Nick De Donder

Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and has been employed since 2008 by Business & Decision Life Sciences at their headquarters in Brussels. He has been moving from being a Data Integration Specialist to Project Manager to Line Manager for the Data Standards team. Since 2020 he is Head of Data Standards. Nick is a member of the SDS team, an authorized CDISC trainer for CDASH, SDTM and Newcomers and a PHUSE committee member since 2017. In 2019 he joined the E3C and is now co-chairing it. Since June 2021 Nick has been product owner of the CORE application.

Dr. Anja Schiel

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc on a range of subjects focusing on oncology, immunology and molecular biology, first at the University of Leiden and later at the University of Oslo, before starting at the Norwegian Medicines Agency (NoMA) in 2012.

At NoMA she is working as Special Adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and from 2019 – 2022 she was Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA.

Since it was established in 2020 she has been a member of the Big Data Steering Group, working on utilising the full potential of the vast amount of health care data for regulatory decision making.

In her role as Team-leader international HTA (iHTA) at NoMA, she has been heavily involved in EUnetHTA JA3 and its successor, EUnetHTA 21. Her particular focus is on parallel EMA-HTA scientific advices, now in the role as Vice-Chair of the JSC-CSCQ.

She is furthermore involved in several academic and PPP projects as member of Scientific Advisory boards on subjects such as RWD, Patient reported outcomes, rare diseases, paediatric drug development and decentralized trials and digital tools.

Bess LeRoy

Bess LeRoy is the Head of Standards Development at CDISC. Bess has been a CDISC team member since 2011. She has over 15 years' experience working in public health research and has held positions at the Framingham Heart Study, the Rotterdam Study, the Arizona Cancer Center, and the Critical Path Institute. 
 
Bess has a BS from the University of Michigan, an MPH from Boston University School of Public Health, and is currently a doctoral candidate at Johns Hopkins Bloomberg School of Public Health

Dave Evans

Dave Evans is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions and as an expert in the areas of information standards, regulatory compliance and quality governance. He was the architect and developer of the first electronic drug submission to the FDA in 1985 and has been responsible for more than 100 electronic regulatory submissions and complex clinical data warehouse systems.

He brings over 40 years' experience to CDISC, serving in various executive-level positions in software development, clinical research, regulatory and healthcare industries. Most recently, he was the Global Head of Quality Governance and Regulatory Compliance for Accenture Life Sciences. Prior to that, he was CIO of Octagon Research Solutions and co-founder of Premier Research and Research Data Corporation. He has also served on the CDISC Board and has been an active member of many other industry organizations and initiatives.

Dave received his MS in Biomedical Engineering from Drexel University and his BS in Biology from Ursinus College.

Yuki Ando

Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Currently she is responsible for the biostatistics review and consultation in the new drug and device review offices in PMDA. Additionally, she works for Office of Advanced Evaluation with Electronic Data, the office which is responsible for the use of patient level electronic study data that are submitted with new drug applications.

Helena Sviglin

Helena Sviglin works in internal policy development and study data governance at the Office of Strategic Programs, FDA-CDER. She is Chair, FDA Study Data Technical Conformance Guide (sdTCG), and Chair, FDA Business Rules. She has expertise in eData responses, and is additionally the Chair for the FDA Data Standards Catalog.

Eftychia-Eirini Psarelli

Eftychia-Eirini Psarelli is statistician on secondment at European Medicines Agency (EMA) in the Methodology Workstream of the Data Analytics and Methods Task Force, where she has been managing EMA's Raw Data project, focusing on utilising raw data to generate evidence for better and more efficient regulatory decision making. Prior to joining the EMA in July 2020, she spent 8 years as a Senior Statistician at the Liverpool Clinical Trials Centre within the University of Liverpool, UK, where she has gained strong analytical skills in the area of statistical programming and data curation.

Dr. Lisa Lin

Lisa Lin is a Study Data Standards Manager at FDA CBER (Center for Biologics Evaluation and Research), currently responsible for all study data standards projects, including study data validation, evaluation and testing of the SEND standard, data standards and analysis tool training and support for CBER reviewers. Previously, Lisa worked at CDER (Center of Drug Evaluation and Research) as a Data Standards Lead where she played an important role in leading study data standards development and implementation. She is also new CDISC board of directors since 2022.

