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Author Archives: Kathryn Tworkoski

KEEP ‘EM COMING: AN OVERVIEW OF IND UPDATES

June 2, 2020 | Kathryn Tworkoski, PhD, RAC  |  Principal Clinical Research Scientist  |  Regulatory Affairs, Medical Writing, Drug Development Consulting

In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of INDs.  In these earlier posts, we mentioned that INDs are “living” documents, which means that they are continuously being updated as a drug development program proceeds.  So today, we thought we’d take a few minutes to discuss the types of IND updates that you may come across.  Let’s start with…

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Current Topics in Orphan Drug Development

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Regulatory AffairsMedical Writing, Drug Development Consulting

Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND meetings, and the submission and maintenance of INDs.  But in October 2018, the FDA released new draft guidance outlining best practices for early drug development and pre-IND meetings for rare diseases.  Given the near-perfect cross-over potential, we thought this was a sign that it was time to review the guidance, as well as rare diseases as a whole.  So in the interest of appeasing the fates, let’s get this show on the road!

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Pro Tips for Protocol Writing

September 28, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Medical Writing Services

Great news; your team has been given the green light to conduct a new clinical study with your favorite compound!  It’s what you’ve been waiting to hear, and now it’s time to seize the opportunity and run full steam ahead!

But first, you have to write a protocol.  The basic structure and content of a protocol are described in the International Council for Harmonisation Good Clinical Practice E6 guideline.  As you would expect, protocols should ultimately outline and justify the planned clinical study.  The type of information presented in protocols includes background information, trial objectives and assessments, trial design, subject selection and treatment, and a brief overview of the planned statistical analyses.

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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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Emerging Key Concepts in Biosimilar Development

March 8, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Biosimilars are a relatively new class of therapeutics. To date, only 4 biosimilars have been approved by the FDA (ZARXIO™, INFLECTRA®, ERELZI™, and AMJEVITA®); 3 of those 4 approvals occurred within the past year, and all 4 approvals occurred within the past 2 years! In this post, we’re going to take a quick look at the FDA’s current thoughts on biosimilar development, as well as a few key concepts in the field.

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