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
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
Across the innovative therapy landscape, regulators and payers are constantly assessing the cost effectiveness of new therapies. In this issue, we highlight the importance of capturing and demonstrating value of the therapy throughout the product development lifecycle to support approval and reimbursement decisions.
SSI Wavelengths Current issue – A HEOR-centric Strategy to Gene Therapy Development Read Now Archive Vol. 2, Issue 2 – Global Medical Affairs Transformation Vol. 2, Issue 1 – The Importance of Patient Engagement Vol. 1, Issue 2 – Articulating the Value of Medical Vol. 1, Issue 1 – HEOR + MA, Fad or Necessity?
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