Claus Bang Pedersen

Claus Bang Pedersen is a biostatistician currently working at the Danish Medicines Agency. With over a decade of experience in the field, Claus has previously held statistical roles at Leo Pharma and Novo Nordisk. He earned his degree in statistics from Aarhus University and has since developed a strong background in biostatistics, with a particular emphasis on clinical trials and regulatory compliance. Claus is known for his analytical mindset, attention to detail, and ability to communicate complex statistical concepts in a clear and concise manner.

Jintao Shi

Expert Data Manager, Standards Governance Advisor

From BI, Biostatistics & Data Sciences department

Monika Kawohl

Monika Kawohl is a Principal Statistical Programmer at the CRO mainanalytics GmbH in Germany and has 30 years of experience in the pharmaceutical industry. She joined the CDISC ADaM team in 2009 and has served as a CDISC authorized ADaM Instructor since 2012. Monika is also co-leading the German-speaking CDISC User Network.

For more than a decade, producers have struggled to create unique PARAM values to fully describe each analysis parameter.  Even when it is less efficient to have fully unique PARAMs, it has been the requirement.

With ADaM IG v3.0 this is expected to change.  PARQUAL (and the paired variable PARTYPE) are expected additions that will allow PARAM to identify multiple analysis parameters.

These are special purpose variables that are intended to be an exception, not a common occurrence. In most cases they will be unnecessary.  However, when the meaning of PARAM essentially remains unchanged except for a single qualifier (such as 'Investigator' 'Central Reader'), PARQUAL can be a useful tool to simplify PARAM.

This presentation will summarize the current requirements of PARAM and PARCATy.  It will review past proposals for PARQUAL and its existence in TAUGs and other documents and introduce the new requirements for PARQUAL and PARTYPE.

Jon Neville

Johannes Ulander

Johannes Ulander is a has more than 20 years' experience in standardizing clinical data and have been involved in implementing CDISC standards from an end-to-end perspective for the last 15 years. For the last 5 years by using linked data and graph databases.

He is a co-founder of data4knowledge and an authorized CDISC SDTM instructor. 

Kirsten Langendorf

Kirsten has worked 20 years in the pharmaceutical industry within programming, IT implementation, process improvement, standards implementation, and statistics. She advises and implements better solutions and processes for use re-use of data and metadata.

She is motivated and driven by implementation of linked-data, metadata-driven solutions, and automated end-2-end process for clinical data. It should be simple and straight forward to use CDISC standards while working with clinical data.

She is supporting CDISC in the development of Biomedical Concepts. Standards Governance, MDR and CDISC 360 - User Experiences Extending Biomedical Concepts to Analysis.

Caroline Francis

I am an Associate Director, Standards Developer in the Data Analysis and Reporting Standards team at AstraZeneca. We cover SDTM, ADaM and output standards with the aim of creating fully traceable end to end standards from data collection to output. I have been a SAS programmer since 2000, moving from Finance in the Pharma in 2006; working with CDISC standards since then. For the past 13 or so years I have been contracting as a SAS Programmer specializing in CDISC standards and study reporting and project management. I re-joined AZ in September 2022 to work in their data standards team after a previous stint with them as a contractor as I was impressed by their commitment to data standards and automation of study reporting by leveraging these standards.

Kathleen Hectors

Kathleen Hectors is working in Clinical Data Standards at Janssen (Johnson & Johnson), as a Data Collection Standards Expert and is located in Beerse, Belgium. In this role, she develops data stream expertise, focusing on ECG and Holter, microbiology, virology and vaccine immunogenicity data.

She develops external data stream strategies, manages controlled terminology and biomedical concept dictionaries, contributes to the scientifically accurate design of eDC library forms and SDTM Metadata Standards. She also supports data managers and clinical programmers on collection and mapping of their trial specific scientific data. Kathleen has 13 years of experience in the pharmaceutical business.

She first joined Janssen as a contractor in 2013 and then became permanent in 2014, working as a Global Data Manager in Infectious Diseases and Vaccines before transitioning to Clinical Data Standards in 2017. Prior to joining Johnson & Johnson, Kathleen worked as a Data Manager at a CRO. Kathleen holds a PhD in Biology from the University of Antwerp, Belgium.

