Curriculum Vitae Julie Block Milstien, PhD Adjunct Professor, Department of Medicine University of Maryland School of Medicine Date September 10, 2009 Contact Information •
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Business address: 685 West Baltimore St – HSF 480 Baltimore, Maryland 21201-1509 USA or 3 bis rue des Coronilles Résidence Parc de Clémentville Bâtiment C 34070 Montpellier, France Business Phone Number 1-410-706-5328 (CVD office) or +334 6706 5779 (in France) Fax Number 1-410-706-6205 (CVD office) Email milstien@medicine.umaryland.edu or jmilstien@gmail.com Foreign Languages French – fluent Spanish – proficient
Education • • •
AB cum laude, Chemistry, Randolph-Macon Woman’s College, Lynchburg, Virginia (now Randolph College), 1964 PhD, Biochemistry, University of Southern California, Los Angeles, California, 1968. Thesis adviser: Thomas H Fife PhD, Thesis title: The Mechanism of Action of α-Chymotrypsin Additional course work (not degree-oriented)in public administration, American University, in statistics and molecular biology at Foundation for Advanced Education in the Sciences, National Institutes of Health (NIH), in epidemiology and biostatistics at the Centers for Disease Control and Prevention and at Johns Hopkins University, 1970-1985
Post-Graduate Education and Training •
Staff Fellow, National Institute of Arthritis and Metabolic Diseases (now NIAMS), National Institutes of Health, 1968-1970, advisor Elliot Charney PhD
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Senior Staff Fellow, National Institute of Arthritis and Metabolic Diseases (now NIAMS), National Institutes of Health, 1970-1971, advisor Elliot Charney PhD, and 1972, on reimbursable detail to National Cancer Institute, National Institutes of Health, advisor Brenda Gerwin, PhD Special Fellow, National Cancer Institute, at National Institute of Allegy and Infectious Diseases, National Institutes of Health, 1972-1973, advisor, Malcolm A Martin, MD
Employment History Academic Appointments •
Adjunct Associate Professor of Medicine, University of Maryland School of Medicine, 2003-2009; Adjunct Professor, July 2009 - present
Other Employment • • • • • • •
Consultant, 1973 – 1974, Litton Bionetics Inc., Bethesda, MD Research Chemist, 1974 – 1985, Office of Biologics Research and Review, Center for Drugs and Biologics, Food and Drug Administration (FDA), Bethesda, MD Chemist, 1985-1988, Reports Evaluation Branch, Office of Epidemiology and Biostatistics, FDA; Acting Chief, August 1985 to September 1986; Manufacturer Liaison, 1986-1988 Scientist, 1988-1994, Biologicals Unit, Department of Health Technologies and Pharmaceuticals, World Health Organization (WHO), Geneva, Switzerland Scientist, 1994-1998, Vaccine Supply and Quality Unit, Department of Vaccines and Biologicals, World Health Organization, Geneva, Switzerland Team Coordinator, 1998-2002, Access to Technologies Team, Department of Vaccines and Biologicals (now Department of Immunization, Vaccines and Biologicalsl), World Health Organization, Geneva, Switzerland Retired, 31 October, 2002, and now consulting for many public health institutions, including the World Health Organization, the Global Alliance for Vaccines and Immunization (GAVI), the International AIDS Vaccine Initiative, Management Sciences for Health, PATH, among others, besides work with the Center for Vaccine Development (CVD) at the University of Maryland School of Medicine
Professional Society Memberships • American Academy of Microbiology, mid-1970’s till 1988 • American Society for Microbiology, 1970-1988 • International Association for Biological Sciences, 1990-2005 (note these dates are approximate)
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Honors and Awards •
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Mid-Level Management Program, Food and Drug Administration, 19831984. This was a competitive award that allowed me to spend a year working in international public health on behalf of the FDA, which led directly to my moving to the World Health Organization Alumnae Achievement Award, Randolph-Macon Woman’s College, 2002. This award, given by my alma mater each year, recognizes alumnae whose activities have had a wide positive impact. Centennial Medal of the Oswaldo Cruz Foundation, Brazil, 2002. This award was given “in recognition of your great contribution to the field of vaccines – strengthening quality control and quality assurance, GMP enforcing, standardization of biological materials, harmonization of regulations, strengthening of the National Quality Control Laboratories, development and product – which have directly impacted in the improvement and better availability of vaccines in the world.” BioManguinhos 30th Anniversary Award, Rio de Janeiro, Brazil, 2006. Given for international work in vaccines and immunization.
