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Tuesday, June 17
 

8:30am EDT

#202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Tuesday June 17, 2025 8:30am - 9:30am EDT
206
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-552-L04-P; CME 1.00; RN 1.00

Imagine a future where AI measures patient burden from provided inputs. In this interactive workshop, participants will design input logic for AI using mock data and protocols, then present their rationale to foster collaborative learning.

Learning Objectives

Define and categorize key factors affecting patient burden in clinical trials; Analyze patient-related data to design effective AI inputs; Evaluate and justify the role of human insight in enhancing AI-driven patient burden assessments for patient-centric trial outcomes.

Chair

Mihail Tanev, DMD, PhD

Speaker

Panelist
Karen Correa, PhD

From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Mihail Tanev, DMD, PhD


Speakers
MT

Mihail Tanev

Medical Advisor, FindMeCure Ltd, Bulgaria
Dr. Mihail Tanev, DMD, PhD is a health practitioner and scientist with a doctorate in Oral Pathology Science and Photochemistry. Coming from a strong academic foundation in disease biology, diagnostics and clinical research, he brings a uniquely cross-disciplinary perspective to the... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Workshop

10:30am EDT

#217: Case Studies of Application of AI in Risk-Based Quality Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-564-L04-P; CME 1.00; RN 1.00

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Recognize the key benefits and challenges of applying AI technologies in RBQM; Identify insights into real-world examples of AI's impact on clinical trial risk management; Discuss strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance; Describe how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Speaker

Panel Discussion: AI Teammates in Trials - Elevating Risk Management and Human Insight
Brian Barnes, MA

Novo Nordisk’s Path to Integrated Quality and Risk Management with AI-Powered Study Builder
Bo Maach-Møller, MPharm

Unlocking AI Potential In RBQM: Today and Tomorrow
Cheng Su, PhD


Speakers
avatar for Artem Andrianov

Artem Andrianov

CEO, Cyntegrity Germany GmbH, Germany
With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical... Read More →
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal... Read More →
BM

Bo Maach-Møller

Vice President, Risk Based Quality Management, Novo Nordisk A/S, Denmark
As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives... Read More →
CS

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical, United States
Cheng is the Executive Director of Data Sciences at BioMarin, where he leads RBQM transformation, AI innovation, and statistical support for research and early development. Prior to joining BioMarin, he led the development of centralized statistical monitoring and directed the Research... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities
Tuesday June 17, 2025 10:30am - 11:30am EDT
201
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-568-L04-P; CME 1.00; RN 1.00

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Recognize participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce, MS

Speaker

Moderator
Donna Libretti Cooke, JD

Panelist
James Lovett, JD

Contributor-Industry
Karen Correa, PhD

Contributor-Academia
Kenneth Getz, MBA


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Karen Correa

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States
Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for James Lovett

James Lovett

CEO, Myonex, United States
James Lovett is Chief Executive Officer and Board Member of Myonex Inc., a leading clinical trial supply company with operations in US, France, Germany and UK and distribution to 80 countries. Myonex partners with pharma and biotech companies, CROs, and other pharma service providers... Read More →
avatar for Carie Pierce

Carie Pierce

Global Head of Growth & Business Development, DIA, United States
Carie serves as Global Head of Growth for DIA. She comes to DIA with over 25 years in the Medical Device, Diagnostic, and Pharmaceutical industry. She has spent much of her career with Terumo Blood and Cell Technologies in various commercial leadership roles, including responsibility... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Keyword Bioethics
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

10:30am EDT

#218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence
Tuesday June 17, 2025 10:30am - 11:30am EDT
207B
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-565-L04-P; CME 1.00; RN 1.00

This session will explore how Intelligent Automation (IA) and AI are transforming R&D and Regulatory Affairs by automating document-heavy processes and driving data-driven decisions. Through real-world use cases presented by industry sponsors, attendees will learn how IA and AI are being applied to improve efficiencies, reduce timelines, and optimize regulatory outcomes.