Vicky Poulsen

Joined Novo Nordisk A/S in 2015 after being a SAS consultant for a decade in the public health sector specialising in End-to-End BI solutions.  She participated in the CDISC Implementation Project shortly after.  In her present position, Vicky leads the standard programming strategy and development efforts that drive the SDTM Generation Framework for SDTM and define.xml automation.

Vicky holds an MPhil in Geographic Information Systems and Network Analysis from the University of Hong Kong.

Obiageli Onwusaka

Dr. Obiageli has over 10 years of experience in public health and clinical research and has led teams in both academia and in the industry. She has focused on providing best practices for success in global clinical research, particularly emerging regions, in areas targeted at context-fit and patient-centered activities and solutions.

She is currently the director, Biostatistics at ClinFocus and is passionate about enhancing the scope of clinical trials particularly recruitment and retention among underserved populations. Dr. Obiageli is currently based in Calabar, Nigeria, a small city in West Africa.

Thierry Escudier

Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry

Thierry is now acting as an independent consultant providing strategic consulting to pharma/CROs and vendors to provide the best services and products for the benefits of the patient’s community

Thierry is very much convinced that digital innovation and patient engagement are the key success factors in the drug development phase  and will impact positively the medicinal product lifecycle.

Manuel Neukum

Manuel Neukum is the Managing Director of the software vendor XClinical and the COO of the EvidentIQ Group. Together with the CEO he is steering the strategy of EvidentIQ and brings it into operational excellence. He works in the clinical trial sector for over ten years and combines his industry and Software Engineering experience with his educational Data Science background 

Norman Stein

Norman Stein studied mathematics at Cambridge University before working for several years in the engineering industry. After taking a PhD in theoretical physics at Manchester University, he worked in a variety of positions in academia and industry, on topics including noise-driven nonlinear systems and protein crystallography.  For the past thirteen years he has been a statistician and data scientist at NorthWest EHealth in Manchester, working on real world clinical trials such as the Salford Lung Study, as well as retrospective data studies using electronic medical records.

Daniel Rolo

Daniel is a Director of Statistical Programming at Bioforum The Data Masters, and has over 10 years’ experience in the Biometrics space within the clinical trials industry. Daniel holds a B.Sc. degree in Computer Science and Geographic Information Systems from the University of the Free State in South Africa. Daniel is passionate about process optimization and harnessing the potential in individuals through structured development and innovative approaches to daily tasks.

Nicolas De Saint Jorre

With more than 26 years of experience in the world of Data Management and Clinical Research, since 2000 I have been developing the Webtrial Electronic Data Capture system. 

I have also been working since 2005 with the company EvidentIQ who is working with the  CDISC standards from data collection to SDTM tabulation with an archiving solution in ODM format. 

In parallel, I devote a large part of my time to the development of a metadata repository system allowing the complete management of all CDISC metadata (CDASH, ODM, SDTM, ADaM, LAB, CT as well as TAs). I have also actively contributed to the CDISC360 project since 2018 in order to set up a prototype of ‘Study Builder’ using a central library of metadata. 

Since 2019, I am working with the Novo Nordisk group on the OpenStudyBuilder as a Business Analyst. Here is was setting up the CDISC Controlled Terminology and the definition of the Models and the Implementation Guides in order to bind them with the metadata of the Protocol, of the Case Report Forms, of the STDM tables to the ADaM datasets in a fully versionned controlled manner.

Jørgen Iversen

Jørgen has been programming for more than 40 years in many industries, the last 17 years in pharma. He has continuously educated himself in computer science in parallel to full time work, and holds a B.Sc. in Computer Science and a Master of IT in Software Construction. In all his work, metadata and standards has always been a key focus point, acknowledging that standards makes programming easier, not harder. The last 4 years Jørgen has devoted all his time to developing metadata, and standards and tools for metadata, at LEO Pharma.

Stuart Malcolm

Stuart Malcolm is Head of Standards, Efficiency and Automation at Veremed where he is responsible for the delivery of software platforms, tools, and techniques to optimise the delivery of clinical trial analysis projects.

Stuart has been working in Clinical Trials for 10 years, and prior to that has 15 years experience of software development in a range of industries including telecommunications, finance and media.

