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Drug granted orphan designation for chemo-induced ototoxicity
The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.
Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.
“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.
“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”
About SENS-401
SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.
SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.
Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved. 
The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.
Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.
“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.
“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”
About SENS-401
SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.
SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.
Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.
Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.
“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.
“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”
About SENS-401
SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.
SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.
Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
Study findings cast doubt on community-acquired pneumonia diagnostic practices
New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.
In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.
“The reliability of these findings must be considered in the clinical management and research of children with CAP,” said lead author Todd Florin, MD, associate research director in emergency medicine at Cincinnati Children’s Hospital Medical Center and his associates. (Pediatrics. 2017;140[3]:e20170310)
In a retrospective cohort analysis, researchers found that just 2.5% of 2,568 hospitalized children with CAP who had a blood culture performed actually grew a pathogen. And of the detected pathogens, 82% were susceptible to penicillin. Streptococcus pneumoniae accounted for 78% of all the pathogens that were found; it was detected in only 2% of all children who had blood cultures taken.
Just 11 children – or 0.43% of the children with a blood culture performed – had growth of a pathogen that was not treatable with penicillin, said lead author Mark Neuman, MD, director of research at Boston Children’s Hospital and his associates (Pediatrics. 2017;140[3]:e20171013).
The analysis was drawn from a cohort of 7,509 children hospitalized from 2007 to 2011, with children with complex chronic conditions excluded. Data for the analysis came from the Pediatric Health Information System Plus database, in which administrative, billing, laboratory, and radiographic information is stored from six tertiary children’s hospitals.
The investigators said that one challenge is that when blood cultures are drawn early in the course of evaluation and treatment, the severity of the child’s CAP might not be apparent, which makes it difficult to know which children would benefit from a blood culture.
“The routine performance of blood cultures in these children may not be indicated,” Dr. Neuman and his associates said. “Researchers in future studies should seek to identify the clinical characteristics of children in whom obtaining blood cultures would lead to changes in clinical management, especially when identifying those patients at risk for CAP caused by organisms not susceptible to guideline-recommended, narrow-spectrum antibiotics.”
Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.
New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.
In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.
“The reliability of these findings must be considered in the clinical management and research of children with CAP,” said lead author Todd Florin, MD, associate research director in emergency medicine at Cincinnati Children’s Hospital Medical Center and his associates. (Pediatrics. 2017;140[3]:e20170310)
In a retrospective cohort analysis, researchers found that just 2.5% of 2,568 hospitalized children with CAP who had a blood culture performed actually grew a pathogen. And of the detected pathogens, 82% were susceptible to penicillin. Streptococcus pneumoniae accounted for 78% of all the pathogens that were found; it was detected in only 2% of all children who had blood cultures taken.
Just 11 children – or 0.43% of the children with a blood culture performed – had growth of a pathogen that was not treatable with penicillin, said lead author Mark Neuman, MD, director of research at Boston Children’s Hospital and his associates (Pediatrics. 2017;140[3]:e20171013).
The analysis was drawn from a cohort of 7,509 children hospitalized from 2007 to 2011, with children with complex chronic conditions excluded. Data for the analysis came from the Pediatric Health Information System Plus database, in which administrative, billing, laboratory, and radiographic information is stored from six tertiary children’s hospitals.
The investigators said that one challenge is that when blood cultures are drawn early in the course of evaluation and treatment, the severity of the child’s CAP might not be apparent, which makes it difficult to know which children would benefit from a blood culture.
“The routine performance of blood cultures in these children may not be indicated,” Dr. Neuman and his associates said. “Researchers in future studies should seek to identify the clinical characteristics of children in whom obtaining blood cultures would lead to changes in clinical management, especially when identifying those patients at risk for CAP caused by organisms not susceptible to guideline-recommended, narrow-spectrum antibiotics.”
Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.
New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.
In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.
“The reliability of these findings must be considered in the clinical management and research of children with CAP,” said lead author Todd Florin, MD, associate research director in emergency medicine at Cincinnati Children’s Hospital Medical Center and his associates. (Pediatrics. 2017;140[3]:e20170310)
In a retrospective cohort analysis, researchers found that just 2.5% of 2,568 hospitalized children with CAP who had a blood culture performed actually grew a pathogen. And of the detected pathogens, 82% were susceptible to penicillin. Streptococcus pneumoniae accounted for 78% of all the pathogens that were found; it was detected in only 2% of all children who had blood cultures taken.
