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jkenimer@bcg-usa.com

 

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EDUCATION:
Ph.D.   Emory University; Biochemistry (1972)
B.S.   Emory University; Chemistry (1966)
   
  • Senior Visiting Scientist, Muscular Dystrophy Laboratory, Institute of Neurology, Queen Square, London, U.K. (Jan. 1984 - Apr. 1984)
  • Foreign Research Fellow, Division of Pharmacology, National Institute of Hygienic Sciences, Tokyo, Japan (Mar. - Dec. 1990)

EXPERIENCE:

CURRENT POSITION:
Sept 1993 to present:		  

CEO, Biologics Consulting Group Inc.
Alexandria, VA

  • Chief Executive Officer of BCG responsible for the overall management of company activities including negotiation of consulting agreements/contracts, management of administrative personnel and functions, marketing, and employee recruitment.
  • Senior Consultant - responsible for the scientific and regulatory review and analysis of a wide range of biologic products at all stages of product development, from pre-IND thorough post-marketing.
   
Jan. 1993 to Sept. 1993   Acting Deputy Director and Supervisory Pharmacologist (GM-14) for the Division of Vaccines and Related Products Applications, FDA, CBER.
  • Management/supervision of PLA/IND reviewers;
  • Review of INDs/PLAs for vaccines and related products;
  • Development of CBER managed review policy; and
  • Inspection of CBER licensed facilities
   
1991 to Dec.1992   Chief, Laboratory of Allergy and Immunochemistry and Supervisory Pharmacologist (GM-14) for the Division of Bacterial Products, FDA, CBER.
  • Supervised research, testing, and regulatory activities;
  • Supervised of the hybridoma facility;
  • Reviewed INDs;
  • Participated on PLA review committees (monoclonal antibody and allergenic products); and
  • Inspected CBER licensed facilities.
   
1989 to 1991   Chief. Laboratory of Cellular Physiology and Supervisory Pharmacologist (GM-14) for the Division of Bacterial Products, FDA, CBER.
  • Supervised research, testing, and regulatory activities;
  • Supervised of the hybridoma facility;
  • Reviewed INDs;
  • Participated on PLA review committees (monoclonal antibody and allergenic products); and
  • Inspected CBER licensed facilities.
   
1984 to 1989   Chief, Laboratory of Cellular Physiology, Research Pharmacologist (GS-13) for the Division of Bacterial Products, FDA, CBER.
  • Supervised research, testing, and regulatory activities;
  • Supervised of the hybridoma facility;
  • Reviewed INDs;
  • Participated on PLA review committees (monoclonal antibody and allergenic products); and
  • Inspected CBER licensed facilities.
   
1978 to 1984  

Research Chemist (GS-13) for the Division of Drug Biology, FDA, Bureau of Drugs (1978-1982); National Center for Drugs & Biologics (1982-1984)

  • Responsibilities included research into the mechanism of action of drug and hormone receptors
   
1976 to 1978  

NIH Staff Fellow, National Institutes of Health, Dr. Marshall Nirenberg's lab at the Laboratory of Biochemical Genetics

  • Conducted research in Dr. Marshall Nirenberg's lab at the Laboratory of Biochemical Genetics at NIH.
   
1974 to 1976  

Postdoctoral Fellow, Georgetown University, Dr. Melvin Blecher's lab at the Department of Biochemistry.
   
1972 to 1974  

Research Associate, UCLA, Dr. Jerome Hershman's lab at the Department of Medicine

  • Conducted research in Dr. Jerome Hershman's lab at the Department of Medicine at UCLA.

FDA SPECIAL ASSIGNMENTS:

  • Member of the Application Policy Task Force - Development and implemention of CBER policies and procedures
  • Member FDA Hybridoma Committee - Preparation of the "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (1987)
  • FDA Inspector since 1986: Have performed numerous domestic and foreign annual and pre-license inspections of biologics facilities

HONORS AND AWARDS:

2006 Appointment to PDA Biotechnology Advisory Board (BioAB)
2002 Appointment to the Governor's Advisory Board for the Virginia Biotechnology Initiative by Governor Warner
1993 FDA Group Recognition Award
1991 FDA Cash Award
1990 FDA Commendable Service Award
1990 Foreign Research Fellowship awarded by the Japan Health Sciences Foundation

