Webinar | Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs




Date: Tuesday, July 23, 2019
Time: 10:00AM EST 

Register Today.

Securing timely and reliable commercial packaging services can be challenging for orphan, niche, and other low-volume drugs that must compete against high-volume drugs for access to finite production capacity at contract packagers.

For the typical contract packager, high-volume drugs are given scheduling priority; low-volume jobs are slotted as gaps become available between larger projects. This common practice makes it challenging to find timely and predictable commercial packaging for low-volume products. For patients for whom the drug in question may be the only therapeutic option available, any delay in packaging that results in a market shortage can have serious consequences.

Companies with orphan, niche, and low-volume drug products have options other than large-scale contract manufacturing services. This webcast will describe one solution:  Working with a clinical supply partner to handle the packaging and potential complex distribution logistics for expanded access programs and commercial supply.

Key Learning Objectives:

  • Identifying challenges unique to low-volume commercial products
  • Exploring packaging and distribution strategies for transitioning from clinical trial to managed access/compassionate use programs while awaiting market approval
  • Evaluating the potential benefit of using a single vendor for clinical and commercial packaging

Featured Speakers:

Karl Jones
Manager, Production Design,
Catalent Bolton

Matthew Stark
Manager, Project Management,
Catalent Kansas City

Register Today.