Clinical Vaccine Development and Biomanufacturing

Programme details

This is a draft timetable and may be subject to change.

Day 1

• Introduction to vaccine types
• Taking lab discoveries into manufacture
• GMP Manufacturing of IMPs -  a QP’s Perspective
• Flu vaccine manufacture and clinical development
• CASE STUDY (Influenza Vaccine Planning)

Day 2

• Introduction to GMP upstream and downstream processes
• Process Development case study
• Manufacturing and quality risk management during the vaccine development and manufacturing process
• Clinical development overview
• Immunomonitoring and Immune correlates

Evening: Walking tour and social evening

Day 3 

• Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford
• ICH Guidelines of Good Clinical Practice
• Clinical trials in developing countries
• The importance of post - vaccination surveillance. Case study: Bacterial Meningitis
• Designing and coordinating large, multi - centre, Phase III clinical trials in different age cohorts: case studies 'Rotavirus, HPV and Zoster'

Day 4

• Statistical considerations when designing a clinical trial
• Adjuvants for vaccines in clinical trials
• Ethical considerations for trials in developing countries
• Closure of meeting / feedback

The above content may be subject to revision during the course development process.

Certification

Participants who attend the full course will receive a University of Oxford certificate of attendance. This will be presented to you prior to the end of the course wherever possible.

The certificate will show your name, the course title and the dates of the course you attended.

Accommodation

Fees

Standard course fee: £1295.00

Payment

Fees include course materials, tuition, refreshments and lunches. The price does not include accommodation.

All courses are VAT exempt.

Register immediately online 

Click the “book now” button on this webpage. Payment by credit or debit card is required.

Request an invoice

Send a completed application form to the course administrator by email or post. Please do not send card details via email.

Student Discounts

On this course we offer a 10% discount to students in full-time higher education. To apply at the discounted rate, please contact us for details.

Tutors

Prof Adrian Hill

Course Director

Director, The Jenner Institute, University of Oxford

Principal areas of research: Malaria vaccines, vectored vaccine development, immunogenetics of infectious disease susceptibility

Adrian Hill trained in medicine at Trinity College Dublin and the University of Oxford, qualifying in 1982. He undertook a DPhil with Sir David Weatherall and John Clegg at the MRC Molecular Haematology unit on the molecular population genetics of thalassaemia in Pacific Islanders. Following further clinical posts in London he returned to the newly opened Institute of Molecular Medicine in 1988 to study genetic susceptibility to malaria as a Wellcome Trust Senior Fellow. In 1995 he was awarded a Wellcome Trust Principal Research Fellowship and in 1996 the title of Professor of Human Genetics. He participated in the founding of the Wellcome Trust Centre for Human Genetics in 1994, and in 2003 co-founded the Oxford Centre for Clinical Vaccinology and Tropical Medicine, which he now chairs. In 2004 he participated in the restructuring of the Edward Jenner Institute for Vaccine Research and in 2005 was appointed director of the new Jenner Institute. He is a Fellow of the Royal College of Physicians, of Magdalen College, Oxford, and of the UK Academy of Medical Sciences

Dr Rebecca Ashfield

Speaker

CSO,  Ducentis Biotherapeutics Ltd

Rebecca Ashfield gained a first degree in Biochemistry and DPhil in molecular biology, both from the University of Oxford.

Dr Ashfield worked for 12 years at Immunocore Ltd, a biotechnology company making protein therapeutics for cancer immunotherapy, and joined the Jenner Institute in 2013 as a senior project manager for pre-clinical malaria, working with Professor Adrian Hill. She is now the CSO of Ducentis Biotherapeutics Ltd.

Dr Wendy Crocker

Course Project Manager / Speaker

Finance and Project Manager, Malaria Vaccine Programme, The Jenner Institute, University of Oxford

Wendy gained a first degree in Biochemistry and Chemistry and PhD in Biological Surface Science, both from the University of St Andrews University. She then went to work for the Royal Society of Chemistry as an Editor and Communication Specialist.

In 2009 she moved to Moscow (Russian Federation) to work as an EC-sponsored technical diplomat working in counter-bioterrorism and counter-WMD for the global security department of the International Science and Technology Centre.

