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The Transplant Therapeutics Consortium (TTC), a public-private partnership (PPP) led by the Critical Path Institute (C-Path), recently published a whitepaper titled "The Importance of Drug Safety and Tolerability in the Development of New Immunosuppressive Therapy for Transplant Recipients" by Stegall et al in the American Journal of Transplantation. As staff members of the Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs and Office of Translational Science, and the Oncology Center of Excellence, we would like to provide our perspective on the TTCs efforts and the whitepaper., (Published 2019. This article is a U.S. Government work and is in the public domain in the USA.)

The Food and Drug Administration (FDA) held a public meeting and scientific workshop in September 2016 to obtain perspectives from solid organ transplant recipients, family caregivers, and other patient representatives. The morning sessions focused on the impact of organ transplantation on patients' daily lives and the spectrum of activities undertaken to maintain grafts. Participants described the physical, emotional, and social impacts of their transplant on daily life. They also discussed their posttransplant treatment regimens, including the most burdensome side effects and their hopes for future treatment. The afternoon scientific session consisted of presentations on prevalence and risk factors for medication nonadherence after transplantation in adults and children, and interventions to manage it. As new modalities of Immunosuppressive Drug Therapy are being developed, the patient perceptions and input must play larger roles if organ transplantation is to be truly successful., (© 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The Food and Drug Administration (FDA) held an open public workshop in September 2011 to discuss the current state of science related to the effects of ischemia reperfusion injury (IRI) on outcomes in kidney transplantation. Topics included the development of IRI and delayed graft function (DGF), histology and biomarkers, donor factors, recipient factors, organ quality and organ preservation by means of cold storage solutions or machine perfusion. Various mechanisms of injury and maladaptive response to IRI were discussed as potential targets of intervention. Animal models evaluating specific pathophysiological pathways were presented, as were the limitations of extrapolating animal results to humans. Clinical trials of various drug products administered in the peri-transplant period were summarized; a few demonstrated early improvements in DGF, but none demonstrated an improvement in late graft function. Clinical trial design for IRI and DGF were also discussed., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.

Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example., (© copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.)

In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for use in treating an infection due to a biological agent used intentionally. The terrorist attacks of 2001 involving anthrax underscore the imperative that safe and effective drugs to manage such infections be readily available in the United States. The approval of ciprofloxacin hydrochloride, which was made on the basis of a surrogate human marker of efficacy, made extensive use of data from an animal model of disease. This represents a new direction in the development of efficacy data in support of drug approval and facilitates the availability of those drugs for which there is an urgent need. This article presents the scientific data and regulatory mechanism that supported the approval of ciprofloxacin hydrochloride for management of postexposure of inhalational anthrax.

Objective: To detail robotic procedure development and clinical applications for mitral valve, biliary, and gastric reflux operations, and to implement a multispecialty robotic surgery training curriculum for both surgeons and surgical teams., Summary Background Data: Remote, accurate telemanipulation of intracavitary instruments by general and cardiac surgeons is now possible. Complex technologic advancements in surgical robotics require well-designed training programs. Moreover, efficient robotic surgical procedures must be developed methodically and safely implemented clinically., Methods: Advanced training on robotic systems provides surgeon confidence when operating in tiny intracavitary spaces. Three-dimensional vision and articulated instrument control are essential. The authors' two da Vinci robotic systems have been dedicated to procedure development, clinical surgery, and training of surgical specialists. Their center has been the first United States site to train surgeons formally in clinical robotics., Results: Established surgeons and residents have been trained using a defined robotic surgical educational curriculum. Also, 30 multispecialty teams have been trained in robotic mechanics and electronics. Initially, robotic procedures were developed experimentally and are described. In the past year the authors have performed 52 robotic-assisted clinical operations: 18 mitral valve repairs, 20 cholecystectomies, and 14 Nissen fundoplications. These respective operations required 108, 28, and 73 minutes of robotic telemanipulation to complete. Procedure times for the last half of the abdominal operations decreased significantly, as did the knot-tying time in mitral operations. There have been no deaths and few complications. One mitral patient had postoperative bleeding., Conclusion: Robotic surgery can be performed safely with excellent results. The authors have developed an effective curriculum for training teams in robotic surgery. After training, surgeons have applied these methods effectively and safely.

Severe obesity is a grave disease in the U.S. as well as other industrialized nations. This disease has many ramifications on both an individual and social levels. It affects 12.5 million people in the U.S., according to national survey data. The health risks of severe obesity include hypertension, hyperlipidaemia, cardiomyopathy, diabetes, hypoventilation disorders, increased risk of malignancy, cholelithiasis, degenerative arthritis, infertility, and psychosocial impairments. Medical weight reduction programmes have rarely achieved long-term success. Most authorities now agree that bariatric surgery is the treatment of choice for well-informed and motivated obese patients with acceptable operative risks, who strongly desire substantial weight loss or who have severe impairments because of their weight. Surgery is indicated for patients with a BMI greater than 40 kg/m2, or for those with serious medical co-morbidities and a BMI greater than 35 kg/m2. Three procedures, the adjustable silicone gastric banding (ASGB), vertical gastric banding (VBG), and gastric bypass (GB), have produced the best results to date. Each of these procedures is much more effective than dietary therapies. Each has advantages and disadvantages, with GB producing greater sustained weight loss in the long-term, with a slightly higher risk of metabolic complications. All can be done with surprisingly low operative mortality. The pronounced weight loss induced with these operations can relieve and bring co-morbid diseases, such as diabetes and hypertension, once thought to be only barely controllable, into full long-term remission.

Objective: To determine how well medical residency programs are prepared to meet the new Accreditation Council of Graduate Medical Education (ACGME) accreditation guidelines for resident scholarly activity., Design: Cross-sectional study using a mailed survey., Participants: Program directors of all ACGME-accredited internal medicine residency programs., Measurements: Program directors were asked to list the scholarly activities and products of their residents and their programs' minimal expectations for resident research; available academic, faculty, technical, and personnel support for resident research; perceived barriers to resident research; and the desired educational and skill outcomes of resident research. The responses of university-based training programs were compared with those of non-university-based programs., Results: 271 program directors returned the survey, yielding a response rate of 65%. Ninety-seven percent of all programs have established scholarly guidelines consistent with accreditation requirements. Although only 37% of programs reported having an organized, comprehensive research curriculum, 70% taught skills important to research. Technical support and resources were generally available for resident research; the most frequently cited barrier to resident research was lack of resident time. University-based and non-university-based training programs differed in important ways. Generally, non-university-based programs had more research activity and structure, and they exceeded university-based programs in the number of oral and poster presentations given at local, state, and national professional meetings., Conclusions: Most programs have in place the basic elements conducive to resident research. Program directors have identified and teach educational outcomes and skills that are likely to have lifelong benefits for most of their graduates.

One aspect of the current drug-testing controversy that has gone relatively unexamined concerns the extent to which student-athletes are fully informed of the testing procedures employed by their institution. College athletes (N = 2,282) participating at 11 NCAA-affiliated institutions nationwide were surveyed as to their awareness of their school's drug-testing program. Results indicate athletes have numerous misconceptions regarding the drug testing to which they may be subjected. Over one-third of the athletes attending "testing" institutions were oblivious to the fact their school was engaged in drug-testing, and more than 70% were unable to correctly identify their school's drug-testing protocol. Implications of such ignorance are discussed.