DIA 2024 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

Learning Objectives

Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

Chair

James Wabby, MHS

Speaker

Panelist
Kimberly Trautman, MS

Panelist
Donna Rycroft, BSN

Panelist
Olivia Wong, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

Learning Objectives

Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc

FDA Perspective on Advanced Manufacturing
Sau L Lee, PhD

Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD

Decentralized Manufacturing of ATMPs
Ursula Busse, PhD, MBA

Panelist
Benjamin Stevens, PhD, MPH

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-553-L04-P; CME 1.00; RN 1.00

Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.

Learning Objectives

Recognize the differences of accelerated pathways in US, EU, Canada, Japan and Australia; Discuss the impact of these pathways on patient access and treatment outcomes; Identify opportunities to increase global collaboration and international patient equity.

Chair

Sunita Zalani, PhD

Speaker

EMA Update
Francesco Pignatti, MD

Health Canada Update
Isabelle Rousse, MSc

PMDA Update
Yoko Aoi, PhD

FDA Update
R. Angelo De Claro, MD

Industry Update
Kathleen Winson, MPH, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-564-L04-P; CME 1.00; RN 1.00

This forum will address experience to date with new meeting types included in PDUFA VII, including Type D and INTERACT. Forum participants will evaluate successes, opportunities for improvement, and discuss how learnings can be shared.

Learning Objectives

Evaluate experiences to date with Type D and INTERACT meetings included in PDUFA VII; Identify opportunities to improve implementation of new meeting types to promote innovation and optimize FDA-Sponsor Interactions.

Chair

Victoria A. Dohnal, RAC

Speaker

Industry Update
Victoria A. Dohnal, RAC

FDA Update
Christy L. Cottrell

FDA Update
Adriane Fisher, MBA, MPH

Industry Update
Alex May, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-573-L04-P; CME 1.00; RN 1.00

The speakers will discuss how to enable external control arms (ECAs) at scale. The session will shed light on how to overcome the scalability and quality challenges of real-world data preparation to scale up ECAs from ad hoc projects to enterprise-level machinery for pharmaceutical clinical development function. It will also include ongoing work to create enterprise infrastructure for high-quality evidence generation using ECAs, including selected results from multicenter ECAs in several therapeutic areas.

Learning Objectives

Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.

Chair

Mayur Saxena, PhD

Speaker

Industry Update
Jussi Leinonen

Industry Update
Victoria Chia, PhD, MPH

Industry Update
Hongwei Wang

Industry Update
Jingyu (Julia) Luan, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-584-L04-P; CME 1.00; RN 1.00

This forum will present metrics developed and tested to understand progress for improving trials by 2030. A panel will provide work in areas of metrics for assessing progress in improving trials and understanding the state of clinical trials in 2024.

Learning Objectives

Discuss current efforts to establish metrics for assessing progress on efforts to improve trials, including improvements to trial design quality and representativeness of trials; Identify areas of trial improvements that may be measured or assessed; Appraise metrics approaches for relevance to improving specific areas of trial operations.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Jennifer Miller, PhD

Panelist
Linda B Sullivan, MBA

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: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.

Learning Objectives

Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.

Chair

Sri Mantha, MBA, MS

Speaker

Industry Update
Sean Darcy

Industry Update
Andrew Bate, PhD, MA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE

Patient Update
Regina Mariam Kamoga, MPA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-643-L04-P; CME 1.00; RN 1.00

Global expert presentations and in-depth panel discussion on the regulatory agilities, regulatory reliance, platform approaches, and other regulatory innovations that are pivotal during public health emergencies and necessary for future pandemic preparedness.

Learning Objectives

Discuss regulatory agilities, reliance and platform approaches which significantly decreased review times internationally for COVID vaccines. Discuss additional CEPI case studies that highlight regulatory innovations to address future public health emergencies, and the inherent complexities of sustaining these innovations from a health authority perspective.

Chair

Helen Bayes Hartman, PhD

Speaker

Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
Donna Boyce, MS, RAC

Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
Debra A Yeskey

FDA Update
David C. Kaslow, MD

Moderator
Khushboo Sharma, MBA

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

Learning Objectives

Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

Chair

Amanda Marie Roache, MS

Speaker

Moderator
Theresa Mullin, PhD

ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA

ICH Patient Engagement
Francesco Pignatti, MD

Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-662-L04-P; CME 1.00; RN 1.00

In this interactive forum, panelists share how they are working across R&D to improve processes and data flows, govern their data, move toward more data-driven processes, and facilitate the use of artificial intelligence (AI) and advanced technologies.

Learning Objectives

Identify how sponsor companies are optimizing their business processes and getting more value from their data across R&D; Discuss approaches for process optimization, data governance and standardization; Describe ways to move towards data-driven business processes and how to enable greater automation and business efficiency across product development.

Chair

Cary Smithson, MBA

Speaker

Panelist
Linda Chong, MBA

Panelist
Rayna Venook, PhD