Then in 2012 she moved to Tbilisi (Georgia) to work for Battelle Memorial Institute coordinating a country-wide public health and veterinary initiative sponsored by the US Defense Threat Reduction Agency to achieve full operational capability of preparedness systems against especially dangerous pathogens.

She presently works for Prof Adrian Hill at Oxford University on vaccine development projects for malaria and emerging pathogens.

Dr Daniel G. Bracewell

Speaker

Professor of Bioprocess Analysis, UCL Department of Biochemical Engineering

Daniel G. Bracewell has made major contributions to fundamentally understanding the recovery of biological products. Generating over £5.5 million in research funds including collaborations with Thailand, India and the USA. He has authored more than 90 peer reviewed journal articles in the area to date and currently supervises 15 doctoral and postdoctoral projects, many of these studies are in collaboration with industry. One such project was the basis from which the spinout Puridify (recently acquired by GE Healthcare) was created.

Dr Mark Doherty

Speaker

Senior Manager, GlaxoSmithKline Biologicals

Mark Doherty obtained a bachelor’s degree in Biochemistry and Microbiology (double major) in 1983 and in Microbiology with 1st class honours in 1986, both from Massey University in New Zealand, before completing a PhD in Immunobiology at the Auckland University School of Medicine in 1989.

Subsequently he worked at the DNAX research Institutes and the National Institutes of Health in the United States, and at the Statens Serum Institute in Copenhagen. During this period, he also held adjunct professorships at the Gade Institute for International Health, at the University of Bergen in Norway and St. John’s School of Medicine in Bangalore, India. He has also been a Gates Senior Visiting Research Fellow at Aeras/NIH, and a WHO Distinguished Visiting Professor at the University of Sao Paulo in Sao Paulo, Brazil.

In 2011, Prof. Doherty joined GSK, where he works today as a senior manager in the Above Brands/Vaccine Science team.Prof. Doherty’s expertise is in the development of the early immune response - particularly the interactions of T cells and antigen presenting cells that can influence the development of T cell helper subsets. In this area, his particular specialties have been immune cell crosstalk and cytokine biology.  This work has focused strongly on practical applications of basic research, such as biosignatures of infection and disease, or adjuvant and vaccine design.

At GSK he provides support and expertise on issues such as adjuvant safety and development, maternal and risk-group vaccination and basic immunology that are relevant to multiple vaccines. He has particular interest in vaccination for older adults and vaccines as a tool for antimicrobial stewardship.

At GSK he continues to work with academic colleagues on ongoing clinical field studies, to publish in peer-reviewed journals, to work as an editor on various immunology journals, to work participate in WHO working groups, and to lecture and teach externally in immunology and vaccinology.

Dr Matthew Downham

Speaker

Associate Director, Manufacturing Science and Technology department, Medimmune UK Ltd

Dr Downham studied for a bachelor of sciences degree (with honours) in industrial biology at London South Bank Polytechnic (UK) which included a placement with Boehringer Mannheim, now Roche (Germany). He then completed a PhD in biochemical engineering (Birmingham University, UK), a post-doctoral fellowship in bio-molecular sciences (Liverpool John Moores University, UK) and a post-graduate certificate in further/higher education (Bolton Institute, UK).

He joined the biopharmaceutical industry in 1997 and has worked for Protherics (UK), Bavarian Nordic (Germany), Morphosys (Germany) and, Novartis Vaccines and Diagnostics (Italy). Throughout this time Dr Downham worked on the pre/non-clinical and early clinical development of either vaccine, antibody or enzyme therapies for a number of infectious, hypertension, inflammatory and oncology indications. He became a European Registered Toxicologist (in 2010) and has co-authored 29 publications/abstracts and 3 international patents.

Dr Downham joined the influenza vaccine franchise of AstraZeneca/Medimmune (UK) in February 2013 as an Associate Director and currently heads the Manufacturing Science and Technology department.

Dr Katie Ewer

Speaker

Senior Immunologist, The Jenner Institute, University of Oxford

Dr Katie Ewer qualified as a Biomedical Scientist in 2000 at the microbiology department of the John Radcliffe Hospital before joining the University of Oxford as a Research Assistant. She gained a PhD in Immunology in 2004 through The Open University for her work with Dr Ajit Lalvani in the Nuffield Department of Clinical Medicine on novel diagnostic tools for tuberculosis. In 2004, she joined VLA (now AHVLA) and managed the roll-out of interferon-gamma-based diagnosis for bovine TB in the UK herd for DEFRA as well as undertaking research to study immune correlates of protection for TB vaccines in cattle.

