Road to First-in-Human Trials for Biologics

Are you a biotech startup eager to navigate the complex landscape of first-in-human clinical trials for biologics? Our upcoming program is designed to equip you with valuable insights needed to understand and prepare for this critical phase of large molecule drug development. 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.

Large molecule biologics often have unique characteristics that may require specialized procedures. Understanding and navigating these pathways while ensuring compliance with stringent and ever-changing regulations can be challenging. How do you adapt your trials strategy to current market conditions?

Join J&J experts as they delve into the basic requirements and considerations necessary to achieve a successful biologics CTA submission. Explore:

• 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 biologics 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 biologics, with a focus on demonstrating safety and laying the groundwork for demonstrating 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 Clinical Trial Application requirements for your First-in-Human trial.

This event is tailored for biotech startups venturing into first-in-human trials with a biologics 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.

Agenda

12:30 CET | Registration opens

13:00 CET | The Johnson & Johnson Innovation Collaboration Model
Tess Korthout | Early Innovation Partner, Johnson & Johnson Innovation

13:15 CET | Preclinical Development
Michaël Maes | Non-clinical safety Lead, Johnson & Johnson

14:05 CET | Chemistry, Manufacturing and Controls (CMC)
Alessandra Orlandi | Senior Director CMC, Johnson & Johnson

14:55 CET | Break

15:15 CET | Clinical Trial Design
Veronique Mathijssen | Global Trial Leader, Johnson & Johnson

16:05 CET | Regulatory Affairs
Siard Houtzager | Associate Director Regulatory Affairs, Johnson & Johnson

16:55 CET | Closing remarks

17:00 CET | Extended Q&A
Speakers available in an informal setting

18:00 CET | Program close