About
With over 20 years of experience in biopharmaceutical research and development, I am a…
Activity
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After 12+ exciting years today has been my last day #teambayer #OnesiteWuppertal. It has been my privilege and pleasure to work with so many…
After 12+ exciting years today has been my last day #teambayer #OnesiteWuppertal. It has been my privilege and pleasure to work with so many…
Liked by Amit Sharma
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This past Friday, I finished my three month internship with Alexion Pharmaceuticals, Inc. As a clinical development intern, my independent project…
This past Friday, I finished my three month internship with Alexion Pharmaceuticals, Inc. As a clinical development intern, my independent project…
Liked by Amit Sharma
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Congratulations to Dr. Morgan Butrovich on her successful PhD defense! Her work improved our understanding of (1) the impact of using various kidney…
Congratulations to Dr. Morgan Butrovich on her successful PhD defense! Her work improved our understanding of (1) the impact of using various kidney…
Liked by Amit Sharma
Experience
Education
Licenses & Certifications
Volunteer Experience
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NKF Konica Minolta Golf Classic National Executive Golf Leadership Committee
National Kidney Foundation
- Present 4 years 8 months
Health
Serve as committee member on the newly formed NKF Konica Minolta Golf Classic National Executive Golf Leadership Committee, a role that is responsible for growing and strengthening financial support through national partnerships to fight kidney disease and increase awareness for organ donation through the NKF Konica Minolta Golf Classic. The National Executive Golf Leadership Committee set a goal of generating new funding for the 2021-2022 seasons.
Publications
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Net Budgetary Impact of Ferric Citrate as First Line Phosphate Binder
Drugs R D
In the base-case model, FC had a net budgetary impact (savings)
Of US$213,223/year per 100 patients treated vs. standard
of care. One-way sensitivity analyses showed a net budgetary
impact of up to US$316,296/year per 100 patients
treated when higher hemoglobin levels observed with FC
translated into a 30% additional ESA dose reduction. -
Cost effectiveness of paricalcitol versus cinacalcet with low-dose vitamin d for management of secondary hyperparathyroidism in haemodialysis patients in the USA
Clinical Drug Investigations
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Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients
J Medical Economics
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Peginestatide for Anemia in Patients with Chronic Kidney Disease not Receiving Dialysis
New England Journal of Medicine
The efficacy of peginesatide
(administered monthly) was similar to that of darbepoetin
(administered every 2 weeks) in increasing and maintaining hemoglobin
levels. However, cardiovascular events and mortality were increased with peginesatide
in patients with chronic kidney disease who were not undergoing dialysis.
(Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers,
NCT00598273 [PEARL 1], NCT00598442 [PEARL 2], NCT00597753 [EMERALD 1],
and NCT00597584…The efficacy of peginesatide
(administered monthly) was similar to that of darbepoetin
(administered every 2 weeks) in increasing and maintaining hemoglobin
levels. However, cardiovascular events and mortality were increased with peginesatide
in patients with chronic kidney disease who were not undergoing dialysis.
(Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers,
NCT00598273 [PEARL 1], NCT00598442 [PEARL 2], NCT00597753 [EMERALD 1],
and NCT00597584 [EMERALD 2].)Other authors -
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SHPT Study: Effects of Paracalcitol or Cinacalcet Treatment on CKD-BMD Markers in Subjects with Secondary Hyperparathyroidism (SHPT).
Nephrology Dialysis and Transplantation
Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia.
Other authors -
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A cost effective complement to managing the vitamin D deficient and anemic dialysis patient in the bundled world.
NNI
Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient…
Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient regiments. This nutraceutical was used in an attempt to replete vitamin D levels and decrease inflammation that dialysis patients experience. Additionally, we investigated the potential of this therapy to reduce the need for erythropoietin-stimulating agents. Results indicate MV-ONE caused: (1) increases in 25-OH vitamin D (p = 0.0058), (2) decreases in ESA dose (p = 0.0475), and (3) no change in C-reactive protein (p = 0.3290). Overall, this suggests the addition of MV-ONE does benefit the vitamin D deficiency and anemia observed in ESRD patients.
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Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study.
Nephrology Dialysis and Transplantation
The study participants are representative of a multinational cohort of patients on haemodialysis with elevated iPTH. The study results will provide valuable information on the best available treatment of SHPT in patients on haemodialysis.
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Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009.