Katie joined the Jenner Institute as a Senior Immunologist in 2008 and co-ordinates immunogenicity testing for pre-erythrocytic malaria and Ebola vaccine trials in Oxford and at field sites in East and West Africa. Her work focusses on describing immune responses to viral vectored vaccines in adults and children, identifying vaccine-induced immune correlates of protection and transcriptional profiling of responses to malaria and Ebola vaccines.

Prof Sarah Gilbert

Speaker

Professor of Vaccinology, Programme Director for Wellcome Trust Strategic Award on Human and Veterinary Vaccine Development, The Jenner Institute, University of Oxford

After a first degree in Biological Sciences at the University of East Anglia, specializing in Microbiology, and a PhD on lipid metabolism in the Biochemistry Department at the University of Hull, Prof Gilbert worked on pentose metabolism in brewing yeasts at the Brewing Research Foundation in Surrey. This led to a research post at the Leicester Biocentre, using molecular biology techniques to study heterologous protein expression in yeast.

Prof Gilbert spent four years at Delta Biotechnology in Nottingham, working on production of recombinant human blood proteins in yeast before moving to Adrian Hill’s group at the University of Oxford in 1994.

Prof Gilbert’s chief research interest is the development of vaccines that work by inducing strong and protective T cell responses. This has included work on DNA vaccines and virus-like protein particles carrying multiple T cell epitopes on their surface, as well as the viral vaccine vectors Modified Vaccinia virus Ankara (MVA), fowlpox and adenovirus.

Following the discovery that heterologous prime-boost immunisation, in which the same antigen is delivered in first one vector and then another, is highly immunogenic in pre-clinical studies, she designed antigen inserts for, and produced DNA, MVA and fowlpox vaccines which were then manufactured for clinical trials in both the malaria and tuberculosis vaccine clinical programmes.

More recently Prof Gilbert has begun to apply the same principles of vaccine development, pre-clinical and clinical testing to new vaccines against influenza. The currently available ‘flu vaccines work by inducing antibodies to highly variable surface proteins of the virus, and slightly different versions have to be manufactured each year to keep up with changes in the virus. However the internal proteins of the ‘flu virus, which are produced inside infected cells, are well conserved, not only from one year to the next, but also between seasonal ‘flu viruses and those normally found only in avian species. Using these antigens, it should be possible to make a vaccine that protects against all subtypes of influenza, and ultimately, to stop a new pandemic in its tracks.

Dr George A. Robertson

Speaker

Dr Robertson began his consulting practice in January 2018 after ten years as the Senior Technical Advisor, Vaccine Development at the global health nonprofit, PATH. For eight of those years, he led and personally advised and authored numerous vaccine manufacturing and development plans and accompanying GMP documents for the Vaccine Development Global Program (later Center for Vaccine Innovation and Access). His work in this highly matrixed, international environment included projects on ETEC, Shigella, rotavirus, influenza, malaria, pneumococcal and yellow fever vaccines. During this time, he was the Quality Officer and as such he approved all GMP documentation for vaccines going into clinical trials to include quality agreements, batch records and deviation reports. Additionally, he set up and led a highly successful developing country vaccine manufacturer quality improvement program at PATH to advance manufacturers to ICH and WHO prequalification quality standards and made over 80 overseas trips to lead and verify progress.

Previously, Dr Robertson had led vaccine quality control operations at major pharmaceutical companies such as Merck and Wyeth and participated actively in commercial development projects for Merck Varicella and Hepatitis A vaccines. His experience and accomplishments have also included vice-presidential leadership positions at small biotech companies such as DOR BioPharma and professional associations such as Parenteral Drug Association (PDA). He received his PhD in Molecular Biology from the University of Pennsylvania.

Dr Mark Sheehan

Speaker

Biomedical Research Centre Ethics Fellow, The Ethox Centre and James Martin Research Fellow, Institute for Science & Ethics, University of Oxford

Mark Sheehan is Oxford Biomedical Research Centre (BRC) Ethics Fellow at the Ethox Centre and a James Martin Research Fellow in the Institute for Science and Ethics. He received his PhD in Philosophy from The City University of New York, where his PhD thesis was on the nature of moral judgements.