National and International Service • • • • •
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Founder, Global Training Network in Vaccine Quality, World Health Organization, 1995 Founding Member, Financing Task Force, Global Alliance on Vaccines and Immunization, 1999-2005 Convener, Regulatory Forum, Phacilitate, Paris, May 2002 Convener, Task Force on Harmonization as a Way to Prevent Vaccine Shortages, Annual Vaccine Colloquium of the Sabin Vaccine Institute, Cold Spring Harbor, NY, October 2004 Chair, WHO meeting to review the vaccine prequalification process, October 2004, resulting in revised procedures, WHO, Procedure for assuring the acceptability in principle of vaccines for purchase by United National agencies, WHO/IVB/05.10. Ad Hoc Reviewer, World Health Bulletin, 2000-present Ad Hoc Reviewer, Eastern Mediterranean Health Journal, 1998-present Ad Hoc Reviewer, Vaccine, 2000-present Ad Hoc Reviewer, Future Medicine, 2005 Ad Hoc Reviewer, Health Affairs, 2005 Manager for World Bank/WHO study on the vaccine industry with the Boston Consulting Group, 2005 Facilitator for WHO Global Training Network Course on Training Skills, Antalya Turkey, May 2008 Member Scientific Advisory Group for PATH Disposable Cartridge Jet Injector project, from September 2008
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I have convened many meetings as part of my responsibilities at FDA and WHO, too numerous to mention. Some of the more important: the first meeting of national regulatory authorities on national regulation of vaccines, in January 1999, which led to WHO’s National Regulatory Authority strengthening project; the first meeting of what then became the Developing Country Vaccine Manufacturers Network, in March 2000.
Teaching Service •
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Since 2004 my major activity with the Department of Medicine has been a joint training project between the CVD at the University of Maryland School of Medicine and the Center pour le Developpement des Vaccins of the Ministry of Health, Mali (CVD-Mali). Professor Karen Kotloff is the principal investigator on this project, funded by Merck Vaccine Network, Africa. With my colleagues both in Baltimore and in Mali, I have developed a comprehensive training program on immunization designed for national immunization staff and vaccinators (physicians and nurses). The initial course, designed for training at the national, regional, and district level, has eight modules given over a seven-day period, and uses primarily interactive adult learning principles. We have trained 11 facilitators in the methodology, in collaboration with the World Health Organization, four of whom are national level staff of the immunization program in Mali. We have also trained 45 national and regional level staff, and, using two-day modules that we also designed, 135 district level staff. We are now in the process of designing and implementing an innovative program of supportive supervision to bring this training to the health center level. By performing extensive baseline and post-training assessments, we have been able to monitor the impact of this training, especially for the introduction of a new vaccine, Haemophilus influenzae type b. The supportive supervision program is one of the first of its kind, and the first to be implemented on national scale. By the end of the project, the training activity should be institutionalized within Mali. We will also add units of this curriculum to the professional medical and nursing curricula. As part of the process of developing CVD-Mali as a competent training center, with activities now coordinated wholly by Malian staff, we worked to develop staff competence to a level so that we could become part of WHO’s Global Training Network. As such, we gave our first Global Training Network course in 2006 for francophone participants from 12 countries. Later that year the CVD-Mali staff and I went to Madagascar to conduct a new national level training program on vaccine management for immunization officials of that country, in collaboration with WHO’s African Regional Office. Additional teaching and presentation activities have been limited to staff seminars and special graduate seminars dealing with international health, including, for example, presentations in Johns Hopkins Bloomburg School
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of Public Health courses 223.687.01, Vaccine Policy Issues, and 223.867.01, Vaccine Seminar, and CVD’s Vaccinology Course. In addition, I have given many presentations at international meetings as part of my responsibilities at FDA and WHO, and as part of my ongoing consulting work.