Nephrology Dial Transplant
The emergence of safety concerns and the subsequent changes in product labeling, reimbursement and clinical practice guidelines all appear to have influenced physician dosing practices resulting in less frequent use of ESAs, lower ESA doses and lower achieved Hb levels in CKD-NOD patients.
Other authors -
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Estimate of maintenance EPO to darbepoetin alfa dose conversion ratio in a hospital-based dialysis patient population.
Curr Med Res Opin
The two methods in estimating the DCR presented here provide payers with an empirical way of comparing ESA utilization for pharmacoeconomic evaluation. DCR results may vary according to patient characteristics; however, mean DCRs of greater than 300:1 were obtained in this analysis. Exclusion of other patient-related factors that may influence ESA dose is a possible limitation of the study.
Other authors -
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• The Role of Vitamin D Receptor Agonists and/or Cinacalcet for Controlling Secondary Hyperparathyroidism in Chronic Kidney Disease.
US Nephrology
Therapeutic strategies for SHPT therefore focus on controlling serum PTH, calcium and phosphate levels and effective treatment options include VDR activation and calcimimetic therapy. VDR activation involves the use of non-selective VDR activators (calcitriol), vitamin D prohormones (doxercalciferol and alfacalcidol), or the selective VDR activators maxacalcitol and paricalcitol. Clinical studies support the efficacy and safety of VDR activators as effective treatments for SHPT and recent…
Therapeutic strategies for SHPT therefore focus on controlling serum PTH, calcium and phosphate levels and effective treatment options include VDR activation and calcimimetic therapy. VDR activation involves the use of non-selective VDR activators (calcitriol), vitamin D prohormones (doxercalciferol and alfacalcidol), or the selective VDR activators maxacalcitol and paricalcitol. Clinical studies support the efficacy and safety of VDR activators as effective treatments for SHPT and recent findings from several large observational studies have also suggested that the benefits of VDR activators may extend beyond the PTH-lowering effect, and could result in direct cardiovascular and survival benefits. Calcimimetics increase the sensitivity of the parathyroid gland to calcium through allosteric modulation of the calcium-sensing receptor, thus decreasing PTH secretion. A number of clinical studies support the use of cinacalcet, the only currently available calcimimetic, as an adjunct to VDR activator therapy in the treatment of SHPT, and a number of recent studies have investigated the role of cinacalcet with concomitant low-dose VDR activator therapy for the treatment of SHPT in dialysis patients, positioning cinacalcet as the primary therapy in the treatment regimen. Consequently, there is considerable debate surrounding the optimal approach to SHPT management and the respective roles of VDR activators and cinacalcet. Ongoing studies such as the IMPACT SHPT trial, a comparison of on-label dose titration protocols for paricalcitol and cinacalcet, should provide useful information in terms of the preferred approach for controlling SHPT in hemodialysis patients.
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Refining the approach to IV iron use in hemodialysis patients: a post-DRIVE analysis.
NNI
Intravenous (IV) iron is a necessary component of the anemia management plan for the hemodialysis patient. Despite the demonstrated benefits of IV iron, questions remain as to the most effective strategies for using IV iron to maintain target hemoglobin (Hb) levels, ensure adequate iron supply, and optimize erythropoiesis-stimulating agent (ESA) therapy. Significant questions also surround the extent of the serum ferritin marker to reliably guide IV iron treatment decisions. The recent Dialysis…
Intravenous (IV) iron is a necessary component of the anemia management plan for the hemodialysis patient. Despite the demonstrated benefits of IV iron, questions remain as to the most effective strategies for using IV iron to maintain target hemoglobin (Hb) levels, ensure adequate iron supply, and optimize erythropoiesis-stimulating agent (ESA) therapy. Significant questions also surround the extent of the serum ferritin marker to reliably guide IV iron treatment decisions. The recent Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) and DRIVE-II studies showed that improvements in Hb levels, iron status, and ESA responsiveness can be achieved with a repletion course of IV iron in patients with serum ferritin levels up to 1200 ng/mL. These studies also demonstrated that higher serum ferritin levels are a poor predictor of positive response to IV iron. We sought to apply the lessons learned from the DRIVE studies in our hemodialysis clinic. We designed this retrospective study to determine if regular, low-dose IV iron administered to patients with serum ferritin levels up to 1200 ng/mL could improve measures of anemia and iron status while optimizing the use of IV iron and ESAs.
