Regulatory and Access Community Connects

Rosie Delaney

VP, Head of Market Access, tranScrip

Dr. Rosemarie Delaney is an accomplished professional with over 25 years of experience in the pharmaceutical industry, serving in senior roles across Pharmaceutical, Vaccine, and Medical Device corporations at UK, European, and Global Director levels. Currently, she is the Vice President and Head of Market Access.

Rosemarie is a seasoned Market Access expert with extensive experience in a wide range of therapeutic areas. Her expertise includes Global Market Access Strategy, Pricing and Reimbursement (P&R), and Value Proposition Development. Her leadership and operational insights have significantly contributed to various organizations.

From 2020 to 2024, Rosemarie served as the Senior Director for Government Affairs and Market Access (GAMA) at Indivior UK Ltd, focusing on treatments for Opioid Use Disorder (OUD) across Europe and Canada. Prior to this, between 2015 and 2020, she was the Director of RD Consulting Ltd, working as a contractor and consultant in Market Access. During this period, she contributed to projects for notable organizations including Norgine, where she held roles such as Interim Global Market Access and Government Affairs Manager and Interim Global Market Access Director. Other roles included Executive Advisor for Lightning Health, Interim Associate Director for Global Market Access at Eisai, and Interim Pricing, Insights, and Market Access Strategist at Pfizer.

Between 2014 and 2013, she was the Disease Area Market Access Lead (Director) for Cardiovascular Europe at Bristol-Myers Squibb, focusing on Atrial Fibrillation. Prior to this, she spent five years (2008-2013) with SANOFI PASTEUR MSD as the Vaccine Market Access Lead in the UK. Rosemarie also held various marketing and leadership roles in SERVIER LABORATORIES LTD from 2000 to 2008, contributing to the Cardiovascular and Diabetes portfolios. Her earlier career includes positions as a Scientific Marketing Specialist at PALL MEDICAL and as a Lecturer in Clinical Pharmacology at the Royal College of Surgeons in Ireland.

Rosemarie’s expertise spans Market Access strategy and execution, Pricing and Reimbursement, Health Technology Appraisal, Payer Insights, and Value Proposition Development. She has extensive therapeutic experience in areas such as Addiction and Opioid Use Disorder, Cardiovascular conditions (e.g., Atrial Fibrillation, Heart Failure, Hypertension, and Iron Deficiency Anaemia), Diabetes, and Vaccines for oncology and infectious diseases (e.g., Gardasil for Cervical Cancer, Zostavax for Shingles). Her oncology experience also includes cervical cancer vaccines, colonoscopy devices, and treatments for hepatocellular carcinoma.

Throughout her career, she has worked on Market Access, Pricing, and Reimbursement for a variety of products, including new formulations of existing drugs such as injectable Buprenorphine, blockbuster cardiovascular compounds like Eliquis, and novel vaccines and medical devices. Her functional expertise lies in Market Access Strategy, Pricing, and Reimbursement, with a proven track record of delivering results.

Louise Knowles

Deputy Director, Innovation Accelerator and Regulatory Science, MHRA

Louise has over 17 years of experience working in Scientific roles across the Civil Service, and joined the MHRA in October 2023. The Innovation Accelerator and Regulatory Science team provides innovators enhanced access to MHRA scientific expertise and regulatory guidance, bringing together the work of the Innovation Office, Horizon Scanning functions as well as leading on the delivery of the Innovative Licensing and Access Pathway (ILAP) and the Innovative Devices Access Pathway (IDAP).  She was previously the Head of Research Capacity and Growth at DHSC and part of the leadership team for the National Institute for Health and Care Research, providing the strategic leadership and oversight of the NIHR Translational Research Infrastructure and NIHR Clinical Research Network as well as leading work to deliver on the ambitions set out in the UK Vision for Clinical Research Delivery. Prior to her role in DHSC she was a Foresight Researcher at the Government Office for Science and led a number of Research Programmes for the Food Standards Agency.

Rosie Lindup

Senior Policy and Public Affairs Manager, BioIndustry Association

What does your role at BIA involve?
Rosie leads the BIA’s policy work on access to medicines, rare diseases, cell and gene therapies and antimicrobial resistance. This involves providing the secretariat for the BIA’s Cell and Gene Therapy Advisory Committee (CGTAC) and Rare Disease Industry Group (RDIG). She is also responsible for organising the BIA’s annual Parliament Day, which brings CEOs and senior representatives from BIA member companies to Westminster to meet with politicians and policymakers.

Previous experience
Previously, Rosie worked as a Senior Research Consultant at a Westminster-based public affairs agency, where she supported clients from a range of sectors, including pharmaceuticals, technology and financial services. Prior to that, Rosie worked as a Management Consultant at KPMG, where she assisted on financial and regulatory projects with large corporate clients. She has a BA in Human, Social and Political Sciences from the University of Cambridge.

Gwenaelle Pemberton

Regulatory Advisor, Syncona

Pharmaceutical Regulatory (RA) & Quality (QA) Leader /Advisor with global and regional experience gained over approx. 35 yrs in large pharmaceutical, biotech and start-ups.  At Syncona (VC), part-time, I advise on regulatory aspects in due diligence and provide direction to Portfolio Companies, inform Boards on Regulatory and Quality risks and how to mitigate them.  At Resolution Therapeutics, part-time, I develop the Regulatory strategy and lead Regulatory activities.

At Beacon Therapeutics, set RA/QA global vision, strategy and drove operation, was part of C-suite. At Gilead, led International Regulatory Affairs (all territories ex-US,) championed recruitment and developed high calibre, diverse and very efficient teams of over 260 in 36 countries, delivering early access of medicines to patients in compliance with complex regulatory environments including in cell therapy (Kite). Was part of the international leadership team.

Executive Coach helping founders, CEO and senior leaders maximise their potential and transition from academia to business enterprise based on extensive experience in senior leadership position including C-suite.

Roz Sutton

Senior Director, Regulatory Affairs, tranScrip Ltd

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.