BioLogistics^sm Management: Autologous Cell Therapy Patient Collections

Multi-center clinical trials of autologous cell-based therapeutics, require extensive upfront coordination of subject screening, collection, packing and shipment of raw materials for manufacturing and of their subsequent return to a site for administration of the finished product to trial participants.

Key has unmatched experience in managing all aspects of cell, tissue, and blood product collection for clinical studies involving cellular therapies. Key refers to these coordination services as BioLogistics^sm.

Key serves as a CCMO (contract collection management organization) providing critical BioLogistics^sm support throughout all phases of clinical studies of autologous cell-based therapies.

Key’s experience and capabilities set it apart from the other service providers:

• Existing relationships with a network of blood product collection sites, e.g. regional blood centers and other biological product collection facilities that have been qualified to serve as collection sites for these studies, allow effective implementation of collections in a time- and cost-efficient manner.

• Independent status allows opportunities to partner with independent blood centers, American Red Cross affiliated regional blood centers and for-profit companies to maximize collection opportunities.

• Previously served as national coordinator for autologous whole blood collection for two clinical trials of a therapeutic cell-based vaccine for multiple sclerosis; a Phase IIb trial and a follow-on open label trial.

• Managed enrollment of subjects at 35 clinical sites across the U.S.
  

• Allowed sponsor to complete enrollment of targeted number of subjects (150) in less than 12 months.

• Currently coordinating collections, packaging, and shipment of autologous leukaphereses from patients with chronic lymphocytic leukemia at dispersed sites across the U.S.

Collection Services for Patients Sourced from Participating Clinical Trial Sites

Key works in a supportive, but critical, capacity when patients are sourced from participating clinical trial sites.

In these circumstances when collection services specified by the sponsor are not available at the investigator site, Key works through its Cell Collection Network^sm, a group of regional blood centers and other biological product collection facilities that have been qualified to serve as collection sites for such studies.

This service eliminates the need for the manufacturer to develop an in-house function for coordinating subject/patient screening and scheduling, as well as product collection and shipment for manufacturing. Key’s role is typically focused around assuring the collection of the desired biomaterials from the patient in a manner that strictly adheres to the protocol requirements.

For investigator sourced patients, Key offers several options:

• Serves as a collection site to which investigators refer their patients for the specialized cell collection procedures called for in the protocol.

• Identifies, qualifies and contracts for the services of other collection sites outside of Key’s Memphis service area, either drawing on the capabilities of the Cell Collection Network^sm or a service provider in the local area. An important aspect of identifying and qualifying collection sites is assessing the site’s ability to serve patients who differ from the population which that site is accustomed to serving. For example, threshold questions used to qualify prospective collection sites include, Can the site accommodate sick or frail patients or patients with limited time? Does the site have the requisite equipment? Is the site staffed to counsel the patient on the procedure, to conduct the procedure and to complete the case report form?

• Provides fully trained personnel and related equipment to perform cell collections in the investigator site. This collection venue tends to be more expensive than referral to a qualified collection site. However, sometimes the use of traveling collectors is necessary to keep the trial on its timetable.

With its partners, Key can perform all or part of the CCMO services listed below:

• Identify potential options for blood product collection in metropolitan areas in which subjects will be enrollment into a study through a clinical study site, prior to initiation of subject enrollment at the study site

• Qualify potential collection sites based on demonstrated experience, expertise, capacity, capability, and willingness to participate, prior to initiation of subject enrollment at the associated study site

• Train collection staff at qualified sites on study procedures, prior to first subject visit to the collection site

• Prescreen subjects for eligibility for blood product collection using Internet-based, FDA-approved health history questionnaire

• Educate subjects about the collection procedure

• Coordinate collection of samples for pre-collection laboratory studies and coordinate performance of testing, as needed

• Coordinate any needed pre-collection visit to collection site by subject

• Schedule collection date and time with subject, collection site, sponsor and manufacturing site

• Ship and confirm delivery at the collection site of materials needed for labeling, packaging, and shipment of collected product to manufacturing site in accordance with sponsor and manufacturer’s specifications

• Confirm arrival of subject at site on date of planned collection

• Confirm successful collection, packaging, and pickup of product at collection site

• Confirm receipt of product at manufacturing site

• Coordinate post-collection assessment of subject, as needed

• Receive and pay invoices for all services from collection site

• Collect, collate, and maintain records associated with apheresis collections, as warranted

• Invoice sponsor monthly for services provided