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.
In my current biotechnology consultant role, I provide scientific, regulatory and operational advice to global private and venture-backed early stage biotechnology companies and closely interact with the major CROs in China. Prior to that, I served as Vice President at Pharmaron, overseeing toxicology and program management operations. Most of my big pharma experience is from AstraZeneca, where my work involved portfolio and program management in Respiratory / Inflammation (Lund, Sweden) as well as CNS / Pain research areas (Montreal, Canada).
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).
Harri Jarvelainen - DVM, PhD, Prof (Adj)
I am a Doctor of Veterinary Medicine, PhD and Adj Professor of Toxicology with 20 years of experience in Toxicology, Pharmaceutical Discovery & Development (e.g. AstraZeneca in Sweden and Canada), and IND/CTA package planning & preparation. Board Certification in Toxicology both from the US (DABT) and Europe (ERT). Experience in managing more than 30 drug development projects and programs - small molecule and various types of biologicals - from target discovery to early development, for a variety of indications.
University of Helsinki
Doctor of Veterinary Medicine
University of Helsinki
DrugCendR Inc.: Chief Operating Officer (La Jolla, CA)
Zenopharm Llc.: Chief Operating Office (New Orleans, LA)
Pharmaron: Vice President (Beijing, China)
AstraZeneca R&D: Assistant Director (Lund, Sweden) and Associate Director (Montreal, Canada)
Nestle: R&D Specialist (Lausanne, Switzerland)
Academic experience: New York University School of Medicine (New York, USA), Max-Planck Institute for Infection Biology (Berlin, Germany), University of Helsinki (Helsinki, Finland)
Diploma of American Board of Toxicology (DABT)
EUROTOX Registered Toxicologist (ERT)
China outsourcing option for emerging biotech
There are more than 800 nonclinical contract research organizations (CROs) in China, most of them in or near Shanghai or Beijing. Most common service areas are preclinical research (toxicology, pharmacology, and animal models), discovery biology as well as pharmaceutical development.
The major Chinese CROs have been conducting GLP toxicology studies for Western clients for already more than 10 years. To date, thousands of GLP and non-GLP studies from these laboratories have supported regulatory submissions – both IND and NDA – to agencies worldwide. The US FDA regularly inspects the CROs for GLP compliance and having a good FDA track record is essential when outsourcing studies to a Chinese CRO.
Navigating the path to IND and first-in-man
Considerations for a successful IND submission
Over the years, I have authored or contributed to more than 30 successful IND submission and I have both the big pharma and biotech perspective on the process. Perhaps the most important step a sponsor can take in order to ensure a successful development of its drug, is to establish an early and ongoing dialogue with a regulatory agency. Transparency in communication of sponsors’ plans for their drug development is a critical component of success with the FDA and other competent authorities. These formal meetings and communications, and the resulting agreements on the future plans, can improve the chances of success dramatically and leverage opportunities for innovative, speedy and 'lean' preclinical early development paths.