DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-518-L04-P; CME 1.00; RN 1.00

Reporting of pre-market and post market safety reports to be submitted in ICH E2B (R3) format to FDA Adverse Event Reporting System (FAERS). The presenters will discuss system readiness, testing approach, challenges, and lesson learned for reporting premarket and post market safety reports, both from FDA’s and industry’s perspective.

Learning Objectives

Recognize that FDA will go live with E2B R3 standard early next year and will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal; Describe regional data elements, system readiness, testing approach, challenges and lesson learned that are key for post market, IND and IND-exempt BA/BE safety reporting, both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Sheila M Estela, BSN, RN

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Subhan Ahmed Sharief

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-536-L04-P; CME 1.00; RN 1.00

This session will present on the shifting regulatory landscape on diagnostics, including laboratory developed tests. Discussions will focus on a new proposed rule, the FDA’s oncology diagnostics pilot program, and global development implications.

Learning Objectives

Explain recent developments in the In Vitro Diagnostic/Companion Diagnostics (IVD/CDx) regulatory landscape in the US; Discuss regulatory implications of the proposed rule on LDTs; Evaluate the impact of FDA IVD initiatives on global drug development programs

Chair

Stephanie Choi, PhD

Speaker

Insights into FDA's Proposed Rule and LDT Initiatives
Cortez McBerry, PhD

New and Anticipated Trends in IVD and LDT Regulation
Laura DiAngelo, MPH

Impact of Changing IVD/LDT Landscape on Global Drug Development Programs
Megan Doyle, JD, MPH

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-552-L04-P; CME 1.00; RN 1.00

Regulatory intelligence is the key to formulating regulatory strategy. We will share the application of AI and critical thinking in developing science and risk-based strategies for the development and lifecycle management of medicinal product.

Learning Objectives

Apply skills learned in this session to set up regulatory intelligence frameworks for their team and/or company; Develop critical thinking skills that are imperative to the interpretation and proper utilization of intelligence data; Identify how to setup and manage tools and processes for surveilling and monitoring regulatory changes.

Chair

Ana Sengupta, MBA, MS, RAC

Speaker

Designing Regulatory Intelligence Framework: Powered by Critical Thinking
Ana Sengupta, MBA, MS, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Susan Carino, MBA, MS, PMP, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Aditi Khurana, MBA, PMP, RAC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Daisuke Tanaka, PhD

Speaker

PMDA Update
Daisuke Koga, MSc, RPh

Industry Update
Atsushi Tsukamoto, PhD, MSc

Panelist
Yoshiaki Uyama, PhD, RPh

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-577-L04-P; CME 1.00; RN 1.00

This forum will describe strategies for patient engagement to help design patient experience studies (PED). Case studies will illustrate the critical impact of patient engagement on the design of PED studies.

Learning Objectives

Examine the critical role that patient engagement can have on the success of patient experience studies; Implement strategies to overcome challenges associated with patient engagement in hard-to-reach populations.

Chair

Ellen Janssen, PhD

Speaker

Lessons Learned from Publicly Funded Patient Engagement Activities
Caroline Vass, PhD

Industry-Led Case Study
Bennett Levitan, MD, PhD

Industry Update
Brett Hauber, PhD, MA

FDA Update
Robyn Bent, MS, RN

Patient Advocacy Perspective
Bellinda King-Kallimanis, PhD, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

MHRA Update
Jason Wakelin-Smith

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: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-614-L04-P; CME 1.00; RN 1.00

Clinical research creates future clinical care. Let's lead in compassionate communication inviting more participation. Patient, site, and patient-focused drug development (PFDD) experts share and invite your participation in improving access through our words.

Learning Objectives

Identify the shame and blame negative words and phrases and their negative impact on patients; Recognize opportunities to improve the patient experience in clinical research as a care option through more compassionate word choice; Describe how to plan and justify optimization of protocol, informed consent, and participant communication language.

Chair

Lani Hashimoto

Speaker

Panelist
Jamie Troil Goldfarb

Panelist
Eddilisa Martin

Panelist
James Duhig, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-627-L04-P; CME 1.00; RN 1.00

Questionnaires, standardized tasks, and DHTs can measure similar outcomes which complicates endpoint selection. This forum discusses a framework to align ontologies for actively-collected and passively-monitored COAs to streamline endpoint strategy

Learning Objectives

Identify biomarkers from actively collected and passively-monitored COAs building upon regulatory definitions; Determine a framework to align ontologies for these measure types enabling rapid, evidence-based, and fit-for-purpose measure selection using case study examples.

Chair

Caprice Sassano, MPH

Speaker

Panelist
Roya Sherafat-Kazemzadeh, MD, PhD

Panelist
Megan Parisi, MS

Panelist
Thomas Switzer, MEd

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

Learning Objectives

Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

Chair

Kiernan Trevett, MSc

Speaker

Industry Update
Michelle Ruiz

Industry Update
John Okudjeto, MSc

MHRA Update
Sophie Radicke, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

Learning Objectives

Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

Chair

Yao-Yao Zhu, MD, PhD

Speaker

Panelist
Katherine A. High, MD

Panelist
Vaishali Popat, MD, MPH

Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD