DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-517-L04-P; CME 1.00; RN 1.00

In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.

Learning Objectives

Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative and explain how sponsors can benefit from participating in Project Orbis.

Chair

Sema Hashemi, MSc

Speaker

Panelist - Australia
Sarah Golding, MD

Panelist - Brazil
Marcelo Moreira, MS

Panelist - Canada
Melissa Hunt, MSc

Panelist - Israel
Michal Hirsh-Vexberg, PharmD

Panelist - Singapore
Anuradha Poonepalli, PhD

Panelist - Switzerland
Ulrich Peter Rohr, DrMed

Panelist - United Kingdom
Julian Beach

Panelist - United States
R. Angelo De Claro, MD

Panelist - United States
Dianne Spillman

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-518-L04-P; CME 1.00; RN 1.00

Among the largest areas of concern with the Inflation Reduction Act (IRA) are potential unintended consequences to pharmaceutical innovation. This forum will convene industry experts to explore the impact of and potential adjustments to the IRA.

Learning Objectives

Discuss the unintended consequences of the IRA on innovation; Examine potential legislative solutions.

Chair

Sarah Martin, PhD, MS

Speaker

Panelist
Gregory Daniel, PhD, MPH

Industry Perspective
Ryan Gough

The Impacts of the Inflation Reduction Act on Biopharmaceutical Investment Decisions
Richard Xie, PhD

Early Signals of IRA Impact: Theoretical and Observed Unintended Consequences
Julie Ann Patterson, PharmD, PhD

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

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-519-L04-P; CME 1.00; RN 1.00

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

Chair

Janis Bernat, MSc

Speaker

Introduction of Regulatory Levers to Address the Problem: Global Implementation of Identification of Medicinal Products Standards
Ron Fitzmartin, PhD, MBA

Panelist
Vada Perkins, DrSc, MSc

EMA Perspective
Isabel Chicharo, MPharm

ANVISA Perspective
Raphael Sanches Pereira, SR

HealthCare Professional Perspective on the Issue and Examples
Joseph Kannarkat, MD

Panelist
Peter Hjelmstrom, MD, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-528-L04-P; CME 1.00; RN 1.00

The International Council for Harmonisation (ICH) was established in 1990 by regulatory authorities and industries in the United States, Japan, and Europe with a mission to harmonize requirements for the development of medicines. Since, the Association was reformed in 2015 to establish ICH as a true global entity, increase participation from regulatory authorities and industry around the world and increase the implementation of ICH guidelines globally thereby speeding access to medicines for patients and supporting the global supply of medicines. It has been nearly 10 years since the ICH reforms were completed. In this session, Regulatory and Industry experts will reflect on how far we’ve come and the progress achieved in harmonizing scientific and technical requirements for the development of medicines since 1990. Speakers will share perspectives on the evolution of medicines development as a result of ICH guideline development. Further, speakers will exchange perspective on future opportunities for international regulatory harmonization with consideration of the increasing globalized nature of medicines development and navigating the evolving landscape and use of innovative approaches before turning it over to the audience to hear their ideas around how to promote international harmonization and continued global drug development and patient access to medicines.

Learning Objectives

Discuss progress in international harmonization of regulatory requirements for the development of medicines since ICH was established in 1990 and its increased global footprint following the reforms in 2015; Evaluate impact of ICH guidelines in global drug development; Identify future opportunities and how ICH can evolve to keep pace with innovation and further promote international regulatory harmonization and increased patient access to medicines.

Chair

Amanda Roache, MS

Speaker

US Regulatory Perspective on the Future of International Harmonization
Theresa Mullin, PhD

Industry Priorities for the Future of International Regulatory Harmonization
Wassim Nashabeh, PhD

ANVISA Perspective on International Global Harmonization and Future Opportunities
Marcelo Moreira, MS

EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities
Peter Twomey, MA, MPharm

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-529-L04-P; CME 1.00; RN 1.00

The forum will explore key legislative proposals affecting FDA regulation of drugs and devices, while FDA and industry prepare to negotiate the next round of user fees and performance goals.

Learning Objectives

Describe key legislative initiatives that could alter FDA's regulation of drugs and medical devices; Discuss the interplay between current FDA legislative proposals and the upcoming FDA user fee negotiations and legislation; Recognize the impact of legislative proposals on FDA and regulated industries.

Chair

Jeffrey K. Francer, JD, MPA

Speaker

Panelist
Andrea Stern Ferris, MBA

Panelist
Barrett Tenbarge

Panelist
Elizabeth Jungman, JD, MPH

Panelist
Grace Graham

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-523-L04-P; CME 1.00; RN 1.00

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Recognize ways to gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

EMA Perspective
Anabela Marcal, PharmD

Perspective on Best Practices for Navigating Divergent Regulatory Feedback - My Perspectives from Previous Experience at FDA
Namandjé Bumpus, PhD

Best Practices for Navigating Divergent Regulatory Feedback
Natalie Tolli, MS, RPh

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-545-L04-P; CME 1.00; RN 1.00

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch, MA, MBA

J&J Experience
Joseph Markmann, PhD, MBA

BMS Experience
Sandra Krogulski, MA

Novartis Experience
David Yao, PharmD