SCDM 2025 Annual Conference

Break · Camden Lobby

Welcome Breakfast & Registration

Workshop

Mastering RBQM: Practical Approaches for Cross-Functional Teams

Shawntel Swannack, J&J · Sas Maheswaran, CluePoints · Adrienne Strickler, J&J

Workshop

AI/ML 101

Derek Lawrence, Saama · Aman Thukral, AbbVie · Aamir Jaka, Saama

Break · Camden Lobby

Workshop: Coffee Break

Break · Room 336

Leadership Forum: Coffee Boost

Room 337+338

Leadership Forum

Joby John, Sitero · Catherine Celingant, Pfizer · Wayne Walker, Medidata · Elizabeth Burger, Spaulding Clinical · Mike McDevitt, Syneos Health · Courtney Ha, Precision for Medicine · Bernd Heinrich, Bayer AG · Robyn Orie, Caidya · Drew Garty, Veeva Systems · Lisbeth Bregnhøj, The Danish Medicines Agency · Torsten Stemmler, Federal Institute for Drugs and Medical Devices · Daniel Bjermo, Swedish Medical Products Agency · Rachel Mead, MHRA · Aman Thukral, AbbVie Inc · Avi Kulkarni, ThoughtSphere

Break · Room 336

Leadership Forum: Coffee Break

Break · Camden Lobby

Workshop: Lunch Break

Break · Room 336

Leadership Forum: Lunch Break

Workshop

Data Requirements for an FDA Submission

Dawn Kaminski, eClinical Solutions · Dan Crawford, Veeva Systems

Workshop

Who are you calling soft? The Importance of Soft Skills in CDS

Joy Allen, MSKCC · Alanna Slaeker, Pfizer · Sujata Aiyangar, Accenture · Christine Panetti, Pfizer · Kristen Feshler, Pfizer

Break · Camden Lobby

Workshop: Coffee Break

Break · Room 336

Leadership Forum: Coffee Break

Networking · Exhibition Hall

Opening Reception

Networking

Leadership Forum Dinner

Break · Exhibition Hall

Welcome Breakfast & Registration

Ballroom I-II

Conference Opening

Carol Schaffer, Pfizer · Avinash Chandarana, MCI Group · Cecilia Calcagno, MSD Innovation & Development GmbH · Manny Vazquez, Merck · Ajitha Akurati, Pfizer Inc. · Derek Perrin, Sarepta Therapeutics

Keynote · Ballroom I-II

Opening Keynote Session

Matthew Griffin, 311 Institute · Ward Lemaire, J&J

Break · Exhibition Hall

Coffee Break & Exhibit

Panel · Risk-Based CDM · Ballroom I-II

From Noise to Insight: Leveraging Pareto’s Principle to Streamline RB-CDM

Pavel Burmenko, Veeva · Christina Dinger, ThoughtSphere · Yun Lu, Navitas Clinical Research, Inc. · Cilla Mistry, GSK · Shobhit Shrotriya, Accenture

Panel · Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms · Regulations & Standards · Clinical Trial Operations · Room 337+338

Metadata for All: Applying Standardization Across the End-to-End Data Pipeline

Erin Erginer, Certara · Chris Decker, CDISC · Lisbeth Bregnhøj, The Danish Medicines Agency · Radhika Kale, Alnylam Pharmaceuticals · Vrinda Gopalmenon, Merck · Fred Bermont, Moderna

Panel · Technology & Data Platforms · Room 339+340

Software Co-Development – Goldilocks Gets What She Wants

Ralph Russo, Pfizer · Drew Garty, Veeva Systems · Ratheesh Nair, Merck · Kenneth Mills, Pfizer · David Sunderhaft, REDCap Cloud

Talk · AI & Cognitive Tech · Room 341+342

Integrating Analytics at Every Step

Alysha Clark, Aperio Clinical Outcomes · Amy Wilson, KCR · Nick Fuller, Eli Lilly & Company · Kevin Rutty, Pfizer · Thomas Dougherty, Novo Nordisk