Grant Support Investigator (10%), 11/1/04-11/1/08. Myron Levine, principal investigator Haemophilus influenzae type b (Hib) conjugate vaccine in infants in Mali, West Africa Bill and Melinda Gates Foundation Annual Direct Costs: $868,842 Total Direct Costs: $3,599,522 Instructor (10%), 11/1/07-10/31/10. Karen Kotloff, principal investigator Mali Immunization Training Initiative: Development of a sustainable immunization infrastructure in Mali, West Africa Merck Company Foundation Annual Direct Costs: $181,819 Total Direct Costs: $545,457 Publications Peer-reviewed journal articles 1. Fife, T.H.# and Milstien, J.B.* Steric Effects in the Deacylation of Acyl Chymotrypsins. Biochemistry, 1967, 6, 2901-2907. 2. Milstien, J.B. and Fife, T.H. Steric Effects in the ImidazoleCatalyzed Hydrolysis of Esters of N-Acetylserinamide and of pNitrophenol. J. Am. Chem. Soc. 1968, 90, 2164-2168. 3. Milstien, J.B. and Fife, T.H. Steric Effects in the Acylation of Chymotrypsin. Biochemistry, 1969, 8, 623-627. 4. Milstien, J.B. and Charney, E. The Rigidity of Polymer Molecules in solution. Electric Dichroism of Poly (n-butylsiocyanates). Macromolecules, 1969, 2, 678-679. 5. Milstien, J.B. and Charney, E. Electric Dichroism Studies. The Interaction of Trifluoroacetic Acid with Poly-Benzyl-L-glutamate. Biopolymers, 1970, 9, 991-1000. 6. Charney, E.,# Milstien, J.B.,* and Yamaoaka, K. Electric Dichroism Studies, Poly Benzylglutamates and Poly Benzylaspartate. J. Amer. Chem. Soc., 1970, 92, 2657-2664. 7. Rossomando, E.F. and Milstien, J.B. Electro-optic Evidence for the Control of the Structure of Bacteriophage fl by a Minor Coat Protein. J. Mol. Biol., 1971, 58, 187-195.
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8. Milstien, J.B. and Rossomando, E.F. Electro-optic Studies on the Effect of Heat Treatment on Stucture in Bacteriophage fl. Virology, 1971, 46, 655-662. 9. Makinen, M.W., Milstien, J.B., and Kon, H. Specificity of Interaction of Haptoglobin with Mammalian Hemoglobin. Biochemistry, 1972, 11, 3851-3860. 10. Gerwin, B.I.# and Milstien, J.B. An Oligonucleotide Affinity Column for RNA-Dependent DNA Polymerase from RNA Tumor Viruses. Proc. Natl Acad. Sci., 1972, 69, 2599-2603. 11. Milstien, J.B. and Ferretti, J.A. The Effect of Polydispersity on the Nuclear Magnetic Resonance Spectra of Poly-Benzyl-L-Glutamate. Biopolymers, 1973, 12, 2335-2349. 12. Martin, M.A.,*# Gelb, L.D., Fareed, G.C., and Milstien, J.B. Reassortment of Simian Virus 40 DNA During Serial Undiluted Passage. J. Virol., 1973, 12, 748-751. 13. Gelb, L.D., Milstien, J.B., Martin, M.A., and Aaronson, S.A. Characterization of Murine Leukemia Virus-specific DNA Present in Normal Mouse Cells. Nature New Biology, 1973, 244, 76-79. 14. Milstien, J.B. and Petricciani, J.C. A Screen for Type-C RNA Viruses in Vaccines. J. Clin. Microbiol., 1975, 1, 353-358. 15. Petricciani, J.C., Milstien, J.B., Seifried, A.S., Wallace, R.E., Johnson, J.B., and McCoy, D.W. Safety of Viral Vaccine Cell Substrates: A ReEvaluation. J. Natl. Cancer Inst., 1976, 57, 915-919 16. Petricciani, J.C., Milstien, J.B. Tests for RNA Tumour Viruses in Cell Substrates used in Virus Vaccine Production. Develop Biol Stand, 1976, 37, 229-234. 17. Milstien, J.B., Walker, J.R., and Eron, L.J. Correlation of Virus Polypeptide Structure with Attenuation of Poliovirus Type I. J. Virol., 1977, 23, 811-815. 18. Milstien, J.B., Walker, J.R., and Petricciani, J.C. Bacteriophages in Live Virus Vaccines: Lack of Evidence for Effects on the Genome of Rhesus Monkeys. Science, 1977, 197, 469-470. 