Profile Details

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USD 330 /hr

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Hire Dr. Harri J.

United States

USD 330 /hr

Biotech consulting - Scientific (Preclinical, Toxicology, Clinical) / Regulatory / Business Dev / Strategy / Operations

Profile Summary

I have 25 years of diverse scientific, managerial and executive experience, including 18 years in pharmaceutical industry. I have managed more than 50 drug development projects and programs - small molecule, peptides and various types of biologicals (e.g. antibodies, recombinant proteins, ADCs) - from target discovery to early development, for a variety of indications (oncology, inflammation, infective, hormonal, rare diseases etc). I have a Doctorate in Veterinary Medicine, PhD in Toxicology, and Toxicology Board Certifications both from the US (DABT; 2006-) and Europe (ERT; 2004-). I have served as Adjunct Professor of Toxicology in University of Helsinki since 2004. In my current independent consultant role, I provide scientific, regulatory and strategic advice to biotechnology companies, with a focus on toxicology, regulatory submission (especially INDs) and early clinical development.

Subject Matter Expertise

• ★ Biotechnology & Bioengineering
• ★ Drug Development
• ★ In vivo Preclinical Toxicology
• ☆ Molecular Biology
• ☆ Protein/Enzyme Engineering
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Bioavailability
• ☆ Clinical Trials
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Product Compliance

Services

• Writing
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Insights

Product Development Formulation, Stability/Shelf Life Testing, Material Sourcing, Product Validation, Manufacturing, Prototyping

Work Experience

Independent Consultant

BiotechGo Consulting

November 2015 - Present

Education

MBA

University of New South Wales

January 2022 - January 2022

PhD (Toxicology)

University of Helsinki

July 1995 - October 2000

Doctor of Veterinary Medicine (Honours)

University of Helsinki

September 1992 - September 1999

Certifications

• Eurotox Registered Toxicologist

  Eurotox

  October 2005 - Present

• Diplomate of American Board of Toxicology

  American Board of Toxicology

  October 2004 - Present