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Hire Alex H.

United States

USD 175 /hr

Biotech & AI Expert 25+y | Drug Discovery | Translational Bio | Assay Dev | IP Strategy & Innovation Acceleration

Profile Summary

AI-driven biotech and translational science consultant with 25+ years of experience across discovery, preclinical, and IP strategy. I help biotech and pharma teams design, de-risk, and accelerate innovation,from protein and RNA therapeutics to IND readiness and freedom-to-operate (FTO) mapping, combining experimental expertise with AI, bioinformatics, and commercialization insight. I’m a scientist-turned-founder with 25+ years of experience across the full drug-discovery and development pipeline, from concept through preclinical validation, IND-enabling studies, and late-stage clinical strategy. My work integrates experimental science with AI and bioinformatics to help biotech teams move from discovery to design, faster, smarter, and with a defensible IP position. I’ve designed and directed programs spanning oncology, virology, rare diseases, and immunology, working with protein, RNA, DNA, and viral therapeutics as well as ADCs, radiotherapeutics, and gene-therapy vectors. My technical background includes assay development, molecular and cell biology, protein engineering, high-throughput screening, and large- and small-animal studies for efficacy, PK/PD, and toxicology. Beyond the bench, I’ve built and led cross-functional R&D teams, managed CROs and global collaborations, and guided startups from seed stage to clinical execution. I specialize in translational strategy, project and portfolio management, regulatory planning, and IP/FTO analysis, ensuring that scientific innovation aligns with commercial and legal pathways. Through my company, Fyled, I bridge science, IP, and AI, developing systems that simulate how design choices influence patentability, exclusivity, and market potential. I collaborate with biotech startups, investors, and legal teams seeking data-driven clarity at the intersection of discovery, protection, and commercialization.

Subject Matter Expertise

• ☆ Computational Biology
• ☆ Microbiology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Zika Virus
• ☆ Retrovirology
• ☆ Adenoviruses
• ☆ Molecular Virology
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Structural Biology
• ☆ Enzyme Activity Assays
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Microarrays
• ☆ Omics
• ☆ Transcriptomics
• ☆ Comparative Genomics
• ☆ Proteomics
• ☆ Genomics
• ☆ Molecular Evolution
• ☆ Chromatin
• ☆ Epigenetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ Next Generation Sequencing (NGS)
• ☆ ATAC-Seq
• ☆ DNA Sequencing
• ☆ Synthetic Genomics
• ☆ Protein Sequencing
• ☆ Gene Expression Analysis
• ☆ Genome Sequencing
• ☆ Mutagenesis
• ☆ Exome Sequencing
• ☆ Recombinant DNA
• ☆ RNA Synthesis
• ☆ RNA Sequencing
• ☆ DNA/Gene Synthesis
• ☆ Oligonucleotide Synthesis
• ☆ Plasmid DNA
• ☆ ChIP-Seq
• ☆ Kinases
• ☆ Monoclonal Antibody Production
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytochemistry
• ☆ Cell Signaling Pathways
• ☆ Gene Regulation
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Histology
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Microbial Biotechnology
• ☆ Biomedical Engineering
• ☆ Biomechanics
• ☆ Data Analysis
• ☆ Data Management
• ☆ Artificial Intelligence
• ☆ Biomarker Discovery
• ☆ Cell Culture
• ☆ Cell Line Engineering
• ☆ Large Scale Cell Culture
• ☆ Cell Surface Receptors
• ☆ Industrial Biotechnology
• ☆ Synthetic Biology
• ☆ Biosensors
• ☆ Bioenergy & Biofuels
• ☆ Microbial Fermentation
• ☆ Chemical Biology
• ☆ Biomolecular Engineering
• ☆ Gene Synthesis
• ☆ Genetic Engineering
• ☆ Gene Editing/CRISPR
• ☆ Protein/Enzyme Engineering
• ☆ Antibody Engineering
• ☆ Gene Delivery
• ☆ Blotting
• ☆ Immunohistochemistry
• ☆ Population Genetics
• ☆ Veterinary Medicine
• ☆ Veterinary Pathology
• ☆ Python
• ☆ Excel
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Target Identification
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Phenotypic Assays
• ☆ High Content Screening/Imaging
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Combinatorial Chemistry
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Bioavailability
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Management
• ☆ Drug Delivery Technologies
• ☆ Liposomes
• ☆ Pharmaceutical Technology
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Software Development
• ☆ Software QA & Testing
• ☆ Cloud Application Development
• ☆ DevOps
• ☆ UI/UX Design
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Qualitative User Research
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ UX Design
• ☆ Presentation Design
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ SEO Medical Writing
• ☆ Healthcare Communications
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Language Translation
• ☆ Grant Writing
• ☆ Fundraising
• ☆ Business Finance
• ☆ Investment Management
• ☆ Business Operations
• ☆ Business Strategy
• ☆ Small Business
• ☆ Data-Driven Decision Making
• ☆ Entrepreneurship
• ☆ Intellectual Property Law
• ☆ Branding
• ☆ Marketing Strategy
• ☆ Market Research
• ☆ Qualitative Market Research
• ☆ Quantitative Market Research
• ☆ Lead Generation
• ☆ SEO & Web Traffic
• ☆ Marketing Analytics
• ☆ Digital Marketing
• ☆ Business Intelligence
• ☆ Innovation Management
• ☆ Management Information Systems
• ☆ Crisis Management & Emergency Preparedness
• ☆ Project Management
• ☆ Corporate Governance
• ☆ Risk Management
• ☆ Management Consulting
• ☆ Advertising

