DIA 2025 Global Annual Meeting: Full Schedule

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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

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 →

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

Level Intermediate
Keyword Artificial Intelligence (AI), Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Patient Experience
Tags Workshop

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

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 →

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 →

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 →

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 →

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

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags 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

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 →

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.

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 →

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

Level Intermediate
Keyword Global Perspectives, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
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