3rd Annual Clinical Data Management Innovation 2025

A cornerstone gathering, showcasing cutting-edge advancements, best practices, and insights shaping the future of clinical data management

17 - 18

September

2025
  • Marriott Princeton at Forrestal, Princeton, USA
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Why attend?

A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

Engaging keynote presentations from industry luminaries, panel discussions featuring perspectives from diverse stakeholders, networking sessions to connect with peers and experts, exhibition area showcasing innovative solutions and technologies, opportunities to interact with FDA representatives and regulatory experts.

The programme will feature a range of speakers from the likes of FDA, Gilead Sciences, Eli Lilly and Company, Takeda, Genentech Roche Group, and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

100+

Attendees

30+

Exhibitors

100+

Attendees

30+

Exhibitors

See What It's All About

Agenda

  • 10 Sep 2024
  • 11 Sep 2024
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8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

9 AM

PANEL: Navigating the learning curve – staying current, automation adoption, and innovating in technologies

  • Discussing the importance of fostering a culture of continuous learning within organizations
  • Sharing insights on successful approaches for transitioning from manual practices to automated workflows in analytics
  • Discussing the advantages of collaborative learning through team-based projects and knowledge sharing sessions
  • Exploring emerging technologies to revolutionize data management practices and improve trial outcomes
  • Developing strategies to address resistance to change and ensuring smooth integration of new technologies within existing workflows

Moderator
Joshua Cox, Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

Panelists
Hyunjae Ryan Kim, Associate Director, Clinical Bioinformatics and Exploratory Analytics, Gilead Sciences

Prasun Mishra, Chief Executive Officer, Agility Pharma

Wendy Morahan, Senior Director Product Management, Clinical Data Analytics, IQVIA Technologies

Kimberly Barnholt, Executive Director, Evidence Generation, Genentech

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company
Prasun Mishra
Chief Executive Officer, Agility Pharmaceuticals
Kimberly Barnholt
Executive Director, Evidence Generation, Genentech, Roche Group
Wendy Morahan
Senior Director, Clinical Data Analytics Suite, IQVIA Technologies

9:30 AM

Enabling AI: Constructing a New Foundation for Clinical Data Management

The clinical data collection landscape has greatly increased in complexity over the past 5 years, while little has changed in terms of CDM roles, methodologies and processes. Artificial intelligence (AI) and machine learning (ML) seem like ideal solutions to address this challenge, however there are still significant hurdles to maximizing the value  AI and ML can deliver.

The introduction of AI to Clinical Data Management highlights a challenge when it comes to driving adoption - Over the past 20 years, CDM engaged in a significant amount of role & task specialization, which has resulted in a house-of-cards structure in which small changes have large systemic implications.

Identifying where AI and ML will make the greatest impact within CDM workflows, acknowledging what processes are misaligned and understanding how CDM roles/skills need to evolve will ensure organizations are well positioned to drive adoption of these emerging technologies.

Speakers

Derek Lawrence
Senior Director, Business Enablement, Saama
Aamir Jaka
Global VP Customer Experience and Success, Saama

10 AM

Unveiling use cases: harnessing synthetic data creation with machine learning

  • Shedding light on diverse use cases where organizations leverage synthetic data to unlock innovation and overcome data limitations
  • Employing models that evolve and learn from real data, ensuring a dynamic and realistic synthetic data generation process
  • Crafting synthetic patient data sets to simulate diverse medical conditions, optimizing precision medicine trial designs
  • Demonstrating how organizations navigate data privacy concerns by using synthetic healthcare data that complies with regulations

Speakers

Satha Thillaiampalam
Associate VP, Biostatistics and Statistical Programming Process and Infrastructure, Loxo Oncology Inc

10:30 AM

Morning refreshments and networking

11:15 AM

Can AI automate the manual data review and resolution process for anomalies?

