Facet Life Sciences was recently featured in Life Sciences Review, spotlighting the firm’s entrepreneurial approach to FDA regulatory strategy for emerging biotechs. Life Sciences Review recently sat down with Dr. Tom Hal...
Blog & Insights
Facet Life Sciences Appoints Frank A. Closurdo as VP, Commercial Services, Strengthening Integrated Regulatory and Market Guidance
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...
Target Product Profile for Emerging Biotech: Strategic Asset or Expensive Distraction?
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...
Facet Life Sciences Evolves Leadership Structure to Strengthen Product Pathmaking Solutions & Deepen Partnership Value
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...
Facet’s Dana Blue Returns to AMWA Regulatory Writing Subcommittee for 2026
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 ...
Why Separating Regulatory and Commercial Strategy Can Kill an Otherwise Promising Biotech
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,...
Behind the Scenes of a Productive Nonclinical Type C Meeting Strategy
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...
Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development
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...
Leveraging Development Opportunities in Radiopharmaceuticals
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...
Facet Life Sciences and XCancer Announce Strategic Partnership to Advance Theranostic Clinical Trials
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...
Understanding the Different Types of Gap Analysis in Life Sciences
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...
Importance of Asset Valuation in Pharmaceutical Research and Development
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 ...
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