Biologics Consulting Group, Inc.

Debra Barngrover

Vince Narbut

EDUCATION:

Ph.D.	Nutritional Biochemistry, Cornell University
B.S.	Colorado State University

EXPERIENCE
CURRENT POSITION Apr 2011- present		Senior Consultant, Biologics Consulting Group, Inc., Southborough, MA

1989 – 2010		Vice President, Supply Chain Risk Management/Product Planning and Strategic Supply/Technology Development, (2001-2010) Genzyme Corporation, Cambridge, MA Managed up to 70 scientists, engineers, and project managers in process development for more than 15 small molecule, recombinant, and non-recombinant proteins (seven commercial) and two viral vectors Responsible for operation product and project management, strategic and capacity planning, package engineering, and product label design. Led Fabry Development Team, managed cross-functional team that delivered clinical and commercial process, and assisted with development of pre-clinical and clinical plans. Served as member of Cold Chain steering committee charged with developing and implementing strategies to meet enhanced worldwide regulatory requirements, substantially reducing shipment failures. Served as Senior Operations Business Unit partner for the Renal group, improving cross-functional communication and reducing budget preparation and review time. Senior Director, Technology Development (1998–2001) Managed 35 scientists and engineers in cell culture process development, clinical/market entry manufacturing of recombinant proteins, analytical development, and support. Completed preparation, including CMC Expert Report, of European filing for Fabrazyme five months early, preventing complete loss of ability to enter European market due to orphan drug restrictions. Selected as Leader, External Pompe Development Team, managed manufacturing contract with German CMO to produce clinical trial material, and led inter-company process improvement and troubleshooting teams, enabling completion of clinical trial with no interruption of life-saving drug. Associate Director/Director, Bioengineering (1992–1998) Managed 14 scientists and engineers in cell culture development of three recombinant proteins. Reconfigured sparging system in production bioreactors which resulted in a two-fold improvement in productivity of marketed product, resulting in a substantially decreased cost of goods and ability to treat more patients. Devised method to test process improvements at pilot scale, avoiding $1M in capital expenditures. Staff/Senior Scientist, Bioengineering (1989 – 1992) Supervised four to seven scientists/engineers. Named Research Affiliate at the Biotechnology Process Engineering Center at M.I.T., leveraging their scientific resources to solve a company analytical gap. Specified and installed first automatic data recording system for pilot plant, enabling more rapid analysis of fermentation data, shortening development and troubleshooting time.
1985 – 1992		Adjunct Professor, Worchester Polytechnic Institute and Tufts University Served on Ph.D. and Masters Thesis Committees for three students; supervised their successful research projects. Staff/Senior Scientist, Bioengineering, Integrated Genetics, Framingham, MA Clinical stage biopharmaceutical company; merged with Genzyme. Ingénieur de Recherches, Technologie des Cellules Animales Recombinees, Elf Biorecherches, Biopharmaceutical research division of Sanofi and Elf Total. Post-Doctoral Research, Massachusetts Institute of Technology
Continuing Education Decision Quality in Organizations and Enterprise Risk Management, Stanford Strategic Decisions and Risk Management Certificate Program Greater Boston Executive Program, M.I.T., Sloan School of Management Supply Chain Management for General Managers, Darden Graduate School of Business Administration
Patents Barngrover, D., Jacobsen, W.J., Nicolakis, D.P., Fleury, J.E. (1998). Continuous settling apparatus. U.S. Patent 57,337,776, issued to Genzyme Corporation. Hayes, M.L., Barngrover, D., Rasmussen, J.R. (1996). Production of enzymatically active glucocerebrosidase from recombinant cells. European Patent 0 568 47 B1, issued to Genzyme Corporation.

Page Updated: August 1, 2011

Bibliography - Publications

Barngrover, D. (2005) alpha-Galactosidase. In Directory of Therapeutic Enzymes, ed. by Barry M. McGrath and Gary Walsh, CRC Press, Boca Raton, FL.

Lee, K., Jin, X., Zhang, K., Copertino, L., Andrews, L, Baker-Malcolm, J, Geagan, L, Qui, H., Seiger, K., Barngrover, D., McPherson, J.M. and Edmunds, T. (2003) A biochemical and pharmacological comparison of enzyme replacement therapies for the glycoplipid storage disorder Fabry disease. Glycobiology 13 (4): 305-313.

Barngrover, D. (2002) Recombinant Protein Treatment (Fabrazyme) for Fabry’s disease. J. Biotech. 95: 280-283.

Griffiths, J., Prior, J., Kennedy, S., McGrath, J., Barngrover, D., Hoppe, H., Edmunds, T., Hayes, M. and Offenbacher, T. (2000) Implementation of cell culture harvest extension for a therapeutic protein. Abstracts of Papers American Chemical Society 219 (1-2): BIOT 100.

Buser, C., Casson, D., Vrabel, M., Barngrover, D. and Schoenfeld, R. (1997) Evaluation of a robotic system for automation of the Carticel autologous chondrocyte service. Abstracts of Papers American Chemical Society 213 (1-3): BIOT 96.

Barngrover, D. (1991). Large Scale Animal Cell Culture for the Production of Pharmaceuticals. In Proceedings of the Interphex- USA Conference, ed. by A.S. Goldberg, Cahners Exposition Group, Des Plaines, IL.

Sardonini, C. A. and Barngrover, D. (1988). Oxygen, Bicarbonate, and Acid Metabolism Determinations in Mouse Cell Microcarrier Culture. Biotech. Bioeng. 32:1073-1078.

