Outsourcing in Clinical Trials UK & Ireland 2021

Join this case study session on how Bayer implemented a DCT trail in the US during COVID, showing how innovation can still be pushed forward despite barriers and even in disrupted times.

• Rethinking trial design – how a DCT trail can move past the barriers and disruption of the pandemic
• A review of the technologies and innovations that made this trial possible

A panel discussion with a difference! One panel seat is saved for the audience – come and join the conversation!

After the disruption of 2020 and 2021, we are offering this opportunity for the industry to come back together to share ideas and reflect on the past 2 years. Join this informal discussion session to share your experiences and thoughts on the challenges and successes since we were last together in 2019.

Discussion points include:

• 2020 & 2021: how did we do? How badly impacted were your trials?
• How did you find remote working? What were the positives and negatives of the ‘new normal’?
• How has COVID impacted our patients, partners and businesses

Moderator: Jennifer Smith, Senior Editor, GlobalData

Panellists:

Alison McMorn, VP, Clinical Development, AMO Pharma 

The perfect chance to network and meet your peers. Delegates will all be assigned a number and tasked to find 3 other numbers in the room, ask them their name and top challenge and reason for attending the conference.

• Exploring how to introduce a new quality compliance management system from a small biotech’s point of view
• Learning from the ground up: tips and tricks learnt along the way and how you can apply this to your business
• Choosing the right vendor partner for you and exploring how to manage the negotiation process so you get the right product for your business
• Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures.

• As the world starts to open back up, it is important to ensure the patient is kept at the heart of trial design
• Debating the importance of diversity on clinical trails and how this was highlighted from the recent BLM movements
• Strategies for improving outcome measurements – ensuring these are important to the patient as well as the sponsor
• Gaining the patient’s trust: exploring how to tackle disinformation and engage patient groups to promote patient trust in clinical trials

We welcome Mohamed Abukar from GlobalData to present his research into how gene therapy research has evolved over the last 10 years, including: 

• Overview of the last decade and the trials during this timeframe
• Reasons for trial uptake, with country and regional focus
• Impact of China on gene therapy trials
• Viral vectors in gene therapy trials
• Implications and predictions for the future

We welcome Pierre Morgan to present this case study style discussion focussing on the commercialisation of a vaccine. The aim of this talk will be to take a realistic look at what is needed for commercialisation so you can plan accordingly.

• Technology impact on scalability and manufacturing lead times
• Evaluating technical feasibility and regulatory acceptability of technology transfers to localize production
• Assessing demand to right-size supply and adjust delivery schedule
• Managing affordability for buyers and corporate profitability objectives through pricing and advanced commitments

Many biotechs choose to wait for the end of their clinical trials before thinking about commercialisation and post-market data collection – but is this the right way to approach post-market studies? Join this workshop session to discuss further.

Our host will give a brief overview of managing post-market studies, including later-phase regulations and processes that need to be planned for. The audience will then be split into groups also working on similar phase trials and within each group you will be asked to discuss: 

• Are you planning your post-market operations? At what stage of a biotech’s lifecycle do you think we should start planning for post-market?
• What can you in clinical operations be doing to prepare your product for market?
• What steps do you think you should be taking now / preparing in order to ensure a smooth transition to post-market? 

We will then come back together as a group to discuss our findings.

• Getting your trial back on track post-COVID-19: are remote solutions the way forward?
• Weighing up the pros and cons of virtual and decentralized trials for rare disease studies
• Has COVID-19 marked an end for the need for regular site visits throughout clinical trials – or should we be looking at hybrid models for the future?

Reserved for:

Decentralised trials are the latest industry trend but how effective are they? In this session we will hear from each of the parties involved in the process to hear how decentralised trials have worked for them.

Discussion points include:

• How ready are our vendor partners and sites to handle the transition to decentralized trials?
• Examining the patient experience, what impact has it had on our patients?
• Is the biotech industry ready to conduct fully remote trials?

• Intro to the new requirements under MDR
• The role of ISO14155 in relation to the MDR
• Recent updates to ISO14155:2020
• Consulting the Expert Panels of the EU commission for advice on Clinical Investigations (Article 61 (2)

• What steps you and your CRO will need to take to be prepared
• Exploring the impact this is likely to have on approval timelines
• How will it affect the UK – are we likely to see the implementation of a similar directive here?

Reserved for the MHRA

Provisional Speaker: Dr June Raine, Director Vigilance and Risk Management, MHRA

We’ve all had to sit through several pitches from vendor companies telling us what they can do for us, but now it’s time to reverse the conversation! Hear from the UK trial industry as they discuss the services they would like to see from their solution providers, including:

• What they like to see in an outsourced partner organisation
• What they would like a partner to know about them / how they work
• What things do they need a partner to do and what they don’t need!
• What things can be best done in house?

• An in-depth look into how GSK kept their trials running throughout the pandemic
• Examining the supply chain perspective – how it is recovering
• The site perspective: insights into how sites are faring throughout the pandemic

Our panel will reflect on the future of the industry and what we think the “new normal” of a world post-COVID and post-BREXIT will look like. As with the opening discussion, one seat will be saved for the audience – we invite your participation in the discussion.

We will attempt to answer such questions as:

• What do we think the next 5 years will hold for us?
• Are we going back to normal or will events of last year change us?
• What are the most important lessons from the pandemic that we need to take forwards?
• What are the technologies and innovations that our panel thinks will have the biggest impact on the industry in the future
• What will be the biggest challenges our panel sees ahead and how can they best be tackled

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT 1  

Decentralized Trials: Oversight and Vendor Management – Best Practices 

Heike Schön, Managing Director and Co-Founder, Lumis International

RT 2 

Outsourcing challenges: finding a CRO best suited for your rare disease study 

Jigar Chheda, Associate Director Clinical Operations, Zogenix

RT 3

Vendor Oversight – Share and Discuss your Tips in Overseeing your Vendors and 3^rd Party Suppliers  

RT 4

Staff Retention – How You Keep Your Staff Happy, Encouraging a Low Turnover in Staff