Connect Streams

StreamStream Description Chair / Co-Chair

Analytics, Big Data & Statistics

 

Analytics, Big Data & Statistics is designed to allow members to share ideas on the interface between statistics, analytics and computing as well as innovative ideas to analyse and manage the big data in our industry. This can be software-related, for example how computing packages can be used to resolve data analytics or statistical issues within the clinical trial field. It can also be statistical in nature, such as improving programmers' understanding of new innovative statistical and analytical methods, or describing statistical/analytical/programmatic approaches in specific areas (e.g. PK/PD; statistical modeling; analytical techniques – use of SAS Graph or R; use of adaptive designs vs. group sequential designs and their implementation, analysis and presentation of biomarker data; analysis of outcomes data; use of registry data and historical or case controls for orphan indications, to name but a few).



Steve Kirby
Chair


Vidya Muthukumar
Co-Chair

Renu Shukla
Co-Chair

Analytical Risk-based Monitoring
*NEW*

The purpose of the Analytical Risk-based Monitoring Stream is to share innovative approaches leveraging real-time access to clinical data and analytics in proactively managing clinical operation risk. Analytical Risk-based Monitoring (ARBM) is a growing field in clinical trial execution. Operation execution of a sustainable risk management strategy in clinical development requires a seamless approach for review of critical data in real time. This approach requires leveraging and relying on new modalities, predictive modeling, analytics, visualisations, and approaches for identifying and monitoring critical endpoints, key risk indicators (KRIs), associated data and processes required for collection of those data.



Hanming Tu
Chair


Bhavin Busa
Co-Chair


Adrienne Strickler
Co-Chair

Coding Tips & Tricks

The Coding Tips & Tricks Stream is dedicated to brief presentations on real-life code, programming tips and best practices, efficiency techniques, undocumented/new features, useful algorithms, macros and other creative uses of software. This session is the perfect forum for beginners and experts alike to share coding tips and tricks that can transform the current state, with techniques that increase efficiencies or provide time/cost savings. If you have found an innovative solution to solve a challenging problem, come share it with the statistical programming community.


Suhas Sanjee
Chair


Saranga Ram
Co-Chair


Kristen Harrington
Co-Chair

Data Handling

The Data Handling Stream is dedicated to many aspects of data handling and database management in life sciences and the pharmaceutical industry. These aspects include extraction and transformation of raw data, metadata definition and handling, data quality, validation and acceptance, analysis data processing, data de-identification and transparency, data mining, master data management and clinical data warehousing. With the increasing complexity of clinical trials data and greater emphasis on delivery of high-quality and submission-ready data, state-of-the-art and novel data handling techniques for managing clinical data are needed and appropriate for this Stream.



Heather Stevens
Chair

Subha Jamburajan
Co-Chair 

Anupama Sheoran
Co-Chair 

Data Standards & Governance

Effective implementation and governance of CDISC data standards is the recommended foundation for efficient collection and analysis of data across studies and sponsors. It is also key to ensuring that data are fit for use by regulatory authorities and other key data consumers. The Data Standards & Governance Stream focusses on how companies are embedding the foundational aspects of existing and future data standards into their business processes. Topic areas will include: underlying concepts, descriptions, explanations, interpretations, and processes designed to support the implementation, management and governance of these data standards.



 

Ellen Asam
Chair

Priya Gopal
Co-Chair

Nancy Haeusser
Co-Chair 

Data Visualization

Seeing the big picture opens your eyes to the data! Visual representations, such as charts and maps, provide a mechanism for people to easily and quickly understand what the data represent and mean. Hundreds of thousands of data points are collected during a typical study. Tables and listings are used for summarisation and to display detailed records; however, tabular summaries and listings take more time to digest. How do we communicate information clearly and efficiently to users? Data visualisation is a powerful technique that is used to understand, interpret and even clean data. The Data Visualization Stream focusses on data visualisation examples, tools and techniques that can be applied to data in our field, to support drug development.