19. Tsuboi, K.K., Milstien, J.B., Seifried, A.S., and Petricciani, J.C. Biochemical Characteristics of Human and Nonhuman Primate Diploid Cell Lines. J. Biol. Standard., 1977, 5, 19-30. 20.Seifried, A.S., Albrecht, P., and Milstien, J.B. Characterization of an RNA Dependent RNA Polymerase Activity Associated with Measles Virus. J. Virol., 1978, 25, 781-787. 21. Charney, E.# and Milstien, J.B.* Electric Dichroism of Poly(riboadenylic acid). Biopolymers, 1978, 17, 1629-1655. 22. Haselkorn, R., Schichman, S., Milstien, J., and Petricciani, J. Characteristics of Bacteriophage ΦV-1 Isolated from Live Virus Vaccines. Proc. Soc. Exp. Biol. Med., 1978, 158, 383-387. 23. Noguchi, P. Wallace, R., Johnson, J., Earley, E., O'Brien, S., Ferrone, S., Pellegrino, M.A., Milstien, J., Needy, C., Browne, W., and Petricciani, J. Characterization of WiDr: a Human Colon Carcinoma Cell Line. In Vitro, 1979, 15, 401-408. Julie Block Milstien
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24. Sprague, J., Eron, L.J., Seifried, A.S., and Milstien, J.B. Cell-free Synthesis of Measles Virus Proteins. J. Virol., 1979, 32, 688-691. 25. Dunlap, R.C., Milstien, J.B., and Lundquist, M.L. Identification and Characterization of Measles Virus 50s RNA, Intervirology, 1983, 19, 169-175. 26. Arrowsmith, J.B., Kuritsky, J.N., Milstien, J.B., and Murano, G. Streptokinase and the Guillain-Barre Syndrome. Ann. Int. Med., 1985, 103, 302. 27. Milstien, J.B. and Kuritsky, J.N. Erythema Multiforme and Hepatitis B. Immunization. Arch. Derm.., 1986, 122, 511-512. 28.Sills, J.M., Tanner, L.A., and Milstien, J.B. Monitoring of Adverse Drug Reactions by the FDA. American Journal of Hospital Pharmacy, 1986, 43, 2764-2770. 29. Milstien, J.B., Gross, T.P., and Kuritsky, J.N. Adverse Reactions reported Following Receipt of Haemophilus Influenzae B Vaccine: an analysis After One Year of Marketing. Pediatrics, 1987, 80, 270274. 30.Faich, G.A., Milstien, J.B., Anello, C., and Baum, C. Sources of Spontaneous Adverse Drug Reaction Reports Received by Pharmaceutical Manufacturers. Drug Information Journal, 1987, 21, 251-255. 31. Shaw, F.E., Graham, D.J., Guess, H.A., Milstien, J.B., Johnson, J.M., Schatz, G.C., Hadler, S.C., Kuritsky, J.N., Hiner, E.E., Bregman, D.J., and Mayner, J.E. Postmarketing Surveillance for Neurologic Adverse Events Reported after Hepatitis B Vaccination: Experience of the First Three Years. Am. J. Epidemiol.., 1988, 127, 337-352. 32. Gross, T.P., Milstien, J.B. Kuritsky, J.N. Bulging Fontanelle after Immunization with Diphtheria-Tetanus-Pertussis Vaccine and Diphtheria-Tetanus Vaccine, J. Ped., 1989, 114 (3), 423-425. 33. Rosa, F.W., Bosco, L.A., Graham, C.F., Milstien, J.B., Dreis, M., Creamer, J. Neonatal Anuria with Maternal Angiotensin Converting Enzyme Inhibition, Ob. Gyn. 1989, 74 (3), 371-374. 34. Milstien, J.B. and Gibson, J.J. Quality Control of BCG Vaccines by the World Health Organization: A review of factors that may influence vaccine effectiveness and safety. Bull. WHO, 1990, 68(1), 93-108 35. Ward, N., Milstien, J.B., Hull, H., Hull, B. A global overview and hope for the eradication of poliomyelitis by the year 2000. Tropical and Geographical Medicine, 1993, pp 45 (5), 198-202 36. Ward, N.A., Milstien, J.B., Hull H.F., Hull, B.P, Kim-Farley, R.J. The WHO-EPI Initiative for the global eradication of poliomyelitis. Biologicals, 1993, 21 (4), 327-334 37. Lemon, S.L., Milstien, J.B. The thermostability of vaccines. Technologies for improving the thermostability of the oral poliovirus vaccine. International journal of technology assess., 1994, 10 (1), 177184.
