Outsourcing in Clinical Trials East Coast 2023

• Uncover pathways for all study teams to be able to include decentralization in their next study
• Discuss strategies for supporting change and adoption at global scale
• Share forecasts for continued adoption and what lies ahead for decentralized and digital trials

In this keynote discussion you will learn how Medidata Acorn AI’s Intelligent Trials solution leverages performance data from 27,000+ clinical trials and 1M+ study sites to:

• Keep trials on track with real time monitoring of performance against similar trials and changing industry conditions – looking deeper into the impacts of COVID-19 and the Ukraine crisis
• Use predictive models to significantly enhance enrollment forecasting and reforecasting, enabling more proactive responses
• Increase patient diversity by leveraging site level patient demographic data

• Key drivers of growth in Asia Pacific specifically China
• Regulatory reform and how this has impacted clinical development
• Case Study: what can the accelerated pathway look like

• Discussing how the COVID-19 pandemic affected global trial management
• Exploring the tools, technologies and data management techniques to streamline the process of monitoring trials running across different territories
• Common pitfalls in international trial management and how to avoid them

Panellists:

Ratan Ratnesh, Head of Procurement, Taiho Oncology

&

Jef Benbanaste, VP of Product, Intelligent Trials, Medidata

• What contributes to noise and variability in data?
• Inter-rater reliability: what is it and why is it important?
• Patient-Reported Outcomes: importance of consistency and accuracy. How can we reach the patients?
• Strategies to minimize noise and strengthen data quality: from training, technology, and surveillance

Getting a varied patient group is getting more and more attention in recent years but can it really help us achieve better results? 

• 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?

• DCT system components & considerations
• Tips on choosing the right DCT system for your global study
• Product and the Patient
• Connected Device Considerations
• Global study deployment

• Understanding the reasons why ethnic minority participation in clinical trials is still low
• Exploring how to work with specific groups on health matters and the impacts this can have
• How telemedicine and decentralized trials can be put at the forefront of diverse patient engagement, breaking down the barriers to minority recruitment
• Strategies for reaching other marginalized communities, e.g. LGBTQ+, differently abled, rural?

Great things happen when you combine the power of synchronous (live) virtual meetings with asynchronous (24/7) web platforms. Done correctly, Sync/aSync strategies can boost productivity and engagement among Sponsors, Investigators, Patients, CRAs and others. Effectively meshing live and 24/7 digital technologies can also yield tremendous value in data capture, quality, cost savings and carbon footprint. This presentation will review use cases and approaches that leverage Sync/aSync methodologies.

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?

• Explore some of the barriers and motivators for patients to participate in decentralized trials
• Understand the places you should consider getting patient input into the development process

In this key note presentation Viroclinics Xellerate, a global logistics specialty services provider and Medicago, a pioneer in plant-based therapeutics, will share their best practices on:

How outsourced global specialty logistics can enable vaccine development in light of pandemic related challenges.

• Flexibility in scaling up and down
• Importance of solution-thinking
• Ability to respond to fluctuations in needs and demands

• Defining Decentralized Clinical Trials
• DCT Modalities at Pfizer
• Value Drivers

• Debating and defining what it means to apply ethics to technology
• Discussing the regulations and policies around the latest technologies and how to ensure you are aligned to these regulations
• How the patient voice should be incorporated
• Advice on reviewing and monitoring your technology to ensure it is following the right policies and procedures

• Virtual Clinical Supply Model
• Direct to Patient Capabilities
• Global Clinical Supply Offering (NEW)
• Medical Procedures, services, and product reimbursement (NEW)
• Improve Site Feasibility and Remove Barriers (NEW) 

Questions include:

• From your experience, what have been the challenging points when buying strategically? Are there any quick solutions to these challenges?
• How to best engage with internal customers’ and external stakeholders’ through collaborations?
• Looking at the bigger picture, with virtual trials now playing a pivotal role, what would need to be considered from a buyer perspective (remote monitoring, patient recruitment, CROS etc.)?
• How do you overcoming the challenges of supplier and vendor risk assessment in virtual world?
• How do you stay one step ahead – anticipating what your R&D team and portfolio need to find your next long-term partners?

