Clinical Trial Supply East Coast 2021

• Hear how Sanofi have embedded Process excellence in R&D to help drive scientific excellence for drug development
• With a focus on how you can build your own strategic roadmap in your organisation, we will look at empowering process efficiency and driving operational excellence in R&D within the pharma industry

With pharma and biotechs’ ambitions to accelerate clinical trial timelines, the supply chain easily becomes the center of attention in the attempt to supply trials faster, more efficiently and with lower waste levels. Learn how connecting and optimizing clinical trial supplies with upstream manufacturing, from Drug Substance production planning to Last-Patient-In, allows for faster and risk-free clinical programs. Through case studies, we will illustrate why the supply chain is one of the key enablers of faster time to market.

Join us and listen to our expert presenter, who will take you through their experience with a CRO and will highlight their learnings and how to avoid such pitfalls.

• Don’t pick a CRO without conducting your own research
• Ensuring that you understand the regional regulations and agreement with the vendor to avoid financial loss
• Managing your communication effectively with your CRO to ensure standards and timelines are being met

• Having a strong understanding of the regulation procedures to avoid any delays or ramifications
• Forecasting your costs in advance to avoid under budgeting
• Outlining your site locations and participant numbers to ensure you have ample supplies

In this presentation, we will be discussing the importance of data availability and how having that data available at your fingertips, in the moment you need it, is critical to the success of your clinical trials. Join us and our expert speaker, Morgan Brandt, PCI’s Digital Product Director, to learn:

• How, from a patient’s perspective, data availability will positively affect their trial information expectations
• What technology is required to help the trial work more efficiently
• How to stay ahead of the competition and improve the bottom line with greater insight

Justin Tarpey, Site Scheduler, Merck

• Looking at individual studies to determine what is needed in advance
• Maintaining a flexible budget for unexpected overdraft
• What is your destination? Investigating the processes and available manufactures and not be left shorthanded.

• 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 you 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

• Revising the planning procedures from the current pandemic to determine what worked and what didn’t

• Looking at the latest cloud-computing innovations to see how they can help improve timelines
• Using AI Technology to help identify order processes to ensure they are delivered without issues
• Applying digital technology at sites to keep them operating during pandemics and to avoid delayed delivers in products

• How to choose the right IRT vendor during the vendor selection process
• Reduce cost and risks by contracting wisely with the IRT vendor
• IRT System setup basic tasks
• How to keep the system performed as expected during the maintenance phase of the study
• System closure tips

• Understanding the role of blockchain as a single source of truth in a complex world
• Analysing and prioritizing distribution and verification processes that could be streamlined with a real-time blockchain implementation
• Evaluating the financial impact of enhanced business intelligence and reduced labor costs
• Identifying the optimal methods to deploy an internal blockchain pilot within your organization

• Logistics alignment with SC strategy
• Main focus drivers – incl. examples
• Our performance management cycle

• Outlining in advance which aspects of the trial will include patient home care and the establishment of DTP/DFP trial components.
• Why having the supply chain team part of the protocol team is essential to ensure the success of the operational and supply chain aspects
• Assessing the latest tracking technology to facilitate a seamless chain from warehouse to patient home

• Recent developments in quality control and quality assurance for stem cell therapies and tissue engineered medicinal products (TEMPS)
• Recent developments in standards for TEMP production and supply that may impact future regulation for stem cell therapy clinical trials
• Anticipating future changes in stem cell clinical trial sponsors quality needs for TEMP supply chains

• Pre-planning – Ensuring the pharmacy is up to code to avoid any regulatory ramifications
• Auditing the pharmacy before agreeing to take part to see whether they have the tools to assist in the supply planning and trial
• Developing a framework to maximize the resources available for the pharmacy during the clinical trial process

• Understanding the gap analysis causing common mistakes and what changes can avoid these; product and process knowledge, supply chain development and supply chain management
• Shifting the paradigm from believing our suppliers are causing problems to accepting that we are part of the cause
• Unpacking new concepts; supply by design, cross-functional alignment, self-qualification, and relationship risk mapping

• Recognizing the fundamental importance of supply chain management and why it should not be neglected from the beginning
• Discussing the best practical modifications to bring into your daily practice
• Forecasting a budget for future vendor collaboration
• Sourcing product import/export and knowing the latest regulations on hand

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

RT1: Determining when to include your quality team in the conversation: working together to ensure compliance, meet timelines, and reduce costs

RT2: Ensuring Your Clinical Supplies Pass US Border Control – Sean Smith, Biological Threat Exclusion Coordinator, US Customs and Border Protection
Adam Pitt, Biological Threat Exclusion Coordinator, US Customs and Border Protection

RT3: Choosing the right CMO to manufacture your product, balancing cost with quality

RT4: How COVID has impacted the Pharmaceutical Supply Chain – Dawn Wright, Global Clinical Supply Planning, Incyte

RT5: Improving the sponsor-site relationship to prevent overburdening your sites and delaying your trial results

RT6: Overseeing Interpersonal Management In Your Supply Chain – Jennifer L. Northcott, CPM, Merck

• Analysing 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

• An update from CBP: how to stay compliant with new customs regulations
• Enhancing the security of the drug supply chain while also ensuring products reach their destination in a manner that is both timely and safe
• Working collaboratively with customs authorities in order to avoid compromising quality