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38.Diaz-Ortega, J.-L., Forsey, T., Clements, C.J., and Milstien, J.B. The relationship between dose and response of standard measles vaccines. Biologicals, 1994, 22, 35-44. 39. Hull, H.F., Ward, N.A., Hull, B.P., Milstien, J.B., de Quadros, C. Paralytic poliomyelitis: Seasoned strategies, disappearing disease. Lancet, 1994, 343, 1331-1337. 40.Batson, A., Evans, P., Milstien, J.B. The crisis in vaccine supply: a framework for action. Vaccine, 1994, 12 (11), 963-965. 41. Milstien, J.B., Griffin, P.D., Lee, J.W. Damage to immunization programmes from misinformation on contraceptive vaccines. Reproductive health matters, 1995, 3 (6), 24-28. 42. Milstien, J.B., Gellin, B.G., Kane, M., di Fabio, J.L., Homma, A. Global DTP Manufacturing Capacity and Capability. Status report: January 1995. Vaccine, 1996, 14 (4), 313-320. 43. Dietz, V., Milstien, J.B., van Loon, F., Cochi, S., Bennett, J. Performance and potency of tetanus toxoid: implications for eliminating neonatal tetanus. Bull. WHO, 1996, Vol 74, Number 6, 619628. 44. Milstien, J., Batson, A., Meaney, W. A systematic method for evaluating the potential viability of local vaccine producers. Vaccine, 1997, Vol 15 (12/13), 1358-1363. 45. Milstien, J., Batson, A. Accelerating availability of new vaccines: the role of the international community. Drug Information Journal, 1998, Vol 32 (1), 175-182. 46.Blomberg, B., Kitler, M.E.,Milstien, J., Dellepiane, N., Fanning, A., Norval, P.Y.,and Spinaci, S. Availability of quality fixed.dose combinations for the treatment of tuberculosis: what can we learn from studying the World Health Organization’s vaccine model? Int J Tuberc Lung Dis, 1999, Vol 3 (11), S371-S380. 47. Lloyd, J.S. and Milstien, J.B.. Auto-disable syringes for immunization: issues in technology transfer. WHO Bull, 1999, Vol 77, pp 1001-1007. 48.Dellepiane, N., Griffiths, E., and Milstien, J.B. New challenges in assuring vaccine quality. WHO Bull, 2000. Vol 78, pp 155-162. 49.Mehta, U., Milstien, J.B., Duclos, P., and Folb, P.I. Developing a national system for dealing with adverse events following immunization. WHO Bull, 2000. Vol 78, pp 170-177. 50.Jodar, L., Duclos, P., Milstien, J.B., Griffiths, E., Aguado, M.T. and Clements, C.J. Ensuring vaccine safety in immunization programmes – a WHO perspective. Vaccine, 2001. Vol 19, pp 1594-1605. 51. Xing, D., Gaines Das, R., O'Neill, T., Corbel, M., Dellepiane, N., Milstien, J.B. Laboratory testing of whole cell pertussis vaccine: a WHO proficiency study using the Kendrick test. Vaccine, 2001. Vol 20 (3-4), pp. 342-351. 52. Milstien, Julie, Dellepiane, Nora, Lambert, Scott, Belgharbi, Lahouari, Rolls, Chris, Knezevic, Ivana, Fournier-Caruana, Jacqueline,
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Wood, David, Griffiths, Elwyn. Vaccine quality - can a single standard be defined? Vaccine, 2002. Vol 20(7-8):1000-3. 53. Milstien, Julie, Lambert, Scott. Emergency response vaccines - a challenge for the public sector and the vaccine industry. Vaccine, 2002, 21, 146-164. 54. Milstien, Julie, Munira, Syarifah Liza and McKinney, Susan Loretan. Issues in selection of DTwP-based combination vaccines, Vaccine, 2003, 21, 1658-1664. 55. Milstien, Julie and Widdus, Roy. Facilitating access to vaccines: an overview of legal and political issues. Pharmaceutical Development and Regulation, 2003, 1 (2), 101-116. 56. Milstien, Julie. Emergency response vaccines: lessons learned in response to communicable diseases. Expert Opinion on Biological Therapy, 2003, 3 (7),1121-1131
57. Milstien, Julie and Belgharbi, Lahouari. Regulatory pathways for vaccines for developing countries. Bulletin of the World Health Organization. 2004, 82 (2): 128-133. 58. Milstien, Julie B. Regulation of vaccines: Strengthening the science base. Journal of Public Health Policy. 2004. 25 (2):173-89. 59. Milstien, Julie B. The health and financial impacts of delaying vaccination. Vaccines: Children & Practice. 2004, 7 (2): 35-38. 60.Milstien, Julie, Cash, Richard A, Wecker, John and Wikler, Daniel. The development of priority vaccines for disease-endemic countries: the risk-benefit calculus. Health Affairs. 2005, 24 (3): 718-728. 61. Milstien, Julie and Kaddar, Miloud. Managing the effect of TRIPS on availability of priority vaccines. Bull WHO. 2006, 84 (5):360-365. 62. Milstien, Julie, Kieny, Marie-Paule, Kaddar, Miloud. The Impact of Globalization on Vaccine Development and Availability. Health Affairs 2006, 25 (4): 1061-1069. 63. Milstien, Julie B, Gaulé, Patrick, Kaddar, Miloud. Access to vaccine technologies in developing countries : Brazil and India. Vaccine 2007, 25 (44): 7610-7619. 64.Milstien, J.B., Tapia, M., Sow, S.O., Keita, L., Kotloff, K. Strengthening immunization in a West African country: Mali. Education for Health 2007, 20: 1-8. 65. Milstien, J.B., Kamara, L., Lydon, P., Mitchell, V., Landry, S. The GAVI Financing Task Force: One Model of Partner Collaboration. Vaccine. 2008 December, 26 (51): 6699-6705. 66. Kamara L., Milstien J.B., Patyna M., Lydon P., Levin A., Brenzel L. Strategies for financial sustainability of immunization programs: A review of the strategies from 50 national immunization program financial sustainability plans. Vaccine. 2008 December, 26 (51): 67176726 67. Lydon P., Levine R., Makinen M., Brenzel L., Mitchell V., Milstien J.B., Kamara L., Landry S. New vaccines in the poorest countries. What did we learn from the GAVI experience with financial sustainability? Vaccine. 2008 December, 26 (51): 6706-6716.
