Outsourcing in Clinical Trials East Coast 2020

Juggling the needs of a shifting portfolio can be challenging – different portfolios we work on, especially those in different therapeutic areas, will have different requirements. In this session we will look at identifying which studies suit internal trials and which it would be most cost and time effective to outsource.

• Debating and identifying which studies suit internal delivery and which should be outsourced using realistic parameters
• Improving on field solidarity – ensuring both internal CRAs and CRO partners are working efficiently together towards the same goals
• How effective use of site managers can help studies to remain within time and budget

• Accessing Australia’s ecosystem for early phase trials. A case study in how Australia’s generous 43.5% tax rebate and numerous skilled personnel make it the ideal environment for trials
• Accelerating patient recruitment in Asia for large complex trials
• The advantage of running global trials with regional CRO partners and the expertise they can offer

By Novotech

• Questions to ask your provider so that you can ensure they have understood your needs
• Identifying exactly what you need from a CRO and what aspects can be better managed in house
• How best to negotiate the best teams and what to look for when reviewing the CVs of potential project managers
• How do you know when you have hit on the right partner? Our panel share their thoughts on what makes them know they have found the right vendor

Session Reserved

Session Title TBC

When working on a study withSusan Lubin tight deadlines, is the full service or FSP model the best way forward?

• Comparing the FSP with full service approach – what are the positives and negatives to both so that you can make the best decision for your trial
• Can working with a preferred partner really save you money and time due to their ability to meet all your needs in house?
• Setting up governance and quality control meetings to ensure you remain in control of all aspects of your trial

Patient Centricity, Patient Engagement, Patients as Partners – these are not just “buzz words”. This talk provides you a comprehensive overview of the rapidly developing landscape in Patient-Centered Clinical Research. You will learn about a myriad of initiatives from regulators, industry, and advocacy groups aimed at improving and accelerating clinical research through collaboration with patients, their communities, and other key stakeholders.

• Defining and clarifying what we mean when use the terms: Patient Centered Research, Patient Engagement and Patients as Partners.
• Reviewing the major regulatory developments in support of Patient Centered Research.
• Gain insights from the largest bi-annual global survey on patient and public perspectives of clinical research, including insights on participant experiences.
• Explore the critically important work being done to measure and evaluate the value proposition of Patient Centered Research activities, sometimes referred to as “Return on Engagement” or “ROE”.
• Analyze concrete examples of Patient Centered Research programs and projects, including sharing research results, collecting and acting-on the patient community’s input and feedback, and developing user-friendly registry websites that educate and empower patients and the public.

This talk will focus on why we should be looking at the top of the patient recruitment funnel – why we should be targeting patients before they have even thought about joining our study – in order to more successfully recruit for trials. This new approach is vital as studies show we are failing at efficiently engaging patients – some experts claim we are still only reaching 10% of our potential pool of patients.

• Strategies for changing the public’s perception of clinical trials and how this can benefit all of us
• How we should be using social media and other tools to engage with your potential audience and encourage them to see you in a positive light
• What we can learn from the oil and gas industries – why are we seen as ‘greedier’ than them?!

Getting a varied patient group is getting more and more attention in recent years but can it really help us achieve better results? In this session our panel will discuss:

• Exploring why, when the USA has one of the most diverse populations worldwide many of us struggle to recruit a varied patient population and whether improving our recruitment can improve our study results
• How Social Determinants of Health could be impacting our trials – will taking these into account improve the data we get from our trials?
• How should we be integrating SDoH’s into our study design to get the most reliable results
• The implications of not getting a diverse patient group – could this affect the safety of your product?

We welcome Timothy Koch to discuss the main requirements for vendor oversight and qualification and how we need to be adapting this risk-based approach into our trials.

• We will provide an update on the ICH E6 R2 regulation including a definition of the key terms
• What this realistically means for you and how to abide by it
• Practical tips on integrating the new guidelines into your current processes and SOPs
• How to document the required processes and what to send to regulators

Time for some group problem solving! Delegates will be split into small groups and we will give you a nightmare scenario. Working together with your teammates, brainstorm ideas that can help you successfully overcome this stumbling block and ensure that the issue has the smallest possible impact on your resources and budget.

10 minutes will be given for each scenario, after which a spokesperson from each team will share your best ideas with the room before we move on to the next scenario.

‘Scenarios’ the groups will have to overcome include:

• Your CRO project manager has decided they want to take early retirement and move to Florida. What strategies do you need to put in place to ensure a seamless transition for your new PM? How would you go about finding the next perfect PM?
• Patients just aren’t interested in your study – recruitment is proving a struggle. How could you innovate your protocol and mix up your strategy to entice patients onto your study?
• Your competitor is launching a similar study to you. What should you do when negotiating with your preferred vendors and sites to ensure that your study is the one that is given their preference and their A-team?

This is a good opportunities for delegates to share their own experiences in problem solving and learn from each other’s ideas.

Blockchain – Exploring the Implications for the Future

In this session Frank Leu, CEO at Novapeutics explores where he sees Blockchain going in the future, its implications and whether we should all be investing in it. Our expert will be answering such questions as:

• How can it be best adapted into a clinical trial?
• Which system should you use? It seems every vendor has the own system but how are we supposed to know which is the best?
• Is the FDA likely to pick it up?
• Will it actually save us money and time in the long run? Exploring examples of when Blockchain has been effectively implemented and the benefits it has had
• How do I persuade my boss that Blockchain is important?