  • Exploring the reasons for inconsistencies in clinical trial data
  • Reviewing the current manual process of identifying discrepancies
  • The role and benefits of GenerativeAI in improving data integrity and enhancing reviewers’ productivity

Speakers

Wendy Morahan
Senior Director, Clinical Data Analytics Suite, IQVIA Technologies

11:45 AM

FIRESIDE CHAT: Discovering the power of open-source technology in clinical data management strategy

  • Delving into the benefits, challenges, and strategic considerations of adopting open-source solutions in the clinical research domain
  • Overview of open-source EDC systems for efficient and flexible data collection
  • Discussing how open-source solutions can significantly reduce software licensing costs
  • Exploring strategies to ensure data security and compliance with regulatory standards when using open-source solutions

Speakers

Harit Nandani
Clinical Data Management Professional
Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

12:15 PM

Oversight for all: achieve data transparency with elluminate

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources:

  • How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
  • AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
  • Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
  • Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

Speakers

Dawn Kaminski
Vice President, Business Development Operations, eClinical Solutions

12:30 PM

AI-Driven Innovation: Automate Trials, Accelerate Success

  • Concept, Value, and Integration
  • The Cost of Switching: SOP/Workflow Adjustments
  • Continuous Process to Improve Accuracy
  • About Taimei

Speakers

Shou Yuan
Director of Global Solutions, Overseas BU, Taimei Technology
Sam Xu
Global Head of BD, Overseas BU, Taimei Technology

12:45 PM

Lunch and networking

2:15 PM

Unveiling innovations in automated data cleaning

  • Utilizing automated algorithms to identify and remove duplicate record, ensuring data accuracy
  • Applying automated rule engines to validate data for authenticity and integrity
  • Using machine learning for predicting potential data errors and proactively addressing them

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

2:45 PM

Increase trial agility with our integrated reporting tool

  • High-level study metrics and plan
  • Discover data outliers with intuitive dashboards
  • Dive deep into the data with the Data Browser
  • Standard Reports, including Key Risk Indicator to track site trends
  • Create unlimited custom, user generated reports

Speakers

Kelsey Buhler
Product Specialist, Viedoc Technologies

3:15 PM

Unleashing the power of digital protocols and automated study designs in clinical research

  • Navigating the paradigm shift towards digital protocols and data flow in clinical research
  • Exploring dynamic, digital protocols that adapt based on real-time data, fostering agility in study conduct
  • Utilizing integrated digital platforms for smooth and secure data flow, minimizing manual interventions
  • Leveraging digital tools for iterative study design, incorporating real-world insights during the planning phase
  • Implementing protocols designed for study reuse with molecular components, reducing redundancy and accelerating study startup

Speakers

Jonathan Chainey
Global Head, Data Standards, PD Data Sciences, Roche and CDISC Board of Directors

3:45 PM

Afternoon refreshments and networking

4:15 PM

Standardizing and analyzing complex clinical biomarker assay data: initiatives, challenges, and the application of an advanced AI platform

  • Biomarkers are objective, measurable indicators that play a crucial role in medical research and drug development
  • The increasing diversity and variability in biomarker data highlight the need for advanced, efficient technologies for data cleaning
  • The application of Cornerstone AI algorithms significantly improved data standardization and error detection

Speakers

Yuan Tian
Associate Director, Clinical Bioinformatics and Exploratory Analytics, Gilead Sciences

4:45 PM

Collaborative Strategies to Bridge Silos in Clinical Trials Data Management

Data Management, Biostatistics, and Data Standards, and External Vendors often operate in silos, yet their collaboration is vital for the success of clinical trials This presentation underscores the role of technology solutions in fostering collaborative environments, for both internal and external teams, to overcome the challenges in clinical trials data management. By bridging the gaps between standards setters and implementers, and between disparate functional teams and external stakeholders, the clinical trial industry can achieve greater transparency, efficiency, and data integrity.

 

Internal Collaboration:

  • Standards and Study Teams
  • Biostatistics and Data Management

External Collaboration:

  • Sponsors/CROs and External Lab Vendors
  • Sponsors and CROs

Speakers

Erin Erginer
Director of Product, Pinnacle 21 by Certara

5:15 PM

Chairperson’s closing remarks

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

END OF DAY 1 AND NETWORKING DRINKS

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

9 AM

Importing FDA Regulated Medical Products

  • Current OIO and FDA Organizational Structure Updates
  • How to avoid delays and benefit from technology that has been deployed at FDA
  • Future of Imports: Data Modernization at FDA
  • Questions

