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Monday, June 16
 

11:00am EDT

#105: Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-511-L04-P; CME 1.00; RN 1.00

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Chair

Tae Hyun Jung, PhD

Speaker

Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD

Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD


Speakers
avatar for Tae Hyun Jung

Tae Hyun Jung

Senior Statistical Reviewer, CDER, FDA, United States
Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases... Read More →
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Digital Biomarkers, Verily, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers at Verily, where she leads the research and evidence generation for digital measures and AI/ML capabilities. She oversees the development, validation, and implementation of the technology in internal and external clinical... Read More →
avatar for Tarik Yardibi

Tarik Yardibi

Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Tarik Yardibi is the Director of Sensing and Measurement at Takeda Pharmaceuticals, operating within the Digital Health Sciences department at Takeda R&D. As a digital health and data science technical leader, Tarik has contributed extensively across both medical device and pharmaceutical... Read More →
avatar for Vadim Zipunnikov

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Vadim Zipunnikov is an Associate Professor of Biostatistics at Johns Hopkins Bloomberg School of Public Health and co-leads the Wearable and Implantable Technology (WIT) group. His research focuses on developing statistical methods for analyzing digital health data from wearables... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

11:00am EDT

#108: Advancing Innovation Through Essential Drug Delivery Outputs
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-514-L04-P; CME 1.00; RN 1.00

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Recognize the technology landscape for more complex drug delivery combination products, specific patient considerations informing design and clinical risk, and the role of new regulatory tools like Essential Drug Delivery Outputs; Discuss current challenges facing combination products to deliver advanced therapies (Cell & Gene) or biologics including submission expectations (IND, NDA/BLAs), verification, validation, Control Strategy, and post-market changes.

Chair

Rumi Raquel Young, MS

Speaker

Overview of complex combination product technologies and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development
James Bertram, PhD, MS, RAC

Industry Perspective on FDA Draft Guidance for Essential Drug Delivery Outputs
Chelsea O'Connell, MS, RAC

Patient Perspectives on Advanced Therapies and use of Complex Combination Products
Stephen Karpen, PharmD


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
avatar for Stephen Karpen

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum |   06: PersonalizedMed-ComboProd-Diagnostics, Forum
 
Wednesday, June 18
 

10:30am EDT

#321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
Wednesday June 18, 2025 10:30am - 11:30am EDT
202A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-627-L04-P; CME 1.00; RN 1.00

Multiple stakeholders, including patients, will demonstrate how patient/site collaboration enhances the simultaneous digital health technologies (DHT)/patient journey to produce potential improvements/efficiencies in patient experience, data capture/quality, equitable access, and site/participant burden.

Learning Objectives

Describe the value of patient involvement to improve site engagement and user experience in application of DHTs in clinical research; Discuss key issues with accessibility of patient-reported outcome measurements; Identify how to incorporate patient-defined measurements into potential clinical endpoint development to better align with patient experience.

Chair

Stacy Hurt, MBA, MHA

Speaker

Patient Involvement to Improve Use of eCOA in Clinical Trials
Stacy Hurt, MBA, MHA

Lets Make Sure Accessibility is Considered in ePRO Best Practices: Are We Risking Our Data?
Florence Mowlem, PhD, MSc

Patient-Defined Flare Measurement Development in Conditions with Known Flares
Nell Meosky Luo

Speaker
Alicia Staley, MBA, MS

Speaker
Brian Hunter, MA


Speakers
avatar for Brian Hunter

Brian Hunter

VP / Chief Operating Officer, CNS Healthcare / Sitecentric, United States
In 20 years with CNS Healthcare, I’ve worked as a CRC, Site Administrator, Director of Marketing, Clinical Development Liaison and Director of Contracts & Trial Management. Through these roles, I’ve had the opportunity to interact with patients, physicians and study teams, and... Read More →
NM

Nell Meosky Luo

Chief Executive Officer, Folia Health, United States
Nell Meosky Luo is the Found & CEO of Folia Health, a patient-driven health informatics company where since 2017, she has led a team to develop novel methods for enabling the collection, analysis, and use of home-reported outcomes of patients and caregivers for precision care and... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Florence Mowlem

Florence Mowlem

Chief Scientific Officer, Umotif, United Kingdom
Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of COAs and the use of DHTs in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked... Read More →
avatar for Alicia Staley

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States
Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum
 
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146BC
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150AB
151A
151B
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201
202A
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209ABC
Ballroom
Ballroom Foyer 3rd Floor
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Exhibit Hall Lunch
Innovation Theater 1
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Innovation Theater 3
L Street Bridge
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Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
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  • 10: RegCMC-Product Quality
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  • 13: Spotlight
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  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming