Please see message below from Elizabeth Wasternack, Executive Director of OTIS
Press release about this new initiative may be found HERE.
Dear Teratology Society Members,
We at the Organization of Teratology Information Specialists (OTIS) are excited to announce the launch of the OTIS Pregnancy and Lactation Review Project (PLRP) to all of you at our sister society. The FDA Pregnancy and Lactation Labeling Rule (PLLR) requires the revision of product labeling, by 2020, for all drugs approved after June 2001. This is a huge volume of work for the pharmaceutical companies. Part of the labeling revisions effort is to review the literature. We hope to tap the expertise of Teratology Society members and other sister societies in addition to our OTIS members to provide a consultation service to the pharmaceutical companies to create comprehensive literature reviews and risk evaluations based on the literature.
We have formed a separate for-profit entity, OTIS, Inc., which is owned by OTIS, our non-profit organization. This will be the principal arm of OTIS that will engage with interested companies who want to use our experts for product literature reviews.
In order to get to this point, we created many documents including: requests for proposals (RFP’s), statements of work, a prospectus and other documents and we would not have been able to do this without the expertise, input, and guidance from the PLRP Advisory Board. They have spent many hours reviewing documents and discussing questions and concerns that might arise during this project. The PLRP Advisory Board includes: Philip O. Anderson, Gerald G. Briggs, Cheryl S. Broussard, Alicia B. Forinash, Jan M. Friedman, Janine E. Polifka, and Anthony R. Scialli.
We are also thankful for the willingness of the individuals who have agreed to be part of the OTIS, Inc. Board of Directors. They will be providing oversight of the business side of OTIS, Inc. as we progress with this project. The OTIS, Inc. board members are: Stephen R. Braddock, Melissa S. Tassinari, Sarah G. Običan, Katherine L. Wisner, and Christina D. Chambers.
The webpage will be www.MotherToBaby.org/OTISInc and will be launching shortly. We will send around a link and notification email when it is live and ready.
In order for this project to be a success, we need your assistance! Please consider becoming an author or peer reviewer for these comprehensive reviews. Also, please help us get the word out to pharmaceutical companies about this service we plan to provide and how we can help alleviate their workload by taking on the assessments for the PLLR requirements. A prospectus for any potential companies is located here: https://simplebooklet.com/pllr.
If you are interested in being an author of one of the assessments or a peer reviewer, please contact Sheena de Giorgio at email@example.com.
Elizabeth Wasternack, CAE, CMP
Executive Director OTIS/MotherToBaby