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.

Kelly is the Director of Clinical Trial Transparency and Disclosure at Pfizer where she provides strategic and operational expertise to support the disclosure of clinical regulatory documents pertaining to Pfizer-sponsored interventional trials on public websites.

Scott has over a decade 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. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.

Francine Lane is the VP of Global Transparency at TrialScope and the Chair of the DIA Clinical Trial Disclosure Community. In her day job, Francine is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders – including sponsors, investigators, regulators, and transparency and patient advocates – to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her current role, Francine served as Director of Product Management at TrialScope.

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. She is now working as a senior specialist for the area of clinical disclosure. 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.

Sorcha McCrohan is a Specialist of Scientific Programs for the Americas Region at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics. Before joining DIA, she conducted COVID-19 research in Chiapas, Mexico, and worked in marketing within Pfizer's Global Vaccines Meningococcal franchise. Sorcha holds a BA in Sociology from Mount Holyoke College and an MSc in Global Health, Disease Prevention & Control from Georgetown University.

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic skills to bridge gaps between scientists, medical providers, payers, governments, and patients. Deborah has vast research experience in translational, clinical, epidemiology, health outcomes, and health delivery fields while working with academia, federal agencies, companies, non-profits, and patient communities. Key patient insights are delivered throughout development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Laura Dodd is the Director of Clinical Trial Transparency at Instem. Laura heads the DIA subgroup on EMA’s Policy 0043/FOIAs, and is a subject matter expert on anonymization for Public Release of Clinical Information and Policy 0070. Laura started working in Data Sharing in 2014. This quickly led to becoming an anonymization expert, which required her to interact with many functional areas to obtain approval to share and fully protect both the intellectual property rights and protected personal data found in the documents. Prior positions include writing CSRs and submission summary documents for 20 years and coordinating research studies for industry, NIH, and the National Cancer Institute.

Zack Fey is a manager on the medical writing team at CISCRP, an organization widely recognized as a pioneer in the field of plain language clinical trial results summaries. Through innovative practices and a deep commitment to patient-centered communication, CISCRP has been instrumental in setting the standard for plain language summaries, shaping industry guidelines, and promoting clinical trial transparency. Zack helps lead a talented team of writers that work together to create plain language results summaries, protocol synopses, and other patient education materials. Since early 2024, Zack has also been guiding a CISCRP and industry collaboration to assess and leverage AI-enabled approaches in patient communication.

Maureen Kashuba has over 20 years of Pharma experience. She leads the Plain Language Summary (PLS) program at Merck Sharp & Dohme LLC, United States. She led the development of the company’s > 1250 term Health Literate Glossary which has been reviewed, tested for cultural competency and approved for use internally. She’s led Patient Panel and Cultural Competency reviews to engage diverse insights on terms and concepts. Maureen co-chairs the DIA PLS Working Group is a member of the MRCT Center Glossary Development Review Team and the EFPIA CREG joint subteam on patient friendly language. She is passionate about clear communication of research information to empower patients to make informed health choices for themselves and their families.

Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

Christopher Pfitzer is the Head of Clinical Trial Transparency Strategy at Biogen where he oversees all plain language and disclosure activities. Chris earned his Master’s degree from NC State University and a Bachelor’s degree from the University of Alabama at Birmingham. Prior to joining pharma, Chris worked extensively with healthcare and nonprofit organizations supporting policy and communications activities.

Francesca Scotti is a pharmaceutical chemist, who worked for pharmaceutical industries before joining EMA in 2016, as a procedure manager in the Human medicines division. In 2019 she joined the clinical trials team, becoming first the business responsible of the EudraCT database, and then taking the lead of the implementation of the revised CTIS transparency rules in the new CTIS public portal, which was launched in June 2024.

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.

Thomas Wicks is an experienced strategic leader with over 20 years in life sciences. As Head of Transparency Operations at Citeline, he spearheads strategy for TrialScope's industry-leading disclosure solutions. Thomas is an established thought leader, having spoken at over 60 conferences and authored over 40 publications on disclosure requirements and transparency trends. Thomas is motivated by empowering teams to accelerate solutions that honor trial participants through transparency.

Raina Agarwal holds 15+ years of experience in Clinical Trial Transparency and Disclosure Domain. She is working as Associate Director, Transparency, at MMS holdings and specializes in anonymization of regulatory packages for EU-CTR, EMA P0070 and HC-PRCI submissions. Raina is hands-on with disclosure regulations for US, EU, and several international registries. Raina has continuously involved in developing and reviewing standard operating procedures, work-instructions, quality checklists for transparency, templates for clinical documents, deploying of automated technology platforms for anonymization of documents. Raina is a strong advocate of cross-functional integration for successful implementation of transparency requirements.

Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora served for 4 years as Director of Operations for a small medical writing company. She transitioned to Transparency and Disclosure in 2014. During her 8 years in Transparency and Disclosure, Lora has overseen delivery of 5500+ redacted and anonymized documents to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, other global disclosure regulations and broader corporate transparency policies for many sponsors.

Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He oversees corporate clinical trial transparency/data sharing strategies and compliance activities; coordinates internal disclosure operations’ training, process improvements and trial transparency policy intelligence.He holds a PhD in Clinical Chemistry from Obafemi Awolowo Univ. Ile-Ife, Nigeria, 1990 and received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001. Dr. Oyelola has over 35 years’ experience in biomedical R&D, and certifications by National Registry of Certified Chemists and American Society for Clinical Pathologists

Ruediger Pankow holds a university degree in Biology and is a Regulatory Affairs professional with more than 17 years of experience in the clinical research and trials regulatory space, mostly in the CRO industry. His specific area of expertise is the EU Clinical Trials Regulation 536/2014 (EU CTR) and EU CTR implementation at industry level, including for his past employer Parexel. Since 2019 he has been continuously involved for ACRO as an industry stakeholders' representative (sponsor product owner / external SME) in EMA's Clinical Trial Information System (CTIS) delivery project, and is DIA instructor of EMA's CTIS sponsor end user training programme.

Healthcare Provider, Researcher, Patient Advocate, Bioethics, Pharmaceutical Law & Policy Professional advancing science through impactful collaboration with stakeholders across the R&D ecosystem to "co-create a healthier future". Optimizing global collaborations as enablers of innovation, inclusion, health equity and access. Never compromising scientific integrity, patient safety, confidentiality, privacy or quality to ensure a future where patients can access clinical research at their point of care, are provided more personalized and flexible options to access their health data and enables more informed decision making.

Dr. Arnold is a staff scientist at the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health in Bethesda, MD, and a results subject matter expert for ClinicalTrials.gov. She is participating in efforts to modernize the ClinicalTrials.gov website and the Protocol Registration and Results System (PRS) database. She also contributes to the development of educational materials and trainings intended to facilitate the successful completion of results submissions to ClinicalTrials.gov. She received her PhD in Biological Chemistry from the University of Michigan, Ann Arbor, and conducted post-doctoral research at the Institute of Genetic Medicine at Johns Hopkins in Baltimore, MD.

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. She specializes in Clinical Trial Transparency, process optimization and program delivery.

With a background in neuroscience, and experience working with health information technology, I have a thorough understanding of health data management, global regulatory standards, and best practices in the field of clinical data privacy. I lead and manage a portfolio of global pharmaceutical companies and strive for innovation by leading the field of science, healthcare, and research into the modern age of technological efficiency, clinical transparency, and data utility.