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Author Archives: Kathryn Tworkoski

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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The Rapidly Expanding World of Rare Diseases

November 4, 2015 | Kathryn Tworkoski, PhD, Clinical Research Scientist | Regulatory Affairs, Drug Development Consulting

When you think about drug development, you probably assume that pharmaceutical companies are most likely to invest in therapies that can be used by a large percentage of the population to treat common diseases. Yet recent years have witnessed an explosion in the development of so-called “orphan” drugs that treat rare diseases.

In 2013, 33% of the New Molecular Entities (NMEs) approved by the Center for Drug Evaluation and Research were orphan drugs and in 2014, 41% of NMEs were orphan drugs. All of which begs the question: what’s driving this interest in orphan drug development?

Rare Diseases

rare
Image courtesy of jk1991
at FreeDigitalPhotos.net

Although an individual rare disease affects fewer than 200,000 people in the US, there are roughly 7,000 rare diseases that impact over 25 million Americans.

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