Navitas Data Sciences will be at PharmaSUG

The Navitas Data Sciences team is delighted to be at PharmaSUG 2022 as a Gold Sponsor. PharmaSUG is an independent, all-volunteer Software Users Group of life science and health research professionals who are focused on utilizing technological solutions in data analytics and come together to share knowledge and insights. Our team will be present to explain how our effective biometric support will aid in running efficient clinical trials.

As the global Functional Service Provider (FSP) division of Navitas Life Sciences, we have global solutions for all of your statistical programming, biostatistics, and data management needs.

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Here is a bit about the experts who will be present at PharmaSUG and the topics that they will critically examine to help shape your clinical data analysis strategy.

GOLD SPONSOR At PharmaSUG 2022

Austin, Texas May 22-25

Kalyan Gopalakrishnan

EVP, M&A and Partnerships,
Navitas Data Sciences

Mike Cox

Director,
Navitas Data Sciences

Greg Weber

Director, Clinical Reporting,
Navitas Data Sciences

Siddharth Kumar

Associate Director,
Clinical Reporting,
Navitas Data Sciences

Kevin Viel

Lead Statistical
Programmer Analyst,
Navitas Data Sciences

Amanda Pietrucha

Senior SPA II,
Navitas Data Sciences

Timothy Harrington

Senior SPA I
Navitas Data Sciences

Kevin Viel, Ph.D., Lead Statistical Programmer Analyst, Navitas Data Sciences; Greg Weber, Director, Navitas Data Sciences; Sid Kumar, Associate Director, Navitas Data Sciences; and Timothy Harrington, Senior Statistical Programmer Analyst, Navitas Data Sciences will be presenting at PharmaSUG 2022.

Tell us a bit about yourself and your professional journey?

Greg Weber: I am a Director with Navitas Data Sciences and have been using the SAS system for over 25 years in the life sciences industry. I have extensive experience in implementing, managing and supporting Clinical Development and Statistical Computing Environments. I have authored technical papers and presented at PharmaSUG, NESUG, and other industry conferences.

Siddharth Kumar: I am an Associate Director with Navitas Data Sciences and have been using SAS for over 16 years and have worked in various CROs in India and the US as a Statistical Programmer Lead, Project Delivery Manager, and Line Manager. I have presented at various industry conferences, including PHUSE and PharmaSUG. I enjoy working at Navitas Data Science as it provides remote work assignments, a flexible schedule, growth opportunities, and excellent leadership.

What will you be presenting at PharmaSUG?

Siddharth Kumar & Greg Weber: Efficient monitoring and management of the clinical programming development and validation lifecycle is vital and can be a challenge in clinical study reporting. There are various methods used by companies to track the progress of clinical deliverables. Our current solution is tracking progress using Microsoft Excel spreadsheets. In our Statistical Computing Environment (SCE), this is not ideal as it requires checking out, downloading, editing the spreadsheet, and then uploading and checking in the updated Excel file. This manual process is both time-consuming and prone to error. In addition, sharing and working collaboratively is problematic as only one user can update the file at a time, so a better solution is desired.

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In this paper, we discuss connecting Smartsheet® with our SAS® LSAF® environment to provide a more collaborative Clinical Programming Deliverable Tracker requiring less intervention from managers and programmers. Smartsheet® is an online service for work management and collaboration that uses a tabular interface and provides workflow capabilities. We demonstrate techniques that utilize HTTP and REST to interact with and update our Smartsheet® Tracker from SAS®, using Proc HTTP along with the LSAF® macro and Smartsheet® APIs. Smartsheet® has become an important part of our SCE ecosystem and, using the processes and techniques developed for our Clinical Tracker, we plan to automate other SCE processes.

What is Navitas Data Sciences’ expertise and experience?

Sid Kumar: Navitas Data Sciences builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers. We have always provided skilled employees to meet our sponsor’s needs. No matter the size and phase of your study, our work is completed with the utmost precision and accuracy. The experience level of our professional resources, coupled with remote worker status, provides for an advanced, efficient, and smart work model for our sponsors.