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68. Milstien J., Costa A., Jadhav S., Dhere R. Reaching International GMP Standards for Vaccine Production: Challenges for Developing Countries. Expert Rev Vaccines. 2009 May, 8 (5): 559-566.
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Non-peer-reviewed journal articles 1. Halliday, David and Milstien, Julie. Supplying the vaccine. World Health, 1995, 48, 18-19. 2. Milstien, Julie, Candries, Brenda. Economics of vaccine development and implementation: changes over the past 20 years. The Jordan Report 20th Anniversary. Accelerated Development of Vaccines 2002, US Department of Health and Human Services, National Institute of Allergy and Infectious Diseases, pp 73-79. Web-based journal articles 1. Milstien, Julie B., Batson, Amie, Wertheimer, Albert I. Vaccines and Drugs: Characteristics of their use to meet public health goals. 2004. Health, Nutrition and Population (HNP) Discussion Paper. The World Bank, 2005, at http://siteresources.worldbank.org/HEALTHNUTRITIONANDPOPU LATION/Resources/281627.10956981401671/MilstienVaccinesDrugsF inal.pdf. 2. Brennan MJ, Fruth U, Milstien J, Tiernan R, de Andrade Nishioka S, Chocarro L; Developing Countries Vaccine Regulatory Network and the Ad Hoc Regulatory and TB Expert Panel. Development of new tuberculosis vaccines: a global perspective on regulatory issues. PLoS Med. 2007, Aug. 4(8):e252. Book Chapters 1. Milstien, J.B. and Seifried, A.S. In vitro Transcription of the Measles Virus Genome. The Replication of Negative Strand Viruses, D.L. Bishop and R.W. Compans, ed., Elsevier-North Holland, 485-491, 1981. 2. Milstien, J.B., Klutch, M.J., Bhatia, B., and Lucas, C.J. Effects of Interferon and Interleukin-2 on Measles Virus Infection of Human Lymphocytes. The Biology of the Interferon Systems, H. Schellekens, ed., Elsevier-North Holland, P.P. 245-250, 1983. 3. Milstien, J.B., Seifried, A.S., Klutch, M.J., and Bhatia, B. The Effects of Interferon on Measles Virus RNA Synthesis. Nonsegmented Negative Strand Viruses, D.L. Bishop and R.W. Compans, e.g., Elsevier-North Holland, PP. 183-190, 1984. 4. Turner, W.M. and Milstien, J.B. Drug-Induced Diseases. Pharmacotherapy. A Pathophysiologic Approach, J.T. DiPiro, R.L. Talbert, P.E. Hayes, G.C. Yee, L.M. Posey, eds., Elsevier, pp. 60-68, 1988. 5. Milstien, Julie, Stephenne, Jean and Gordon, Lance. A primer on large-scale manufacture of modern vaccines. Chapter 89. New
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Generation Vaccines, eds MM Levine et al. New York: Marcel Dekker Inc, 2004, pp 1081-91. 6. Milstien, Julie. Desenvolvimento Technológico de Vacinas: projeções para 2015. Chapter 8. Vacinas, Soros Imunizações no Brasil, eds Paulo Marchiori Buss, José Gomes Temporão, José da Rocha Carvalheiro. Rio de Janeiro: FIOCRUZ, 2005, pp 147-191 (in Portuguese). 7. Dietrich, Guido, Milstien, Julie, Jadhav, Suresh, Stowe, Peter C. Manufacturing of Vaccines. In press. 2009. Chapter 15. New Generation Vaccines, 4th edition, eds MM Levine et al. New York: Marcel Dekker 8. Milstien, Julie B., Dellepiane, Nora, Belgharbi, Lahouari, Chocarro, Liliana and Wood, David. Assuring Vaccine Quality by Strengthening Regulatory Agencies: The Work of the World Health Organization. Chapter 13. In press 2009. New Generation Vaccines, 4th edition, eds MM Levine et al. New York: Marcel Dekker