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing

Research Technology Scouting, Fact Checking

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Legal Consulting

Data & AI Statistical Analysis, Image Analysis, Algorithm Design-Non ML

Product Development Formulation, Recipe Development, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing

Work Experience

CEO Founder

Fyled Inc

September 2024 - Present

Chief Scientific Officer

Stealth BioTherapeutics (United States)

February 2024 - Present

Director of Therapeutics

Earli Inc

June 2019 - February 2024

Post Doctoral Researcher

UW-Madison

June 2016 - May 2019

Post-doctoral researcher

University of Amsterdam / AMC

May 2015 - May 2016

PhD student

University of Amsterdam / AMC

February 2011 - April 2015

Research technician

University of Amsterdam / AMC

April 2003 - January 2011

Education

PhD

University of Amsterdam

April 2011 - April 2015

Certifications

• New Product Development & Innovation

  UW-Madison Center for Professional and Executive Development

  https://www.credential.net/wfikbsqh#acc.nVBSgbjG

  May 2019 - Present

Publications

JOURNAL ARTICLE

Lise Sarah Namer, Alex Harwig, Stephan P. Heynen, Atze T. Das, Ben Berkhout, Raymond Kaempfer (2023). HIV co-opts a cellular antiviral mechanism, activation of stress kinase PKR by its RNA, to enable splicing of rev/tat mRNA . Cell Bioscience.

Michael J. Bellecourt, Ananya Ray-Soni, Alex Harwig, Rachel Anne Mooney, Robert Landick(2019). RNA Polymerase Clamp Movement Aids Dissociation from DNA but Is Not Required for RNA Release at Intrinsic Terminators . Journal of Molecular Biology. 431. (4). p. 696--713. Elsevier {BV}

Alex Harwig, Robert Landick, Ben Berkhout(2017). The Battle of RNA Synthesis: Virus versus Host . Viruses. 9. (10). p. 309. {MDPI} {AG}

(2017). The Battle of RNA Synthesis: Virus versus Host . Viruses.

Alex Harwig, Sebastien Pfeffer, Zita Kruize, Zhenhuang Yang, Tobias Restle, Ben Berkhout (2017). Analysis of AgoshRNA maturation and loading into Ago2 . PLOS ONE.

