Scientific Consulting · Translational Medicine

Biomarker & multi-omics strategy for translational drug programs

Giuseppe Astarita

Ph.D. — Biochemistry & Molecular Biology

Senior scientific consulting for biotech and pharma teams that need actionable biomarkers, fit-for-purpose assays, and interpretable omics data across neuroscience, rare disease, metabolic disorders, inflammation, and nutrition.

90+Publications
13K+Citations
10Granted Patents
20+Clients Served
90+
Peer-Reviewed Publications
13K+
Citations
10
Granted Patents
20+
Clients Served
Lipidomics Metabolomics Proteomics Biomarker Strategy LC-MS/MS Translational Neuroscience Metabolic Disorders Inflammation Rare Disease Nutrition & Food Science

Twenty years translating biology into decisions

I founded MyMetabolome to bring senior-level scientific expertise directly to the organizations that need it — without the overhead of a large consultancy. My work sits at the intersection of lipid biology, multi-omics mass spectrometry, and translational drug development.

Over two decades I have built omics platforms and biomarker programs from the ground up at Denali Therapeutics and Arkuda Therapeutics, advancing assets through proof-of-concept in Alzheimer's, Parkinson's, lysosomal storage disorders, frontotemporal dementia, and neuroinflammation. A particular focus has been lysosomal trafficking and its role in brain disease — including progranulin biology, GBA-related lipid dysregulation, and sphingolipid pathway alterations connecting lysosomal dysfunction to neurodegeneration. I have led CRO partnerships, shaped regulatory-facing evidence packages, and presented at Scientific Advisory Board (SAB) meetings.

My expertise extends well beyond neuroscience. I have applied multi-omics approaches to metabolic disorders (insulin resistance, hepatic steatosis, cardiometabolic disease), inflammation and immune biology (oxylipins, eicosanoids, endocannabinoid system), and nutrition and food science — areas interconnected at the level of lipid biology and metabolic pathway dysregulation.

What sets my work apart is depth in lipid biology — one of the fastest-growing areas in drug discovery and precision medicine — combined with the strategic and leadership experience to translate that science into portfolio-level decisions.

I also hold an adjunct faculty position at Georgetown University, where I lead NIH- and Alzheimer's Association-funded research and mentor the next generation of translational scientists.

What I Offer

Consulting Services

Senior scientific expertise delivered directly — from early biomarker strategy through clinical execution and beyond.

Abstract multi-omics network translating molecular measurements into biomarker insight.
01

Biomarker Strategy

End-to-end biomarker planning for clinical programs — defining MOA, pharmacodynamic, and patient stratification endpoints. Study design, protocol input, and regulatory-facing evidence packages.

02

Multi-Omics Platform Design

Design and oversight of lipidomics, metabolomics, and proteomics workflows using LC-MS/MS and immunoassay platforms (Olink, SomaLogic). Targeted and untargeted approaches across plasma, CSF, serum, and tissue — spanning neurodegeneration, metabolic disorders, inflammation, and nutrition research.

03

Assay Development & Validation

Fit-for-purpose assay development and validation for translational and clinical biomarker readouts. CRO selection, oversight, and quality management to ensure regulatory-ready data.

04

Experimental & Study Design

Hypothesis generation, sample procurement strategy, experimental design, and power analysis for metabolomics and lipidomics studies. Preclinical-to-clinical translation, selection of internal standards, and analytical solutions tailored to classes of molecules of interest.

05

Scientific Advisory

Strategic scientific input for drug development programs, pipeline decisions, and portfolio planning. Expert review of biomarker plans, regulatory documents, and clinical protocols.

06

Grant & Publication Support

Scientific writing, grant strategy, and publication support for academic and industry partners. Experienced in NIH, foundation, and industry-sponsored research frameworks.

07

Data Analysis & Interpretation

High-throughput data processing, statistical analysis, pathway enrichment, and visualization for metabolomics and lipidomics datasets. Integration of multi-omics outputs with clinical and phenotypic data to extract actionable biological insights.

08

Metabolic Disorders & Inflammation

Specialized consulting for programs in cardiometabolic disease, insulin resistance, hepatic steatosis, and inflammatory conditions. Deep expertise in oxylipin profiling, eicosanoid biology, endocannabinoid signaling, and lipid mediator panels as pharmacodynamic and patient stratification endpoints.

09

Nutrition & Food Science

Metabolomics and lipidomics applications in food science, nutritional research, and functional ingredients. Study design and biomarker strategies for omega-3/6 biology, dietary intervention trials, and food quality assessment.

How I Work

Engagement Models

Flexible structures to match where you are — from a one-time expert review to embedded, ongoing program leadership.

01 · Defined Scope

Project-Based

A fixed-scope deliverable with a clear timeline — a biomarker strategy, assay validation plan, study design, or data analysis package. Best when you know the question and need it answered well.

02 · Ongoing

Advisory Retainer

Monthly access to senior scientific judgment — on-call review of protocols, CRO outputs, and pipeline decisions. Best for teams that want continuity without a full-time hire.