Learning Objectives

Discuss AI applications in drug discovery, clinical trials, regulatory, manufacturing, and pharmacovigilance; Explain practical use cases of AI in Regulatory Operations; Discuss advancing fit-for-purpose, risk-based frameworks for AI and global regulatory alignment.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

AI: Accelerating Clinical Trials Through Smarter Site Selection
Kevin Bugin, PhD, MS, RAC

Harnessing AI and Automation in Regulatory:  Insights from the Recent DIA RIM Intelligent Automation Survey
Cary Smithson, MBA

Industry Perspective
Cedric Berger, PhD, MBA

AI-Driven Drug Development: Transforming Life Sciences with Data and Innovation
Sridevi Nagarajan, PhD, MS, MSc


Speakers
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States
Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management... Read More →
avatar for Cedric Berger

Cedric Berger

Head of Knowledge Extraction and Integration, F. Hoffmann-La Roche, Switzerland
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for Sridevi Nagarajan

Sridevi Nagarajan

DIA Communities Lead for AI in Healthcare, Ayusarogya, United Kingdom
An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →
avatar for Cary Smithson

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session |   03: Data-Tech, Session

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster; Discover how digital protocols are already driving connections and efficiencies at research sites; Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Speakers
DM

Denise Meade

Vice President, Life Sciences and MedTech, Verily, United States
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-578-L04-P; CME 1.00; RN 1.00

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Speaker

Panelist
Joseph Dustin


Speakers
avatar for Joseph Dustin

Joseph Dustin

Founder and Managing Partner, eClinical Consulting, United States
For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up 12 year run with Medidata. He has worked with top Pharmaceutical, Biotech and CRO... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

1:45pm EDT

#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS


Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Melissa Heidelberg

Melissa Heidelberg

Director, Global Bioethics and Technology Ethics Lead, Takeda, United States
I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Director, Office of Clinical Policy, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

#245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-583-L04-P; CME 1.00; RN 1.00

This session examines the relationship between protocol complexity, participant burden, and enrollment challenges, alongside the development and impact of participant feedback questionnaires. Patient advisors and attendees will interpret results and discuss improvements in trial performance.

Learning Objectives

Discuss patient participation burden based on protocol design characteristics and requirements; Identify design elements driving elevated levels of burden and impacting clinical trial performance; Recognize how to manipulate results into practical improvements for clinical research projects; State the value of participant feedback and compose rationale for inclusion of feedback in future studies; Describe strategies to reduce and address clinical trial and portfolio-wide participation burden.

Chair

Lani Hashimoto

Speaker

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Sabina Kineen

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Patrick Gee, SR, PhD, MS

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Stephanie Manson, PhD

Addressing Participation Burden in Clinical Trials: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA


Speakers
avatar for Patrick Gee

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States
As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Lani Hashimoto

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States
Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Rare Disease Patient Advocacy, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
SM

Stephanie Manson

Founder, Trial By Patient, United States
Dr. Manson is the author of the Study Participant Feedback Questionnaire (SPFQ) which has been implemented across the Transcelerate network to collect quantitative feedback on the patient experience. She is also the founder of Trial By Patient, a structured approach to receiving patient... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum

1:45pm EDT

#248: Embracing ICH E6(R3) with Risk-Based Quality Management
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-586-L04-P; CME 1.00; RN 1.00

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.

Learning Objectives

Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.

Chair

Madeleine Whitehead

Speaker

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS


Speakers
avatar for Abigail Dirks

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →
MW

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom
Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#251: China Town Hall
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-589-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.

Chair

Ling Su, PhD

Speaker

Brief Introduction from the NMPA
Feng Zhu

The Progress of China's Drug Review and Approval Reform
Jianwu Zhang, PhD

Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective
Wei Zhang

The Past Decade of China's Biopharma Innovation
Xiaoyuan Chen, PhD


Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
avatar for Ling Su

Ling Su

Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
JZ

Jianwu Zhang

Division Director, Drug Registration Department, National Medical Products Administration, China
FZ

Feng Zhu

Director, Cooperation Department, China Center for Food and Drug International Exchange (CCFDIE), China
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   02: ClinTrials-Ops, Session

1:45pm EDT

#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-591-L04-P; CME 1.00; RN 1.00

In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.

Learning Objectives

Recognize the pros/cons and challenges in designing clinical trials with composite endpoints; Discuss advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.

Chair

Xiaoyu Cai, PhD

Speaker

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD

Application of Win Statistics in Non-Malignant Hematology
Wenquan Wang, PhD

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD


Speakers
avatar for Xiaoyu Cai

Xiaoyu Cai

Insmed, Inc., United States
Xiaoyu Cai is an Associate Director, Biostatistics at Insmed, Inc. Prior to joining Insmed, she served for seven years as a Mathematical Statistician at the Center for Drug Evaluation and Research, Office of Biostatistics, within the U.S. Food and Drug Administration. She earned her... Read More →
QT

Qian Tang

University of Iowa, United States
Qian Tang is a Ph.D. candidate in Statistics at the University of Iowa, specializing in machine learning, optimization, and statistical computation. Her research focuses on developing efficient algorithms for analyzing high-dimensional data, with applications in statistical learning... Read More →
avatar for Jialu Wang