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate® Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

• Operational analytics including enrollment, protocol compliance and safety
• Risk-based analyses and insights with elluminate RBQM
• Operational knowledge for data-driven development with elluminate CTMS
• Centralized issue management across roles in operations, data and medical review
• Sample tracking, data forecasting and financial performance indicators

ArisGlobal has been serving life sciences for 35 years, and LifeSphere eTMF was the first system to support TMF Reference Model document types and the TMF Exchange Mechanism Standard. Join our tech showcase to see how our eTMF and CTMS leverage the eTMF Exchange Mechanism Standard to provide the following benefits to our customers across the globe:

• Sponsors will discover how utilizing clinical systems that support the TMF Exchange Mechanism Standard can supply CRO trial oversight
• Learn how CROs can offer a way to supply visibility and transparency to sponsors in a real-time manner
• By leveraging solutions that support the TMF Exchange Mechanism Standard, Sponsors and CROs have the opportunity to lower costs between Sponsor and CRO systems, increase efficiency and improve the overall Sponsor/CRO relationship

• Debating the opinion that the pandemic has allowed out of the box thinking to find new solutions to old problems
• The rise of new technologies as solutions: what new techs have our panel been able to experiment with over the pandemic?
• Which new technologies are a useful investment and which aren’t worth the hype?
• Keeping the innovation going – how to ensure new ideas and ways of doing things continue to be nurtured in a “normal” world

Shaheen Lakhan, CMO, Click Therapeutics

&

Todd M Solomon, Director of Clinical Development & Head of Digital Psychiatry, MindMed

Further panellists welcome, please apply

• Key learnings from running DCT/hybrid trials so far
• Points to consider designing your coming clinical trials using DCT processes and technologies
• The building blocks in your DCT/Hybrid trials

• A review of the challenges faced by trials in the Alzheimer’s space
• Exploring how technology can be harnessed to streamline trial operations
• Lessons learnt: what advice can be taken forward for other trial managers

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

• YPrime will discuss the role of the patient in clinical trials and how technology has impacted its evolution
• The importance of patient retention will be highlighted, as well as how technology plays a critical role in patient engagement by providing a customizable, user-focused experience throughout a clinical trial

We welcome Bonnie Bain from GlobalData to present her research into the state of the Biopharmaceutical industry in 2022. Including:

• Identification of key themes that were triggered by COVID-19 and how they are shaping the biopharmaceutical industry, both today and into the future
• Key emerging technologies and disrupters
• Industry, regulatory and macro-economic factors affecting pharma in 2022

Don’t miss this talk; it is crucial for the biopharmaceutical industry to recognize the factors shaping the clinical trial landscape in order to maximize their future success.

Whether clinical trial innovation is a benefit or a burden is in the eye of the beholder. Join industry veterans Malia Lewin and Tom Julian for a discussion about innovation that considers the implications from different stakeholder perspectives. Audience interaction is encouraged as we explore what drives, scares, and inspires us along the innovation journey.

• Best practices for CRO contract costing to reduce common pitfalls and avoid stretching your budget during the trial
• Identifying and implementing the most effective budgets ensuring it fits with your trial priorities
• Debating the role training and knowledge plays within your clinical team to avoid errors and misallocation of funds
• Highlighting tips on accurate forecasting to ensure reliable cost models

Tired of dealing with data silos, low response rates, tedious results analysis of site feasibility surveys?

The first portion of this interactive session will focus on your pain points with site selection as it pertains to site identification and feasibility questionnaires. We will poll the audience on the issues their teams face (including any complications around managing recipients in rolling feasibility, CDA statuses, exclusive site networks, etc.) and any solutions they have implemented to resolve those obstacles. The audience will have the opportunity to discuss their thoughts with colleagues and hopefully with some site representatives as well!

We will then review how GlobalData has experienced some of the audience’s main pain points issues being resolved through sophisticated electronic feasibility questionnaires with various case studies.

• Decentralized Clinical Trials are becoming the new norm – but let’s consider the impact on every step of the Clinical Workflow.
• Digitization and decentralization go hand in hand – but does this approach lead to the “consumerization” of clinical trials and redefine how patients engage with providers?
• The characteristics of Decentralized Clinical Trials present multiple Supply Chain challenges – is collaboration the solution to these challenges and importantly, are they worth rising to?

Our panel will reflect on the future of the industry and what we think the “new normal” of a world post-COVID will look like.

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

Misinformation surrounding clinical trials are more prevalent than ever in our society. But how can this be improved through better community engagement and communication?

