Clinical Vaccine Development and Biomanufacturing

Programme details

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

Day 1

• 9:00 - 10:15: Course introduction
• 10:15 - 11:00: Introduction to vaccine types
• 11:00 - 11:20: Coffee Break
• 11:20 - 12:20: Taking lab discoveries into manufacture
• 12:20 - 13:30: Lunch
• 13:30 - 14:30: GMP Manufacturing of IMPs -  a QP’s Perspective
• 14:30 - 15:30: Flu vaccine manufacture and clinical development
• 15:30 -  15:50: Coffee Break
• 15:50 -  17:00: CASE STUDY (Influenza Vaccine Planning)

Day 2

• 9:15 - 10:30: Introduction to GMP upstream and downstream processes
• 10:30 - 10:50: Coffee Break
• 10:50 - 11:50: Process Development case study
• 11:50 - 12:50: Manufacturing and quality risk management during the vaccine development and manufacturing process
• 12:50 - 14:00: Lunch
• 14:00 - 15:00: Clinical development overview
• 15:00 - 15:20: Coffee Break
• 15:20 - 16:30: Immunomonitoring and Immune correlates

Evening: : Walking tour and social evening

Day 3 

• 9:00 - 11.15 : Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford
• 11:15 - 11:30: Coffee Break
• 11:30 - 12:30: TBC
• 12:30 - 13:45: Lunch
• 13:45 - 14:45: Clinical trials in developing countries
• 14:45 - 15:45: The importance of post - vaccination surveillance. Case study: Bacterial Meningitis
• 15:45 - 16:10: Coffee Break
• 16:10 - 17:10: Designing and coordinating large, multi - centre, Phase III clinical trials in different age cohorts: case studies 'Rotavirus, HPV and Zoster'

Day 4

• 9:30 - 10:30: Statistical considerations when designing a clinical trial
• 10:30 - 10:50: Coffee Break
• 10:50 - 11:50: Adjuvants for vaccines in clinical trials
• 11:50 - 13:30: Ethical considerations for trials in developing countries
• 13:30 - 14:30:  Lunch
• 14:30 - 15:00: 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 Certificate of Attendance. The sample shown is an illustration only and the wording will reflect the course and dates attended.

Accommodation

Fees

Standard course fee: £1295.00

Funding

There are a limited number of opportunities for fully or partially subsidised places for individuals working in low and middle income countries. Email us for further details.

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

Dr Rebecca Ashfield

Speaker

Senior Project Manager, The Jenner Institute, University of Oxford

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

She carried out post-doctoral research into regulation of gene transcription and Type II Diabetes, and was awarded junior research fellowships by Magdalen College and Worcester College Oxford.

Dr Ashfield then worked for 12 years as a project and collaborations manager 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.

Dr Helen Bright

Speaker

Director and Head of Flu Manufacturing, Science and Technology, Biopharmaceutical Development, MedImmune

Helen Bright is an immunologist with over 25 years’ experience in the biopharmaceutical industry. She has a degree in microbiology from the University of Newcastle upon Tyne and a PhD in virology and immunology. 

She is currently Director and Head of Influenza Manufacturing Sciences and Technology in Biopharmaceutical Development at Medimmune. She is responsible for the research, selection and development of vaccine strains for the seasonal and pandemic live attenuated influenza vaccine.

Previously, she has successfully led anti-viral, immune modulation and vaccine discovery projects in infectious diseases, respiratory and oncology therapeutic areas at GSK and Pfizer.

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 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 Lucy Dorrell

Speaker

Senior Clinical Lecturer, Honorary Consultant in GUM/HIV, The Jenner Institute, University of Oxford

Lucy Dorrell obtained a Bachelor of Medicine from the University of Southampton in 1988. After junior hospital posts during which she obtained MRCP, she began her research career in 1993 as a Clinical Research Fellow in Communicable Diseases and Genitourinary Medicine at Imperial College, London with Professor Jonathan Weber.

She was awarded a DM degree in 1998 from the University of Southampton for her research into antigen-presenting cell function in HIV infection. She was subsequently awarded an MRC Clinical Training Fellowship to study immunological mechanisms of resistance to HIV-1 and HIV-2 under Professor Sarah Rowland-Jones at MRC Laboratories, The Gambia and at the Weatherall Institute of Molecular Medicine. In 2000 she was awarded an MRC Clinician Scientist Fellowship, which she took up in 2002 after completing clinical specialist training and obtaining a CCST in HIV/GUM.

