolina State University (NC STATE) in Raleigh, North Carolina, offers to provide Web-based, classroom, and hands-on laboratory training to the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) field and operational personnel as specified in the solicitation identified as FDA-SOL-07-00189. In particular, BTEC proposes to design and develop four courses to include both biopharmaceutical and pharmaceutical topics, which will be determined after contract award; implement a training delivery system; and deliver courses to 30 students in the base year (June 2007 ? May 2008) at a cost of $193,000. Estimated lodging and travel costs to attend on-site training would add another $17,000 in the base year. In subsequent option years, BTEC would deliver four training courses at a cost of $68,000 - $79,000 per year.