lance gordon cv 03042015

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Lance K. Gordon, Ph.D. CURRICULUM VITAE Date of Birth : December 11, 1947 Place of Birth : Chicago, Illinois Marital Status : Married Home Address : 13961 SE 7 th Street Home Telephone: (425) 429-3944 Bellevue, WA 98005 Mobile: (650) 438-9808 Email: [email protected] Employment History Director Neglected Infectious Diseases, Bill & Melinda Gates Foundation; 2011-2015 President and CEO, ImmunoBiologics Corp.; 2007-2011 President and CEO, VaxGen, Inc., (NASDQ); 2001-2007 Executive Director North America, Acambis plc (LSE); 1999- 2001 President and CEO, OraVax, Inc. (NASDQ):1990-1999 CEO, North American Vaccine, Inc. (AMEX): 1988-1990 Associate Director, Clinical Pharmacology, E. R. Squibb: 1987-1988 Director Vaccine R & D, Connaught Laboratories Ltd.; 1983- 1987 Immunology Section Head, Connaught Laboratories Inc.; 1980- 1983 Professional Affiliations Member, United States National Vaccines Advisory Committee (NVAC), Department of Health and Human Services: 2005 - 2009 1

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Page 1: Lance Gordon CV 03042015

Lance K. Gordon, Ph.D.

CURRICULUM VITAE

Date of Birth: December 11, 1947Place of Birth: Chicago, IllinoisMarital Status: MarriedHome Address:

13961 SE 7th Street Home Telephone: (425) 429-3944Bellevue, WA 98005 Mobile: (650) 438-9808

Email: [email protected] Employment History

Director Neglected Infectious Diseases, Bill & Melinda Gates Foundation; 2011-2015

President and CEO, ImmunoBiologics Corp.; 2007-2011

President and CEO, VaxGen, Inc., (NASDQ); 2001-2007

Executive Director North America, Acambis plc (LSE); 1999-2001

President and CEO, OraVax, Inc. (NASDQ):1990-1999

CEO, North American Vaccine, Inc. (AMEX): 1988-1990

Associate Director, Clinical Pharmacology, E. R. Squibb: 1987-1988

Director Vaccine R & D, Connaught Laboratories Ltd.; 1983-1987

Immunology Section Head, Connaught Laboratories Inc.; 1980-1983

Professional Affiliations

Member, United States National Vaccines Advisory Committee (NVAC), Department of Health and Human Services: 2005 - 2009

Member, NVAC Working Group on Vaccine Finance, 2006 – 2009Member, NVAC Working Group on Adolescent Vaccines, 2006 – 2008Member, NVAC Subcommittee on New Vaccines and Supply, 2005 – 2008

Member, NVAC Vaccine Safety Working Group, 2008 – 2011

Vaccine Saftey Working Group; Chair Epidemiology & Surveillance SubGroup

Member, Sabin Vaccine Institute, Board of Trustees: 2003 – 2011Chairman, Compensation and Conflict Committee, 2007 – 2011

Member ImmunoRegen Biosciences Board of Directors, 2007 – 2011Chairman, Audit Committee, 2008 – 2011

Member, Meningitis Vaccine Project, Expert Panel, WHO and PATH: 1999 – present

Consultant to the Canadian HIV Vaccine Initiative (CHVI); 2008 - 2009

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Lance K. GordonAdjunct Associate Professor, McMaster University, Hamilton, Ontario,

1984 – 1987

Member, American Association of Immunologists; current

Member, American Society for Microbiology; current

Member, American College of Clinical Pharmacology; inactive

Member, International Association of Biological Standardization;

inactive

Education

B.A. Zoology; 1973, University of California at Humboldt

Ph.D. Biomedical Science, Immunology; 1978, University of

Connecticut, Farmington Medical Center, Pathology Department,

Farmington, Connecticut

Postdoctoral fellowship, 1978-1980, Washington University School of

Medicine, Department of Intenal Medicine, St. Louis, Missouri

Continuing professional education

The UCLA Anderson, Director’s Training and Certification Course, 2006The Karrass course on effective negotiating, 1983, 1995, 2005Multiple courses in project management, ~ 1982, 1995, 2003The Harvard Law School course on negotiation, ~ 1998AMA’s Course for Presidents and CEOs, ~ 1996Financial Management for Non-financial Managers, ~ 1985AMA course on Management and Motivation, ~ 1983

Work Experience

2011-2015; Director Neglected Infectious Diseases, Bill & Melinda Gates Foundation

Dr. Gordon joined the Global Health Program of the Bill & Melinda Gates Foundation in 2011. During his tenure as Director Neglected Infectious Diseases (NID), the team developed and implemented strategies addressing a portfolio of infectious diseases of the poor. These included Dengue, Japanese Encephalitis, Human Papilloma Virus, Rabies, Guinea Worm, Human African Trypanosomiasis, Visceral Leishmaniasis, Schistosomiasis and the Soil Transmitted Helminths. The strategies encompassed investments and partnerships in drugs, vaccines, diagnostics, vector control, operational

