Robert G. Schaut, PhD

I help biotech, pharma, animal health, diagnostics, and investors make better R&D decisions.

That runs from target and program assessment through translational strategy, clinical planning, external partnerships, and AI-enabled research — the same set of decisions I have owned as a lab lead, a program director, a chief scientific officer, and a founder.

$16M Net-new research contracts delivered while building Oracle Health's external research partnership program.

2 Sole-inventor patents generated from early-pipeline discovery work at Elanco.

$10M Series A supported with the founding team for a prostate cancer vaccine; authored the Phase I protocols.

27 Peer-reviewed publications across immunology, infectious disease, vaccines, and translational science.

Background

Both ends of the pipeline

I am an immunologist and R&D leader who has run research programs across industry, government, and academia. I have owned work at both ends of the pipeline — target identification through development handoff, and preclinical data through Phase I protocol design — which is unusual enough that it is normally why clients call.

At Oracle I grew an external research partnership program from two scientists to twelve and $16M in net-new contracts, running collaborations with Wake Forest Institute for Regenerative Medicine, the Salk Institute, and the U.S. Centers for Disease Control and Prevention. At Elanco I led the U.S. target enablement laboratory, where the discovery work produced two sole-inventor patent filings. Before that I led the immunology program for E. coli O157:H7 vaccine discovery at the USDA-ARS National Animal Disease Center.

Today I am founder and CEO of LateraDX, a companion-animal diagnostics company built around a smartphone-read multiplex lateral-flow platform, and chief scientific officer at Socium Therapeutics. I recently concluded an advisory engagement with Wake Forest Institute for Regenerative Medicine on the design of a One Health research center.

My technical depth is in infectious disease immunology, vaccinology, and checkpoint biology — PD-L1 and T cell exhaustion — with a GLP/GCP and USDA/FDA-CVM regulatory track record behind it.

Roles

Current and recent

2025 — Present

LateraDX — Founder & Chief Executive Officer. Companion-animal diagnostics; scientific direction, R&D roadmap, and commercialization strategy.

2018 — Present

Socium Therapeutics — Chief Scientific Officer. Bacterial-vectored prostate cancer vaccine; clinical planning and CRO/CMO oversight.

2025 — 2026 · Concluded

Wake Forest Institute for Regenerative Medicine — Scientific Consultant & Advisor. One Health research center design and translational strategy.

Credentials

Education, service, and recognition

Education

PhD, Immunobiology — Iowa State University, 2012. Dissertation on the effects of respiratory viral infections on innate immune function in myeloid cells.
BS, Biochemistry, Cell & Molecular Biology — Drake University, 2007.

Appointments & societies

Adjunct Associate Professor, Veterinary & Biomedical Sciences — South Dakota State University, 2020–2025.
American Association of Veterinary Immunologists — elected board member, 2017–2020.
American Association of Immunologists; American Society for Microbiology.

Peer review & service

Standing reviewer — PLoS ONE, PLoS Neglected Tropical Diseases, Veterinary Parasitology.
Institutional Animal Care and Use Committee, Elanco Animal Health, 2021–2022.

Certifications

Leveraging Neuroscience for Team Performance and Impact — Duke University, 2023.
Lean Six Sigma Green Belt — Purdue University & Elanco, 2020.
Agile methodologies and change management — Oracle, 2022–2024.

When I can help

Six decisions I am usually brought in for

Most engagements start at a decision point — something needs to advance, get de-risked, get partnered, or get stopped, and the internal team is too close to it or too thin to make the call on schedule.

R&D portfolio & pipeline review

Decide what to advance, de-risk, partner, or stop. Go/no-go frameworks, gate criteria, and an honest read on probability of technical success.

Translational & clinical strategy

Turn strong preclinical science into a credible development plan — Phase I/II planning, protocol design, and the preclinical package that has to support it.

Scientific due diligence

Pressure-test technologies, assets, mechanisms, and management assumptions for investors, acquirers, and boards.

