About Me
In my current biotechnology consultant role, I provide toxicology, regulatory, operational and management advice to biotech companies worldwide. I have a successful track record in taking early stage biotech companies (e.g. academic spinoffs) into IND-enabling studies and early clinical development using the virtual operational model, maximizing the efficient use of available funding. I have a deep knowledge in fund raising and efficient utilization of preclinical CROs and CDMOs in China and clinical CROs in Asia Pacific (incl. clinical programs in Australia).
Most of my big pharma experience comes from AstraZeneca, where my work as a toxicology expert involved portfolio and toxicology program management in Respiratory / Inflammation (Lund, Sweden) as well as CNS / Pain research areas (Montreal, Canada). Over the years, I have managed more than 30 INDs. I received my Veterinary Medicine and PhD degrees at University of Helsinki, and my MBA from Australian Graduate School of Management. I undertook postdoctoral training at New York University Medical Center and Max Planck Institute. I have Toxicology Board Certifications both from the US (DABT; 2006-) and Europe (ERT; 2004-). I am an author on over 40 peer-reviewed scientific publications, book chapters and patents, and have served as Adjunct Professor of Toxicology at University of Helsinki since 2004.
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Our Phase 1 trial publication is now out, along with the commentary ‘CEND-1: a game changer for pancreatic cancer c… https://t.co/Z4kJOHBkkP -
Excited to partner with AGITG and its amazing network of GI oncologists and research hospitals! @GICancer… https://t.co/VuXuFmiKaU
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RT @VFinnishProbs: What a prime minister looks like when their country wins the Ice Hockey World Championship!! 🏆🏆🏆😀🍻 #Leijonat https://t.co/inHOB42Ces
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Jealousy is a primitive and powerful emotion. https://t.co/rFJCTLsE1V
Profile
INDEPENDENT Biotechnology CONSULTANT
Harri Järveläinen - DVM, PhD, DABT, ERT, Adj Prof
Doctor of Veterinary Medicine, PhD, MBA and a board-certified toxicologist (US and EU) with experience in managing more than 50 drug development projects and programs - small molecules, oligonucleotides, molecular degraders, peptides and various types of biologicals - from target discovery to early development, for a variety of indications (oncology, CNS, inflammation, respiratory, rare diseases).
Education
University of Helsinki
Doctor of Veterinary Medicine
University of Helsinki
PhD (Toxicology)
Australian Graduate School of Management
MBA (Medical Technology and Pharmaceuticals)
Experience
Cend Therapeutics Inc.: Chief Operating Officer (San Diego, CA; Melbourne, Australia - now Lisata Therapeutics / NASDAQ: LSTA)
Senior Executive and/or Director of several emerging biotech companies, incl. President/Chief Business Officer of Endotarget, Inc., Chief Operating Officer of Ractigen Therapeutics, and Chief Operating Officer of Zenopharm.
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)
Certificates
Diploma of American Board of Toxicology (DABT, since 2006)
EUROTOX Registered Toxicologist (ERT, since 2004)
Memberships incl.:
American Society of Clinical Oncology (ASCO); American Association for Cancer Research (AACR); European Society for Medical Oncology (ESMO); Society of Toxicology (SOT); American College of Toxicology (ACT); Roundtable of Toxicology Consultants; Australian Institute of Company Directors (AICD)
China outsourcing option for emerging biotech
Chinese CROs
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
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.