Pia Kasperkovitz

Lead nonclinical safety strategy for first-in-class immunocytokines and protein conjugates in oncology and immunology, guiding early regulatory engagement, submissions, and translation into clinical trial design. Represent toxicology in leadership forums and mentor colleagues in nonclinical development and translational safety.

Advanced nonclinical safety strategies for multi-specific antibodies, gene therapies, vaccines, and immune modulators across oncology, rare, and infectious diseases. Led a matrix team of experts to integrate preclinical findings into clinical trial design and global submissions, enabling progression from discovery into the clinic. Shaped Roche’s cell and gene therapy safety approach through subject matter expertise and external collaborations, while mentoring colleagues and guiding organizational strategy in translational safety.

Led safety strategy for immuno-oncology and vaccine programs, including checkpoint inhibitors, T cell therapies, and bi-specifics, advancing candidates from target selection through early clinical development. Represented Drug Safety in global health authority interactions and authored regulatory submissions. Co-led Takeda’s global Immunotoxicology network and contributed to cross-industry working groups including BioSafe and HESI-ITC, shaping immunosafety science and advancing translational approaches to risk mitigation.

Drove safety strategy and regulatory submissions enabling FDA orphan drug and breakthrough therapy designations for first-in-class CAR T therapies in multiple myeloma, including Abecma, the first FDA-approved CAR T for this indication. Led development of translational bioassays enabling early clinical implementation and monitoring. Chaired cross-industry CAR T safety groups and mentored colleagues in translational safety, assay development and biomarkers.

Led preclinical-to-clinical translation of immune safety findings for RNAi therapeutics, including development of a novel infusion regimen that enabled approval of the first-ever RNAi drug, Onpattro. Designed models and assays to characterize immunostimulation, biomarkers, and immunogenicity risk, driving clinical implementation and safety monitoring. Managed cross-functional teams and authored regulatory submissions spanning multiple therapeutic areas.

Host-pathogen interactions and innate immune responses to fungal infections PI: Jay Vyas MD PhD, Dept of Medicine, Division of Infectious Disease

Cross-collaborative project across multiple labs focused on Innate Immunity, Host-Pathogen interactions, Toll-like Receptors (TLRs) and anti-microbial defense PI: Hidde Ploegh

Toll-like receptors and innate immunity PI: Douglas Golenbock

Dissertation: “From Genomics to STAT-1 in Rheumatoid Arthritis”. Pioneered research on the molecular pathology of Rheumatoid Arthritis using RNA profiling to characterize disease heterogeneity. PI: Cornelis Verweij, PhD

Awarded M.Sc. cum laude on August 31st, 2001