DIA 2024 Global Annual Meeting

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

Steve Jobs. Elon Musk. Innovators who create new things or solve problems in new ways. But how do you be creative? How can a team come up with new development plans, trial designs, or enrollment strategies? Learn decision science’s proven process.

Learning Objectives

Recognize decision science mindset (expand versus contract, alternative versus value focused); Identify framing and re-framing techniques; Identify and clarify value criteria; Demonstrate value criteria to systematically develop creative solutions.

Chair

Tyler Ludlow, MBA

Speaker

Creativity and Innovation within Clinical Drug Development
Candice Junge, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.

Learning Objectives

Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.

Chair

Kassa Ayalew, MD, MPH

Speaker

Update from the Danish Medicines Agency
Lisbeth Bregnhoj, PhD, MPharm

Update from Industry
Prasanna Rao

Update from the FDA
Cheryl Grandinetti, PharmD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-585-L04-P; CME 1.00; RN 1.00

Data linkage is a methodology to capture data from patients before, during, and after a clinical trial. The panel will discuss the challenges of conducting randomized clinical trials (RCTs) linked with real-world data (RWD), and will emphasize the data linkage methodologies and current needs.

Learning Objectives

Describe the methodology of data linkage, a relatively new method to collect individual patient data before, during, and after a clinical trial outside the randomized clinical trial (RCT) setting; Discuss challenges for different stakeholders involved in utilization of real-world evidence (RWE) and more specifically data linkage, including industry, regulators, and payers/HTA.

Chair

Aaron Kamauu, MD, MPH, MS

Speaker

Panelist
Francesco Pignatti, MD

Panelist
Kajsa Kvist

Panelist
Brian Bradbury, DrSc, MA

Panelist
Akshay Vashist

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-608-L04-P; CME 1.00; RN 1.00

The impact of disease progression modeling (DPM) on medical product development has yet to be fully realized. This forum will describe DPM and its current applications in clinical trials and highlight the value of DPM to advance decision making and clinical development efficiency.

Learning Objectives

Describe disease progression modeling (DPM) and its current applications in clinical trials; Define the value of DPM to enhance decision making throughout the medical product development lifecycle; Discuss multi-stakeholder effort to advance clinical trial and medical product development efficiency through the increased recognition, value, and consistent use of DPM.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Herbert Pang, PhD, MBA

Panelist
Karthik Venkatakrishnan, PhD

Panelist
Jenny Chien, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-619-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator.

Chair

Cammilla Horta Gomes, MA, MPharm

Speaker

Panelist
Antonio Barra Torres, MD

Panelist
Patricia Oliveira Pereira Tagliari, LLM, MPH

Panelist
Bianca Zimon, LLM

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

Learning Objectives

Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

Chair

Ana Padua, MSc, RPh

Speaker

EMA Update
Veronika Jekerle, PhD, RPh

Sustainability and CMC (Chemistry, Manufacturing and Controls)
Benjamin Stevens, PhD, MPH

Industry Update
Anders Vinther, PhD, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

Learning Objectives

Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

Chair

Gregory Powell, PharmD, MBA

Speaker

MHRA Update
Phil Tregunno

Patient Update
Dave deBronkart

Physician/EHR update
Auren Weinberg, MD, MBA