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Lance K. Gordonresearch, advocacy and policy development. The NID team led creation of the London Declaration on Neglected Tropical Diseases, a multi-sector public / private partnership supporting global efforts to control or eliminate a group of 10 Neglected Tropical Diseases. The team also helped a Chinese-manufacturer successfully achieve WHO prequalification for its Japanese Encephalitis vaccine, the first Chinese pharmaceutical product to receive WHO prequalification. NID investments in The Carter Center’s Guinea Worm Eradication Program contributed to a 93% decrease in the number of cases annually (1794 in 2010 vs. 126 in 2014). In HPV the foundation’s NID team made investments in improving the coverage of both preventive vaccines and cervical cancer screening and preventive treatment programs. These investments include funding WHO’s process to update their guidance to NRAs regarding recommended requirements for licensure of new vaccines, investing in the development of lower cost HPV vaccines to facilitate coverage of the poor and evaluating innovative delivery strategies to increase the coverage of cervical cancer screening and preventive treatment programs.

2007 – 2011; President & CEO, ImmunoBiologics Corporation

Dr. Gordon was the founding President and Chief Executive Officer of ImmunoBiologics Corporation. ImmunoBiologics Corporation, (IBC), was incorporated to commercially develop new and replacement vaccines and immunobiologic products for human infectious diseases. IBC’s first initiative was to establish commercial manufacture of halal vaccines in Malaysia. IBC (Malaysia) had an established relationship with a major vaccine manufacturer in India for the supply of halal bulk antigens as vaccine intermediates. IBCM had arranged for formulation / fill / finish services with an established pharmaceutical company in Malaysia having a major focus on halal pharmaceuticals. The Malaysian partner’s filling facility was constructed and commissioned specifically for halal vaccines. It had already been inspected by the Malaysian NRA and approved for vaccine manufacture. IBCM’s plans for completing development through licensure were reviewed in advance by the Malaysian regulatory authority. The Malaysian NRA advised the company that its plans for manufacture and development seemed appropriate and consistent with international standards . IBCM’s interational marketing partner has already received an advance purchase commitment for the first one million doses of product once licensed. IBCM planed to develop facilities for primary manufacture of additional vaccines in Malaysia.

2001 – 2007; President & CEO, VaxGen, Inc.

Dr. Gordon was the President and Chief Executive Officer, and a member of the Board of Directors of VaxGen, Inc., a NASDQ listed company.

During his tenure Dr. Gordon was responsible for:

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Lance K. Gordon Recomposing the Board of Directors and Executive Management team.

The completion of two multinational phase 3 clinical studies of an investigational AIDS vaccine in approximately 8,000 subjects. These studies were conducted in the United States, Europe and Thailand.

Expanding the Company’s portfolio of product development initiatives to include vaccines for Neisseria meningitides group B, Clostridium difficile, a recombinant anthrax vaccine and monoclonal antibody as well as an attenuated smallpox vaccine.

The creation of a contract manufacturing subsidiary, Celltrion Inc., in South Korea. VaxGen realized approximately $150 million revenue, net of investments, expenses and fees, through the creation of Celltrion.

The expansion of VaxGen’s staff from approximately 85 to 300 including the de novo creation of cGMP Manufacturing and Quality Affairs departments as well as a significantly expanded Regulatory Affairs department.

The award of two contracts to VaxGen by the US National Institutes for Allergy and Infectious Diseases for the development of the Company’s recombinant anthrax vaccine. VaxGen realized revenue of approximately $101 million through these NIAID contracts awarded in 2002 and 2003. These contracts were awarded after an open competitive process.

The award to VaxGen in 2004 of a contract for the supply of 75 million doses of its recombinant anthrax vaccine for civilian biodefense by the newly created DHHS Office of Public Health Emergency Preparedness. This contract was valued at $875.5 million with options for expansion to approximately $950 million.

The creation of a VaxGen owned and operated cGMP manufacturing facility in South San Francisco, California. This facility was created for pilot and commercial manufacture of bacterial and mammalian cell culture biologic products. Subsequent to the award of the first of the Company’s anthrax contracts the facility was developed adequate to product up to 50 million doses of Bulk Drug Substance for VaxGen’s anthrax vaccine annually.

The creation of a partnership with the Chemo-Sero Therapeutic Research Institute (Kaketsuken) of Kumamoto, Japan, for the US and international development of an attenuated smallpox vaccine. This product was already licensed and marketed in Japan. VaxGen completed preclinical studies of the vaccine in the USA, including non-human primate safety and disease challenge studies. VaxGen also completed a phase I/II clinical study in the USA under IND. A new

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Lance K. Gordonlarge scale manufacturing facility was created in Kumamoto, Japan to supply the US market.

Multiple public and private equity financing rounds were completed from 2001 through 2006. These financings were principally managed by the investment banks CIBC and Punk Ziegel. From 2001 through 2006 VaxGen raised over $100 million in equity capital. During this time the Company’s market capitalization exceeded $400 million.

Revenues, excluding equity financing, were over $250 million during 2001 through 2006.

1990 - 2001; President & CEO, OraVax, Inc., Director North America, Acambis plc

Dr. Gordon was the founder, President, Chief Executive Officer and a member of the Board of Directors of OraVax Incorporated, from its inception in 1990 though its acquisition by Peptide Therapeutics Group plc in May of 1999. From May of 1999 through February of 2001 Dr. Gordon continued as Executive Director of North American operations for Peptide Therapeutics Group and as a member of its UK Board of Directors. In December of 2000 Peptide Therapeutics was renamed Acambis plc and OraVax was renamed Acambis Inc.

During his tenure Dr. Gordon was responsible for:

The creation of a company engaged in the development of vaccines and monoclonal antibodies for the treatment or prevention of human infectious diseases. Active projects at OraVax included viral vaccines for the prevention of Japanese Encephalitis, Dengue, Yellow Fever, West Nile, and smallpox as well as bacterial vaccines for Helicobacter pylori, and Clostridium difficile. The company also developed a candidate prophylactic monoclonal antibody for RSV. These candidate products were in various stages of development from pre-clinical through phase 3 during Dr. Gordon’s tenure. Subsequent to Acambis’ acquisition by Sanofi the Japanese Encephalitis and smallpox vaccine candidates have been successfully licensed. The dengue vaccine candidate, a ChimerivaxTM construct initiated at OraVax, has also been developed by Sanofi through successful completion of two phase III efficacy studies. In 2013 Sanofi advanced the Clostridium difficile vaccine candidate into a phase III efficacy study.

OraVax completed multiple rounds of venture capital financing with consistent increases in valuation, generating over $80 million in working capital.

OraVax successfully completed an IPO, lead managed by DLJ and co-managed by Cowen in 1995. A public secondary financing was also completed in 1997, lead managed by Cowen and co-managed by DLJ. Market capitalization exceeded $450 million.

Growing the Company’s staff from inception to over 250. This included R&D, clinical, regulatory, manufacturing, quality and finance departments.

The creation and management of a joint venture with Pasteur Merieux Connaught (now Sanofi Pasteur). The joint venture was for the development of vaccines against

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Lance K. GordonHelicobacter pylori and Hepatitis C. OraVax received approximately $140 million in funding from PMC.

The creation of multiple corporate partnerships with companies including Pasteur Merieux Connaught, Aventis Pasteur, Medeva, CSL, BioReliance, Baxter Healthcare and Virus Research Institute.

Multiple CRADAs including one with the Walter Reed Army Institute of Research for development of vaccines for enterotoxigenic E. coli and a second with WRAIR relating to the shared use of the WRAIR cGMP pilot plant at Forrest Glen, Maryland.

The creation of a partnership with Aventis Pasteur for the development of vaccines against dengue virus. This agreement included $27 million in R&D funding to OraVax and a significant royalty. The dengue vaccines were based on OraVax’s proprietary ChimeraVax technology.

The merger of OraVax with Peptide Therapeutics of Cambridge, UK in 1999. Alex Brown investment bank represented OraVax in the transaction. A £ 40 million financing was completed on the LSE in 1999 on the strength of the business combination.

In 1999, the award by the US Centers for Disease Control of a contract to OraVax for the development of a cell culture manufactured smallpox vaccine. This contract was initially for the development through licensure and supply of 40 million doses of finished product and was valued at $347 million. Subsequent to 9/11 the contract was increased to include supply of over 200 million doses of vaccine. Acambis realized revenues in excess of $750 million and FDA license was granted in 2007.

1988 – 1990; CEO, American Vaccine Corp., North American Vaccine, Inc.

Dr. Gordon was the founding Chief Executive Officer of North American Vaccine, Inc., and a member of its Board of Directors. As the result of mergers and acquisitions during his tenure the Company was variously known as Selcore Laboratories, American Vaccine Corporation and North American Vaccine, Inc.. The Company’s primary objective was the development, through manufacture, licensing and marketing, of a new vaccine for the prevention of pertussis infections (whooping cough). Exploratory research was conducted on bacterial conjugate vaccines. The Company was subsequently acquired by Baxter Healthcare.

During his tenure Dr. Gordon was responsible for:

Converting seed debt financing into equity. Completing the initial private financing of Selcore Laboratories.

Developing the Company’s operations in Laurel and Beltsville, Maryland and a staff of approximately 70 engaged in research development and pilot manufacture.

Directly handled regulatory affairs as Responsible Head.

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Lance K. Gordon Completed a reverse merger with a public shell corporation, OVEX Fertility Corporation

which provided the Company, subsequently known as American Vaccine Corporation, with approximately $4 million in cash and a NASDAQ listing.

Negotiating an agreement with the National Institute of Child Health and Human Development under which the NICHD would conduct a Phase 3 pivotal trial of the Company’s acellular pertussis vaccine. Additionally the NICHD agreed to purchase supplies of the investigational vaccine from the Company. The trial was successful and the acellular pertussis vaccine, Certiva, was licensed by the US FDA in 1998.

A merger of American Vaccine Corporation with the ex-Canadian assets of BioChem Pharma in 1990. As a result of this merger the American Vaccine Corp acquired the non-Canadian rights to several licensed vaccines controlled by BioChem Pharma and the Company was renamed North American Vaccine to reflect its rights in these products.

