DIA 2024 Global Annual Meeting

Component Type: Social Event

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-677-L04-P; CME 1.00; RN 1.00

Session will focus on considerations with successful as well as unsuccessful use cases for generating regulatory grade safety studies using secondary data under new FDA Guidance.

Learning Objectives

Describe considerations when using secondary data to generate real-world evidence for regulatory-grade post-marketing studies; Describe key elements to consider when implementing feasibility assessment to identify real-world data sources.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

FDA Update
Marie Bradley, PhD, MPH, MPharm

Value of Real-World Data/Real-World Evidence to Assess Potential Safety Signal: Use Case- Ophthalmology
Angelika Manthripragada, PhD, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-683-L04-P; CME 1.00; RN 1.00

Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. This statistical session will discuss the critical aspects of safety analysis including the shortcomings of the way we estimate safety signals today focusing on the incorporation of advanced statistical methodologies for signal detection and wider evaluation of specific events such as adverse events of special interest. Additionally, the session will delve into regulatory considerations and best practices for presenting safety analyses to regulatory agencies. Understanding the expectations and requirements of regulatory bodies is essential for successful drug development, and the session will provide valuable guidance in this regard.

Learning Objectives

Describe key aspects in planning safety analyses, and their pivotal role in ensuring the safety of pharmaceutical products; Discuss regulatory considerations and best practices for presenting safety analyses to regulatory agencies; Identify quantitative assessment and characterization of adverse events of special interest (AESIs) in the drug lifecycle; Discuss the shortcomings of the way we currently estimate safety outcomes and a call to action to change that.

Chair

George Kordzakhia, PhD

Speaker

Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS

Industry Update
Michael A. Fries, PhD, MA

FDA Update
Cesar Daniel Torres, PhD, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

Learning Objectives

Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
J. Lynn Bass, PharmD, RPh

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Sonja Hokett, PharmD, MS, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

Learning Objectives

Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

Chair

Lindsay Hughes, PhD, MS

Speaker

Panelist
Silas Buchanan

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-681-L04-P; CME 1.00; RN 1.00

This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.

Learning Objectives

Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.

Chair

Rasika Kalamegham, PhD

Speaker

Collaboration Perspective
Jane Elizabeth Myles, MSc

FDA Perspective
M. Khair ElZarrad, PhD, MPH

Industry Perspective
Dylan Bechtle, MS

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

Learning Objectives

Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Christina Mack, PhD, MPH

Panelist
Paul Strijbos, PhD

Panelist
Jeffrey Nahum Siegel, DrMed, MD

Panelist
Martha Azer, PharmD, RPh

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: Forum
Level: Intermediate

Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

Learning Objectives

Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Radicke, MSc

Panelist
Patroula Smpokou, MD

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 to transform clinical data operations across the clinical trials lifecycle across use cases such as integration, summarization, translation, content generation, and knowledge extraction. The use of generative AI will be discussed for applications such as smart data review and edit checks, workflow automation, and real-time data transformation.

Learning Objectives

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

Chair

Lichen Shen

Speaker

Creating Production Grade (Gen)AI-Powered Software for Clinical Trials
Lichen Shen

Industry Update
Sharmin Nasrullah, MS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-685-L04-P; CME 1.00; RN 1.00

The session will share findings from a recent mixed-method study that examined the different types of racial microaggressions patients experience while participating in clinical trials and how these interactions affect their experience.

Learning Objectives

Describe findings from a recent study examining common forms of racial discrimination experienced by patients in clinical trials; Discuss the impact that these interactions can have on patient-reported outcomes, including patient trust and willingness to participate in another study at that site or location; Discuss evidence-based solutions that can reduce exclusion in clinical trials.

Chair

Jennifer Kim, PhD

Speaker

How Microaggressions Can Impact the Patient Experience in Clinical Trials
Sharon Rivera Sanchez

Research Perspective: The Science of Exclusion in Clinical Trials
Ruby Madison Ford, MPH

Amplifying the Patient Voice: Incorporating the Patient Experience
Perla Nunes

Industry Update
Rodney Winley

Industry Update
Elizabeth Rosenkrands-Lange, MPH, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-687-L04-P; CME 1.00; PDU 1.00 PMI 21664WZFGG; RN 1.00

Through strong sponsorship, stakeholder management, and communication practices, many companies have been more effective at bringing innovation and new learnings from external organizations and consortia back into their respective companies.

Learning Objectives

Recognize how dedicating resources can enable your organization to enhance talent and innovation, increase value, and maximize your investment in consortia participation; Discuss the application of best practices around communicating new solutions/tools and events to the right internal stakeholders to maximize uptake; Describe building a coalition of internal champions to support collaboration.

Chair

John Richard Dobbins, MEd

Speaker

Industry Update
Sarah McKay Tremethick

Industry Update
Toni Spears, BSN

Industry Update
John Z. Sun, PhD, MBA, PMP

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-688-L04-P; CME 1.00; RN 1.00

Challenges remain in the implementation of reliance. This session will bring together stakeholders to discuss the utilisation of assessment reports, and recommend ways to ensure effective and efficient systems in the future.

Learning Objectives

Recognize the value of assessment reports in enabling reliance; Describe current use of public and non-public information for enabling regulatory reviews; Discuss how documentation and information sharing could improve to ensure reliance becomes successful.

Chair

Magda Bujar, PhD, MSc

Speaker

WHO Update
Samvel Azatyan, MD, PhD

Reference Agency Viewpoint
Emer Cooke, MBA, MSc

Relying Agency Viewpoint
Patricia Oliveira Pereira Tagliari, LLM, MPH

Industry Viewpoint
Susanne Ausborn, PhD

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-689-L04-P; CME 1.00; RN 1.00

Global regulatory affairs is a critical function at the key interface between the innovation from our pipelines and patients. The world around us is changing very rapidly leading to implications and opportunities for regulatory affairs. We must evolve. But how?

Learning Objectives

Identify what global changes are leading to an evolved regulatory affairs organization; Discuss what skillset global regulatory affairs professionals of the future will need.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

FDA Update
M. Khair ElZarrad, PhD, MPH

Academic Update
Maria Florez, MA

Industry Update
Nicole Mahoney, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD
Katherine Tyner, PhD

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Adam C Fisher, PhD

Panelist
R. Angelo De Claro, MD

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Steffen Thirstrup, MD, PhD

Panelist
Francesco Pignatti, MD

Component Type: Social Event

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-24-691-L04-P; CME 1.25; RN 1.25

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Kim Quaintance-Lunn

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Julia Tierney, JD

Panelist
Anindita Saha

Panelist
Tamy Kim, PharmD