“We received notification today from Regulatory that the Supplemental Biologics License Application (sBLA) has received FDA APPROVAL today. I would like to extend my congratulations and thank you to the Navitas programming team who worked tirelessly to support this! This is fantastic news! A huge accomplishment for the team!” Director, Statistical Programming
Top 10 US Pharmaceutical Company


Tell us a bit about yourself and your professional journey?

Kevin Viel: I knew as a kid that I wanted to be a researcher, to be on the cutting edge of knowledge and technology. The summer that I graduated high school, I got a job washing dishes. A month later, I took a work-study position in an electronic microscopy lab and even worked with chimpanzees briefly. The next summer, I joined the Rich Research Laboratory of Interventional Cardiology at Emory University. I was performing survival surgery on animal models and radiolabeling platelets with Indium-111 and quantitating deposition using a gamma camera. I directly applied my coursework every week under the guidance of some of the world’s best researchers. Finally, immersed in independent research and supporting other investigators, my position was eliminated prior to a merger. A friend and educator, Nancy Brucken, recruited me to this field. Had that career development happened in reverse order, the academic research by our international team would have been much more successful. The project management and execution in the field of clinical trials provides unsurpassed experience for the best causes. Many of us in this field are happy to meet the challenge and use our skills, talents, and education to improve the health and well-being of our patients, their families, and their healthcare providers, to whom we are deeply indebted. The field of clinical trials is the pinnacle of research, and I would rather be in no other career, not even an astronaut.

What will you be presenting at PharmaSUG?

Kevin Viel: I realized after working in a community-based hospital (with a translational research institute!) that I might make more of a contribution by improving data than winning a Nobel Prize. Genomics data is fascinating, challenging, and enormous; we can expect that every clinical trial in 10-15 years will require genomics data.

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I am presenting an extension of my efforts to use SAS as a bioinformatics tool and introducing more NCBI resources, including the SARS-CoV-2 Data Hub. Using that data, I demonstrate how to generate the realm of possible variants that might occur with a single nucleotide substitution, the most common variant in genomics.

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I demonstrate how to estimate the binding affinities of peptides containing and not containing those variants in the grooves of MHC-II, a criterion for binding T-cell receptors, using the standalone tools from the Immune Epitope Database.

What is unique about Navitas Data Sciences?

Navitas Data Sciences both supports and cultivates its employees. My manager worked hard to find a placement for me that fit both my skills and interests. When friends ask me what I do, I sometimes respond that I solve the most challenging puzzles every day and Navitas ensures that I am intrigued and challenged every week.


Tell us a bit about yourself and your professional journey?

Timothy Harrington: I have been a SAS programmer since 1994, and have been in Clinical Trials FDA submissions for most of that time, Quality Control (QC) for 16 years, and Pharmacokinetic (PK) data for over 10 years.

I have attended 14 PHARMASUG conferences, and presented at most of them. I have been with Navitas Life Sciences for 16 years.

What will you be presenting at PharmaSUG?

Timothy Harrington: I will be presenting on the topic “Evaluating and Correcting Nominal and Actual Relative Time Measurements in Clinical Trials PK data”

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How do you maximise the benefits of Clinical trial Data?

Navitas Data Sciences leverages the expertise and experience of its experts who are service oriented with a global reach, and ensure the establishment and maintenance of a professional relationship with customers.

Focus on QC and good data visualization are important aspects to maximising the benefits of clinical trial data.

Case Study: Statistical Programming support for an urgent ISS for a top 20 global pharmaceutical company

A top 20 pharmaceutical company developing innovative therapeutics for people with life-threatening diseases had an urgent need for Statistical Programming Support for an Integrated Summary of Safety (ISS) for a submission and a subsequent need to support their ongoing studies.

Learn how we worked with the sponsor to deliver Statistical Programming support and provide key data insights to power better decisions and drive successful outcomes.

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