Biopharmaceutical Section

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Biopharmaceutical Section

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Biopharmaceutical Mentoring Program Announcement

The Biopharmaceutical Section is pleased to introduce a mentoring program for the enhanced benefit of its members!

Networking can be challenging but is beneficial. Meeting others in our profession can help us quickly learn the ropes, improve our careers, and contribute to statistical profession. Finding a mentor has its challenges and keeping that in mind, the Biopharmaceutical Section is initiating the mentoring program based on the mentoring blueprint created by the Committee on Applied Statisticians.
The goal of this initiative is to help members further enrich and enhance their professional experience through achieving personal and professional goals. This may commonly occur through sharing of knowledge and experience between a professional practitioner and someone entering the profession of statistics. A constructive mentorship relationship can take many forms and may occur at any stage of career with benefits for both mentor and a mentee. We will provide hands-on resources for mentors and mentees to facilitate their interactions. Information related to the mentoring activities and additional resources for mentors and mentees will also be made available via Biopharm website in future (http://community.amstat.org/BioP/aboutus/mentoringprogram).

Currently we are looking for mentors and mentees for this mentoring program. Are you interested in becoming a mentor to a statistician and helping initiate this program? Are you a potential mentee, or can you nominate a statistician who may be looking for a mentorship program? If so, please email contact info to the (biopharmmentoring@gmail.com) with the subject: "Biopharm Section Mentoring Program". It would be helpful if you also send a resume to help us match mentors and mentees by June 15. Please contact Amarjot Kaur (Amarjot_kaur@merck.com) or Jennifer Gauvin (jennifer.ls.gauvin@gsk.com) if you need any additional information or clarification related to this program.

The Biopharmaceutical Section welcomes everyone to 2014 JSM in Boston!

This year we will be celebrating the 175th anniversary of ASA at JSM. Our section has many activities on the program starting with its continuing education program. We are offering three full day short courses at JSM. On Saturday (Aug 2nd) of the JSM, Alexei Dmitrenko, Jeff Maca (both of Quintiles) and Devan Mehrotra (Merck) will give a short course on Analysis of Clinical Trials: Theory and Applications. On Monday (Aug 4th) of the JSM, Brian Wiens (Alcon Labs) will teach his class on the Design and Analysis of Non-inferiority Trials. On Tuesday (Aug 5th) of JSM, Dr. Richard Simon from National Cancer Institute will present a short course on Genomic Clinical Trials and Predictive Medicine.

In addition, we will have 6 invited sessions, 22 sponsored topic contributed sessions, and 26 contributed sessions! I will highlight a few to entice you to join us and strongly advise that you go to the ASA website (www.amstat.org) and check out the program now on-line.

Sunday at JSM (Aug 3rd)
2:00PM Statistical Challenges for Cancer Clinical Trials Organizer: Sudhakar Rao, Janssen pharmaceutical
4:00PM Data Monitoring Committees - Do they have role in Post-Marketing Approval Commitments? Organizer: Vipin Arora, AbbVie, Inc

Monday at JSM (Aug 4th)
8:30 AM Go/No-Go: the practice for developing best-in-class product from statistical perspective Organizer: Xuan Liu, AbbVie
10:30 AM Global development of biopharmaceutical products: past, present and future
Organizer: Bo Yang, AbbVie
10:30 AM Biopharmaceutical Section Student Paper Competition Chair: Richard McNally, Covance
2:00PM The Role of Statisticians in Risk-Based Monitoring and Fraud Detection in Clinical Trials Organizer: Richard C. Zink, JMP Life Sciences, SAS Institute

Tuesday at JSM (Aug 5th)
8:30 AM Statisticians' Contributions to Public Health Achievements of the 20th Century Organizer: Christy Chuang-Stein, Pfizer Inc
10:30AM Impact of missing data on trial success and approval of potentially efficacious therapies Organizer: Abdul J Sankoh, Vertex Pharmaceuticals
2:00PM Impacts of emerging global clinical trials transparency initiatives Organizer: Theodore Lystig, Medtronic, Inc.

Wednesday at JSM (Aug 6th)
8:30 AM Statistical planning of an adaptive design in early phase trials Organizer: Bo Huang, Pfizer Inc.
10:30AM Approaches for Benefit-Risk Assessment in Clinical Development Decision-Making Organizer: Weili He, Merck & Co., Inc.
2:00PM Innovative Designs in Vaccine Clinical Trials Organizer: Robert D. Small, Sanofi Pasteur

Thursday at JSM (Aug 7th)
8:30 AM Design and analysis of large outcomes trials Organizer(s): Charlie Cao, Takeda Development Center Americas, Inc.
10:30 AM Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence Organizer(s): Byron Jones, Novartis Pharma AG

Many of the contributed submissions are excellent so we urge you not to skip these. The poster sessions: these are great if you like having a one on one discussion with the authors. This year we also have a hybrid kind of presentation, the SPEED session (like speed-dating…. only better). In the SPEED session, you get to hear a short 5 minute talk on each presentation with 20 such talks in a session. In the following session, you get to talk with the authors and enjoy some refreshments. In addition, our section will sponsor 1 roundtable discussion sessions on Wednesday. Please check out the details and registration information on the JSM website.

Of course, while you tell your boss that you are coming for all the intellectual stimulation, I urge section members to attend our reception and business meeting on Aug 5th (Tuesday). Check the program for the time and place. Please come and be engaged!

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