La Jolla Move-In: Pancreatic Oncology Clinical Trial Site Complete Documentation Package
This package stands up one clinical trial site, in La Jolla, San Diego, for one disease and one protocol. It is the successor to the eleven-document San Francisco package, which described a general oncology site operating on demand for twenty-four hours a day and serving 168 unique participants across fifteen cancer types in a single day with twenty-nine robot instances. The La Jolla site is smaller in every dimension that can be counted, and that narrowing is the point rather than a concession. A Phase 1 trial in resectable pancreatic ductal adenocarcinoma treats up to eighteen par- ticipants across a 3+3 dose escalation. A facility sized for 168 participants a day would spend its federal award on capacity the protocol forbids it to use. Every requirement in the thirteen documents that follow the legislative part is derived from the protocol rather than from a service-line planning ratio. During final edit- ing, FDA approved Rasonque (daraxonrasib) for specified adults with metastatic pancreatic adenocarcinoma; that approval does not extend to the resectable perioperative protocol here. The choice of La Jolla follows from the partner. The intended partner of choice at the feasibility stage is UC San Diego Moores Cancer Center, which sits in the same community plan area, roughly 1.6 miles from the leasehold described here. The twelve-step feasibility sequence, the sponsor-investigator determination, and the required positioning language are set out in the repository and are carried into this package without soft- ening. No agreement of any kind exists. UC San Diego is not described here as a partner, a sponsor, a trial site, or an endorser, and nothing in this package has been shown to it for approval. The driver for the move-in is the body of work behind it. Between June 2025 and August 2026 the author deposited twenty papers that together carry a pancreatic oncology trial from drug identification through simulation, regulatory adaptation, protocol, investigational new drug application, and funding. Federal policy moved in the same window: the White House report Science: A New Golden Age asks the roughly $200 billion annual federal research portfolio to prioritize the individual scientist over legacy institutions, and its annexed fiscal year 2028 budget priorities memorandum asks agencies for long-duration grants and non-federal cost share. This package is what an independent scientist does with a five-year award once the policy and the evidence are both in hand.
Authors
- Kevin Kawchak (ORCID: https://orcid.org/0009-0007-5457-8667)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2026-09-01
- DOI
- https://doi.org/10.5281/zenodo.22216518
- Primary Topic
- Pancreatic and Hepatic Oncology Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00