PROFESSIONAL SOCIETIES:

Regulatory Affairs Professional Society (Member 1995 - present)
  • 1995 - Biologics Editor of RAPSNews
  • 1996 - Member of Educational Program Planning Committee
Parenteral Drug Association
International Association for Biologicals
IInternational Society for Cellular Therapy

RECENT CONFERENCE/SYMPOSIUM PARTICIPATION/PRESENTATIONS

October 2006 Biologics Track Chair for the 2006 RAPS Annual Conference
May 2006 American Society of Gene Therapy (ASGT) meeting
January 2006 Phacilitate Cell and Gene Therapy Meeting
October 2005 RAPS 2005
September 2005 PDA/FDA Joint Regulatory Conference
July 2005 Trade Mission to the Czech Republic & Polland
June 2005 BIO 2005
November 2004 MEDICA Trade Fair, Dusseldorf, Germany
October 2004 RAPS Annual Meeting 2004
September 2004 Jetro BioMission, BioJapan 2004, Tokyo, Japan
September 2004 PDA/FDA Joint Regulatory Conference
June 2004 BIO 2004
April 2004 RAPS mission to Russia
January 2004 Williamsburg BioProcessing Conference
October 2003 JETRO BioMission to Osaka
May 2003 ISCT 2003 Annual Meeting, Arizona
April 2003 Therapeutics Vaccine Meeting
October 2002 Presented lecture at 2002 Virginia Biotechnology Summit and Governor's Conference, October 2002, McLean, VA.
September 2002 Presented lecture at 2002 PDA/FDA Joint Regulatory Conference, September 23-25, 2002, Washington, DC.
May 2002 Presented GTP lecture at Second Annual 2002, Somatic Cell Therapy Symposium, May 3-5, 2002, Sanibel Island, FL
April 2002 Presented lecture at FDLI 45th Annual Educational Conference, April 15-16, 2002, Washington, DC.
June 2001 Presented lecture at FDLI's "The Changing Environment of Biologics," June 13-14, 2001. Washington, DC.
October 1999 Presented lecture at RAPS Annual Conference & Exhibition 1999, October 3-6, 1999, Washington, DC.
May 1998 Presented lecture at the ACS meeting, Chicago, May 28-30, 1998
April 1998 Organized and presented at the RAPS Biologics Workshop, April 20-22, Washington, D.C.
November 1997 Presented a lecture at the IBC Vaccine meeting, Washington, DC
June 1997 Presented a lecture at the Bio’97 meeting, Houston
May 1997 Organized and presented at the annual RAPS Biologics Workshop, Boston
May 1997 Presented a lecture at the annual ACS meeting, Chicago
April 1997 Presented a lecture entitled "Achieving successful approvals and marketing privileges in a "Global" Regulatory Environment" at a Conference on Vaccines sponsored by the Institute for International Research, Alexandria
January 1997 Lectured at an in-house course on Drug Development presented by the Pharmaceutical Education and Research Institute (PERI) - San Francisco
October 1996 Presentation scheduled entitled "Regulatory Aspects in the Development, Manufacturing, and Use of Biological Products" at the ACS/AAPS meeting, Chicago
March 1996 Member of the Program Committee for the RAPS Advanced Regulatory Briefing for Biologics/Biotechnology, Waltham, MA
January 1996 Presented a lecture entitled " Regulatory Reforms - Concerns of an ex-Regulator" at the DIA 4th Annual Biotechnology Meeting, Jan 28-30, Newport Beach, CA
October 1995 Presented three lectures (Biologics, ELA, & CMC issues) at the 1995 ISPE meeting, Boston, MA (Oct 9-11)
September 1995 Organized and presented at two sessions (INDs/PLAs, Vaccines) at the RAPS Annual Meeting, September 1995, Washington, DC
May 1995 Organized a presentation at the RAPS Annual Biologics Approval Workshop entitled "Chemistry, Manufacturing and Controls, Analytical Procedures and Stability", Washington DC
January 1995 Chaired a session at the 1995 BioEAST meeting entitled "Preclinical Regulatory Issues for Biological Products".
December 1994 Developed a course entitled "Regulation of Biologics: CBER Policies and Expectations" for the Center for Continuous Education. Presented Dec 1994 - San Diego; March 1995 - Boston; Nov 1995 - San Francisco; April 1996, Alexandria, VA; December 1996, San Diego; July 1997 – Alexandria; San Diego, April 1998
September 1994 Organizer of Biologics Workshops I/II/III at RAPS 18th Annual Conference and Exhibition, Washington, DC
June 1994 Presentation at the BioWEST/BioPacifica '94 conference on "Strategies for Changing Manufacturing Processes", San Diego, CA.
January 1994 Presentation at BioEAST '94 entitled "PLA/ELA: Hints on Better Submissions"
December 1993 Developed and presented a course entitled "Preparing the Technical Sections for Recombinant INDs and PLAs (with special focus on E. coli products)" for the Center for Professional Advancement, East Brunswick, NJ.