Michael Badlani
Chair


Roopali Lakhe
Co-Chair

Dan Schramek
Co-Chair

Leadership

Following the successful inaugural PhUSE US Connect, this year, the Leadership Stream will continue to apply innovative, collaborative and engaging approaches to each of the sessions, with a view to creating take-away messages for all. Open to everyone, the Leadership Stream is again set to be interactive and fun, and we are working to engage some excellent presenters to help stimulate and lead the debate. (Presentation is by invitation only; however, all are welcome to attend the Stream.)



Karen Curran
Chair
 

James McDermott
Co-Chair

Sangeeta Bhattacharya
Co-Chair

Machine Learning & Artificial Intelligence
*NEW*

The current field of artificial intelligence (AI) grew out of academic theories from the 1950s. It has been refined over decades and, combined with a steady progression in computing power, has transformed the mere idea of AI into reality. AI itself encapsulates many subfields such as machine learning, natural language and speech processing, automated reasoning, knowledge representation, neural networks, evolutionary computation and algorithms, and deep learning, just to list a few. The Machine Learning & Artificial Intelligence Stream is focussed on introducing the community to these topics and exploring how we can utilise these approaches to drive clinical drug development and better outcomes for patients.



Michael Rimler
Chair


Yingqiu Yvette Liu
Co-Chair

Feryal Tanriverdio
Co-Chair 

Poster Presentations

A poster is worth a thousand words, and an hour of conversation and networking. Poster Presentations provides an opportunity to cover any of the Stream topics in a visual and engaging manner. Posters are ideal for presentations that include graphics, source code, statistical or thought-provoking concepts, novel data management or handling techniques, innovative ways to implement data standards, and much more. Posters increase visibility, allow participants to review at their own pace, and provide for engaging in conversation to discuss the topics presented.



Narasimha Ayyalas
Chair

Steven Huang
Co-Chair


Carol Baker
Co-Chair

Submissions & Agencies 

The regulation of clinical data is governed by constantly evolving rules, standards and regulations on data transparency and protection, GxP, ICH, 21 CFR Part 11 compliance, validation, version control, process management and continuous improvement processes. Clinical data is regulated on all aspects of submission-related activities including interactions with health authorities, site inspections and audits. The Submissions & Agencies Stream invites you to share your experiences and have open discussion on the challenges and benefits of working in a highly regulated industry.



Paul Nevills
Chair

Lilliam Rosario
Co-Chair


Maria Dalton
Co-Chair

Software Demonstrations 
*NEW*

The Software Demonstrations Stream focusses on the demonstration of new or recently released software and tools. It may include new programming platforms, reporting systems or data management tools and new innovative applications utilising a variety of new and established technologies. Each demonstration has the goal of highlighting potential for enhanced optimisation, increased efficiency or user-friendliness in the day-to-day undertaking of biometrics processes and tasks.

James Gunter
Chair

Jim Vasquez
Co-Chair

Edita Karosiene
Co-Chair

Standards Implementation

The Standards Implementation Stream is dedicated to the implementation of industry standards, such as CDISC, to support the acquisition, exchange, analysis, submission and archival of clinical data and metadata in life sciences and the pharmaceutical industry. This Stream focusses on the implementation of these standards using scripts, macros and tools that are not platform-specific.




Crystal Allard
Chair

Andrew Miskell
Co-Chair


Cynthia Stroupe
Co-Chair 

 

Strategy & Programming

 

 

The Strategy & Programming Stream will examine some of the softer skills. As an industry, we often focus on the common programming languages, data standards and technology, but there is more to making us efficient and successful within the work environment. With an ever-changing environment, staff have more opportunities to learn and move around, giving more importance to how we retain the right people. With our distributed model of working within global teams, management of this diverse team and quality of the deliverables becomes a key activity for all managers. In our group of presentations, we will learn how we can cope with these challenges.

Georgina Wood
Chair

Sara Modin
Co-Chair

Kala Shivalingaiah
Co-Chair

Trends & Technology

The Trends & Technology Stream concentrates on the many new and emerging trends within life sciences that have an impact on those working with data. These could include hot topics driven by external factors such as public opinion and the application of innovative technologies in the life sciences sector.

Avinash Reddy Pati
Chair

Mary Varughese
Co-Chair


Lisa Lyons
Co-Chair

 

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