Salma Ameen

Salma is a Statistical Programming Associate Director at AstraZeneca, with 20 years of experience in the pharmaceutical industry. She has received her master’s degrees in Business Administration and in Management Information System.​

As the TMF Functional Process Expert for Statistics and Programming, Salma has utilized her expertise to train her colleagues and facilitate her department’s TMF filings ensuring compliance with Completeness, Timeliness and Error Rate.​

Salma has been with Early Oncology Programming at AstraZeneca since 2007.​

Jesse Anderson

Project management, data science, and regulatory policy professional with over 8 years of federal government service. Extensive experience with building and maintaining professional relationships, driving policy initiatives across multiple organizations, and managing multiple priorities. Organized and detail-oriented with a passion for pharmaceutical policy initiatives, big data, and healthcare quality.

Sylvia Baedorf Kassis

Sylvia Baedorf Kassis, MPH is a clinical research professional with 24 years of experience in a variety of academic clinical research roles.

Over the past 6 years, she has had the privilege of focusing her career on health literacy and participant engagement efforts in the clinical research space, effectively facilitating initiatives that unite divergent perspectives into deliverables that offer harmonized and practical solutions to real-world challenges.

When Sylvia is not working, she enjoys hiking, paddle boarding, creative writing, painting, and playing the violin.

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.

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.

Dr. Ron Fitzmartin

Ron serves as Sr. Informatics Advisor, Center for Biologics Evaluation and Research, Food and Drug Administration. In this capacity Ron contributes to the development and implementation of strategy and guidance related to the electronic submissions and standardized data in support of the regulatory review of medical products. Specific focus areas include: study data standards; Identification of Medicinal Products; and ICH M11: electronic Structured Harmonised Protocol.

Prior to FDA, Ron was Managing Partner at Decision Analytics LLC. In addition, he was V.P., Informatics & Knowledge Management at Daiichi Sankyo, Inc. Other positions included V.P., Biostatistics, Data Management and Informatics at Daiichi Medical Research, Inc. and Group Executive Director, Biostatistics & Clinical Operations at Purdue Pharma.

Ron has been a regular speaker, session and meeting chair at numerous DIA and other industry meetings. In 2005, Ron was the DIA Annual Meeting Program Chair, Washington, DC. In 2006, Ron was elected DIA’s President-elect and served as President 2007-2008. During Ron's tenure as President, DIA established offices in India and China. Currently, Ron serves on the editorial board for the DIA journal (Therapeutic Innovation & Regulatory Science), as well as a DIA Honorary Fellow.

Ron received a PhD in statistics from the University of Maryland, an MBA from the University of New Haven, and a BS (political science) & MS (statistics) from Southern Connecticut State University.

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.

Rammprasad Ganapathy

Passionate about automation, with experience in statisticalvprogramming, EDC, and standards development. Enjoys R and SAS programming and leads software development projects.

Yogesh Gupta

Yogesh Gupta is Programming standards Sr. Director at Pfizer, where he provides leadership to Global Standards team for robust governance and implementation of end-to-end standards to support SDTM deliverables across the Pfizer Portfolio. He has almost twenty-five years of experience in the Pharmaceutical Industry with over 19 years at Pfizer. Yogesh expertise is in end-to-end systems/processes and Remote team management. He has led overall enterprise level programs that includes data flow process continuous improvement, data architecture and audit readiness essentials for Pfizer's Clinical Data Analysis and Reporting System codebase.

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.

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.

William Illis

Experienced Drug Development Business and Information Technology Leader with proven track record of successfully partnering with global business colleagues and internal/external suppliers to develop to deliver drug program submissions through operational excellence, and to develop new capabilities through process re-engineering, implementation of standards and information technology to improve Drug Development processes and deliverables.

Progressively increasing responsibilities in Drug Development Business and IT leading delivery functions and operations, and transformation programs.

End-to-end knowledge of drug research and development processes joined with proven expertise in strategic and tactical analysis, information technology, solution delivery, system support, clinical data management and reporting, clinical data standards, clinical trial operations, shared business services, outsourcing, regulatory compliance, system validation and risk management.

Lex Jansen

Lex Jansen is an independent consultant, currently working as Senior Director, Data Science Development at CDISC. Before he was a Principal Solution Consultant and Principal Software Developer at SAS Institute. ​

Amanda Johnson

Active participant in several CDISC standards teams with a passion for standards management, currently focused on supporting submissions requirements for regulatory authorities. Experienced in CDISC SDTM, ADaM, metadata management, standards control, etc.