Fractional CSO / Head of R&D

Add senior scientific leadership without making a full-time hire. Standing availability to the CEO, the team, and the room where decisions get made.

External innovation & partnerships

Structure research collaborations, CRO and CMO strategy, umbrella agreements, IP terms, and technology partnerships that survive legal review.

AI & data strategy for R&D

Identify practical AI/ML use cases tied to real scientific workflows and decisions — target ID, antigen design, biomarker discovery, in silico screening.

Depth

Breadth of experience

Discovery

Target identification and validation; assay design and ex vivo / in vitro de-risking platforms.
Immunology, vaccinology, and checkpoint biology — PD-L1, T cell exhaustion, mucosal and γδ T cell responses.
Small molecule and biologic candidates advanced from bench through proof of concept.

Development

Phase I/II planning, protocol authorship, and investigator brochure alignment.
CRO and CMO oversight as both study monitor and sponsor representative under regulated conditions.
GLP/GCP execution and USDA / FDA-CVM submissions, meetings, and dossier alignment.

AI/ML & data

Generative and predictive ML for target ID, vaccine antigen design, and in silico screening.
Non-animal and in silico model strategy under the FDA Modernization Act 2.0.
Multi-omic and clinical dataset standardization; FAIR principles with HL7 FHIR and OMOP.

One Health & animal health

Market mapping, white space analysis, and cross-species translational strategy.
Companion animal, livestock, and zoonotic disease programs.
Research center and program design bridging human, animal, and environmental health.

Selected work

Programs I have owned

Seven engagements that show the range — advisory, program leadership, discovery, clinical, and founding. Each one is work I ran directly, not a portfolio I supervised from a distance.

Wake Forest Institute for Regenerative Medicine

SCIENTIFIC CONSULTANT & ADVISOR
2025 – 2026

The situation. Institute leadership wanted to build a One Health research center bridging human, animal, and environmental health, and needed the program structure, research portfolio, and translational strategy designed before committing to it.

What I did. Advised on center design and portfolio planning, shaped the AI/ML-driven research initiatives, and guided external partnership development with industry and government sponsors.

Outcome

Retained directly by the institute after my Oracle engagement ended, extending a multi-year collaboration originally established when I was Oracle's site lead at Wake Forest Innovation Park.

Oracle Health

DIRECTOR & PRINCIPAL INNOVATION SCIENTIST
STRATEGIC RESEARCH PARTNERSHIP PROGRAM
2022 – 2024

The situation. Oracle Health had two scientists and an ambition to build external research partnerships, with no program structure, no contracting template, and no delivery team.

What I did. Built the program to a cross-functional team of twelve PhD-level AI/ML, data, and life scientists and project managers. Negotiated umbrella research and IP agreements with legal for multi-group projects, and directed AI/ML programs across regenerative medicine analytics, bioreactor process optimization, and in silico vaccine target screening.

Outcome

$16M in net-new revenue and contracts during tenure, with active programs at Wake Forest Institute for Regenerative Medicine, the Salk Institute, and the U.S. CDC. The umbrella agreement structure shortened contracting cycles for every collaboration that followed.

Elanco Animal Health

SENIOR RESEARCH SCIENTIST
U.S. LABORATORY LEAD, TARGET ENABLEMENT
2019 – 2022

The situation. The early discovery portfolio needed target validation and vaccine efficacy testing capacity, and too many programs were failing late — after the expensive work had already been done.

What I did. Led the target enablement laboratory and built ex vivo and in vitro de-risking platforms that raised probability of technical success and killed weak programs earlier. Scouted emerging intervention areas — antibiotic alternatives, immunomodulatory compounds, bacterial and mRNA vaccines — and presented candidate strategies to oversight and steering committees. Created a grant-directed program that used USDA-NIFA funding to underwrite mechanistic work on high-risk projects.

Outcome

Two sole-inventor patents filed from the discovery data: compounds for improving animal digestive health, and interferon-gamma compositions for prevention or control of pathogen infection. External capital added to internal discovery budgets; spend cut on projects that would have failed later.

