About the practice
Crawling Stone Consulting is a principal-led cell and gene therapy translational strategy and regulatory affairs firm based in Pittsburgh, Pennsylvania. The name reflects the practice's conception of the work: deliberate progress over difficult terrain, on a fixed bearing toward the clinic.
Nicholas P. Shinners, PhD
Senior executive and translational drug development leader with more than a decade of industry experience advancing cell and gene therapy assets from discovery research into first-in-human trials. Directed three first-in-human INDs as program lead, served as sole client-side point of contact for CDMO-manufactured clinical drug product, and authored and chaired milestone FDA CBER meetings across both T cell and genome-editing modalities.
The practice exists because academic sponsors, early-stage companies, and investors are frequently separated from the clinic by a gap in program management and regulatory quality that no single discipline within their organization is positioned to close. Closing it requires an individual who has carried a product through each stage and is accountable for the whole.
Before founding Crawling Stone, Dr. Shinners held program, process development, and manufacturing leadership positions at Bellicum Pharmaceuticals, BlueSphere Bio, and Nurix Therapeutics, and advised on cell and gene therapy intellectual property at DLA Piper. He trained as a B cell immunologist at Vanderbilt University, Harvard Medical School, and MD Anderson Cancer Center, where his postdoctoral work on zinc finger nucleases constituted an early entry into therapeutic genome editing.
Programs advised to date
- Inducible CAR-T
- TCR T cell
- Tumor-infiltrating lymphocytes
- Nonviral CRISPR and base editing
- Lipid nanoparticle delivery
- Ocular gene therapy
- Automated and closed cell manufacturing
- Academic-origin programs
Career
Industry, legal, and academic appointments in sequence.
- 2024 to present
Founder and Principal Consultant
Crawling Stone Consulting, LLC, PittsburghPrincipal advisor to biotechnology, pharmaceutical, venture, and academic clients across the translational arc from discovery research through IND clearance and clinical execution, with direct accountability for regulatory strategy, CMC control strategy, and FDA engagement across client portfolios.
- 2023 to 2024
Technical Advisor, Intellectual Property and Patent Prosecution
DLA Piper LLP, PhiladelphiaResponsible for all technical aspects of cell and gene therapy matters within the practice group: authorship and amendment of provisional, PCT, and national-phase applications, responses to USPTO office actions, and technical assessment in support of transactional due diligence.
- 2021 to 2023
Senior Director, Cell Therapy Process Development and Technical Operations
Nurix Therapeutics, San FranciscoFull operational accountability for process development and clinical manufacturing across the cell therapy portfolio, representing CMC on the executive asset team. Sole point of contact for CDMO manufacture of clinical drug product for the DeTIL-0255 program in gynecologic cancers (NCT05107739), with in-process oversight from starting-material procurement through post-formulation. Chaired the CMC sub-team and led six process development scientists across two manufacturing processes. Nurix Lightning Award, 2022.
- 2019 to 2021
Program Lead
BlueSphere Bio, PittsburghLed multiple TCR T cell therapy assets from discovery research to IND filing, with ownership of cross-functional communication, risk projection, timeline development, and portfolio prioritization. Authored FDA INTERACT briefing materials, Module 4 preclinical reports, integrated drug development plans, and Target Product Profiles, and standardized the discovery-to-process-development handoff.
- 2013 to 2019
Program Lead; Scientist II; Scientist I
Bellicum Pharmaceuticals, HoustonAdvanced from discovery research scientist on the first inducible CAR-T platform to program lead with operational ownership of the CAR-T pipeline. Led three first-in-human T cell therapy IND submissions from discovery through filing, serving as Study Director for the IND-enabling preclinical program: PSCA GoCAR-T for pancreatic, prostate, and gastric adenocarcinoma (NCT02744287); PRAME TCR with an iCasp9 safety switch for AML, MDS, and uveal melanoma (NCT02743611); and HER2 dual-switch CAR-T for HER2-overexpressing solid tumors (NCT04650451).
- 2010 to 2013
Postdoctoral Fellow, Lymphoma and Myeloma
MD Anderson Cancer Center, HoustonDesigned and iteratively refined zinc finger nucleases as a therapeutic approach to activated B cell-like diffuse large B cell lymphoma, and developed the cellular and biochemical assays to assess editing efficacy and efficiency.
- 2007 to 2010
Postdoctoral Fellow, Microbiology and Molecular Genetics
Harvard Medical School, BostonCharacterized the signaling pathways through which Epstein-Barr virus latent membrane protein 1 orchestrates viral transformation and latency. NIH T32 training grant award.
- 1999 to 2007
PhD, Microbiology and Immunology
Vanderbilt University Medical School, NashvilleDissertation establishing Bruton's tyrosine kinase as an essential component of BAFF receptor-mediated NF-κB activation and peripheral B cell survival. NIH T32 training grant award. Previously research assistant and laboratory manager in the same department.
- 1998
BS, Zoology
University of Wisconsin–MadisonConcentration in cellular and molecular biology.
Begin with a program, a question, or a portfolio.
Most engagements begin with a short call to establish where the program stands and which decision comes next, whether it concerns regulatory strategy, manufacturing, nonclinical development, clinical readiness, intellectual property, or the disposition of a portfolio.