The IND Journey Phase I - Navigating Success
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 with Sharon Ayd, Ph.D., Vice President & Principal Regulatory Center of Excellence (CoE) Advarra Consulting along with Leslie Paul, MS., Director, Quality CoE. 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
Vice President & Principal
Former FDA Investigator
Director, Quality Center of Excellence
Who should watch?
This content applies to sponsors and CROs at growing biopharma and pharma companies. It also contains relevant insight for early-stage companies, biologics, and emerging biotech companies. Anyone involved at any product development stage in advancing investigational new drugs (IND) to market at clinical research organizations.
Attendance at this program has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations
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Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour