DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-520-L04-P; CME 1.00; RN 1.00

The past decade has seen significant strides in machine learning and AI technologies. This session will provide an in depth investigate the various uses of machine learning and AI-based simulations within clinical development, ranging from data analysis, endpoint selection, the potential improvement of decision making within trial teams by clarifying tradeoffs to clinicians and statisticians, and more.

Learning Objectives

Describe the potential benefits of simulations in clinical trial protocol development and trial analysis, and the benefits of employing machine learning tools throughout clinical development; Discuss the novel approaches to conducting studies with such tools incorporated and relate to the regulatory guidance for adaptive trial design where relevant.

Chair

Raviv Pryluk, PhD

Speaker

Doing More with Less: Using ML to Drastically Improve Trial Simulation and Design
Raviv Pryluk, PhD

Clinical Trial Simulation: the Antidote to Wishful Thinking
Sam Miller, MSc

Digital Twins for Clinical Trials
Charles Fisher, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-532-L04-P; CME 1.00; RN 1.00

Evidence shows that improving diversity in clinical trials requires early planning. The session presents a cost analysis and case examples from an expert panel on the impact of incorporating patient diversity tactics and resources early in the process.

Learning Objectives

Discuss how to quantify the cost and resources required to execute tactics that increase clinical trial diversity; Explain how the exclusion of patient diversity tactics in budget planning impacts diversity and overall study milestones; Identify considerations that can influence leadership decision-making around diversity during the budget planning process.

Chair

Lloryn Hubbard

Speaker

Industry Update
Ryan Brown, MPA

Industry Update
Steve T. Satek, MBA

Industry Update
Monica Eason

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-544-L04-P; CME 1.00; RN 1.00

This session is focused on sharing experience with E19 implementation from multiple stakeholders to identify successes and challenges.

Learning Objectives

Describe development of E19 and principles of selective safety data collection; Discuss experiences with E19 implementation from different perspectives; Identify FDA initiatives to promote broader use of E19.

Chair

Mary Thanh Hai, MD

Speaker

EMA Update
Priya Bahri, PhD, RPh

Health Canada Update
Fannie St-Gelais, PhD

Industry Update
Anastasia Lesogor, DrMed

FDA Update
Eileen Craig, DrMed

Implementing Selective Safety Data Collection/E19 More Broadly
Kevin Bugin, PhD, MS, RAC

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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-571-L04-P; CME 1.00; RN 1.00

Many rare diseases share the same underlying molecular etiology that are therapeutically targetable. Basket trial design based on molecular etiology enables more patients to gain access to clinical trials and accelerate identification of new therpies

Learning Objectives

Recognize the potential of basket trial design in rare disease; Apply basket trial design in rare diseases with share molecular etiologies.

Chair

David Andrew Pearce, PhD

Speaker

Shared Platforms Approaches/Technologies for Rare Diseases
Philip (P.J.) Brooks, PhD

Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
Christina Waters, PhD, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-597-L04-P; CME 1.00; RN 1.00

This session will discuss patient advocacy groups and pharmaceutical companies and the co-created the patient advocacy leaders and drug development industry network (PALADIN), a US focused pre-competitive and disease agnostic Consortium, to advance the pace of medicines development.

Learning Objectives

Describe progress made by PALADIN (patient advocacy leaders and drug development industry network), a pre-competitive alliance of 20+ organizations formed in 2023; Discuss how the Consortium was established, it’s mission and governance; Identify year one resources created to optimize collaborations; Discuss priority year two activities and long-range plans.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
Kenneth Getz, MBA

Patient Perspective
Hollie Schmidt, MS

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

Learning Objectives

Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

Chair

Sophie Radicke, MSc

Speaker

FDA Update
Carolyn A Volpe, PharmD, MS

Update from Ghana
Adela Ashie

MHRA Update
Sarah Vaughan

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

Learning Objectives

Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Lynne Yao, MD

Panelist
Tara Croft, MBA

Panelist
Sandy Milligan, JD, MD

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
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

Learning Objectives

Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

Chair

Kanwaljit Singh, MD, MBA, MPH

Speaker

Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
Najat Bouchkouj, MD

Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
Paulla Dennis

Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
Stephanie Cherqui, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: Industry Update
Jill Yersak

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.

Learning Objectives

Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.

Chair

Yoshiaki Uyama, PhD, RPh

Speaker

PMDA Perspective
Yoko Aoi, PhD

Pharmaceutical Industry Perspective
Romi Singh, PhD

FDA Update
Douglas Pratt

Taiwan Perspective
I-Chun Lai, MD, MS

China Perspective
Yangfeng Wu, MD, PhD

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