Chemistry, Hope College, Holland, MI (1970)

Senior Consultant, Biologics Consulting Group, Inc.
Darnestown, MD.

Director (Nov. 2006 – Dec. 2008) & Chief, Branch 2 (Nov. 2005 – Nov. 2006) FDA, CDER, Office of New Drug Quality Assessment, Division of Pre-Marketing Assessment I. Silver Spring, MD.

• Provided executive leadership and scientific direction to a multidisciplinary scientific and professional  stafF
• Participated in the development of policies and procedures affecting the review process
• Represented the Center, the FDA, the Public  Health Service, and the Federal Government on committees
• or at scientific meetings with both national and international groups and organizations
• Provided  regulatory and scientific advice consistent with regulations and Agency policy
• Responsible for scientific sufficiency of recommendations, proposals, communications, conclusions,
• and decisions which are accepted as authoritative
• Responsible for CMC reviews of  New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) for six Clinical Divisions, including Pulmonary, Metabolism and Endocrine, Anesthetics and Analgesics, CardioRenal, Neurology, and Psychiatry
• Evaluated Branch Chiefs, Review Chemists, and Support Staff performance and promotion
• Managed personnel and financial resources needed to implement Division goals, including budget, training, and recruitment

Deputy Director (Apr. 2004 – Oct. 2005)  Chemist (Detail) (Feb. 2004 – Mar. 2004), FDA, CDER, Office of New Drug Chemistry,  Division of New Drug Chemistry II. Rockville, MD.

• Managed regulatory operations and provided scientific direction to the professional staff
• Participated in developing  policies and procedures affecting the review process, particularly for biotechnology, natural, and peptide products
• Represented the Center, the FDA, the Public  Health Service, and the Federal Government on committees or at scientific meetings with both national and international groups and organizations
• Responsible for scientific sufficiency of recommendations, proposals, communications, conclusions and decisions which are accepted as authoritative

Chief, Laboratory of Chemistry, FDA, CDER, Office of Biotechnology Products, Division of Therapeutic Proteins,  (Oct. 2003 – Jan. 2004) Bethesda, MD.

Chief, Laboratory of Chemistry, FDA, CBER, Office of Therapeutics Research and Review, Division of Therapeutic Proteins, (Oct. 1999 – Sep. 2003) Bethesda, MD.

• Served on and chaired review committees for Biological License Applications (BLAs) to determine their acceptability for marketing approval
• Reviewed the CMC  of original biologics Product License Applications (PLAs) and supplements
• Participated in pre-approval establishment inspections
• Reviewed cytokine, growth factor, hematologic growth factors, tumor vaccine, therapeutic enzyme, and replacement enzyme IND applications for adequate product characterization and description of manufacture
• Provided guidance to industry and the public on technical problems of production, product testing, regulations and current policies relevant to regulation of biologics and biotechnology products
• Participated in the development of policies and procedures affecting the review process
• Mentored several  new doctoral-level product reviewers
• Supervised  veteran doctoral scientists engaged in  regulation of traditional  biologics and biotechnology products
• Directed a laboratory investigating the proteolytic processing of cytokines and growth factors.

Division Director (Acting), FDA, CBER, Office of Therapeutics Research and Review, Division of Cytokine Biology, Bethesda, MD.

• Provided executive leadership and scientific direction to a multidisciplinary scientific and professional staff
• Responsible for review and evaluation of  BLAs and Supplements for cytokine products
• Directed the review and evaluation of IND applications for cytokine products
• Directed laboratory programs and research efforts to evaluate cytokine products
• Represented the Center, the FDA, the Public Health Service, and the Federal Government on committees or at scientific meetings with both national and international groups and organizations
• Responsible for scientific sufficiency of recommendations, proposals, conclusions and decisions which are accepted as authoritative

Chief, Chemical Biology Laboratory, FDA, CBER, Office of Therapeutics Research and Review, Division of Cytokine Biology, Bethesda, MD.

