An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and biotech companies flexibility, freedom, and consistent control of outsourced laboratory needs.
Drug developers with an abundance of overflow lab testing or limited lab space and staffing are ideal candidates for what Alcami calls an Extended Workbench program. Additional support may also be critical if the US Food and Drug Administration (FDA) approves the acceleration of your drug product. The chart below is a summary of the FDA’s drug development descriptions for when a product has significant implication on a patients’ welfare (FDA, 2018).
FDA Drug Development Designations
Types of Extended Workbench/FTE Programs
Extended Workbench programs are designed specifically around the client’s needs including variables of size, management, and scope.
Early Phase/Development: Contract development and manufacturing organizations (CDMOs) with experience leading clients from early phase to commercialization have the ability to provide a FTE platform in this space. These programs are designed to be an extremely flexible, unique offering that allows the client the freedom to adjust priorities based on need and results. Early phase Extended Workbench programs are also designed for short term use and allow for a fixed cost structure for a development project.
Multi-Year Multi-Product: An FTE allows CDMOs to effectively be a client’s single vendor testing source for their pipeline. These partnerships usually include long term relationships, with multiple products consisting of routine stability and release testing for the pipeline. A multi-year, multi-product Extended Workbench Program supports any timeline changes, analysis to support any FDA response, and any further development and method validation that may be needed.
Multi-Year One Product: Utilization of an Extended Workbench can also be tailored to a single product platform taken from early phase all the way through commercial launch. These programs support the ever-changing timeline landscape with the flexibility to adjust priorities and rush requests with a dedicated staff who provide the benefit of planning around a fixed monthly cost.
Abbreviated Case Study
Alcami offers its Extended Workbench for an extensive number of programs and has dedicated personnel to achieve client needs. Each program has a dedicated project management team that focuses on consistent, real-time communication, and transparency.
Alcami began work on Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in the fall of 2014. Alcami 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.
“Our versatile Extended Workbench solution was an excellent fit for our partners at Flexion, whose accelerated timeline, robust clinical trial program, and specific testing requirements mandated dedicated laboratory resources to get their product to market,” said Alcami Chief Commercial Officer, Syed T. Husain. “It was a privilege to have collaborated with Flexion, leading to the approval of ZILRETTA, and we are pleased our Extended Workbench will continue to support their product.”
“For the past four years, Alcami has been one of our most trusted collaborators,” said Mike Clayman, M.D., President and Chief Executive Officer of Flexion. “They have been able to both respond to and anticipate our needs as Flexion has transitioned into a commercial organization, and we look forward to their ongoing support.”
Alcami can provide management of sample shipment from your site to Alcami facilities along with timeline management for planning and proactive communication of testing priorities to meet regulatory and manufacturing requirements.
Selecting the right outsourcing partner for an FTE agreement involves research and exploring multiple companies— and ultimately finding the CDMO 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 to effectively act as an internal resource for your business. The Extended Workbench program has the capability, capacity, and flexibility to meet a wide range of laboratory needs.
FDA. (2018). Development & Approval Process (Drugs). Retrieved July 2, 2018, from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm