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Category Archives: Drug Development Consulting

Ready to Submit Your Initial IND?

April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND activities. Continue reading this post to understand the process of submitting an initial IND and the subsequent IND-related steps to take as you proceed towards your marketing application.

Let us start with …

IND components

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Before you file your IND…

March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs can be opened at any stage of product development, the main focus of this post is on pre-IND activities for those being submitted to support first-in-human studies.

Nonclinical and CMC activities

During a new drug’s early preclinical development, it is necessary to determine that the product will not expose humans to unreasonable risk when used in limited, early-stage clinical studies, and that it exhibits pharmacological activity that justifies commercial development. To that end, nonclinical and chemistry, manufacturing, and control (CMC) data should be collected to include in an IND and support the initiation of a clinical trial. These components of an IND include:

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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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