Talk · Room 343+344

Redefining Patient Centricity in the Clinical Data Management & Science Ecosystem

Mike McDevitt, Syneos Health · Adriaan Kruger, nuvoteQ · Hemant Gawande, Cognizant · Katrina Filer, IQVIA

Demo · Ballroom I-II

From Complexity to Clarity: Simplifying SDTM Mapping for Faster, Compliant Submissions

Kristin Kelly, Certara

Demo · Room 337+338

iMednet Reimagined: A Smarter, More Intuitive Way to Power Clinical Trials

Bill Mogg, Mednet

Demo · Room 339+340

Reduce Cycle Times with the elluminate Clinical Data Cloud

Jason Konn, eClinical Solutions

Demo · Room 341+342

Streamline the End-to-End Data Flow with Automation and AI

Nick Klatt, Veeva · Faisal Sufi, Veeva Systems

Demo · Room 343+344

Zelta: Creating the future of instant database builds

Judi Hall, Alimentiv · Jennifer Duff, Zelta by Merative

Break · Exhibition Hall

Lunch & Exhibit

Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms · Regulations & Standards · Soft Skills · Ballroom I-II

What is the Single Biggest Opportunity Ahead of Us in the Next 5 Years?

Jon Young, Veeva · Donald Thampy, Merck · Mike McDevitt, Syneos Health · Tanya du Plessis, Bioforum the Data Masters · Mark Penniston, Atorus Research Inc

Demo · Ballroom I-II

AI-Driven Approach to Transforming Clinical Data Management and Patient Monitoring

Aamir Jaka, Saama · Sean Taylor, Saama

Demo · Room 337+338

From mid-study mayhem to reporting Zen: Purpose-built tools for Data Managers

Gregory Tullo, Viedoc

Demo · Room 339+340

Implementing a Clinical Data Platform to Drive Transformation to Clinical Data Science

Olgica Klindworth, Medidata, Dassault Systemes · Evan Hughes, ICON

Demo · Room 341+342

Combining eSource, EDC and RBQM to drive automation & operational efficiency

Eric Schnitzer, CRScube

Demo · Room 343+344

Ready, Set, Adopt: Building a Seamless AI Transition for Clinical Data Teams

Shou Yuan, Taimei Technology Inc.

Break · Exhibition Hall

Coffee Break & Exhibit

Panel · Clinical Trial Operations · Ballroom I-II Foyer

The Research Coordinator Experience

Joe Lengfellner, Memorial Sloan Kettering Cancer Center · Therica Miller, Icahn School of Medicine at Mount Sinai · Renata Panchal, Memorial Sloan Kettering Cancer Center · Rebecca Hudson, University of Maryland Baltimore, Center for Vaccine Development and Global Health

Talk · Risk-Based CDM · Room 337+338

Mitigating Risk from RBDM Using Analytics, Visualization & AI/ML

Devdatt Patel, Pfizer · Diego Alonzo Rodríguez Méndez, ICON · Daniel Bjermo, Swedish Medical Products Agency · Diane Lacroix, eClinical Solutions LLC

Talk · Clinical Data Competencies & Cross-Functional Interactions · Clinical Trial Operations · AI & Cognitive Tech · Room 339+340

From LLMs to SLMs: Will Clinical Data Science redefine Clinical Trial Execution?

Abby Abraham, Precision for Medicine · Jia Chen, Medidata Solutions · Gaurav Bhatnagar, Tilda Research · Manuj Vangipurapu, Clinion AI Technologies Pvt Ltd

Talk · Technology & Data Platforms · Room 341+342

Accelerating Clinical Trial Innovation: Cloud-Powered Solutions for Next-Generation Research

Jeff Beeler, Amazon Web Services · Terry Morris, Eli Lilly · Gopi Gopinath, Merck

Room 343+344

One Year Later: Best and Worst Examples of Simplifying and Standardizing in 2025

Drew Garty, Veeva Systems · Leianne Ebert, Alcon Laboratories · Michael Buckley, Memorial Sloan Kettering Cancer Center · Donald Thampy, Merck

