DIA 2024 Global Annual Meeting: Full Schedule

2:15pm PDT

#130: Interactive Safety Graphics in the Regulatory Decision-Making Process

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:

Broader use of interactive displays in submissions

Sponsor provides interactive package(s)

Regulators/sponsors use their own interactive package(s)

Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

Learning Objectives

Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

Chair

Greg Ball, PhD

Speaker

Panelist
Scott Proestel, DrMed, MD

Panelist
Y. Veronica Pei, MD, MEd, MPH

Panelist
Glen Wright Colopy, PhD, MSc

Panelist
David Nahamya

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Glen Colopy

Head of Data Science and Statistics, Wildfell Software, United States

Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →

David Nahamya

Secretary to the Authority, Uganda National Drug Authority, Uganda

David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Scott Proestel

Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States

Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Forum | 01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#276: The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-608-L04-P; CME 1.00; RN 1.00

The impact of disease progression modeling (DPM) on medical product development has yet to be fully realized. This forum will describe DPM and its current applications in clinical trials and highlight the value of DPM to advance decision making and clinical development efficiency.

Learning Objectives

Describe disease progression modeling (DPM) and its current applications in clinical trials; Define the value of DPM to enhance decision making throughout the medical product development lifecycle; Discuss multi-stakeholder effort to advance clinical trial and medical product development efficiency through the increased recognition, value, and consistent use of DPM.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Herbert Pang, PhD, MBA

Panelist
Karthik Venkatakrishnan, PhD

Panelist
Jenny Chien, PhD

Speakers

Summer Starling

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States

Jenny Chien

Associate Vice President, Global PK/PD and Pharmacometrics, Eli Lilly and Company, United States

Dr. Chien is an associate VP and a scientific lead in the Global PK/PD and Pharmacometrics Department at Eli Lilly and Company. She received her Ph.D. degree in Pharmaceutical Sciences from the University of Washington, Seattle in 1997. Dr. Chien is recognized for her expertise in... Read More →

Herbert Pang

Expert Statistical Scientist, Genentech, A Member of the Roche Group, United States

Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics... Read More →

Karthik Venkatakrishnan

Vice President, Global Head of Quantitative Pharmacology, EMD Serono, United States

Karthik Venkatakrishnan is Vice President and Global Head of Quantitative Pharmacology at EMD Serono, Inc., Billerica, MA, with accountability for leadership of Clinical Pharmacology, Translational M&S, and Pharmacometrics. Previously, he held roles in Clinical Pharmacology at Pfizer... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH

Speakers

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States

Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 03: Data-Tech, Forum | 11: Statistics-Data Science, Forum | 02: ClinTrials -ClinOps, Forum

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum