Actionable Insights from the International Collaborative Research Program in Bioscience Innovation & Law

https://ift.tt/NyT9XDd

Actionable Insights from the International Collaborative Research Program in Bioscience Innovation & Law

Artificial Intelligence

Actionable Insights from the International Collaborative Research Program in Bioscience Innovation & Law

Edited by Timo Minssen and Marcelo Corrales Compagnucci, the symposium convenes leading researchers from the International Collaborative Bioscience Innovation & Law Program, which is supported by a generous scientifically independent grant from the Novo Nordisk Foundation (NNF).

Edited by Timo Minssen and Marcelo Corrales Compagnucci, the symposium convenes leading researchers from the International Collaborative Bioscience Innovation & Law Program (Inter-CeBIL), which is supported by a generous scientifically independent grant from the Novo Nordisk Foundation (NNF).


This post launches a Digital Symposium on legal and ethical pathways for key challenges in sustainable health and life science, including:

  • Advanced Medical Computing, AI & Quantum Technology
  • Pandemic Preparedness and Anti-Microbial Resistance
  • Sustainable Innovation in the Health and Life Sciences: Ecosystems, Drug Regulation, Data Infrastructures, Green Technologies and “Biosolutions”

The Inter-CeBIL initiative fosters knowledge networks to address legal and ethical challenges in health and life science innovation. It provides tailored legal and regulatory support to patients, researchers, businesses, and incubators, driving progress in healthcare and biotechnology. Legal challenges and fragmented regulations are holding back the potential of personalized medicine. In Nature Medicine, we recently explored practical technical and legal solutions. This symposium similarly will build bridges from research to adoption.

Addressing Grand Challenges

Inter-CeBIL’s mission targets three key areas with real-world use cases that translate academic insights into practice. This symposium explores all three and will be featured on the Bill of Health through July 2025.

1. Advanced Medical Computing

Advanced computing technologies, including algorithms, artificial intelligence (AI), and quantum computing, are revolutionizing drug discovery, medical devices, and digital health. These advancements hold immense potential to improve health outcomes and patient care, but they also raise many legal, ethical & regulatory issues.

This symposium’s commentaries provide a deep dive into the following topics:

Marcelo Corrales Compagnucci argues that European regulators, through the EDPB’s Opinion 28/2024, are reinforcing stricter GDPR compliance for AI systems, emphasizing anonymization challenges, limits of legitimate interest, and risks of unlawfully processed data.

Peter Davis examines the recent export controls implemented in Europe, the US and Japan on quantum technologies, and the effect that this may have on cross-border collaboration and research on health-related applications of quantum computing.

Sebastian Porsdam Mann, Timo Minssen and Marcelo Corrales Compagnucci outline some of the implications of new generative AI models such as DeepSeek-R1 for medical healthcare and research.

Hannah Smith explores the implications of neurotechnologies expanding beyond their traditional medical and clinical settings to direct consumer access to these advanced tools. Can current EU rules appropriately respond to potential privacy risks and efficacy concerns without unduly hindering innovation?

Emma Kondrup looks at how AI-driven medicine may change how we understand informed consent, and whether existing legislative frameworks provide a good enough safeguard against its risks.

2. Pandemic Preparedness and Antimicrobial Resistance

The COVID-19 pandemic underscored the importance of regulatory agility and innovation in pandemic preparedness. Simultaneously, it exacerbated the global challenge of antimicrobial resistance (AMR), as highlighted in research by Minssen et al. and Weldon et al. Drug-resistant infections, already a severe threat to global health, have become even more problematic in the wake of the pandemic.

To address the need for innovation, conservation, access and prevention, our activities include publishing op-eds, calls for actionand articles, as well as managing networks and organizing conferences including actors from the Global South.

In this symposium, Isaac Weldon examines how evolving pandemic preparedness frameworks—such as the revised International Health Regulations (2024), the pandemic agreement under negotiation at WHO, and proposed EU pharmaceutical reforms—intersect with antimicrobial resistance governance, highlighting regulatory challenges, power asymmetries, and the need for more resilient global health strategies. 

3. Sustainable Innovation: Ecosystems, Drug Regulation, and Data Infrastructure

Sustainability in life sciences demands addressing environmental, social, and governance (ESG) challenges while navigating increasingly complex regulatory ecosystems. Issues like data-sharing frameworks, greener research and development (R&D) practices, and more inclusive clinical trials are central to achieving a sustainable future. Another main study in this key area involves the study of biotechnologies and so-called biosolutions. We recently published a study for the European Commission on these issues. The discussions in this symposium explore key insights on the following areas:

Gabriela Lenarczyk examines how recent rulings—such as in Salix Pharmaceuticals v. Norwich  and Vanda Pharms. Inc. v. Teva Pharms. USA, Inc. in the U.S. and key EPO decisions (T 1437/21T 0816/22)—expose tensions between clinical trial transparency requirements and pharmaceutical patent protection, arguing for calibrated reforms like a disclosure grace period and clearer ‘new matter’ guidelines.

Laura Valtere introduces the latest events in Europe regarding New Genomic Technologies in plant breeding. She explains the proposed changes in both the intellectual property framework and Genetically Modified Organism (GMO) regulation.

A Global Perspective on Innovation

By integrating with innovation ecosystems across Denmark, Europe, the US, and globally, Inter-CeBIL aims to foster a robust and competitive bioscience innovation framework that delivers meaningful health impacts for patients. Our goal is to bridge the gap between drug R&D and patient care while tackling global health challenges. This work includes perspectives and lessons from Low- and Middle-Income Countries (LMICs) and the Global South, recognizing that true health security can only be achieved when no one is left behind.

Through this symposium, we will share key insights and developments in this rapidly evolving field, highlighting our latest research and policy contributions. To learn more about Inter-CeBIL’s vision, mission, and ongoing projects, stay tuned to this symposium, explore our website, and connect with our team.

About the authors

Tim Minssen is an Inter-CeBIL Research Affiliate, and Professor of Law at the University of Copenhagen, as well as founding director for the Center for Advanced Studies in Bioscience Innovation Law (CeBIL)

Marcelo Corrales Compagnucci is an Inter-CeBIL Research Affiliate, and Associate Professor and Associate Director at the Center for Advanced Studies in Bioscience Innovation Law; Faculty of Law at the University of Copenhagen.

The post Actionable Insights from the International Collaborative Research Program in Bioscience Innovation & Law first appeared on Petrie-Flom Center.

February 18, 2025 at 05:30PM
https://ift.tt/BMteQiG
lgorelik

Lascia un commento

Il tuo indirizzo email non sarà pubblicato. I campi obbligatori sono contrassegnati *