News & Events CTI Excels in the Logistics of Cell and Gene Therapy Programs

CTI Excels in the Logistics of Cell and Gene Therapy Programs

August 30, 2019

CTI Excels in the Logistics of Cell and Gene Therapy Programs
Regulatory authorities around the world are approving more therapies and receiving more investigational new drug applications (INDs) in the cell and gene therapy (CGT) space than ever before. In 2018, the FDA Center for Biologics Evaluation and Research (CBER) received more than 150 INDs for gene therapy products, bringing the total number of active INDs up to nearly 800 applications, numbers similarly reflected at regulatory agencies around the world. As the area of research has grown, so has the pressure on bioprocessing and manufacturing facilities. Since cell technologies create a unique set of challenges related to supply chain logistics, understanding those challenges and planning accordingly is a crucial component to running a successful study and subsequently commercializing and bringing a therapy to market. Below are some things to keep in mind when planning for a CGT program.

 

Time Sensitivity
The CGT process can be a particularly time-sensitive endeavor. As an example, the cells would be drawn from the patient, sent to a facility to be genetically altered, then sent back for patient infusion. Also during this bioprocess, the patient’scells must be cryo preserved or else the cells could perish. The lives of sick patients, who typically have failed alternative therapies, are in jeopardy if the process doesn't happen fast enough, a critical time slot is missed, or if they're given another patient’s cells.   With a critically-ill patient waiting for their therapy, executing this process in an efficient manner is critical.

When choosing a CRO to manage this process, it is important to look for a team who understands not only how the process works, but also how it might go wrong so they can actively mitigate those risks.

Manufacturing Requirements
Because autologous cell therapies are personalized products with a batch size of one, CAR-T manufacturing requirements are highly labor intensive and manualized. Even more important, the bottlenecks around manufacturing are highly individualized, and in the cell gene space they depend on adequate staffing and anticipating time slots between patient apheresis and reinfusion (the turnaround time from apheresis to reinfusion, is approximately 2 weeks). Scheduling treatments for these critically ill patients requires an experienced manufacturer who can work well with your sites and utilize the most recent scheduling technology to prevent issues before they occur.

 

New Technology
The challenges inherent to autologous cell therapy manufacturing has given rise to sophisticated, robust new technology and software that can algorithmically assess both patient time slots and the labor requirements, equipment utilization, shift schedules (i.e. task duration), and capacity needed to treat each patient in real-time to prevent bottlenecks from happening early on. 

However, new software is only as good as the people behind it. Sometimes it makes sense to use this robust new technology, but sometimes for smaller studies it doesn't make sense. It is important to have an experienced study management team who understands this field, and then if applicable, the intricacies of the software.

How CTI Can Help
CTI is a key member of the Alliance for Regenerative Medicine and has managed approximately 50 programs involving gene therapies from Phase I-IV, natural history and registry programs, and encompassing nearly 1,500 patients at 400 sites in 30 countries. We continue to expand our presence in this therapeutic area and collaborate with vendors to meet the challenges ahead. Our team has the practical knowledge to help guide our partners through the entire clinical process.
To find out more about our expertise and how we can help you with running your clinical program, visit our website or fill out our contact form to start a conversation with one of our team members.
 

                                       The CTI Way

Every month, we choose a theme highlighting characteristics of our company culture, something we describe as "The CTI Way." This month's theme is "accomplish."

The industry we work in is a constantly-changing landscape full of both new opportunities and new challenges. Regardless of what comes our way, the support of our sponsors, partners, and teammates allows us to always remain focused on what we want to accomplish - improving the lives of chronically and critically-ill patients around the world.
 

                             The Year of the Employee

Every month, we'll be spotlighting one of our employees and their contributions to CTI. We are successful as a company because of our passionate and talented employees, who work tirelessly to bring life-changing drugs to patients around the world.

Jane Ahlrichs RN, BSN, M.Ed.
Executive Director, Clinical Project Management
Jane joined CTI in 2001 as a Senior Clinical Project Manager where she worked to develop protocols and transplant training materials. It was through those efforts that many of CTI's study management practices were established. 

Now in her current role as Executive Director, she is integral in the development and training of the CPMs and CPCs across CTI globally. She continues to help develop and refine our clinical trial processes while maintaining a leadership role for countless studies. With nearly 40 years of industry experience, she is able to act as an invaluable resource to her team. Jane has worked on multiple global projects throughout her career, including work on CTI's very first gene trial and many more regenerative medicine programs since.


Want to join Jane and our CTI team? Click to see our current job opportunities, includingnew expansion across the United States!
 

                                                 Additional Highlights

Upcoming Meetings We'll be Attending
SSIEM                                                                         Cell Therapy World Asia
Rotterdam, The Netherlands                                       Tokyo, Japan
September 2-6                                                             September 18-19

Nordic Life Science Conference                               ESGCT Meeting
Copenhagen, Denmark                                                Barcelona, Spain
September 10-12                                                         October 22-25

CAR-TCR Summit                                                      AASLD
Boston, MA                                                                  Boson, Massachusetts
September 10-13                                                         November 8-12
 
 
 
CTI Cares 
The Pan-Mass Challenge raises money for life-saving cancer research and treatment at Dana-Farber Cancer Institute through an annual bike-a-thon that crosses Massachusetts. 
Learn more and donate
New Hires & Promotions
 
CTI is thrilled to welcome all of our new employees, and to congratulate our recently promoted employees! 
Join Our Team!
 

We're looking to build our team in the following US cities:
  • Atlanta, GA
  • Boston, MA
  • Chicago, IL
  • Cincinnati, OH
  • Covington, KY
  • Dallas, TX
  • Houston, TX
  • Indianapolis, IN
  • Philadelphia, PA
  • Raleigh, NC
  • San Francisco, CA
  • San Diego, CA
  • Washington DC
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