BIBLIOGRAPHY:

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, CRC Press. Chapter: Biologics (2003) Kenimer and Jessop.
Hershman, J. M., W. R. Starnes, J. G. Kenimer and R. A. Patillo. Human Chorionic Thyrotropin, In Proceedings of the IV International Congress on Endocrinology, (ed) R. O. Scow. Exerpta Medica, Amsterdam, (1972).
Kenimer, J. G., J. M. Hershman and H. P. Higgins. The Thyrotropin in Hydatidiform Moles is Human Chorionic Gonadotropin. J. Clin. Endocrinol. Metab. 40, 482 (1975).PDF
Kenimer, J. G., L. G. Young and D. P. Groth. Purification and Properties of Rat Liver Adenine Phosphoribosyltransferase. Biochem. Biophys. Acta 384, 87 (1975).PDF
Higgins, H. P., J. M. Hershman, J. G. Kenimer, R. A. Patillo, T. A. Bayley and P. Walfish. The Thyrotoxicosis of Hydatidiform Mole. Ann. Intern. Med. 83, 307 (1975).PDF
Hershman, J. M., J. G. Kenimer, H. P. Higgins and R. A. Patillo. Placental Thyrotropin. In Perinatal Thyroid Physiology and Disease, (ed) D. A. Fisher and G. N. Burrow. Raven Press, New York (1975).PDF
Hershman, J. M., J. G. Kenimer, A. Kojima and R. L. Saunders, Assay of Thyroid Stimulating Hormone. In Hormones in Plasma, Vol. II, (ed) H. Antoniades, Exerpta Medica, Amsterdam (1976).
Horger, III, E. O., J. G. Kenimer, M. Azukizawa, J. M. Hershman, P. C. Kansal and A. B. Leaming. Failure of Triiodothyronine to Prevent Propylthiouracil-induced Hypothyroidism and Goiter in Fetal Sheep. Obstet. Gynecol. 47, 46 (1976).PDF
Kenimer, J. G., V. Goldberg and M. Blecher. The Endocrine System: Interaction of Prostaglandins with Adenylyl Cyclase-Cyclic AMP Systems. In The Prostaglandins, Vol III, (ed) P. W. Ramwell, Plenum Press, New York (1977).PDF
Groth, D. P., L. G. Young and J. G. Kenimer. Adenine Phosphoribosyl-transferase from rat liver. In Methods in Enzymology, Vol LI, (eds) P.A. Hoffee and M. E. Jones, Academic Press, New York.
Nirenberg, M., S. Wilson, H. Higashida, J. Thompson, G. Eisenbarth, F. Walsh, A. Rotter, J. Kenimer and S. Sabol. Synapse Plasticity. Pontificiae Academiae Scientiarium Scripta Varia 45, 123 (1978).PDF
Kenimer, J. G. and M. Nirenberg. Desensitization of Adenylate Cyclase to Prostaglandin E1 or 2-Chloroadenosine. Mol. Pharm. 20, 585 (1981).PDF
Kenimer, J. G. Desensitization of PGE1 receptors in Neuroblastoma-Glioma Hybrid Cells. Prostaglandins 23, 311 (1982).PDF
McGee, R. and J. G. Kenimer. The Effects of Exposure to Unsaturated Fatty Acids on Opiate Receptors, Prostaglandin E1 Receptors and Adenylate Cyclase Activity of Neuroblastome X Glioma Hybrid Cells. Mol. Pharm. 22, 360 (1982).PDF
Alleva, J. J., J. G. Kenimer, A. W. Jordan and C. Lamana. Induction of Estrogen and Progesterone Receptors and Decidualization in the Hamster Uterus by Cholera Toxin. Endocrinology 112, 2095 (1983).PDF
Habig, W. H., J. G. Kenimer and M. C. Hardegree. Retrograde Axonal Transport of Tetanus Toxin: Toxin Mediated Antibody Transport. In Frontiers in Biochemical and Biophysical Studies of Proteins and Membranes, (ed) T. Y. Liu, et al., Elsevier, New York (1983).PDF