• Exploring why communities can become mistrustful of clinical trials
• Who is the demographic of people more likely to be swayed by misinformation and mistrust? What can the industry do to engage and educate these groups of people?
• What can be done better? Taking an honest look at areas the clinical trials industry may be failing in to effectively represent the communities they are trying to help
• Exploring how can these issues be faced through better community engagement and communication

• Questions to ask your provider so that you can ensure they have understood your needs
• Identifying exactly what you need from a vendor and what aspects can be better managed in house
• Combatting “status quo” bias – identifying when it is best to move despite being comfortable with the vendor you know
• 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

• Reviewing and defining effective data policy and how to ensure this is communicated effectively across all teams
• Tips on putting clear objectives, policies and processes in place to streamline and futureproof data
• How a robust database can improve data quality and remove issues around data integrity
• Applying and integrating these processes with outsourced partners, ensuring all parties are on the same page

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.

RT 1

Remote Working & Return to the Office – How we made it work for us

This discussion will look at the transition to working from home that many of us had to adjust to during the pandemic. Share your thoughts on how you made it work for your employees, the benefits and negatives you saw and of course whether you think the trial manager of the future will be a remote worker or office-based.

Alice Drumheller, Vice President of Clinical Operations, Sensei Bio

RT 2

Advancing Data Analytics to New Frontiers During the COVID-19 Pandemic Restart

Paresh Patel, Director Data Science & Technologies, Otsuka

RT 3

Promoting Diversity and Inclusion in Clinical Trials: How You Can Help to Include Under-Represented Communities

This group will be discussing practical steps you can take to promote diversity and inclusion in clinical trials.

RT 4

Opening up: A Discussion on Returning Supply Chains to “Normal” in a Post-Pandemic World

We will discuss adaptations made to supply chains since the pandemic began – and are these adaptations planned to be continued? How can we ensure robost supply chains moving forwards?

Blockchain – Is the Biggest Buzzword in Technology the Best Weapon Against Counterfeit Drugs?

Blockchain is often pointed to as one of the new technologies most likely to revolutionize clinical trials supply – but how useful could it be in tackling counterfeit drugs:

• With the counterfeit drugs market being worth an estimated $200 billion, what is the role Blockchain can play in combatting counterfeit drugs and tracking product authenticity?
• How likely is it that governments will introduce new regulations in regards to labelling and tracking products throughout the supply chain – and what role can Blockchain play in this
• Is the cost of setting up Blockchain worth it in your company? What are the alternatives?
• A quick review of real world evidence in regards to Blockchain – how it has been successfully used in supply chain management and the lessons learnt from this

How We Did It: Getting Device Approval Through the FDA’s Breakthrough Devices Program 

• A review of what the FDA Breakthrough Devices Program is
• How we got approval and a walkthrough of the approval process
• Lessons learnt and the benefits of this program
• What companies need to know when seeking approval in the US through this route – could this be the right program for your device?

CASE STUDY: Company Expansion: Handling the Growing Pains 

We welcome X from X to discuss how they expanded their company and overcame the associated challenges.

• Translating your company into a larger business when you only have a small workforce – do you outsource to cover processes that can no longer be dealt with in house?
• Discussing and debating at what stage you should look to step up your workforce and invest in expansion
• Surprises and challenges that arose when expanding the company – and how these were overcome
• Discussing the solution providers that helped with the expansion process – how to make the decision on what help to bring in

Working with a Smaller, Niche Supplier: Can this be the right option for your trial?  

• Benefits and opportunities that can come with working with a smaller niche supplier on your trial – and how this compares to working with a large CRO
• Identifying the pitfalls and challenges that come with working with a smaller supplier – 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 – tips and tricks
• 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?

ROUNDTABLE: Starting Over: How to Recognise When Trial Protocols Need to be Redone

Recognising that your trial protocols aren’t working is a difficult thing to do. Join this group to discuss red flags and key signs that could indicate that a trial needs to be abandoned and restarted with new protocols. 

Moving Forward for Rare Disease Studies: Are Decentralized and Virtual Trials a Permanent Solution?

• 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
• Considerations needed for a rare-disease specific remote trial
• How a virtual trial can benefit the rare disease patient

A Fresh Look at Patient Recruitment Focusing on the Top of the Funnel – Is Our Image the Problem? 

