Ann Sutton

asutton@bcg-usa.com

 

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EDUCATION:

M.P.H. Johns Hopkins University (1992)  
M.A. University of Utah; Microbiology (1970)  
B.A. University of Utah; Microbiology (1968)

EXPERIENCE:

CURRENT
POSITION:		 Vice President, Bacterial Products, Biologics Consulting Group, Inc.
1998 to
present
  • Provide comprehensive consultation on a wide variety of projects involving products derived from bacterial and viral source materials. 
  • Product experience includes vaccines against bacterial, viral, and fungal diseases, therapeutic products derived from bacterial sources, vectored tumor vaccines, live biotherapeutic products, in vivo diagnostic antigens, and products for the diagnosis and prevention of parasitic diseases.  
  • Apply knowledge of regulatory requirements and industry standards of practice to development strategies and to evaluation of compliance status.
  • Interpret regulations, guidance, and FDA procedures as applied to specific cases.  Write/revise regulatory submissions
  • Advise on cGMP and its practical application.  Analyze corrective action plans, technical documents and procedural documents. 
  • Perform on-site evaluations to observe the work environment, equipment, and operations. Interview technical, scientific and regulatory staff to understand and elicit information.  Write reports analyzing status of regulatory compliance and advising corrective actions.
  • Apply statistical and epidemiological concepts to evaluation of plans for lab analysis of manufacturing samples and clinical samples, and to strategic planning for clinical development and analysis of clinical data.
  • Provide training in regulatory affairs and GMP, customized for client needs. 
  • Provide advice and direct assistance in developing appropriate Master production and control records and processing SOPs.
  • NIH review panel service:
    • 2007:  Clinical Trial Planning Grants (R34), NIAID/ Division of Microbiology and Infectious Diseases.
    • 2006:  RFA for Partnerships for Hepatitis C Vaccine Development, by NIAID; (CMC and regulatory reviewer).
    • 2005:  RFP for HIV Clinical Research Management Support by NIAID/Division of AIDS.
    • 2004:  RFP to establish a regulatory affairs center to support clinical studies and product development by NIAID/Division of Allergy, Immunology, and Transplantation.
 
1991-1997 Associate Director for Regulatory Affairs, Division of Bacterial Products, CBER/FDA
 
  • Responsible for coordinating all IND and PLA review activities by DBP
  • Advisor to Director on regulatory policy
  • Trainer, CBER regulatory affairs training sequence
    • Acellular pertussis vaccines review group
    • National Vaccine Program labeling review project
    • Combination Vaccines Guidance document
    • REGO committees for managed review, changes to be reported
    • CBER strategic plan, Promotion & Tenure evaluation policies for scientific and regulatory staff
    • CMC Guidance for Vaccines, chair of bacterial vaccines subproject
    • CBER representative, WHO Conference on DTP and DTP-based combination vaccines and polio eradication in Asia, Bandung, Indonesia.  1994
    • Instructor, CBER Reviewer Training program. 1992-1997
 
1987-1991 Microbiologist, Division of Biological Investigational New Drugs, Office of Biologics Research and Review, FDA
 
  • Primary regulatory reviewer for biologics INDs including vaccines, plasma fractions, and therapeutic products.
  • Managed review of INDs, formulated consensus documents based on reviews by product and clinical specialists.
  • Communicated with regulated industry and sponsors regarding product development and interpretations of FDA policy.
  • Continued participation as inspector of manufacturing facilities, both pre-licensing and annual inspections.
  • Executive Secretary (ad hoc), Vaccines and Related Biological Products Advisory Committee (September 1991)
 
1971-1987 Microbiologist, Division of Bacterial Products, Bureau of Biologics, FDA (later the Office of Biologics Research & Review)
 
    • Served as research associate in studies of pathogenic mechanisms in bacterial disease, especially diseases caused by encapsulated bacteria.
    • Developed animal and in vitro models of disease and immune response, assays for antibody and antigens.
    • Performed as a reviewer of INDs and member of licensing committees for meningococcal polysaccharide, Haemophilus b polysaccharide, and Haemophilus b conjugate vaccines.
    • Served as inspector of manufacturers of biologic products.
    • Served as technical expert to foreign manufacturing establishments (PL480 assignment to Meningitis Project, Cairo, Egypt (April, 1976) and trained personnel on site at CBER
    • Served as technical expert to foreign manufacturing establishments and trained personnel on site at CBER.
 