Kenimer, J. G., W. H. Habig and M. C. Hardegree. Monoclonal Antibodies as Probes of Tetanus Toxin Structure and Function. Infect. Immun. 42, 942 (1983).PDF
Nirenberg, M., S. P. Wilson, H. Higashida, A. Rotter, K. Kruger, N. Busis, R. Ray, J. G. Kenimer, M. Adler and H. Fukui. Synapse Formation by Neuroblastoma Hybrid Cells. In: Cold Spring Harbor Symposia on Quantitative Biology, Vol. XLVII: Molecular Neurobiology. Cold Spring Harbor Laboratory (1983).PDF
Nirenberg, M., S. P. Wilson, H. Higashida, A. Rotter, K. Kruger, N. Busis, R. Ray, J. G. Kenimer and M. Adler. Modulation of Synapse Formation by Cyclic Adenosine Monophosphate. Science 222, 794 (1983).PDF
Dickson, J. G., H. M. Prentice, J. G. Kenimer and F. W. Walsh. Identification and Characterization of Neuron-Specific and Developmentally Regulated Gene Transcripts in the Chick Embryo Spinal Cord. J. Neurochem. 46, 787 (1986).PDF
Burns, D. L., J. G. Kenimer and C. R. Manclark. Role of the A Subunit of Pertussis Toxin in Alteration of Chinese Hamster Overy Cell Morphology. Infect. and Immun. 55, 24 (1987).PDF
Brennan, M. J., J. L. David, J. G. Kenimer, and C. R. Manclark. Lectin-like Binding of Pertussis Toxin to a 165 kDa Chinese Hamster Ovary Cell Glycoprotein. J. Biol. Chem. 263, 4895 (1988).PDF
Habig, W. H., E. A. Neale, J. G. Kenimer, K. A. Groover, J. A. Halpern, and M. C. Hardegree. Properties of a Unique Monoclonal Antibody Against Tetanus Toxin. Proceedings of the Eighth International Conference on Tetanus, p 66-70, Pythagora Press., Rome (1989).PDF
Inoue, K. and J. G. Kenimer. Muscarinic Stimulation of Calcium Influx and Norepinephrine Release in PC12 Cells. J. Biol. Chem. 263, 8157 (1988).PDF
Kenimer, J. G., J. Kim, P. G. Probst, C. R. Manclark, D. G. Burstyn, and J. L. Cowell. Monoclonal Antibodies to Pertussis Toxin: Utilization as Probes of Toxin Function. Hybridoma 8, 37 (1989)PDF
Kim, K. J., W. N. Burnette, R. D. Sublett, C. R. Manclark and J. G. Kenimer. Epitopes on the S1 Subunit of Pertussis Toxin Recognized by Monoclonal Antibodies. Infect. and Immun. 57, 944 (1989).PDF
Thompson, J., G. Dickson, S. E. Moore, H. J. Gower, W. Putt, J. G. Kenimer, and F. S. Walsh. Alternative Splicing of the Neural Cell Adhesion Molecule (N-CAM) Gene Generates Varient Extracellular Domain Structure in Skeletal Muscle. Genes and Development 3, 348 (1989).PDF
Chandler, D. K. F., L. D. Olson, J. G. Kenimer, P. G. Probst, S. Rottem, M. W. Grabowski, and M. F. Barile. Biological Activities of Monoclonal Antibodies to Mycoplasma pneumoniae Membrane Glycolipids. Infect. and Immun. 57, 1131 (1989).PDF
Takashima, Akihiko and J. G. Kenimer. Muscarinic-Stimulated Norepinephrine Release and Phosphoinositide Hydrolysis in PC12 Cells are Independent Events. J. Biol. Chem. 264, 10654 (1989).PDF
Kaslow, Harvey R., J. D. Schlotterbeck, and J. G. Kenimer. Monoclonal Antibodies that Inhibit the ADP-Ribosyltransferase but not the NAD-Glycohydrolase Activity of Pertussis Toxin. Infect. and Immun. 58, 746 (1990)
