www.biotechgo.com: Scientific, Regulatory and Operational Services for Biotech
I work with early-stage biotech companies and help them to reach their early development milestones efficiently (e.g. first-in-man with seed-level financing).
Scientific and regulatory consulting: designing and managing fast-moving discovery / preclinical / toxicology programs (mostly IND-enabling) and preparation of regulatory submissions to Western agencies (US FDA, EMA) and/or the Chinese FDA (CFDA).
Strategic and management consulting: developing and optimizing strategies for biopharma research & development, portfolio & pipeline and business development.
For my early-stage partners, my unique solution is to outsource most studies to the leading CROs in China. The total cost of a typical preclinical project (US IND) can be reduced from US $1M to $300,000, while the quality - with a proper CRO selection and oversight - can be comparable to any Western CRO. I spend most of my time in China and I am able to provide you the in-depth understanding and flexibility to meet the challenges of your fast-moving preclinical project. Running the studies in China also opens the possibility to a China development arm, or early selling / out-licensing of China-specific rights (while retaining the rights for the rest of the world).