Networking · Ballroom I-II Foyer

#SCDM25 Happy Hour

Sunrise Awakening

Break · Exhibition Hall

Welcome Breakfast & Registration

Ballroom I-II

SCDM Business Meeting

Carol Schaffer, Pfizer · Ward Lemaire, J&J · Jonathan Andrus, Society for Clinical Data Management · Patrick Nadolny, Sanofi · Stephen Cameron, ICON

Welcome & Day 1 Highlights

Ballroom I-II

Regulatory Townhall

Marc Wartenberger, CRIO · Cheryl Grandinetti, U.S. Food and Drug Administration · Kassa Ayalew, U.S. Food and Drug Administration · Torsten Stemmler, Federal Institute for Drugs and Medical Devices · Rachel Mead, MHRA · Daniel Bjermo, Swedish Medical Products Agency · Lisbeth Bregnhøj, The Danish Medicines Agency · Anindita Saha, FDA · Myriam Salem, Health Canada · Alicja Kasina, Health Canada

Break · Exhibition Hall

Coffee Break & Exhibit

Regulations & Standards · Ballroom I-II

Help! I Have an Upcoming Inspection!” – Regulatory Inspection Best Practices for the Clinical Data Manager

Kevin Rutty, Pfizer · Kelly Torfs, SGS Pharma · Yasuharu Shibata, MSDKK · Kavita Dada, Food and Drug Administration

Room 337+338

Generations and Culture – How Prepared are We to Welcome the Next Gen Workforce

Saritha Chamarthi, Amgen · Jennifer Sustin, Cytel · Krista Bossi, MMS · Mike McDevitt, Syneos Health

Talk · Technology & Data Platforms · Clinical Trial Operations · AI & Cognitive Tech · Room 339+340

An AI-Driven Era of Interconnected Data Review, Analytics and Clinical Operations

Patrick Nadolny, Sanofi · Richard Young, CluePoints

Technology & Data Platforms · Room 341+342

Getting the Most from Technology to Strengthen the Patient – Site Relationship, Reduce Burden on Site Staff, and Pave the Way for the Use of AI

Bruce Hellman, uMotif Ltd · Hannah Kulkarni, CRIO · Aneesh Vaze, Clinical Research Philadelphia

Panel · Room 343+344

How to Prepare for the AI Shift in Clinical Trials: Insights, Challenges, and Next Steps

Rhonda Hines, Icon · Sylvain Berthelot, CRScube · Shobhit Shrotriya, Accenture · Miguel Lemaire, GSK

Demo · Ballroom I-II

Revvity Signals Clinical: Revolutionizing Data Access with an Agentic AI-Powered Custom Listing Generator

Christie Quarles, Revvity Signals · Philip Ross, Revvity Signals Software

Demo · Room 337+338

From Spreadsheets to Standards: Streamlining Clinical Metadata with Pinnacle 21 MDR

Julie Ann Hood, Certara

Demo · Room 339+340

From Protocol to Submission: The Impact of AI-Assisted Authoring on timelines, quality, and cost

Noble Shore, Veridix

Demo · Room 341+342

Crushing the Status Quo: See Agentic AI & Intelligent Automation in Action

Christina Dinger, ThoughtSphere · Joe Lebers, ThoughtSphere

Demo · Room 343+344

One-click Study Build: How Medidata is Transforming EDC Design with AI

Marco Amorim, Medidata Solution

Break · Exhibition Hall

Lunch & Exhibit

Ballroom I-II

Beyond the Horizon A Retrospective Look, a View of the Present & Gazing to the Future

Demetris Zambas, Pfizer Inc · Ward Lemaire, J&J · Kavita Dada, Food and Drug Administration · Kellie Richardson, Pfizer Inc. - New York, NY · Sarah Clark, AstraZeneca

Talk · Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms · Ballroom I-II

The Role of ICH-M11 and Digital Data Flow (DDF)

Kimberly Tableman, ESPERO · Joe Lebers, ThoughtSphere · Torsten Stemmler, Federal Institute for Drugs and Medical Devices · Chris Decker, CDISC · Cal Collins, OpenClinica · Luke Dunlap, Axtria