Sumesh Kalappurakal

Experienced Director with a demonstrated history of working in the hospital and health care industry. Skilled in CRO Management, Clinical Data Management, Clinical Trials, Good Clinical Practice (GCP), and Clinical Development. Strong business development professional with a Artificial Intelligence: Implications for Business Strategy focused in Artificial Intelligence from Massachusetts Institute of Technology - Sloan School of Management.

Jiannen Kang

Jiannan (Jane) Kang co-leads CDISC ADaM ADA sub team since Aug 2022. Jane earned MS in Computer Science in Towson University and MD in Bio-Medical Engineering from Shanghai Medical College. She gained 19+ years programming experiences in safety, efficacy, and immunogenicity analysis in multiple TA studies at Merck. In recent 8 years, her focus is supporting PK and ADA analysis and reporting.

Linda Lander

Linda Lander is an independent contractor, currently working as Director Data Science and Biomedical Concepts Product Owner at CDISC. Before she was Director Data Standards at GlaxoSmithKline​

Jordan Li

Dr. Jordan Li is a subject matter and terminology expert from the National Cancer Institute Enterprise Vocabulary Services (NCI EVS) with over 10 years of experience creating and publishing CDISC terminology. She leads multiple CDISC controlled terminology teams and is responsible for CDISC Questionnaire, Ratings and Scales terminology development and publication. Jordan is also a CDaSH and SDTM standards developer and leads multiple standards development teams, including the Microbiology and Immunogenicity domain and SDS team.

Dr. Lilliam Rosario

Lilliam Rosario, PhD is the Director of the Office of Computational Science, OTS, CDER, FDA. Dr. Rosario has been with the Agency for over 20 years. For the last 10 years, she has led the Office of Computational Science in its mission to provide CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training. Dr Rosario drives the implementation of effective tools, technologies, and services that enable regulatory reviewers to apply their expertise to information. In OCS, she prioritizes innovation and collaboration with a mantra to “keep it small, keep it focused, and keep it moving”. Dr. Rosario also fosters knowledge sharing and collaboration with outside partners to advance thinking and promote innovative solutions in support of regulatory review. In recognition of the Office’s accomplishments, Dr. Rosario received an Innovation Award during the 6th annual FedHealthIT in 2020. Dr. Rosario has a B.S. in Chemistry from the University of Puerto Rico and doctorate in Neuroscience from Rutgers University. Lilliam is inspired daily by her family. In her free time, she likes to run, hike, and practice yoga and really enjoys TED talks and audiobooks.

Michelle Lumicao

Michelle Lumicao is a Principal Data Standards Specialist at Syneos Health, where she is a member of the Data Standards and Governance group as an SDTM SME. She has more than 17 years of experience in clinical research. She worked in Data Management for 4 years and in Statistical Programming 13 years. She has been a CDISC volunteer for CORE and the Digital Health Technologies Team.

Shanshan Ma

Shanshan has been working in pharmaceutical industrial for nine years and has solid knowledge and hands on experience in conducting data analysis in medical terminology and drug development process from SAP through FDA submission in oncology area. With the participation in in-house SDTM automation process, she built an intensive understanding for CDISC compliance implementation in real data. And this presentation is based on her experience with previous employer, BeiGene.

Frederik Malfait

Frederik Malfait is Senior VP of Information Architecture at Nurocor, focused on delivering the Nurocor Clinical Platform for digitalized clinical development. Before that he has consulted for the biotech industry with assignments across Drug Safety, Clinical Data Management, Statistical Programming, and Clinical Data Standards. He has designed a semantic MDR for a large pharma, co-initiated the PhUSE CSS Semantic Technology working group and the CDISC Protocol Entities project, and consulted for TransCelerate, and designed the initial implementation of the CDISC Library API and Browser.

He holds a Master Degree in Mathematics.

