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Apr 07 2021


8:00 am - 9:00 am

Roundtable Discussion: Challenges and Opportunities in Clinical Trial Supply Forecasting

Executives of Amgen, Incyte, BioMarin and Tenthpin will address the formidable challenges and opportunities in Clinical Trials, the incubator for drug development. The forecast of supplies critically determines the overall ability to treat clinical patients, and if not performed effectively will result in excessive inventory produced and significant waste due to the expiration of drugs produced. One of our BSMA drug manufacturer members claims it has $1 Billion of inventory in clinical trials.

Our panelists will explore the critical assumptions which impact the forecast model and how they can be monitored for an efficient feedback loop which optimizes value and quality of results, cost of trials and investments made, patient care and risk.

These are the fundamental questions to be answered:

  • How can the twin objectives of serving a Fixed Total Number of Patients for a study and supply of 100% of its requirements be optimally achieved in the context of a model with numerous changing assumptions?
  • What are the requirements for integrating the ecosystem of clinical trials?
  • How should the assumptions be monitored for adaptive forecasting?
  • What metrics are necessary to ascertain the optimization desired?


KEY POINTS: Accuracy of clinical forecasts is driven by:
1. Patient enrollment by country and patient screening rates,
2. Depots established in regions,
3. Real time feedback from systems such as EDC/IVR/CTMS,
4. Manufacturing lead time and capacity,
5. Manufacturing quality and reliability delivered in early-stage production, and
6. Timeliness of status feedback for every node of the trials network.

The event is finished.