Katja Wosikowski

Strategic Guidance

• Expert advice on nonclinical development strategies for all therapeutic modalities.
• Recommendations on prioritizing critical studies now versus those suitable for later stages.

Tailored Program Design and Execution

• Development of customized pharmacology, DMPK, and toxicology programs to align with the sponsor’s objectives and regulatory requirements.
• Translation to early clinical studies and hands-on oversight of PK, ADA and Biomarker analysis in clinical studies and interpretation of results. 

Scientific Alliance and Vendor Management

• Support in selecting and managing CROs, ensuring alignment with project goals.
• Proactive oversight of study conduct as a sponsor-designated study monitor, ensuring the quality and timeliness of deliverables
• Comprehensive review, analysis, and interpretation of results and study reports.

Regulatory Documentation and Submissions

• Preparation and compilation of non-clinical documentation for submissions such as CTA, IND, and IB.
• Budgeting and timeline planning for CTA/IND-enabling non-clinical packages.
• Engagement with regulatory authorities on non-clinical matters, including responses to questions

Program Evaluation and Due Diligence

• Assessment of nonclinical programs for partnering opportunities, due diligence, and GAP analysis for preclinical projects, including in-licensed assets.

Operational Support

• Hands-on support with day-to-day operational challenges
• Reliable, knowledgeable, and adaptable support tailored to meet client needs

Nonclinical and Translational Drug Development expert and licensed pharmacist, binging over 25 years of experience in drug discovery and development of a wide range of innovative therapeutics. These include small molecule inhibitors, mRNA therapeutics, antisense molecules, fusion proteins, antibodies, antibody-drug conjugates, and herbal medicines. My expertise covers multiple therapeutic areas, including oncology, ophthalmology, neurology, thrombosis, and respiratory diseases. For most of my clients, I adopt a hands-on approach, actively engaging in day-to-day operational tasks to ensure seamless project execution.

Education

• MSc in Pharmacy (Drs, Diploma)
• Qualification as licensed Pharmacist (Approbation)
• PhD: Pharmacology, Molecular Biology