Cost-effectiveness analyses

Participation of Data and Safety Monitoring Committees: Apotek; Biogen-Idec; Cleveland Clinic; Glaxo Smith Klein Pharmaceuticals; Gilead Pharmaceuticals; Modigenetech/Prolor; Merck/Ono Pharmaceuticals; Merck; Neuren; PCT Bio; Revalesio; Sanofi-Aventis; Teva; Vivus; NHLBI (Protocol Review Committee); NINDS; NMSS; NICHD (OPRU oversight committee);

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(1) Consortium of MS Centers, speaker honoraria; (2) Bayer, speaker honoraria (3) Teva, Speaker honoraria

(1) Multiple Sclerosis, Editorial Board, 2010-present (2) JASN, 2013- present, statistical consultant

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Consulting, Speaking fees & Advisory Boards: Alexion; Allozyne; Bayer; Celgene; Coronado Biosciences; Consortium of MS Centers (grant); Diogenix; Klein-Buendel Incorporated; Medimmune; Novartis; Nuron Biotech; Receptos; Spiniflex Pharmaceuticals; Teva pharmaceuticals

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(1) NINDS Grant with Multiple Sclerosis as the patient population (2) NARCOMS MS Patient Registry

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No direct grants, but work on studies funded to the Consortium of MS Centers subcontracted for analysis of NARCOMS Registry.

