DIAmond Sessions

DIAmond Sessions represent rare opportunities for deeper connection with regulatory leadership through insightful dialogue. Join us in San Diego, CA to help chart new horizons and processes toward the interconnected future of global health.

DIA 2024 DIAmond Sessions will allow for deeper discussions into critical themes from the keynote plenary session. Expect thought-provoking conversations around some of the major themes of DIA 2024, including an exploration of combination products, AI and innovation, and what is happening with regulatory convergence.

• Monday, June 17

   Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives

  11:00AM -12:00PM 
  

  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.

• Tuesday, June 18

   International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

  10:00-11:00AM 
  

  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.

• Wednesday, June 19

   Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products

  10:00-11:00AM 
  

  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.

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