PCMG25 Speakers

Since joining Johnson & Johnson in 1996, Kevin has held various leadership positions in Regulatory Affairs, Quality, Supply Chain, IT and Vigilance. He is currently Regulatory Affairs Director, Medical Device Interface.

Kevin chaired the MedTech Europe EUDAMED Working Group, co-chaired GS1’s Basic UDI-DI work group and has been a key advocate for industry participation in EUDAMED testing and development. He is a member of the EFPIA Drug/Device Combination Working Group.

Kevin graduated in Biomedical Chemistry from Sheffield Hallam University, including an Erasmus exchange at the Université Catholique de Louvain in Brussels. Kevin is fluent in French and English and based in Alsace, France.

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I am a clinical trial professional and strategist helping with the reshaping clinical research in Africa through data-driven insights and bold partnerships. With a passion for transforming healthcare outcomes, I drive clinical trial growth, stakeholder engagement, and ecosystem development across Sub-Saharan Africa. An experienced professional with a 20-year demonstrated history of working in clinical trials in EMEA with a sub-Saharan Africa focus in the last 10 years. Skilled in quality assurance, project management, monitoring, team management and business development across multiple indications.

I relocated to Kenya (from the UK) in 2014 with the aim of bringing the experience and expertise I have garnered over the years to the clinical trial industry in Kenya (and Sub-Sahara Africa as a whole); to bring quality clinical trial solutions to an underserved region. In the last 10 years, while based in sub-Saharan Africa, I have led initiatives that expand clinical trial activity, foster strategic collaborations with global health organizations and unlock opportunities in LMICs. My work bridges the gap between data and decision-making, ensuring that every partnership and project contributes to sustainable, impactful health solutions.

I thrive at the intersection of strategy, science, and partnerships— navigating complex regulatory landscapes, and championing clinical research innovation in emerging markets. Among the close collaborations are key strategic relationships with vaccine manufacturers, site management organisations, logistics and supply chain specialists. These relationships are crucial to strengthening the clinical trial ecosystem in Africa.

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In his role at Parexel, Stephen is accountable for leading and directing Parexel’s AI and clinical data strategies.

Stephen began his career in academia (London), where he held various research and teaching positions. He subsequently joined the pharmaceutical industry where, over a period of 25+ years, he has led a number of global functional groups at Pfizer and GSK, including Research Statistics, Clinical Statistics, Quantitative Sciences, Clinical Operations, and Development DDA (Digital, Data & Analytics).
During this period, Stephen has also been honoured to serve on the Boards of a number of professional and not-for-profit organisations including: PSI (Statisticians in the Pharmaceutical Industry) Board Chair, RSS (Royal Statistical Society) Vice President, CDISC (Clinical Data Interchange Standards Consortium) Board Chair. He is currently a member of the Board of CRDSA (Clinical Research Data Sharing Alliance), Chair of the ACRO (Associations of Clinical R esearch Organisations) AI/ML Committee, and has just joined the CTTI (Clinical Trials Transformation Initiative) Executive Committee.

Stephen studied Mathematics and Statistics at, respectively, University of York and Imperial College, London.

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Marieme Ba is the Founder and Managing Director of Pharmalys Limited, a Contract Research Organisation originally set up in the UK in 2008 and subsequently implemented in Senegal in 2012.

Marieme has a strong commitment to advocacy for strengthening national and regional high standards health research capacities in Sub-Saharan Africa. She is currently engaged at making effective use of her expertise to facilitate the development and registration of new treatments and vaccines in the region. With her company, she is involved in several consortia of public and private institutions to strengthen ethical and regulatory capacities for health research in Africa.

Marieme was born and raised in Senegal. She received both her master’s degree in biochemistry and postgraduate diploma in immunology and haematology from the University of Paris 7 Jussieu. She also took some business courses at the Institut Supérieur de Gestion of Paris.

Marieme started her professional career in France as a market researcher in the pharmaceutical industry. She then held managerial positions at the European divisions of a German pharmaceutical company, setting up their clinical research departments in France, the UK, and Ireland. She built an extensive experience in the conduct of international clinical trials and a strong expertise of other types of research projects.

Today, Marieme is capitalising on her strong scientist and entrepreneur background to give back to the African health research community by setting up PACE (Pharmalys Academy of Clinical research Excellence), driven by one goal: to Count Africa In, in the field of clinical research.

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Marie Moores is a highly experienced biopharma industry executive with over 28 years of expertise in oncology drug development. She joined BioInvent International AB as Chief Operating Officer in 2022, where she oversees the company’s day-to-day operations to ensure the successful delivery of its strategic objectives.

Prior to her time at BioInvent, Marie held senior executive positions in the contract research organization (CRO) sector, where she collaborated with a diverse array of pharmaceutical, biotechnology, and medtech clients. Her extensive experience in guiding these organizations from the discovery stage to clinical implementation underscores her commitment to advancing innovative treatments and improving patient outcomes.

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Keith has dedicated over 20 years to the field of clinical research, specialising in patient engagement and retention. As the founder of patientRx Ltd., he is committed to making clinical trials more patient-centric whilst ensuring trials meet scientific, operational and commercial objectives. Working predominantly with biotech in the US, UK and Europe, Keith also supports companies acting as a strategic advisor and board member for companies in the biopharma health-tech supply chain.