Socium Therapeutics

CHIEF SCIENTIFIC OFFICER
2018 – PRESENT

The situation. A bacterial-vectored prostate cancer vaccine with strong preclinical immunology, a founding team, and no financing or clinical path.

What I did. Translated the preclinical immunology into an investment case for venture audiences and raised the round with the founding team. Authored the Phase I protocols with the scientific advisory board, shaped the planned Phase IIa/b design, and aligned the investigator brochure with the preclinical and published evidence. Manage CRO and CMO relationships covering trial planning, drug lot validation, and investigational product release.

Outcome

$10M Series A closed, with clinical protocols authored and the development path defined.

LateraDX

FOUNDER & CHIEF EXECUTIVE OFFICER
2025 – PRESENT

The situation. A smartphone-read multiplex lateral-flow platform sitting inside a university, with real companion-animal diagnostic potential and no company around it.

What I did. Founded the company and led technology licensing negotiations with The Ohio State University for the foundational IP. Recruited the founding scientific team, structured founder and employee equity, and built the capital strategy — investor materials, financial model, and a non-dilutive pipeline spanning NSF SBIR, NIH STTR, and state translational programs. Established data intake standards and cloud architecture, and direct AI/ML model development and analytical validation.

Outcome

Company built from concept through university licensing, founding team, and a live dual-track dilutive and non-dilutive funding strategy.

Oracle Digital Government

DIRECTOR & LEAD SENIOR PRINCIPAL DATA SCIENTIST
DATA PROGRAMS
2024 – 2025

The situation. A healthcare, life science, and animal health portfolio whose most valuable data sat in fragmented government and NGO systems — much of it still on paper — and was therefore unusable for modeling.

What I did. Owned the portfolio: partner negotiation, roadmap, timelines, and budget, with two direct and four indirect reports. Directed integration of fragmented sources into cloud AI/ML analytics environments, including data IP terms and controlled-access handling, applying FAIR principles with HL7 FHIR and OMOP. Converted paper diagnostic and field records into training-ready datasets with the partners who held them.

Outcome

Previously inaccessible data opened for modeling, with proof-of-concept outcomes reported to the executive team and headcount and budget approved as the program expanded.

USDA-ARS, National Animal Disease Center

SENIOR RESEARCH FELLOW
2016 – 2019

The situation. E. coli O157:H7 behaves as a commensal in cattle, which makes it a hard vaccine target and had defeated earlier approaches.

What I did. Led the immunology program, comparing mRNA, whole-cell (modified-live and chemically inactivated), and subunit strategies head to head. Engineered the recombinant strains the program depended on by Lambda Red recombineering and CRISPR-Cas9, and built the ELISA, flow cytometry, mass spectrometry epitope mapping, histology, IgA repertoire, and microbiome readouts.

Outcome

Identified mucosal γδ T cell IFNγ production as a correlate of protection and reduced fecal shedding — a mechanism, not just an endpoint — published across six first- or co-first-author papers.