• Served on review committees for Biologics PLAs  to determine their acceptability for marketing of new  biologic and biotechnology products
• Reviewed the chemistry, manufacturing, and controls  of original Biologics PLAs and Supplements
• Led several pre-approval and annual establishment inspections
• Reviewed  cytokine, growth factor, and enzyme IND applications for adequate product characterization and description of manufacture
• Provided guidance to industry and the public on technical problems of production, product  testing, regulations and current policies relevant to regulation of biologic and biotechnology products
• Participated in the development of policies and procedures affecting the review process
• Mentored several new doctoral-level product reviewers
• Supervised doctoral scientists  engaged in research and regulation of biotechnology products
• Directed a laboratory  investigating the structure and  function of bioactive peptides and growth factors, structures of post-translational  modifications, and the proteolytic  processing of cytokines and growth factors
• Editorial Board Member, Peptide Research (1988 – 1996)

Nov. 1979 - Jan. 1993

Chief, Chemical Biology Laboratory, FDA, CBER, Division of Biochemistry and Biophysics, (Mar. 1983 – Jan. 1993) Bethesda, MD.

Research Chemist, FDA, Bureau of Biologics, Division of Biochemistry and Biophysics,  (May 1981 – Feb. 1983) Bethesda, MD.

Research Chemist, Biochemistry Branch, FDA, Bureau of Biologics, Division of Bacterial Products, (Nov. 1979 – Apr. 1981) Bethesda, MD.

• Established  and directed a laboratory investigating structures of complex glycoconjugates of microbial cell surface origin, bacterial polysaccharides, lipids, peptides, and post-translational modifications using high resolution mass spectrometric analysis
• Reviewed the CMC sections of original Biologics PLAs and Supplements for bacterial and viral vaccines
• Reviewed vaccine IND applications for adequate product characterization and description of manufacture
• Participated in review and inspection of the regulated industry, in one case, leading to a Federal Injunction against a violative sponsor and resulting in a letter of commendation from Commissioner of Food and Drugs
• Testified in court as a technical expert witness and received letter of commendation from state’s Attorney General
• Performed several official analytical analyses
• Associate Editor, Microbial Immunity, Journal of Immunology (1978-1981)

Senior Staff Fellow, Biochemistry Branch, FDA, Bureau of Biologics, Division of Bacterial Products, Bethesda, MD.

• Research investigating structures and immunochemical properties of bacterial polysaccharides used in human vaccines

Staff Fellow, National Institutes of Health, NIAID, Laboratory of Immunogenetics, Bethesda, MD.

• Research investigating structures and immunochemical properties of rabbit immunoglobulins and of complex carbohydrates of microbial origin

Research Associate, The Rockefeller University, Laboratory of Immunology and Immunochemistry, New York, NY

• Research investigating  protein structures and immunochemical properties of rabbit immunoglobulin allotypes and idiotypes
• National Research Service Award, National Institutes of Health

Graduate Assistant, The Pennsylvania State University, Biochemistry Department, University Park, PA.

• Research on the immunochemical and chemical structure of the Forssman glycosphingolipid from sheep erythrocytes
• R. Adam Dutcher Award, Department of Biochemistry, The Pennsylvania State University

REGULATORY AND TRAINING HIGHLIGHTS

1999                Basic Food and Drug Law Course, FDA
1996                Therapeutic and Biotechnology-Derived Therapeutic Products and Allergenic Products, ORA
1995                Inspector Certification, Inspector of Cytokine Products
1994                Core Reviewer Training, CBER
1994                Core Inspection Training, CBER
1994                Inspection of Parenteral Products, CBER
1984                Inspector’s Course, FDA
1981                Basic Food and Drug Law Course, FDA
1981                Contracting Officer Training, NIH
1981                Expert Witness, Boise, Idaho

HONORS AND AWARDS

2008    CDER Special Recognition Award “For outstanding effort in protecting the public health by ensuring that contaminated heparin products are not imported into the United States.”

2008    CDER Team Excellence Award “For laboratory activities that led to publicly available analyticalmethods to ensure quality of heparin and to identification of the contaminant causing adverse events.”

