Introducing the PHUSE/FDA Data Science Innovation Challenge Stream Chairs

A healthy relationship between PHUSE and the FDA has been building since 2007 when Dr Armando Oliva gave the PHUSE conference keynote. During the PHUSE US Connect in Baltimore back in March of this year, Stephen and Lilliam sat down to have their annual review of the FDA/PHUSE relationship and looked to see how they could build on the catalogue of success.

PHUSE events bring together a vast global network of skilled people and drive inspiration for attendees. At the US Connect 2019, Dr Mitra Ahadpour gave a keynote on the Monday morning focused on the global opioid crisis – it was here that Stephen and Lilliam looked to see how they could leverage the expertise of the Computational Science Symposium (CSS) environment.

Leverage sparks innovation. Individuals could use their skills differently to how they do at the CSS (which is more around developing new processes and new ways of working) by moving development into a solution, in an attempt to solve these crises. Stephen and Lilliam agreed to have a follow-up call with Dr Ahadpour and see what the biggest challenges were – and that really was the catalyst!

 

James R. Johnson, PhD
Opioid/Substance Use Disorder
Retired Biostatistician and Pharmacokineticist

 

 

Jim Johnson is a retired biostatistician and pharmacokineticist. Jim spent over 35 years supporting both nonclinical and clinical research and development of drugs and devices in the pharmaceutical and biotechnology industries. In his career he had broad therapeutic experience with novel therapies in pain management, inflammatory diseases, cardiology, and arthritis. He also has a vast history with regulatory submissions (lead statistician on six NDAs) and international regulatory agency interactions, including advisory committees and DSMBs.

Jim has published numerous peer-reviewed abstracts and articles and is a frequent presenter at PHUSE conferences. He also held an Adjunct Professor of Clinical Research position for eight years at Campbell University College of Pharmacy & Health Sciences, teaching and mentoring graduate students, and he was the Principal Investigator for the Data Coordinating Center for the five-year SPARC study on cardiac imaging outcomes. Jim earned a PhD from the North Carolina State University in Raleigh, NC, USA.

 

 

Patricia Hegarty
Drug Safety Surveillance 
Statistical Programmer at Bayer HealthCare

 

Patty Hegarty has worked in the pharmaceutical industry for over 20 years, serving in various roles across monitoring, data management, and statistical programming. In her current role at Bayer, she drives implementation of industry standards within statistical programming, and ensures compliance with health authority regulations for submission of electronic data packages.

Patty is thrilled to be a part of the first PHUSE/FDA Data Science Innovation Challenge and looks forward to seeing the tangible outcomes from this unique opportunity.

 

 

Beverly Hayes
Approach for Predicting Drug Interactions
Director, Statistical Programming & Analysis at Johnson & Johnson, Early Development & Clinical Pharmacology

 

 

Bev Hayes has over 25 years of experience in pharmaceutical clinical R&D statistical programming. Throughout her career she has supported, and led teams to support, clinical development and global submissions across a variety of therapeutic areas. Currently, she heads the Early Development and Clinical Pharmacology Statistical Programming & Analysis (SP&A) group at Janssen Research & Development.

As someone with an educational background in computer science and software engineering, Bev has always been inspired by her work, having the ability to leverage technical expertise in a way that has a positive impact on the lives of patients and their loved ones. As such, she is particularly excited to be a part of the Data Science Innovation Challenge to explore technical solutions to advance and improve global public health.

For more information, visit innovation.phuse.eu

 

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