Design, construction and commissioning of the Company’s cGMP manufacturing facility in Beltsville, Maryland. This facility was used for commercial manufacture of Bulk Drug Substance for its acellular pertussis vaccine.

Achieving a $270 million market capitalization on the AMEX exchange.

1987 - 1988: Associate Medical Director, E.R. Squibb & Sons

Dr. Gordon was the Associate Director for Infectious & Inflammatory Diseases, Clinical Pharmacology - Drug Medical Affairs at E. R. Squibb & Sons, Inc., Princeton, New Jersey. He was responsible for the design and implementation of clinical pharmacology programs for new drugs against infectious and inflammatory diseases, including phase I through early phase II clinical trials. Routine duties included the preparation of clinical protocols, implementation and monitoring of clinical studies, analysis of results and preparation of final reports for inclusion in New Drug Applications to the FDA. Active project areas included oral antibiotics (Aztreonam), an investigating lipid complex formulation of Amphotericin B (Fungizone), a topical steroid cream (Tipredane) and studies of a novel therapeutic agent in Rheumatoid Arthritis. He also designed clinical programs for anti-viral compounds and Platelet Activating Factor (PAF) inhibitors emerging from Squibb’s research. During his tenure Dr. Gordon completed training in clinical pharmacology and became a member of the American College of Clinical Pharmacologists.

1983 - 1987: Director, Bacterial & Viral Immunology Research, Connaught Laboratories Limited

Dr. Gordon was the Director, Bacterial and Viral Immunology Research, Connaught Research Institute, Connaught Laboratories Limited, Willowdale, Ontario, a Company with a 70 year operating history. Connaught was subsequently acquired by Pasteur Merieux and through mergers is now part of Sanofi Pasteur.

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Lance K. GordonDuring his tenure Dr. Gordon was responsible for:

All of the Company’s bacterial and viral vaccine research which included Bacteriology, Virology, Biochemistry, and Immunochemistry Research Laboratories as well as a fully equipped and staffed pilot plant for development and manufacture of vaccines for clinical use.

Active projects including acellular pertussis vaccines, the H. influenzae b conjugate vaccine, pediatric combination vaccines (DTP, DTaP, DTaP-Hib and DTaP-Hib-polio), gonorrhoea, a family of semi-synthetic conjugate vaccines and research on the respiratory viral pathogens, RSV and Parainfluenza.

Membership in the Research Project Management Committee, Conjoint Test Development Committee and MIS Advisory Committee

Continued responsibility as the project director for the H. influenzae b vaccine project in the U.S.

During 1986 he was responsible for the development of the Company’s five-year global strategic plan encompassing research, medical, manufacturing, sales and marketing.

He was project manager for Connaught Ltd’s Acellular Pertussis Vaccine Project from September 1983 until his departure in 1997. A monovalent Acellular Pertussis Vaccine was successfully developed and a Phase I clinical trial in 18 month olds completed. Phase II studies with the acellular vaccine formulated with diphtheria and tetanus toxoids (DTaP) were conducted in two month olds in Canada. Over 400 two month olds received three doses of the new trivalent vaccine. Clinical trials of this vaccine were conducted in the U.S. by NIH-NIAID investigators at Baylor Medical College. Clinical studies were also conducted of combinations of DTaP with the inactivated polio vaccine during Dr. Gordon’s tenure.

During each of his four years with Connaught Limited he won the Company’s prize for peer reviewed publications.

1980 – 1983; Immunology Section Head, Connaught Laboratories, Inc.

Dr. Gordon was the Immunology Section Head at Connaught Laboratories Inc., Swiftwater, Pennsylvania. Connaught Laboratories, Inc. was a wholly owned subsidiary of Connaught Laboratories Limited in Ontario, Canada. He was responsible for the development of new immunologic procedures as well as a variety of R&D activities. Activities of the Section included radioimmunoassay of animal and clinical trial sera, in-vivo immunologic function testing, and vaccine R&D. Specific projects included the company’s

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Lance K. Gordonmeningococcal, pertussis, viral influenza, H. influenzae b and veterinary projects.

During his tenure Dr. Gordon was responsible for:

The invention and development of the first bacterial conjugate vaccine to receive FDA licensure. The vaccine was shown to be safe and effective for the prevention of meningitis, bacteremia and epiglottitis in infants caused by Haemophilus Influenzae type b systemic bacterial infections. Initial patents for the vaccine were filed in 1981, with several US and international patents being awarded to the Company in succeeding years. Dr. Gordon was listed as sole inventor on the family of patents. The vaccine, marketed as ProHIBiT® was licensed by the US FDA in December of 1987.

As H. influenzae b Vaccine Project Director from inception of the project through licensure, Dr. Gordon’s responsibilities included coordinating all areas of product development; production, quality control, other sections of the research department, the medical department and marketing.

Dr. Gordon was directly responsible for the original research on the project, interacted with clinical investigators and regulatory agencies, prepared clinical protocols and regulatory submissions, and presented the results of preclinical and clinical studies at national and international meetings.

Development of a production process (pilot plant), scale-up, the preparation of vaccine lots for clinical trial, patent application, IND submission, and the initiation of clinical trials and their conduct.