Leininger E., J. G. Kenimer, and M. J. Brennan. Surface Proteins of Bordetella pertussis: Role in Adherence. In. Manclark, C. R. (ed). Proceedings of the Sixth International Symposium on Pertussis. Department of Health and Human Services, United States Public Health Service, Bethesda, Maryland. DHHS Publication Np. (FDA) 90-1194.PDF
Ewanowich C. A., E. Leininger, J. G. Kenimer, and M. S. Peppler. Mechanisms of Bordetella pertussis Invasion of HeLa 229 Cells. In. Manclark, C. R. (ed). Proceedings of the Sixth International Symposium on Pertussis. Department of Health and Human Services, United States Public Health Service, Bethesda, Maryland. DHHS Publication Np. (FDA) 90-1194.PDF
Leininger, E., M. Roberts, J. G. Kenimer, I. G. Charles, N. Fairweather, P. Novotny, and M. J. Brennan. Pertactin (P69) an Arginine-Glycine-Aspartic Acid-containing Bordetella pertussis Protein that Promotes Adherence to Mammalian Cells. Proc. Natl. Acad. Sci. USA 88, 345 (1991).PDF
Kenimer, J. G., P. G. Probst, A. B. Karpas, D. L. Burns, and H. R. Kaslow. Monoclonal Antibodies Against the Enzymatic Subunit of Both Pertussis and Cholera Toxins. Develop. Biol. Standard. 73, 113-141 (1991).PDF
Myojo, Y., K. Inoue, J. G. Kenimer, and H. Higashida. Phosphoinositide-Dependent Ion Channels and Secretion in Neuron-like Cells. In Protein, Nucleic Acid and Enzyme, Supplement 36, No. 3: Phospholipid Metabolism and Pathological Condition in Animal Cells, 615-619 (1991) Kyoritsu, Tokyo, Japan (Japanese).
Leininger, E., C. A. Ewanowich, A. Bhargave, M. S. Peppler, J. G. Kenimer, and M. J. Brennan. Comparative Roles of the Arg-Gly-Asp Sequence Present in the Bordetella pertussis Adhesins, Pertactin and Filamentous Hemagglutinin. Infect. and Immun. 60, 2380 (1992).PDF
Leininger, E., P. G. Probst, M. J. Brennan, and J. G. Kenimer. Inhibition of Bordetella pertussis filamentous hemagglutinin-mediated cell adherence with monoclonal antibodies. FEMS Microbiology Letters 106, 31 (1993). PDF, HTML
Takashima, A. and J. G. Kenimer. Regulation of muscarinic stimulation of norepinephrine release and PI hydrolysis during cell growth in PC12 cells. Neurosci. Letters (In press).PDF
Araki, T., J. G. Kenimer, A. Nishimune, H. Sugiyama,R. Yoshimura, and H. Kiyama. Identification of the metabotropic glutamate receptor-1 protein in the rat trigeminal ganglion. Brain Research 627, 341 (1993)PDF
Shah, D.N., and J. G. Kenimer. Product License Applications (PLAs) and Establishment License Applications (ELAs) for Biological Products. In Encyclopedia of Pharmaceutical Technology, Volume 13 (ed) J. Swarbrick and J. C. Bolan. Marcel Dekker, Inc., New York (1995).
Kenimer, J.G. Vaccines: current regulatory issues. Current Opinion in Biotechnology 8: 357-360 (1997)PDF
Kenimer, J.G. PDUFA, REGO and Other Regulatory Reforms: Current and Future Impact on CBER. Regulatory Affairs Focus, Vol 2, Issue 11: 17-19 (1997)

 
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