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Category Archives: Drug Development Consulting

What is the FDA’s Biomarker Qualification Process?

May 26, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Similar to Clinical Outcomes Assessments (COAs), biomarkers also have a qualification program that was developed by the Center for Drug Evaluation and Research (CDER) as one of the Drug Development Tools (DDT) Qualification Programs.

scopeJust like our previous post on the COA Qualification Program, this post discusses the Biomarker Qualification Program from a drug-development point of view.

What is a biomarker?

A biomarker is a measurable indicator used to assess: (1) a normal biologic process, (2) a pathogenic process, or (3) a response to an intervention or exposure.

One important thing to keep in mind is that, unlike COAs, biomarkers do not assess how individuals feel, function, or survive in their daily lives. As such, biomarkers are less subjective than COAs.

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What is the Clinical Outcome Assessment Qualification Process?

May 13, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Clinical Outcome Assessments (COAs) can be qualified through the COA Qualification Program, one of the Drug Development Tools (DDT) Qualification Programs developed by the Center for Drug Evaluation and Research (CDER) at the FDA.

In a previous post, we discussed that COAs currently under development, as well as those relied upon in recent drug approvals, have been included in the pilot COA compendium. In this post, we will discuss the COA Qualification Program – stay tuned for an upcoming post on the Biomarker Qualification Program, as well.

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FDA’s Pilot Clinical Outcome Assessment Compendium – A Valuable Drug‑Development Resource

April 28, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

The three R’s (reduce, reuse, and recycle) typically conjure up ideas about conserving natural resources but they are also a great illustration for how FDA’s newly-available pilot clinical outcome assessment (COA) compendium can increase the efficiency of the drug-development process.

By collating and summarizing COAs across many different disease states and indications, the publically-available COA compendium should allow drug developers to reduce the amount of time spent on the development of new COAs, reuse existing COAs as appropriate, and potentially recycle elements of existing COAs to create meaningful measures in clinical areas where no COAs currently exist.

But maybe we should take a step back and start at the beginning…


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Record Numbers of FDA‑Approved Drugs: Recent Trends

March 10, 2016 | Kathryn Tworkoski, PhD, Clinical Research Scientist | Regulatory Affairs, Medical Writing Services, Drug Development Consulting

Everyone knows that getting FDA approval of a new drug, whether it be a new molecular entity (NME) approved through a new drug application (NDA) or a new therapeutic biologic approved through a biologic license application (BLA), can be extremely challenging. But did you know that in 2014 and 2015, CDER approved record numbers of new drugs?

So what do I mean by “record numbers?” And are there any trends in the recent increases in approvals? Let’s take a more detailed look.

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Formal Meetings with FDA for Biosimilar Products

February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to great lengths to disavow us of this perception because, as we have discussed before, there cannot be a true generic version of a biologic product.

The FDA recently finalized a procedural guidance entitled “Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants.” Since these meetings are intended to discuss the development of biosimilar products, it is somewhat appropriate that FDA chose to be “non-generic” in its design of these meetings!

Differences between BsUFA and PDUFA Formal Meetings

Formal meetings between Sponsors and the FDA on biosimilar development programs were authorized by the Biosimilar User Fee Act of 2012 (BsUFA), which was included in that year’s Food and Drug Administration Safety and Innovation Act (FDASIA). While the BsUFA meeting program is similar to the Pharmaceutical Drug User Fee Act (PDUFA) meeting program, there are some meaningful differences.

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