Stuart is a co-chair of the Phuse Emerging Trends and Technologies working group, he regularly presents at conferences and intermittently blogs on www.metadatadriven.com

Siddhant Prabhu

Sid has 5 years of R&D experience, specifically in clinical development, across global Pharmaceutical and Biotechnology organizations. He has deep experience in technology-led solution delivery including knowledge of CDISC SDTM/ADaM standards, medical data review business processes, and the governance setup for clinical data reuse. He has delivered multiple projects in the R&D domain spanning areas including strategy, operating model development, process optimization, clinical technology selection/implementation, and analytics. 

Thomas Rye Olsen

Thomas is a Scientific Student Assistant in Biostatistics at Novo Nordisk, Denmark and has since september been working on a project to automatic define ADaM databases using Machine Learning.

He is a undergradstudent from Department of Computer Science, University of Copenhagen, studying Machine Learning and Datascience on his third year. He also holds a bachelor's degree in Humanities from Roskilde University. His main interest is currently exploring new Machine Learning models and methods to interpret and explain the models, as well as getting hands-on experience.

Henning P. Föh

Henning is a Statistical Programming Director in Biostatistics at Novo Nordisk A/S Denmark and has over 15 years of experience in the pharma industry. He holds a MSc in Physics and has previously worked as a researcher within the field of satellite orbit determination as well as consultant for SAS Institute supporting various industries including Pharma, Tele, and Supply Chain. His main interest is currently the strategic clinical development of new indications and drugs for authority approvals and building up strong project teams across locations and organizations. 

Rebecca Leary

Rebecca Leary is a Senior Project Manager with responsibility for the IMI2 funded, conect4children (c4c) project.  Rebecca is based in the John Walton Muscular Dystrophy Research Centre at Newcastle University . c4c is creating a pan-European clinical trials network for paediatrics, which will address the barriers to delivering effective paediatric clinical trials Rebecca is the co-lead of the data work package in c4c, this work package has a focus on improving the interoperability and harmonisation of paediatric clinical data collecting in clinical trials. Recently she established the Global Paediatric Data Forum to encourage international collaboration around data harmonisation. 

Rebecca also co-leads the Education work package of c4c and chairs the Communication and Dissemination Board of the project. 

Prior to managing c4c she managed the neuromuscular European Reference Network EURO-NMD, and was part of the secretariat of the global TREAT-NMD alliance which facilitates translational research; bringing therapy for patients with rare neuromuscular diseases. 

Ankur Krishnan

Currently, Ankur is the Data and Project Manager at Heidelberg Institute of Global Health (HIGH) for the ECRAID-Base project. He is involved in making the ECRAID-Base studies and (meta)data ‘FAIR-by-design’, through developing – i) CDISC-compliant eCRFs for the observational studies within ECRAID-Base, ii) cross-walks between CDISC – OMOP CDM (through EHDEN project) and CDISC – HL7 FHIR (through Horizon Standardization Booster project), iii) machine-actionable study- and site-level metadata schemas and, iv) machine-actionable Data Management Plan (DMP).

He has over 5 years of experience in data standards, harmonization, collection and management within the translational and evidence-based clinical research landscape. And, 7 years of experience in project management.
He worked as a Senior Clinical Research Coordinator for the DEPRESSD project in Canada (2018 – 2021), where he was involved in systematic reviews and IPDMAs (Individual Participant Data Meta-analyses) of four depression screening tools (PHQ, HADS, EPDS and GDS) and in developing a Living Systematic Review of Mental Health in COVID-19, which aim to develop and apply rigorous methods on assessing depression screening tool accuracy that minimize bias and provide evidence to inform research and policy to improve mental health care.

Prior to that, he worked as a researcher in molecular epidemiology, genomics and metabolomics in India (2015 – 2016: Cardio-metabolic Adversities) and Canada (2017 – 2018: Schizophrenia, psychosis and depression). And, he has worked as an Assistant Editor for the Taylor & Francis Group in India (2013 – 2015).
He holds Master’s degrees in Forensic Science (2011 – 2013: NICFS, New Delhi, India) and Applied Biotechnology (2016 – 2018: McGill University, Montreal, Canada).

