DIA 2024 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-525-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

Learning Objectives

Summarize the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speaker

Opening Remarks and Introductions
Lili Cao, MS

Initiatives to Bring More New Drugs to Patients, and Faster
Zhimin Yang, MD

Recent Developments in Regulatory Science and Regulation
Jiangyong Yu

Advancing Clinical Research in China: A Clinical Oncologist’s Perspective
Shun Lu

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

Learning Objectives

Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

Chair

Kenneth Getz, MBA

Speaker

Speaker
Linda B Sullivan, MBA

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-554-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Speaker

Panelist
Sophie Sommerer

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-556-L04-P; CME 1.00; RN 1.00

Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This session will provide an in-depth discussion of the challenges for reviewing clinical data and suggest potential strategies to improve the DILI identification process. Topics that will be covered include (1) regulatory guidance on structured DILI data submission, (2) how interactive data visualizations tools can enhance the ability to detect potential cases of DILI and (3) the approach to populations with elevated transaminases at baseline and why the modified eDISH (mDISH) approach has important limitations.

Learning Objectives

Describe the regulatory guidance for how to submit structured data pertaining to drug-induced liver injury (DILI) data; Discuss how to utilize interactive visualization tools to identify potential cases of DILI; Identify the challenges for detecting DILI when liver tests are abnormal at baseline.

Chair

James Buchanan, PharmD

Speaker

Regulatory Guidances for Submitting Structured DILI Data
Y. Veronica Pei, MD, MEd, MPH

Use of Interactive Visualization Tools to Identify Potential Cases of DILI
James Buchanan, PharmD

Addressing the Challenges of DILI Detection in Clinical Trials with Abnormal Baseline Liver Tests
Paul Hayashi, MD, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

Learning Objectives

Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

Chair

David Meats

Speaker

AI and Technology Trends and Regulation Introduction
David Meats

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD

Regulation Guidance
Louise Lind Skov, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-589-L04-P; CME 1.00; RN 1.00

This forum will present the considerations in global development strategy to approach to broader market including Japan for maximizing worldwide patient access and business opportunity. The panelists are from pharma and biotech.

Learning Objectives

Describe how to maximize the value of innovative products for the global market and benefit patients worldwide; Discuss how to apply the learnings to the clinical development strategy to expand target market effectively considering patient access to innovative drugs; Identify how to influence to regulators, industry, and trial sites to improve local environment to reduce hurdles and enhance global simultaneous development.

Chair

Eri Sekine

Speaker

Panelist
Leyna Mulholland, PharmD, PhD, MS

Panelist
Toshiharu Sano, RPh

Panelist
Xiaojun (Wendy) Yan, MD, MBA

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

There have been many legislative and regulatory efforts in the US to address drug shortages and address assurance of supply. This session will provide an overview of these legislative and regulatory actions and provide recommendations to support drug shortage mitigation and supply chain transparency. This session will also demonstrate why addressing the issue of drug shortages is so critical, by addressing the impact of drug shortages from the patient perspective.

Learning Objectives

Define various US legislative and regulatory actions to address drug shortages and understand their impact on assurance of supply and supply chain transparency; Understand the direct impact of drug shortages to the patient; Discuss themes and industry recommendations to address drug shortage prevention.

Chair

Demetra Macheras, MBA

Speaker

Patient Perspective
Laura Bray, MBA

Evidence-Based Policy Reforms to Reduce Drug Shortages Today and Into the Future
Tony Lakavage, JD

ISPE Drug Shortages Initiative: Where We Have Been and Where We Are Going
Demetra Macheras, MBA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-624-L04-P; CME 1.00; RN 1.00

This panel will discuss different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability.

Learning Objectives

Recognize the different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability; Discuss the appropriate data models for primary and secondary data and how clinical data managers can potentially help RWD and trial data to meet the evidentiary requirements for regulatory decision-making.

Chair

Jesper Kjær, MS

Speaker

Panelist
Davera Gabriel, RN

Panelist
Jonathan Chainey

Panelist
Stacy Tegan

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

Learning Objectives

Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

Chair

Raviv Pryluk, PhD

Speaker

Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
Tanya Russell, PhD, MS, RPh

Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
Jenny Higley, MS

Harnessing the Power of Site Engagements Using Data-Driven Clinical Analytics
Sanghita Bhattacharya, PhD

Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
Raviv Pryluk, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-672-L04-P; CME 1.00; RN 1.00

Join us for a multi-stakeholder discussion to learn more about the practical tools and considerations available to help sponsors get started or improve their participant communications including lay protocol synopses, lay summaries, and participant data return.

Learning Objectives

Recognize the problems in explaining benefit and risk to patients and lay audiences; Define meaningful communication of information to research participants; Identify how evolving collaborations, proactive planning, interoperability, digital health advancements, and secure data management enable participant data return options that do not compromise data integrity, confidentiality, or submission timelines.

Chair

Jean Sposaro, MHS, LLM

Speaker

Individual Participant Data Return: Feasible, Personal, and Actionable Options to Support Informed Decision-Making
Jean Sposaro, MHS, LLM

Patient Perspective
T.J. Sharpe, PMP

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-684-L04-P; CME 1.00; RN 1.00

This session provides new thinking and examples of how to design and implement qualitative research around genetic testing and precision medicine for oncology patients.

Learning Objectives

Discuss approaches to designing, executing, and analyzing qualitative research around patient perceptions of genetic testing and precision medicine; Discuss unmet needs around patient education and the integration of genetic counselor into care team; Examine the application of a behavioral framework to understand decision to get a genetic testing for oncology patients.

Chair

Wesley D Peters, MS

Speaker

Measuring Value in Oncology: Are we Keeping Pace with Science?
Solange Corriol-Rohou, DrMed, MD, PhD

Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
Jennifer Malinowski, PhD, MS

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-686-L04-P; CME 1.00; RN 1.00

This session will discuss use of generative AI in the clinical trials lifecycle across use cases such as integration, summarization, translation, content generation, and knowledge extraction.

Learning Objectives

Discuss the challenges associated with existing clinical workflow; Identify specific uses cases where such challenges exist in study startup, study conduct, and study closeouts; Describe how generative AI will transform the clinical workflow to operate seamlessly driving faster patient recruitment and efficient site selection or trial conduct.

Chair

Lichen Shen

Speaker

Industry Update
Aman Thukral, MPharm, MS

Industry Update
Jonathan E Shough

Industry Update
Lindsay Hughes, PhD, MS

Industry Update
Sharmin Nasrullah, MS