Blog

All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.

The Push for Patient-Focused Drug Development

January 10, 2022 | Julia DiFiore, PhD  |  Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise...

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Keep ’em Coming: An Overview of IND Updates

June 2, 2020 | Kathryn Tworkoski, PhD, RAC  |  Principal Clinical Research Scientist 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...

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Current Topics in Orphan Drug Development

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases,...

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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...

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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...

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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...

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