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Why Sponsors Choose to Switch Access Program Vendors

Picture of Ana Paula Tediosi

Ana Paula Tediosi

WEP’s Head of Expanded Access Strategy, Ana Tediosi, is a recognized expert in the field of Expanded Access. She has a wealth of experience navigating asset transitions that include EAPs. Her deep understanding of the sponsor's perspective uniquely positions her to guide companies through the complexity of Expanded Access Strategies and implementation.

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Feeling dissatisfied with the level of service provided by an Access Program vendor is not uncommon for pharmaceutical and biotech companies. Many Sponsors that choose to outsource the management of their access program(s), be it Expanded Access or Post-Trial Access, will consider switching their vendor at some stage throughout the duration of their program.

WEP has supported Sponsors with this process, transitioning access programs away from the initial vendor over to WEP. Below are some of the most common pain points we hear from Sponsors that are considering a potential switch from their current vendor:

  • Their vendor has a one-size-fits-all delivery model and is slow to adapt or tailor its solution to address niche program requirements, disease-specific delivery models, or any unforeseen challenges that arise. The Sponsor may feel like this a cut and paste scenario for your program.

  • Their vendor’s internal processes are inflexible, meaning the management of site requests and patient fulfilment is done by individual groups who often are not communicating effectively, causing delays and site frustration that falls back to the Sponsor.

  • Their vendor does not have solid global regulatory expertise and struggles to manage requests from countries such as France and Brazil. These countries have complex and country-specific processes that must be followed for an access program to be successful.

  • While their vendor has excellent subject matter experts, it lacks a consistent point of contact for the Sponsor and a dedicated project management team to oversee program delivery and effectively coordinate the various teams of experts.

  • Their vendor offers a complete solution to the Sponsor. However, many of the critical components for delivery are managed through sub-contractors or acquired companies that are not culturally aligned with the vendor and are internally fragmented.

  • Their vendor is saturated, managing numerous programs, and so is unable to give the necessary attention and support to the Sponsor team and the sites it serves.

  • The Sponsor chose the vendor with the lowest price, only to discover that a lower cost often results in reduced service levels.

  • The treating sites are expressing dissatisfaction with the level of service they are receiving, which may harm the Sponsor’s reputation and its future drug commercialization efforts.

  • The Sponsor decided to continue working with its clinical trial CRO for its EAP, but the CRO lacks the specialized knowledge and expertise that dedicated EAP vendors offer, leading to poor program execution.

Conclusion

If you are experiencing any of the issues outlined above, please feel free to connect with WEP to discuss how we operate to assess if we fit your needs appropriately. From there, we can determine if rescuing your access program, and ultimately improving treatment access for your patients, is right for you.

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