Wayne, PA — June 2, 2026 — Facet Life Sciences, a product pathmaker for emerging biotechnology and pharmaceutical companies, today announced the appointment of Frank A. Closurdo as Vice President, Commercial Services. This addi...
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...
Wayne, PA — May 13, 2026 — To support continued growth, Facet Life Sciences, a product pathmaker for emerging biotechnology, pharmaceutical, and device developers, today announced executive team changes. Facet helps lean scienc...
Shaping The Future of Regulatory Writing Education Facet Life Sciences is proud to share that Dana Blue, Strategic Program Champion and Medical Writing Team Manager, has been asked to rejoin the Regulatory Writing Subcommittee ...
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...
Phoenixville, PA — Facet Life Sciences, a leader in regulatory strategy and drug development services, today announced a strategic partnership with XCancer®, a global leader in theranostic clinical research, to accelerate the d...
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 ...
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