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Kasturi Puranam, PhD, Promoted to Principal Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 23 September 2020 – In March 2020, Kasturi Puranam, PhD, was promoted to the position of Principal Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Kasturi joined the IMPACT family in January 2015 after spending a number of years as a research scientist at Duke and then at UNC. Kasturi’s love of science is evident in every project she takes on, enabling her to write exceptionally scientifically-sound documents whilst focusing on the key document messages. During her time at IMPACT, Kasturi has worked on a variety of documents, including IND components, protocols, IBs, CSRs, briefing documents, and NDA modules. Kasturi is always willing to tackle new and challenging projects – a true strength that makes her an excellent addition to any project team.

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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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Kelly D’Arezzo Promoted to Senior Quality Control Specialist

RESEARCH TRIANGLE PARK, NC: 13 May 2020 – In April 2020, Kelly D’Arezzo was promoted to the position Senior Quality Control Specialist at Impact Pharmaceutical Services, Inc. (IMPACT).

Kelly joined IMPACT in April of 2019 as a Quality Control (QC) Specialist. Prior to joining IMPACT, Kelly served as a Project Manager at ICON in the Language Services-Translations department, where she managed a variety of projects at different stages within the clinical trial process.
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Dominic Luciano, PhD, Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 13 May 2020 – In February 2020, Dominic “Nick” Luciano, PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Since joining the company in January of 2017 as a Clinical Research Scientist, Nick has proven himself to be an exemplary team player, a gifted mentor, and a brilliant scientific writer. Prior to joining IMPACT, Nick earned a BS in Biology from Indiana University of Pennsylvania and a PhD in Neurobiology from Duke University. As a Clinical Research Scientist, he has authored a multitude of clinical study reports (CSRs) and has experience authoring many types of regulatory documents, including Module 2 clinical summaries for New Drug Application (NDA) submissions, Investigator’s Brochures, clinical protocols, FDA briefing documents, and safety narratives. His work has supported clients across a broad range of therapeutic areas, including neurology, oncology, respiratory disorders, and immunology. Most recently he is serving as the Project Manager for a multi-CSR project for one specific compound.
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Caroline Drucker, PhD, Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 13 May 2020 – In February 2020, Caroline Drucker, PhD, was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Caroline joined IMPACT in May of 2017 as a Clinical Research Scientist. Within her first year, Caroline quickly became an independent writer known for her reliability, production of high quality documents, problem solving, and professional demeanor. During her time at IMPACT, Caroline has been involved in authoring a variety of challenging and complicated documents, including protocols, Clinical Study Reports (Phase 1 to Phase 3), narratives, Investigator’s Brochure updates, Agency briefing documents, and efficacy focused submission documents across a wide range of therapeutic areas. In addition, Caroline has recently seamlessly taken on the project management of a strategic alliance with one of the company’s largest clients, and she quickly became the “go to” person for both the IMPACT medical writers and the client.
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