Clinical Trial Supply 2020 - A Virtual Conference

In this session we welcome Derrick Kearney from the US Customs and Border Protection to answer your questions. Including:

• Who is the best contact for my questions about import?
• What are the common mistakes you see in regards to companies importing device components and how do we get around them?
• What mitigation plans are in place in case the US sees another lockdown situation?
• Will we still be able to send and receive supplies from abroad?
• What would you say is the main issue / requirement that US based companies don’t know but should?

• How can an IRT that can be flexible to changes in your trial structure be best put in place?
• Examining the cost of an IRT system; and weighing up the advantages of building your own ‘adaptive’ solution as opposed to purchasing one pre-built
• Posing the question of whether trials will need to be increasingly better adapted to uncertain world situations – and examining how an IRT can relate to these uncertain and adaptive trials
• Would an IRT be the best solution for an adaptive clinical trial or are there other solutions that it would be better to invest in?

In this session we will explore considerations for deciding on packaging options when taking your drug from a clinical trial to market. Including:

• Packaging for clinical trials is often not focused on cost effectiveness, whereas commercial packaging needs to be designed to be as cost effective as possible – what can we do to bridge this gap?
• Should we be designing packing for trial drugs with commercialization in mind? Will this help save us money and time in the long run or will it jeopardize the efficacy of our clinical trials?
• What lessons can we give to our colleagues in the commercial department based on what we have learnt from the trial stage? Are our two departments communicating effectively to design the best possible commercial packaging?

• Maintaining transparency and communication in a D2P trial
• Exploring whether D2P can increase diversity in clinical trials and the potential benefits increased diversity can bring
• Arguing that a mobile site doesn’t guarantee patient centricity and patient satisfaction – examining the patient need for face to face contact with their medical providers.
• How are patients likely to react to a D2P trial? The factors to consider when proposing a remote trial to patients

• Sourcing from abroad and regional considerations in order to ensure successful import and export
• Contingency planning and risk management – what steps is it sensible to put in place?
• Examining whether the recent pandemic showed weaknesses in the comparator stocks
• Single Sourcing vs. Decentralized Sourcing – examining the pros and cons

• Adaptations they have made to their company (if anything) since the pandemic began – and are these adaptations planned to be continued?
• What was the biggest challenge faced during COVID and how these were overcome
• Has COVID fundamentally changed the way their business is run? What changes, positive and negative, have been brought on by the virus?

• The impact of smartphones and other at-home technologies that allow the clinic to ‘come to you’
• Exploring the benefits that simple measures such as a user-friendly website can bring for patient enrolment and engagement
• Managing chain of custody and postal disruptions for remotely collected patient samples
• How innovations in clinical supply can support and streamline the D2P experience

Even though most companies had contingency plans in place for disrupted times, as Mike Tyson once said “everyone has a plan until they get punched in the face”. And COVID-19 has certainly punched us all in the face.

So how are we all doing really? In this session we welcome Luke Moyer for this interactive discussion on how the clinical trial supply industry can support each other, stay motivated, inspired and connected whilst working remotely even during these challenging times.

We invite delegates to participate in this session, with your feedback requested on what you are struggling with and we also want to hear your thoughts on what you’re doing to maintain the health and well being of your supply chain (and of your employees!).

• Exploring the factors that mean that single use packaging is more beneficial – e.g. regions that are hard to transport from, regulations that mean returning packaging is more difficult
• Should we all be moving towards multi-use packaging as a more economical and environmentally friendly option?
• Do we think that it is worth investing in multi-use packaging when virus contamination concerns mean that we are reluctant to reuse packaging?
• Examining the public’s perception of packaging and whether as the public becomes more aware of environmental concerns, the demand for multi-use packaging will increase

We welcome Peter Shapiro from GlobalData to present his research into how COVID has affected supply chain and the lessons we can learn from this moving forward.

• Impact COVID-19 has had on the pharmaceutical industry – reviewing the top concerns and mitigation plans
• What are the real risks the industry faces moving forward – a dive into the areas of the supply chain that have been affected and those which have remained stable
• Planning scenarios – how the data can help frame your response moving forward

• Introduction to big data: Sources, applications and challenges
• Reviewing big data analytics & cloud computing: players, collaborative models, data integration and representation
• Implications of AI, data analytics and robotic process automation (RPA) in digital health, medical devices, wearable and supply chain management
• Running intelligent clinical trials and supply chain operation using advanced analytics, machine learning, AI, smart labeling and tracking

• 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?
• Surprises and challenges that arose when expanding the company – and how these were overcome
• Discussing the solution providers that helped with the commercialization process – how to make the decision on what help to bring in

Increasing development timelines and decreasing R&D returns are putting pressure on the pharma and MedTech industries – only those companies staying ahead of the technological curve are likely to thrive over coming years.

• Inaccurate supply forecasting and poor product tracking / authentication are causing delays and profit loss across the industry – new technologies are vital in combating these weaknesses in supply chain management
• The risk of being ‘risk adverse’ – how the conservative pharma industry is damaging itself by being slow to take on new technologies
• Summary on the emerging healthcare technologies for solving above-mentioned challenges – from Blockchain, AI, deep data Mining, and the internet of things  – and how they are expected to disrupt the industry

• Do your research: understanding what service you are looking for collaborators
• Creating a suitable framework between you and the manufacturer
• Identifying the key elements to ensure quality is met
• Ensuring both parties have understood the paperwork before working together

• Using AI to constantly survey the entire supply chain and the benefits of this
• The roles AI can play in supply chain management – from predicting demand to ensuring data privacy to managing and engaging patients
• Cyberattacks and the safety of relying on AI and machine learning – can it all go wrong and what is the worst case scenario if it does?

We will look at the practical and logistical challenges (and benefits!) of working in a model that is entirely dependent on outsource vendors

• Examining the start-up process and the importance on partnering with the right provider
• Assessing ways of oversight and management when you are outsourcing: how do you ensure your partners are working towards your goals
• Impact of COVID on vendors – exploring methods for getting the attention of your preferred vendors when many other sponsors are also re-starting trials at a similar time

Think Tank sessions offer delegates the possibility of delving into a topic and unpacking this in a thoughtful and constructive manner. Our speaker is a subject matter expert in their field and comes prepared to answer questions which will allow a deep dive into the topic.

Scenario: What happens if you lose a key partner? Take some time to explore if we are too reliant on our outsourced vendor partners – what can happen if they fail or are unable to function due to world events? What steps should you put in place to ensure your trial stays running even if one partner is lost?

• Considering what makes a clinical trial complex, including sensitivity, shelf-life, temperature control requirements, and special formulation
• Outlining the added complications in your supply chain that arise from working with extended release drugs, from manufacturing with different formulas, to forecasting the supply demand
• Learn how to effectively plan for sustained dosage to ensure that you inventory levels are accurate
• Providing the CEO perspective of working with complex supply chains in start-up settings

• Analyzing the right vendor for the right product
• Ensuring your supplier has the right material on hand to avoid disruption
• Reauditing past supplies and evaluating what they can bring to the table

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!