Prior to his PhD, he received an MA (Hons) and a BA (Hons)/BSc from the University of Melbourne. Prior to coming to Oxford he was a lecturer in the Centre for Professional Ethics at Keele University, Ethics Fellow at the Mt. Sinai Medical School, New York and Adjunct Lecturer in the Philosophy Department at The City College of New York.

As BRC Ethics Fellow, Mark is involved in Research Ethics and Patient and Public Involvement (PPI) across the Oxford NIHR BRC themes. This involvement includes discussions with researchers about research ethics issues in their work, collaborating on research proposals with ethical components and conducting research on issues in research ethics, ethics generally and PPI that engage with the research themes within the BRC. As a member of the Institute for Science and Ethics, Mark is involved in research identifying and critically analysing ethical issues and problems arising in stem cell science, cloning, artificial reproduction and genetics.

The Institute is part of the Oxford Martin School and so he is also involved in a number of collaborations with other parts of the School. Mark has set up and teaches (with the considerable help of colleagues) a series of sessions on research ethics aimed at researchers in the Medical Sciences Division and at the Oxford Radcliffe Hospital. From Hilary term 2011 he will lead (again with the help of colleagues) a seminar series in the Centre for Doctoral Training in Healthcare Innovation in the Institute for Biomedical engineering on the ethics and biotechnology.

He also teaches Medical Ethics and Law to the Graduate Entry Medical students at the Medical School and lectures on the Medical Law and Ethics course in the Law School.

He has published in such journals as the Journal of Applied Philosophy, the Journal of Medical Ethics, the Cambridge Quarterly on Healthcare Ethics and the American Journal of Bioethics. With colleagues from the Centre for Professional Ethics at Keele University, he has just completed an EU-funded textbook on research ethics.

He is a member of the Advisory Group for National Specialised Services (AGNSS) and the Thames Valley Priorities Forum (MOBBB) for the South Central Strategic Health Authority. He also sits on the University’s Social Sciences and Humanities Inter-Divisional Research Ethics Committee and is an external member of the Goldsmith’s Research Ethics Committee.

He is a Senior Research Fellow in Philosophy at St. Benet’s Hall.

Current Research Themes: 1.Research Ethics and Governance 2.Ethics and Reproductive Technologies 3.Ethical issues in Resource Allocation 4.Commercialisation and Health 5.Methodology in Applied Ethics and Bioethics

Laura Merson

Speaker

Associate Director, Infectious Diseases Data Observatory (IDDO)

Laura Merson joined ERGO and IDDO in 2015 to support new platform initiatives for emerging infections and neglected tropical diseases, including coordination of the Ebola Data Sharing Platform. This joint position integrates many of Laura’s research interests including exploring issues in sharing biomedical research data and in changing the paradigm of clinical research in outbreaks to enable rapid research response to emerging infections. As an executive member of the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), Laura has contributed to the development of standardized, open-access research protocols designed for outbreak response in collaboration with the World Health Organization. Before moving to Oxford, Laura spent more than six years building capacity in research design, implementation and ethics across Asia and Africa as Head of Clinical Trials for the Oxford University Clinical Research Unit Viet Nam.

Dr Matthew Snape

Speaker

Consultant in Paediatrics and Vaccinology, NIHR Oxford Biomedical Research Council & Oxford University Hospitals NHS Trust

Dr Matthew Snape is a consultant in General Paediatrics and Vaccinology at the Oxford University Hospitals NHS trust and an Honorary Senior Clinical Lecturer at the University of Oxford. After completing basic training in paediatrics at the Royal Children's Hospital, Melbourne, he worked in the paediatric intensive care unit at St Mary's Hospital, London. While caring for children suffering overwhelming infections he developed an interest in the prevention of these illnesses by immunisation. This led him to the Oxford Vaccine Group, part of the University of Oxford, Department of Paediatrics, where he has undertaken paediatric clinical trials of meningococcal, pneumococcal, influenza and Hepatitis B vaccines. Dr Snape is partially funded by the Oxford Partnership Comprehensive Biomedical Research Centre.

