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.

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.

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.

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.

Jennifer Vande Weghe is Director of Clinical Transparency & Disclosure for Amgen Inc., overseeing clinical trial registration and results posting, publication of clinical reports under Policy 0070, implementation of the PhRMA/EFPIA data sharing principles, and related initiatives. In her previous roles in Amgen’s Global Regulatory Writing group she supported filings for new oncology and cardiovascular products. She holds a PhD from UC Berkeley and a US RAC.

Janice Branson is the Statistics Development Head for Immunology and Dermatology in Clinical Development & Analytics at Novartis. She holds a MSc. in Biometry from University of Reading and a BSc. in Mathematics, Statistics and Computer Science. After post graduate studies at University of Reading U.K., Janice joined Pfizer in UK. In 2001. Janice moved to Novartis, Basel taking on a role in the statistics group supporting early development. Over the last years Janice has had increasing roles of responsibility and along with leading the global statistics group for the Immunology and Dermatology Franchise, since early 2013 Janice is the Statistics lead across Novartis on clinical trial data transparency and implementation of Policy 0070.

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.

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.

Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

Jørgen holds a B.Sc. in Computer Science and a Master in IT Software Construction. He has worked in a number of industries in Denmark for the last 30 years as a programmer, and for the last 12 years at LEO Pharma as a statistical programmer. Jørgen has more than 25 years of experience in SAS programming implementing many solutions for public and private industries. Jørgen is a subject matter expert in SAS programming, CDSIC standards and IT systems at LEO Pharma.

Stephen Morehouse has over 20+ years of expertise in pharmaceuticals, biotech, and diagnostics and has a strong focus on improving business operations in R&D. He leverages his scientific, regulatory and compliance expertise, and operations background and has been called on to support critical business activities for the life sciences industry and has worked with small, mid-sized and large organizations. Stephen has a strong focus on supporting the implementation of new technology within R&D and is the clinical trial disclosure lead at PA.

Despina holds a Bachelor's degree in Chemistry as well as a Master’s degree in Business Administration (MBA). Before joining the European Medicines Agency, Despina worked for 6 years in the pharmaceutical industry in various Regulatory Affairs roles. She joined the European Medicines Agency in 2011, where she had been working as a Scientific Administrator within the Procedure Management Department specialising in the handling of referral procedures. Since January 2017, Despina is working as a Clinical Data Publication Manager in the Documents Access and Publication Service.

Aleksandar Rusanov is a Legal Adviser in the Legal Department of the European Medicines Agency. He is dealing with various legal issues including access to documents, transparency, proactive publication of clinical data, referrals, advanced therapy medicinal products, pharmacovigilance, clinical trials, medical devices, etc. He also appears in Court on behalf of EMA in access to documents cases. Before joining the EMA, Aleksandar was an Associate in a leading international law firm and advised clients on a wide range of matters relating to medicinal products and medical devices. Aleksandar was also seconded to a number of pharmaceutical companies to assist in activities relating to compliance and promotion of medicinal products.

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.

Steve is the head of the Policy 0070 disclosure team at Bristol-Myers Squibb and is also Group Director of Clinical Scientific Writing for Immuno-Oncology. In addition to his transparency-related activities, Steve manages the preparation of submission-related documentation and oversees all company SOPs and guidance documents related to medical writing. Steve and his team have prepared five Policy 0070 submissions, gaining valuable knowledge along the way via interactions with EMA as well as through his memberships on the TransCelerate Clinical Data Transparency CSR subteam and the EFPIA Policy 0070 subgroup.

Vesela joined the Clinical Disclosure group at LEO Pharma in December 2015, as part of the Medical Communication team. She is currently overall responsible for implementing LEO’s clinical trial transparency and disclosure strategy. Vesela is a pharmacist by training and has previously worked with counselling patients in the pharmacy, and as a pharmacovigilance consultant. Having the experience of working and talking directly with patients is a strong motivation for Vesela in her current role to provide more insight for the patients about their therapy and help them make better informed choices.

Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

Ada Adriano holds a Master’s degree in Pharmaceutical Biotechnology and a Postgraduate degree in Regulatory Affairs and Market Access. Prior to joining the European Medicines Agency, she worked in research and drug discovery and in consultancy firms as a Pharmacovigilance Officer. She joined the Access to Documents team at the European Medicines Agency in 2014. Since September 2016, she has been working as a Clinical Data Publication Manager, focused on the implementation of Policy 0070 on publication of clinical data.

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.

Jack has leveraged his interest in design, technology and automation to build a career in software development. He is currently focused on information automation solutions for the life sciences, insurance and lending industries. “These heavily regulated industries have no choice but to automate their information workflows as they grapple with fewer resources, shorter timelines and more public date disclosure”, stated Yeager.

Dr. Dias, Head of Supply and Availability at EMA since 2021, leads key initiatives including co-chairing the HMA/EMA Task Force and chairing the Medicine Shortages SPOC Working Party. With a pharmacy degree from Lisbon and a PhD from Cardiff, she joined EMA in 2004, specialising in quality for 10 years before leading policy and crisis coordination. Dr. Dias now oversees EMA's extended mandate on shortages under Regulation (EU) 2022/123.

Woo Song is a co-founder of Xogene Services LLC, a leader in innovative solutions for clinical transparency. Prior to Xogene, Woo co-founded Intrasphere Technologies, Inc., a technology and services provider to the biopharmaceutical industry, which was acquired by Deloitte Consulting in 2011. While at Intrasphere, Woo created PharmaCM, a leading clinical disclosure platform, now owned by Citeline. A former derivatives trader, Woo is also a founder of Reval, a Software-as-a-Service platform for treasury and risk management with over 650 corporate clients globally. Reval was sold to Ion Investment Group in 2016.