1970-1971 Microbiologist, Division of Virology, Division of Biologics Standards, NIH
 
  • Served as research associate in studies of Epstein Barr Virus and its role in infectious disease and cancer.
  • Utilized tissue culture techniques including suspension and anchored; viral culture in embryonated eggs; serologic assays including viral neutralization, complement fixation.

ADDITIONAL TRAINING:

2010 2010 PDA Vaccine Conference, PDA/FDA, Rockville MD
2008 SERE 100 Code of Conduct Training Course (online). US Joint Forces Command.
2008 AT Level 1 Awareness Training (online). US Joint Forces Command.
2007 Anthrax; Bridging Correlates of Protection in Animals to Immunogenicity in Humans. FDA/NIAID. Gaithersburg, MD
2005 Follow-On Protein Pharmaceuticals.  FDA/DIA. Arlington, VA.
2004 Neonatal Vaccination Workshop. CDC/FDA/NIH/NVP. McLean, VA.
2000 Statistics in Process Validation. Institute of Validation Technology. Washington DC.
2000 Impact of Team Biologics on the Vaccine Industry. DIA. Washington DC.
2000 Validation of Manufacturing Processes for Biologics. PDA/FDA. Washington DC.
1992 Applications of the Case Control Method.  Johns Hopkins University School of Hygiene and Public Health, Baltimore MD.
1992 Clinical Trial Monitoring and Interim Analysis in the Pharmaceutical Industry, PMA/FDA, Washington DC.

HONORS AND AWARDS:

1997   FDA Commendable Service Award, Acellular Pertussis Vaccine Review Group
1996   CBER Hope Hopps Memorial Award
1993   FDA Group Recognition Award, Childhood Vaccine Group
1992   FDA Group Recognition Award, Desert Shield/Storm Task Force
1988   FDA Commendable Service Award, Haemophilus b Conjugate Vaccine Licensing Group
1986   FDA Award of Merit, Haemophilus b Polysaccharide Vaccine Control Group
1982   FDA Commendable Service Award (Individual)

PROFESSIONAL SOCIETIES:

  • American Association for the Advancement of Science (AAAS)
  • Parenteral Drug Association (PDA)
  • Regulatory Affairs Professional Society (RAPS)

REGULATORY PRESENTATIONS:

2009

Rocky Mountain Regional Centers for Excellence Annual Meeting, Utah State University, Logan UT. 

“Developing Chemistry, Manufacturing and Control Content from Laboratory Investigations.”
   
2006   First International DIA Conference: Developing Probiotics as Foods and Drugs-Scientific and Regulatory Challenges. University of Maryland College Park, Adelphi, MD
   
2004   Biophex2004 Conference & Expo, San Francisco, CA. Developing Chemistry, Manufacture and Control Information from Laboratory Investigations.
   
2003   RAPS Annual Conference & Exhibition, Baltimore MD. CMC Expectations for the Development of Biologics.
   
2001   12th International Symposium on the Biology of Actinomycetes, Vancouver, BC. Recombinant Bacterial Sources for Biologic Products: Characterization and testing according to regulatory guidelines.
   
2000   Institute for International Research, Process Controls for Biologics
   
1999   Barnett/Parexel Conference, Vaccines '99: Strategies to File a Successful Registration with the FDA
   
1999   RAPS Annual Meeting: The BLA Process: "Components of the Application"
   
1999   IBC USA Conferences, IBC's Vaccine Summit: Chemistry, Manufacturing and Control for Vaccines & the BLA
   
1998   Hood College, Frederick, MD, Regulatory Compliance Certificate Program: "Post-approval of the BLA; The FDA Modernization Act of 1997"
   
1998   RAPS Biologics Approval and Compliance Workshop: "Chemistry, Manufacturing & Control"
   
1996   Food & Drug Law Institute (FDLI), 40th Annual Educational Conference: "Office of Vaccines Research & Review Update"
   
