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. virtual companies, university spinoffs) worldwide. My focus is on building tailored, highly cost-effective non-clinical and clinical programs that enable the rapid execution of clinical and regulatory development strategies of my clients. I have been part-time based in China since 2012 and utilize the local CROs and CMOs for cost effective and high quality solutions for my clients. 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.
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 (pre-IND etc.). Drafting of the electronic Common Technical Document (“eCTD”). Orphan Drug Designations. GLP/GMP inspections / audits.
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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