Conference programme

Keynote Speaker

Arun Rao  Deputy Assistant Attorney General, US Department of Justice, Washington, DC

Keynote Speaker

Mark Abdoo  Associate Commissioner for Global Policy and Strategy, US Food and Drug Administration, Washington, DC

Dr Ryan Reeves  Director of Science and Technology, International Space Station US National Lab, Melbourne, Florida

How can we ethically and effectively share and value health data for both primary and secondary use? Join our panel of experts as they will explore the opportunities and challenges of leveraging health data to improve healthcare outcomes, drive innovation, and advance research. We’ll delve into key questions such as: How can we ensure data privacy and security while promoting data sharing? What are the ethical considerations around data ownership and informed consent? Which should be the boundaries between the processing of health data, privacy and the development of innovation in health? What are the concerns and challenges for the international transfer of data between the US and EU due to the shield, Data Governance Act and European data space? Don’t miss this discussion on the cutting edge of health data sharing and valuation.

The M&A panel will focus on recent worldwide M&A activity in the life science sector, and market dynamics that are impacting levels of M&A activity.  The panel will consider various types of deals as well as alternatives to M&A such as licensing and collaboration deals between biotechs and big pharma.  Considerations such as the state of capital markets and regulatory developments will also be reviewed.

During the past decade, the Food industry has been under constant transformation.  From climate change to consumer awareness and a pandemic, the sector faced variations that tested its resilience and innovation ability. With increased interest in plant-based options, sustainable food production, and consumer health concerns with affordability, disruptive technologies are emerging.

Our panel aims to discuss how those trends and standards for increased transparency and safety will reflect in new regulatory and post-market realities.

Expedited programs such as accelerated approval has been a critical tool to get promising new treatments to patients more quickly and have been the subject matter of an EU legislative proposal. However, such programs are increasingly a source of controversy, with new pressures emerging with respect to the trade-offs associated with residual uncertainties in approvals based on certain biomarkers or clinical endpoints, the costs of such products, the speed of confirmation of effectiveness via post-market clinical trials, and the use of real-world evidence to support such confirmation. This panel will take a comparative look at such expedited programs and examine these evolving regulatory and legal issues.

The pandemic triggered various threats to the patent system in various jurisdictions. Some of them were temporary and unharmful but others seem to sustain trends and intimidation against innovators, especially in some fields such as biotechnology.

The panel will analyze and comment on practices including potential restrictive patentability criteria, patent backlogs, compulsory licensing, weak patent enforcement, litigation strategies, and lack of regulatory data protection.

The discussion will include the weight of the TRIPS waiver expansion and WHO pandemic treaty and the central role USTR have in determining IP policies which could have influence in the public and private sectors.  

The mRNA space, especially in the context of the global rollout of the vaccines, also intersects with ongoing global IP policy issues. In many ways, pandemic, also demonstrated how innovators and governments were able to make progress together to improve global health.  

A life sciences company in the crosshairs of a government investigation faces wide variability in the penalties that can be brought against it and any responsible individuals within the company.  Learn from government and in-house lawyers across the globe about the risk of criminal liability for regulatory violations.  The panel will provide a comparison of the framework used in different countries for making prosecutorial decisions, and the compliance considerations that companies should consider minimising potential criminal exposure.