Talk · Clinical Trial Operations · Room 337+338

From Data to Empowerment: Innovating CDM Through Patient-Centricity

Kimberly Dley, ICON · Courtney Ha, Precision for Medicine · Karen Wood, Medidata

Talk · Room 339+340

Navigating and Leading the Next Industry Revolution in Clinical Data Management

Tanya du Plessis, Bioforum the Data Masters · Wayne Walker, Medidata · Nicole Pollard, eClinical Solutions

Panel · Technology & Data Platforms · Room 341+342

Real World Use of eSource in Clinical Research Data Transfers Using HL7 FHIR Standards

Michael Buckley, Memorial Sloan Kettering Cancer Center · Thanh Tran, Astellas Pharma US Inc · Renata Panchal, Memorial Sloan Kettering Cancer Center · Zach Taft, IgniteData

Talk · Room 343+344

Quality by Design: Risk Management Keeping End Results in Mind With Seamless Planning & Execution

Nikhil Scaria, Alcon · Sujata Aiyangar, Accenture · Amanda Langel, Foster Data Collective · Cilla Mistry, GSK

Demo · Ballroom I-II

Agentic AI for Smarter Audit Trail Review and RBQM Integration

Jayasree Ivaturi, Maxis AI · Joanne Gonzalez, LyfeSci Research & Innovation

Demo · Room 337+338

Implementing Risk-Based Data Management with Veeva CDB

Pavel Burmenko, Veeva · Eric Jacobson, Veeva

Demo · Room 339+340

AI-Enhanced Monitoring: Assessing Clinical Quality of Subjective Data

Ashley Gates, Signant Health

Demo · Room 341+342

Consent by Proxy? Let’s Talk LARs

Mark Epstein, OpenClinica · Chris Weiss, OpenClinica

Demo · Room 343+344

“The AI-Driven Clinical Development Ecosystem”: From Data Pipelines to R&D Cloud to AI Platforms

Shakthi Kumar, EDETEK

Break · Exhibition Hall

Coffee Break & Exhibit

Panel · Ballroom I-II

ICH E6 (R3) and the Data Revolution: Are You Ready?

Tanya du Plessis, Bioforum the Data Masters · Patrick Nadolny, Sanofi · Catherine Celingant, Pfizer · Dawn Kaminski, eClinical Solutions · Cheryl Grandinetti, U.S. Food and Drug Administration

Panel · Technology & Data Platforms · Room 337+338

Unlocking Efficiency in Oncology Trials: Scaling eSource for Enhanced Data Management

Mats Sundgren, European Institute of Innovation through Health Data (i-HD) · Therica Miller, Icahn School of Medicine at Mount Sinai · Richard Yeatman, IgniteData · Joe Lengfellner, Memorial Sloan Kettering Cancer Center

Talk · Risk-Based CDM · Room 339+340

Enhancing Data Integrity and Risk-Based CDM Strategies through Early Protocol Engagement

Trina Chowdhury, Trio Translational Research in Oncology · Rishi Raj, SENSAN BIOSCIENCES · Hetal Chheda, Cognizant Technology Solutions · Amanda Marshall, Carelon Research

Talk · AI & Cognitive Tech · Room 341+342

Practical Use(s) of AI for EDC Study Design and Build

Michael Barrera, Medidata, a Dassault Systèmes company · Marco Amorim, Medidata Solution · Ninad Mantri, ICON plc · Dorian Tisdale, Johnson & Johnson

Talk · Clinical Data Competencies & Cross-Functional Interactions · Room 343+344

Evolution of CDM to CDS-Need of the Hour for Early Phase Trials

Reema Deb, Syneos Health Inc. · Terri Sampo, Veramed · Bo Zheng, AskBio · Tom Auckinson, Bayer