Speakers

Dan Solis
Assistant Commissioner for Import Operations, FDA
Steven Chiu
Import Specialist, FDA

9:30 AM

Metadata repositories: leveraging standards, expertise, and AI

  • Strategy to combine standard CRF design with different sponsor preferences
  • Applying study-specific metadata to expand your metadata repository
  • Increasing efficiency on downstream processes by automation and easily obtainable AI

Speakers

Davy Baele
Team Leader, CDM Programming, International Drug Development Institute – IDDI

10 AM

Fostering trust through good data stewardship: building relationships with research participants

  • Defining the concept of data stewardship within the context of clinical research
  • Exploring patient perspectives, hopes, and concerns about research data sharing
  • Fostering participant community understanding of risks and benefits of future use and sharing of clinical trial data

Speakers

Laurie Herraiz
Associate Director, Regulatory Knowledge & Support, Clinical and Translational Science Institute, UCSF

10:30 AM

Morning refreshments and networking

11:15 AM

Modernizing data integrity: leveraging analytics for quality data capture beyond traditional edit checks

  • Implementing advanced analytics techniques for enhancing data integrity beyond conventional edit checks
  • Exploring strategies to modernize data capture methods for improved quality assurance
  • Leveraging analytics tools to identify anomalies and ensure data accuracy throughout the clinical trial process

Speakers

Chris Helton
Senior Director, Data and Analytics, Diabetes, Eli Lilly and Company

11:45 AM

Driving data quality: EHR to EDC technology for improved clinical data collection

  • Overview how EHR to EDC technology can address common clinical data management challenges, with a demonstration of Flatiron’s EHR to EDC tool, Clinical Pipe
  • Review of recent research that delves into the potential time and cost savings when using EHR to EDC technology
  • Exploration of the benefits of EHR to EDC technology for clinical data managers and how to adopt in your organization

Speakers

Abhishek Dabral
Director, Clinical Data, Flatiron Health
Paul Salcuni
Senior Data Scientist, Flatiron Health

12:15 PM

Harnessing AI/ML for seamless clinical data lifecycle management

  • Streamlining processes form data inception to submission for faster and more efficient trials
  • Enhancing data collection through real-time monitoring, adaptive forms, and predictive analytics for improved data quality
  • Accelerating data tabulation with automated extraction, transformation, and loading (ETL) processes, reducing manual efforts
  • Navigating compliance requirements for data submission through intelligent automation

Speakers

Prasun Mishra
Chief Executive Officer, Agility Pharmaceuticals

12:45 PM

FIRESIDE CHAT: Aligning expectations with today’s data managers: redefining the Data Manager’s role

  • Navigating the changing dynamics in data management and the imperative to align expectations with the capabilities of today’s data managers
  • Recognizing the evolution towards strategic roles, including data governance, compliance, and leveraging advanced technologies
  • Embracing individuals with proficiency in emerging technologies, including data analytics, machine learning, and cloud computing
  • Emphasizing the importance of effective communication and collaboration between data mangers and stakeholders
  • Advocating for ongoing training and professional development to keep data managers abreast of latest technologies and best practices

 

Speakers

Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company
Tony Hung
Director, Clinical Data Management, Denali Therapeutics

1:15 PM

Lunch, networking and prize draw!

2 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

2:15 PM

Problem-Solving Roundtable Discussions

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical data management. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Managing clinical data collection and verification strategies as EDC becomes minimized while DDC and eCOA solutions continue to grow
Megan L. Dunham, Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

ROUNDTABLE 2
Discussing the critical and evolving role of standards
Jonathan Chainey, Global Head, Data Standards, PD Biometrics, Genentech, Roche Group

ROUNDTABLE 3
Managing the growth in data sources for clinical trials
Binitha Prasad, Director, Clinical Data Management, Jazz Pharmaceuticals

Speakers

Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals
Jonathan Chainey
Global Head, Data Standards, PD Data Sciences, Roche and CDISC Board of Directors
Binitha Prasad
Director, Clinical Data Management Jazz Pharmaceuticals

3:45 PM

Close of conference

End Of Conference

2024 Speakers

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Joshua Cox
Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