2007    CDER Team Excellence Award “For excellence in collaborative scientific and regulatory review and approval of the first inhaled insulin for the treatment of diabetes mellitus in adults.”

2006    FDA Group Recognition Award “For outstanding service to FDA and the American public byapproving a new human growth hormone under the 505 (b)(2) regulatory pathway.”

2006    CDER Leadership Excellence Award “For exemplary leadership in both the Office of New Drug Chemistry and the Office of New Drug Quality Assessment.”

2005    CDER Special Recognition Award “For providing scientific and regulatory support in the development, presentation, and resolution of legal cases involving counterfeiting, misbranding and distribution of unapproved drugs.”

2005    CDER Excellence in Communication Award “ For planning and executing two public workshops on the timely and important topic of Follow-on Protein Pharmaceuticals.”

2004    CDER Special Recognition Group Award “For exceptional performance in the review of Iaronidase             Application, the first product approved for the treatment of mucopolysaccharidosis Type I”

2003    CBER Group Recognition Award “For upholding the highest scientific standards in efficiently and effectively reviewing a new therapy for treatment of Fabry’s disease.”

2001    CBER Outstanding Service Award  “For outstanding leadership in creation of CBER regulatory guidance policies, mentoring of CBER personnel, and evaluation of novel CBER products.”

1996    CBER Commendable Service Award “For superior performance in completing guidance for industry in the area of synthetic peptide substances.”  as a member of the Synthetic Peptide Subcommittee/Biotechnology Technical Committee, CDER.

1994    CBER Commendable Service Award  “For outstanding performance in the chemistry and manufacturing review of cytokine products.”

1993    CBER Letter of Personal Commendation, Review Committee for Betaseron, Director, CBER, FDA

PROFESSIONAL SOCIETIES

American Society for Biochemistry and Molecular Biology
American Association of Immunologists
The Harvey Society
Sigma Xi
American Chemical Society

REGULATORY PRESENTATIONS

REGULATORY COMMITTEES

BIBLIOGRAPHY

1. Fraser, B.A. and Mallette, M.F.: An improved isolation method and new composition data for Forssman hapten from sheep erythrocytes. Immunochemistry 10:745-753, 1973.

2. Fraser, B.A. and Mallette, M.F.: Two new assays for Forssman hapten. Immunochemistry 11:181-190, 1974.

3. Fraser, B.A. and Mallette, M.F.: Structure of Forssman hapten glycosphingolipid from sheep erythrocytes. Immunochemistry 11:581-593, 1974.

4. Ziolkowski, C.H.J., Fraser, B.A., and Mallette, M.F.: Ceramide composition of sheep erythrocyte Forssman hapten, an isohapten system. Immunochemistry 12:297-302, 1975.

5. Mudgett, M., Fraser, B.A., and Kindt, T.J.: Nonallelic behavior of rabbit variable-region allotypes. J. Exp. Med. 141:1448-1452, 1975.

6. Kindt, T.J., Mudgett, M., Sogn, J.A., Fraser, B.A., and Aasted, B. “ Allotype expression and the regulation of immunoglobulin synthesis” in Antibodies in Human Diagnosis and Therapy. E. Haber and R. Krause, eds., Raven Press, New York, pp. 29-40, 1976.

7. Coligan, J.A., Fraser, B.A., and Kindt, T.J.: A disaccharide hapten from streptococcal Group C carbohydrate that crossreacts with the Forssman glycolipid. J. Immunol. 118:6-11, 1976.

8. Fraser, B.A., Johnstone, A.P., Gordon, S.M., and Kindt, T.J.: The response of rabbits to streptococcal hyperimmunization. Cold Spring Harbor Symposium on Quantitative Biology. 41:689-698, 1976.

9. Margolies, M.N., Cannon, L.E., Kindt, T.J., and Fraser, B.A.: The structural basis of rabbit VH allotypes: serologic studies on a1 H chains with defined amino acid sequence.  J. Immunol. 119: 287-294, 1977.

