Nick Duran Email & Phone Number

United States

Durham, North Carolina, Us

Phase 1-3 Oncology Clinical Trial Monitoring from start-up to closeout

Brisbane, California, Us

Ph.3 randomized, double-blinded, placebo-controlled trial evaluating efficacy and safety of atacicept in subjects with Lupus Nephritis (LN). Atacicept is an investigational recombinant fusion protein that binds to the cytokines B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to autoimmune diseases, including LN.

South San Francisco, Ca, Us

CX-228-301 study startup sapanisertib in r/r sqNSCLC in NFE2L2/KEAP1 mut NGS-screened subjects

South San Francisco, Ca, Us

Studies: ENTRATA, CANTATA, KEAPSAKE, CX-228-301

South San Francisco, Ca, Us

Supporting global operations for Calithera's Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial comparing CB-839 in Combination with Cabozantinib v. Placebo in Patients w. Advanced or Metastatic Renal Cell Carcinoma (RCC)Locations: US / UK / EU (ES, IT, FR, DE,) / AU / NZ

San Rafael, Ca, Us

Managed CMOs and clinical supply vendors, coordinating end-to-end clinical drug product labeling and packaging processes over all programs and protocols, adhering to foundational cGMP regulations, and communicating across internal teams and business sites, supporting joint Technical- and Clinical-Operations’ timelines.

San Rafael, Ca, Us

Managed end-to-end primary and secondary labeling and packaging processes from initiating content-design requests with external vendors, and shepherding document approvals within QA and Regulatory, to coordinating delivery timelines among parallel Supply Chain and Manufacturing Fill/Finish activities.

Negotiated an expanded scope developing individual contributions from R&D to within ClinOps, training in an inter-departmental role on ph. I/II oncology trials. Within R&D Scope: Designed bead-based, multiplex bioassays assessing M13 bacteriophage, and phage display-derived antibodies, as well as bi-specific antibody characterization under the internal Antibody Engineering Development Program. Collaborated with Chemistry to conduct cell viability/cytotoxicity assays on novel, in-house compounds, expanding a series of new microtubule-inhibitor in vivo ADC studies.

Developed HTS assays to characterize serum-, cell supernatant-, and purified-mAbs across protein(s)/protein families for nomination to product candidates for further drug development.

Emeryville, Ca, Us

Developed and conducted Preclinical assays for IND-enabling studies in the Toll-like Receptor (TLR)-based, immunomodulatory pipeline; served dual functionality in Preclinical R&D and Research QA. Supported preclinical data based on Immunostimulatory Sequences (ISS) of CpG Oligodeoxynucleotides (ODN) immunomod. platform, to advance programs in Ragweed allergy, Hepatitis B, and Non-Hodgkin's Lymphoma. (See www.aacrjournals.org link: Acknowledgements, p. 5633)

Berkeley, Ca, Us

Staff Research Associate for the Molecular and Cellular Biology Upper Division Lab in Immunology, generating cell lines, preparing class materials, managing lab supplies, improving operations manual, and optimizing core data results to directly support undergraduate study.