Speakers
Roz Sutton
Rubina Ahmed
Gillian Livock
Naho Yamazaki
Panel session
Roz has 25 years of regulatory experience in a variety of different companies including Roche Pharma and GlaxoSmithKline as well as SME companies such as DLRC and Medeva Group- Research. She has held positions of growing impact and responsibility over the years from regulatory professional to team leader and group director.
She brings extensive regulatory expertise, including FDA and EU Scientific Advice, Paediatric Investigation Plans, Orphan Drug strategy, MAA submissions, Clinical Trial Applications, Investigational New Drug Applications, FDA Model Informed Drug Development, Breakthrough Designation, PRIME applications and PRIME Rapporteur interactions, Due Diligence and Gap analysis.
Roz holds a BSc in Pharmacology and a Certificate of Training Practice, an accredited qualification from the Institute of Personnel. Over the course of her career, she has gained extensive experience in various leadership and regulatory roles within the pharmaceutical industry, particularly at Roche Pharma and DLRC Regulatory Consultancy, as well as in research with Medeva Group.
At Roche Pharma, Roz served as both a Team Leader and Regulatory Lead. In this capacity, she was responsible for driving global regulatory strategies, including assessing accelerated approval pathways, special designations, and developing pediatric strategies. She led health authority interactions and provided regulatory expertise for due diligence activities. In response to the COVID-19 pandemic, Roz embraced agile working approaches, ensuring the integrity and safety of ongoing studies. Additionally, she created a global early talent program aimed at developing future-ready regulatory affairs professionals and led a cross-functional team focused on reducing clinical trial costs by minimizing IMP wastage and utilizing generics and biosimilars in place of branded products.
As a Senior Program Manager at Roche, Roz continued to drive innovative global regulatory strategies and adopted agile working methods, including simplifying the IND process to facilitate FDA reviews. Her role involved EU partner and regulatory lead responsibilities in the neuroscience therapy area, where she developed global regulatory strategies for Alzheimer’s and Huntington’s diseases. She also pioneered discussions with the FDA as part of their model-informed drug development pilot, which led to a successful collaboration with the agency.
During her time at DLRC Regulatory Consultancy, Roz served as a Regulatory Team Leader, where she developed and implemented commercially focused global regulatory strategies, particularly within the Oncology Franchise. She also project-managed the preparation, review, and submission of regulatory documents, including MAA submissions, Scientific Advice, Paediatric Investigation Plans, Orphan drug applications, and clinical trial applications (INDs).
Earlier in her career at Medeva Group Research, Roz led product license variations for labeling and CMC changes, submitted clinical trial applications, and managed interactions with the MHRA, further enhancing her regulatory expertise.
Roz’s diverse experience has equipped her with a comprehensive skill set in global regulatory affairs, clinical trial management, and cross-functional leadership, making her well-prepared to navigate complex regulatory environments and contribute to the success of pharmaceutical development projects.
Dr Rubina Ahmed is the Director of Research, Policy and Services at Blood Cancer UK where she is accountable for the delivery of the charity’s mission-focused programmes. Her team is responsible for delivery of research funding programmes; health information and services that support people affected by blood cancer including a bespoke clinical trials support service; and policy and advocacy work. The charity recently published the Blood Cancer Action Plan, which highlights the importance of clinical trials in blood cancer.
Rubina holds a PhD in Immunology and an MSc in Management. She has broad experience as a senior leader in the health and life sciences sector working in strategy development and implementation, scientific research funding, policy and influencing, change management, health inequalities, and delivery of beneficiary services by charities. She has developed her career across both the public and charity sector, including in roles with the Wellcome Trust, Cancer Research UK and the Stroke Association. Rubina has worked extensively with national bodies and policymakers, including serving on the Stroke Delivery Programme Board for NHS England, development of national clinical guidelines, clinical trials funding and regulations, and with organisations such as the AMRC and Richmond Group of Charities.
Alongside her role at Blood Cancer UK she is a Council Member of the British Science Association – a charity focused on the engagement of the public in science; and for Pro Bono Economics – a charity which works to demonstrate the economic value of civil society organisations to policy and decision-makers.
Gill Livock is a seasoned executive with extensive experience in driving commercial strategy and growth across clinical development. As Chief Commercial Officer, she leverages her expertise in market analysis, strategic partnerships, and customer engagement to drive business performance and expand market reach.
With a career spanning over two decades, Gill has held key leadership roles in both established Fortune 100 companies and innovative double unicorn startups. Her strategic vision and ability to adapt to changing market dynamics have consistently led to the development of successful commercial initiatives and revenue growth. She is known for her collaborative approach, strategy development and fostering cross-functional teams to deliver exceptional results.
Gill holds a MBA in Life Sciences and is passionate about mentoring the next generation of leaders. Outside of her professional commitments, she enjoys supporting her children in their activities and you will most likely find her in a stable, walking the dogs or reading a book.
Naho is Deputy Director of Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to ensuring clinical trial participants are representative of the population who will benefit from the findings of research, embedding meaningful patient and public involvement and engagement in research, and making research transparency the norm. She joined the HRA in Sep 2019, having worked on developing and influencing a range of life sciences policy at the Wellcome Trust, NSW Ministry of Health in Australia and the UK Academy of Medical Sciences.
Kym Eves is a principal at ReNable Research, an innovative Trial Delivery Company that helps companies deliver clinical trial enrollment as well as promising new tools that make drug development so much easier. With a career spanning a variety of senior management and board roles, Kym has a rare combination of SMO/CRO/Biotech/Clintech leadership experience, giving her an exceptionally deep understanding the problems and challenges faced by every trial and drug development stakeholder and which has been distilled in the world’s first Enrollment Delivery Platform. Kym founded one of the first Site Management Organisations in the US, is an Ernst & Young UK Life Sciences Entrepreneur of the Year, and a recipient of the Gold Stevie Award for Female Executive of the Year in Europe, the Middle East, and Africa. She is a member of the London Mayor’s Business Advisory Board and a former Entrepreneur in Residence for Life Sciences at Cambridge Enterprise.