Peter Van Reusel

Peter Van Reusel provides executive leadership to the development and implementation of clinical standards in line with CDISC's strategy and operational plans, working closely with the President and CEO, as well as CDISC staff and stakeholders. He has over 20 years of experience in senior roles in pharma and at CROs, providing standards expertise and carrying out other standards work in various organizational settings. A long-time, CDISC-authorized instructor, Peter has helped significantly in developing CDISC training courses. He previously served as CDISC's European Liaison, shepherding relationships with key European regulatory, academic, and biopharma stakeholders. Peter is also an active PHUSE collaborator.

Amy Palmer

Amy Palmer is the Head of Standards Development Operations at CDISC. Amy has been with CDISC since 2013. She is a member of the CDISC Technical Leadership Team and leads the Global Governance Group. Amy has over 28 years' experience working in clinical research. She has been involved in the development of multiple therapeutic area user guides as well the foundational standards and has been working with CDISC standards since 2010. 

Amy has a BS from Mary Washington College and an MPH from the University of Montana.

Els Janssens

Els Janssens has more than 10 years of experience in the field of Clinical Data Management and started at SGS Health Science in 2012. After gaining experience in pharma overseeing DM CRO activities, she returned to SGS as DM Data Standards and Process Manager responsible for maintaining the CDISC SDTM standards. In her current role as Executive Manager Secure Data Office, she is responsible for the overall management of a dedicated unblinded team within Data Management.

Els holds a master's degree in Industrial Sciences: Biochemistry, a master's degree in Cellular Biotechnology and a PhD in Biomedical Sciences.

Bhavin Busa

Bhavin Busa is a thought leader in the areas of data standards, programming, analytics, and regulatory submission. He is a Principal and Co-Founder of Clymb Clinical. He is very passionate about leveraging standards and technology to expedite data review, analysis, and submission processes. He is a PHUSE Steering Committee member, co-chair PHUSE US Connect, CDISC Analysis Results Standards Co-Lead and is currently a board member of the CDISC Open-Source Alliance (COSA) team.

Smriti Anand

I'm a Statistical Programmer at Pfizer. Currently focused on using open-source technologies to add value to Clinical Analysis and Submissions. I'm relatively new to the field, but I like innovating new solutions to existing problems and I'm usually trying to find a way to use R in everything.

Nynne Louise Berthou Storm

Nynne Storm joined Novo Nordisk A/S in 2018 and has worked as a Statistical Programmer on and across various projects and studies. Currently focusing on pooling of data for submission. She has a PhD from the Technical University of Denmark within the field of Geomagnetism.

Louella Schoemacher

Louella Schoemacher is a statistical programmer working for OCS Life Sciences. She has a background in nutrition which triggered her interest in research. Within clinical research she is passionate about data visualization and standardizing processes.

Graham Downing

Since late 2018, Graham Downing has been with UCB BioSciences GmbH, based in Germany, where he heads Clinical Data and Innovation within Global Clinical Science and Operations. Graham is a multi-functional clinical trial operations professional who champions the appropriate use of technologies to streamline processes and the time to trial readout.

He is a global leader integrating solutions addressing business plans; enabling ability to realize digitization, be more efficient across operations, enhance data-driven oversight, and metrics driven delivery.

With more than 35 years industry experience spanning Biostatistics, IT, Clinical Data Management, and various technology roles; and having served in companies in the UK, USA and, since 2013, in Germany, Graham is a key leader at UCB as they embed standards and deliver digital business transformation.

Sam Hume

Sam Hume leads the CDISC Data Science team, which collaborates with CDISC staff and stakeholders to develop tools and standards that support clinical and translational data science.  Sam directs delivery of the CDISC Library metadata repository that houses all CDISC standards, co-leads the CDISC Data Exchange Standards team, co-leads CORE, and leads the technical CDISC RWD efforts. He has 25 years’ experience in clinical research informatics and has held a number of senior technology positions in the biopharmaceutical industry. He holds a doctorate in information systems.

Jozef Aerts

Jozef Aerts is CEO of a small consultancy and software company specialized in CDISC standards. Jozef is also a CDISC volunteer for more than 20 years and CDISC instructor.

Madeleine De Forest-Brown

Madeleine De Forest-Brown is a full stack software engineer with a background in mechanical engineering. With over a year of experience at Lindus Health, she is part of a small team developing a cutting-edge clinical trial platform. Driven by her passion for the intersection of technology and healthcare, Madeleine is excited to be a part of a company that is accelerating clinical trials and bringing treatments to patients faster.