1995   Institute for Advanced Studies in Immunology and Aging (IASIA) work group meeting, influenza and pneumococcal vaccines in adults: "Clinical Trial Outcomes and Implications for Labeling/Marketing"
   
1991   BioEast91: "How to Prepare INDs"
   
1989   Society for Quality Assurance (SQA) Annual Meeting: "Good Manufacturing Practices for Biotechnology Products"
   
1988   American Association for Laboratory Animal Sciences (AALAS), branch meeting: "The Points to Consider Documents"

BIBLIOGRAPY:

  1. Sutton, A. 2008. Product development of probiotics as biological drugs. Clin Inf Dis 46: S128-S132.
  2. Sutton, A. 2008. Environmental assessment requirement for live biological drugs.  Clin Inf Dis 46:S112- S114.
  3. Anthony, B.F. and A. Sutton.  1997. The role of the Food and Drug Administration in vaccine testing and licensure.  In  New Generation Vaccines, Marcel Dekker, Inc. New York, NY
  4. Karakawa, W.W., A. Sutton, R. Schneerson, A. Karpas and W.F. Vann.  1988. Capsular antibodies induce type-specific phagocytosis of capsulated Staphylococcus aureus by human polymorphonuclear leukocytes.  Infect. Immun. 56:1090.
  5. Fattom, A., W.F. Vann, S.C. Szu, A. Sutton, X. Li, D. Bryla, G. Schiffman, J.B. Robbins and R. Schneerson.  1988.  Synthesis and physicochemical and immunological characterization of pneumococcus type 12F polysaccharide-diphtheria toxoid conjugates.  Infect. Immun.  56:2292.
  6. Vann, W.F., R.P. Silver, C. Abeijon, K.Chang, W. Aaronson, A. Sutton, C.W. Finn, W. Lindner and Mark Kotsatos. 1987.  Purification, properties, and genetic location of Escherichia coli cytidine 5’-monophosphate N-acetylneuraminic acid synthetase.  J. Biol. Chem. 262:17556.
  7. Schneerson, R., J.B. Robbins, J.C. Parke, Jr., C. Bell, J.J. Schlesselman, A. Sutton, Z. Wang, G. Schiffman, A. Karpas and J. Shiloach.  1986.  Quantitative and qualitative analyses of serum antibodies elicited in adults by Haemophilus influenzae type b and pneumococcal type 6A capsular polysaccharide-tetanus toxoid conjugates. Infect. Immun. 52:519.
  8. Sutton, A., W.F. Vann, A. B. Karpas, K.E. Stein and R. Schneerson.  1985. An avidin-biotin based ELISA for quantitation of antibody to bacterial polysaccharides. J. Immunol. Methods 82:215.
  9. Schneerson, R., J.B. Robbins, C.Y. Chu, A. Sutton, W. Vann, J.C. Vickers, W.T. London, B. Curfman, M.C. Hardegree, J. Shiloach, S. C. Rastogi.  1984.  Serum antibody responses of juvenile and infant rhesus monkeys injected with Haemophilus influenzae type b and pneumococcus type 6A capsular polysacchride-protein conjugates.  Infect. Immun. 45:582.
  10. Schneerson, R., J.B. Robbins, C. Y, Chu, A. Sutton, G. Schiffman and W.F. Vann.  1983.  Semi-synthetic vaccines composed of capsular polysaccharides of pathogenic bacteria covalently bound to proteins for the prevention of invasive diseases. Progr Allergy 33: 144.
  11. Kayhty, H., R. Schneerson, A. Sutton.  1983.  Class-specific antibody response to Haemophilus influenzae type b capsular polysaccharide vaccine.  J. Inf. Dis. 148:767.
  12. Achtman, M., A. Mercer, B. Kusecek, A. Pohl, M. Heuzenroeder, W. Aaronson, A. Sutton, R.P. Silver.  1983. Six widespread bacterial clones among Eschericia coli K1 isolates.  Infect. Immun. 39:315.
  13. Hanson, L.A., C. Brinton, B. Carlsson, U. Dahlgren, I. Mellander, A. Sutton and T. Soderstrom.  1982. The mucosal immune response in the neonate.  Acta Paediatr. Scand. Suppl.  296:53.