Arranging for an NIAID-sponsored efficacy study which was conducted in approximately 3,000 Inuit infants in Alaska and a second, company sponsored study conducted in approximately 62,500 infants in Finland. Direct costs to Connaught for the Finish efficacy study were approximately $600,000, substantial resources were provided by the Finish National Health Institute at no cost.

Presentations to the Immunization Practices Advisory Committee (ACIP) and the Redbook Committee of the American Academy of Pediatrics which lead to a recommendation for universal use of the vaccine in all US infants 18 months through 6 years of age.

In the years following the license of the Connaught ProHIBiT® vaccine for the prevention of infant bacterial meningitis, similar Hib conjugate vaccines were licensed by other companies. The age of immunization was extended down to 2 months of age and it is estimated that over 99% of infants in the Americas are now immunized. The incidence of Hib infant meningitis has been reduced by an estimated 99.04% as the result of successful

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Lance K. Gordonimmunization campaigns. Hib conjugate vaccines are now widely used in Europe and South Africa and are finding their way into the poorest countries.

Education

Graduate Education

Ph.D. Biomedical Science, Immunology, University of Connecticut, 1978. The Immunology Program was in the Department of Pathology at the University's Medical School in Farmington, Connecticut. The formal course work for the program included the first year medical school curriculum and a year of course work in advanced immunology. Dr. Gordon’s minor specialty was molecular genetics. His major advisor in Connecticut was Irving Goldschneider, M.D.

Postdoctoral Training

Dr. Gordon completed a postdoctoral fellowship in the Department of Medicine, Division of Allergy and Immunology, Washington University School of Medicine, St. Louis, Missouri from 1978 until 1980.

During January 1978 to December 1980, he was an NIH fellow in the Division of Allergy and Immunology, Department of Medicine, Washington University Medical School, St. Louis, Missouri. His mentor was Charles W. Parker, M.D., Division Chief and Howard Hughes, Major Investigator.

Related Work Experience

1969 - 1971; Stanford University Medical School, Pathology Department, Stanford, California. Research technician for Irving L. Weissman, M.D.. As such he was involved in a variety of projects in cellular immunology.

1967 - 1969; O'Connor Hospital, San Jose, California, Pathology assistant. Duties: assist in surgical and autopsy pathology, general laboratory assistance.

PUBLICATIONS (not including publications by companies formed or managed)

1. Goldschneider I, Gordon LK, Morris RJ., Demonstration of Thy-1 antigen on pluripotent hemopoietic stem cells in the rat., J Exp Med. 1978 Nov 1;148(5):1351-66.

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Lance K. Gordon2. Ritter MA, Gordon LK, Goldschneider I., Distribution of identity of Thy-1-bearing cells during ontogeny in rat hemopoietic and lymphoid tissues., J Immunol. 1978 Dec;121(6):2463-71.

3. Gordon LK, Hamill B, Parker CW., The activation of blast transformation and DNA synthesis in human peripheral blood lymphocytes by wheat germ agglutinin., J Immunol. 1980 Aug;125(2):814-9.

4. Goffstein BJ, Gordon LK, Wedner HJ, Atkinson JP., Cyclic AMP concentrations in human peripheral blood lymphocytes. Changes in association with cell purification., J Lab Clin Med. 1980 Dec;96(6):1002-41.

5. Lance K. Gordon. A reliable method for repetitively bleeding rabbits from the central artery of the ear. J.Imm.Methods, 44:241, 1981.

6. Lance K. Gordon and Charles W. Parker: A micro-fluorometric assay for the measurement of de novo DNA synthesis in individual cells. J.Immunology, Vol. 127, October 1981.

7. Gordon LK, Parker CW., A microfluorometric assay for the measurement of de novo DNA synthesis in individual cells., J Immunol. 1981 Oct;127(4):1634-9

8. Co-author of Vaccines chapter for: Priorities in Biotechnology Research for International Development, page 67-86, 1982, National Academy Press, Washington, D.C.

9. Gordon, L.K. Characterization of a hapten-carrier conjugate vaccine. H.influenzae-diphtheria conjugate vaccine. In: Chanok, RM, Lerner, RL, Eds, Modern Approaches to Vaccines. Cold Spring Harbor Laboratory 393-396, 1984

10. Lepow, M.L., J. Samuelson, and L.K. Gordon: Safety and immunogenicity of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in adults. J.Infect.Diseases, Vol. 150:402-406, 1984.

11. Lepow, M.L., J. Samuelson, and L.K. Gordon: Safety and immunogenicity of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in infants 9-15 months: J.Pediatrics 106:185-189, 1985.

12. Gordon, L.K. 1984. Procedimiento para prepara un conjugado covalente de polisacarido / toxoide de difteria o tetano soluble en agua. Spanish Patent Office #523.905/2, 1984.

13. Gordon, L.K. 1984. Haemophilus influenzae b polysaccharide exotoxoid conjugate vaccine. Republic of South Africa, Patent Office #83/4939, 1984.

