The Journey to Approval: Navigating the Road from EoP2 to NDA Submission

“The road from end of phase 2 to NDA submission involves juggling challenges across multiple domains, weaving together regulatory, quality, nonclinical, clinical, and commercial requirements and perspective. Our goal is to provide an overview of the NDA preparation process so you can navigate the journey with greater confidence and efficiency.” 

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Here are the top 7 takeaways from this webinar and their timestamps in the downloadable file. Feel free to skip around to the sections that are most interesting to you, or save the file for later viewing. 

1. 05:11: Regulatory agency communication is critical.
   “The first major regulatory milestone is the end of phase 2 meeting with the FDA. The purpose of this meeting is really to determine readiness to advance to phase 3 and to evaluate the phase 3 plan and protocols. This meeting is also the opportunity to obtain feedback from the agency on the overall NDA strategy and to identify any additional information necessary to support a marketing application.” 
2. 08:08: How to prepare for a successful pre-NDA meeting.
   “There are really four pillars…We have strategic planning, regulatory alignment, risk mitigation, and proactive resource management.” 
3. 16:28: The intricacy of submitting an NDA in eCTD format.
   “It’s really important to engage a partner with experience in eCTD publishing who can help to streamline the process of compiling these larger submissions which are very interconnected and have a submission-ready dossier at the end.” 
4. 23:38: Streamlining the CMC process.
   “An important thing to keep in mind is having in hand all letters of authorization to reference any active substance master files, any drug master files, or any other component that has proprietary information associated with it and is somehow involved as a part of your manufacturing process…To do this, it is important to get in touch with your vendors early on…” 
5. 31:27: Developing an initial pediatric study plan (iPSP).
   “The iPSP outlines the sponsor’s plan for studies that will be conducted to assess the safety and efficacy of your drug in a pediatric population. It doesn’t have to be a full lockdown plan for FDA. It’s a proposed plan. It’s your initial plan and you can almost have a decision tree where one initial step informs subsequent steps. The FDA would like to see that you’ve thought it through and it’s feasible.” 
6. 35:52: Nuances of oncology NDAs.
   “There are unique challenges and considerations when advancing an oncology drug from late stage clinical development to regulatory approval. There are also some collaborations that really aid and help in moving your products forward…” 
7. 45:58: Ideal timelines for the NDA preparation process.
   “Engaging with the FDA and other relevant agencies early and often allows for developers to proactively address concerns raised by regulators…This allows you to plan for or adjust your NDA submission strategy and potentially timing.”