Optimizing The Path To First-In-Human Clinical Trials: An Integrated Approach To Design And De-Risk Your Candidate

Developing new drugs is a complex and risky journey, especially for biologics. Tight timelines and limited resources put pressure on getting it right the first time. Many promising candidates fail due to issues with efficacy, safety, or manufacturability.

Optimizing your early drug development process is key. Outsourcing can play a role in early development, but choosing the right partner is crucial to avoid overwhelming your internal team.

In this webinar, Dr. Yvette Stallwood from Lonza’s Mammalian Early Development Services group shares technical case studies that showcase key activities, from humanization and molecular reformatting to early protein expression and in vitro safety assessment.

• Manage complex data and identify potential risks early to select the best candidate for further development.
• Ensure optimal molecule design, assess and mitigate risks upfront, and achieve early protein expression for confirmation of key product characteristics. This minimizes the need for expensive and time-consuming adjustments later.
• Partnering with Lonza's Mammalian Early Development Services can help you design and de-risk your molecule, accelerating the path to clinical trials and GMP manufacturing.

Learn more about the common challenges faced by drug developers in the early stages, why a suboptimal risk assessment can derail your project, and how an integrated approach can streamline your early drug development process and get you to clinical trials faster.