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Category Archives: Drug Development Consulting

The Ins and Outs of INDs

February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot of questions about the best way to prepare for an Investigational New Drug (IND) submission. So we’ve decided to tackle those questions in a series of blog posts. In this introductory post, we’re going to focus on some background information that will help explain the overall purpose and requirements of an IND.

Let’s start with . . .

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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…

rec

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