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...
Blog
Dive into Facet Life Sciences’ blog for expert articles and insights on regulatory trends, scientific developments, and industry news.
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...
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 ...
Identifying and Closing Gaps Before NDA Filing
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 ...
Three Key Considerations for Navigating FDA Oversight in Radiopharmaceutical Product Development
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...
Navigating the CMC Journey in Radiopharmaceuticals
Insights from the “Tinker to Treasure” Webinar The development of radiopharmaceuticals offers tremendous potential for both the diagnosis and treatment of disease. However, turning early-stage research into a market-ready produ...
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