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DIAmond Sessions

Conversations on Today’s Priorities!

DIA 2023 GAM Keynote!

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

    DIAmond Sessions 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.

Session Chair and Speakers


Dave deBronkart

Patient Advocate, E-Patient Dave, LLC


Junaid Bajwa

Practicing Physician, UK’s National Health Service; Chief Medical Scientist, Microsoft Research, United Kingdom


Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson


Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom

Session Chair and Speakers


Emer Cooke

Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands


Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan


Alison Cave, PhD

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom


Anthony Lawler, MD, MBA

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia


Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

  • Wednesday, June 19

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


    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.

Session Chair and Speakers


James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie


William Daunch

Chief Technology Officer, Focal Medical, Inc.


Andrea Gray

Biomedical Engineer Advisor, CBER, FDA


Michael Lehmicke

Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine


Rob Schulz

Vice President, Clinical Research, TA Lead, Neuromuscular Disease, Cytokinetics

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