Just 11 children – or 0.43% of the children with a blood culture performed – had growth of a pathogen that was not treatable with penicillin, said lead author Mark Neuman, MD, director of research at Boston Children’s Hospital and his associates (Pediatrics. 2017;140[3]:e20171013).
The analysis was drawn from a cohort of 7,509 children hospitalized from 2007 to 2011, with children with complex chronic conditions excluded. Data for the analysis came from the Pediatric Health Information System Plus database, in which administrative, billing, laboratory, and radiographic information is stored from six tertiary children’s hospitals.
The investigators said that one challenge is that when blood cultures are drawn early in the course of evaluation and treatment, the severity of the child’s CAP might not be apparent, which makes it difficult to know which children would benefit from a blood culture.
“The routine performance of blood cultures in these children may not be indicated,” Dr. Neuman and his associates said. “Researchers in future studies should seek to identify the clinical characteristics of children in whom obtaining blood cultures would lead to changes in clinical management, especially when identifying those patients at risk for CAP caused by organisms not susceptible to guideline-recommended, narrow-spectrum antibiotics.”
Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.
FROM PEDIATRICS
Key clinical point:
Major finding: In one study, only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability in cases in which paired assessments were done 20 minutes apart after patients presented to the ED with suspected CAP. In another study, just 2.5% of hospitalized children with CAP who had a blood culture performed actually grew a pathogen.
Data source: An ongoing prospective cohort study of 128 pediatric patients presenting to an emergency room with suspected CAP, and a retrospective analysis of data collected on hospitalizations from 2007 to 2011 at six tertiary children’s hospitals.
Disclosures: The studies were funded by the National Institutes of Health and by other grants to individual researchers. For the physician exam study, no relevant financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reports receiving research funding from and other financial relationships with BioFire Diagnostics.
Navigating the complex landscape of IBD therapies
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week® 2017.
In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).
Ustekinumab is a monoclonal antibody to interleukins 12 and 23, and was approved for moderate to severe CD last year on the basis of the pivotal UNITI-1, UNITI-2, and IM-UNITI trials (N Engl J Med. 2016;375:1946-60). A weight-based intravenous loading dose was shown to be effective at inducing clinical response in both patients who had failed or were intolerant to anti-TNF therapy and those who had not. The responders in both induction trials were randomized to two subcutaneous doses of ustekinumab or placebo, and at the end of the 44-week trial, the drug met multiple efficacy endpoints, including clinical remission, clinical response, steroid-free remission, and sustained clinical remission. In another abstract, the rate of tuberculosis reactivation within the clinical development program of ustekinumab across all indications (6,581 patients, over 12,000 patient-years of follow-up) was significantly lower at 0.02 cases per 100 patient-years compared with the rates seen in the golimumab (0.24 per 100) and infliximab (0.39 per 100) development programs (Gastroenterology 2017;152[5 Suppl 1]:S596), illustrating that the safety profile of ustekinumab may be significantly different from that of anti-TNF agents.
Tofacitinib, which inhibits mainly JAK1 and JAK3 receptors, is an emergent oral small molecule drug for UC. Three phase 3 randomized placebo-controlled trials (OCTAVE-1, OCTAVE-2, and OCTAVE Sustain) of tofacitinib treatment in moderately to severely active UC patients have been recently published (N Engl J Med. 2017;376:1723-36). The rates of clinical remission at week 8 were significantly greater in patients who were treated with 10 mg tofacitinib than placebo in both induction trials, and results were similar regardless of anti-TNF exposure status. Clinical responders in the induction studies were randomized to placebo or two doses of tofacitinib. At week 52, remission rates were significantly higher in the patients treated with 10 mg tofacitinib twice daily and 5 mg tofacitinib twice daily than those receiving placebo. The percentages of tofacitinib-treated patients who achieved mucosal healing were significantly greater than those in the placebo group. Serious infections occurred significantly more frequently in the tofacitinib than placebo group during induction, but not during maintenance. However, rates of herpes zoster were higher with maintenance therapy at 10 mg twice daily (5.1%) than with placebo (0.5%). A recently published phase 2 study of filgotinib, a selective JAK1 inhibitor, reported that the remission rate at week 10 was significantly higher in active CD patients receiving 200 mg of filgotinib daily than in those receiving placebo (Lancet 2017;389:266-75). A phase 2 trial of another selective JAK1 inhibitor, upadacitinib (ABT-494), for induction therapy in CD patients with a history of failure or intolerance to TNF-antagonists, was presented at DDW (Gastroenterology 2017;152[5 Suppl 1]:S1308-9). Higher rates of clinical remission at week 16 were seen in patients on 6 mg upadacitinib twice daily than placebo, and several doses of upadacitinib were significantly better than placebo for inducing endoscopic remission at week 12 or 16. Serious adverse events were seen in 9%-15% of CD patients treated with these two agents (vs. 4%-5% in placebo-treated patients).