Amiel Kollek

Amiel Kollek is a full-stack software engineer who has been at Lindus health for just over a year. Prior to joining Lindus Health, he worked at Meta on both consumer and business facing products. Amiel is thrilled to be part of a small fast-moving team focused on improving clinical trials and ultimately benefiting patients.

Kevin Burges

In his 24 years at Formedix, CDISC has been a core focus. He was a founding member of the CDISC XML Technologies Governance team, and currently sits on the Data Exchange Standards team helping drive the future technical direction of CDISC standards. He works closely with customers to define new feature enhancements for the ryze platform.

Eyal Wultz

Chris Connolly

Ms. Connolly is an advocate for data standardization given its potential to expedite development of preventive approaches, harm reduction strategies, and quality therapies to improve health outcomes. Christine is the CDISC Head of Standards Projects and Project Manager for the Tobacco Implementation Guide (TIG) project responsible for development of TIG v1.0 standards. She has led initiatives, developed, and implemented data standards for over ten years and has twenty-five years of experience working in global clinical trials in both academic and pharmaceutical settings.

Chrissie Cai

Ms. Cai is a Data Quality Management Team Supervisor at the Division of Regulatory Science Informatics, Office of Science at the Center for Tobacco Products of FDA.  Her passion lies in data standards, and she strongly believes that they play an essential role in ensuring that data is both usable and meaningful.  

As a new member of the Tobacco Implementation Guide (TIG) project, Chrissie is currently overseeing the development of TIG v1.0 standards in collaboration with CDISC.  Furthermore, she is leading the Data Governance and Data Management initiatives at CTP, constantly seeking ways to improve the data management processes and enhance data quality within her organization.

Angelo Tinazzi

Angelo is a Senior Director in the Statistical Programming Department at Cytel in Geneva leading the Standards, Systems, CDISC Consulting group.

He has more than 25 years of experience in the field of Clinical Research in the area of data management and statistical programming with different roles in Academic Organizations, CROs and Pharmaceutical Industries, in Italy, Switzerland and UK.

Angelo is a member of the European CDISC Committee (E3C) since 2015 where he also manages the Italian speaking user network group. In 2018 he became a CDISC Authorized Instructors for ADaM.

Sarah McLaughlin

Sarah McLaughlin is a member of the Global Data Management and Standards team at MSD. She has enjoyed a 35 year career working with health research data in hospital, university, think tank, start up, biotech, CRO and pharmaceutical company settings. She has been an SDTM instructor for CDISC and a volunteer on CDASH and several TAUGs.

Adrian Czaban

I am currently a Statistical Programming Specialist at Novo Nordisk, and I've been working as a programmer since finishing my PhD in Genetics in 2015. I am a lead programmer on one of the projects, but I also like to take part in many new improvement ideas and initiatives, sometimes going beyond Biostatistics. I enjoy trying new things, especially if I can use my knowledge in programming and standards in a place where they haven't been applied before. I live in Copenhagen with my wife and two small daughters, who despite being only 4 and 1,5 years old are already into coding.

Caro Sluijter

Caro obtained her masters in Biomedical Science with a major in Epidemiology from the Radboud University in Nijmegen. For the last four and a half years at OCS Life Sciences, Caro, as a project lead, has been involved in multiple CDISC data conversion projects. Part of her work in these projects is to create Define-XMLs which are ready for submission. Furthermore, in her role as the proposition lead training, Caro is also involved in the creation and delivery of multiple trainings, such as Define-XML training. 

Dr. Matilde Kam

Matilde Kam, PhD, as Division Director, she has strategic and oversight responsibility for matters pertaining to analytics and informatics including data standards, data integrity/data quality, data visualization and other data tools, scientific computing and statistical programming activities in OB.

Prior to joining the FDA, Matilde had significant experience in building and overseeing highly effective statistics and analytics groups in the pharmaceutical industry. She is a Fellow of the American Statistical Association  (ASA) and is currently ASA Vice President (2021 to 2023). She received her PhD in Statistics degree from the Pennsylvania State University.

Dr. Y. Veronica Pei

Dr. Y. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as an Associate Director for Biomedical Informatics in the Office of New Drugs at the FDA.  In this role, Dr. Pei is involved in development, implementation, and support of bioinformatics initiatives as well as data standards within OND.  She is the current FDA topic lead for ICH M11 expert working group on the Structure and Content of Clinical Protocols.  She also serves as lead for the FDA Standard Tables and Figures Integrated Guide.