Barngrover, D. (1986). Substrata for Anchorage Dependent Cells. In Mammalian Cell Technology, ed. by W.G. Thilly, Biotechnology Series ed. by J. Davies, Butterworths, Stoneham, MA.

Labit, C. and Barngrover, D. (1986) Effects of perfusion rates on cell growth and protein production: studies done with VERO cells transfected with the human growth hormone gene (VEH1). In Therapeutic agents produced by genetic engineering: Quo Vadis? The example of growth hormone and its releasing factor, ed. by A. Joyeaux, G. Leygue, M. Morre, R. Roncucci and P.H. Schmelk, MEDSI, Paris.

Aguilon, F., Koehl, M., Barngrover, D. and Lupker, J.H. (1986). Pilot-scale production of hGH with transformed VERO cells. In Therapeutic agents produced by genetic engineering: Quo Vadis? The example of growth hormone and its releasing factor, ed. by A. Joyeaux, G. Leygue, M. Morre, R. Roncucci and P.H. Schmelk, MEDSI, Paris.

Barngrover, D., Thomas, J. and Thilly, W.G. (1985). High Density Mammalian Cell Growth in Bicarbonate-Free Media: Effects of Different Carbohydrates. J. Cell Sci. 78: 173-189.

Barngrover, D.A. and Dills, W.L., Jr, (1983). Effects of Fructokinase Inhibitors and Dietary Conditions on the Metabolism of D-Xylulose and Xylitol in Isolated Rat Hepatocytes. J. Nutr. 113: 522-530.

Vickrey, H.V., Thilly, W.G., Barngrover, D., Joseph R.R. and McCann, D.S. (1982). Microcarrier Culture of Murine Hepatocytes. J. Cell Biol. 95: A458.

Thilly, W.G., Barngrover, D.A. and Thomas, J.N. (1982). Microcarriers and the Problem of High Density Cell Culture. From Gene to Protein: Translation into Biotechnology, Miami Winter Symposia, ed. by F. Ahmad, E.E. Smith, J. Schultz and W.J. Whelan, Vol. 19: 75-81.

Barngrover, D.A., Stevens, H.C. and Dills, W.L., Jr. (1981). D-Xylulose-1-phosphate: Enzymatic Assay and Production in Isolated Rat Hepatocytes. Biochem. Biophys. Res. Commun. 102: 75-80.

Invited Presentations/Papers

“Supply Chain Risk Management”, Life Sciences Supply Chain Working Group, March 11, 2009, Cambridge, MA

"Reverse Process Development, Starting at the End", BioPharm '95, June 13, 1995, Boston, MA

"Recombinant Protein Production From CHO Cells Attached To Microcarriers In Stirred Tank Bioreactors", BioEast '95, Jan 9, 1995, Washington, DC.

"Large Scale Animal Cell Culture", ASM, Sep. 1994, Boston, MA

"Large Scale Animal Cell Culture for the Production of Pharmaceuticals", Interphex-USA Conference, April 1991, New York, NY.

Papers and Posters Presented

Alex, P.A., D.A Barngrover and R.W. Swartz. Quantitative Description of the Metabolism of Non-recombinant and Recombinant C127 Anchorage-Dependent Cells. 200th ACS National Meeting, August 1990.

Bergh, M.L.E., B. Friedman, D. Barngrover, M. Hayes and J. Kutzko. Processing and Glycosylation of Human Glucocerebrosidase Expressed in Insect Cells and in Chinese Hamster Ovary Cells. 200th ACS National Meeting, August 1990.

Nicolakis, D.P., C.A. Sardonini, and D.A. Barngrover. Comparison of Alternative Technologies using a Recombinant CHO Cell Line. 199th ACS National Meeting, April 1990.

Ferrara, D.T., W. Jacobsen, D.P. Nicolakis, C.A. Sardonini, H. Hoppe, and D.A. Barngrover. Dependence of recombinant mammalian cell productivity on substrate and culture method. 199th ACS National Meeting, April 1990.

Alex, P. A., D. Barngrover, and R. W. Swartz. Development of Small Scale Model to Investigate the Rate Limiting Kinetics of C127 Anchorage-dependent Cells during Perfusion. 198th ACS National Meeting, September 1989.

Nicolakis, D.P., C.A. Sardonini, M. Travi and D. Barngrover. On-line Determination of Mammalian Cell Densities in Stirred Tank Bioreactors. Fourth International Congress on Computer Applications in Fermentation Technology, September 1988.

Barngrover, D.A., J.E. Jensen, K.W. Davidson, E.N. Candela and J.A. Sadowski. Uptake and Metabolism of Vitamin K in Recombinant Cells Producing Protein C. 73rd FASEB Annual Meeting, March 1989.

Sardonini, C. and Barngrover, D. Oxygen, Bicarbonate, and Acid Metabolism Determinations in Mouse Cell Microcarrier Culture. 192nd ACS National Meeting, September 1986.

Aguilon, F., Koehl, M., Barngrover, D. and Lupker, J. Fermenter Production of Human Growth Hormone by Recombinant Vero Cells. French Society for Microbiology, 1984.

Barngrover, D.A. and Dills, W.L., Jr., D-Xylulose-1-Phosphate Production in Xylitol-Treated Rat Hepatocytes. 65th Annual Meeting of Federation of Amer. Soc. of Exper. Biol., April 1981.