Clinical Vaccine Development and Biomanufacturing

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 will come 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.

If you’re uncertain whether this course is suitable for your requirements, please contact us by email at vaccinology@conted.ox.ac.uk with any questions you may have.

Programme details

The below programme may be subject to revision.

Each day will start at 9am (unless otherwise stated) and finish no later than 6pm. The exact timings will be confirmed closer to the start date.

All timings are British Summer Time (UTC+1). A world clock, and time zone converter can be found here: https://bit.ly/3bSPu6D

Day 1 – Monday 2 November

• Welcome, Introductions and Course Introduction
• Prelude to human and veterinary vaccinology: scientific, manufacturing and regulatory synergies
• Introduction to vaccine platforms
• The clinical vaccine development process
• Immune mechanisms and finding correlates of protection
• Clinical development of a vaccine against lung cancer
• Key challenges and considerations in Phase 3/4 trial management

Day 2 – Tuesday 3 November

• Introduction to biomanufacturing
• Taking lab discoveries into manufacture – a COVID19 case study
• Fundamentals of technology transfer
• Statistical considerations when designing a clinical trial
• Safety testing of novel biological and viral vaccines
• Vaccine Production Considerations in Good Manufacturing Practice (GMP) (Part I)

Day 3 – Wednesday 4 November

• Visit to Clinical Biomanufacturing Facility (CBF), University of Oxford (Depart 08:30)
• Vaccine Production Considerations in GMP (Part II) 
• Introduction to GMP upstream and downstream processes
• Process Development case study
• Introduction to RNA vaccine technologies
• Industry case study: Vaccine development at Moderna against Respiratory Syncytial Virus (RSV)
• Meet-the-speakers Q&A at The Oxford Wine Café, Little Clarendon Street (17:30-19:00)

Day 4 – Thursday 5 November

• Case study: Phase 3 vaccine trials in Africa – the R21 malaria vaccine story
• Ethical considerations for trials in developing countries
• Regulatory vaccine trial applications in the UK, Europe and beyond
• The importance of post-vaccination surveillance. Case study: Bacterial Meningitis (finish 14:30)

Attending in person

Further details will be emailed to you two weeks ahead of the course, including registration information. 

Please get in touch if you have not received this information within five working days of the course start date.  

In the meantime, you may wish to plan your travel: Travel information 

Online course information:

The online version of the course will be broadcast live on Microsoft Teams. You will have access to all the live sessions as they are taught in the classroom.

You will be able to ask questions via the ‘Chat’ feature on Teams and we will also provide two-way video/audio so you can see the tutors teaching and ask questions directly (you will need to use a connected device with a microphone for this such as a laptop or smartphone).

If you are taking the course online, you will not be able to participate in the tour of the Clinical Biomanufacturing Facility (CBF), University of Oxford, or the Meet-the-speakers Q&A.

In order to successfully attend this course online, your connected device should meet the following IT requirements – https://onlinesupport.conted.ox.ac.uk/system-requirements/

Accessing the online course

Details about accessing the private Microsoft Teams course site will be emailed to you during the week prior to the course commencing.

Please get in touch if you have not received this information within three working days of the course start date. 

IT requirements

For those attending the course remotely, the course will be streamed using Microsoft Teams. You will be required to follow and implement the instructions we send you to fully access Microsoft Teams on the University of Oxford’s secure IT network.

To participate you must be familiar with using a computer for purposes such as sending email and searching the Internet. You will also need regular access to the Internet and a computer meeting our recommended minimum computer specification.

It is advised to use headphones with working speakers and microphone.

Prof Sandy Douglas

Group Head / PI, University of Oxford

I am an academic clinician and hold a Wellcome Trust Postdoctoral Fellowship for Clinicians (i.e. Career Development fellowship). My main interests are the development of antibody-inducing vaccines against the sporozoite stage of malaria and the development of a novel thermostable rabies vaccine.

In earlier work, I identified the potential of PfRH5 as an antigen capable of inducing highly potent strain-transcending neutralising antibodies against the disease causing blood-stage of Plasmodium falciparum and demonstrated that PfRH5-based vaccines could achieve in vivo protection against a virulent P. falciparum challenge. These vaccines are now in clinical trials.

Dr César López-Camacho

Dr. César López-Camacho is currently a Senior Researcher at the Jenner Institute where he works on genetic-vaccine development for arthropod-borne pathogens, with a special interest in tick-borne pathogens.

He holds a PhD in Molecular Biology from the University of Manchester, United Kingdom, and has held four postdoctoral positions in molecular biology, fidelity of gene expression, and vaccinology at UMASS Medical School-USA, University of Vermont College of Medicine-USA and the Jenner Institute at University of Oxford, respectively.
His contribution encompasses the development of a Zika virus vaccine, a Chikungunya virus vaccine and other vaccines for infectious agents (HPV, T. cruzi and malaria).
He is interested in antigen design and optimisation of antigen expression in vivo.

During the coronavirus pandemic, his scientific activity encompassed the design and protein production of SARS-CoV-2 antigens to be utilised as diagnostic tools, for coronavirus research applications and for the exploration of the immune responses in COVID-19 convalescent individuals.