Elena Herrera-Carrillo, Zong-liang Gao, Alex Harwig, Matthias T. Heemskerk, Ben Berkhout(2017). The influence of the 5΄-terminal nucleotide on AgoshRNA activity and biogenesis: importance of the polymerase III transcription initiation site . Nucleic Acids Research. 45. (7). p. 4036--4050. Oxford University Press ({OUP})

van der Velden YU, Kleibeuker W, Harwig A, Klaver B, Siteur-van Rijnstra E, Frankin E, Berkhout B, Das AT, Virology, 2015, vol. 488, pp. 96-107 .

Harwig A, Das AT, Berkhout B, Current opinion in HIV and AIDS, 2015, vol. 10, no. 2, pp. 103-109 .

Harwig A, Herrera-Carrillo E, Jongejan A, van Kampen AH, Berkhout B, Molecular therapy. Nucleic acids, 2015, vol. 4, pp. e247 .

Turrini F, Marelli S, Kajaste-Rudnitski A, Lusic M, Van Lint C, Das AT, Harwig A, Berkhout B, Vicenzi E, Retrovirology, 2015, vol. 12, no. 1, pp. 104 .

Liu YP, Karg M, Harwig A, Herrera-Carrillo E, Jongejan A, van Kampen A, Berkhout B, RNA biology, 2015, vol. 12, no. 1, pp. 92-100 .

Herrera-Carrillo E, Harwig A, Berkhout B, RNA biology, 2015, vol. 12, no. 4, pp. 447-456 .

Herrera-Carrillo E, Harwig A, Liu YP, Berkhout B, RNA (New York, N.Y.), 2014, vol. 20, no. 9, pp. 1410-1418 .

Harwig A, Das AT, Berkhout B, Current opinion in virology, 2014, vol. 7, pp. 47-54 .

Harwig A, Berkhout B, Das A, Retrovirology, 2013, vol. 10, no. Suppl 1, pp. P24-P24 .

Wagschal A, Rousset E, Basavarajaiah P, Contreras X, Harwig A, Laurent-Chabalier S, Nakamura M, Chen X, Zhang K, Meziane O, Boyer F, Parrinello H, Berkhout B, Terzian C, Benkirane M, Kiernan R, Cell, 2012, vol. 150, no. 6, pp. 1147-1157 .

Das AT, Vrolijk MM, Harwig A, Berkhout B, Retrovirology, 2012, vol. 9, pp. 59 .

Das AT, Harwig A, Berkhout B, Journal of virology, 2011, vol. 85, no. 18, pp. 9506-9516 .

Harwig A, Berkhout B, Das AT, Retrovirology, 2011, vol. 8, no. Suppl 2, pp. P31-P31 .

Müller N, Harwig A, Berkhout B, Das AT, Retrovirology, 2011, vol. 8, no. Suppl 2, pp. P52-P52 .

Vrolijk MM, Harwig A, Berkhout B, Das AT, Retrovirology, 2009, vol. 6, pp. 13 .

Das AT, Harwig A, Berkhout B, Retrovirology, 2009, vol. 6, no. Suppl 2, pp. P24-P24 .

Vrolijk MM, Ooms M, Harwig A, Das AT, Berkhout B, Nucleic acids research, 2008, vol. 36, no. 13, pp. 4352-4363 .

Das AT, Klaver B, Centlivre M, Harwig A, Ooms M, Page M, Almond N, Yuan F, Piatak M Jr, Lifson JD, Berkhout B, Retrovirology, 2008, vol. 5, pp. 44 .

Das AT, Klaver B, Harwig A, Vink M, Ooms M, Centlivre M, Berkhout B, Journal of virology, 2007, vol. 81, no. 20, pp. 11159-11169 .

Das AT, Harwig A, Vrolijk MM, Berkhout B, Journal of virology, 2007, vol. 81, no. 14, pp. 7742-7748 .