Julie Holtzople is a seasoned Clinical Trial Transparency professional. She spent 10 years building Clinical Transparency and Data Sharing at AstraZeneca, becoming an expert in Plain Language Summaries, Clinical Document Anonymization and Clinical Data Sharing. She also led the implementation and readiness for EU CTR Transparency requirements. Julie has been an active member of numerous CTT working groups and organizations contributing to CTT standards and best practices. Prior to AstraZeneca, she started her career as a management consultant working at Ernst & Young and then Booz Allen. Julie has recently returned to consulting as an independent. She specializes in Clinical Trial Transparency, process optimization and program delivery.

Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk A/S. She is now working as independent Clinical trials transparency expert. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she has served as Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

Scott has 15 years of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. Scott is designated as a CTIS subject matter expert by the EMA and serves as EuropaBio representative for the EU Clinical Trials Regulation.

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has been the support and coordination of J&J’s Clinical Trial Data Transparency Initiative. She is the Chair of the J&J Bioethics Committee and serves as a bioethics subject matter expert for internal and external policy work. Ms. Childers began her career in industry as a chemist and then project manager for global drug development teams. Ms. Childers is also the co-chair of the DIA Bioethics Community.

Stephen is a founding member of Real Life Sciences, Inc. (RLS), a software as a service company that automates the extraction, integration and analysis of unstructured patient data for life sciences organizations. Stephen brings over a decade of experience in natural language processing and machine learning, including product development and analytics roles in pharmacovigilance, outcomes research and clinical data management. Since 2015, Stephen has overseen the development of RLS' lead product ARARA, which supports EU Policy 0070 and 0043 disclosure requirements through automated redaction and anonymization of clinical study documents.

Cathal Gallagher is the Associate Director of Clinical Transparency & Trial Disclosure at Regeneron, with over a decade of experience in clinical trial data technology. Specialising in data and document transparency, Cathal develops and implements technical solutions to ensure compliance with EMA Policy 0070 and Health Canada’s PRCI. Known for his strategic approach and dedication to regulatory compliance, he advocates for transparency as a cornerstone of ethical research. Cathal’s interests include blockchain technology, fitness, and continuous self-improvement.

Sarah Lyons is a Vice President responsible for IQVIA’s Data Transformation & AI Platforms serving healthcare and life science organizations globally with capabilities spanning privacy-enhancing technologies, natural language processing, and AI-enabled language solutions. In addition to serving clients worldwide, she participates in multiple industry forums and consortiums to promote data sharing across the healthcare ecosystem. Sarah was previously the head of Privacy Analytics, an IQVIA company specializing to privacy solutions for enabling the safe and responsible uses of data.

Caragh Murray has 23 years of pharmaceutical industry experience in both early and late clinical development and was a Regulatory Medical Writer for much of that time. Since 2017, Caragh has been involved in Janssen’s Plain Language Summary program to develop a unified approach for preparation of summaries of clinical study results informed by both regulatory guidance and audience considerations.

Kathy B. Thomas-Urban, PhD, is an independent consultant and medical writer with more than 20 years of experience in the pharma industry and academia. She has extensive knowledge of clinical trial disclosure USA and EU laws and processes, as well as clinical trial database entries, internal guidelines and processes to assure compliance. Previous appointment includes Head of Medical Writing at Altana Pharma AG in Konstanz, Germany. Current work includes international consulting on Clinical Trial Disclosure and Transparency (theoretical, legal, and practical aspects ? with emphasis on the US and EU requirements).

Céline Bourguignon has a track record of more than 25 years in the healthcare sector at European and international level both in the public and the private sector. Céline joined GSK in 2021 to lead the Greater China and Intercontinental & Emerging Market Regulatory Policy team. She joins from Cardinal Health where she served during the last three years as head of Quality, Regulatory and Clinical Affairs for the EMEA region, and as a member of the European Leadership team.Céline held various Chair or Vice-Chair positions within Medtech Europe (Eudamed, UDI & Supply chain, Regulatory Affairs Committee).

Anne Cutting has over 30 years’ experience spanning the clinical development process. For the first 12 years within Data Management and Statistics, then as a Business Change Manager leading and managing change initiatives within the R&D organisation. For the past 5 years, working in the Data Transparency space, managing GSK’s clinical document publication in line with GSK’s transparency commitments and external regulations. Anne also lead GSK’s developing lay summaries capability and other areas in support of future regulations. Since June this year, Anne has taken on additional responsibilities in support of GSK’s governance of Human Subject Research.

