PADE Inspections: What You Need to Know & Why

The October 2022 updates to the Chapter 53 of the FDAs Post-marketing Adverse Drug Experience (PADE) Inspection Manual resulted in a few key changes. We’ve helped our clients prepare, oftentimes mobilizing not only within PV, but across cross-functional partners (ex. MedInfo, Quality, Marketing, Regulatory, & Legal). While PADE inspections build upon the successes (or shortcomings) … Read more

Early Biotech Milestones

A Biotech is born. You’ve chosen the founding team and identified the therapeutic and disease model. You’ve also secured a preliminary investment round. Now it’s time to beat the odds by progressing through initial milestones towards commercialization. To make it to market, you must navigate the following: Funding Milestones Early Clinical Milestones First-In-Human (IND US-CTA … Read more

What are Digital Therapeutics (DTx)?

What are Digital Therapeutics? The field of Digital Therapeutics is nebulous and confusing. Compounded by a world of wellness applications and non-clinically validated patient support tools, it’s challenging to differentiate digital interventions. For start-ups and well established pharmaceutical giants, the path is equally unclear for how to effectively build an organization that is focused on … Read more