PointCross Life Sciences is a Foster City, California software and services company that turns the messy data of drug development into FDA-ready submissions. Through its XBIOM platform and eDataValidator, it standardizes nonclinical and clinical study data to CDISC SEND, SDTM and ADaM formats, runs a Hadoop-based data repository for sponsors, and supplies the U.S. FDA itself with the software reviewers use to read nonclinical submissions. The company quietly powers roughly a quarter of all FDA SEND submissions.
Seneca Therapeutics is a clinical-stage biopharmaceutical company developing targeted oncolytic immunotherapeutics built on SVV-001, a non-pathogenic Seneca Valley Virus that selectively replicates in solid-tumor cells expressing the TEM8/ANTXR1 receptor. Founded by oncolytic-virus pioneer Dr. Paul Hallenbeck, the company pairs SVV-001 with immune modulators and checkpoint inhibitors to spark systemic anti-tumor immunity, and is advancing a Phase I/II trial in high-grade neuroendocrine neoplasms while building a pipeline of armed and neo-antigen viral constructs.