Publication record

27 peer-reviewed papers

View the complete publication list

Schaut RG, Palmer MV, Boggiatto PM, Kudva IT, Loving CL, Sharma VK. Mucosal IFNγ production and potential role in protection in Escherichia coli O157:H7 vaccinated and challenged cattle. Sci Rep. 2021;11(1):9769.
Boggiatto PM, Schaut RG, Olsen SC. Enhancing the detection of Brucella-specific CD4+ T cell responses in cattle via in vitro antigenic expansion and restimulation. Front Immunol. 2020;11:1944.
Curtis AK, Reif KE, Kleinhenz MD, Martin MS, Skinner B, Kelly SM, Jones DE, Schaut RG, et al. Development of a subcutaneous ear implant to deliver an anaplasmosis vaccine to dairy steers. J Anim Sci. 2020;98(6):skz392.
Mir RA†, Schaut RG†, Looft T, Allen HK, Sharma VK, Kudva IT. Recto-anal junction and fecal microbiomes of cattle experimentally challenged with Escherichia coli O157:H7. Front Microbiol. 2020;11:693. (†co-first authors)
Mir RA†, Schaut RG†, Allen HK, Looft T, Loving CL, Kudva IT, Sharma VK. Cattle intestinal microbiota shifts following Escherichia coli O157:H7 vaccination and colonization. PLoS One. 2019;14(12):e0226099. (†co-first authors)
Boggiatto PM, Schaut RG, Kanipe C, Kelly SM, Narasimhan B, Jones DE, Olsen SC. Sustained antigen release polyanhydride-based vaccine platform for immunization against bovine brucellosis. Heliyon. 2019;5(8):e02370.
Schaut RG, Boggiatto PM, Loving CL, Sharma VK. Cellular and mucosal immune responses following vaccination with inactivated mutant of Escherichia coli O157:H7. Sci Rep. 2019;9(1):6401.
Sharma VK, Akavaram S, Schaut RG, Bayles DO. Comparative genomics reveals structural and functional features specific to the genome of a foodborne Escherichia coli O157:H7. BMC Genomics. 2019;20(1):196.
Vrentas CE, Schaut RG, Boggiatto PM, Olsen SC, Sutterwala FS, Moayeri M. Inflammasomes in livestock and wildlife: insights into the intersection of pathogens and natural host species. Vet Immunol Immunopathol. 2018.
Vrentas CE, Boggiatto PM, Schaut RG, Olsen SC. Collection and processing of lymph nodes from large animals for RNA analysis. J Vis Exp. 2018.
Sharma VK, Schaut RG, Loving CL. Vaccination with killed whole cells of Escherichia coli O157:H7 hha mutant emulsified with an adjuvant induced vaccine strain-specific serum antibodies and reduced E. coli O157:H7 fecal shedding in cattle. Vet Microbiol. 2018.
Schaut RG, Loving CL, Sharma VK. Escherichia coli O157:H7 virulence factors differentially impact cattle and bison macrophage killing capacity. Microb Pathog. 2018.
Schaut RG, Brewer M, Hostetter J, Mendoza K, Vela-Ramirez J, Kelley S, Kaelin D, Jackman J, Dell'Anna G, Howard JM, Sathe S, Narasimhan B, Zhou W, Jones DE. Single dose polyanhydride-based vaccine platform promotes and maintains anti-GnRH antibody titers. Vaccine. 2018.
Schaut RG, Brewer MT, Mendoza K, Jackman J, Narasimhan B, Jones DE. A polyanhydride-based implantable single dose vaccine platform for long-term immunity. Vaccine. 2018.
Grinnage-Pulley TL, Roychoudhury R, Kabotso DEK, Rintelman C, Schaut RG, Toepp AJ, Gibson-Corley K, Parrish M, Pohl NL, Petersen CA. Leishmania-derived trimannose modulates inflammatory response to significantly reduce Leishmania (L.) major-induced lesions. Infect Immun. 2017.
Toepp A, Schaut RG, Scott BD, Mathur D, Berens AJ, Petersen CA. Leishmania incidence and prevalence in US hunting hounds maintained via vertical transmission. Vet Parasitol Reg Stud Reports. 2017.
Schaut RG, Brewer M. Development of a bead-agglutination assay for rapid detection of Tritrichomonas foetus. Vet Parasitol. 2017.
Schaut RG, Grinnage-Pulley T, Esch K, Toepp A, Duthie M, Howard R, Reed S, Petersen CA. Recovery of antigen-specific T cell responses from dogs infected with Leishmania (L.) infantum by use of vaccine associated TLR-agonist adjuvant. Vaccine. 2016.
Schaut RG, Ridpath JF, Sacco RE. Bovine viral diarrhea virus type 2 impairs macrophage responsiveness to Toll-like receptor ligation with the exception of Toll-like receptor 7. PLoS One. 2016.
Schaut RG, Lamb IM, Toepp AN, Scott B, Jeronimo S, Wilson M, Harty J, Waldschmidt T, Mendes-Aguiar C, Coutinho J, Petersen CA. Regulatory IgD^hi B cells suppress T cell function via IL-10 and PD-L1 during visceral leishmaniasis. J Immunol. 2016.
Vida B, Toepp AN, Schaut RG, Esch K, Juelsgaard R, Shimak R, Petersen CA. Immunologic progression of canine leishmaniosis following vertical transmission in United States dogs. Vet Immunol Immunopathol. 2016.
Schaut RG, Juelsgaard R, Ramalho-Ortigao M, Petersen CA. Vertically transmitted Leishmania infantum from North American dogs maintains ability for vector-borne transmission in Lutzomyia spp. Emerg Infect Dis. 2015.
Roychoudhury R, Martinez PA, Grinnage-Pulley TL, Schaut RG, Petersen CA, Pohl N. Acid-triggered degradable reagents for differentiation of adaptive and innate immune responses to Leishmania-associated carbohydrates. Angew Chem Int Ed. 2015.
Esch KJ, Schaut RG, Lamb IM, Clay G, Lima ALM, do Nascimento PRP, Whitley EM, Jeronimo SMB, Sutterwala FS, Haynes JS, Petersen CA. Activation of autophagy and the NALP3 inflammasome during Leishmania infantum-associated glomerulonephritis. Am J Pathol. 2015.
Schaut RG, McGill J, Neill J, Ridpath J, Sacco R. Bovine viral diarrhea virus type 2 in vivo infection modulates TLR4 responsiveness in differentiated myeloid cells which is associated with decreased MyD88 expression. Virus Res. 2015.
Smirnova NP, Webb BT, McGill JL, Schaut RG, Bielefeldt-Ohmann H, Van Campen H, Sacco RE, Hansen TR. Induction of interferon-gamma and downstream pathways during establishment of fetal persistent infection with bovine viral diarrhea virus. Virus Res. 2014.
Richeson JT, Kegley EB, Powell JG, Schaut RG, Sacco RE, Ridpath JF. Weaning management of newly received beef calves with or without continuous exposure to a persistently infected bovine viral diarrhea virus pen mate. J Anim Sci. 2013.