Smad7 regulates the signaling of transforming growth factor (TGF)-beta1, an anti-inflammatory cytokine. Mongersen is an orally delivered anti-sense oligonucleotide that inhibits Smad7 and restores TGF-beta1 signaling, and is being developed for CD. The efficacy of induction therapy for active CD patients with limited active disease (terminal ileum or proximal colon) was demonstrated in a phase 2 study (N Engl J Med. 2015;372:1104-13). Interestingly, this study showed significantly higher rates of clinical remission at day 15 with mongersen. However, there were no endoscopic data available in this trial, baseline serum C-reactive protein concentrations were low, and did not decrease significantly. This drug appears to be well tolerated, and serious adverse events were not significantly higher than for placebo. In a phase 1b study, correlations between clinical and endoscopic outcomes were explored, and among 52 CD patients, SES-CD reductions of at least 25% at week 12 were seen in 37% of mongersen-treated patients (Gastroenterology. 2017;152[5 Suppl 1]:S198).
In summary, the future of IBD medical therapy is bright due to the recent introduction of therapies with novel mechanisms of action and favorable safety profiles (e.g., vedolizumab and ustekinumab), potentially lower-cost biosimilars, and multiple compounds in the drug development pipeline.
Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.
Copper IUDs increase bacterial vaginosis risk
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.
This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.
The African women in this study were all free of HIV and sexually transmitted infections; on average, they were about 26 years old; and most were married and sexually active. As part of a larger look into the role of vaginal dysbiosis in HIV acquisition, they were given five options for contraception: three kinds of injectables; one implant; and the nonhormonal copper IUD.
The women were divided almost evenly among the five options. The researchers followed them for 6 months with routine vaginal swabs and polymerase chain reaction testing during the follicular phase of menses. Women who opted for the copper IUD were slightly less likely to report being married and sexually active.
Almost a third of the women had BV at baseline, a little higher than the prevalence in American women.
Women who opted for hormonal contraceptives had no change in BV prevalence or vaginal microbiota.
However, BV prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days. There was an increase in concentrations of Gardnerella vaginalis and Atopobium vaginae that was not seen in the hormonal contraception groups. Overall, copper IUDs showed a twofold increase in the relative risk of BV.
“I don’t think there’s anything here that’s particularly alarming. This would not dissuade me from recommending a copper IUD. It’s a very effective and safe nonhormonal way of having long-acting reversible contraception, but if a woman gets a copper IUD and she has recurrent BV, you need to understand that the IUD may be playing a role,” Dr. Hillier said in an interview at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.
The increased risk is probably because IUDs cause heavier and longer menstrual bleeding, which is known to disturb the vaginal microbiome. Work is underway to see if removing the IUD reverses the effects, Dr. Hillier said.
Most of the women in the study opted to keep their IUDs in place after 6 months.
The Gates Foundation supported the work. Dr. Hillier is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
AT IDSOG
Key clinical point:
Major finding: Baterial vaginosis prevalence in women who opted for the copper IUD increased from 27% at baseline to 34% at 30 days, 39% at 90 days, and 44% at 180 days.
Data source: A longitudinal cohort study of 234 women.
Disclosures: The Gates Foundation supported the work. The senior investigator is a consultant for Merck and Symbiomix and a researcher for Becton Dickinson and Cepheid.
Transitioning From Pediatric to Adult Health Care: A Journey With Lennox-Gastaut Syndrome
25 Years of groundbreaking gastric cancer research
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
In 1992, the AGA Research Foundation issued the first AGA-R. Robert and Sally D. Funderburg Research Award in Gastric Cancer to support research into this previously underfunded area. There have been 26 recipients of the AGA-Funderburg award to date, comprising an honor role of distinguished national leaders in gastroenterology. Each recipient has addressed different aspects of the disease, providing a dramatic improvement in the understanding and treatment of gastric cancer.