03 · Embedded

Fractional / Interim

Hands-on, part-time leadership of an omics or biomarker function — building platforms, hiring teams, and driving programs. Best for early-stage groups standing up capability.

Getting started is simple. Reach out with a short note about your program and where you need support. We'll have an initial call to scope the work and agree on the right format and timeline — no obligation. Start a conversation →

Recent Work

Selected Engagements

Anonymized highlights from MyMetabolome consulting engagements — spanning early-stage biotech, large pharma, and academic partnerships across translational programs.

2020 — 2026

Academic Partners — Translational Multi-Omics

Long-running advisory and analytical work across translational research programs. Multi-omics data analysis and biological interpretation supporting downstream publications and grant submissions.

2020 — 2026

Early-Stage Biotech Startups — Multi-Omics Lab Build-Outs

Long-running advisory work guiding multi-omics laboratory setup, instrumentation selection, and recruitment of expert scientific teams for early-stage biotech ventures.

2025

Multi-Omics Services Startup

Advised on multi-omics integration strategy and commercial positioning for biotech and pharma clients spanning discovery and translational programs.

2024

Analytical-Services Startup — Lab Build-Out

Established laboratory SOPs, instrumentation roadmap, and high-throughput mass spectrometry workflows for routine customer-facing analytical services.

2023 — 2024

Clinical-Stage Neurodegeneration Biotech — Biomarker Strategy

Designed biomarker panel strategy for a clinical-stage program. Defined fluid biomarker selection, assay readiness criteria, and translational endpoints.

2021 — 2022

Large Pharmaceutical Company — Assay Development

Advised on assay development for biomarkers and enzymatic activity measurements in CSF and plasma matrices to support translational and clinical-stage programs.

2020 — 2022

Microbiome-Focused Startup — Multi-Omics & IP Support

Analyzed and presented microbiome multi-omics datasets. Findings contributed to patent applications.

Client identities withheld under standard consulting confidentiality. References available on request for serious inquiries.

Career

Selected Experience

Two decades spanning academia, CRO, and biopharma — from platform building to senior program leadership.

2020 — Present
Principal Consultant
MyMetabolome Consulting · Belmont, MA
Advising biotech and pharma clients on translational biomarker strategy, multi-omics platform design, and clinical study integration across neuroscience, rare disease, and metabolic disorders.
2012 — Present
Adjunct Assistant Professor
Georgetown University · Washington, DC Concurrent
NIH- and Alzheimer's Association-funded research in lipidomics and omics biosignatures in neurodegenerative disease. Teaching and mentorship in translational mass spectrometry.
2022 — 2023
Senior Director, Biomarker Discovery
Arkuda Therapeutics · Watertown, MA
Led biomarker strategy for clinical-stage programs in neuroinflammation and lysosomal biology. Built integrated multi-omics pipelines (LC-MS/MS, Olink, SomaLogic). Managed CRO partnerships and regulatory-ready assay validation programs.
2020 — 2022
Senior Scientific Manager
Metabolon · San Francisco, CA
Delivered global metabolomics, lipidomics, and proteomics solutions for pharma and biotech clients. Scientific leadership in experimental design, platform selection, and biomarker interpretation.
2016 — 2020
Principal Scientist, Head of Omics Mass Spectrometry
Denali Therapeutics · South San Francisco, CA
Built centralized multi-omics MS platform supporting biomarker discovery across Alzheimer's, Parkinson's, and lysosomal storage disorder programs. Multiple assets advanced to proof-of-concept. Co-authored 8 publications and co-invented 4 patents.
2011 — 2016
Principal Scientist & Strategic Manager
Waters Corporation · Milford, MA
Advanced LC-MS technologies for lipidomics and metabolomics. Contributed to instrument development, publications, and intellectual property in translational biomarker applications.
Scientific Record

Publications & Patents

90+
Publications
13,000+
Citations
54
h-index
10
Granted Patents
2024
Granulins Rescue Inflammation, Lysosome Dysfunction, Lipofuscin, and Neuropathology in a Mouse Model of Progranulin Deficiency
Cell Reports · Root J., Mendsaikhan A., Taylor G., ... Astarita G. et al.
2023
Metabolomics and Lipidomics Strategies in Modern Drug Discovery and Development
Drug Discovery Today · Astarita G., Kelly R., Lasky-Su J.
2022
Ion Mobility Mass Spectrometry in the Omics Era: Challenges and Opportunities for Metabolomics and Lipidomics
Wiley Analytical Science · Astarita G. et al.
Get In Touch

Work Together

I work with biotech and pharma companies, CROs, startups, and academic groups at any stage — from early platform strategy to late-phase clinical biomarker execution. If you're looking for senior scientific expertise in lipidomics, metabolomics, translational biomarker strategy, experimental design, or data analysis and interpretation across neuroscience, metabolic disorders, inflammation, or nutrition research, I'd welcome a conversation.

Location Belmont, MA · Greater Boston