  14. Soderstrom, T., C.C. Brinton, Jr., L.A. Hanson, P. Larsson, K.G. Rosen, A. Sutton and R. Schneerson.  1982.  Intestinal colonization and antibody response.  Infection 10: 324.
  15. Tarr, P.I., S. w. Hosea, E.J. Brown, R. Schneerson, A. Sutton and M.M. Frank. 1982.  The requirement of specific anticapsular IgG for killing of Haemophilus influenzae by the alternative pathway of complement activation.  J. Immunol. 128:1772.
  16. Sutton, A., R. Schneerson, S. Kendall-Morris and J.B. Robbins.  1982. Differential complement resistance mediates virulence of Haemophilus influenzae type b. Infect. Immun. 35: 95.
  17. Schneerson, R., J.B. Robbins, O. Barrera, A. Sutton, W. B. Habig, M.C. Hardegree, J. Chaimovich.  1980.  Haemophilus influenzae type b polysaccharide-protein conjugates; model for a new generation capsular polysaccharide vaccines.  In New Developments with Human and Veterinary Vaccines. Alan R. Liss, Inc. New York, NY.
  18. Silver, R.P., W. Aaronson, A. Sutton and R. Schneerson.  1980.  Comparative analysis of plasmids and some metabolic characteristics of Escherichia coli K1 from diseased and healthy individuals.  Infect. Immun. 29:200.
  19. Schneerson, R., O. Barrera, A. Sutton, and J.B. Robbins.1980. Preparation, characterization and immunochemistry of Haemophilus influenzae type b polysaccharide-protein conjugates. J. Exp. Med. 152:361
  20. Orskov, F, I. Orskov, A. Sutton, R. Schneerson, W. Lin, W. Egan, G.E. Hoff and J.B. Robbins.  1979.  Form variation in Escherichia coli K1:  Determined by O-acetylation of the capsular polysaccharide.  J.Exp. Med. 149:669.
  21. Glode, M.P., E. B. Lewin, A. Sutton, C.T. Le, E.C. Gotschlich and J.B. Robbins.  1979.  Comparative immunogenicity of vaccines prepared from capsular polysaccharides of group C Neisseria meningitidis O-acetyl-positive and O-acetyl-negative variants and Escherichia coli K92 in adult volunteers.  J. Inf. Dis. 139:52.
  22. Moxon, E.R., M.P. Glode, A. Sutton, J.B. Robbins.  1977. The infant rat as a model of bacterial meningitis. J. Inf. Dis. 136 (suppl):S186.
  23. Glode, M.P., A. Sutton, J.B. Robbins, G.H. McCracken, E.C. Gotschlich, B. Kaijser, and L.A. Hanson.  1977. Neonatal meningitis due to Escherichia coli K1.  J. Inf. Dis. 136 (suppl):S93.
  24. Glode, M.P., A Sutton, E. R. Moxon, and J.B. Robbins. 1977. Pathogenesis of neonatal Escherichia coli meningitis: induction of bacteremia and meningitis in infant rats fed E. coli K1.  Infect. Immun. 16:75.
  25. Wong, K.H., O. Barrera, A. Sutton, J. May, D.H. Hochstein, J.D. Robbins, J.B. Robbins, P.D. Parkman and E.B. Seligmann, Jr. 1977. Standardization and control of meningococcal vaccines, group A and group C polysaccharides. J. Biol Stand. 5: 197.
  26. Levin, D.M., K.H. Wong, H.Y. Reynolds, A. Sutton, and R.S. Northrup.  1975.  Vi Antigen from Salmonella typhosa and immunity against typhoid fever.  II. Safety and antigenicity in humans.  Infect. Immun. 12:1290.
  27. Northrup, R.S., A. Sutton, and J.P. Craig. 1975. Interrelationships between cholera toxin, cholera toxoid, and cellular immunity. Jap. J. Med. Sci. Biol. 28:76.
  28. Sutton, A. and S. Marcus. 1971. Standardization of coccidioidin by bioassay in guinea pigs. Proc. Soc. Exp. Biol. Med. 136:257.

 
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