DIA 2024 Global Annual Meeting: Full Schedule

12:15pm PDT

#118 RT: Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development

Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development (Monday, June 17 | 11:00AM - 12:00PM PDT). Space is limited.

Chair

Lindsay McNair, MD, MPH, MS

Speakers

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States

Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Monday June 17, 2024 12:15pm - 1:15pm PDT
Ballroom 20 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 02: ClinTrials -ClinOps, Session

Tags Session

11:00am PDT

#234 RT: Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process

Component Type: Session

Join the Clinical Safety & Pharmacovigilance/Statistics & Data Science Community for a follow up round table discussion tied to session: Interactive Safety Graphics in the Regulatory Decision-Making Process (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Greg Ball, PhD

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 →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 01: ClinSafety-PV, Session

Tags Session

11:00am PDT

#233 RT: Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA

Component Type: Session

Join the Real-World Evidence Community for a follow up round table discussion tied to session: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA (Monday, June 17 | 2:15pm - 3:15 PM PDT). Space is limited.

Chair

Jingyu (Julia) Luan, PhD

Speakers

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session

Tags Session

11:00am PDT

#232 RT: Roundtable Discussion: Innovation in Manufacturing Globally

Component Type: Session

Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Brett Howard, JD, PhD

Speakers

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 10: RegCMC-Product Quality, Session

Tags Session

2:15pm PDT

#259 RT: Roundtable Discussion: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team

Component Type: Session
Level: Intermediate

Join the Professional Education, Training & Development/Project Management Community for a follow up round table discussion tied to session: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team (June 17 | 3:30-4:30PM PDT). Space is limited.

Learning Objectives

identify ways to apply concepts and techniques from the session

Chair

Tyler Ludlow, MBA

Speakers

Candice Junge

Executive Director, Neurology Program and Clinical Lead, Ionis Pharmaceuticals, Inc., United States

Candice Junge has over 20 years experience in drug development including preclinical research, clinical development and commercial readiness. She is currently an Executive Director, Neurology Program and Clinical Lead at Ionis Pharmaceuticals and is responsible for end-to-end drug... Read More →

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States

Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 07: ProjectManagement-StrategicPlanning, Session | 13: ProfDevelopment, Session

Level Intermediate
Level Intermediate
Tags Session

2:15pm PDT

#257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives

Component Type: Session

Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

Chair

Terry Katz, MS

Speakers

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 08: RD Quality-Compliance, Session

Tags Session

2:15pm PDT

#258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability (Tuesday, June 18 | 8:00am - 9:00AM PDT). Space is limited.

Chair

Demetra Macheras, MBA

Speakers

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States

Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session | 10: RegCMC-Product Quality, Session

Tags Session

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

Chair

Brooke Casselberry, MS, RAC

Speakers

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 03: Data-Tech, Session | 09: Regulatory, Session

Tags Session

11:00am PDT

#330.1 RT: Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases

Component Type: Session

Join the Medical Writing Community for a follow up round table discussion tied to session: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases (Wednesday, June 19 | 10:00AM-11:00AM PDT). Space is limited.

Chair

Regina Lynn Preciado

Speakers

Regina Lynn Preciado

Senior Director of Content Strategy Solutions, Content Rules, Inc., United States

Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 04: MedAffairs-SciComm, Session

Tags Session

11:00am PDT

#330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation

Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.

Chair

Chaitanya Koduri

Speakers

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 10: RegCMC-Product Quality, Session | 09: Regulatory, Session

Tags Session

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent

Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Karla Childers, MS

Speakers

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 →

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 05: Patient-Focused Drug Dev, Session

Featured Topics Ethics
Feature Topics Ethics
Tags Session

2:15pm PDT

#357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience

Component Type: Session

Join the Digital Acceleration Community for a follow up round table discussion tied to session: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Cesar Vinces

Speakers

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session | 03: Data-Tech, Session

Tags Session