My biotech consultancy works with small-medium sized biotech companies from the US and EU. IND-enabling packages with seed-level financing.
My services include:
1) Nonclinical consulting, such as management of fast-moving and cost-effective discovery / preclinical / toxicology programs (mostly IND-enabling) and preparation of regulatory submissions to Western agencies (US FDA, EMA) and/or the Chinese FDA (CFDA).
2) My niche is to outsource everything to Chinese CROs and CMOs, leading to significant (up to 75%) cost savings to these early stage companies. More info: https://www.linkedin.com/pulse/chinese-cros-accelerated-cost-effective-early-phase-harri
3) As the programs progress towards IND/Phase I, I also contribute to Series A fund raising and various aspects of transformation into a clinical stage company.
4) Raising Chinese VC funding and partnering / out-licensing the China arm of the dual-compliant program.
More info here: https://www.linkedin.com/pulse/chinese-cros-accelerated-cost-effective-early-phase-harri
I have more than 20 years of diverse scientific, managerial and executive experience, including 12 years in pharmaceutical industry – covering the development of small molecules and biologicals from discovery to early development in multiple therapeutic areas. I received my Veterinary Medicine and PhD degrees at University of Helsinki and undertook postdoctoral training at New York University Medical Center and Max Planck Institute. I am an author on over 30 peer-reviewed scientific publications and have served as Adjunct Professor of Toxicology at University of Helsinki since 2004. I have Toxicology Board Certifications both from the US (DABT) and Europe (ERT).
Specialties: Drug discovery and development, IND, preclinical, toxicology, discovery toxicology, pharmaceuticals, biologicals, pharmacology, project management, China, CRO, oncology, peptides, proteins, animal models, CFDA, FDA, cancer.