Transplant, FDA Sectors Debate Clinical Trial Approaches
In what might be characterized as an ongoing disagreement between transplantation and the Food and Drug Administration (FDA), the June 2 session at ATC 2009, "Controversies in Transplantation: Making Clinical Trials Relevant," addressed the process for FDA approval of immunosuppressive drug regimens.
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Diligent monitoring and effective clinical management were strategies recommended for addressing the development of cytomegalovirus (CMV) and polyomavirus BK-associated nephropathy in transplant patients. Experts presented their various perspectives on "CMV and BK Virus: Controversies and Challenges" during the June 2 Sunrise Symposium at ATC 2009.
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Attendees seeking to learn the latest in "Kidney Immunosuppression: Novel Agents" did not leave this ATC 2009 session disappointed. Among the topics addressed during this June 2 Concurrent Session were the pharmacokinetics of a tacrolimus and sotrastaurin combination and the immunosuppressive inefficacy of a sotrastaurin and mycophenolic acid (MPA) combination.
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Organ transplantation has had a rocky relationship with the news media, but when examined broadly, the relationship has improved the specialty and increased awareness of organ donation, said ASTS President John P. Roberts, MD, during his presidential address on June 2 during ATC 2009.
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Looking back on her term as president of the American Society of Transplantation during her 2009 American Transplant Congress address in Boston, Barbara Murphy, MD, marveled not only at what the Society has accomplished in that year, but also how much AST has grown since she became a member.
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