Harri Järveläinen DVM, PhD, MBA, DABT, ERT, Adj Prof

Doctor of Veterinary Medicine, PhD, MBA and a board-certified toxicologist (US and EU) with 20+ years of industry experience in managing more than 50 drug development projects and programs – small molecules, oligonucleotides, peptides and various types of biologicals – from target discovery to early development, for a variety of indications (oncology, CNS, inflammation, metabolism, respiratory, rare diseases). 

I provide independent technical and strategic support – especially preclinical/toxicology, regulatory and clinical – to virtual and emerging biotech firms, facilitating the development of innovative candidate drugs, always striving for maximum efficiency and cost-effectiveness. Each program support starts by creating customized preclinical drug development strategies (planning; what to do and when – and what not to do). I then help with the design, outsourcing, implementation and interpretation of e.g. CMC, pharmacology, PK/ADME, and toxicology studies. For each regulatory submission, I author regulatory documents (IND, CTD, IB, BLA, NDA, CTA, MAA) including sections for pharmacology, PK/ADME, toxicology, guidance to clinical investigators, and selection of clinical starting doses, and can also lead the interactions with FDA on your behalf.

I have been predominantly based in China since 2012, giving me deep insight into the leading CROs and the strategic as well as operational considerations of working with them. For many programs, a comprehensive IND-enabling package can be executed with a total budget of less than $1 million – and, depending on scope, the entire process from contracting to draft reports can be completed in under six months. This efficiency is possible when leveraging top FDA-inspected Contract Research Organizations (CROs) in China.

I actively work with global clients, assisting in toxicology CRO selection, vendor inspections, vendor audits, and GLP/non-GLP toxicology study monitoring – especially in China, where I am recognized as the leading GLP auditor / study monitor. More recently, I have also expanded my work to India and Japan. Over the years, I have contributed to more than 200 GLP toxicology studies and 40 CRO audits.

For more info, please visit http://www.biotechgo.com or email me: harri [at] this domain address.