Hyderabad

14th July 2018

Life Cycle of a Drug – From a Statistian's and Programmer's Standpoint. Safety and Efficacy End Points in Breakthrough Therapies

 

Summary:

The PhUSE Hyderabad Single Day Event (SDE) was held on 14th July 2018 with the theme “Life Cycle of a Drug – From a Statistician's and Programmer's Standpoint. Safety and Efficacy End Points in Breakthrough Therapies” and witnessed the highest number of attendees at a PhUSE Single Day Event, with over 210 participants.
 
The day started with Mayank Anand providing a PhUSE update and introducing the SDE Chairs Shrishaila Patil and Lakshmikanthan Santhanakumar to the audience. As the day progressed, Sunil Gupta provided programmers great insights into best programming practices, Advanced SAS techniques and CDISC compliance techniques. Ranjith introduced the audience to concepts of Breakthrough Therapy Designation and its importance.
 
The SDE witnessed diverse topics from industry experts including “Evaluating Anthropometric Growth End Points with Z-Scores and Percentiles”, “Primary End Points Analysis in Pivotal Submission Studies –  From a Statistical Programmer's Perspective”, “PROC MI – A New Tool to Deal with Laboratory Missing Data in ADaM”, “Neutropenia End Points and their Effect on Cancer Patients”, “Data Analysis – Gateway to Unlocking the Potential of Drug Development” and “Life Cycle of a Drug – How Does this Cycle Work?”. There were detailed presentations on breakthrough therapy such as “A Peek at the Drug Development Process and End Points in Breakthrough Therapies”, “Different FDA Review Designations, and Features that Statistical Programmers Need to Know for Breakthrough Designations (BTDs)”.
 
The panel discussion was motivating and had good participation from the audience. Interesting questions were asked by programmers about career development and retention in today’s evolving and challenging environment.

 

Presentations:

Better CDISC Compliance Techniques Results in Faster Breakthrough Therapies – Sunil Gupta, Cytel

Expediting Drug Development – The FDA's New Breakthrough Therapy Designation – Ranjith Prayankotveettil, PPD

Evaluating Anthropometric Growth End Points with Z-Scores and Percentiles – Pradeep Umapathi and Snehal Sanas, Covance

Primary End Points Analysis in Pivotal Submission Studies – From a Statistical Programmer's Perspective – Vikramaditya Yandapalli, PAREXEL

PROC MI – A New Tool to Deal with Laboratory Missing Data in ADaM – Jaganadha Rao Gundu, CTS

A Peek at the Drug Development Process and End Points in Breakthrough Therapies – Samuel Lella & Visweswara Yadalam, Quanticate

Life Cycle of a Drug – How Does this Cycle Work? – Parin Shah, Cytel

Neutropenia End Points and their Effect on Cancer Patients – Rosina Jose, ICON

Different FDA Review Designations, and Features that Statistical Programmers Need to Know for Breakthrough Designations (BTDs) – Puli Raju Mandati, GSK

Data Analysis – Gateway to Unlocking the Potential of Drug Development – Prabhu Kuppuraj & Chinnappa Aduri, Novartis

 

View the event brochure.

 

Sponsorship:

 

 

Photos from the day:

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