Web-Based Training Program
Web-based distance training has become a standard training tool for the Biopharmaceutical Section. The section launched the program in March 2007 as a service to its membership and to provide an alternative to live training courses. (This program is supported by the ASA Center for Statistics Education.) As travel and hotel rooms are becoming increasingly more expensive, web-based communication channels have emerged as a low-cost way to deliver training. Also, web-based training allows busy members to attend when they can’t take a couple days out of their busy schedules.
This year’s program has included the following two-hour webinars:
- Nonparametric Dose Response Models in Bayesian Adaptive Designs
Andrew P. Grieve, King’s College, London - Data Monitoring in Practice: Making Your Data-Monitoring Committee Effective
Janet Wittes and Matt Downs, Statistics Collaborative - An Introduction to the Nonlinear Mixed Effects Model and Pharmacokinetic/Pharmacodynamic Analysis
Marie Davidian, North Carolina State University - Statistical Analysis of Short-Term Studies in Regulatory Toxicology Using R
Ludwig A. Hothorn, Leibniz University Hannover, Germany - A Predictive Approach to Process Optimization with Applications to Pharmaceutical Development and Manufacturing
John Peterson, GlaxoSmithKline
The program has attracted the attention of industry statisticians, academic researchers (especially researchers specializing in biostatistics), government statisticians (including statisticians working at regulatory agencies), and graduate students. Our goal is to make the audio and slides available for those who missed the live webinar.
For more information about the web-based training program, visit the section’s website.
Additional materials and interactive options are available at Biopharmaceutical Network’s website.
It’s a cliché, but it’s true: My year as chair has flown by quickly. During this year, the section has continued to thrive as a constructive entity within the ASA. As always, the section thrives only because so many of our members contribute their time and talents to the process.
With apologies to those who I may inadvertently omit and to the others who contribute in less visible but vital roles, I want to acknowledge the efforts of our executive committee. I thank the following:
Anna Nevius, past chair
Steve Wilson, chair-elect
Steve Gulyas, treasurer
Rick Caplan, secretary
Dionne Price, program chair
Jeff Maca, program chair-elect
Devan Mehrotra, publications officer
Alex Dmitrienko, Mani Lakshminarayanan, and David Bretier, Council of Sections representatives
Ram Suresh, Venkat Sethuraman, Veronica Taylor, Thomas Keefe, Patricia Stephenson, and Anna Legendza, executive committee members
David Henry, Jose Alvir, Debbie Panebianco, and Amit Bhatthacharyya, Biopharm Report editors
Mani Lakshminarayanan and Venkat Sethuraman, distance training (webinars)
Ivan Chan and Qian Graves, co-chairs of the FDA/Industry Statistics Workshop
Russ Helms, corporate sponsor committee chair
Neal Thomas, Fellows committee chair
Christie Clark, student paper competition chair
Heather Thomas, contributed paper award chair
Yongming Qu, poster competition chair
Ed Luo and Ram Suresh, membership survey
This list is incomplete, as it excludes many who assisted with conferences (either presenting or helping to “run the show”), served on committees, or participated in a project. Rest assured, however, that the contributions of all are appreciated. The section cannot operate without your help, and we are always looking for volunteers. I was thrilled with the enthusiasm shown by new volunteers at JSM and welcome “new enthusiasm” at any time. Please contact Wilson at stephen.wilson@fda.hhs.gov to volunteer.
Accomplishments
So what did we accomplish this year? Our distance learning program has continued to be successful. Lakshminarayanan and Sethuraman, with the support of ASA Education Programs Associate Rick Peterson, brought us webinars on various topics, with more coming in the near future.
Gulyas and Jeremy Jokinen’s work with Creative Street has continued on our Web Clip Statistical Outreach Program. This website is designed to get high-school and college students thinking about careers in statistics. Take a look and provide suggestions for additional entries to flush it out. If you are interested in helping, contact Gulyas at sgul@lundbeck.com, Jokinen at jjokine1@its.jnj.com, or Wilson.
Last but not least, there are a few administrative details to discuss. It seems section members voted for charter changes, but the new charter was not properly cataloged. Nevius has taken care of this. And with the help of Nevius, Kannan Natarajan, and others, I have whipped the operations manual into modernized shape. It is intended to be a living document that stays updated annually, rather than once every 13 years. Finally, Nevius is preparing a history of the FDA/Industry Statistics Workshop, which is now in its Nth year. This September, we were unsure of what N was, which is why Nevius decided a history was in order.
Once again, thank you to everyone who has helped keep the section lively and productive.
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