Tailored Drug Development Strategy for Emerging Biotech
I provide senior-level advisory support for early-stage drug development, with emphasis on toxicology, nonclinical strategy, regulatory positioning, China CRO execution, virtual R&D operations, and program management. With hands-on experience from over 50 development programs / 300+ GLP toxicology studies, incl. small molecules, peptides, protein degraders, 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 nearly two decades of hands-on operational experience with major CROs in China, including WuXi AppTec, Pharmaron, Joinn, and Medicilon. Well-structured China-based programs commonly provide substantial cost and timeline advantages relative to US execution, particularly for technically complex or non-human-primate studies. In practice, sponsors often observe two- to three-fold cost differences, alongside materially shorter study timelines under well-managed conditions.
Beyond vendor selection, I am directly involved in CRO qualification, study oversight, audits, protocol optimization, and monitoring, supported by appropriate documentation and regulatory-aware practices. This structure is designed to reduce both scientific and compliance risk while ensuring that outsourced studies remain aligned with global regulatory expectations.
Services
IND-enabling services
I provide comprehensive IND-enabling support tailored to early-stage development programs, with emphasis on disciplined, cost-effective planning and regulator-aligned execution. With experience contributing to more than 50 successful IND, IMPD, and CTA submissions, I have supported a broad range of modalities, including small molecules, biologics, recombinant proteins, peptides, and oligonucleotide-based therapeutics, across therapeutic areas such as oncology, CNS, GI, inflammation, and rare diseases. My work focuses on regulatory strategy, nonclinical data package planning, and preparation of key electronic Common Technical Document (eCTD) sections to ensure submission readiness and facilitate regulatory review.
STRATEGIC CONSulting and program management
I offer hands-on strategic guidance and program leadership for early-stage biotech companies, based on experience advancing assets from early financing through first-in-human studies and signal-generating Phase 1/2 trials. My approach is tailored to each program’s stage, scientific characteristics, and risk profile, with focus on defining and achieving value-driving milestones such as IND submission and clinical proof of concept. I support clients in navigating complex development decisions, prioritizing critical activities, and optimizing timelines, budgets, and operational structures to maintain program momentum.
toxicology AND REGULATORY SUPPORT
As a board-certified toxicologist (US and EU) with over 25 years of experience, I provide expert support across nonclinical safety strategy, GLP toxicology, and regulatory risk assessment. I have designed, monitored, and interpreted more than 300 GLP toxicology studies and regularly advise on study design, data interpretation, and regulatory implications of nonclinical findings. My experience includes direct interaction with regulatory authorities such as the US FDA, China NMPA, and Australia TGA, including support for pre-IND and other key meetings, as well as strategic input on development pathways and regulatory designations. The objective is to ensure scientifically sound and regulatorily defensible progression toward first-in-human studies.
leading China CRO expert - selection, AUDITing and monitoring
I provide independent CRO selection, GLP auditing, and nonclinical study monitoring services across China and the broader APAC region. Based in Beijing, I bring nearly two decades of direct operational experience working with leading CROs in China. I am personally involved throughout the engagement lifecycle, from CRO identification, bid evaluation, and protocol review to study oversight, milestone tracking, and documentation. Services include GLP and quality system audits, on-site monitoring, data and report review, and expert input on study conduct and interpretation, ensuring outsourced programs remain aligned with global regulatory expectations.
Contact
Use the form below to contact me. You can also email me: harri @ [this domain].