Archives: Agenda

• Latest advancements with sourcing, labelling, and filing strategies for auxiliary medicinal product
• Identifying the right packaging and storage solutions based on your bespoke needs to accelerate your drug supply
• Improved expiry date predictions to avoid relabeling and reduce wastage
• Recognizing different labelling requirements globally and how to ensure total adherence: What are the implications of the revised Annex 13 on labelling of IMPs
• Enhancing label management with cloud-based technology to improve quality control and avoid
  unnecessary recalls

Chair: Bei Li, Senior Director, Clinical Supply  Management, Gilead Sciences

• Gaining enough traction for smallersoftware solutions companies with promising products to sustain their presence in the clinical ecosystem
• How to best implement innovative vendor services to ensure they work within the pre-existing CRO universe
• When CROs have too much power, how can we ensure innovation isn’t stifled?
• What are the best ways to balance risk mitigation and innovation in a traditionally slow-paced industry?

Chair: Mariam Iqbal, Director, Clinical Business Operations, Intercept Pharmaceuticals

• Advanced technology in clinical supply chain
• Case study – isolating objectives and delivering results through technology
• Emerging technologies, risks and regulatory considerations – identifying trial supply use cases for AI/ML

• Transitioning from existing capabilities  and architecture to integrating powerful new solutions to optimize trial supply
• Technology to determine next actions in preventing supply disruption, detect temperature excursions earlier and ensure patient safety
• Obtaining increased data points to validate or adjust predetermined excursion criteria
• Minimize discarding of potentially viable drug supply wi

• Discuss how patient insurance in the United States can impact a clinical trial patient’s experience in accessing therapies (i.e. SOC, comparators)
• Discuss how companies are currently addressing improving Diversity Equity and Inclusion (DEI) in clinical trials and how appropriate medication access can support DEI
• Supply chain considerations and optimizing the patient experience
• FDA guidance on DEI plans for clinical trials

• What are the latest technological advances and innovative systems adopted by the industry that can enhance cold chain distribution: What should be on your radar?
• Hot topic in cold chain logistics: Sustainability – Aligning market growth with responsible practices to ensure businesses are making smarter decisions regarding the planet
• Efficiently and effectively outsourcing management of temperature-sensitive materials to ensure your cold chain is never compromised
• Expanding capacity on cold chain resources and enhancing end-to-end management to keep up with increasing demand and limited supplies

Increasingly pharmaceutical companies are committing to reduce their carbon footprints in the execution of clinical trials. This session will cover how implementing innovative clinical trial supply technologies and sustainable processes can:

• result in a more efficient use of human resources
• reduce the number of logistical resources required
• reduce waste
• save money
• lower the carbon footprint impact