Insights from Experts: What Happened at PHUSE US Connect 2023 and PHUSE India Single Day Event

Navitas Data Sciences has a strong global footprint that helps provide local expertise and support, as well as global reach and scalability. Our teams recently participated at PHUSE US CONNECT 2023 held in Orlando and at the PHUSE INDIA Single Day Event in Hyderabad.

PHUSE US Connect 2023

Navitas Data Sciences is the Functional Service Provider (FSP) for Navitas Life Sciences, providing bespoke global solutions to support Statistical Programming (SAS and R), Biostatistics, and Data Management needs.

We recently showcased as a Platinum Sponsor at the PHUSE US Connect 2023, an event dedicated to promoting the advancement of clinical research and development through the use of technology and data. Navitas Data Sciences has a long-standing association with PHUSE US Connect, showcasing as a Platinum Sponsor/Exhibitor since 2020 and as an Exhibitor since 2018. Prior to that, our experts attended Single Day Events (SDE) from 2012. This year saw the biggest attendee list at PHUSE US CONNECT with 675 attendees from across 19 countries and 162 companies.

Kathy Greer, Executive Vice President Professional Services, Andee Garrison, Lead SPA II, Kevin Viel, Lead SPA, and Jeff Dickinson, Senior Project Manager attended the PHUSE Connect 2023, which was an insightful and informative event that brought together pharmaceutical professionals, regulators, and technology experts from around the world. The conference was held in Orlando, Florida, USA, and it offered a range of sessions, workshops, and networking opportunities over the course of four days.

The conference featured presentations and discussions on various topics related to the pharmaceutical and biotech industries, with overarching discussions on empathy, diversity, and inclusion. There were a lot of insights on current trends shared during intense presentations from experts from across the industry, with an emphasis on data visualization.

One of the Popular Booths at PHUSE CONNECT 2023

Navitas Data Sciences had the opportunity to showcase its expertise in Statistical Programming (SAS and R), Biostatistics, Data Management and Project Management in a bright, well laid out, and very informative booth. Mike Cox, Director of Business Development at Navitas Data Sciences was thrilled to have so many people stop by the booth.

During the conference, our experts engaged in stimulating discussions with other industry experts who visited our booth and engaged in interesting discussions regarding the use of R Programming and Real-World Evidence in clinical research. They also discussed the importance of data quality and the challenges associated with managing and integrating data from various sources.

Leveraging our Global and Geo-diverse Footprint for an Insight-rich Round Table Discussion

One of the highlights of the conference was a round table discussion on “Working & Managing in a Multicultural and Geo-diverse Landscape.”

“Diversity, empathy, and inclusion should be among the top considerations of any manager. Working virtually with global teams allows us to experience different cultures and beliefs that should be recognized and celebrated by planning deliverables and timelines to encompass these and encouraging other team members to take on work to help all.”

Kathy Greer,
Executive Vice President Professional Services
Navitas Data Sciences

The panelists discussed that working in a multicultural and geo-diverse environment requires a high level of preparation, foresight, and empathy. During this roundtable, the members highlighted practical challenges, including multifarious holidays, global disruptions, and diverse customs and conventions.

Navitas Data Sciences leveraged its vast experience to discuss tangible strategies to address these challenges such as using proactive technology to help with advanced planning and backup resource assignments for continuity while using strategies like Pecha Kucha and those from “Kiss, Bow or Shake Hands.”

“Managing a geo-diverse workforce offers innumerable benefits from multiple and varied perspectives to cost-effectiveness and around-the-clock support. However, it is important to incorporate a regard of local workforces to leverage these advantages. Respecting and valuing all customs, traditions, and structures creates a robust team that benefits everyone.”

Andee Garrison,
Lead SPA II,
Navitas Data Sciences

The talk on empathy focused on building strong relationships while allowing others to grow. The members agreed that it’s important to be supportive while offering space for others to share without being intrusive. Additionally, being vulnerable helps leaders present an open environment for individuals and teams to develop and strengthen without judgment or condescension.

Engaging Presentation by Jeff Dickinson

Jeff Dickinson, Senior Project Manager, spoke about “Programming CDISC ADaM, ADNCA using R Programming and {admiral}.”

The presentation provided practical tips on using R Programming and {admiral}, as well as how to ensure quality. Attendees learned about ways to navigate the various considerations associated with the use of these data tools.

“There was definitely a lot of buzz around open-source technology and ways the Pharma industry can leverage the power of open source. For example, I’ll highlight OS11: Why Roche Invests in Building Open-source Software for Clinical Reporting by Thomas Neitmann.
I’ve been working with Thomas on adding Pharmacokinetic (PK) data programming to an R package called {admiral} which is used for creating analysis datasets (ADaM). Coincidentally, we were able to release an updated versions of {admiral} (version 0.10.0) while we were at the conference.
It was nice to have the opportunity to meet people in person with whom I have been collaborating over the past year.”

