Providing early development solutions that allow biotech companies to reach their IND milestones with seed-level financing
I work with emerging biotech / startup companies (e.g. university spinoffs) worldwide. These companies have novel and innovative science discoveries that have helped them to raise seed capital – e.g. SBIR or EU funding, up to $500,000 – to commercialize their innovations. Even though this allows some early studies and preclinical validation, it is not even nearly sufficient to run a full IND-enabling program in the USA or EU. Another issue is the lack of drug development experience – especially in the case of an academic spinoff.
I provide scientific, regulatory and operating expertise needed to accelerate and increase the probability of success of drug development, without blowing up the budget. BiotechGo is the only China –based independent consultancy that is focused on providing cost effective, yet the highest quality, early development solutions for biotech companies worldwide. A preclinical IND-enabling program at the best CROs (focused on running studies for Western regulatory submission purposes) can be completed with ~$300k, instead of >$1M in the US. Programs involving primates can benefit even more. I am passionate for science, and have the drive & determination integral to the success of our partners. Even though I am based in China, I frequent in the US and Europe, allowing for face-to-face interactions.
IND enabling services & solutions in support of regulatory submissions (e.g. US FDA), with a cost-effective and time-saving development plan implementation. Experience on more than 30 successful IND / IMPD / CTA programs and submissions: biologicals, small molecules, peptides; indications such as oncology, CNS, GI and inflammation.
Dossier preparation and regulatory strategy for successful IND / CTA applications. Regulatory agency (FDA) interactions and meetings. Drafting of the electronic Common Technical Document (“eCTD”).
Helping clients with important strategic and tactical decisions to make through the preclinical / early development phase. Securing the most appropriate preclinical program to support the clinical development plan(s). Track record on strategic and operational support to run biotech companies up to phase II.
More than 20 years of experience in toxicology, board certifications both from the US (DABT) and EU (ERT). Experience in designing, running, interpreting and reporting of hundreds of toxicology studies - GLP and non-GLP, general toxicology, safety pharmacology etc. Small molecules, antibodies, ADCs, peptides.
Everything to ensure you meet your goals — efficiently, economically, and often ahead of schedule. Tailor a path towards a successful IND, based on the evaluation of the maturity of a compound's development, anticipated risks and the options available.
Being based in China, BiotechGo has a unique access to the top CROs in the country and the ability to tailor, control and execute fast-moving and cost-effective nonclinical programs for the biotech worldwide. Other China-specific activities include CMC outsourcing, local partnering, licensing and Chinese VC fundraising.
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