Dave Iberson-Hurst

Dave has over 40 years’ experience across several industries with the last 20 years spent in the pharmaceutical industry combining his technology and software development experience with clinical data standards.

During this time, he has worked on, and led, several CDISC teams, co-led CDISC’s eSource initiative (eSDI) and presented in many forums in Europe, the US, and elsewhere across the globe. He has worked closely with the FDA, EMA, HL7, ISO, and other standards organizations and was was a member of CDISC's Blue Ribbon commission.

 He is a partner at data4knoweldge in Copenhagen and is focused on getting greater value and utility from clinical trial data.

Siddarth Shah

Siddharth has 19 years of technology led business transformation experience advising life sciences companies in the various areas within R&D (Study design, Investigator Platform, clinical trial management, regulatory intelligence and safety automation), commercialization and manufacturing. His recent experience includes setting up of a Design Studio to implement innovation in study design at scale, collaboration with industry consortiums like TransCelerate, building digital clinical platforms, creating business case and adoption strategy for digital initiatives with high business impact, driving ventures and partnership management. Siddharth holds a MBA from Johnson & Wales University, and a B.E. in Instrumentation & Control systems from Nirma Institute of Technology. Protocol optimization with DDF During this session, you can see a practical adoption of the DDF vision, by achieving protocol optimization (SOA) optimization in conjunction with open source assets from TransCelerate.

Suman Kumar

Suman Kumar has 20+ years of experience working for Life Sciences companies and brings a specific focus on creating specialized products offerings in areas of medicine development. He has a deep understanding of the Clinical R&D landscape having worked with large pharmaceuticals, contract research organizations, niche data vendors and more. He has led multiple large scale Clinical Data Analytics programs that aim to reduce cycle time and bring therapies faster to patients.

Kai Zhao

Zahra Karimaddini

Zahra Karimaddini, PhD, has a background in computational biology, data science and personalized medicine. Zahra received her PhD in Computation Biology and Bioinformatics from ETH ZŸrich, with a focus on applied mathematics in neural development. Later she joint Roche as a postdoctoral researcher with a focus on machine learning in cancer biology. Since 2020 she has worked as Data Standards and Governance Specialist at Roche. In this role she is working on development and enhancement of various nonCRF data models, including digital measures, that collect clinical trial data F.A.I.R.ly and regulatory compliant.

In addition to her work at Roche, Zahra is recently leading the Digital Health Technology (DHT) subteam at CDISC to develop data standards for using DHTs in clinical trials.

Gitte Frausing

Karen Roy

Karen Roy was responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs. She is currently working for CDISC managing the transition of the Model to becoming a CDISC Standard.

Until recently, Karen was responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for their Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and then strategy. In her role as CSO, she led all Phlexglobal partnering across the clinical space, had key strategic input into the development of their eTMF, PhlexTMF and served as a Board member. 

Karen graduated as a Pharmacist in South Africa and entered the Pharmaceutical Industry working for Eli Lilly in Sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal. 

Sujit Khune

Sujit has Master in Clinical Research and Regulatory affairs and he is currently working as Clinical Data Engineering Lead at Novo Nordisk, Denmark. He has over 15 years of experience working on CDISC standards. In his current role he is responsible for crafting and engineering industry-scale data pipelines that will ingest, harmonize and unify thousands of clinical trials that are core to Novo Nordisk’s mission. He is current co-lead of European CDISC Coordinating Committee (E3C). 

Marius Conjeaud

John Owen

John Owen has worked with CDISC for over 7-years. After supporting the project management of various Therapeutic Area User Guides, John now also works in identifying and growing CDISC’s development activities to advance standards across a wide range of therapeutic areas and heads up the CDISC Project Management Office. John graduated from The University of Wales, Collage of Cardiff with a Bachelors Degree in Biology. Working within the pharmaceutical industry in clinical data management, clinical programming, and standards development roles.

John Owen has worked with CDISC for over 7-years. After supporting the project management of various Therapeutic Area User Guides, John now also works in identifying and growing CDISC’s development activities to advance standards across a wide range of therapeutic areas and heads up the CDISC Project Management Office. John graduated from The University of Wales, Collage of Cardiff with a Bachelors Degree in Biology. Working within the pharmaceutical industry in clinical data management, clinical programming, and standards development roles.

