Episode Summary
Edward Narke is a Principal and Regulatory Managing Director, Brian Lihou is the Head of Operations and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed, Brian and Meranda join the show to share their collective experiences in the field of CMC. They dissect the process of filing for an Investigational New Drug (IND) and a New Drug Application (NDA), the concept of ‘rest-of-world awareness,’ and the importance of storyboards and timelines for document submission.
What We Covered
- 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry
- 5:12 – The process of filing an Investigational New Drug (IND) and a New Drug Application (NDA)
- 18:54 – What it means to have ‘rest-of-world awareness’ as you author an NDA
- 22:37 – Ed, Brian and Meranda speak to the importance of storyboards and telling a story from the right perspective
- 28:55 – Ed, Brian and Meranda break down the detailed development process, including the work that Design Space InPharmatics does
- 39:28 – The document review process, timelines for submissions and tracking projects
- 49:00 – Ed, Brian and Meranda conclude the podcast and thank the audience for listening
Tweetable Quotes
Links Mentioned
Design Space InPharmatics – LinkedIn
Design Space InPharmatics – Twitter
Edward Narke on LinkedIn
Brian Lihou on LinkedIn
Meranda Parascandola on LinkedIn