Upcoming Webinar
Putting Pharmacovigilance into Action:
The ASA Biopharmaceutical Section is pleased to announce the following webinar, presented by Dr. Frank W. Rockhold and Dr. Tjark Reblin on September 16, 2021. The Distance Learning Team is hosting a new webinar series on Partnerships between Statisticians and Clinical Professionals in the Biopharm Industry. Each quarter we will have a clinical and statistical scientist pair to provide pragmatic and motivating examples of cross-disciplinary scientific engagement in biopharmaceutical research. If you have any question about this event, please contact Michelle Zhang (michelle.zhang@affamed.com).
3rd Quarter (10:00 – 11:30 am Eastern Time, September 16, 2021)
Speakers: Dr. Frank W. Rockhold1 and Dr. Tjark Reblin2
1 Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University Medical Center
2 Global Head of Drug Safety and Risk Management, ViforPharma, Gattbrugg, Switzerland
Moderator: Dr. Greg Ball
Registration Link: BIOP webinar series: Putting Pharmacovigilance into Action Tickets, Thu, Sep 16, 2021 at 10:00 AM | Eventbrite
Abstract
Every pharmaceutical company collects, analyzes, and reports safety data collected in trials and in the general use on their products to fulfill regulations and detect new signals to keep their product labels up to date. While those actions have an indirect benefit for the patient, to truly help them and their healthcare practitioners it is necessary to go beyond the raw data and translate the information into the benefit to risk context, informing risk management plans and specific mitigation actions that are derived from data. The goal of pharmacovigilance should be to minimize pain and suffering in patients who strive to benefit from the medicine prescribed by their physician. By properly characterizing benefits and risks of medicines in appropriate populations and semi-quantitatively or quantitatively estimating whether and to which extent the benefits outweigh the risks one can create tangible context for regulators, prescribers, and patients. This informs specific action plans for the health care provider to optimize the use of the treatment ensuring the right medicine gets to right patient. We will present our experience on some specific examples derived directly from our joint experience in safety and pharmacovigilance.
A message for 2021 ASA Fellow Candidates
This message is intended for BIOP members who plan to submit their ASA Fellows dossiers in 2021. Effective October 1, 2020, as approved by the Biopharmaceutical Section Executive Committee, an anonymous BIOP section working panel of dossier reviewers has been formed. The reviewers serving on the panel are experienced statisticians including former and present members of the ASA Committee on Fellows. Nominators from BIOP are encouraged to send completed dossiers for review to a current chair of the BIOP Fellows Committee (Ilya Lipkovich, ilya.lipkovich@lilly.com). All dossiers will be treated in strictest confidence. Nominators may anonymize the dossier before sending. The reviewing committee chair will send it to one of the available reviewers and provide feedback regarding potential gaps and improvements within approximately two weeks. Please submit for review well in advance of the ASA submission deadline, in order to receive feedback in time to make adjustments to the dossier. The committee will not share any personalized information about the reviewed dossiers with the BIOP Section Executive Committee, or any other committee beyond the reviewers.
You can see more details at BIOP page
We encourage you to take advantage of this service offered to the members of BIOP, and give our members the best opportunity to achieve the honor of ASA Fellow.