In his previous leadership role he led effective patient recruitment strategies whilst serving as Director of Operations and subsequently Commercial Director. His commitment to ethical research is evident in his role as Chair of the Fulham Research Ethics Committee.

Throughout his career, Keith has consistently shared his insights by authoring and presenting on patient recruitment and engagement. He’s driven by a desire to optimise clinical trials through patient-centric strategies, ensuring effective and ethical research solutions for all stakeholders – biotech and pharmaceutical companies, patients, and researchers alike.

Keith is currently focused on the commercialisation of multi-stakeholder platform, driven by lived experience, proven methodology and AI assisted technology to support better patient engagement and retention in clinical research.

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Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and regulatory roles, he has gained deep understanding of broad aspects of the drug development process and the ecosystem behind it.

Kai combines his innovation mindset and nimble execution with several years of experience working at Johnson & Johnson Innovative Medicine R&D in various roles. Today, Kai leads DEEP Measures Oy as a Founder and CEO, having started this initiative within J&J with DEEP becoming an independent company in 2022. DEEP’s core mission is to accelerate the adoption of harmonized digital measures of health to be transform the way human health is managed.

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Jennifer Warneke serves as the Global Head of Biotech GPL Operations. Acting as the voice of Parexel Biotech and its Biopharma clients, she partners cross-functionally in the development and implementation of organization wide operational best practices and processes as well as overseeing Biotech delivery.

Prior to joining Parexel, Jennifer served as the Senior Vice President, Clinical Operations for G1 Therapeutics, Inc., an oncology focused biopharmaceutical company. She oversaw clinical operations, data management, and clinical trial supplies. Her experience includes serving as the Senior Vice President Global Oncology Operations at Syneos Health, where she oversaw operational and financial delivery for the oncology business unit, with direct management of its 1400 staff. Prior roles at Syneos Health include Vice President, Oncology Clinical Operations overseeing the oncology clinical operations team; Vice President, Clinical Development, overseeing resource management of the oncology business unit; and Vice President Global Operations Management leading integration workstreams for the merger between InVentiv and INC. Research as well as the evolution of the Trusted Process, Syneos Health’s Operating Model.

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Dr. Jacqueline Mirera is the Medical Director and Principal Investigator at the Clinical Research Health Network (CREA-N), a site management organization dedicated to advancing clinical research in Africa through innovative models, expansion into underserved geographies, and enhanced community engagement with an aim of expanding research accessibility, efficiency, and quality in diverse populations.
Dr. Mirera is currently a fellow in Epidemiology and Biostatistics at the University of Nairobi, focusing on Tuberculosis and HIV research. Her growing interest in implementation science aligns with her long-term academic and research aspirations. She holds a Master of Business Administration in Healthcare Management from Strathmore University in Nairobi, Kenya, and a medical degr ee from Kairuki University in Tanzania.

With over a decade of medical experience, Dr. Mirera transitioned from general practice to clinical research, where she has played a pivotal role in the successful execution of multiple clinical trials in a diverse range of therapeutic areas, including hematology, virology, immunology, and both infectious and non-infectious diseases. She has successfully collaborated with multiple stakeholders to ensure impactful research outcomes that benefit local communities while aiming to bridge gaps in healthcare equity.

Currently, Dr. Mirera is the Principal Investigator in several ongoing studies focusing on respiratory diseases, Tuberculosis (TB) vaccines, and infectious diseases, including Human Papillomavirus (HPV). Alongside her role as PI, she oversees other key CREA-N initiatives, including the establishment of disease registries and digital tools aimed at enhancing clinical trial efficiency, patient recruitment, and long-term research sustainability within the research network.

As the Principal Investigator at CREA-N, Dr. Mirera is focused on strengthening clinical research infrastructure across Africa while integrating emerging technologies into existing frameworks. A strong advocate for inclusive research, she prioritizes community engagement and collaboration with local healthcare systems, policymakers, and research institutions to ensure sustainable growth in clinical trials. Her interests span clinical trials in infectious and non-infectious diseases, investigator-initiated studies, proof-of-concept research, and medical device trials.

Committed to strengthening the clinical research landscape in Kenya and across Africa, Dr. Mirera continues to champion the development of research capacity in underserved regions, foster collaborations that enhance research opportunities, and expand site networks to improve the efficiency and impact of clinical trials across the continent.

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Graham Belgrave is an experienced clinical research professional with over 41 years’ experience in the clinical research industry, including Outsourcing and Vendor Management, clinical development and science and operations.

He is a Chartered Scientist, Companion of the Chartered Management Institute, Fellow of the Royal Society of Medicine, Executive Coach and Mentor and an assessor for the UK Science Council as a member of the IBMS.

He has worked in large pharma and biotech for over 32 years and in CROs for a further 9 years, spanning a variety of leadership, operational and commercial roles, across a wide range of therapeutic areas. Graham has been a Chair and Speaker at many conferences as well as member and supporter of PCMG and Institute of Clinical Research (ICR) for many years and has recently joined the the ICR Board in March 2025 to help drive the re-establishment of ICR as the foremost UK organisation for clinical researchers.

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