Ahead of the Game: Preparing for SEND Format for Biologics Before It Becomes a Requirement

The concept of Clinical Data Interchange Standards Consortium (CDISC) standardization has become familiar to most companies. Biopharmaceutical companies must now submit both nonclinical and clinical data in CDISC formats to the Center for Drug Evaluation and Research (CDER) for all new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

While the same is true when submitting clinical data to the Center for Biologics Evaluation and Research (CBER) for biologics license applications (BLAs), biotech companies aren’t yet required to use the Standard for Exchange of Nonclinical Data (SEND) format when submitting nonclinical (or animal) data. But all of that is expected to change soon. That means biotech and biopharma companies with biological products in discovery will need to submit their data in the SEND format.

The challenge for companies will be to change the way they gather information. Typically, nonclinical data is mostly included as information, in the form of reports, as opposed to data. In the future, though, developers of biologics will have to join their small-molecule counterparts in meeting U.S. Food and Drug Administration (FDA) guidance on gathering nonclinical data.

Once they have the raw data, it will need to be converted into the SEND format, which is the nonclinical parallel to the Study Data Tabulation Model (SDTM) format used for clinical data.

Tools, methods and people

To meet SEND standards, biopharma companies will have to define the methods, assign the people, and develop the tools and material to standardize nonclinical data requirements for submission along the same lines as clinical data. For companies already gathering nonclinical data but not yet ready to scale up to SEND, it’s advisable to store data in the SDTM format, which means they won’t be scrambling to meet the requirements when they do come in.

Companies will also need to ensure that the tools they use to collect nonclinical data are properly validated. These include laboratory information systems, e-lab systems and biomarker technologies.

They should also familiarize themselves with the SEND implementation guide, which directs the organization, structure and format of standard nonclinical tabulation datasets that are exchanged between organizations, such as sponsors and contract research organizations (CROs), and that are required for submission to regulatory authorities.

Typically, companies will work with external CDISC experts to convert their data from raw to the standardized format required by the authorities. However, it’s still advisable to have some knowledge of the SEND requirements to ensure that the required raw data is gathered in structured data formats.

Contact DXC Technology to learn how we can help you with your CDISC requirements and help you prepare for the SEND format before it becomes a CBER requirement.


Han Zou is manager of Life Sciences Biometrics at DXC, and Rao Mandava is CDISC Lead at DXC.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s

%d bloggers like this: