Clinical Trial Supply East Coast 2022

• Is the pandemic truly over in the shipping world?
• What countries are still having major issues post pandemic.
• Sharing our story on the major challenges we’ve faced.
• How to best compete for storage spaces.
• Tips and techniques for ensuring smooth deliveries of all shipments

• Navigating KPIs and trends that will strongly impact the future of clinical supply chain
• How sustainability, ethics, waste reduction and faster timelines enable each other
• What changes can be conducted in biopharma organisations to anticipate these changes
• Illustration through case studies

• Overcoming the barriers in each step of a decentralized trial: where did we waste the most time?
• Are decentralized trials worth the extra hassle?
• Adjusting ongoing trials to be fitted for direct to patient, what works and what doesn’t.
• Standardization of decentralized trials: how collaboration and regulation can work for everyone.

There are many different variables that affect drug waste and/or stock-outs within a clinical trial, so when it comes to forecasting, how do we facilitate specificity and intention in our decision making to help garner more overall accuracy in end-to-end forecasting?

• Discuss forecasting challenges from a clinical operations and clinical supply perspective
• Understand the best practice of utilizing forecasting tool outputs to help optimize drug level management from the start
• Explore how modern technology helps facilitate overall visibility of clinical supply data to help optimize forecasting from the beginning

• How are industry professionals managing waste management and preventing over stocking.
• Working with a CRO to prevent excess waste.
• Is it worth it to really trim the fat on every trial?
• Highlighting the downsides to over management?

Global Diversity – Our planet Earth is a vast and diverse place

Understand different countries, cultures, healthcare systems and distribution processes have an impact on supply strategy selection

Supply Strategy Diversity – You can’t do the same thing everywhere

Understand the value of a supply partner who can provide supply strategy diversity

Vendor Diversity – Clinical supplies are not the only thing a trial needs

Understand the value of a supply partner who can provide services beyond supplies

• What are the primary drivers pushing people out of the clinic?
• Patient reactions to home treatment compared to hospital visits.
• Does culture influence the way decentralized trials are viewed?
• Defining the extra steps to promote recruitment in decentralized trials.
• The need to include Minority populations in decentralized clinical trials and how to recruit them

• Overview of different sourcing models
• Assessing options to determine optimal strategies
• Working in a wholly outsourcing model; maintaining a strong supplier base

Sterile filling/finish and Lyophilization remains one of the most critical processes in biopharmaceutical manufacturing. In this presentation Aimee will take you on the journey of the vial, addressing:

• High technique driven processes
• Sterility Assurance and processing steps
• Why to Lyophilize
• Considerations for high level controls and requirements for every one of its critical manufacturing milestones.

• Helping make sure your goods pass through at border inspection.
• Case studies of inspections: when it really goes wrong and how to tackle it.
• Breaking down the issues with cold chain at customs, how to ensure it doesn’t spend time stuck at the border.
• Highlighting the key takeaways for ensuring a smooth inspection as we look to the future.

Speaker Hosted Roundtables

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 30 minutes, and delegates may attend up to 2 roundtables

• Exploring the struggles of decentralized trials in the supply chain and what success stories have we had.
• IRT Data in clinical supply analytics –
  • Discuss hosting IRT data versus reliance on IRT vendors for reporting.
  • Review critical challenges for using IRT data.
• Current Trends in Comparator Sourcing – what’s going wrong, what are the underlying causes and what innovations are emerging as a result?
• Q&A Session with the US Border Force – Here to help with any questions you may have about how to get goods in and out of the country

• Innovation in labelling has changed the game but has it made things easier.
• With the extra demand to go bigger with trials and pool supplies, can we keep up and does Just in Time labelling help.
• How to effectively plan for a smooth international trial.
• Should you leave label translation up to your CRO.

• A conversation on the successes and lessons learned in implementing large-scale global studies with robust demands

• Looking into the milestones of manufacturing from preclinical to clinical
• How to manage fund raising and financing a novel GMP product
• Covering the biggest challenges you will face with a start-up

• What is blockchain and what role will it play in the clinical trial world.
• How will you need to adapt in the future to work with blockchain.
• Why should someone adopt this complex technology when it will be a huge time investment.

• Supply risks associated with recruitment & trial design
• Trials which benefit the most from automating site resupply strategy
• Considerations when designing automated resupply strategies

• • Why traditional planning tools are insufficient for decision making under uncertainty?
  • The power of digital twins in enabling a data driven approach to key strategic decisions
  • How companies need to adapt in the future to work with prescriptive analytics ?

• • Focusing on the Importation process in order to increase product importation efficiency

   

  • Relevance of affirmations of compliance in speeding up FDA entry review

   

  • Good documentation eases the stress for your broker and the FDA entry reviewer

• Looking into the details of a CAR-T supply chain
• How a CAR-T supply chain can positively impact your other supply routes
• What are the next steps in the future of CAR-T supply and what will make it a smoother process

• What are the regulators doing and how will this affect your supply chain?
• How best to prepare for a formal customs audit.
• How do you value your investigational medicinal product against what a customs valuation is.
• Why it’s best to really look up what your CRO’s do in customs movements.

• What is expanded access and when do we use it?
• How do we plan for expanded access?
• Who needs to be involved with expanded access and what is the key to its success?
• What are means to get the medicine to the patient?

• An overview of the latest regulatory changes in the EU.
• What are the impacts on the clinical supply chain.
• What steps do you need to take to ensure a smooth transition.
• What might the future of EU regulation hold?

• Asking CMO’s what we can do for them to balance out this relationship.
• How can we all work together to harmonise the supply chain and strengthen those partnerships.
• How to communicate better and remove the blame culture from our industry.

• Forecasting, ensuring we have enough drugs at the right time for patient
• Labelling and lead times to ensure the drugs get to where they need to and are not held up with paperwork
• How to talk to sites in order to have the appropriate paperwork in place
• When to pull the trigger, what info is needed from both sides regarding availability

• Perceiving inspections as a check point, rather than a stop point of your study
• Ensuring your supply chain isn’t negatively affected
• Steps to ensure a positive outcome from an audit

• Key areas to focus on to become a successful Clinical Supply Project Manager
• Core competencies and skillsets of a Clinical Supply Project Manager
• Understanding the supply chain from a Clinical Supply Project Managers point of view

Session Reserved for Tive

Session Reserved for Oracle Health Sciences

• What promising psychedelic drugs are on the market and in clinical trials?
• For which disease indications are psychedelic drugs showing promise?
• What are the requirements for controlled substance manufacturing and the opportunities for manufacturers?
• What are the complexities of the treatment regimen for psychedelic drugs in trials?

• Comparing the use of IRT against a more homebrewed design.
• What are the cost benefits of different systems and can a smaller firm really make use of them?
• Forecasting global trials: what are the big differences when working for a smaller firm.

• Automation of temperature data ingestion, data review and data exchange
• Integration of temperature data with dispensation  (IRT/RTSM) and other eClinical systems
• Examples of cost savings for small and large molecule trials
• Traceability, inspection readiness, and patient safety

• Investigating the parts of the supply chain that can be improved with AI.
• Will adopting different technology 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
• Will the industry adapt in time with the changing of technology?