With Professor Andrew McMichael she set up a programme of translational research evaluating therapeutic immunisation in HIV-1 infection with novel DNA and modified vaccinia virus Ankara-vectored HIV-1 vaccines developed at MRC Human Immunology Unit. She was awarded a HEFCE Clinical Senior Lectureship in 2007.

Her research team is conducting further clinical therapeutic vaccination studies while also investigating mechanisms which determine success or failure of host immune control of HIV.

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.

Prof Adrian Hill

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 Sonali Kochhar, M.D.

Clinical Associate Professor, Department of Global Health, University of Washington, Seattle; Scientific Researcher, Department of Public Health, Erasmus University Medical Center, Rotterdam and Medical Director, Global Healthcare Consulting

Dr Sonali Kochhar has twenty years of experience in a Leadership position for Global Phase I-IV Clinical Research, Epidemiology and Safety Studies for Vaccines and Drugs conducted in the USA, Europe, Asia, Africa and India in Adult and Pediatric populations, Infectious Diseases (HIV/AIDS, Influenza, Group B Strep, RSV, Diarrheal Diseases, Malaria, Tropical diseases), Vaccines for Pregnant Women, Introduction of New Vaccines, Pandemic Preparedness, Translating research into programs by Healthcare Systems Strengthening (including Governance, Capacity Building, Logistics and Supply Chains) for Immunization and Maternal and Child Health programs, HIV/AIDs Prevention, and Treatment, Research Ethics for Vaccines for Epidemics, and working with vulnerable and at-risk populations (including women, adolescents, children, MSMs,  IDUs and Sex Workers).

Dr Kochhar has conducted multiple studies- including vaccine clinical trials- in Kenya, Uganda, Zambia, The Gambia, South Africa, the United States, India, Bangladesh and Nepal. She provides expertise for Vaccine Research and Development (including for Viral Vectors (MMV, AAV, Ad-5 etc.), DNA, Proteins, Inactivated, Subunit Vaccines, Adjuvants etc.).

She has co-authored international Vaccine Safety Research Standards, Case definitions of Adverse Events for Vaccines Research, Guidelines for Vaccine Safety Research and Template Research Protocols. She is the Lead for the development of Maternal and Neonatal Case Definitions for Maternal Immunisation (MI) and has co-authored international guidelines for vaccines in pregnant women clinical trials and studies.  The definitions and guidelines are being utilized in clinical research, studies and AEFI surveillance for Vaccines and Maternal and Child Health Research globally. She is a member of various International Steering and Executive Committees, International Scientific Advisory Boards and serves as Guest Faculty for International Vaccinology Programs (including the LIVE (Leading International Vaccinology Education) Master’s Program, Europe).

As the Medical Director for the International AIDS Vaccine Initiative earlier, she was responsible for the clinical development of several vaccine candidates in India and Africa. As the Clinical Research and Drug Development Specialist, she has provided leadership for clinical research for PATH. Prior to IAVI, she was responsible for teams and activities spanning 11 South-East Asian countries for Eli Lilly and Company, providing technical expertise, strategy, and supervision. 

As the Country Director for the USAID | DELIVER PROJECT for John Snow India Pvt. Ltd., an International Health Consultancy Organization, she led efforts to translate research into programs by Healthcare Systems Strengthening (including Capacity Building, Logistics and Supply Chains) for Immunization and Maternal and Child Health programs, and enhance the use of technology for health systems planning and monitoring.

Prof Tarit Mukhopadhyay

Speaker

Senior lecturer, Department of Biochemical Engineering, University College London

Tarit is a senior lecturer in the Department of Biochemical Engineering at University College London. For the past ten years he has been working in the field of vaccine bioprocess development on a range of bacterial and virus vaccines. His early work with the Health Protection Agency, involved working on a novel Meningitis B vaccine and the UK licensed Anthrax vaccine.

Since then his research targets include the upstream and downstream processing of conjugate vaccines and virus vectors such as adenovirus, AAV and lentivirus. These include thermo-stable formulation of lentiviruses, novel chromatographic separation techniques for AAV and high-cell density production of adenoviruses.

In 2014, Tarit joined the EU funded (FP7) FLUTCORE consortium to utilise virus like particles to create a universal influenza vaccine expressed in Pichia pastoris. The idea is to create a platform manufacturing process that is independent of antigen switching.

A main focus of his research is scale-down and scale-up. The primary methodology is to create scale-down models that mimic the processing environment to determine CQA/CPP that can be accurately applied to the commercial scale. The obvious benefits of this are reducing time to market and cost.

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

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.

Prof 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.