DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-533-L04-P; CME 1.00; RN 1.00

This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.

Learning Objectives

Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
Vada A. Perkins, DrSc, MSc

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

Support of Digital Protocol Initiatives
Chris Decker, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.

Learning Objectives

Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.

Chair

Robert "Skip" Nelson, MD, PhD

Speaker

FDA Update on ICH E11A EWG on Pediartic Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD

Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-559-L04-P; CME 1.00; RN 1.00

Neurological disorders are complex and multifaceted, with symptoms that can vary widely. Wearable sensors and digital health technologies enable objective collection of data at the patients' home, providing unprecedented ways for tracking diseases.

This session will include presentations from several NIH-funded and Investigator-initiated studies focused on collecting digital measures of disease progression, including in patients with progressive supranuclear palsy, Parkinson disease, Alzheimer’s and ALS, and their potential impact on clinical trials and care for individuals with neurological disorders.

Learning Objectives

Demonstrate innovative wearable sensors and digital technologies capable of accurately detecting and monitoring neurological disease symptoms; Identify methods for seamlessly integrating wearable sensors with existing healthcare systems to ensure continuity of care.

Chair

Ashkan Vaziri, PhD

Speaker

NIH Update
Yuan Luo, PhD

Academic Update
Bijan Najafi, PhD, MSc

Industry Update
Sharon Tamir

Industry Update
Ashkan Vaziri, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

Learning Objectives

Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

Chair

Hilmar Hamann, PhD

Speaker

EMA Update
Lorenzo De Angelis, PhD

Industry Update
Carlyn Crisostomo, MBA

Industry Update
Alexandra (Zan) Cha, PhD, MA

Industry Update
Timothe Menard, PharmD, MSc

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-692-L04-P; CME 1.00; RN 1.00

Social media is an important new source of real-world data (RWD) for patient-focused drug development. This session will present a review of considerations from an industry and regulators perspectives when listening to social media from patients.

Learning Objectives

Summarize the work done by group of experts from companies’ members; Discuss the challenges and opportunities of exploiting real-world data (RWD) from social media listening for R&D purposes and regulatory submissions; Propose best practices.

Chair

Thierry H Escudier, MSc

Speaker

Industry Update
Sarah Lyons

Academic Update
Philipp Cimiano, PhD

Industry Update
Vishakha Sharma, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

Learning Objectives

Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

Chair

Char Leung

Speaker

Industry Update
Rune Bergendorff, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

Learning Objectives

Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

Chair

Leonardo Semprun Semprun, RPh

Speaker

Electonic Product Information Regulatory Evolution in Brazil
Nélio Cézar de Aquino, SR, MSc

Electronic Product Information in Low to Middle Income Countries
Rutendo Kuwana, RPh

Industry Outlook in Brazil: Exploring eLabeling Perspectives
Rosana M. Mastellaro, PharmD, RPh

Considerations for Implementation and Adoption of Digital Labels
Maria Cristina Mota Pina, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

Learning Objectives

Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

Chair

Steffen Thirstrup, MD, PhD

Speaker

EMA Update
Sabine Haubenreisser, PhD, MSc

Industry Update
Laura T. Pizzi, PharmD, MPH

Patient Update
Dave deBronkart

Industry Update
Brian Bradbury, DrSc, MA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

Learning Objectives

Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

Chair

Malin Kristina Fladvad, PhD, MSc

Speaker

Unlocking the Potential of IDMP: Global Use Cases
Ron Fitzmartin, PhD, MBA

Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Hilmar Hamann, PhD

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

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

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson

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

Demystifying Site Engagement: Leveraging an Omnichannel Approach with 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: 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