DIA 2024 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-529-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) is making its presence known in health care, presenting unprecedented opportunities and challenges. It is crucial to devise strategies that ensure its ethical and responsible utilization for the betterment of health care and society. This imperative can only be met by harnessing the collective power of the broad Healthcare ecosystem. Join us for an engaging DIAmond session featuring esteemed panelists from technology companies, pharmaceuticals, patient advocacy groups, and academia/research to delve into how we can leverage the momentum of AI while establishing a foundation of trust. In this session, we will address the following questions: • How is the health care data landscape evolving in conjunction with AI, and what implications does it hold in terms of opportunities and concerns for our stakeholders? • What expectations do stakeholders have of us as leaders in ensuring ethical innovation? • What emerging practices, supported by real examples and lessons learned, are paving the way for the integration of ethical considerations into actionable strategies? • Where should we seek cross-sector partnerships to further propel momentum and establish standards for the ethical and responsible deployment of AI? Let us unite in paving the way towards a future where innovation is fueled by trust, driven by the responsible utilization of our burgeoning capabilities.

Learning Objectives

Define responsible innovation and ethical use of artificial intelligence (AI) in health care and life sciences; Explore the intersection of ethical considerations with technological advancements; Examine the role of cross-sector partnerships in driving trusted and responsible AI use.

Chair

Martin Hodosi, MSc

Speaker

Panelist
Junaid Bajwa, MD, MBA, MSc, FRCP

Panelist
Karla Childers, MS

Panelist
Dave deBronkart

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-581-L04-P; CME 1.00; RN 1.00

Innovative approaches have the potential to create new opportunities for patients, but they also bring challenges to regulators, called to evaluate, and supervise products for which traditional regulatory approaches might not be appropriate. Global regulators will discuss how regulatory science is key to develop solutions and how regulators worldwide need to work together to overcome such challenges.

Learning Objectives

Explore how to make faster progress with translating regulatory science research outputs into practice, for accelerating and improving medicine development and use; Discuss generalizable success stories and examples with challenges to an efficient translation; Describe and critically review hurdles and success factors.

Chair

Antonio Barra Torres, MD

Speaker

Promoting International Regulatory Convergence Through Regulatory Science
Emer Cooke, MBA, MSc

Path for Future Collaboration Utilizing Regulatory Science
Yasuhiro Fujiwara, MD, PhD

Regulatory Science Impact Stories
Robert M. Califf, MD

ICMRA Summit 2023: Regulators Working Together Towards the Future
Anthony Lawler, MD, MBA

Panelist
Alison Cave, PhD

Panelist
Pamela Aung-Thin

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-646-L04-P; CME 1.00; RN 1.00

Advanced Therapies and combined advanced therapies 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. When developing an advanced therapy product, there are many things to be considered – relationships between tissue, biologic, and device development as well as early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Advanced therapies are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, advanced therapies and combined advanced therapies are innovative products and could provide solutions as well as cures for previously untreatable conditions, which can truly change the face of the industry. Speakers will be FDA and industry leaders and FDA illustrating hot topics and example case studies in a panel discussion for us to navigate the future regulatory framework for unmet medical needs and next generation of medical products.

Learning Objectives

Analyze latest regulatory expectations and challenges; Identify potential future innovation platforms; Acknowledge potential and future global convergence/harmonization initiatives for combination products; Describe the regulatory challenges and opportunities ahead.

Chair

James Wabby, MHS

Speaker

FDA Update
Andrea Gray, PhD

Panelist
Rob Schulz

Panelist
William Daunch, PhD

Panelist
Michael Lehmicke, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD
Katherine Tyner, PhD

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Adam C Fisher, PhD

Panelist
R. Angelo De Claro, MD

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Steffen Thirstrup, MD, PhD

Panelist
Francesco Pignatti, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-24-691-L04-P; CME 1.25; RN 1.25

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Kim Quaintance-Lunn

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Julia Tierney, JD

Panelist
Anindita Saha

Panelist
Tamy Kim, PharmD