Dive into Facet Life Sciences’ blog for expert articles and insights on regulatory trends, scientific developments, and industry news.
This article by Facet’s own Tom Hallam, Ph.D., MBA, first appeared in the Innovation Insights section of Life Sciences Review. Nearly half of New Drug Application (NDA) or Biologics License Application (BLA) submissions have hi...
One question we hear regularly from emerging biotechs is: Do we really need a formal Target Product Profile right now? Like many good answers to regulatory questions, “it depends.” A great TPP that is grounded in data and stra...
For many small biotech teams, regulatory and commercial strategies are treated as sequential activities: first secure FDA approval, then figure out how to sell the product. Chronologically, that seems reasonable. Strategically,...
How a novel pediatric gene therapy developer leveraged regulatory gap analysis to align with FDA expectations By Tom Hallam, Ph.D., MBA For emerging pharmaceutical companies navigating the road to U.S. market approval, the righ...
What every developer should know to maximize BTD value by Dr. Jason Mercer, Ph.D., RAC and Strategic Program Innovator The Food and Drug Administration’s (FDA’s) Breakthrough Therapy Designation (BTD) program offers spons...
By Randy Goodman, PhD In the evolving landscape of innovative therapeutics, radiopharmaceuticals stand out as a powerful modality to diagnose, target, and treat disease at the molecular level. This interest and excitement is re...
By Lisa Jenkins VanLuvanee, Ph.D. I hear all the time from life sciences CEOs and innovators, “I don’t know what I don’t know, and that keeps me up at night.” One of the best ways to address this situation is to obtain a gap an...
by Randy Goodman, PhD Asset valuation activities play a crucial role in pharmaceutical research and development. Knowing the value of an asset or collection of assets is especially important for licensing partnerships, mergers ...
Submitting a New Drug Application (NDA) is one of the most resource intensive steps in drug development. For small life science companies, success depends on more than simply reaching the submission milestone. The true measure ...
Radiopharmaceuticals present a distinct set of development and regulatory challenges. These agents can be used for both diagnostic imaging and targeted radiotherapy. They combine radioactive isotopes with pharmaceutical and bio...
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