Antje Walz

Bridging the Gap from Bench to Bedside Are you navigating a complex First-In-Human filing or refining your dose-selection strategy? Whether you are a biotech startup accelerating a flagship asset or an investor de-risking a portfolio, I provide the strategic PK/PD and Clinical Pharmacology expertise to move your program forward with confidence. With over 20 years of experience advancing 20+ drugs to the clinic, I help you navigate the "Four Rights": the right target, right molecule, right patient population and right dose. How tkc suisse accelerates your success: Clinical Candidate Selection: De-risking portfolios through target validation and biomarker-integrated PK/PD models to ensure only the most viable candidates advance. Human Dose Selection & Regulatory Strategy: Leveraging advanced modeling and simulation to select human starting doses and provide expert representation in scientific advice meetings with the FDA, EMA, DKMA, BfArM, and PEI to secure successful IND/CTA filings. Dose Optimization & Project Optimus: Implementing innovative trial simulations to maximize the benefit-risk profile for cancer patients, fully aligned with the FDA’s Project Optimus. Pipeline De-risking: Conducting deep-dive technical due diligence on external assets to evaluate in-licensing opportunities and development risks. Ready to optimize your development path? 📩 Message me on LinkedIn to discuss your program. 🌐 Visit: tkcsuisse.ch 📧