Jialu Wang

Statistician, Vertex Pharmaceuticals, United States
Jialu is a senior biostatistician at Vertex Pharmaceuticals. She closely works with health economic and research and market access teams for reimbursements and HTA submissions of multiple therapies. She also works on late Phase 3b/4 studies. Her research interests include adaptive... Read More →
avatar for Wenquan Wang

Wenquan Wang

Senior Director, Pfizer, United States
Wenquan got his PhD degree in Biostatistics from the University of Iowa. He was an assistant professor at University of Alabama at Birmingham before joining the pharmaceutical industry. He has over 20 years of experience in applying statistics in translational research and phase I-IV... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

#262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-594-L04-P; CME 1.00; RN 1.00

This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. The session will address the challenges sites face in adopting new technologies, from budget constraints to staff resistance, and the challenge of integrating automation into existing workflows.

Learning Objectives

Explain how automation and integration reduce site burden and improve trial efficiency; Identify compliance challenges in implementing automated systems; Discuss best practices for overcoming barriers to technology adoption.

Chair

Denise N Bronner, PhD

Speaker

Strategic Implementation of Automation
Amber Michelle Hill, PhD

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration and Compliance
Cal Collins


Speakers
avatar for Denise Bronner

Denise Bronner

Founder & CEO, Empactful Ventures, United States
Denise N Bronner, Ph.D. has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global... Read More →
avatar for Cal Collins

Cal Collins

Chief Technology Officer, OpenClinica, LLC, United States
Cal co-founded OpenClinica with colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active... Read More →
avatar for Amber Hill

Amber Hill

Founder & CEO, R.grid, United Kingdom
avatar for Kimberly Tableman

Kimberly Tableman

Founder & CEO, Espero, United States
With a robust background in clinical development and a sharp focus on digital health, my journey has led me to found ESPERO, where we're revolutionizing drug development through insight-driven protocol design. At the helm of ESPERO, my team and I are committed to enhancing operational... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-595-L04-P; CME 1.00; RN 1.00

We present trends and insights from an analysis of participant payment language of more than 7,500 consent forms reviewed by a large, independent IRB and discuss the ethical implications of insufficient compensation for trial participants.

Learning Objectives

Explain trends and insights in clinical trial participant payments based on 7500 clinical trial ICFs collected and analyzed between 2019 and 2024; Examine the language used to describe payments and how that impacts participants; Discuss ethical issues and assumptions about IRB approval of participant compensation for research.

Chair

Kelly Fitzgerald, PhD

Speaker

Panelist
Kelly Fitzgerald, PhD

Panelist
Donna Libretti Cooke, JD


Speakers
avatar for Donna Libretti Cooke

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States
DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →
avatar for Kelly Fitzgerald

Kelly Fitzgerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States
Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

4:00pm EDT

#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-602-L04-P; CME 1.00; RN 1.00

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?

Learning Objectives

Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance

Chair

Melissa Herman, MSc

Speaker

Industry Perspective
Maria Apostolaros, JD, PharmD, MS, RPh

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS


Speakers
avatar for Maria Apostolaros

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →
MP

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark
Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.
avatar for Lesley Maloney

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session |   09: Regulatory, Session |   02: ClinTrials-Ops, Session

4:00pm EDT

#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum


Speakers
avatar for Stiina Aarum

Stiina Aarum

Senior Scientific Specialist, Scientific Advice, Product Development Scientific, European Medicines Agency, Netherlands
avatar for Adriana Racolta

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
Adriana Racolta, PhD is an industry professional with 12 years of experience in the field. As a Director of Regulatory Affairs at Pfizer Inc., she spearheads the company's efforts to implement diagnostic regulatory requirements in support of precision medicine development. In this... Read More →
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
avatar for Jennifer Tucker

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Forum |   09: Regulatory, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-606-L04-P; CME 1.00; RN 1.00

Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.

Learning Objectives

Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Explain statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.

Chair

Xiang Zhang, PhD

Speaker

Externally Controlled Trials in Oncology: Regulatory Considerations and a Case Example
Arup Sinha, PhD

Panelist
Charles Lee, MBA, MS

An EU Regulatory Perspective on External Controls
Andrew Thomson, PhD, MA, MS

Uncovering the Challenges of Utilizing RWE in Regulatory Decision Making: Barriers, Mitigations and Future Directions
Ran Duan, PhD


Speakers
RD

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States
avatar for Charles Lee

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →
AS

Arup Sinha

Statistician, OTS, CDER, FDA, United States
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
XZ

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States
Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   02: ClinTrials-Ops, Session
 
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143ABC
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Room 145-147 Lobby
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TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
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  • Regulatory Reliance
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