Effective Oct. 1, a new policy (3.1.14) created to define the PHS Guideline will allow members to use either the 1994 or the 2013 version. It will also require members to specify which version they are using in the donor highlights section of DonorNet. Click here
for more information, or see a comparison of the guidelines.
The AST recently provided the OPTN with comments on the plain language policy rewrite. View the comments here
This extensive three-day course focuses on non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.
November 12-14, 2013
College Park, MD
For more... Read More...
Repopulation of the immunosuppressed retrorsine-treated infant rat liver with human hepatocytes
Xenotransplantation (login required)
Humanized chimeric mice have been generated by transplanting h-hepatocytes into the livers of the diseased-liver transgenic mouse model with immunodeficient background. These mice with livers mostly replaced by human (h) hepatocytes have been proved to be useful for research on drug metabolism and toxicity and on intrahepatic pathogens such as hepatitis. However, their small body size prohibited collecting sufficient biological samples and made surgical... Read More...
When: Monday, Sept. 16,1-5:30 p.m.; and Tuesday, Sept. 17, 8 a.m.-3:30 p.m.
Where: Sheraton Pentagon City Hotel, 900 South Orme Street, Arlington, VA
This meeting allows members of the DTCP to come together to identify challenges that the community has identified related to donor management research. Participants will work toward consensus on issues related to donors, identify issues related to informed consent in the recipient, recognize and address informed consent issues regarding the effect of research on... Read More...
Your 2014 membership dues must be paid in full by March 1, 2014 in order to receive the member-discounted registration rates for the World Transplant Congress (WTC)
. No exceptions will be made.
If you are not a member of AST and wish to receive the member-discounted registration rate to the WTC, you must submit your application for membership by January 15, 2014. Late submissions will not be accepted. If your membership is approved, your dues must be paid by March 1, 2014.
Please contact AST Member Services with any questions... Read More...
URGE YOUR MEMBERS OF CONGRESS TODAY TO SUPPORT ROBUST FEDERAL FUNDING FOR NIH AND MEDICAL RESEARCH
As Members of Congress have embarked on a month long August recess period back in their home States and Congressional Districts, it is imperative that they continue to hear from their constituent AST members regarding the unfinished and inadequate approach that Congress has taken thus far with regard to NIH and medical research funding in FY 2014.
As you know, AST's Public Policy Committee and Wash, DC Government Relations office continue to meet daily with Congressional decision-makers on... Read More...
To: primary program administrators, primary physicians, primary surgeons, primary data coordinators, OPTN representatives, and transplant program directors.
Beginning in August, UNOS Data Quality will introduce a new process for verifying with transplant programs the current status (living or dead) of certain candidates waitlisted and recipients transplanted and/or followed post-transplant at the transplant program. This process will involve use of data from other sources to supplement patient status information known to the transplant program. Information in some of these sources must be... Read More...
On July 11th, AST, ASTS, and UNOS were informed by CMS in a teleconference that they are initiating a pilot program called Focused Quality Assessment and Performance Improvement (FQAPI). This new survey strategy will be rolled out starting on Monday, July 15th, and we're told would involve 10 programs initially. It will follow the standard practice of unannounced notice to selected centers. The CMS official assured us that this start would be a pilot and that there would be no citations or 2567's issued in response to the results. The results will be carefully reviewed internally to address... Read More...
The U.S. Food and Drug Administration (FDA) recently approved the New Drug Application (NDA) for ASTAGRAF XL™ (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. The full press release can be read here