A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants pharmaceutical and biotech companies the flexibility, freedom, and consistent control of their outsourced laboratory programs. In this article, we will discuss the benefits of establishing an FTE program with an outsourcing partner and examine the customized solutions that are available for a broad spectrum of testing needs.
Alcami’s Extended Workbench offering is an FTE program tailored to your specific needs. An Extended Workbench program can vary in size, management approach, and scope, and is available across any pharmaceutical platform, from small molecule API to biologic drug product.
TYPES OF FTE PROGRAMS
Clinical Phase Development: The most versatile FTE platforms come from contract development and manufacturing organizations (CDMOs) that can support the entire product lifecycle, with experience leading clients from early phase stages through commercialization. When specifically tailored to support clinical phase work, these programs are designed to be extremely flexible. They are unique to the customer, granting them the freedom to adjust priorities based on need and real-time results. Clinical phase FTE programs can also be designed for short-term use, yet also allow for a fixed cost schedule that can be budget-critical for customers managing cost during the development phase.
Multi-Year One Product: An Extended Workbench can also be tailored to a single product, from early phase all the way through commercial launch and ongoing supply. These programs offer dedicated staff to support the ever-changing timeline landscape, flexibility to adjust priorities and rush requests, and the benefit of planning around a fixed monthly cost. Best of all, a full-time equivalent program provides a close familiarity with a product, which drives right-first-time execution and a higher level of technical input into the analytical strategy for the product.
Multi-Year Multi-Product: With a broad-reaching FTE, CDMOs can effectively act as a client’s single vendor testing lab. These partnerships usually include long-term relationships, with routine stability and release testing for multiple products in their portfolio. A multi-year, multi-product FTE program ensures resourcing to support any timeline changes, rapid analysis to support FDA responses, and further development and method validation that may be needed throughout the lifecycle of the products.
Flexible resource pool beyond contracted employees
Support for all scopes of work without laborious contract and change order management
Dedicated project management and technical leadership
24/7 digital access
Alcami-managed resources and capital equipment
Versatility in work priorities
Alcami-sponsored audits of our laboratory testing sites
PROVEN TRACK RECORD
Alcami offers its Extended Workbench for a wide-ranging number of programs and has dedicated personnel to support client needs. Each program has assigned project management that focuses on consistent, real-time communication and transparency.
When Alcami was contracted to work on Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in the fall of 2014, the company helped Flexion meet demanding FDA requirements during the review of the New Drug Application (NDA), which ultimately resulted in the US approval of ZILRETTA for the treatment of osteoarthritis-related knee pain on October 6, 2017. The product was officially launched nationwide in late November 2017. Alcami’s Extended Workbench offering gave Flexion the speed and versatility required to navigate the application and approval process. Transitioning to their commercial support phase, Alcami and Flexion have extended their working relationship through 2020.
Selecting the right outsourcing partner for an FTE agreement should focus on finding a contract service provider that best aligns with your needs. Alcami is committed to providing a creative and custom-tailored solution for your company. Our goal is to provide a seamless, integrated approach that acts as an effective external resource for your business, that is as dedicated and responsive as an internal team. The Extended Workbench program has the capability, capacity, and flexibility to meet a wide range of laboratory needs.