10. Coligan, J.A., Fraser, B.A., and Kindt, T.J. “ Immunochemistry of streptococcal Group C polysaccharide and the nature of its crossreaction with the Forssman glycolipid” in Progress in Clinical and Biological Research. “Cell Surface Carbohydrates and Biological Recognition,” Alan R. Liss, New York, pp. 601-612, 1978.

11. Mudgett-Hunter, M., Yarmush, M., Fraser, B.A., and Kindt, T.J.: Rabbit latent group a allotypes: characterization and relationship to nominal group a allotypic specificities. J. Immunol. 121:1132-1138, 1978.

12. Fraser, B.A., Thunberg, A.L., and Kindt, T.J.: Variable region correlates of group b allotypes: amino acid sequence of the V region of a b9 L chain from a homogeneous antibody. Eur. J. Immunol. 8:380-385, 1978.

13. Fraser, B.A., Tsui, F.P., and Egan, W.: Mass spectral studies of isomeric D- ribofuranosylribitol disaccharides from the capsular polysaccharides of Haemophilus influenzae type b and Escherichia coli K 100. Carbohydr. Res. 73:59-65, 1979.

14. Lee, C.J. and Fraser, B.A.: The structures of the cross reactive type 19 (19F) and 57 (19A) pneumococcal capsular polysaccharides. J. Biol. Chem. 255:6847-6853, 1980.

15. Lee, C.J., Fraser, B.A., Szu, S., and Lin, K.T.: Chemical structure of and immune response to polysaccharides of Streptococcus Pneumoniae. Rev. Infect. Dis. 3:323-331, 1981.

16. Phillips, L.R. and Fraser, B.A.: Methylation of carbohydrates by dimsyl potassium in dimethyl sulfoxide. Carbohydr. Res. 90:149-152, 1981.

17. Phillips, L.R. and Fraser, B.A.: Derivatization of  beta-propiolactone in biological mixtures for enhanced gc/ms determination.  Biomed. Mass Spectrom. 8:327-331, 1981.

18. Gotschlich, E.C., Fraser, B.A., Nishimura, O., Robbins, J.B., and Liu, T.Y.:  Lipid on capsular polysaccharides of gram-negative bacteria. J. Biol. Chem. 256:8915-8921, 1981.

19. Hoffman, T., Hirata, F., Bougnoux, P., Fraser, B.A., Goldfarb, R.H., Herberman, R.B., and Axelrod, J.: Phospholipid methylation and phospholipase A2 activation in cytotoxicity by human natural killer cells.  Proc. Natl. Acad. Sci., USA  78:3839-3843, 1981.

20. Fraser, B.A., Gotschlich, E.C., Nishimura, O., and Liu,T.Y.: “Capsular polysaccharide interactions” in  Bacterial Vaccines, J.B. Robbins, J.C. Hill, and J.C. Sadoff, eds., Thieme-Stratton, Inc., New York, pp. 242-246, 1982.

21. Buko, A.M., Phillips, L.R., and Fraser, B.A.: Peptide studies using a fast atom bombardment high field mass spectrometer and data system. I. Sample introduction, data acquisition and mass calibration. Biomed. Mass Spectrom. 10:324-333, 1983.

22. Buko, A.M., Phillips, L.R., and Fraser, B.A.:   Peptide studies using a fast atom bombardment high field mass spectrometer and data system. II. Characteristics of positive ionization spectra of peptides, m/z 858 to m/z 5729. Biomed. Mass Spectrom. 10:408-419, 1983.

23. Buko, A.M., Phillips, L.R., and Fraser, B.A.: Peptide studies using a fast atom bombardment high field mass spectrometer and data system. III. Negative ionization: mass calibration, data acquisition, and structural characterization. Biomed. Mass Spectrom. 10:387-393, 1983.

24. Phillips, L.R., Nishimura, O., and Fraser, B.A.: The structure of the repeating oligosaccharide unit of the pneumococcal capsular polysaccharide, type 18C. Carbohydr. Res. 121:243-255, 1983.

