Developing our Inclusion and Diversity Plan and supporting guidance

Shaun is a health services researcher interested in efficient trial design, particularly around inclusive recruitment and retention and the effective presentation of research evidence. He led the development of the National Institute for Health Research INCLUDE Ethnicity Framework, a tool to help trialists design ethnically inclusive trials and PRECIS-2, a tool to match trial design decisions to what the users of the results need.

He leads an initiative called Trial Forge that aims to be more systematic about how we identify, generate and use research evidence in making trial design, conduct, analysis and reporting decisions. In 2019 Trial Forge won the international CochraneREWARD Prize for outstanding work in reducing waste in research.

Collaborating with the HRA and MHRA on the development of their Inclusion and Diversity Plan and its supporting guidance was a welcome and natural extension of Shaun’s existing work. For trials to be more inclusive, all parts of the trial ecosystem need to make judgements as to whether the design, conduct analysis and reporting of a trial is as inclusive as it should be. The HRA and MHRA are central partners to work with in this ecosystem.

Mahendra is a trailblazing pharmacist and global leader. He is a member of the Teaching Faculty at UNESCO, and Patron of the Commonwealth Pharmacists Association.  He has also served the Royal Pharmaceutical Society as an elected national board member and as treasurer.

Mahendra is the first to be awarded a Fellowship from NICE with a programme that became national across healthcare faculties at over 40 universities. He was also the first to be made International Fellow of the Indian Pharmaceutical Society for his work in many states across India to help reduce antimicrobial resistance.

Mahendra is the founding member and Director of the Centre for Research Equity through pharmacy, communities and healthcare at the University of Oxford, which culminated from his work with the Covid 19 treatment trials for the Principle and Panoramic trials to promote and support inclusive research UK-wide.

Mahendra is Professional Advisor to the Chief Pharmaceutical Officer NHS England and champions UK-wide the importance of equality, diversity and inclusion in professional practice. In 2022, he was awarded the OBE for his outstanding contributions to pharmacy, and in 2023, he was awarded an honorary degree of Doctor of Health by the University of Bradford.

Megan Salt is a Senior Program Director in regulatory affairs at Roche/Genentech and serves as a Regulatory Lead for advancing inclusive research. She earned her PhD from the University of California, San Francisco in Biomedical Science before moving to Pharma. She has worked across a variety of regulatory affairs oncology programs at Roche/Genentech. As a Regulatory Lead for advancing inclusive research, she works with regulatory and cross-functional leaders across the organisation to develop and implement diversity action plans for global clinical development programs.

Sat Shetage is a Regulatory Program Director and has been an active member of the Advancing Inclusive Research Squad at Roche. Sat earned his PhD at the University of Hertfordshire, UK and has worked in the pharmaceutical industry for almost 10 years. Sat believes that inclusive research is the right thing to do and the time to act is now. Driven by this passion, Sat collaborates with numerous stakeholders internally within Roche and externally to further inclusive research as a priority.

Clare has over 25 years industry experience, including 10 plus years in a senior management capacity. She has held management positions in data management, phase I operations, strategy and planning, project management and global project delivery. She is now Global Head of Digital Health and Innovation at Fortrea where she is helping to change the face of how clinical research is developing. She specialises in strategy development for both internal and external partners. Clare's special interest lies in the relationship between the caregiver and physician team and how the use of digital technology can augment this.

A multi- award-winning scientific innovator with strong commercial acumen and a proven track record in medical devices and pharmaceuticals. With a PhD in medicine, she maintains broad clinical and scientific interests including wound healing, diabetes, cardiovascular, respiratory, inflammatory diseases, ophthalmology and orthopaedics.

Consulting since 2010, Joanne formally established Covesea Clinical Consulting Ltd in 2020. Providing strategic clinical development advisory and operations support, she helps UK as well as international clients to navigate the complex pathways toward global regulatory approval and commercialisation. She additionally retains an Honorary Senior Lectureship (Associate Professor) at the William Harvey Research Institute, Queen Mary University London.

Joanne has substantially contributed to significant pre-clinical and clinical evidence packages, leading to successful market approvals and acquisition. Notably, she was instrumental in the patent generation, product development and clinical evidence generation which eventually led to acquisition of Thirty technology Woundcare by Convatec, in April 2023, for circa £176 M. She additionally acts as Scientific Advisor to Ascension Life Fund and Empirical Ventures.

In 2023, Joanne became a member of the first cohort of the (Start Codon/ RBW) Diverse Directors Programme. She has been a board Observer and also a Board Member/ Director of a small UK Biotech.

