Tailored drug development solutions for emerging biotech
I offer tailored support for early-stage drug development, with a focus on toxicology, regulatory strategy, China CRO outsourcing, virtual R&D operations, and program management. With hands-on experience from over 50 development programs - including small molecules, peptides, protein degraders (PROTACs), RNA therapeutics, and various biologics such as antibodies, recombinant proteins, ADCs, and oncolytic viruses - I support a wide range of therapeutic areas, including oncology, CNS, inflammation, endocrinology, and rare diseases.
I work closely with biotech founders and teams to reach key regulatory milestones such as IND submissions and clinical proof of concept, while keeping operations lean and timelines accelerated. My approach emphasizes efficiency and strategic planning, helping clients avoid unnecessary preclinical studies and excessive R&D spend.
Based in Beijing, I have over 15 years of experience working directly with leading CROs and CDMOs in China (WuXi AppTec, Pharmaron, Joinn, Medicilon etc.) and, more recently, India. The cost advantage in these regions is often two- to three-fold compared to the US, especially for studies involving non-human primates, and can significantly reduce both budget and timelines. I personally oversee CRO selection, qualifications, audits, and monitoring - ensuring that your outsourced studies meet global standards and move forward without delay.
Services
IND-enabling services
I provide comprehensive IND-enabling support tailored to early-stage development programs, with a focus on disciplined, cost-effective planning and execution. With experience contributing to over 30 successful IND, IMPD, and CTA submissions, I’ve supported a wide range of modalities - including small molecules, biologics, recombinant proteins, peptides, and oligonucleotides - across therapeutic areas such as oncology, CNS, GI, inflammation, and rare diseases. I assist clients with regulatory strategy, data package planning, and drafting of electronic Common Technical Document (eCTD) sections to ensure readiness for regulatory submission and review.
STRATEGIC CONSulting and program management
I offer hands-on strategic guidance and program leadership for early-stage biotech companies, drawing from a proven track record of advancing programs from seed financing through signal-generating Phase 1/2 trials and into late-stage development or exit. My approach is tailored to each asset’s stage and risk profile, focusing on defining clear, value-driving milestones such as IND submission and clinical proof of concept. I help clients navigate development decisions, optimize timelines and budgets, and maintain momentum through critical inflection points.
toxicology AND REGULATORY SUPPORT
As a board-certified toxicologist (US and EU) with over 25 years of experience, I provide expert guidance across all aspects of nonclinical safety assessment. I have designed, monitored, and interpreted more than 200 GLP toxicology studies and regularly support clients in preparing for and responding to regulatory inspections. My work includes direct engagement with regulatory authorities such as the US FDA, China NMPA, and Australia TGA, including managing pre-IND and other key meetings, as well as securing special designations such as Orphan Drug and Fast Track. I offer strategic input throughout the IND-enabling process to ensure a smooth and efficient path to first-in-human studies.
China and APAC CRO selection, AUDITing and study monitoring
BiotechGo offers expert GLP auditing and nonclinical study monitoring services across China and the APAC region, including India and Japan. Based in Beijing, I bring over 15 years of experience working with leading CROs in China and provide direct, on-the-ground support tailored your program. As an independent consultant, I personally manage every aspect of the engagement - from CRO identification, bidding, and selection to protocol development, study oversight, and milestone tracking. My services include detailed GLP audits, on-site monitoring, data review, and expert input on study reports. Whether for a single exploratory study or a full IND-enabling package, I ensure quality, compliance, and alignment with international regulatory standards.
Contact
Use the form below to contact me. You can also email me: harri @ [this domain].