Dr. Jerry Calver's Profile
The following profile has been divided into several categories: Education, Employment, Career Highlights, Recent Publications and Articles, and Special Career Awards. Click on the appropriate heading above or return to the home page.
Honours Bachelor of Science in Biochemistry (1971) Return to top of page or to home page. President of Calver Biologics Consulting Inc. - January 2003 to Present Professor for the University of Ottawa - January 2005 to April 2005 Acting Chief Vaccines - June 2002 to December 2002; July 2001 to November 2001; November 1999 to March 2000 Head, Bacterial and Parasitological Vaccines - June 1996 to June 2002 Head Pertussis and Neisseria - 1989 to June 1996 Biologist - 1971 to 1989 Return to top of page or to home page. 1. Carded inspector; conducted inspections of biological/vaccine manufacturing facilities both national and international; including the following facilities:
2. Reviewed Chemistry and Manufacturing sections of drug submissions; IND, SND, NDS and NC’s for bacterial vaccines, some viral vaccines and biotherapeutics. Involved in the review, licensing and inspection of the following: Whole Cell Pertussis Vaccines Haemophilus influenzae b Conjugate Vaccines Meningococcal Polysaccharide and Conjugate Vaccines Pneumococcal Polysaccharide and Conjugate Vaccines Oral Vaccines, Viral Vaccines and Therapeutics 3. Organized, designed and managed the lot by lot release, laboratory testing program for bacterial vaccines for both the domestic and for the World Health Organization market; reviewed in-house test results and manufacturer’s certificates of analysis. Established alternate non-lethal endpoints for pertussis potency assay in mice, diphtheria and tetanus toxoid potency assays in guinea-pigs and botulinum toxin toxicity assay in mice. 4. Developed and presented five day training courses on Lot Release of Vaccines and Laboratory Access as part of the Global Training Network of the World Health Organization (WHO); sessions in Ottawa in 1999 and 2000; one in Armenia in 2000. The course is designed to provide trainees from WHO regions with an understanding of the lot release system for bacterial and viral vaccines, including the reasons for lot release of vaccines, procedural requirements and guidelines, the protocol review process, the requirement for testing, the characteristics required for a testing laboratory and the options available for external testing. Protocol review and testing requirements as according to WHO summary protocols are discussed for pertussis, tetanus toxoid, combination vaccines, Haemophilus b conjugate vaccines, measles and oral polio vaccines. 5. Participated with WHO in a two person mission to Islamabad, Pakistan, in June, 2000 to assess the vaccine control activities of the National Control Authority/ National Control Laboratory for Vaccines in Pakistan; presented the Lot release and Lab Access course to a select group of National Control Laboratory members, inspectors and government producers of vaccines. 6. Participated as the expert in bacterial vaccines for Bureau of Biologics (Health Canada) task force to the Ukraine (two separate visits, 1997 and 1999) to provide advice on the establishment of a vaccine control agency; provided advice and laboratory training to visiting scientists and technical staff from the Ukraine. 7. Participated as a member of an expert team for PAHO which visited Brazil in 1996 for evaluation of a vaccine manufacturer, Institut Butantan. Return to top of page or to home page. 1. "Implementation of the 3 Rs in Regulatory Testing of Vaccines in Canada" G. A. Calver. Refer to “Advancing Science and Elimination of the Use of Laboratory Animals for Development and Control of Vaccines and Hormones” Dev Biol. Basel Karger, 2002 vol. 111: 211-216. 2. “The International Symposium on Regulatory Testing and Animal Welfare: Recommendations on Best Scientific Practices for Biologicals: Safety and Potency Evaluations” K. Cussler, J. Kulpa and J. Calver, ILAR Journal, Vol 43, Supplement, 2002. 3. “Vaccine Regulation in Canada” G. A. Calver. At World Vaccine Congress, Montreal, Canada, April, 2002. 4. “Quality Evaluation of Biologics” G. A. Calver. At University of Ottawa, Canada, March, 2002. 5. “A Quantitative Analysis for the ADP-ribosylating Activity of Pertussis Toxin: An Enzymatic-HPLC Coupled Assay Applicable to Formulated Whole Cell and Acellular Pertussis Vaccine Products” Allan J. Menzies, Terry Cyr, Jerry Calver and Larry W. Whitehouse. Biologicals, 2001, 29: 81-95. 6. Presentation of “Implementation of the 3 Rs in Regulatory Testing of Vaccines in Canada” G. A. Calver. At the IABS meeting “Advancing Science and Elimination of the Use of Laboratory Animals for Development and Control of Vaccines and Hormones” November 13, 2001, Utrecht, The Netherlands. 7. Presentations by G. A. Calver: “Pertussis Toxin Quantitative Analysis: An Enzymatic-HPLC Coupled Assay Applicable to Formulated Whole Cell and Acellular Pertussis Vaccine Products” and “Humane End-point for Pertussis Potency assay” at the Ad Hoc WHO Working Group on Pertussis Vaccines. Bethesda, Maryland, November 12, 2000. 8. “Tetanus and Diphtheria Vaccines Potency Testing in Canada” G. A. Calver. Proceedings of the Symposium “Tetanus Vaccines for Human Use” Pharmeuropa, Special Issue, October 2000. 9. “The effect of detergents in the size exclusion chromatographic method for the separation and identification of acellular pertussis vaccine components” M. Girard, B. Simmons, N. Drouin and G. Calver. At the 14th symposium of the protein society, August, 2000, San Diego, California. 10. Presentation of “Tetanus and Diphtheria Vaccines Potency Testing in Canada” G. A. Calver. At the Symposium “Tetanus Vaccines for Human Use” June 23, 2000. 11. “Acellular Pertussis Vaccines: Neutralization by Immune Sera of the Lethality of Pertussis Toxin and Viable Bordetella pertussis for Chick Embryos” G. A. Calver. Biologicals, 1999, 27: 143-147. 12. Poster Presentation. “Enhancing Laboratory Animal Well Being Through Refinement by Establishing Non-lethal End-points in Regulatory assays of Certain Biologicals” Gerald Calver, Josefina Gavieres, Nazar Shakarchi and Pierre Thibert. Third World Congress on Alternatives and Animal Use in the Life Sciences. August 29, 1999, Bologna, Italy. 13. “Pertussis toxin quantitative analysis: an enzymatic-HPLC coupled assay applicable to formulated whole cell and acellular pertussis vaccine products” A J Menzies, T Cyr, J Calver and L Whitehouse. At the 1st International Symposium on Separations in the Biosciences, Amsterdam, The Netherlands, March, 1999. Return to top of page or to home page. 1. Assistant Deputy Minister, Health Products and Food Branch, Award of Certificate of Appreciation, March 2002, “In recognition of exceptional contribution to the expedited review of meningitis vaccine 2001". 2. Government Merit Award received in 1991 for an Exceptional and Distinguished Contribution to the Effectiveness and Efficiency of the Public Service. Return to top of page or to home page. |