Joshua Cox has been honing his data management expertise in the drug development industry for nearly 20 years.  After breaking into the industry and gaining exposure to diverse therapeutic areas and development approaches with a CRO, Joshua has focused the last 15-years in sponsor driven early phase oncology.  He has enjoyed opportunities with bio-tech start-ups as well as established big pharma companies, each engagement adding valuable knowledge and experience to his skillset.  Joshua has led the development of data management departments by conceiving and implementing fit for purpose and results-driven technologies and processes always with an eye toward innovation and efficiency.  Now pursuing leadership opportunities outside the confines of traditional data management, Joshua is eager and excited to be a part of teams pursuing novel solutions to known challenges as well as employing cutting edge strategies and technologies to elevate the already high standards we expect and ultimately get the best medicines to the patients in need.

Session Details:

Chairperson’s opening remarks

2024-09-11, 8:50 AM

Session Details:

FIRESIDE CHAT: Discovering the power of open-source technology in clinical data management strategy

2024-09-10, 11:45 AM

Session Details:

Chairperson’s opening remarks

2024-09-10, 8:50 AM

Session Details:

PANEL: Navigating the learning curve – staying current, automation adoption, and innovating in technologies

2024-09-10, 9:00 AM

Session Details:

Unveiling innovations in automated data cleaning

2024-09-10, 2:15 PM

Session Details:

Chairperson’s closing remarks

2024-09-10, 5:15 PM

Session Details:

FIRESIDE CHAT: Aligning expectations with today’s data managers: redefining the Data Manager’s role

2024-09-11, 12:45 PM

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Jonathan Chainey
Global Head, Data Standards, PD Data Sciences, Roche and CDISC Board of Directors

Jonathan Chainey is an Executive Director and Global Head, Data Standards & Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across all Roche sponsored early & late phase clinical trials.  He is currently serving on CDISC’s board of directors and is chair of CDISC’s Technical Advisory Committee.

Over the past 25 years Jonathan has worked within the biopharmaceutical industry in the U.K., Switzerland, and United States. in a range of disciplines including pre-clinical pharmacological research (Ciba-Geigy), clinical data management (Parexel), statistical programming & analysis (Pfizer, Novartis), applications development (Pfizer, Roche), and process analysis, data standards & governance (Roche).

Jonathan has a scientific background and education including a BSc (Hons) Pharmacology, University of Bath, U.K. He is a British citizen and currently located in the San Francisco Bay Area, California.

Session Details:

Problem-Solving Roundtable Discussions

2024-09-11, 2:15 PM

Session Details:

Unleashing the power of digital protocols and automated study designs in clinical research

2024-09-10, 3:15 PM

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Tony Hung
Director, Clinical Data Management, Denali Therapeutics

I started my career at Everest Clinical Research in CDM. I later joined Gilead's CDM team focusing on infectious disease therapeutic area. I transitioned to commercial (sales analytics) for almost 3 years to better understand the lifecycle of drug post approval. I decided to return to CDM and joined Biomarin to better understand rare diseases. Post Biomarin, I spent some time at Nektar before landing the position at Denali, focusing on rare disease trials again.

Session Details:

FIRESIDE CHAT: Aligning expectations with today’s data managers: redefining the Data Manager’s role

2024-09-11, 12:45 PM

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Kimberly Barnholt
Executive Director, Evidence Generation, Genentech, Roche Group

Kimberly Barnholt has been a healthcare leader in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr. Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

Session Details:

PANEL: Navigating the learning curve – staying current, automation adoption, and innovating in technologies

2024-09-10, 9:00 AM

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Binitha Prasad
Director, Clinical Data Management Jazz Pharmaceuticals

Session Details:

Problem-Solving Roundtable Discussions

2024-09-11, 2:15 PM

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Satha Thillaiampalam
Associate VP, Biostatistics and Statistical Programming Process and Infrastructure, Loxo Oncology Inc

Satha Thillaiampalam has been leading various responsibilities within the biopharmaceutical industry. Throughout his twenty-year career as a Biostatistician and Statistical Programmer, he has led numerous strategic initiatives involving cross functional teams to continuously improve systems, processes, and governance. In his current role, he leads the processes and infrastructure activities for oncology biostatistics department within Lilly. His key interests are optimizing operational efficiency and developing high performing systems by leveraging advancements in technology and standards.

