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Category Archives: Drug Development Consulting

In Case You Missed It: Four Themes from the DIA 2016 Annual Meeting

July 7, 2016 | Jennifer Moen, PhD, RAC, Principal Clinical Research Scientist | Medical Writing Services, Regulatory Affairs, Drug Development Consulting

Did you miss the DIA 2016 Annual Meeting? If so, no worries! This post presents 4 themes that were evident throughout the conference. Please remember that these are based on my own personal DIA experience – other attendees may have come away with different messages.

Here we go…

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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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