DIA 2025 Global Annual Meeting

Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-504-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! Cell and Gene Therapies (CGTs) are a rapidly expanding area in the pharmaceutical sector, offering the potential to address serious unmet medical needs in many indications. Yet some of the conceptual frameworks in this field differ dramatically from those of traditional pharmaceutical medicines, specifically with regard to CMC, Non-clinical and Clinical requirements and Health Authority expectations. This short course will help those who have pharmaceutical sector experience but are newcomers to the CGT field ‘get into the right frame of mind’ to think about CGT development. Participants will be introduced to requirements for each of the major disciplines for regulatory submissions: CMC, Non-clinical and Clinical. The course will also explain the rationale behind the CMC approach to CGT manufacture and basic CMC regulatory expectations for CGT products, including process and product characterization, comparability and process validation. Biological mechanisms for CGTs will also be discussed, with a focus on how mechanistic understanding can inform the design of in vitro and animal studies to provide non-clinical evidence of safety and efficacy. Key principles for clinical development of CGTs will be presented, with an emphasis on clinical study design elements that are critical for Health Authority evaluation of benefit-risk. Case studies of recent FDA approvals will be showcased to highlight key clinical considerations and changes in the regulatory environment for CGTs. The course features ex-Health Authority Regulators presenters who have a combined 20 years of experience at the FDA and EMA. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals involved in or interested in gaining an understanding of the basics of cell and gene therapy development, including regulatory personnel, clinical operations personnel, researchers and investigators, medical writers, and commercial specialists.

Learning Objectives

• Demonstrate why cell and gene therapies (CGT) require a different and very specialized regulatory approach compared to small molecules and biologics
• Develop knowledge of CGT-specific considerations and requirements for CMC, Non-Clinical, and Clinical development
• Analyze important regulatory considerations for CGT development programs

Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-507-L04-P; CME 2.75; IACET 2.75; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere! Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. Implementation of a strategy includes the compilation of the plans and/or documents pertaining to strategic partnerships, intellectual property (IP) initiatives, product development approaches, quality management systems (QMS) optimizations, and regulatory submission plans into the integrated regulatory strategy for the complete “asset” as the traditional “ways of working” and/or processes will be challenged when developing an innovative combination product. This short course will explore key challenges and opportunities, offering practical exercises and a structured framework for success. It will focus on mitigating regulatory risk(s) in submissions timeliness and addressing issues such as excessive queries from health authorities, additional testing needs, and delays that impact time to market. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Entry/Intermediate professionals in quality, product development, and risk management who are suppliers/CDMOs or patent attorneys.

Learning Objectives

• Analyze the latest regulatory expectations and challenges for complex devices and combination products
• Explain potential future innovation platforms
• Identify opportunities to integrate regulatory strategies across functional areas including risk management activities and content between Sponsors, Suppliers and CDMOs

Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-25-509-L04-P; CME 7.50; RN 7.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere!Patient experience data, through patient-reported outcomes (PROs) and other clinical outcome assessments (COAs) are an increasingly important component of regulatory drug submissions and health technology assessments (HTAs). Instructors will take participants on an in-depth evaluation of the key topics important in successful ePRO implementation, including:

• Selecting, adapting and developing patient-reported outcome measures to meet protocol objectives
• The case for ePRO – when to select an electronic approach, and when paper might suffice
• ePRO implementation best practices to ensure good measurement science
• Migration validity considerations and evidentiary requirements
• Language, translation and licensing considerations
• Implementation steps including vendor selection and user acceptance testing (UAT) best practices
• Modality choices – web vs app, and bring-your-own-device (BYOD) considerations
• Hot topics such as data change processes, mixing modes, special populations, etc.
• Q&A – discussion of participants' own hot topics.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals who have experience in clinical trials and patient engagement and wish to develop their skills on how PRO measurement is best implemented in clinical drug development programs.

Learning Objectives

• Demonstrate when to select electronic capture, when to use web vs app, and when to enable patients to use their own devices (BYOD)
• Apply industry best practices to ePRO implementation, translations and other processes such as PRO data changes
• Describe the implementation steps, possible bottlenecks and mitigations, and user acceptance testing best practices

Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-25-508-L04-P; CME 7.50; RN 7.50

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account/ My Events. According to the FDA (as well as other regulators), corrective and preventive action (CAPA) management and lack of proper investigation of challenges is a top observation among companies in the industry. In this short course, through interactive case studies, participants will learn how to conduct a proper investigation into a robust root cause analysis using industry standard tools in a toolkit approach. Additionally, participants will explore the challenges of proper CAPA planning and define appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. Real-life case studies from various FDA 483s will be explored to showcase how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

• Determine the best approach to train individuals on industry best practices in CAPA management
• Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and effectiveness checks to ensure compliance and remediation of observations
• Analyze case studies for techniques and strategies that will help solidify how to use the different tools

Component Type: Forum
Level: Basic

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Component Type: Session
Level: Basic

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Component Type: Session
Level: Basic

Through this session, we will explore the advantages of incorporating AI and digital pathology for drug and biomarker discovery as part of a long-term CDx partnership. We will also explore potential regulatory challenges in this ever-evolving space.

