Cell Collection Survey for Industry - Online Survey Software

As the fields of cell and gene therapies grow, so may the burdens on both apheresis cell collection centers and industry as companies sponsor multiple protocols. Standardization of some common collection parameters may reduce this burden on both. Improved consistency and standardization would also improve product quality and potentially improve patient outcomes while reducing errors and audit fatigue.

The Standards Coordinating Body has convened a working group of experts from apheresis cell collection centers, industry, processing laboratories, accreditation bodies, research centers, and other stakeholders to work towards these goals. Two surveys have been developed to assess current practices. One is intended for apheresis collection centers to assess common challenges with multiple protocols and data collection. The second is for industry to identify overlap and identify areas of alignment. A summary of the responses of both will be used by the work group as a foundation for next steps.

You are receiving this to collect information on the apheresis cell collection centers' perspective. Thank you for taking the time to complete the survey! It should take about 15-20 minutes and your input is integral to SCB’s standards initiatives and our goals to expedite the delivery of cell and gene therapies to patients. For the purposes of data collection, please base your responses on pre-COVID-19 operations.

If you are not the correct contact for this survey, please forward to that person or email [email protected] with the correct contact’s information.

DEMOGRAPHICS

What is your center? Use the bar to help you search the list.

In what country is your center located?

In what state is your center located?

Is your center a part/member of a larger system or organization?

Yes, my center is part/member of [name of larger system/organization]

How many cell collections for gene and cell therapy does your center perform per year?

1-10

11-30

31-50

51-100

100+

Is your center currently collecting cells for commercial therapies and/or trials for cell and gene products?

Yes, collecting for commercial cell and gene therapies

Yes, collecting for cell and gene therapy clinical trials

Yes, collecting for both commercial and preclinical/clinical cell and gene therapies

Within your center, how many staff members participate directly in apheresis collection activities?

1-5

6-10

11-15

16-20

20+

If you are not adequately staffed to perform clinical trials, what are your staffing needs? Please select all that apply.

Clinical staff

SOP writers

Billing staff

Education/training staff

Unsure

Other (please specify)

We are adequately staffed

Within the last year, for how many different companies or collaborators, internally or externally, has your facility provided collection services?

1-3

4-6

7-9

10-12

12+

For what patient age group(s) does your center have the ability to perform cell collection? Please select all that apply.

Pediatric patients

Adult patients

For how many cell and gene therapy products is your center currently collecting starting material?

Please include both the number of commercially sponsored therapies as well as therapies in internal clinical trials.

2-4

5-7

What are the three biggest challenges relevant to collection for cell and gene therapy products currently facing your center?

What options have you considered to address those challenges?