In early drug development, optimizing your path to first-in-human clinical trials is critical to ensure the most efficient use of limited resources and tight timelines. However, a large portion of biologics fail during development due to issues with efficacy, safety, or manufacturability. Outsourcing of activities plays a major role in the early drug development journey, but this puts further strain on limited internal resources, so selecting the right partner is critical. The development team needs to focus on managing the integration of multiple data streams to make the right decisions, as well as identifying and mitigating key risks in selecting the optimal lead development candidate.
This is significantly aided by ensuring optimal molecule design, early risk assessment and mitigation, as well as early expression of the protein where key product attributes can be confirmed and are unlikely to change significantly during scale-up. This early work enables clinical development and minimizes the requirement for bridging work, which can cause delay and increased cost.
In this webinar, Dr. Yvette Stallwood from Lonza’s Mammalian Early Development Services group shares technical case studies that provide insight into key activities, from humanization/deimmunization and molecular reformatting, through early protein expression, to in vitro safety assessment.
Key learning points
- Challenges that drug developers face in the early space
- Pitfalls of suboptimal risk assessments
- An integrated approach to design and de-risk early drug development candidates to streamline the path to GMP