25. Manning, D., Fraser, B.A., Kahn, R.A., and Gilman, A.G.: ADP-ribosylation of transducin by islet activating protein, identification of asparagine as the site of ADP-ribosylation. J. Biol. Chem. 259:749-756, 1984.

26. Phillips, L.R., Nishimura, O., and Fraser, B.A.: Synthesis of and fast atom bombardment mass spectrometry of N-acetylmuramyl-L-alanyl-D-isoglutamine (MDP). Carbohydr. Res. 132:275-286, 1984.

27. Lo, S.S., Fraser, B.A., and Liu, T.Y.: The mixed-disulfide in the zymogen of Streptococcal  proteinase: characterization and implication for its biosynthesis. J. Biol. Chem. 259:11041-11045, 1984.

28. Buko, A.M. and Fraser, B.A.: Peptide studies using a fast atom bombardment high field mass spectrometer and data system. IV. Disulfide-containing peptides. Biomed. Mass Spectrom.12:577-585, 1985.

29. Marshak, D.R. and Fraser, B.A.:  “Structural analysis of brain peptides” in Brain Peptides Update - Volume 1, J.B. Martin, M.J. Brownstein, and D.T. Krieger, eds., John Wiley and Sons, New York, pp. 9-35, 1987.

30. Sherwood, N.A., Sower, S.A., Marshak, D.R., Fraser, B.A., and Brownstein, M.J.:  Primary structure of gonadotropin-releasing hormone from lamprey brain. J. Biol. Chem. 261:4812-4819, 1986.

31. Fraser, B.A.: “Fast atom bombardment mass spectrometry: applications to peptide structural analysis”  in Proteins: Structure and Function, J. L’Italien, ed., Plenum Press, New York, pp. 241-249, 1987.

32. Jaffe, H., Raina, A.K., Riley, C.T., Fraser, B.A., Holman, G.M., Wagner, R.M., Ridgway, R.L., and Hayes, D.K.: Isolation and primary structure of a peptide from the corpora cardiaca of Heliothis zea with adipokinetic activity. Bioch. Biophys. Res. Comm. 135:622-628, 1986.

33. Wagner, R.M. and Fraser, B.A.: Use of immobilized exopeptidases and volatile buffers for analysis of peptides by fast atom bombardment mass spectrometry. Biomed. Environ. Mass Spectrom. 14:235-239, 1987.

34. Wagner, R.M. and Fraser, B.A.: Analysis of peptides containing oxidized methionine and/or tryptophan by fast atom bombardment mass spectrometry. Biomed. Environ. Mass Spectrom. 14:69-72, 1987.

35. Burgess, W.H., Mehlman, T., Marshak, D.R., Fraser, B.A., and Maciag, T.: Structural evidence that beta-endothelial cell growth factor is the precursor of both beta-endothelial cell growth factor and acidic fibroblast growth factor. Proc. Natl. Acad. Sci., USA 83: 7216-7220, 1986.

36. Lee, C.J., Fraser, B.A., Boykins, R.A., and Li, J.P.: Effect of culture conditions on the structure of pneumococcal type 19A(57) capsular polysaccharide. Infect. Immun. 55:1819-1823, 1987.

37. Lively, M.O., El-Maghrabi, M.R., Pilkis, J., D’Angelo, G., Colosia, A.D., Ciavola, J., Fraser, B.A., and Pilkis, S.J.: Complete amino acid sequence of rat liver 6-phosphofructo- 2-kinase/fructose-2,6-bisphosphatase. J. Biol. Chem. 263:839-849, 1988.

38. Marshak, D.R. and Fraser, B.A.: “Characterization of synthetic polypeptides by mass spectrometry” in High Performance Liquid Chromatography in Biotechnology. W. Hancock ed., John Wiley and Sons, New York pp. 531-550, 1990.

39. Jaffe, H., Raina, A.K., Fraser, B.A., Keim, P., Rao, K.R., Zhang, Y.S., Lancaster, J.L., and Hayes, D.K.: Isolation of two neuropeptides in the AKH/RPCH-family from horseflies           (Diptera). Bioch. Biophys. Res. Comm. 151:656-663, 1988.

