DIA 2025 Global Annual Meeting

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: Forum
Level: Intermediate

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Understand what an Essential Drug Delivery Design Output is and compare it to other CMC terminology, including Critical Quality Attributes (CQA), Established Conditions, Primary Function, and Essential Performance; Analyze current challenges facing novel combination products; Review key guidance highlights, including submission expectations (IND, NDA/BLAs), Control Strategy, Post-market changes, verification, and validation testing.

Chair

Rumi Raquel Young, MS

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

Fatima Khaiser, MA

Component Type: Session
Level: Intermediate

Precision medicine integrates advanced technology and healthcare to tailor treatments to individuals, aiming to enhance outcomes. However, the rise of artificial intelligence (AI) and advanced technologies in this field introduces new ethical complexities. Privacy, informed consent, and social justice remain central concerns, but evolving technologies brings additional challenges, such as biases in algorithmic predictions and the transparency of decision-making processes. AI-driven models used to predict treatment outcomes or develop personalized care plans can reflect societal biases if trained on unrepresentative or flawed data. This raises concerns about fairness, as patients could be unjustly stratified based on genetic, racial, or socioeconomic factors. Precision medicine, which stratifies patients by genetic profiles, risks perpetuating discrimination or exacerbating health disparities.

Learning Objectives

Understanding of bioethical impact within the next generation of medcine; Ackowledge the importance of the inclusion of diverse, representative populations and handling of incidental findings—unanticipated results that arise during genetic screening—must be ethically integrated into research protocol.

Chair

James Wabby, MHS

Speaker

Ethics in the Era of Precision Medicine and Advancing Technologies
James Wabby, MHS

Ethics in the Era of Precision Medicine and Advancing Technologies
Amanda Burkhardt, PhD

Component Type: Session
Level: Advanced

This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test

Learning Objectives

Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Explore approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Component Type: Session
Level: Intermediate

The FDA has published a final rule to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act. The publication of the rule has far-reaching implications for the quality and availability of diagnostic tests in the United States, as well as impacts on pharmaceutical product research. This session will discuss the final rule in a panel format, focusing on the impact to various stakeholders, as well as current compliance efforts and next steps for ensuring compliance. The session will also address the impact of the recent election, legislative and executive actions, and litigation, on the FDA’s regulation of laboratory developed tests.

Learning Objectives

List requirements of the LDT Final Rule and phased approach to regulation; Summarize implications of the FDA LDT Final Rule for patients, developers, health care systems, providers and regulatory decision making; Discuss approaches to implementing requirements of the final rule.

Chair

Courtney Granville, PhD, MPH

Component Type: Forum
Level: Intermediate

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Component Type: Session
Level: Intermediate

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Analyze the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC