25 February 2025, 13:00 – 18:00 CET, Leiden & virtual
Do you know what it takes to start your first clinical trial? Submitting a Clinical Trial Application (CTA) is a critical early milestone for every biotech company.
Johnson & Johnson Innovation – JLABS invites you for a program that takes an in-depth look into essential aspects of a CTA such as preclinical development, clinical trial design, regulatory strategy, drug metabolism pharmacokinetics, and chemistry, manufacturing & controls.
Start-ups, early innovators and entrepreneurs are welcome to register. We also welcome stakeholders supporting these start-ups.
Overview
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.
Johnson & Johnson invites you for an in-depth look into different aspects in the journey towards filing a CTA for small molecules, including Antisense Oligonucleotides (ASOs), siRNA and small peptides. As competition for funding is fierce, startups are expected to demonstrate a clear blueprint for their clinical trials strategy, and we want you to be ready.
Join us for a series of short presentations exploring the basic requirements and considerations necessary for small molecule CTA submission. The presentations will highlight the following:
- 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.
This event is tailored for biotech startups venturing into first-in-human trials with a small molecule asset, but should also provide valuable insights for other early innovators and first-time entrepreneurs active in this space. We also welcome stakeholders supporting these startups.
For more information about the schedule and the speakers, visit Johnson & Johnsons website.
Source: J&J