Networking · Ballroom I-II Foyer

Leadership Mashup

Demetris Zambas, Pfizer Inc · Rick Ittenbach, Cincinnati Children's Hospital/Univ of Cincinnati · Mike McDevitt, Syneos Health · Stephen Cameron, ICON · Dawn Kaminski, eClinical Solutions · Joe Lengfellner, Memorial Sloan Kettering Cancer Center · Sarah Clark, AstraZeneca · Donald Thampy, Merck · Therica Miller, Icahn School of Medicine at Mount Sinai · Lisbeth Bregnhøj, The Danish Medicines Agency · Bernd Heinrich, Bayer AG · Richard Young, CluePoints · Priyadharshini Lobow, Eli Lilly and Company · Courtney Ha, Precision for Medicine · Julie Filipenko, Graviton Bioscience · Zack Lemka, Clinical Trials Statistical and Data Management Center - University of Iowa · Chris Decker, CDISC

Poster · Ballroom I-II Foyer

Poster Presentations

Sudharsan Krishnaraj, Pulmovant · Umamaheswari Adiseshan, Zifo · Richard Rogers, Axtria · Manny Vazquez, Merck

Networking · Phillips Seafood Restaurant | Inner Harbor Baltimore

Networking Reception

Break · Exhibition Hall

Welcome Breakfast & Registration

Room 337+338

Guiding the Evolution to Clinical Data Scientist: Innovation, Certification and Learning Continuity

Deepak Kallubundi, Fortrea · Kelly Chelnik, Johnson & Johnson, MedTech · Patrick Nadolny, Sanofi · Eva Martin, SCDM

Talk · AI & Cognitive Tech · Room 339+340

Generative AI and Clinical Development: Exploring the Frontier of AI Governance

Mari Sugimoto, A2 Healthcare Corporation · Munenori Takata, Tohoku University Hospital · Yasuhiro Yoshimaru, Kowa Research Institute · Stephen Cameron, ICON

Talk · Clinical Data Competencies & Cross-Functional Interactions · AI & Cognitive Tech · Soft Skills · Room 341+342

From Accidental Data Managers to Intentional Leaders: Building High-Performing Teams in Clinical Data Science

Leianne Ebert, Alcon Laboratories · Michelle Marlborough, Veeva Systems · Sarah Clark, AstraZeneca

Break · Exhibition Hall

Coffee Break & Exhibit

Panel · Clinical Data Competencies & Cross-Functional Interactions · Room 337+338

Establishing KPIs That Matter

Joby John, Sitero · Kevin Johns, Veeva · Seema Agrawal, Takeda · Tracey Malloy, Merck & Co. Inc

Talk · Risk-Based CDM · Clinical Data Competencies & Cross-Functional Interactions · Technology & Data Platforms · Clinical Trial Operations · Room 339+340

Is It Time to Shift Gears in RBQM Implementation? – Arrival of RBQM 3.0

Abby Abraham, Precision for Medicine · Olgica Klindworth, Medidata, Dassault Systemes · Jennifer Stewart, Premier Research · Jonathan Rowe, ZS Associates, Inc. · Arunkumar Krishnamurthy, Novo Nordisk

Technology & Data Platforms · Room 341+342

eCOA Landscape evolution

Leigh Bobowski, Pfizer Inc · Zabir Macci, IQVIA Technologies · Kieran Connolly, Veeva

Talk · Clinical Data Competencies & Cross-Functional Interactions · Soft Skills · Room 343+344

Navigating Clinical Data Management: A Comprehensive Guide with a SCDM Compass

Lori Zellman, ICON Clinical Research · Abigail Knight, Astellas Pharma Global Development · Rick Ittenbach, Cincinnati Children's Hospital/Univ of Cincinnati · Johan Vermeulen, Bioforum the Data Masters Inc.

Ballroom I-II Foyer

SCDM Awards Ceremony

Keynote · Ballroom I-II

Closing Keynote Session | Beyond the Pandemic - How COVID-19 Transformed Clinical Trials and Data Management (with Dr. Sara Brenner, FDA Principal Deputy Commissioner)

Jonathan Andrus, Society for Clinical Data Management · Sara Brenner, US FDA

Break · Ballroom I-II Foyer

Networking Lunch