The AGA Research Foundation is thankful for the continuous funding from the Funderburg family, which has provided the opportunity for gastric cancer research discoveries that otherwise would not have been funded. Learn more about the Funderburgs and the impact of this award in AGA Perspectives, http://agaperspectives.gastro.org/reflecting-25-years-groundbreaking-gastric-cancer-research.
What are the complications of proton pump inhibitor therapy?
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Talking to your patients about PPIs
AGA has developed talking points about research released associating PPIs with dementia, chronic kidney disease, and the latest research associating PPI use with all-cause mortality. These resources can help you educate your patients on the data and on the risks and benefits of using PPIs in their care.
- • PPIs and dementia: http://www.gastro.org/news_items/2017/07/20/how-to-talk-with-your-patients-about-ppis-and-dementia.
- • PPIs and chronic kidney disease: http://www.gastro.org/news_items/how-to-talk-with-patients-about-ppis-and-chronic-kidney-disease.
- • PPIs and all-cause mortality: http://www.gastro.org/news_items/a-guide-to-conversations-about-the-latest-ppi-research-results.
Talking to your colleagues about PPIs
AGA members have been discussing this new data linking PPIs to death. Weigh in by visiting the AGA Community, www.community.gastro.org.
Use the AGA Clinical Guidelines app to participate in MACRA
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
In 2017, eligible clinicians can use the AGA Clinical Guidelines app — through attestation of its use — to meet your 2017 CMS Merit-based Incentive Payment System (MIPS) pick your pace requirements as one way to try to avoid a payment penalty in 2019. The AGA Clinical Guidelines app has also been proposed by CMS as a 2018 Improvement Activity under MIPS.
How do you attest for 2017?
First, search for and download the AGA Clinical Guidelines app via the Apple App Store or Google Play.
After actively using the AGA Clinical Guidelines app, you will be able, in the near future, to go to the CMS Enterprise Portal to attest that you have met the 2017 MIPS improvement activity participation requirement. AGA will let you know when the portal opens.
CMS lowered the cost performance category to 0% in the 2017 pick your pace year and gave clinicians three reporting options under MIPS.
- Option one: Report to MIPS for a full 90-day period or full year on quality, improvement activities, and advancing care information, and maximize the chance to qualify for positive payment adjustments.
- Option two: Report less than a year, but for the full 90-day period on one quality measure, more than one improvement activity, or more than the required measures in advancing care information to avoid penalties and receive a possible positive update.
- Option three: Report one quality measure, one improvement activity, or report measures of advancing care information to avoid penalty.
Advanced Alternative Payment Models are another way to participate in MACRA in 2017.
What are improvement activities?
The MIPS pathway under the Medicare Access and CHIP Reauthorization Act (MACRA), uses quality and cost data to determine your payment, and replaces the previous framework that included the Medicare EHR Incentive Program, the Physician Quality Reporting System and the Value-Based Payment Modifier program. Physicians participating in MIPS will be scored on four categories:
- Quality.
- Advancing care information.
- Improvement activities.
- Cost.
The AGA Clinical Guidelines app is one way to satisfy participation in the improvement activities category.
AGA Future Leaders Program receives national recognition
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
AGA is proud to share that the AGA Future Leaders Program has been recognized with the 2017 Power of A Silver Award from the American Society of Association Executives. The Power of A Awards recognize a select number of organizations annually for innovative and effective programs that have a positive impact. The Power of A Awards are the association industry’s highest honor.
The AGA Future Leaders Program, which launched in March 2015, provides a pathway for selected participants to develop the leadership skills necessary to serve AGA. The 1.5-year program provides opportunities for participants to network, connect with mentors, develop leadership skills, and learn about AGA’s governance and operations while advancing their careers and supporting the profession. During the program, participants work on creating fresh and innovative projects to support AGA and the field.
The AGA Future Leaders Program’s commitment to encouraging innovation and building the GI workforce are key reasons it was recognized with this prestigious award.
Please join us in congratulating all of the AGA Future Leaders Program participants, mentors, program chairs, and staff for their part in this accomplishment. To learn more about this program, visit the AGA Future Leaders Program web page, http://www.gastro.org/about/initiatives/aga-future-leaders-program.
Pediatric News welcomes Dr. Lenore Jarvis
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
Pediatric News welcomes Lenore Jarvis MD, MEd, to its editorial advisory board.
Dr. Jarvis is a pediatric emergency medicine physician at Children’s National Health System, and assistant professor of pediatrics at George Washington University, both in Washington.
