Road to first-in-human trials for small molecules | Johnson & Johnson | Hybrid

What: Road to first-in-human trials for small molecules | Johnson & Johnson

When: February 25, 2025 | 1 - 6 pm

Where: Hybrid | Leiden (NL) and Online via Zoom

Who: Biotech startups, early innovators and first-time entrepreneurs

Info: Are you a biotech startup eager to navigate the complex landscape of first-in-human clinical trials for small molecules? Our upcoming program is designed to equip you with valuable insights needed to understand and prepare your Clinical Trial Application (CTA), a critical early milestone for every biotech company.

Event highlights:

• Preclinical development strategies: We will discuss the groundwork necessary before advancing to clinical trials, including toxicity, drug metabolism & pharmacokinetics.
• Chemistry, Manufacturing & Controls (CMC): We will address the complexities of CMC to ensure your manufacturing processes and quality control measures meet regulatory standards. This includes optimizing the manufacturing of your Active Pharmaceutical Ingredient (API) and drug product formulations.
• Clinical trial designs: We will explore strategies for designing effective clinical trials specific to small molecules, with a focus on demonstrating safety and laying the groundwork for proving efficacy. Topics include operational aspects such as clinical trial site recruitment and patient enrollment.
• Regulatory strategies: We will elaborate on the European regulatory landscape, focusing on CTA requirements for your first-in-human trial.

Registration:more information here