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?!

Electronic Informed Consent: The First Thing to Introduce for a Modern, Streamlined Study   

While they may be flashy, technologies such as DCTs, wearables, Machine Learning and blockchain can be expensive, hard to learn and difficult to immediately integrate into most studies. However there are other technologies you can invest in such as Electronic Informed Consent that can position you as a modern, future-ready institution.    

• An overview of Electronic Informed Consent and how it can be quicker and easier in the long run to implement an electronic system
• Facing up to the challenges in implementation such as adhering to regulations over different regions and developing a platform
• Exploring the impact on patient engagement – will it really lead to easier recruitment and fewer patient dropouts?
• How the pandemic has streamlined the adoption of virtual solutions for patient consent and the benefits this has had

Conducting Trials in North Africa and The Middle East: Key Considerations and Best Practices

In this session, we welcome X to break down the various challenges and benefits that come with expanding into emerging markets in North Africa and the Middle East.

This session will cover:

• Regulatory considerations – exploring what US companies need to be aware of before submitting a trial in these territories
• Unpacking the cultural differences and taking a realistic look into how this could impact your trial protocol and design
• Exploring the benefits such as large, treatment naïve populations, lower costs etc.
• The other side of the coin: downsides that need to be taken into consideration such as a lack of infrastructure, slower regulatory processes etc.

 Launching Your First Clinical Trial: Top Tips and Lessons Learnt

• Advice on vendor negotiation and management – how to ensure you are working with a partner who can cater to your specific trial needs
• Staying on budget and sticking to timelines: advice on how this can be done
• Exploring governance and risk control – ensuring you remain in control of all aspects of your trial
• Lessons learnt: what advice should be passed on to a first time trial manager

Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations

• Starting off strong: What you need to know before launching your rare disease trial
• Change your mindset: how rare diseases require a much more individual approach to patient recruitment
• Preparing for your study: ensuring you have understood the impact on patients and their caregivers
• Finding the right vendor partner: how to ensure your CRO can handle a rare disease trial

The Single Most Important Technology You Can Have: Cybersecurity

With many of us turning to remote monitoring and virtual at home data tracking solutions – how can we ensure this data is accurate and secure?

• The argument that cybersecurity is the single most important investment your company can make – and why it is that so many companies are ignoring the issue and failing to adequately protect their data
• Data breaches and cyberattacks – how to remain vigilant at all stages
• Exploring how you cannot innovate other areas of your supply chain with wearables, AI, virtual site visits etc if your data protection and cybersecurity is not adequate

Unpacking the hype: are decentralised trials a realistic solution?

• Exploring whether decentralised trials can increase patient satisfaction in clinical trials and the potential benefits increased satisfaction and recruitment can bring
• Overcoming the challenges in remote data management and collection
• The regulators’ response – a realistic look on how likely a decentralised trial is to be passed by the regulators using case study examples

• Enhance your knowledge of patient co-creation processes to ensure appropriate input is taken into consideration during all phases of the clinical research life cycle and allow for patient-centric trial design.
• Understand FDA guidance on incorporating patient feedback, as well as recommended best practices and current challenges with traditional methodologies.
• Explore how you can utilize a novel technology-enabled approach to optimize your research study to be more patient-centric and alleviate the current burden associated with the collection of on-going feedback from key stakeholders.

• Understand the intersection of Psychedelic Drug Development, Digital Medicine & DCT
• Examine the advantages of using a DCT platform to collect Precision Psychiatry Data
• Discuss challenges and benefits associated with developing and deploying a custom-built platform ‘in-house’

• How do you identify what you need
• Where do you find what you need?
• How do you build a Mobile Data Suite?
• How to put what you’ve found into practical operation

For clinical trials to detect a true treatment effect, the measurement approach must be reliable and valid. With current regulatory guidance to incorporate Patient Reported Outcomes (PROs) as critical endpoints, it is crucial that studies utilize evidence-based decisions in the design, deployment, and management of PRO data. PROs inherently rely on participant buy-in, comprehension, and motivation to contribute to the advancement of medical and scientific knowledge. In this presentation, we will look at:

• Strengths and limitations of PROs, with specific attention to optimizing these endpoints in decentralized trials that deploy ePRO data capture technology
• Reducing the time to unlock more accurate clinical evidence needed to bring new treatments to market by incorporating these methods