Unlocking the Path to Drug Development Success: A Webinar for Early-Stage Biotechs

California Life Sciences invites you to an essential online event designed to empower early-stage biotech companies. This webinar, featuring Avance Clinical’s scientific and regulatory affairs experts from both Australia and the United States, will showcase the clinical trials landscape and regulatory frameworks that are essential for accelerating drug development programs towards global approval.

Navigating the Journey from Concept to Clinic:

Our experts will delve into the intricacies of the drug development process, offering deep dives into the critical phases of bringing a therapeutic concept to the clinic. From the foundational steps in preclinical research to the pivotal milestones of Phase I and II clinical trials, attendees will gain the following valuable insights:

• Understand the comprehensive regulatory environment and how to navigate it efficiently to avoid common pitfalls.
• Identify key considerations and strategies for successful preclinical development, ensuring a solid foundation for subsequent trial phases.
• Gain insights into the planning and execution of Phase I and II trials, including patient recruitment, study design, biomarkers for decision making, and critical regulatory touchpoints as well as expedited regulatory pathways such as breakthrough designation, Fast track, Priority Review and Orphan Drug designation.
• Explore the latest trends and advancements in biotech clinical trials and regulatory science that can be leveraged to expedite drug development processes.

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Why Attend?

This webinar is an opportunity for biotech and R&D leaders to advance their understanding of the current clinical trials and regulatory landscape. Learn from the experts at Avance Clinical how to streamline your drug development program, mitigate risks, and navigate the pathway to successful regulatory approvals.

Speakers:

• Kevin Leach PhD, DAB: Senior Vice President, Scientific and Regulatory Affairs, Avance Clinical
• Jorgen Mould: Senior Director, Scientific & Regulatory Services, Avance Clinical