40. Lifson, J.D., Hwang, K.M., Nara, P.L., Fraser, B., Padgett, M., Dunlop, N.M., and Eiden, L.E.: Synthetic CD4 Peptide derivatives that inhibit HIV infection and cytopathicity. Science 241: 712-716, 1988.

41. El-Maghrabi, M.R., Pilkis, J., Marker, A.J., Colosia, A.D., D’Angelo, G., Fraser, B.A., and Pilkis, S.J.: cDNA Sequence of rat liver fructose-1,6-bisphosphatase and evidence for down-regulation of its mRNA by insulin. Proc. Natl. Acad. Sci. USA. 85: 8430-8434,1988.

42. Jaffe, H., Raina, A.K., Riley, C.T., Fraser, B.A., Bird, T.G., Tseng, C.M., Zhang, Y.S., and Hayes, D.K.: Isolation and primary structure of a neuropeptide hormone from Heliothis zea with hypertrehalosemic and adipokinetic activities. Biochem. Biophys. Res. Comm. 155:344-350, 1988.

43. Jaffe, H., Raina, A.K., Riley, C.T., Fraser, B.A., Nachman, R.J, Vogel, V.W., Zhang, Y.S., and Hayes, D.K.: Primary structure of two neuropeptide hormones with adipokinetic and hypotrehalosemic activities isolated from corpora cardiaca of horseflies (Diptera). Proc. Natl. Acad. Sci. USA. 86:8161-8164, 1989.

44. Wagner, R.M., Woods, C.W., Hayes, J.A., Kochansky, J.P., Hill, J.C., and Fraser B.A. Isolation and identification of a novel peptide from the accessory gland of the female house fly, Musca domestica. Biochem. Biophys. Res. Comm. 194:1336-1343, 1993.

45. Hill, J.C., Flannery, G.M., and Fraser, B.A. Identification of alpha-carboxamidated and     carboxy-terminal glycine forms of peptides in bovine hypothalamus, bovine pituitary, and       porcine heart extracts. Neuropeptides 25:255-264, 1993.

46. Wagner, R.M., Kochansky, J.P., Richeson, A., Hayes, J.A., Hill, J.C., and Fraser, B.A. “Identification of a peptide from the female reproductive system of the house fly, Musca domestica” in  Insect Neurochemistry and Neurophysiology 1993, A.B. Borkovec, M.J. Loeb, eds, CRC Press, Boca Raton, FL, pp. 281-284, 1993.

47. Hill, J.C., Flannery, G.M., and Fraser, B.A. HPLC purification and mass spectrometricidentification of 5,5’-substituted-2,4-imidazolidinedithiones. J. Chromatogr. 664:63-70,1994.

48. Woodcock J., Griffin J., Behrman R., Cherney B., Crescenzi T., Fraser B., Hixon D., Joneckis C.,  Kozlowski S., Rosenberg A., Schrager L., Shacter E., Temple R., Webber K., and Winkle H. The FDA’s assessment of follow-on protein products: a historical perspective. Nature Reviews 6:437-442, 2007.

49. Guerrini M., Beccati D., Shriver Z., Naggi A., Viswanathan K., Bisio A., Capila I., Lansing J.C., Guglieri S., Fraser B., Al-Hakim A., Gunay N.S., Zhang Z., Robinson L., Buhse L., Nasr M.,  Woodcock J., Langer R., Venkataraman G., Linhardt R.J., Casu B., Torri G.  and  Sasisekharan R.. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nature Biotechnology 26:669-75;2008.

50. Kishimoto T.K.,  Viswanathan K., Ganguly T., Elankumaran S., Smith S., Pelzer K., Lansing J.C., Sriranganathan N., Zhao G., Galcheva-Gargova Z.,  Al-Hakim A., Bailey G.S., Fraser B., Roy S., Rogers-Cotrone T., Buhse L., Whary M., Fox J., Nasr M., Dal Pan G.J., Shriver Z., Langer R.S., Venkataraman G., Austen K.F., Woodcock J., and Sasisekharan R. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 358:2457-67; 2008.