Learning Objectives

Discuss the importance of a complete development lifecycle of drug and companion diagnostic; Describe a complete development lifecycle of a drug and companion diagnostic; Describe potential regulatory challenges facing AI, Digital Pathology, and CDx development.

Chair

Greg Morehouse

Component Type: Session
Level: Basic

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Explore Gen AI’s potential to enhance productivity; Master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Learn how to frame questions, analyze responses, and extract actionable insights more effectively; Hands-on exercise on practical use cases in areas such as market research, information mining, and competitive intelligence.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc

Component Type: Forum
Level: Basic

Data science, AI and LLMs are redefining how we conduct clinical development to be faster, more efficient and more patient-centric. The National Insititute of Health, in partnership with the private sector, is leading the charge in driving change.

Learning Objectives

Describe examples of NIH innovation in tech-enabling clinical development through the application of data science, AI and LLMs; Identify potential opportunities for future public-private partnerships to accelerate tech enablement of clinical development.

Chair

Peter Ronco

Component Type: Session
Level: Basic

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Component Type: Forum
Level: Basic

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Understand the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Adapt to and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Component Type: Session
Level: Basic

Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.

Learning Objectives

Evaluate the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives like the FDA's Diversity Action Plan in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.

Chair

Anna Bode, PhD

Component Type: Workshop
Level: Basic

Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.

Learning Objectives

Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.

Chair

Leanne Woehlke, MA

Component Type: Forum
Level: Basic

Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.

Learning Objectives

Gain insight into the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Understand the impact of AI/ ML on time savings, investment, and deployment of organizational resources.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Speaker
Amanda Donovan

Speaker
Nareen Katta, MBA, MS

Component Type: Session
Level: Basic

The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.

Learning Objectives

Understand the basics of health literacy and how they relate to health outcomes; Apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.

Chair

Chantelle Rein-Smith, PhD

Component Type: Forum
Level: Basic

Diversity in clinical trials is a widely discussed topic, but have you considered how diversity in career journeys influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths.

Learning Objectives

Understand how diversity within regulators supports medicines development for patients and society; Explore how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators); Examine how diversity in recruitment and career pathways supports diversity in decision making in medicines development.

Chair

Paula Walker, MA

Component Type: Session
Level: Basic

Attend this session to learn how to maximize agility and attract the best talent to get the critical work of medicines development and manufacturing done. Come and explore novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry.

Learning Objectives

Explore an approach to partnering with academic centers for workforce development aligned with business needs; Analyze a case study on tailoring development opportunities and career paths based on workforce feedback to enhance retention and engagement; Investigate how highly regulated industries have embraced the Future of Work, with insights for the pharmaceutical sector; Examine the evolution of the pharmaceutical industry in a historical context and its implications for the Future of Work.

Chair

Sheila Mahoney Jewels, MBA

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Listening and Learning to Develop and Retain Key Talent 
Denyse Baker

Component Type: Forum
Level: Basic

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Propose improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy) to converge clinical research and clinical ca

Chair

Allison Cuff Shimooka, MBA

Component Type: Session
Level: Basic

This session will provide an update on recent industry initiatives to transform towards a data-centric protocol, demonstrate real use cases leveraging digital protocol information, and share thoughts on how to prepare for the change required.

Learning Objectives

Understand how various digital protocol collaborations are working together including ICH M11, Transcelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Demonstrate the digital protocol in action from design through regulatory review; Prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Transforming the Study Protocol from a Document-Centric to a Data-Centric World to Enable AI, Drive Automation, and Design Be
Chris Decker, MS

Preparing for ICH M11: Am I Prepared?
Robert DiCicco, PharmD

Component Type: Session
Level: Basic

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Component Type: Forum
Level: Basic

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; Learn about the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders? 
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Component Type: Session
Level: Basic

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Component Type: Session
Level: Basic

This session aims to explore the potential, innovative and safe applications of these technologies in the realm of drug and medical device development, featuring speakers from health authorities, academia and/or industry.

Learning Objectives

Describe what synthetic data and digital twins are; Apply AI to generate synthetic data and digital twin; Illustrate the potential of synthetic data and digital twins in medical product development.

Chair

Di Zhang, PhD

Component Type: Forum
Level: Basic

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Analyze how mentorship reduces silos and evaluate its impact on engagement, retention, and growth; Learn how to assure success of mentoring programs through clear roles and responsibilities; Illustrate examples fostering collaboration; Summarize mentorship evolution via success stories; Differentiate reverse mentorship's role in reducing hierarchies.

Chair

Carol Morales