Also on record

Patents, funding, and invited talks

Patents

Compounds and Methods for Improving Animal Digestive Health. Sole inventor. Filed May 2021.
Interferon-gamma Compositions for the Prevention or Control of Pathogen Infection. Sole inventor. Filed May 2021.

Grant funding

National Science Foundation — Microscale High-Throughput Plant Cell Processing, 2024–2028.
Found Animal Foundation — Vaccine delivery device for lifelong anti-GnRH antibody titers, 2015–2016.
National Institutes of Health — Tropical Medicine Research Center, AI030639, 2013–2015.
USDA — Intervention Strategies to Control Viral Diseases of Cattle, 2009–2012.

Invited talks

Whole cell vaccination controls Shiga toxin-producing E. coli O157:H7 shedding via antibody and γδ T cell IFNγ-mediated responses — Autumn Immunology Conference, Chicago, 2017.
A novel IgD^hi B cell population correlates with disease progression in Leishmania infantum-infected dogs — Great Plains Emerging Infectious Diseases, Iowa City, 2015.
Complete list of 19 conference presentations available on request.

Engagement options

Three ways to work together

Two questions decide an engagement, and they are independent: what shape the work takes, and how it is billed. The three shapes below cover most situations. Any of them can be billed hourly — which is how I prefer to work, and usually how a client gets the most for the money.