AI Cure will discuss the potential use of AI in clinical operations (and whether it’s a cost-effective choice!) in the following areas:

• Organisation of your TMFs – Examining how AI can make TMFs quicker, easier to use and containing more reliable data
• Project management – looking at examples when using AI has helped companies keep track of their projects, saving time and helping organise their teams
• Site management – exploring how AI can streamline the difficult processes – focusing on our panel’s experience in payment processes, thereby reducing pressure on your teams
• We will of course also discuss the feasibility of adapting AI into our trials – will it make the above processes any easier or is this a technology we can manage without?

Session reserved for AI Cure

In this session we will investigate how to avoid your TMF being the weak point in your trial and how digitalisation of your records results in a stronger study.

• Moving to an electronic TMF – what you need to know and the benefits it can have in streamlining the organisation and accessibility of your trial records
• The drawbacks to a paper TMF and the implications on your study if the records are not correctly kept
• The different systems vendors are offering and clarifying the main components your eTMF needs to have – from customisable user roles to automatic backup systems and the ability to easily search for the information you need
• Auditing – how a more reliable digital TMF can be more likely to pass the auditing process

• How new technologies can be employed to make decentralized trials possible and discussing what tools need to be in place before you launch a decentralized trial
• Managing the admin responsibilities that conducting trials off-site can involve – getting it right so that the trial is run efficiently and saves your staff time
• The different models that can be utilized – from a completely virtual trial to a hybrid approach – ensuring that you pick the right model for your study in order to effectively streamline your processes

In this session, we welcome Brandon Maggio to discuss telemedicine and its implications for the future of patient centricity.

• How telemedicine and decentralized trials can be put at the forefront of patient engagement, breaking down the barriers to recruitment and giving us a better perspective on how your product will act within a particular population
• Exploring the overall perspective on why telemedicine can improve patient centricity and exploring if this method can reduce dropouts
• Examining the future of telemedicine and the uses it can have in improving study processes today

In this session Cathleen Platt, Head of Clinical Operations at Click Therapeutics, will discuss how she is working to make their trials more patient-focused and the technologies that can be utilised to achieve this goal, including:

• Ways to keep in touch with your patients (specifically newsletters) and how this has impacted engagement and retention rates
• Creating a patient-focused website to give reliable and interesting information on your trial and products and the benefits this has had on ease of patient recruitment
• To what extent does using even the most basic technologies make you look more modern and approachable in the eyes of your patients and how effectively does an innovative approach boost your profile above that of competing trials?

We are pleased to welcome Colleen Kostic to discuss how to ensure your business is FDA inspection ready in light of the new guidelines on vendor qualification.

• Tips on what your company can do to prepare and guidelines on what the FDA expects to see
• Working together with your vendors and suppliers to ensure that everyone is on the same page in terms of what is expected
• Working with your CRO to ensure that you have the correct up to date data on patient safety

In this session we will discuss how to obtain high quality imaging data and the benefit the best possible imaging can have in evaluating, measuring and quantifying product effects

• Examining site set-up and qualification and the importance of choosing the right partner at the start of your trial
• Working with your Imaging partner, including phantom management and analysis of data
• The role that site-training and web-based training using services such as Litmos can help you get the best possible Imaging results

By Invicro

In this session, we will debate the differences in approach to clinical trials that large and small pharma have and the pros and cons of each method. The format of the debate is as follows:

• Moderator opening remarks
• Initial audience vote
• Arguments For
• Arguments Against
• Interactive debate/Q&A
• Final audience vote

Our panelists will debate:

• Large pharma companies are better at picking up and adapting to new technologies
• Large pharma companies attract the best talent in terms of their employees
• Full service models (which are more likely to be used by larger companies) are the best at achieving results

• Can a small company handle specific requirements better than a large CRO? Identifying the pitfalls and weaknesses in your smaller suppliers – what questions do you need to ask to ensure they can adequately cover your needs?
• How can we mitigate and minimise the risk that something could go wrong when relying on one small supplier? Is this something that is riskier for small biotechs as they are more likely to be relying on one partner?
• Exploring ways to look into the backgrounds of your small supplier – how to best get reliable information on the reputation of a small supplier. Where is the best place to go to for recommendations on a supplier whose advice can we most trust?

How you can bring your study back into your control when things look like they’re going wrong based on the experience of mTem.

Including:

• What to do when relationships break down – steps you can take to monitor a CRO that you believe are not working to your standards and ensure that your trial is delivered successfully
• Working on your relationship with your CRO so that concerns can be raised before they have a chance to negatively impact your trial
• Best practices in re-monitoring your data if needed in order to ensure that the data you have received is reliable
• Dealing with high turnover of Project Managers – what negotiation strategies can we use to ensure that we are always getting the A-Team
• The steps we should all be taking to cover ourselves in case the worst should happen and we are let down by our CRO

We invite attendees to celebrate World Clinical Trials day by taking some time to reflect on why they got into clinical trials in the first place, what motivates you to do what you do, how your colleagues inspire you and your hopes for the future of healthcare.

Please do share your thoughts with your colleagues and write down any thoughts on the papers provided.

Our chairperson will gather up your notes and read them back to the room – a good opportunity to remind yourself of why we are all here working in this sector.

With an ever-more competitive market, how do we ensure the best teams?

• Exploring the strategies we can employ to ensure that we receive the best possible proposal from our preferred vendor even when having a smaller portfolio means that we don’t have the most leverage
• “Sharpen your pencil” – Exploring negotiation techniques so that we can ensure the best possible team and get the attention of our preferred vendor in a crowded marketplace
• Retention of your project manager and your team – are there strategies we can employ to ensure our ideal team isn’t pulled off our project?

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 45 minutes, and delegates may attend up to 2 roundtables.