Jeff Dickinson,
Senior Project Manager,
Navitas Data Sciences

Exceptional Poster Presentation by Kevin Viel

Kevin Viel provided an interesting overview on “A Standard Data Set Format for the Validation of Tables and Listings in Regulatory Submissions for Clinical Trials,” breaking it down into manageable segments that were easy to understand, skillfully weaving in relevant statistics and research findings to boost understanding.

“My poster presented a standardized Validation Data Set (VALDS) intended to remove questions about variables: names, labels, formats, type, and values, while specifically used to manually spot-check a Table or Listing included in the CSR. Such a data set ‘looks like’ the output to a much greater extent emphasizing the correspondence between a value in the data set and the displayed value in the cell of its output, for instance, to identify width or formatting issues in the output that may affect the displayed value and complicate its interpretation by a reviewer.
Attendee response included epiphany “Oh! A structure like this would allow new resources to join a team and be productive more rapidly; no need to learn the conventions of the teams if we have an (industry) standard.” Additionally, by using a COMPUTE block and the SAS INDENT STYLE, my paper presents SAS code to eliminate leading spaces for some values. More uniformity and minimum “decoration” of values should lead to more accurate, more efficient Validation and fewer required updates to program between deliveries, projects, or authors.”

Kevin Viel,
Lead SPA,
Navitas Data Sciences

PHUSE INDIA SINGLE DAY EVENT - March 18^th, 2023, Hyderabad

Navitas Data Sciences is a trusted partner for the life sciences industry, providing high-quality services and innovative solutions that help clients to succeed in an increasingly competitive and complex environment. Navitas Data Sciences sponsors the Single Day Events in India to bring together industry experts from the pharmaceutical and healthcare industries to discuss the latest trends, technologies, and challenges facing these sectors.

Shrishaila Patil, Senior Vice President of Statistical Programming, continues as the PHUSE India Single Day Event (SDE) Lead for 2023. Shrishaila has been associated with PHUSE since 2014 having served as a volunteer, presenter, chair, events coordinator, and producer for multiple single day events in India. As a contributor to the great success of several events over 2022, we look forward to seeing the outputs of Shrishaila’s continued dedication over the coming year and further building of the PHUSE community.

Sharing Insights, Stories, and More at PHUSE INDIA SINGLE DAY EVENT

The PHUSE India Single Day Event was held on 18^th March 2023 at Hyderabad on “Open-source technologies in Data Science and Analytics – Making it happen, making it matter.” Several presentations resulted in an informative and engaging day. Attendees had the opportunity to engage in lively discussions and ask questions of the panelists, with many new ideas and perspectives emerging from these conversations.

Swapnil Udasi, Senior Manager of SAS Programming, Kusumanjali Kosuri, Associate Manager of SAS Programming, Harish Ponugoti, Principal SAS Programmer, and Shrishaila Patil from Navitas Data Sciences

In addition to the informative sessions, the event also featured several networking opportunities, allowing attendees to connect with colleagues and make new contacts in a relaxed and informal setting.

Shrihaila Patil with

• Jagadeesh Rudraswamymath, Global Head - Clinical Data Acquisition and Management, Data Operations, GDO at Novartis
• Dr. Silke H., Global Head of Statistical Programming (TA: Onco), Global Head of Biostatistics Operational Excellence at Merck KGaA, Darmstadt
• Guillaume Breton, Development Units and Statistical Programming, Global Head, Novartis

Overall, the PHUSE India Single Day Event in Hyderabad was a resounding success, providing valuable insights and connections for all attendees.

Navitas Life Sciences team was impressed by the breadth and depth of knowledge shared at the PHUSE events, and they look forward to implementing some of the insights and ideas they gained. Overall, the event was a great success and a valuable opportunity for Navitas Life Sciences to connect with other leaders in the industry and continue driving innovation in clinical research.

Navitas Life Sciences offers a range of services from Phase I-IV Clinical Trials, regulatory affairs, pharmacovigilance, and medical affairs. The company's expertise spans a wide range of therapeutic areas, including oncology, neurology, cardiovascular, and respiratory diseases.

In addition to its core services, Navitas Life Sciences also offers a range of technology-enabled solutions that help clients leverage data and insights to make more informed decisions, improve efficiency, and drive innovation.

On-Demand Webinar: Enhance your Data Science toolkit with open-source tools - How R can create efficiencies in data review and insight

Listen to our On-Demand Webinar, Enhance your Data Science toolkit with open-source tools – How R can create efficiencies in data review and insight, as our subject matter experts explore how R can create efficiencies in data review and insight. The webinar explores the following key topics:

Motivation

• The need of the hour
• The evolving Data Science toolkit
• Open-source tools – are they reliable?

Use case for R

• Current trends
• Regulatory requirements
• Challenges and validation of R

The Navitas Data Sciences perspective

• Assessment of industry readiness
• Navitas Data Sciences’ preparation and lessons learned

Watch Now

Presenters

Shrishaila Patil,

Vice President, Statistical Programming
Navitas Data Sciences

Troy Ruth,

Director, Clinical Reporting,
Navitas Data Sciences

To know more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.