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Lance K. Gordon

14. Gordon, L.K. 1985. Haemophilus influenzae b polysaccharide exotoxoid conjugate vaccine. United States Patent #4,496,538, 1985, U.S. Patent Office.

15. Gordon, L.K. 1986. Haemophilus influenzae b polysaccharide exotoxoid conjugate vaccine. Swedish Patent Office #0098581, 1986.

16. Gordon, L.K. 1986. Haemophilus influenzae b polysaccharide exotoxoid conjugate vaccine. Canadian Patent #1 210 695, 1986.

17. Gordon, L.K. 1986. Polysaccharide exotoxoid conjugate vaccines. United States Patent #4,619,828, 1986, U.S. Patent Office.

18. Gordon, L.K. 1986. Haemophilus influenzae b polysaccharide exotoxoid conjugate vaccine. European Patent Office #0 098 581, 1986.

19. Gordon, L.K. 1987. Haemophilus influenzae b polysaccharide-diphtheria toxoid conjugate vaccine. United States Patent #4,644,059, 1987, U.S. Patent Office.

20. Eskola, J., H. Peltola, P.H. Makela, H. Kayhty, V. Karanko, J. Samuelson, L.K. Gordon. Antibody levels achieved in infants by course of Haemophilus influenzae type b polysaccharide/diphtheria toxoid conjugate vaccine. The Lancet, May 25, 1985:1184-1186.

21. Wedner, H.J., Bahn, G., Gordon, L.K., Fischman, C.M. Inhibition of lectin-induced lymphocyte activation by 2-cyclohenene-1-one: analysis of DNA synthesis in individual cells by BUdR quenching of Hoechst 33258. Int.J.Immunopharmacol., 1985, 7, Vol.1:25-30.

22. Gordon, L.K. Studies on the combined administration of Haemophilus influenzae type b - diphtheria toxoid conjugate vaccine (PRP-D) and DTP. Dev.Biol.Stand. (Switzerland) 1986, 65:113-21.

23. Lepow, M., M. Randolph, R. Cimma, D. Larsen, M. Rogan, J. Schumacher, B. Lent, S. Gaintner, J. Samuelson, L. Gordon. Persistence of antibody and response to a booster dose of Haemophilus influenzae type b polysaccharide diphtheria toxoid conjugate vaccine in infants immunized at 9-15 months of age. Pediatrics, 1986, 108:882-886.

24. Gordon, L.K. Studies on the combined administration of Haemophilus influenzae type b - diphtheria toxoid conjugate vaccine (PRP-D) and DTP. Develop.Biol.Standard., 1986, Vol. 65, pp. 113-121.

25. Kayhty, H., J. Eskola, H. Peltola, M.G. Stout, J.S. Samuelson, L.K. Gordon. Immunogenicity in infants of a vaccine composed of Haemophilus influenzae type b capsular polysaccharide mixed with DPT or conjugated to diphtheria toxoid. J.Infect.Dis., 1987, 155;100-106.

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Lance K. Gordon

26. Berkowitz, C.D., Ward, J.I., Meier, K., Hendley, J.O., Brunell, P.A., Barkin, R.M., Zahradnik, J.M. Samuelson, J.S., Gordon, L.K. Safety and immunogenicity of Haemophilus influenzae type b polysaccharide and polysaccharide diphtheria toxoid conjugate vaccines in children 15 to 24 months of age. J.Pediatr., 1987, 110:509-514.

27. Lepow, M.L., Barkin, R.M., Berkowitz, C.D., Brunell, P.A., James, D., Meier, K., Ward, J.I., Zahradnik, J.M., Samuelson, J.S., McVerry, P.H., and Gordon, L.K. Safety and immunogenicity of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in infants. J. Infectious Diseases, 1987, 156:591-596

28. Eskola, J., H. Peltola, A.K. Takala, H. Kayhty, M. Hakulinen, V. Karanko, E. Kela, P. Rekola, P-R. Ronnberg, J.S. Samuelson, L.K. Gordon, P.H. Makela. Efficacy of Haemophilus influenzae type b polysaccharide-diphtherial toxoid conjugate vaccine in infancy. New England Journal of Medicine, 1987, 317:717-722

29. Kayhty, H., Eskola, J., Peltola, H., Makela, P.H., Karanko, V., Gordon, L.K., Samuelson, J.S. Response to a booster dose of Haemophilus influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine in children initially immunized at 3-5-7 or only 7 months. Natl. Public Health Inst., Helsinki, Finland. Pediatr.Res. 19, Vol. 10:1104, 1985.

30. Gordon LK., Studies on the combined administration of Haemophilus influenzae type B--diphtheria toxoid conjugate vaccine (PRP-D) and DTP. Dev Biol Stand. 1986;65:113-21.

