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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 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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Kathryn Tworkoski, PhD, RAC Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 27 Mar 2018 – In March 2018, Kathryn Tworkoski, PhD, RAC was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Kathryn joined the IMPACT family in November of 2014 as a Clinical Research Scientist. During her time at IMPACT, Kathryn has served as a writer in our early phase group, as well as for multiple NDA/BLA submissions, and has earned her Regulatory Affairs Certification (RAC). She has been lead writer on a diverse array of complex documents, including INDs, CSRs, IBs, protocols, narratives, submission summary documents, manuscripts, and IMPACT blog posts, across a wide range of therapeutic areas. Kathryn has consistently received positive feedback for the quality of her work and critical assessment of data both internally from her IMPACT colleagues and externally from Sponsors. She has also become a mentor and reviewer to junior writers and has always been willing to lend a helping hand to her colleagues whenever needed.

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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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IMPACT’S Making an IMPACT Initiative Celebrates the Second Half of 2017

RESEARCH TRIANGLE PARK, NC: 24 January 2018 – In the second half of 2017, IMPACT’s employees continued their generous efforts via the Making an IMPACT community service initiative. Together, we held several donation drives for various charities, as well as our annual Season of Giving series of mini-events.

IMPACT’s 4th annual Crayons2Calculators Fill that Bus! drive
In August, Beth Pultorak spearheaded the 4th annual Crayons2Calculators “Fill that Bus!” drive. Crayons2Calculators helps more than 10,000 local children in need by providing their teachers with basic school supplies and educational tools.

IMPACT employees supported Durham public schools by donating 4 large bins of supplies to Crayons2Calculators’ annual Fill That Bus! event!

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