Richard Tarrant

Speaker

Quality Assurance Manager, Clinical Bio-Manufacturing Facility, University of Oxford

Richard completed his degree in Molecular and Cellular Biology at the University of Kent in 2006, which included an Industrial placement within the Biopharmaceutical Centre of Excellence for Drug Discovery at GSK in Beckenham, Kent. 

After a short-term role at the MHRA, Richard worked for three years at Lonza Biologics as a virus validation Study Director. 

He then went on to complete a PhD in Biochemical Engineering at University College London, focusing on the downstream process of monoclonal antibodies with particular emphasis on Host Cell Protein characterisation and removal. 

Richard joined the CBF in 2013, initially as its Quality Control Manager, and is now a Quality Assurance Manager and also training to become a Qualified Person (QP). 

Dr Mike Whelan

Speaker

Vaccine Developer

Mike is a BSc Biochemist and then completed his PhD in Immunology at the Royal London Hospital. Post-doctoral study at the Institute for Animal Health (IAH) focused in investigating CTL responses in horses infected with Equine Herpesvirus 1. This was then followed by working as a post-doctoral scientist at The Edward Jenner Institute for Vaccine Research examining the immune activation of dendritic cells and their role in defining TH1/TH2 immune responses.

Mike then moved over into industry and spent seven years as Head of Research at Onyvax Ltd. This company was developing allogeneic whole cell vaccines for cancer. Mike’s team was involved in both pre-clinical proof of concept studies, and then the examination of samples from both Phase I and II clinical trials. He joined iQur Ltd in 2006 and his team helped develop a universal influenza vaccine based on a novel virus like particle vaccine platform. Mike is currently working as a freelance consultant.

Dr Ly-Mee Yu

Speaker

Associate Professor and Deputy Academic Director, Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, Oxford

Ly-Mee Yu has over 20 years of experience as a medical statistician and specifically in clinical trials for the past 12 years.

She has worked in a wide range of clinical areas and also a member of the Oxford Tropical Research Ethics Committee, as well as a member of Data and Safety Monitoring Committee, and Trial Steering Committee of several national and international trials.

Application

Level and demands

Vaccinology is a cross-disciplinary subject and the most exciting developments in vaccinology have occurred when people from diverse research, business and medical backgrounds have used their skills to collectively tackle problems in vaccine design, manufacture and distribution.

Our course participants will therefore reflect the diversity of the subject and be from business, academic, clinical and veterinary backgrounds. The course will be of particular interest to research scientists, programme managers, clinical trial coordinators, nurses, physicians and veterinarians. The course will be accessible to people already working in the field or to those who wish to enter the field.

People from the following organisations and companies have attended the Oxford Vaccinology Programme:

Baxter BioScience, Baxter Innovations GmbH, Boehringer Ingelheim Animal Health GmbH, Centre for Clinical Vaccinology and Tropical Medicine (University of Oxford), Clinical Biomanufacturing Facility (University of Oxford), Commission on Human Medicines, Cumbria and Lancashire Health Protection Unit, Datamonitor, Department of Paediatrics (University of Oxford), Division of Public Health and Primary Health Care (Oxford), Drug Delivery Solutions, European Medicines Agency (EMEA), Emergent BioSolutions Inc, Federal Ministry of Animal Resources and Fisheries, Genecom, Glide Pharma, ICON Clinical Research, IDT Biologika GmbH, Imaxio, Inocul8, Institute for Animal Health (IAH), Irsicaixa, Laboritorios Leti, S.L., London School of Hygiene and Tropical Medicine, Medicago R&D, MHRA, Moredun Research Institute, Novartis, Nuffield Department of Clinical Medicine (University of Oxford), Oxford Vaccine Group, PATH Malaria Vaccine Initiative (MVI), Pfizer Ltd, Sagittarius IP, Solvay Biologicals, Solvay Pharmaceuticals Inc, Statens Serum Institut, Subiaco Associates Ltd, The Jenner Institute (University of Oxford), Tropical Medicine (University of Oxford), Vaccibody AS, Veterinary Laboratories Agency, Wellcome Trust Centre for Human Genetics, World Health Organisation, Wyeth

If you're uncertain whether this course is suitable for your requirements, please email us with any questions you may have.