In terms of intellectual property activities, he is an inventor and collaborator in vaccine-related patents and he is an author in more than 30 scientific publications related to vaccinology.  

Susanne Hodgson

Clinician Scientist, Nuffield Department of Medicine, University of Oxford

Dr Elizabeth Clutterbuck

Elizabeth is a BRC and James Martin School funded Post Doctoral Researcher in the OVG lab, mainly working on B cell studies based around the clinical trials.
Prior to working in OVG she completed an MSc in Immunology at Kings College London, followed by an 18 month post as a Guest Researcher in the Respiratory Diseases Branch at CDC in Atlanta.

Elizabeth’s main focus now is on B cell responses to vaccine antigens and has developed assays to identify antigen specific B cells by ELISpot and Flow Cytometry. This work has been applied to studies both in the UK and in Fiji where the data are being used to help optimise pneumococcal vaccine schedules.

Saul Faust

Saul N Faust is Senior Lecturer in Paediatric Infectious Diseases and Immunology and Director of the Wellcome Trust Clinical Research Facility at the University of Southampton. As an MRC Clinical Training Fellow in Paediatric Intensive Care and Infectious Diseases and then Clinical Lecturer at Imperial College London, he completed his PhD on the pathophysiology of coagulation abnormalities in meningococcal sepsis, work that led directly to clinical trials in paediatric intensive care. Current projects include work to bridge the clinical-laboratory interface in paediatric infectious diseases, immunology and respiratory medicine (including biofilm-related clinical diseases), developing local and national collaborative clinical trials in paediatric infectious diseases, and conducting paediatric and adult vaccine trials as part of the UK academic paediatric vaccine group. Saul is currently Chair of the UK NIHR Medicines for Children Clinical Speciality Group for Allergy, Infectious Diseases and Immunity.

Dr Shawkat Hussain

Dr. Shawkat Hussain is the Associate Director of Bioprocess and Analytical Development (BiPAD) at the Jenner Institute, a role he has held since January 2025.

He spearheads research to streamline regulatory requirements and reduce the costs of translational biologics and vaccines for Phase 1 trials. Shawkat leads the Chemistry, Manufacturing, and Controls (CMC) development and technology transfer of biologics within the group, including vaccines targeting Epstein-Barr Virus and Junin.

Previously a Senior Scientist, Shawkat has over three years of experience within the BiPAD group, contributing to scientific and strategic initiatives. He now helps shape the direction of the BiPAD Core Facility, manages staff and budgets, oversees collaborations with internal and external partners, and supports academic development within the wider team.

He has a strong background in bioprocessing, which started with a PhD in Biochemical Engineering from UCL, followed by 3 years as Downstream Principal Scientist at Fujifilm, primarily working on monoclonal antibodies (mAbs) and other biologics. Within that time, he also served as DSP Lead within the then-newly formed Process Characterisation unit at Fujifilm, overseeing projects spanning at least 12 months, and directly managing more than 4 scientists.

What Shawkat enjoys most about the group is the people and the collaborative environment, the strategic impact of the work, and the opportunity to lead innovations that directly support the development of life-saving vaccines.

Prof Ly-Mee Yu

Professor of Clinical Trials and Biostatistics, Co-Director of the Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, Oxford

Ly-Mee Yu has over 30 years of experience as a medical statistician and specifically in clinical trials for the past 20 years.

She has worked in a wide range of clinical areas and has published over 200 articles in peer-reviewed journals. She is currently the lead statistician of two platform adaptive decentralised clinical trials to evaluate treatment for COVID-19 in the community.  She is a panel member of the NIHR  Research Programme for Social Care and the Definitive Interventions and Feasibility Awards (HRB Ireland). She is also a member of the CHM Cancer Vaccines Expert Working Group (CVEWG) and has sat on various NIHR funding boards and the Oxford Tropical Research Ethnics Committee. She is a chair/member of data and safety monitoring committee, and the trial steering committee of several national and international trials.

Dr Richard Tarrant

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 Patience T Brace

Senior Vaccine Production Scientist, Pandemic Sciences Institute

Prof Daniel G. Bracewell

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 Matthew Snape

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.

Alison Lawrie

Senior Vaccine Development Co-ordinator and Head of Regulatory Affairs, The Jenner Institute

To be eligible for a certificate of attendance, you will need to attend the whole course. Participants who meet this criterion will be emailed after the end of the course with a link, and instructions on how to access their University of Oxford digital certificate. 

The certificate will show your name, the course title and the dates of the course you attended. You will also be able to download your certificate or share it on social media if you choose to do so.

Fees

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

If you require an invoice for your company or personal records, please contact the course administration team at vaccinology@conted.ox.ac.uk

Payment is then accepted online, by credit/debit card, or by bank transfer.

Although not included in the course fee, accommodation may be available at our on-site Rewley House Residential Centre. All bedrooms are en suite and decorated to a high standard, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.

To check prices, availability and to book rooms please visit the Rewley House Residential Centre website. 

Enrolled students are entitled to discounted accommodation rates for the purpose of study, at Rewley House, and can contact the administration team for the promotional code to use for making online accommodation bookings via the website.

Module code: O26C001C9Y

If you would like to discuss your application or any part of the application process before applying, please contact us on vaccinology@conted.ox.ac.uk

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