Session Details:

Unveiling use cases: harnessing synthetic data creation with machine learning

2024-09-10, 10:00 AM

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Prasun Mishra
Chief Executive Officer, Agility Pharmaceuticals

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

Session Details:

PANEL: Navigating the learning curve – staying current, automation adoption, and innovating in technologies

2024-09-10, 9:00 AM

Session Details:

Harnessing AI/ML for seamless clinical data lifecycle management

2024-09-11, 12:15 PM

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Harit Nandani
Clinical Data Management Professional

Harit Nandani has 12+ years of experience in clinical trials data and technology leadership for both diagnostics and therapeutic trials. He specializes in clinical trial data management and analysis, configuring systems for population-scale studies, and using analytics tools to monitor projects. Currently, he is the Director of Clinical Data Management at GRAIL, overseeing data and systems for trials in the UK and US supporting early cancer detection diagnostics development. He has worked on projects enrolling over 300,000 participants, leading to the development of the Galleri test, which has detected over 50 types of cancer and has been named one of TIME Magazine's best inventions and The Atlantic's 10 most promising breakthroughs of 2022. Prior to GRAIL, Harit led late-stage pivotal trials in Oncology at Gilead Sciences and worked in various clinical research roles at a CRO and a small biopharmaceutical development company.

Session Details:

FIRESIDE CHAT: Discovering the power of open-source technology in clinical data management strategy

2024-09-10, 11:45 AM

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Megan L. Dunham
Associate Director, Clinical Data Innovation, Jazz Pharmaceuticals

Session Details:

Problem-Solving Roundtable Discussions

2024-09-11, 2:15 PM

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Laurie Herraiz
Associate Director, Regulatory Knowledge & Support, Clinical and Translational Science Institute, UCSF

Laurie Herraiz has a diverse background in clinical research in academic medical centers, having started her career as an NIH-funded clinical trialist at the University of California San Francisco (UCSF). She transitioned into the field of human subjects regulations and compliance, where she eventually served as the Director of the Human Research Protections Program and the Institutional Review Board. Her expertise spans clinical trial operations, regulations, and privacy law, while her current work incorporates community engagement with data governance. With her extensive knowledge and leadership, she finds great professional satisfaction in helping investigators navigate the complex regulatory landscape and bridging the gap between participants and researchers.

Session Details:

Fostering trust through good data stewardship: building relationships with research participants

2024-09-11, 10:00 AM

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Derek Lawrence
Senior Director, Business Enablement, Saama

Derek is the Senior Director of Business Enablement at Saama and has over 14 years of experience in clinical research, with strong focus in biometrics, programming, systems implementation & integration, and software development. Prior to joining Saama, Derek spent his career in the CRO & software development spaces, where he supported Data Management and Biometrics activities in multiple roles. An enthusiastic advocate for change & innovation, he helps drive the adoption of new processes & tools in CDM and CDS.

Session Details:

Enabling AI: Constructing a New Foundation for Clinical Data Management

2024-09-10, 9:30 AM

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Shou Yuan
Director of Global Solutions, Overseas BU, Taimei Technology

Session Details:

AI-Driven Innovation: Automate Trials, Accelerate Success

2024-09-10, 12:30 PM

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Sam Xu
Global Head of BD, Overseas BU, Taimei Technology

Session Details:

AI-Driven Innovation: Automate Trials, Accelerate Success

2024-09-10, 12:30 PM

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Erin Erginer
Director of Product, Pinnacle 21 by Certara

Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.

Session Details:

Collaborative Strategies to Bridge Silos in Clinical Trials Data Management

2024-09-10, 4:45 PM

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Davy Baele
Team Leader, CDM Programming, International Drug Development Institute – IDDI

Davy Baele is Team Leader, CDM Programming with over 15 years of experience with CDISC SDTM submissions. Prior to joining IDDI more than 10 years ago, he gained lots of expertise in the field as Data Integration Specialist and Project Manager for legacy SDTM data conversion projects whilst also being a member of the CDISC SDS and define.xml team in 2012-2013. At IDDI, Davy was able to develop, implement, and optimize SDTM processes and tools. As a Team Leader he is very grateful to have a motivated team of CDM Programming Specialists that share his passion and positive attitude to continuously improve robustness and efficiency on the daily CRO deliverables.