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Nutritional therapy to attenuate inflammation in HD patients: fact or fiction?
NNI
The hemodialysis (HD) patient is often marked by constant malnutrition, inflammation, and atherosclerosis, resulting in an increased risk of cardiovascular events and mortality. This chronic inflammatory state is often the result of increased oxidative stress. Nutritional supplementation may become an additional therapy to lower this inflammatory burden. By providing these patients with nutritional supplement and antioxidant therapies consisting of alpha-lipoic acid, cholecalciferol, ascorbic…
The hemodialysis (HD) patient is often marked by constant malnutrition, inflammation, and atherosclerosis, resulting in an increased risk of cardiovascular events and mortality. This chronic inflammatory state is often the result of increased oxidative stress. Nutritional supplementation may become an additional therapy to lower this inflammatory burden. By providing these patients with nutritional supplement and antioxidant therapies consisting of alpha-lipoic acid, cholecalciferol, ascorbic acid, and Gamma-Tocopherol, providers may reduce overall inflammation and improve HD outcomes in patients with end-stage renal disease.
Projects
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PEAK: Performace and Accountabilty in Kidney care; www.kidneycarequality.com
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Kidney Care Partners’ Performance Excellence and Accountability in Kidney Care (PEAK) is a voluntary quality improvement campaign to reduce mortality among first-year dialysis patients by 20 percent by the end of 2012 – an effort to extend, even save, 10,000 lives – a real goal for real change.
All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their…Kidney Care Partners’ Performance Excellence and Accountability in Kidney Care (PEAK) is a voluntary quality improvement campaign to reduce mortality among first-year dialysis patients by 20 percent by the end of 2012 – an effort to extend, even save, 10,000 lives – a real goal for real change.
All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their disease and to manage it appropriately is an essential ingredient to high-quality care for newly diagnosed patients.
Working with researchers and other experts in the kidney care community, the PEAK Campaign will initiate a systematic community-wide process of identifying and sharing ‘breakthrough’ practices that will improve survival rates.
Campaign participants believe that in addition to improving and extending the lives of people with kidney failure, PEAK will also help reduce hospitalizations which in turn will help lower Medicare costs.
The community is partnering with Brown University and Quality Partners of Rhode Island to measure our success in improving patient outcomes and developing tools to reduce mortality in first-year dialysis patients.
Consistently over the past ten years, end-stage renal disease (ESRD) survival rates have improved; however, first-year mortality has remained stable compared to overall mortality. The kidney care community has recognized the need to improve the first-year mortality rate as compared to other industrialized nations.
The PEAK campaign was launched by Kidney Care Partners (KCP), a broad-based coalition of kidney patient advocacy groups, health care professional organizations, dialysis service providers and manufacturers who seek to improve quality of care available to the 400,000 Americans currently diagnosed with kidney failureOther creators -
Organizations
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Renal Physicians Association
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International society of Nephrology
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American Society of Nephrology
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European Renal Association
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National Kidney Foundation
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- Present
More activity by Amit
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Dear Anjali, Congratulations on starting your medical journey! This is such an incredible achievement, and I couldn't be more proud of you. I know…
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What a loss for nephrology and beyond. Dr Barry Brenner was an original thinker and a world-class expert. He will be missed for eternity…
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Thrilled to Announce Our Successful $105M Series B Funding Round!
Thrilled to Announce Our Successful $105M Series B Funding Round!
Liked by Amit Sharma
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👇Final call to join tomorrow’s session - Register via link below & Come join! Should be insightful & fun 🙌 https://lnkd.in/dYh43CUM Labena…
👇Final call to join tomorrow’s session - Register via link below & Come join! Should be insightful & fun 🙌 https://lnkd.in/dYh43CUM Labena…
Liked by Amit Sharma
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Thanks to the Unicycive team for the hard work and dedication!
Thanks to the Unicycive team for the hard work and dedication!
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I am so very proud of my son Spencer Evans-Cole for spending his summer at Mississippi State University completing a National Science Foundation…
I am so very proud of my son Spencer Evans-Cole for spending his summer at Mississippi State University completing a National Science Foundation…
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Check out my recent op-ed for @RealClearHealth where I call on Congress to support the New Era of Preventing End-Stage Kidney Disease Act (H.R…
Check out my recent op-ed for @RealClearHealth where I call on Congress to support the New Era of Preventing End-Stage Kidney Disease Act (H.R…
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