31. Ward, J.I. Greenberg, D., Anderson, P., Burkart, K., Christenson, P., Gordon, L., Kayhty, H., Kuo, J., and Vella, P. Variable quantitation of Haemophilus influenzae type b anti-capsular antibody by radioantigen binding assay. Journal of Clinical Microbiology, 1988, 26:72

32. Eskola, J., Kayhty, H., Gordon, L.K., Hovi, T., Stenvik, M., Ronnberg, P.R., Kela, E., Peltola, H. Simultaneous administration of Haemophilus influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine with routine diphtheria-pertussis-tetanus and inactivated polio vaccinations of childhood. Pediatric Infectious Disease Journal, 1988, 7:480

33. Lepow ML, Cimma R, Larsen D, Schumacher J, Rogan M, Randolph M, Gaintner S, Samuelson J, Gordon L., Persistence of antibody to Haemophilus influenzae type b at 4 years of age in children previously immunized with polysaccharide antigen alone or conjugated with diphtheria toxoid., J Pediatr. 1988 May;112(5):741-2.

34. Berkowitz CD, Ward JI, Chiu CE, Marcy SM, Gordon L, Hendley JO, Meier K, Marchant CD, McVerry P., Persistence of antibody and booster responses to reimmunization with Haemophilus influenzae type b polysaccharide and

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Lance K. Gordonpolysaccharide diphtheria toxoid conjugate vaccines in children initially immunized at 15 to 24 months of age., Pediatrics. 1990 Mar;85(3):288-93.

35. Frayha HH, Dent P, Shannon HS, Johnson SE, Gordon L., Safety and immunogenicity of subcutaneous H. influenzae vaccines in 15-17 month-old children., Clin Invest Med. 1991 Oct;14(5):379-87.

36. Monath TP, Gordon LK., Strengthening the biological weapons convention., Science. 1998 Nov 20;282(5393):1423.

37. “Meeting the Biodefense Challenge: A “Roadmap” for a National Vaccine Strategy”. Report of the CBACI National Vaccine Strategy Working Group, Chemical and Biological Arms Control Institute, Septembe 2004. (Copy available)

38. Milstien, JB, Stephenne, J, Gordon, L, A primer on large-scale manufacture of modern vaccines., 89: 1081-1091, In; New Generation Vaccines, Third Edition, Revised and Expanded, Marcel Dekker, Inc., 2004.

39. Kennedy A, Gordon L, Stokley S, Salesa J., Mandates for adolescent Immunizations: Recommendations from the National Vaccine Advisory Committee (NVAC) Adolescent Immunization Working Group., American Journal of Preventive Medicine, 2008, 35(2), 145-151

40. Dekker C, Gordon L and Klein J, Dose Optimization Strategies for Vaccines: The Role of Adjuvants and New Technologies, Feb 2008, http://www.hhs.gov/nvpo/nvac/reports/index.html

41. Feinberg M, Gordon L, Industry Perspectives: Ensuring Vaccination of Children and Adolescents Without Financial Barriers, Pediatrics, Dec 2009, 124, S563-S564

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Scientific Abstracts

1. Lance K. Gordon, and Charles W. Parker: Evidence of a second, early, lymphocyte activating activity of wheat germ agglutinin. Fed.Proc. 39:573, 1980.

2. Boies, E.G., D.M. Granoff, R.S. Munson Jr., J. Samuelson, and L.K. Gordon. Enhanced immunogenicity of PRP-D, a new synthetic conjugate vaccine for prevention of Haemophilus influenzae type b (Hib) disease, Pediatric Research, 1983. 17:265A.

3. Lance K. Gordon. Vaccines: Presentation at the Biotechnology in Health Care Conference, Robert S. First Inc., White Plains, N.Y.

4. Lance K. Gordon. Entry of academic biomedical scientists into industry; technology transfer and innovation conference, Robert S. First Inc., White Plains, N.Y. 1982.

5. Gordon, L.K., J.I. Ward, C. Berkowitz and J.M. Zahradnik, Safety and Immunogenicity in infants of a new Haemophilus influenzae type b capsular polysaccharide (PRP)-diphtheria toxoid (D) conjugate (PRP-D). Spring Session, American Academy of Pediatrics, 1984.

6. Zahradnik, J.M. and L.K. Gordon, 1984. Augmented antibody (Ab) responses in infants administered a new Haemophilus influenzae type b capsular polysaccharide (PRP) diphtheria toxoid conjugate vaccine (PRP-D). Pediatric Research, Vol. 18:289A.

7. Ward, J., C. Berkowitz, J. Pescetti, K. Berkart, J. Samuelson, L. Gordon, 1984. Enhanced immunogenicity in young infants of a new Haemophilus influenzae type b (HIB) Capsular polysaccharide (PRP)-diphtheria Toxoid (D) conjugate vaccine. Pediatric Research, Vol 18:287A.

8. Lepow, M.L., J.S. Samuelson, L.K. Gordon. Safety and immunogenicity of H.influenzae b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in infants 714 months. Abstract of the 1984 Interscience Conference on Antimicrobial Agents and Chemotherapy, October 1984, Washington, D.C.

9. Deveikis, A., K.S. Kim, J.I. Ward, K. Burkhart, L. Gordon. Comparison of protective efficacy of sera from adult recipients of PRP or PRP-D vaccines against H.influenzae type b (Hib). Twenty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, D.C., 1984. Abstract #832.

10. Zahradnik, J.M. and L.K. Gordon. Serum antibody (ab) responses to H.influenzae type b polyribosephosphate (PRP)-diphtheria toxoid conjugate (PRP-D) vaccine in infants previously inoculated with purified PRP vaccine. ICAAC, 1984. Abstract #298.

