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Author Archives: Kathryn Tworkoski

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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University Resources for Aspiring Scientific and Medical Writers in the Research Triangle Park Area

February 22, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Medical Writing Services

Finding a job is hard—finding a job in a new field can be even harder. As someone who recently broke into the field of medical writing I’m familiar with the associated challenges, but I can also tell you that the reward is more than worth the work!

Image courtesy of Renjith Krishnan at FreeDigitalPhotos.net

IMPACT recently created a series of blog posts to help others make similar career transitions by highlighting local resources available to aspiring scientific and medical writers.

Previous posts discussed professional networking tips, how to use social media to make your transition, and professional organizations for emerging medical writers.

In this post, I’ve compiled a list of useful programs and opportunities provided by local universities in the Triangle area of North Carolina. Italic text denotes opportunities that are available to everyone, even people not affiliated with a university.

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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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