Outsourcing in Clinical Trials UK and Ireland 2022

• An overview of proposals for the UK’s clinical trial legislation designed to make the UK the best place to research and develop safe and innovative medicines
• Results from the MHRA’s consultation: feedback on proposals
• What the new clinical trial legislation will mean for the future of clinical trials in the UK

• What criteria is most important when selecting a CRO as a biotech or SME?
• Is therapeutic expertise the most important factor in vendor selection?
• Weighing up the pros and cons of choosing a small CRO vs a large global CRO as a biotech or SME

Chair: Reynald Castañeda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

• Understanding MHRA regulations in relation to running decentralised trials in the UK
• How easy is it to incorporate remote monitoring and wearables into your clinical trial?
• Working constructively with patients and advocacy groups to ensure your trial is accessible and patient focused
• Is decentralisation always best for patients? Considering hybrid trials as a means to cater to all patient needs
• Beyond just pandemic crisis management: what is next for virtual, remote and decentralised clinical trials in the UK and Ireland?

MODERATOR:

Reynald Castañeda, Clinical Trials Editor, Clinical Trials Arena, GlobalData

PANELLISTS:

Krzysztof Potempa, Founder and Chief Executive Officer, Braincures

Suki Malhi, Senior Director, Clinical Affairs, Oakhill Bio

• Balancing degree of oversight over your CRO: how involved should you be?
• Looking at how trial sponsors can maintain good outsourcing partnerships
• Aligning vendor and sponsor teams under one shared goal to deliver your trial smoothly and efficiently

• Why eCOA is an important part of your trial design
• Why patient insights are key to both trial design and your eCOA strategy
• Why it is important to ensure that the right eCOA are selected for your study population by identifying the unique challenges of rare disease and oncology patient populations
• Highlight the lessons learned from COVID and how we can define a new norm for research which puts the participants at the center
• How your eCOA strategy needs to focus on the global perspective and to ensure inclusivity
• Why it is important to monitor your eCOA compliance and identify triggers early so that sites can be active partners in the study

• End to end trial coverage without an exorbitant price tag: how to budget and keep costs minimal
• Creating and building a network of external support to run your clinical trial
• Key lessons learned: what would we have done differently?

• Decentralised clinical trials are becoming the new norm, but let’s consider the impact on every step of the clinical workflow
• Digitisation and decentralisation go hand in hand, but does this approach lead to the “consumerisation” of clinical trials and redefine how patients engage with providers?
• The characteristics of decentralised clinical trials present multiple supply chain challenges: is collaboration the solution to these challenges and importantly, are they worth rising to?

• What constitutes a good sponsor-CRO relationship?
• Handling communications with CROs in situations where you have never met face to face: what can you do to make the relationship easier?
• Considerations when choosing a CRO in order to facilitate a strong partnership
• Remote communications: best practice for selecting and working with a CRO when working remotely

• 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

• Breaking down all that you need to know about CBP and other agency importation requirements to facilitate clinical supply shipments
• Receive detailed information on how to correctly declare biological products at the US border (Ports of Entry)
• Discover which biological products may have transportation restrictions that must be factored into your clinical supply chain strategy
• Covering the importance of permit requirements, including looking at whether a biological material may be hand-carried in the air environment, and what the proper labelling and packaging criteria are

Chair: James Rudge, Technical Director, Neoteryx

• Why are racial and ethnic minorities often underrepresented in clinical trials?
• Methods to engage minority communities and demographics who might not usually participate in clinical trials
• Utilising social media as part of patient recruitment

• An overview of the process of designing a decentralised trial for the first time
• Regulatory challenges in the UK when it comes to decentralised trials and what to consider during planning and design stages
• Assessing the benefits of decentralised vs traditional vs hybrid

• Challenges today: the track and trace landscape, site burden, and trends
• Deep dive into shipment and site storage tracking
• Data silos across the supply chain and how technology can be leveraged to a centralized model
• Use case: the drug journey taking into account regulation requirements
• Tips for implementation and key takeaways

• What new tools and technologies are available to support patient recruitment and how should you leverage these?
• Using social media creatively to engage patients and improve retention rates
• How technology can foster a seamless patient experience through your trial

• What are the benefits of remote monitoring patients in clinical trial design?
• What are the concerns about remote sampling in clinical trials?
• What can be reliably measured from dried blood microsamples and how does that effect clinical trial design and deployment
• Pharmaceutical approach to offering remote sampling in clinical trials

Reserved for Senior Representative, GlobalData

• NIHR feasibility service in the UK, a short overview of the current process, the advantages for common disease areas and why a slightly different approach is needed for rare disease
• How to identify potential sites to approach for initial discussions and feasibility information
• How can patient advocacy groups support the site or investigator identification process?
• OR feasibility process and site selection, an overview of our process including developing a robust study specific FQ, building relationships with site staff and presenting results to the sponsor

• Impacts of Brexit and the future of British clinical trials within the European landscape
• COVID-19 recovery and lessons learned from the pandemic
• Why have clinical trials in the UK recovered more slowly post COVID?
• Working in conjunction with the NHS to run clinical trials during and after the pandemic
• Has the anti-vax movement in the UK had an impact on a declining trust in the clinical trial industry?

PANELLISTS:

Jeff Pilot, Senior Clinical Project Manager, Norgine

Barbara Hepworth-Jones, Director Capability Building, Global Clinical Operations, GSK

Note: given the political nature of this panel discussion, panellists’ views are their own and not necessarily their employers’ official stance.

• Understanding team dynamics and staff motivators during the Great British Resignation
• Recruitment and finding experienced clinical trial professionals in order to build a strong team to deliver your clinical trial effectively
• Considerations for training and encouraging your team to embrace new technology

IRT as a tool to manage your trial supply chain with flexibility, visibility, and control. uncover how clinical trials can leverage a flexible IRT to improve supply chain efficiency and help you control unforeseen circumstances. In this presentation, we will discuss:

• Challenges to optimizing clinical supply chains
• Leveraging technology to create real-time visibility and streamline drug supply management
• How trials are using flexible IRT to gain control over their supply chains

• Advanced technologies to maximize patient recruitment predictability at different
• stages
• Forecasting recruitment under different restrictions
• Optimal cost-efficient recruitment design, sites/countries selection
• Centralized statistical monitoring and detecting unusual data patterns
• Forecasting future recruitment performance
• Forecasting event counts in event driven trials (oncology, CRV)

• Understanding MHRA orphan designation and how this differs from EMA regulations
• How can orphan drug status from the MHRA support clinical development for rare diseases?
• Navigating hurdles around data and evidence for studies with smaller numbers of patients
• Ensuring early access to drugs and how to make sure drugs are both safe and quickly available to the British market

• End to end supplier processes from selection to retirement: what is needed
• Is the supplier review process a one size fits all or should you be looking at this on a case by case basis?
• Supplier documentation: what should we have? Is there a minimum or a defined set?
• Keeping on top of records and the importance of this: managing records internally
• When an inspector calls: what does the inspector want to see?

During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Topic TBC

Dalila Karbiche, Senior Clinical Project/Programme Manager, Oxsonics Therapeutics

Outsourcing challenges: finding a CRO best suited for your study

Milena Kanova, Vice President Clinical Operations, Palladio Biosciences, Inc., a Centessa company