Programme

Please note that this programme is still subject to changes
 

09.20–09.30        Welcome and Introduction from the Co-Chairs

  • Dr June Raine CBE, Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Tim Stonehouse, Chairman, BIA Regulatory Affairs Advisory Committee, and VP, Head of Regulatory Affairs, Autolus


09.30–09.40        Keynote address: Lord Syed Kamall, Parliamentary Under-Secretary of State for Technology, Innovation and Life Sciences

09.40-10.10         Presentation by Dr June Raine CBE, Chief Executive Officer, MHRA

10.10–10.25        Session break

10.25–12.30        SESSION ONE: Transforming the regulatory environment to drive innovation and enable patient access to cutting-edge medicines

10.30–10.40        Accelerating recruitment and new ways to deliver clinical trials – CPRD Sprint and decentralisation of trials

  • Mandy Budwal-Jagait, GPvP Operations Manager & Lead, MHRA
  • Tim Williams, CPRD Head of Interventional Research, MHRA


10.40–10.55        The UK Innovative Licensing and Access Pathway (ILAP) - A streamlined approach to regulation and patient access

  • Daniel O’Connor, Expert Medical Assessor, MHRA
  • Carla Deakin, Programme Director, Commercial & Managed Access, NICE


10.55–11.05        BIA Member Feedback on First year of ILAP

  • Tim Stonehouse, Chairman, BIA Regulatory Affairs Advisory Committee, and VP, Head of Regulatory Affairs, Autolus


11.05–11.20        Pharmacovigilance advances for COVID-19 vaccines

  • Katherine Donegan, Pharmacoepidemiology Research & Intelligence Unit Manager, MHRA


11.20–11.30        Patients as partners in medicine development

  • Lisa Campbell, Senior Medical Assessor, MHRA
  • Anne Lennox, Patient representative


11.30–12.30        Panel Discussion/Q&A

12.30–13.30        Lunch break – Networking opportunity

13.30–15.00        SESSION 2: New innovative technology transforming product development 

13.30–14.00        Case studies: How we are using Artificial Intelligence (AI) in product  development

- Identifying Predictive Factors of Patient Dropout in Alzheimer's Disease Clinical Trials, PJ Allen, Acorn AI Labs Medidata PJ Allen, Dassault Systemes (3DS)

- Can AI tackle the leading cause of death and disability in the UK? Paul Goldsmith, Closed Loop Medicine.


14.00–14.15        Artificial Intelligence (AI) across the lifecycle

  • Johan Ordish, Head of Software & Related Devices, MHRA
  • Beatrice Panico, Leading Senior Medical Assessor, MHRA


14.15–14.30        Ethics on using AI for medicines

  • Brhmie Balaram, Head of AI Research and Ethics, NSX AI Lab
  • Fiona Maini, Principal Global Compliance & Strategy Manager, MEDIDATA


14.30–15.30        Panel Discussion/Q&A

15:30–15.45        Closing remarks

  • Dr June Raine CBE, Chief Executive Officer, Medicines and Healthcare products Regulatory Agency, and
  • Steve Bates OBE, Chief Executive Officer, BioIndustry Association