Consultants are a key source of technical expertise

MVP enlists the expertise of external consultants. The following consultants are currently involved in the project:

Costante Ceccarini, PhD, MSc
MVP Technical Advisor, Vaccine Research and Development

Costante Ceccarini brings more than 35 years of academic and industrial experience in vaccine research and development to MVP. He served on the faculty of the City University of New York (1970–1980) and was a visiting professor at the Albert Einstein College of Medicine during summer 1979. His industrial experience includes several directorships at Sclavo Diagnostics International (1981–1990). He also served as director of research and development and director of vaccine development at Chiron, Sienna (1991–1998), where his unit successfully developed several vaccines, including the meningococcal C conjugate for the U.K. market. Costante Ceccarini has published 65 papers in international peer-reviewed journals. He received an MSc in biology from Oberlin College in Ohio and a PhD in biochemistry/biology from Princeton University in New Jersey.

Paul Derbyshire, PhD
MVP Technical Advisor, Vaccine Development and Licensure

Paul Derbyshire is an independent regulatory consultant with over 20 years of experience in the provision of scientific and regulatory advice to the biopharmaceutical industry. He has extensive international experience in the clinical development, manufacture, and registration of innovative pharmaceutical products, mainly derived from biotechnological processes. Paul Derbyshire has applied his scientific and regulatory expertise to the development and licensure of a large number of innovative medicinal products both in Europe and the United States in the areas of hemophilia, infertility, regenerative medicine, oncology, diabetes, infectious and immunological diseases encompassing recombinant proteins, vaccines, growth factors, cytokines, monoclonal antibodies, blood products, and new chemical entities. Paul Derbyshire holds a PhD in biological sciences from Warwick University, England.

Katharina Hartmann, MSc
MVP Technical Advisor, Serious Adverse Event Management

Katharina Hartmann brings over 25 years of pharmacovigilance experience to MVP. Since 2003 she has been head of pharmacovigilance at Berna Biotech Ltd in Bern, Switzerland. She is also senior lecturer in pharmaceutical sciences at the Federal Institute of Technology in Zürich (ETHZ) and president of the Examination Board for the Federal Examinations in Pharmaceutical Sciences. Previous work experience includes scientific collaborator/deputy director of the Swiss Drug Monitoring Center SANZ—the spontaneous reporting system in Switzerland (1990–2001)—and scientific collaborator at the Scientific Drug Information Center of the Swiss Pharmaceutical Society (1978–1989). Katharina Hartmann studied pharmaceutical sciences at the ETHZ. She has gained a wide range of experience in drug and vaccine safety and is author or coauthor of various publications on drug and vaccine safety and of textbook chapters on pharmacovigilance and drug safety, such as annual editions of Meyler's Side Effect of Drugs, available in both German and English.

Musa Hassan-King, PhD, MSc
MVP Technical Advisor, Clinical Serology

Musa Hassan-King has over 30 years of experience in the field of clinical serology, and he reviews and advises on the MVP serology strategy. From 1976 to 2002 he worked for the British Medical Research Council both in the Gambia, as a senior scientist, and in Nigeria, as a research fellow. He also spent some time in Sierra Leone as a research officer. From 2002 to 2006 he worked on the meningococcal ACYW135 project at Chiron's clinical serology laboratory in Marburg, Germany. He has authored and coauthored numerous scientific publications on meningococcal disease and related topics. Musa Hassan-King received his PhD in clinical microbiology from Ahmadu Bello University Medical School, Nigeria, and he has an MSc in immunology from Brunel University in the United Kingdom.

Jean Petre, PhD
MVP Technical Advisor, Vaccine Research and Development

Jean Petre is an independent consultant dedicated to supporting production and development projects, particularly in developing countries. A trained chemist who specialized in molecular biology, he previously worked for SmithKline Biologicals. He has worked extensively in the field of vaccine development and has made significant contributions to the development of recombinant hepatitis B, acellular pertussis, Haemophilus influenzae type B, and several multivalent pediatric combination vaccines. At Biocine (now Chiron Vaccines) he developed new presentations of combined vaccines, including glycoconjugates, to suit collaborative projects with developing country vaccine manufacturers. Jean Petre earned his PhD in chemistry from the Free University of Brussels, Belgium.

Neil Ravenscroft, PhD
MVP Technical Advisor, Vaccine Research and Development

Neil Ravenscroft is associate professor in the department of chemistry at the University of Cape Town (UCT), South Africa. He has established a Bioanalytical and Vaccine Research Unit to assist with the development of carbohydrate-based vaccines through the application of appropriate physicochemical methods of analysis. He spent his sabbatical leave from UCT assisting MVP in developing the characterization package required to license the meningococcal A conjugate vaccine under development and preparing a draft of the WHO recommendations to assure the quality, safety, and efficacy of group A meningococcal conjugate vaccines. His laboratory continues to provide bioanalytical support to MVP. Neil Ravenscroft received a PhD in organic chemistry from the UCT and conducted postdoctoral research at the University of British Columbia, Canada; UCT and Rhodes University, South Africa; and the Max-Planck Institut für med. Forschung, Germany. He was a senior scientist at Chiron (now Novartis Vaccines) in Siena, Italy, where he initiated their nuclear magnetic resonance program for analysis of carbohydrate vaccines. Neil Ravenscroft has published research articles and reviews on the physicochemical characterization of vaccines and serves on the WHO task force determining the new guidelines for glycoconjugate vaccines. He and his laboratory are involved in the development of an affordable South African Hib conjugate vaccine.

Graciela Spizzamiglio
MVP Technical Advisor, Quality Assurance, Document Validation, Vaccine Licensure

Graciela Spizzamiglio has made contributions to MVP on issues relating to quality assurance, document validation, and vaccine licensure. She has more than 25 years of experience working with sera and vaccines and has expertise in the principles of production, quality control, and related regulatory matters within the field of vaccine development. Her career started at the National Institute of Microbiology in Buenos Aires, Argentina, where she was a microbiology specialist in enterobacteria and production and quality control of diagnostic kits, sera, and vaccines. In 1995 she became director of the National Center for Quality Control of Biological Products in Argentina, where she was responsible for quality control and standardization of vaccines, sera, and diagnostic kits. She currently works as a consultant to WHO on the quality of vaccines offered for supply to UN agencies. The author of several papers, she has made numerous presentations and has given training courses on microbiology and quality assurance. Graciela Spizzamiglio holds an MSc in biology from Buenos Aires University and has also been trained at the US Centers for Disease Control and Prevention in Atlanta.