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Abstracts and/or Proceedings 1. Assaad, F., Dömök, I., Hatch, M., Magrath, D.I., Milstien, J., Minor, P.D., Obejeski, F., Reeve, P., Schild, G.C., Tagaya, I., van Wezel, A. Poliovirus strain characterization: a WHO Memorandum. Bull. WHO, 1980, 58, 727-730. (meeting report) 2. Turner, W.M., Milstien, J.B., Faich, G.A., and Armstrong, G.D. The Processing of Adverse Reaction Reports at FDA. Drug Information Journal, 1986, 20, 147-150. 3. Sills, J.M., Faich, G.A., Milstien, J.B., and Turner, W.M. Postmarketing Reporting of Adverse Drug Reactions to the FDA: An Overview of the 1985 Guideline. Drug Information Journal, 1986, 20, 151-156. 4. Milstien, J.B., Faich, G.A., Hsu, J.P. Knapp, D.E. Baum, C., and Dreis, M.W. Factors Affecting physician Reporting of adverse reactions. Drug Information Journal, 1986, 20, 157-164. 5. Clements, C.J., Strassburg, M., Cutts, F.T., Milstien, J.B., Torel, C. Global Control of Measles. New Strategies for the 1990s. Control of Virus Diseases. 2nd ed. E. Kurstak, ed. Marcel Dekker, Inc, pp 179-211, 1993. 6. Ward, N.A., Kim-Farley, R.J., Milstien, J.B., Hull, H.F., Torel, C., de Quadros, C. Poliomyelitis Eradication: The Expanded Programme on Immunization of the World Health Organization. Control of Virus Diseases. 2nd ed. E. Kurstak, ed. Marcel Dekker, Inc, pp 247266,1993. 7. Milstien, J.B., Evans, P., Batson, A. Discussion: Vaccine production and supply in developing countries. 1994. Vaccination & World Health, eds Cutts and Smith, John Wiley, pp 60-66. 8. Milstien, J., Grachev, V., Padilla, A., Griffiths, E. WHO activities towards the three Rs in the development and control of biological products. Brown, Cussler, Hendriksen eds. Dev. Biol. Stand., 1996, 86, 31-39. 9. Milstien, J., Lemon, S. Regulatory Considerations for New Stabilised Poliovaccines. Dev. Biol. Stand., 1996, 87, 181 - 189. 10. Milstien, Julie B., Lemon, Stanley M., Wright, Peter F. Development of a More Thermostable Poliovirus Vaccine, Journal of Infectious Diseases, 1997, Vol 175, Supplement 1, pp: S247-S253. 11. Hendriksen, C., Spieser, J.M., Akkermans, A., Balls, M., Bruckner, L., Cussler, K., Daas, A., Descamps, J., Dobbelaer, R., Fentem, J., Halder, M., Kamp, M. van der, Lucken, R., Milstien, J., Sesardic, D., Straughan, D., Valadares, A., Validation of alternative methods for the potency testing of vaccines. ATLA 1998, Vol 26, 747-761. 12. Milstien, J.B. and Dellepiane, N. Alternatives and Developing Countries, in Brown, F, Hendriksen, C, Sesardic, D (eds): Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use. Dev. Biol. Stand. Basel, Karger, 1999, Vol 101, pp 203-208.
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13. Milstien, J.B. Immunization-related products: introduction to the panel discussion. Vaccine, 2001. Vol 19, pp 1592-3. 14. Milstien, J. Regulatory Processes and Three Rs Alternatives. In: Brown F, Hendriksen C, Sesardic D, Cussler K (eds). Advancing Science and Elimination of the Use of Laboratory Animals for Development and Control of Vaccines and Hormones. Dev Biol Stand. Basel, Karger, 2002. Vol 111. pp 15-19. 15. Duclos, P., Delo, A., Aguado, T., Bilous, J., Birmingham, M., Kieny, M.P., Milstien, J., Wood, D., Tarantola, D. Immunization safety priority project at the World Health Organization. Seminars in Pediatric Infectious Diseases. 2003, 14 (3), 233-239. 16. Milstien, Julie. Challenges and potential solutions to innovative vaccine development in developing countries. Ehrlich II, 2 nd World Conference on Magic Bullets, 3-5 October, 2008, Nuremberg, Germany. Invited abstract, accepted for oral presentation. 17. Milstien, Julie. Challenges and potential solutions to innovative vaccine development in developing countries. Vaccine, 2nd Global Congress, 7-9 December, 2008, Boston, MA USA. Published in Peocedia in Vaccinology, 2009. Vol 1 (1): 183-188..