Focused project

4–12 WEEKS · HOURLY OR FIXED SCOPE

Strategy, diligence, or development work on one defined question
Program and experimental design critique with specific de-risking recommendations
Competitive and pipeline landscape, or regulatory pathway analysis, as the question requires
Written report and a readout session with your team
Defined follow-up window for clarifying questions at no additional cost

Fractional leadership

1–3 DAYS/WEEK · HOURLY OR MONTHLY RETAINER

CSO, Head of R&D, or senior advisor, embedded with your team
Standing weekly call with the CEO or scientific lead, plus support between calls
External meetings as your subject matter expert — investor, partner, regulator
Experimental design review on demand
Warm introductions from my network where mutually beneficial

Advisory & diligence

ONGOING OR TRANSACTIONAL · HOURLY OR DAY RATE

Board, scientific advisory board, or investor advisory seats
Scientific due diligence for investors and acquirers
Expert network and expert witness support
Regulatory subject matter expertise for USDA, FDA/CVM, and EMA engagements
Rush turnarounds where a decision cannot wait

Fees

How I bill

Four billing structures, each suited to a different kind of certainty. Hourly is the default and the one I recommend for most engagements; the others exist for the cases where they genuinely fit better.

Hourly

Preferred

You pay for the work actually done, billed in quarter-hour increments against an itemized monthly statement. No minimum commitment, no retainer to start, and no paying for scope that turned out to be unnecessary.

Prepaid blocks of hours are available at a reduced rate for clients who expect to come back repeatedly.

BEST WHEN the question is still taking shape, the work may expand or stop early, or you want to start small and see whether this is useful before committing.

Day & half-day rate

A flat rate for blocks of dedicated time — on-site work, workshops, gate reviews, and sitting in the room as your subject matter expert with an investor, partner, or regulator. Travel days are billed at the half-day rate.

BEST WHEN the commitment is a calendar block rather than a deliverable.

Fixed scope

One number, agreed in writing before work starts, for a deliverable with a known shape — a diligence memo, a landscape report, a program review. The price does not move once we have signed, and neither does the scope without a written amendment.

BEST WHEN you need budget certainty, or the spend has to be approved by someone who was not on our call.

Monthly retainer

A committed number of hours per month at a rate below the standard hourly, invoiced monthly, with a three-month minimum so there is time to be useful. Unused hours roll forward one month.

BEST WHEN you need standing access to senior scientific leadership rather than a defined piece of work.

Rates arrive in a one-page proposal within 48 hours of our scoping call.

The rate card is available on request and covers all four structures. What moves it is the depth of the question, the volume of data to review, and the turnaround you need — expert witness work and rush turnarounds carry a separate rate, quoted before anything starts.

There is no charge for the scoping call, the proposal, or the follow-up window after delivery. If an hourly engagement is running toward more time than we discussed, you hear it from me before the hours are spent, not on the invoice.

Process

From first call to handoff

Scoping call

A 30-minute conversation at no cost, to determine whether and how I can help and which engagement structure fits your situation. If I am not the right person, I will say so and point you toward someone who is.

Proposal

A one-page written proposal within 48 hours: deliverables, timeline, billing structure and rate, and start date. No decks, no boilerplate.

Kickoff

On signature, a 60-minute kickoff to align on goals, data access, and success criteria. Work begins the same week.

Delivery

Weekly check-ins during the engagement, written deliverables on schedule, and direct access between calls for time-sensitive questions.

Handoff

A readout session with your team, a written executive summary, and a defined follow-up window for clarifying questions at no additional cost.

Both ends of the pipeline

Current and recent

Education, service, and recognition

Six decisions I am usually brought in for

R&D portfolio & pipeline review

Translational & clinical strategy

Scientific due diligence

Fractional CSO / Head of R&D

External innovation & partnerships

AI & data strategy for R&D

Breadth of experience

Programs I have owned

Wake Forest Institute for Regenerative Medicine

Oracle Health

Elanco Animal Health

Socium Therapeutics

LateraDX

Oracle Digital Government

USDA-ARS, National Animal Disease Center

27 peer-reviewed papers

Patents, funding, and invited talks

Three ways to work together

Focused project

Fractional leadership

Advisory & diligence

How I bill

Hourly

Day & half-day rate

Fixed scope

Monthly retainer

Rates arrive in a one-page proposal within 48 hours of our scoping call.

From first call to handoff

Scoping call

Proposal

Kickoff

Delivery

Handoff

Typical clients