Frank Menius

Frank Menius is a graduate of The University of North Carolina and holds a graduate certificate in Applied Statistics and Data Management from NC State University. Mr. Menius is a former police officer, having served the City of Raleigh 12 years prior to transitioning into programming and data science.  Mr. Menius specializes in clinical trial submission standards, has extensive experience in define.xml creation and is actively working to bring CDISC data standards to the eCOA and IRT environments. Frank is also a volunteer with the CDISC ADaM sub team working to build ADaM QRS supplement standards.​

Sandra Minjoe

Sandra Minjoe has been part of the CDISC ADaM team since 2001, proposed structures that became ADSL and OCCDS, is a former ADaM Team Lead, and continues to work on sub-teams. She focuses on the fundamental principles of traceability and analysis-readiness and Sandra consults on ADaM standard implementation.

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.

Tasha Nagamine

Tasha is an entrepreneur and seasoned technologist with 10+ years of experience in AI, research, and tech strategy. She brings deep expertise in RWD to build data-driven products that have processed over 100 million patient lives. Tasha received her BS in physics from Brown University and left a PhD in deep learning at Columbia University to start Droice.

Jon Neville

Jon Neville has been working in CDSIC standards development since 2009. He has been working at CDISC for 6 years, where he is currently Senior Director, Standards Development at CDISC

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.

Kapila Patel

Kapila Patel has over 20 years of experience in the areas of Data Standards and providing technical support to clinical trial systems/data. Previous publications cover topics including metadata curation, data integration, and SDTM and ADaM implementation. Kapila is member of the CDISC SDS NSV subteam, Curator Forum, PHUSE SDTM ADAM Implementation FAQ team, and icSDRG team. ​

Srinivasa Rao Mandava

Srinivasa Rao Mandava has long years of work experience in science, software and technology segments as clinical data standard articulator, coordinator, facilitator and integrator between sponsors, regulators, providers, processors, reviewers and approvers in life science, pharmaceutical and biotechnology areas of both sponsor and CRO settings. He has participated in the articulation, standardization and analysis of more than 300 clinical studies data and ten new blockbuster drugs in cancer, cardiovascular, sleep disorder, diabetes and Hepatitis indications got approved.  He also has been involving in various roles with CDISC such as advisory committee member, US Interchange planning committee member, conference session chair and presenter.

Donna Sattler

Charles Shadle

I excel at delivering successful projects, solutions and services. This is possible by leveraging the strong communication, negotiation and team building skills I've developed leading teams and interacting with internal and external stakeholders as well as executive and leadership teams. Equally responsible is my focus and adherence to the vision, scope and planning necessary to success as well as ownership/management of risk, budget and time

Cindy Stroupe

Has been at UCB, Inc. for almost 20 years as a statistical programmer and now as a Standards Manager focusing on analysis standards and end-to-end implementation. Support within the CDISC ADaM team has included participation in the following sub-teams: ADaM Conformance, ADaM & Implementation Guide version 1.2, ADaM Implementation Guide version 1.3 and ADaM Library Team. Currently serving as Future ADaM Team Lead, planning to move into the Team Lead role beginning in January 2024.

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.

Mikkel Traun

Mikkel Traun is a Principal System Developer at Novo Nordisk A/S, where he has been working on innovative solutions in the biomedical field. He is also a current CDISC COSA Board member, contributing to the advancement of industry standards for clinical research data. Mikkel played a key role in the CDISC 360 project and DDF initiative, which aimed to improve data sharing and collaboration across the clinical research community. Additionally, he is known as the brain behind OpenStudyBuilder, an open-source software platform that simplifies the creation and management of clinical study data. With his extensive expertise in open source and biomedical concepts, Mikkel is a creative innovation frontrunner in the industry.

Akash Trivedi

Akash is helping Life Science companies rethink their protocol development approach to include the use of protocol digitalization tools and enable digital dataflow across medical writing, data acquisition, data management, and STDM transformation. To help drive the industry forward, he has worked with industry consortia, such as TransCelerate and CDISC, to develop the Unified Study Definitions Model (USDM) and associated Study Definitions Repository. Akash believes the digital transformation of clinical development will improve the quality of data and bring lifesaving therapies to patients sooner.

Dr. 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.

Zelos Zhu

I'm Zelos Zhu, a Data Solutions Engineer at Atorus Research, where I have the privilege of serving as a core developer for the R-Package, Admiral. My journey into clinical trials began as a Research Assistant at UCSF Breast Care Center and later as a Clinical Data Scientist at Boehringer Ingelheim, where I worked primarily on early phase oncology trials. When I'm not delving into the intricacies of data, you'll often find me pursuing my passions such as: cooking up delicious meals, embarking on breathtaking hikes, and scaling V2s at the local bouldering gym.