Successfully advancing new drugs and life-saving therapies to market for emerging pharma and biotech organizations is an elongated process, involving complex challenges throughout product development. For these companies, the first major inflection point is the start of a Phase I clinical study.

A proactive, cross-functional, and risk-based early development plan is critical to a successful journey. This plan outlines the initial regulatory pathway, and contains details on the clinical trial design, and information on how and where the investigational product (IP) is manufactured. Building the investigational new drug (IND) requires compliance with many regulations. It also informs the Food and Drug Administration (FDA) on the translation from non-clinical pharmacology/toxicology work to justify the starting point for First-In-Human (FIH) studies.

Join us for a comprehensive guide through Phase I of the IND journey. Explore the latest strategies for advancing IND submissions. The webinar will dive into current IND submission challenges and recommend strategies for early-stage biopharma companies to achieve a successful outcome from their first pre-IND meeting with the FDA.

• Gain an in-depth understanding of the IND process
• Learn successful strategies for a pre-IND meeting
• Understand how to identify chemistry, manufacturing, and controls (CMC) risk factors
• Understand the importance of developing a clinical development plan

• Presenters

Sharon Ayd

Ph.D., MBA

Vice President & Principal, Advarra Consulting

Leslie Paul

Director, Quality Center of Excellence, Advarra Consulting