Chief Scientist and Executive Director of the NNEdPro Global Institute for Food, Nutrition and Health

Bye-Fellow of Fitzwilliam College and Director of Research (‘TIGR2ESS’ GCRF Flagship Project on Food, Nutrition and Education), University of Cambridge

Professor of Global Nutrition, Health and Disease, Ulster University

Sumantra (Shumone) Ray is a Licensed Medical Doctor as well as a registered nutritionist (public health), with special interests in cardiovascular disease prevention and nutrition education in global food and health systems. As Chief Scientist and Executive Director of the NNEdPro Global Institute for Food, Nutrition and Health, most recently Professor Ray has been cross-appointed as a Director of Research at the University of Cambridge and Co-Lead for the Food, Nutrition and Education Work Package for the ‘TIGR2ESS’ Programme in India (2017-22) led by Cambridge and supported by UK Research and Innovation's Global Challenges Research Fund (GCRF).

Professor Ray is a Bye-Fellow of Fitzwilliam College at the University of Cambridge, and, additionally, holds a fractional personal chair appointment as Professor of Global Nutrition, Health and Disease at Ulster University where he served an Advisory Board Member to the high-impact GCRF Latin American SAFEWATER programme (2017-22). In addition, he has a number of honorary/visiting professorial appointments, including Imperial College London in the UK, and internationally. He is also the founder and Co-Chair of the flagship journal, BMJ Nutrition, Prevention and Health as well as the founder and principal investigator for the multi-award-winning Mobile Teaching Kitchen International Initiative currently operating successfully in India, Mexico, USA and the UK.

Since 2008 Professor Ray and NNEdPro have pioneered efforts in studying the positioning and implementation of medical and health-systems related nutrition education, working across over 65 countries through regional networks convened by NNEdPro and its International Academy of Nutrition Educators.

Paula is Emeritus Professor of Nursing, at Birmingham City University. Her research has examined the experiences of a wide range of social groups, including street dwellers and members of minority ethnic communities, which have highlighted the multiple ways in which prejudice and discrimination can affect access to healthcare. Paula has also taken an active role in research ethics in academic settings and, more recently, in the HRA in promoting understanding of the importance of including members of socially marginalised communities in research studies.

I have had a background mainly in the charity sector, both larger charities but especially smaller charities in underserved communities. I have also worked in mental health. My current role is focused around engaging with the public health, development and engagement with my own community, Knowle West, and how this also relates to its context in the City of Bristol and beyond.

I have been involved in various public contributor roles recently, particularly around improving public health. It has been good to be part of the work with HRA, in order to support improvements in medical trials, in a way that serves to draw in a wider and more representative cross-section of groups. It is also positive to see the quality and standard of research in the UK offer exemplary models and guidance.

Chris is a senior statistician at the University of Nottingham. He previously worked at the University of Leicester Biomedical Research Centre and the Pragmatic Clinical Trial Unit at Queen Mary, University of London. He currently advises researchers on research inclusion and quantitative methodology at the Research Support Service, formerly known as the Research Design Service. He is also the co-creator of the Research Design Service EDI Toolkit.

Kieran Prior is currently Engagement and Impact Lead in the ECMC (Experimental Cancer Medicines Centres) Network, based within Cancer Research UK (CRUK) and co-funded by CRUK, National Institute for Health and Care Research, the Little Princess Trust, and the health boards of the Devolved Nations. In this role Kieran is working with the ECMC Network and beyond to improve equity of access to experimental clinical trials. This involves developing guidance and roadmaps to engage with underserved communities to address issues regarding trust and awareness and to reduce barriers to participation in research that will ultimately create more representative trial populations.

Dr Jodie Allen leads Clinical Trial Diversity at AstraZeneca with responsibility for global strategy and capability building across clinical development and operations. A Medical Sociologist by training, Jodie has 20+ years experience working in academia, life science consulting, and in the pharmaceutical industry. Dr Allen delivers large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.

A ‘family carer’ with over 35 years' experience; hence has extensive experience of dealing with NHS health professionals particularly GPs, pharmacists, and community mental health care personnel.

He has over 13 years’ experience of involvement in health education, training and research, a co-author of a number of papers, a co-applicant on many research applications and has assisted university academics / clinicians in successfully obtaining national funding on a number of occasions.

He sits on several NHS England committees, National Institute for Health and Care Research committees, and has been a public contributor at the Health Research Authority for over 11 years, assisting with various work-streams.

I have experience working in clinical trial delivery and research governance, and I have helped to facilitate clinical research across a range of disease areas within the NHS.

I am dedicated to improving the representation of underserved groups in clinical research. I believe that the topic of inclusion must be addressed at all stages of study design, engagement, and delivery. It is far too important of an issue to be an afterthought. Adopting intersectional approaches to inclusion initiatives, in my opinion, is critical to ensure meaningful and effective outcomes.