Combating Coronavirus – Lessons learnt and challenges ahead

Explore a visual summary of the plenary panel and Q&A looking at how COVID-19 has impacted clinical trials.

Combating Coronavirus: Lessons learnt and challenges ahead

One of the first sessions of the week featured a panel discussion on the lessons the industry has learnt from COVID-19 and the challenges that still lay ahead. The panel explored some of the following questions:

What are the ethical and regulatory considerations?

How to scale the manufacturing of these products?

How technologies such as AI and modelling can be used to speed up the development timelines

Can clinical trials run during a pandemic?

How do clinical development laboratories remain open?

The race to develop a vaccine for COVID-19

COVID-19 Rapid Response Working Group

What is the long lasting regulatory impact of changing expedited clinical trials and regulatory pathways?

Evidence of companies jumping the gun and trying to get product onto the market too quickly: enforcement ramping up against this

Supply change management: shortages and impact on supply chain

What will be cost of this and how will it impact contractual obligations? Supply contracts: acquiring safety stock, second sources: steps to make your supply chain reliable and ensure supply continuity but supply is a cost centre so at odds

Is interaction between the IRB and the board of directors needed in order to set priorities? (clinical care vs research)

How can we maintain public confidence in the management of vaccine development?

How do we get global co-operation in the roll-out?

How do we decide who gets the vaccine first?

Panel

Moderator: Janis Little, Vice President, R&D Quality, Moderna
Professor Robert Dingwall, Professor of Sociology, Nottingham Trent University
Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative (CTTI)
Elizabeth Eagling-Vose, Director, Head of Clinical Operations, Vaccitech
Dr Bodo Lutz, Clinical Risk Management and Data Integrity QA, Novartis
Dr Oren Cohen, Chief Medical Officer and Head of Clinical Pharmacology Services, Covance
Fiona Maini, Principal - Global Compliance and Strategy, Medidata