Tailored drug development solutions for emerging biotech
BiotechGo® provides tailored early drug development solutions with a focus on toxicology and regulatory consulting, virtual operations (incl. CRO and CDMO outsourcing and management), and overall drug development strategy. Track record of more than 50 drug development projects and programs - small molecule, peptides, protein degraders (PROTACs), RNA therapies and various types of biologicals, such as antibodies, recombinant proteins, oncolytic viruses, ADCs - for a variety of indications (oncology, inflammation,CNS, endocrinology, rare diseases etc).
We are focused on helping our partners to reach their regulatory milestones - such as INDs, clinical PoCs - with lean operations and expedited timelines, minimizing unnecessary spend on operations and R&D (incl. non-essential preclinical studies). For over 15 years, we have outsourced studies to leading Chinese CROs and CDMOs (Wuxi Apptec, Pharmaron, Joinn etc.), and more recently India as well. A toxicology program price difference between the top preclinical CROs in China vs. the US is routinely 2-3 -fold, and with programs involving monkeys even more. The higher cost in the US - typically combined with much longer lead times - is simply not justifiable for most early-stage companies. As a consultant I have managed dozens of GLP toxicology studies at the leading, US FDA-inspected CROs in China and India, and can assist in the selection, qualifications and management (audits, monitoring) of CROs in Asia for your programs.
Services
IND-enabling services
IND enabling services & solutions in support of regulatory submissions (e.g. US FDA), with disciplined and cost-effective development plan implementations. Contribution to more than 30 successful IND / IMPD / CTA programs and submissions: biologicals, small molecules, recombinant proteins, peptides, oligonucleotides; indications such as oncology, CNS, GI, inflammation, rare diseases. Drafting of the electronic Common Technical Document (eCTD).
STRATEGIC CONSulting and program management
Successful track record in taking early-stage biotech companies from seed-stage financing into signal-generating Phase 1/2 trials, all the way up to randomized clinical trials and exit. I will tailor a path towards value-creating milestones (such as IND, clinical PoC), based on the evaluation of the maturity of a compound's development, anticipated risks and the options available.
toxicology AND REGULATORY SUPPORT, CRO and study audits
I am a board-certified toxicologist (US and EU) and have more than 25 years of experience in toxicology, incl. designing, running, interpreting and reporting GLP toxicology studies (200+), and manage inspections by regulatory authorities. Regular interactions year with regulatory agencies (US FDA, China NMPA, Australia TGA) managing e.g. meetings (pre-IND etc.) and designations (Orphan Drug and Fast Track) etc. CRO selection, GLP vendor inspections / audits, GLP and non-GLP toxicology study monitoring, technical due diligence.
APAC expertise
Being mostly based in Asia (Beijing, China), I have a unique access and familiarity with the CROs and CDMOs in China, and recently also India and Japan. Although these organizations are often US FDA-inspected and provide equal quality data compared to their Western counterparts, it is crucial - and these days also a regulatory expectation - to carefully oversee the conduct of your outsourced studies at all stages.
Contact
Use the form below to contact me. You can also email me: harri @ [this domain].