Events

Annual Life Sciences conference: Clinical Trials and AI - Legal Challenges and Pitfalls

Event date: 14/11/24
Location: Penningtons Manches Cooper, 125 Wood Street, London, EC2V 7AW

This event is designed to bring together anyone working in the biotech, pharma, techbio, med tech, or tech sectors who are interested in hearing about the legal issues around the use of artificial intelligence (AI) in life sciences and in particular around use involving clinical trials data. We welcome anyone from these sectors, whether or not you are early stage or at clinical stage, and whether or not you are already using AI.

Our conference sessions include:

Keynote: Unlocking Potential - Using AI in Clinical Research
Professor Martin Wilkins, Professor of Clinical Pharmacology, Imperial College, London

Insights into the FDA’s approach to the evaluation of modelling and simulation evidence
Professor Steve Niederer, The Alan Turing Institute

The European Landscape of AI and Data Regulation
Cécile Théard-Jallu, partner, De Gaulle Fleurance 

Harnessing AI for Clinical Trials: Navigating the Options and Ensuring Regulatory and Data Protection Compliance
Lisa Page (Penningtons Manches Cooper) and Nora Pook (Penningtons Manches Cooper)​

This session will delve into the transformative impact of AI on clinical trials, with a particular focus on the use of AI on pre-existing clinical data. The discussion will address key legal considerations, including data protection, consent requirements, and intellectual property (IP) rights.

  • Overview of AI systems’ use in clinical trials and regulatory backdrop/requirements for the AI systems UK/EU/FDA
  • Initial use case for Pre-screening of patients and any regulatory hurdles
  • Data protection considerations and approach with examples also of client advice
  • Use cases for clinical trial management/post trial use of data (historical and current)- regulatory considerations.
  • Data protection aspects for the above use cases especially for use of pt data that is not a part of the trial (Anonymised vs Pseudonymised data).

The Global Landscape of AI and Data Regulation 
This session will provide an overview of the regulatory landscape impacting AI, data, and associated rights within life sciences. Our expert panel will cover the UK’s regulatory environment, while external panelists will address key regulatory requirements in other jurisdictions such as in the US and Europe. Discussions will focus on how these regulations influence the development and deployment of AI in biotech and medtech, highlighting compliance strategies and future trends.

Panel Discussion: Real-World Applications of AI in Clinical Trials Data
Hosted by Dr Lisa Page, partner, Penningtons Manches Cooper

Panel:

  • Mitul Patel, head of bioinformatics, M:M Bio
  • Shini Pattni, Lindus Health
  • Professor Martin Wilkins, Professor of Clinical Pharmacology, Imperial College, London
  • Steve Niederer, The Alan Turing Institute

This panel will share real-world experiences and the discussion will explore practical challenges, successes, and lessons learned, offering attendees valuable insights into the application of AI in the field.

Join us for a morning of insightful discussion, expert opinion and valuable networking opportunities with professionals in the life sciences sector. As part of conference we will also provide a light breakfast and lunch to follow the sessions.

Date: Thursday 14 November
 
Time: 9.00am - 2.00pm

RSVP: here


Speakers

Lisa Page

Lisa Page

Partner
+44 (0)121 312 2577|
Email Lisa

Nora Pook

Nora Pook

Senior associate
+44 (0)1865 813747|
Email Nora

Penningtons Manches Cooper LLP

Penningtons Manches Cooper LLP is a limited liability partnership registered in England and Wales with registered number OC311575 and is authorised and regulated by the Solicitors Regulation Authority under number 419867.

Penningtons Manches Cooper LLP