The transition from end of phase II (EoP2) to new drug application (NDA) submission is a complex and critical period in bringing new therapies to patients. For sponsors, this stage of development involves juggling challenges across multiple disciplines, from regulatory, nonclinical and chemistry, manufacturing and controls (CMC) to quality, clinical and commercial.

Putting a well-planned NDA playbook in place ensures that all prerequisite pre-filing activities are completed and that the documents and data necessary for submission have been collected in the appropriate formats. Successful execution of this playbook requires a clear understanding of timelines and careful coordination across disciplines, as well as the ability to troubleshoot issues as they arise on a real-time basis.

In this webinar, the expert speaker will discuss key considerations across the core drug development disciplines for developing a comprehensive NDA strategy and explore opportunities for streamlining the path from EoP2 to NDA submission.

Register for this webinar today to understand how new therapies can be developed by streamlining the path from end of Phase II trials to NDA submission.

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Speaker

Fedra Molaie-Holagh, Vice President, Regulatory Affairs, Premier Consulting

Fedra Molaie-Holagh is a Vice President of Regulatory Affairs at Premier Consulting. She has over 21 years of experience in the pharmaceutical and biotech industry, with over 19 years focused on regulatory affairs.

In her previous role, she led the regulatory, quality and pharmacovigilance teams at Acerus. She has also worked at Amgen, Novartis Animal Health, YM Bioscience and BGP Pharma on teams managing innovative products at different stages of development, as well as post-registration product stewardship, in a wide spectrum of therapeutic areas, including oncology, nephrology, pain and men’s health.

Fedra has experience with health authorities in Canada, the US, the EU, Australia and Japan through health authority interactions, including scientific advice and EoP2 meetings and through submissions including INDs, CTAs, NDSs, NDAs, MAAs and BLAs. She holds an HBSc in molecular genetics from the University of Toronto.

Message Presenter

Who Should Attend?

This webinar will benefit managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:

Regulatory affairs
Project management
Pipeline strategy
Medical affairs

What You Will Learn

Attendees will learn about:

Critical steps to NDA submission after completion of phase II studies
Recommended timelines for key activities
Nuances in NDA strategy for oncology therapeutics
Real-world examples of challenges in preparing for NDA submission and potential solutions to those challenges

Xtalks Partner

Premier Consulting

Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.