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...
Blogs
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 ...
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...
Behind the Scenes of an FDA Type C Meeting: A Case Study in Using Gap Analysis to Align Nonclinical Strategy in a Rare Pediatric Disease
By Tom Hallam, Ph.D., MBA For small pharma companies navigating the road to US market approval, the right nonclinical regulatory strategy, built with expert consulting and scientific guidance, can mean the difference between ef...
Why Strategic Statistical Consulting is Essential & The Role of a Statistician in FDA Meetings
When preparing for a meeting with the FDA, most Sponsors focus on regulatory affairs, clinical leads, or medical officers. However, one role that is becoming increasingly central and often overlooked is the statistician. Whethe...
How Do I Determine Good Regulatory Guidance?
by Lisa Jenkins VanLuvanee, Ph.D. For small biotech and medical device companies without internal regulatory experts, knowing whether you’re getting the right advice can be a real challenge. In this interview, Dr. Lisa Je...
Everyone is Talking About HEOR! What Exactly is it and Why is it Relevant to You?
By Dr. Randy Goodman Ph.D., MHA, FACHE, PMP, BCMAS HEOR stands for Health Economics and Outcomes Research. It is a science that combines health economics, which focuses on the allocation of healthcare resources, and outcomes re...
Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development: Key Lessons from a Case Study
by Dr. Jason Mercer, Ph.D., RAC and Strategic Program Innovator FDA’s Breakthrough Therapy Designation (BTD) program offers sponsors a powerful opportunity to expedite development of promising therapies for serious or life-thr...
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