Other Brief Communications 1. Milstien, J.B., Gross, T.P., and Kuritsky, J.N. Informed Consent reply to Letter to the Editor. Pediatrics, 1988, 81, 471-472. 2. Milstien, Julie B., Evans, Peter, Batson, Amie. Cholera Vaccines: lessons from Rwanda and elsewhere (letter), Lancet, 1997. Vol 349, 957-958. 3. Kane, M., Milstien, J. Immunogenicity of low-dose plasma-derived hepatitis B vaccine. Lancet, 1997, Vol 350, 1102. 4. Milstien, Julie B., Batson, Amie. Funding for vaccination (letter). Lancet, 1998, Vol 352, 579. 5. Milstien, J.B., Zaffran, M., Wood, D.J., and Griffiths, E. Letter to the Editor. Biologicals, 1999, Vol 27, pp 277-8. 6. Milstien, J. Vaccine vial monitors. Indian Pediatrics, 2001. Vol 38, pp107-108. 7. Milstien, J. Regulatory pathways for developing market vaccines (Editorial) Expert Rev. Vaccines. 2003, 2(5), 599-601. 8. Milstien, Julie B. Regulatory pathways for developing market vaccines redux. (Editorial) Expert Rev. Vaccines. 2005, 4 (3): 241-243. 9. Batson, Amie and Milstien, Julie B. The GO License : Only Part Of The Solution. (Perspective) Health Affairs 2008, 27 (1): 140-142. Additional Publications
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From 1998-2002 I was a part of a WHO group to develop position papers on vaccines which would define WHO policy for specific diseases or symptom complexes. Between 2001-2002, I chaired this group. Examples of the work can be seen at http://www.who.int/immunization/documents/positionpapers_intro/en/ index.html Between 1995 and 2006 I collaborated with other authors to develop pa WHO monograph on temperature stability of vaccines. The latest version is entitled Temperature Sensitivity of Vaccines, WHO/IVB/06.10, and can be found at http://www.who.int/immunization/documents/WHO_IVB_06.10/en/index.html During my years at WHO I authored or co-authored a number of WHO policy statements, most having to do with vaccine regulation and vaccine quality.
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Major Invited Speeches •
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Vaccine Supply Issues, at the 9th Annual Vaccine Colloquium of the Sabin Vaccine Institute was focused on the Global Vaccine Shortage: the Threat to Children and What to Do about It, Cold Spring Harbor, NY, October 2002 Global Trends and Issues in Vaccine Supply, at the National Forum on Infectious Diseases, Washington, April 2003 World Health Organization’s Role in Improving Vaccine Supply, at the 8 th Conference of the International Society of Travel Medicine, New York, USA, May 7-11, 2003 Challenges involved in expanding immunization programs to include new vaccines, at the Child Youth Health Conference, Vancouver, British Columbia, 12 May, 2003 Regulatory Pathways for Developing Market Vaccines, at the Global Research Forum, Seoul, Korea, June 2003 Regulatory considerations for changing Hib vaccine dose post-licensure, at the Gates Foundation, Seattle, September 2003 Synthesis of work of Task Force on Harmonization, at the Follow-up Congress on Vaccine Shortages, Cold Spring Harbor NY, October 2003 Regulatory Issues in Development of Malaria and Other Developing Market Vaccines, at the 2nd MALVAC Meeting, Maputo, Mozambique, November 2003 Meeting rapporteur, WHO Meeting on Intellectual Property Rights in Developing Countries, Geneva, April 2004, WHO/IVB/04.21 Regulatory Pathways for Developing Market Vaccines, at the Global Research Forum, Bahia, Brazil, June 2005 Summary of Vaccine Industry Study at the Developing Country Vaccine Manufacturers Meeting, Pune, India, October 2005 Regulatory Expectations of Manufacturers at the Developing Country Vaccine Manufacturers Meeting, Pune, India, October 2005 Review of heat/freeze sensitivity of new vaccine products, at the TechNet 21, Mexico City, Mexico, October 2006 Developed background papers and served as rapporteur on sessions on middle income countries’ access to vaccines at the WHO meetings on New and Underused Vaccine Introduction, Geneva, June 2007 and June 2008 Learning from the WHO Updated Guidelines for Storage and Monitoring of Temperature Sensitive Vaccines around the Globe, at Cool Chain Europe, January 2008 Introduction of New Vaccines in Middle Income Countries, at WHO, Global Immunization Meeting, Geneva, February 2008 Vaccine regulatory approval: overview and policy issues, at Johns Hopkins Bloomberg School of Public Health, Vaccine Policy course, February 2008, also February 2007 and February 2006
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