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11. Lepow, M.L., J.S. Samuelson, L.K. Gordon. Safety and immunogenicity of H.influenzae b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in infants 714 months. ICAAC, 1984. Abstract #833.

12. Gordon, L.K., M.L. Lepow, J. Zahradnik, J.O. Hendley, J. Samuelson. Comparison of the age of immunocompetence to H.influenzae type b (Hib) capsular polysaccharide alone and as a covalent conjugate vaccine with diphtheria toxoid. Fed.Proc. 44:214A, 1985.

13. Berkowitz, C.D., J.M. Zahradnik, J.O. Hendley, R. Barkin, P.A. Brunell, K. Meier, M. March, J. Samuelson, L. Gordon, J.I. Ward. Haemophilus influenzae type b (HIB) polysaccharide vaccine: Safety and immunogenicity of PRP and PRP-D conjugate vaccines in children 16-24 months. Pediatric Research, Vol. 19, No. 4, April 1985. Abstract #512.

14. Lepow, M., R. Barkin, K. Meier, J. Zahradnik, C. Berkowitz, D. James, P. Brunell, J. Samuelson, and L. Gordon. Studies of safety and immunogenicity of Haemophilus influenzae type b polysaccharide diphtheria toxoid conjugate vaccine (PRP-D) in children 7-14 months of age. Pediatric Research, Vol. 19, No. 4, April 1985. Abstract #1134.

15. Lepow, M., L. Gordon and J. Samuelson. Response to a booster dose of H.influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in children initially immunized at 9-14 months. Pediatric Research, Vol. 19, No. 4, April 1985. Abstract #1135.

16. Zahradnik, J. and L.K. Gordon. Serum antibody (Ab) kinetics following H.influenzae type b polyribosephosphate (PRP-D) vaccine given to infants: 1 yr follow-up and booster dose response. Pediatric Research, Vol. 19, No. 4, April 1985. Abstract #1184.

17. Lepow, M., L. Gordon and J. Samuelson. Persistence of antibody and response to booster dose of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine at 2 years of age in children immunized at 7 to 14 months. Twenty-fifth Interscience Conference on Antimicrobial Agents and Chemotherapy. September 29 to October 2, 1985, Minneapolis, Minnesota. Abstract #275.

18. Kayhty, H., J. Eskola H. Peltola, P.H. Makela, V. Karanko, L.K. Gordon and J.S. Samuelson. Response to a booster dose of Haemophilus influenzae type b capsular polysaccharide-diphtheria toxoid conjugate vaccine in children initially immunized at 3, 5, and 7 months or only at 7 months. Twenty-fifth Interscience Conference on antimicrobial Agents and Chemotherapy. September 29 to October 2, 1985, Minneapolis, Minnesota. Abstract #276.

19. Zahradnik, J.M. and L.K. Gordon. Serum antibody persistence and response to a 12-month booster dose of Haemophilus influenzae type b

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Lance K. Gordonpolyribosephosphate-diphtheria toxoid conjugate vaccine in infants first vaccinated at age 3 months. Twenty-fifth Interscience Conference on Antimicrobial Agents and Chemotherapy. September 29 to October 1985, Minneapolis, Minnesota. Abstract #277.

20. Gordon, Lance K. Comparison of the antibody response to the H.influenzae b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) vs. a control PRP polysaccharide vaccine in 2-26 month old children. 53rd Conjoint Meeting on Infectious Diseases, November 1985, Toronto, Canada.

21. Gordon, J.K. Studies on the combined administration of Haemophilus influenzae type b-diphtheria toxoid conjugate vaccine (PRP-D) and DTP, MMR and Polio vaccines. IABS Congress on Use and Standardization of Combined Vaccines. December 1985, Bilthoven, The Netherlands.

22. Gordon, L.K., J.I. Ward and M.L. Lepow. The role of molecular size and protein/polysaccharide composition in determining the immunogenicity of an H.influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in 7-14 month old children. FASEB (Federation of American Societies for Experimental Biology), April 1986, St. Louis, Missouri.

23. Gordon, J.K., D.J. Herrmann, P. McVerry and J.S. Samuelson. Conversion of the-independent antibody response to Haemophilus influenzae type b polysaccharide (PRP) to a T-dependent response by covalent conjugation to diphtheria toxoid. 6th International Congress of Immunology, July 6-11, 1986, Toronto, Canada.

24. Gordon, L.K., D.W. Stainer, S.E. Johnson and E.W. Pearson. Laboratory characterization and clinical evaluation of an Acellular pertussis vaccine in eighteen month old children. Washington Workshop on Acellular Pertussis Vaccines, October 1986.

25. Berkowitz, C.D., J.I. Ward, J.O. Hendley, K. Meier, P. McVerry, L. Gordon, C. Chiu, L. Guravitz. Persistence of antibody (ab) to Haemophilus influenzae type b (HIB) and response to PRP and PRP-D booster immunization in children initially immunized with either vaccine at 15 to 24 months. Society for Pediatric Research, April 1987.

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