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene has been member of the Clinical Trials Facilitation Group (CTFG) member since 2008 and the Danish representative of the EU Commission’s expert group concerning clinical trials since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she is involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trial applications including VHP. Lene has a background as Master in Pharmacy.

Dr Sheuli Porkess is the Executive Director Research, Medicine & Innovation at the Association of the British Pharmaceutical Industry. Sheuli’s career began in clinical medicine in the NHS and subsequently has included a number of medical leadership roles at a national, regional and international level working in the Netherlands, Nordics, Germany and UK. Sheuli also has run her own consultancy. Sheuli is a Fellow of the Faculty of Pharmaceutical Medicine in the UK and is on the Board of Examiners for the Faculty.

A hospital pharmacist before becoming inaugural Professor of Pharmacy at Leeds, Theo has 35 years of research improving patient information and ‘user testing’ the information with lay people. This led to forming the spin-out company Luto Research, a leading provider of user testing services. Synergies between the University and Luto underpin recent work, notably how best to present benefit and harm information. Currently he is working in policy and practice on making the new clinical trial ‘layperson summaries’ fit-for-purpose. He has a Lifetime Achievement Award from Fédération Internationale Pharmaceutique.

PhD, a clinical pharmacist with academic scientific & educational experience. After moving to pharmaceutical industry & clinical research over 15 years ago, she followed her passion - scientific disclosure and ethics. As publication lead in GSK Vaccines & later in Shire, she has led publication & scientific disclosure teams in different therapeutic areas and at all stages of drug development. After moving to Medical Evidence Generation team she was responsible for Collaborative Research between company and external institutions. Scientific publications lead in Galapagos, Belgium biotech company. Slavka is an accredited member of the EMWA, an EMWA Conference Director, and a certified medical publication professional with the ISMPP.

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

Amanda has extensive experience in health research, research ethics and patient engagement. She currently works as a freelance consultant and medical writer specialising in lay summaries. Formerly Amanda was Head of Policy and Public Affairs at the Health Research Authority (HRA) in the UK from 2012 to 2019. During th8is time she led an EU wide taskforce to work on the development of EU guidelines for lay summaries of clinical trials. Early in her career she worked for Boots Pharmaceuticals as Head of Business Information for before moving to the Department of General Practice at the University of Sheffield as a Research Fellow. She later took up the post of Director of Research & Development at the Northern General Hospital in Sheffield.

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.

Loes Markenstein LL.M is working as a legal professional in the field of health law and data protection law. During her time working at the Central Committee on Research involving Human Subjects (CCMO) she was involved in redrafting the template Subject Information Sheet to comply with GDPR. Presently she is working at the Dutch Data Protection Authority with a focus on the processing of personal data in the health care sector and in health research.

Milagros Blazquez has 10 years of experience working in the Clinical Trials. She joined BMS in 2009 as Clinical Site Manager in Argentina. In 2014, she moved to Belgium and joined the Global Clinical Trial-Submission Unit, which she headed up for 3 years. At that time, she joined the BMS EU CTR implementation team and became a tester of the EU Portal. Since early 2019, she has been working in the position of Clinical Trial Applications and Transparency Process Lead and took over the leadership of the BMS EU CTR team. Milagros is currently representing EFPIA as Sponsor Product owner, contributing to the EU CTIS development. Milagros holds a Master Degree in Biochemistry from the University of Buenos Aires.

André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

Nate is Disclosure and Transparency professional with over 7 years of experience in the environment, working with CROs, Big Pharma, Non-Profit, and Small Biotech, as well as being a member of the DIA Disclosure Community Core Team, PhUSE CTD working group, Co-Author of Disclosure and Transparency white papers, and creator of the West Coast Disclosure and Transparency Community. At Ionis, Nate leads the Transparency Department and also manages Regulatory Policy.

Grant has considerable experience of providing due diligence regulatory support on major corporate transactions in the food, medical devices & life science sectors. Grant has expertise of advising on a wide range of regulatory issues that arise in the day-to-day conduct of a food business, including: borderline classification of products; nutrition & health claims; labelling & packaging; hygiene standards; advertising & marketing regulation; and product recall. In the pharmaceutical sector Grant regularly advises on a broad range of regulatory matters. He has authored & co-authored various articles in professional journals in addition to writing a chapter on regulatory data protection in the textbook, Navigating European Pharmaceutical Law.