Ward Puttemans

Ward Puttemans is a data standards data manager and lab controlled terminology subject matter expert at SolCur outsourced to argenx. He holds a Bachelor of Bio-medical Laboratory Technology, Option in Pharmaceutical and Biological Laboratory Technology from the University Colleges Leuven-Limburg.

Ward started his career at Janssen as part of liquid and parental drug development team and transitioned to clinical data manager afterwards. After working at 7 years at Janssen he moved to UCB where he manages eCRF and SDTM standards and controlled terminology.

4 years later he moved to SolCur and works as a consultant at argenx managing standards. Ward is a co-lead on the CDISC Controlled Terminology User Guide (CTUG) team and a member of the Lab SDS sub team.

Erin Muhlbradt

Dr. Erin Muhlbradt is a contractor for the National Cancer Institute's Enterprise Vocabulary Services (NCI EVS) and has been working with CDISC for more than 15 years. She is the CDISC and NCI EVS project lead for CDISC terminology development and is responsible for overseeing the activities of all CDISC controlled terminology teams.

Dr. Muhlbradt holds a Bachelor of Science Degree (Honors) in Molecular and Cellular Biology from the University of Glasgow (Glasgow, Scotland) and a Doctoral Degree in Tumor Biology from Georgetown University (Washington DC).

Dr. Muhlbradt leads or co-leads 13 terminology teams, is a member of the CDISC Technical Leadership Committee (TLC), a member of the SDS team, a co-lead of the SDS Genomics team, a co-lead of the SDS Cell Phenotyping team, a terminology representative for therapeutic area standards development teams, and a terminology representative for the CDISC Global Governance Group.

She is also a CDISC Authorized Instructor.

Janneke van Blijswijk

Janneke is Consultant in the RDE practice area at ZS Associates and has worked with Big and Mid-size Pharma across R&D and Medical with pre-clinical, clinical as well as real-world data. She has broad expertise in R&D strategy and organizational design, biomedical research, real world evidence, data standardization and clinical development. Janneke also has a strong scientific knowledge base, ranging from basic biomedical concepts (including a PhD in immunology), to more applied sciences, e.g. in the context of clinical data or cell & gene therapies.

Hanne Van Kints

Hanne van Kints works as a Principal Standards Specialist at Novo Nordisk A/S. She has more than 30 years' experience within the pharmaceutical industry and data management. She has worked across all areas within data management and has participated in several IT and business improvement projects. She is supporting end-to-end standardisation, CDISC SDTM implementation, use of DMW and other CDMS systems.

Jasmine Kestemont

Jasmine Kestemont is an entrepreneurial business leader with significant experience in both Sponsor and services organizations.

Jayashree Vedanayagam

11 Years experience in ADaM & TLF Clinical Analysis and Programming. Currently working on developing solutions based on open-source technologies for Clinical Analysis and regulatory submissions. Passionate about data science and visualization.

Jenn Mastri

Jennifer Mastri is an Associate Director in Global Clinical Data Standards at Merck with over 20 years of data management experience across multiple functional areas. Prior to Merck she was part of the team responsible for developing a global data management library in the Accenture LLC, Accelerated Research and Development Group in addition to putting into operation two new external data capture systems. Currently, she is responsible for oversight and maintenance of the global library vaccine data standards along with acting as the data blinding subject matter for data standards.

Matthew Phelps

Matthew Phelps joined Novo Nordisk A/S to work on the newly formed Data Science Automation Team as a Statistical Programming Specialist in April 2022. Previously he worked as an epidemiologist at the Danish Heart foundation doing registry-based research. In addition to research, he had a lot of fun programming in R and developing public-facing Shiny apps.

Paul Fenton

Paul Fenton has over 20 years’ experience in the development, deployment and validation of computerized systems for use in regulated clinical trials. He has worked on major clinical technology projects both in the EU and North America and has a strong background in standards and systems and process integration.

As CEO of Montrium, he leads the overall vision for the connect platform which focuses on the organization and analysis of clinical trial information. He is a long standing member of the TMF Reference Model Steering Committee and Chair of the CDISC TMF Reference Model Standards sub-group. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.

James Conway