Session Details:

Metadata repositories: leveraging standards, expertise, and AI

2024-09-11, 9:30 AM

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Chris Helton
Senior Director, Data and Analytics, Diabetes, Eli Lilly and Company

Session Details:

Modernizing data integrity: leveraging analytics for quality data capture beyond traditional edit checks

2024-09-11, 11:15 AM

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Dawn Kaminski
Vice President, Business Development Operations, eClinical Solutions

Dawn has over 25 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as former Co-Chair of the annual conference (2018-2021) and currently serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and Biometrics services as well as overseeing the Proposals and Solution Consulting departments.

Session Details:

Oversight for all: achieve data transparency with elluminate

2024-09-10, 12:15 PM

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Kelsey Buhler
Product Specialist, Viedoc Technologies

Kelsey Buhler has been a Product Specialist at Viedoc Technologies since 2021, and specializes in providing technical demos, support, and project management for Viedoc study builds. Prior to her role at Viedoc, she has 7 years combined experience as a Data Manager/Project Manager at a Medical Device CRO, a Data Entry Specialist, and a Clinical Subjects Associate, where she would obtain consent from subjects in clinical trials. All these experiences drive her passion for user-friendly Electronic Data Capture (EDC) systems that increase efficiencies for the subjects, site, and all other study users.

Session Details:

Increase trial agility with our integrated reporting tool

2024-09-10, 2:45 PM

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Wendy Morahan
Senior Director, Clinical Data Analytics Suite, IQVIA Technologies

Wendy has 25+ years experience in the life sciences industry with a career spanning academic research, preclinical drug discovery, and clinical trials, culminating in a focus and passion for delivering technology solutions that help bring treatments to patients faster.  Wendy is currently part of the product strategy leadership team for IQVIA Clinical Data Analytics Suite (CDAS), providing both SaaS solutions for the market as well as IQVIA’s internal CRO needs.  As part of the CDAS team, Wendy is responsible for strategy, product management leadership, and Go to Market activities.

Session Details:

PANEL: Navigating the learning curve – staying current, automation adoption, and innovating in technologies

2024-09-10, 9:00 AM

Session Details:

Can AI automate the manual data review and resolution process for anomalies?

2024-09-10, 11:15 AM

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Aamir Jaka
Global Vice President, Customer Experience and Success, Saama
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Abhishek Dabral
Director, Clinical Data, Flatiron Health

Session Details:

Driving data quality: EHR to EDC technology for improved clinical data collection

2024-09-11, 11:45 AM

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Paul Salcuni
Senior Data Scientist, Flatiron Health

Session Details:

Driving data quality: EHR to EDC technology for improved clinical data collection

2024-09-11, 11:45 AM

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Dan Solis
Assistant Commissioner for Import Operations, FDA

Dan Solis is a recognized expert in FDA’s import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. He brought leadership to the Office of Import Operations in March 2020, during the Covid-19 pandemic and became permanent Assistant Commissioner in November 2020.

Session Details:

Importing FDA Regulated Medical Products

2024-09-11, 9:00 AM

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Yuan Tian
Associate Director, Clinical Bioinformatics and Exploratory Analytics, Gilead Sciences

Session Details:

Standardizing and analyzing complex clinical biomarker assay data: initiatives, challenges, and the application of an advanced AI platform

2024-09-10, 4:15 PM

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Steven Chiu
Import Specialist, FDA

Started with the FDA in 2009 as a Consumer Safety Officer in the San Francisco District Office (Alameda, CA) and focused primarily on imported FDA regulated products including Field Work, Entry Review, FSVP (Foreign Supplier Verification Program), and Special Operations. Have also conducted GMP inspections of Foods, Seafood HACCP, and Dietary Supplement manufacturers. Also worked in the South San Francisco Resident Post from 2013 to 2019 and currently stationed in the San Francisco District Office. Promoted to Import Specialist in 2023.

Session Details:

Importing FDA Regulated Medical Products

2024-09-11, 9:00 AM

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