Multiplex IHC/IF and RNAscope assay development, validation, and CRO tech transfer for oncology and cell therapy programs.
Eighteen years developing and validating these assays inside major US biopharma organizations — including building a translational pathology function from the ground up. Now I do that work for teams who need the expertise without hiring for it.
A multiplex panel that looked fine in discovery falls apart at CRO qualification. Fixation drift across sites turns into a batch effect nobody can explain. An antibody that was never properly validated becomes the basis for a patient-selection decision. By the time these surface, they cost months — and sometimes the dataset.
Panels move to a CRO without a qualification plan, acceptance criteria, or a defined failure path.
Fit-for-purpose validation is assumed rather than documented, and the gap appears under review.
Pre-analytical variability is never characterized, so nobody can separate biology from artifact.
Two core engagements. Both start with the same thing: looking hard at what you actually have before recommending anything.
A structured review of your existing IHC, multiplex IF, or ISH assay package against fit-for-purpose and clinical-trial-assay standards. I tell you what will hold up, what won't, and what to fix first.
You get:
Typically 2–3 weeks, fixed fee.
Hands-on ownership of the work itself: designing and optimizing the panel, validating the antibodies, selecting the CRO, writing the transfer plan, and staying on the calls until the assay qualifies at the receiving site.
You get:
Project-based or ongoing retainer.
Fractional translational pathology leadership for teams that need senior judgment one or two days a week rather than a full-time hire — biomarker strategy, tissue and biobanking operations, digital pathology and image-analysis workflows, SOP and QC framework development, and vendor governance. These usually come up inside the engagements above. If that's what you need, say so and we'll scope it.
18+ years, PhD-level, hands-on
I've spent 18 years developing and validating tissue biomarker assays — multiplex IHC and immunofluorescence, RNAscope and ISH — across oncology, immuno-oncology, and cell therapy programs. Not managing the work from a distance. Doing it.
That work has spanned discovery through clinical development at large pharmaceutical organizations and clinical-stage biotechs: building single-plex and multiplex IHC assays, validating antibodies as prognostic and predictive biomarkers, developing chromogenic and fluorescent multiplex panels for bispecific and cell therapy programs, and transferring validated assays to internal laboratories and external CROs.
I have also built a translational pathology function from nothing — selecting staining and imaging platforms, writing the SOPs and QC frameworks, hiring and training the team, establishing a tissue biobank, and owning assay development and validation for an active clinical study including CRO selection and tech transfer.
That last part is why PathologyEdge exists. Most teams that need this expertise need it for a defined stretch of work, not forever. Hiring for it takes months and a headcount you may not have. Full background and references are shared directly with prospective clients.
I provide scientific and technical advisory on assay development and validation. I am not a board-certified pathologist and do not provide diagnostic interpretation or clinical sign-out. I do not operate a clinical laboratory or provide certification, accreditation, or regulatory guarantees.
Work delivered in-house at major US pharmaceutical and clinical-stage biotech organizations.
Founded and scaled a translational pathology function from inception — platform selection, SOPs, QC frameworks, and team.
Led clinical-trial assay development and validation for an ongoing Phase I/II study, including CRO selection, tech transfer, and qualification.
Owned tissue-biomarker strategy across multiple CAR-T solid-tumor programs, informing patient selection and dose decisions.
Directed antibody validation campaigns establishing specificity, sensitivity, and fit-for-purpose performance for prognostic and predictive biomarkers.
Transferred chromogenic and fluorescence IHC assays to internal labs and external CROs while preserving platform fidelity.
Established an internal human tissue biobank with commercial biospecimen vendors supporting an oncology portfolio.
PhD-level scientist with peer-reviewed publications in leading journals including Nature Communications, Hepatology, Toxicological Sciences, Frontiers in Immunology, and the Journal of Cell Biology (cover article), covering immuno-oncology biomarkers, targeted therapy, and cell biology.
Full CV, publication list, employment history, and client references are provided directly to prospective clients on request or under NDA. I keep a limited public profile; that is a deliberate choice and not a reflection of the depth of the background behind this work.
Thirty minutes on what you're building, where it's stuck, and your timeline. If I'm not the right person, I'll tell you on that call and point you somewhere better.
I go through your protocols, validation data, images, and CRO documentation. Then you get a fixed scope, a fixed fee, and a delivery date before any work starts.
Written findings and a prioritized plan, walked through live with your team. Implementation questions after delivery are part of the engagement, not a new invoice.
Tell me what you're working on and where it's stuck. If there's a fit, I'll propose a scope and a fee. If there isn't, I'll say so.