New-Drug Development: Succeeding With the FDA (Australia)

March 31, 2022 | 2:00 PM AEDT / 11:00 PM EDT (March 30)

Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the steps — and how the agency works — can alleviate the stress and get your product on the path to approval. This webinar examines some key questions and issues to put you on sound footing as you begin the process.

Electronic submission of IND applications: Sponsors must submit IND applications electronically through the FDA gateway. Understand and follow the formatting rules to avoid potentially costly delays.

Adherence to GMPs: Sponsors must demonstrate that their drug product and substance are manufactured according to good manufacturing processes, starting with Phase 1 CMC data that ensures patient safety.

Use of foreign-generated data: Study data generated outside the U.S. can support US INDs or Marketing Applications, provided those studies follow good clinical practices and meet other conditions.

Expedited pathways and orphan designations: The FDA offers several avenues to accelerate approval of new drugs: orphan designation, fast-track approval, breakthrough therapy designation, accelerated approval, and priority review. Which might apply to your product?

The regulatory timeline: We’ll walk through what our clients can expect from the kickoff meeting through critical development milestones.

Presenter:

Kristi Miller, Ph.D.

Senior Vice President, Regulatory Affairs
Premier Consulting

Kristi Miller leads the team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines (CMC, Nonclinical, Clinical, Device and Regulatory Writing). She has over 15 years of experience in the pharmaceutical industry in delivering both regional and international regulatory strategy for pharmaceutical and biotech drug development teams.  Her experience encompasses providing regulatory leadership and execution of strategy for products across development (pre-IND through post marketing) in multiple therapeutic areas of immunology/inflammation, ophthalmology, oncology and other rare diseases.  Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast track applications, pediatric strategies, and marketing applications. 

Kristi received her PhD in tumor cell biology and her previous roles have included positions at Pharmacyclics, and Genentech.