U01 NS 042685 (Cutter) 09/23/2005 – 08/31/2015 NIH/NINDS Thymectomy Plus Prednisone vs. Prednisone Alone in NonThymomatous Myasthenia Gravis This multinational clinical trial aims to assess the utility of thymectomy in treating nonthymomatous Myasthenia Gravis patients comparing surgery plus medications versus medications alone. U01 NS 45719 (Lublin) 09/30/2003 – 11/30/2013 NIH/NINDS A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing Remitting Multiple Sclerosis. The purpose of this project is to assess the impact of combination therapy in the treatment of RRMS. P30 DK 079337 (Agarwal) 09/01/2008 – 07/31/2013 NIH/NIDDK UAB/UCSD O’Brien Core Center for Acute Kidney Injury Research The major objective of this grant is to provide state-of-the-art core resources to address experimental questions for the advancement of AKI research P30-AI 027767 (Saag) 03/01/2009 – 02/28/2014 NIH/NIAID UAB Center for Aids Research is organized as a partnership between the University of Alabama at Birmingham and the Southern Research Institute. The primary purpose of this partnership is to generate interdisciplinary AIDS research efforts. This Center is responsible for planning, evaluating, managing and documenting a broad array of research activities within two institutions. Particular emphasis is placed upon linking clinical and basic science through the use of shared facilities and to translate as quickly as possible fundamental knowledge about AIDS and its related disorders into clinical treatment and prevention programs. No number assigned (Mark) 10/01/2009 – 09/30/2013 National Multiple Sclerosis Society Rehabilitating Extremity Use after Multiple Sclerosis This project compares CI therapy and complementary and alternative medicine treatments to determine their changes in the extent of more-affected arm use in the life setting and maximal movement ability in the laboratory for individuals with multiple sclerosis. R01 HD 064729 (Tita) 04/01/2010 – 03/31/2014 NIH/NICHD Caesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) Trial A multicenter randomized trial to determine the efficacy and safety of a modified (extended-spectrum) antibiotic prophylaxis strategy at cesarean delivery to reduce surgical site infections. UL1 RR 02577 (Kimberly) 05/19/2008 – 04/30/2013 NIH/NCRR UAB Center for Clinical & Translational Science (CCTS) The major goal of this Medicare United with Simple Clinical trials Expanded network (MUSCLE) is to conduct comparative effectiveness research by developing a “network of networks” for conducting pragmatic trials of therapeutics for chronic musculoskeletal diseases. R01 AG 021927 (Marson) 07/01/2010 – 06/30/2015 NIH/NIA Functional Change in Mild Cognitive Impairment (COINS) This R01 project investigates longitudinal change in higher order functional abilities in patients with MCI, and develops predictor models for clinical progression and conversion from MCI to dementia. U01 HL 102235 (Kinsella/Cutter) 09/07/2010 – 06/30/2013 NIH/NHLBI Phase II Trial of Sildenafil in Newborns with Persistent Pulmonary Hypertension This Phase II, multi-center, randomized, double-blind, placebo-controlled trial pursues the hypothesis that IV sildenafil will acutely reduce pulmonary artery pressure and improve oxygenation in near-term and term infants with PPHN, thus reducing the need for rescue therapy iNO and/or ECMO. P30 DK 074038 (Yoder) 09/30/2010 – 06/30/2015 NIH/NIDDK Hepato/Renal Fibrocystic Diseases Core Center. The University of Alabama at Birmingham Recessive Polycystic Kidney Disease Core Center (UAB RPKDCC) has established a NIDDK-funded, interdisciplinary center of excellence in PKD-related research, with specific emphasis on recessive PKD. Among the five Cores, the UAB RPKDCC includes the ARPKD Clinical and Genetic Resource, a Core resource designed to develop a unique set of clinical, genetic, and educational resources for ARPKD. The Core has three primary objectives: (1) to extend the observational study of ARPKD initiated by the North American ARPKD Database; (2) to provide a mechanism for genetic evaluation of patients with both classic ARPKD and unusual phenotypes of recessive PKD; and (3) to develop educational tools for physicians and patients regarding the natural history, cause, development and effects of the disease, genetic testing, and clinical trials applicable to ARPKD. R01 AG 037561 (Schneider) 04/01/2011 – 03/31/2014 NIH/NIA Synthesis of Longer-Term Alzheimer Disease Studies in Order to Model and Improve Clinical Trials Methods and Outcomes: Alzheimer Disease Clinical The results of this research will have a broad and lasting impact on trial designs for Alzheimer disease, mild cognitive impairment, and neurodegenerative disorders, and trials in which cognitive improvement is a targeted outcome. It will address important issues in the assumptions underlying the design decisions. This will lead to better understanding and improvement in the methods for future clinical trials and improve the likelihood for identifying effective treatments, as well as identifying ineffective treatments earlier in development. No number assigned (Cutter) 01/01/2004 – 12/31/2012 Consortium of MS Centers (CMSC) North American Research Consortium on Multiple Sclerosis (NARCOMS) The goals of this project are to facilitate a confidential way for patients to supply valuable information to researchers about their course of disease that may lead to more effective treatments and care for people living with MS, while reducing the time and cost of conducting studies; provide a worldwide research resource for people living with multiple sclerosis so they can provide information about themselves and their course of disease; and develop new collaborations between researchers, patients, and healthcare providers. UAB provides programming and analytic support for the NARCOMS registry. BAA-NIAID-DMID-NIHAI2010101 (Gnann/Kimberlin) 10/01/2011 – 09/30/2016 NIH/NIAID These contracts are to accomplish coordinating of various clinical trials with titles listed below: Safety Tolerability and Pharmacokinetics of CMX-001 in Renal Transplant Recipients with BKV Viremia: A Phase IIA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study A Pharmacokinetic/Pharmacodynamic and Resistance Evaluation of Intravenous Ganciclovir in Premature Infants Adaptive Sequential Study Evaluating Prevention of Neonatal HSV: Detection of Maternal Shedding at Delivery Followed by Preemptive Antiviral Therapy in Exposed Neonates A Phase II 6 Weeks Oral Valganciclovir versus Placebo in Infants with Congenital CMV Infection and Hearing Loss 1U34AR062891-01 (Saag) 04/01/2012 – 03/31/2014 NIH/NIAMS Planning Grant for the Active ComparaTor Osteoporosis Large Simple Trial (ATLAST) The overall goals of this project are to collaborate with an advisory group of national osteoporosis, clinical trial, and community research experts to: (1) finalize the study protocol with respect to the study population, recruitment plan, primary and secondary outcomes, data collection/analysis plan; (2) develop a manual of procedures; and (3) develop effective linkages to Medicare data for long-term surveillance of participants.

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(1) Consortium of MS Centers (2) Myasthenia Gravis Foundation of America, grant for MG Registry

Pythagoras, Inc. Sub S Corporation - President.

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