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Diabetes Programs: Referral Isn’t Enough
Many patients who could benefit from intensive lifestyle interventions to reduce and prevent diabetes may not be getting the opportunity, according to researchers at Montefiore Health System (MHS).
Beginning in 2010, MHS partnered with the YMCA of Greater New York to provide the YMCA’s 1-year Diabetes Prevention Program (DPP) to patients in Bronx-based primary care clinics. During an office visit, eligible patients were told of their risk for developing diabetes and asked whether they were interested in participating. Physicians referred patients who said yes. Schedule and location for 16 core sessions were based on availability of coaches, space for the sessions, and patient demand.
Over the study period, 1,249 patients were referred to the DPP. For up to 1 year after referral, MHS placed patients in 66 core groups. “Placed” meant they were scheduled to attend a session. Patients who attended ≥ 3 sessions were considered “enrolled.” Of MHS patients referred to the YMCA’s DPP, only 34% were placed. Of those, 47% attended ≥ 3 sessions.
More than half (53%) of placed patients were never enrolled. But when they do enroll the study shows patients have good results. One-third of patients lost ≥ 5% of their body weight during their enrollment. The average weight loss was 3.4%.
The study points to some areas for improvement, the researchers say. Reducing the lag time between referral and the start of the sessions, for instance, would maximize the likelihood of enrollment. Patients who started their sessions within 2 months of their referral date were more often enrolled compared with those who had to wait ≥ 4 months (54% vs 22%). The researchers also note that the timing of referrals and sessions are important considerations, and efforts should be made to coordinate them.
Targeting younger patients and Spanish-speaking adults also would help. Attrition among younger participants is of “particular concern,” the researchers say, given that about 26% of adults aged < 60 years have prediabetes. Patients aged 18 to 44 years, the bulk of the patients referred, were least often placed compared with patients aged ≥ 45 years. Patients who preferred sessions in Spanish were less often placed than those who preferred English.
Finally, the researchers point out that health care providers have an important role in placing patients: The number of referrals that a provider made was associated with whether or not the patient was placed.
Many patients who could benefit from intensive lifestyle interventions to reduce and prevent diabetes may not be getting the opportunity, according to researchers at Montefiore Health System (MHS).
Beginning in 2010, MHS partnered with the YMCA of Greater New York to provide the YMCA’s 1-year Diabetes Prevention Program (DPP) to patients in Bronx-based primary care clinics. During an office visit, eligible patients were told of their risk for developing diabetes and asked whether they were interested in participating. Physicians referred patients who said yes. Schedule and location for 16 core sessions were based on availability of coaches, space for the sessions, and patient demand.
Over the study period, 1,249 patients were referred to the DPP. For up to 1 year after referral, MHS placed patients in 66 core groups. “Placed” meant they were scheduled to attend a session. Patients who attended ≥ 3 sessions were considered “enrolled.” Of MHS patients referred to the YMCA’s DPP, only 34% were placed. Of those, 47% attended ≥ 3 sessions.
More than half (53%) of placed patients were never enrolled. But when they do enroll the study shows patients have good results. One-third of patients lost ≥ 5% of their body weight during their enrollment. The average weight loss was 3.4%.
The study points to some areas for improvement, the researchers say. Reducing the lag time between referral and the start of the sessions, for instance, would maximize the likelihood of enrollment. Patients who started their sessions within 2 months of their referral date were more often enrolled compared with those who had to wait ≥ 4 months (54% vs 22%). The researchers also note that the timing of referrals and sessions are important considerations, and efforts should be made to coordinate them.
Targeting younger patients and Spanish-speaking adults also would help. Attrition among younger participants is of “particular concern,” the researchers say, given that about 26% of adults aged < 60 years have prediabetes. Patients aged 18 to 44 years, the bulk of the patients referred, were least often placed compared with patients aged ≥ 45 years. Patients who preferred sessions in Spanish were less often placed than those who preferred English.
Finally, the researchers point out that health care providers have an important role in placing patients: The number of referrals that a provider made was associated with whether or not the patient was placed.
Many patients who could benefit from intensive lifestyle interventions to reduce and prevent diabetes may not be getting the opportunity, according to researchers at Montefiore Health System (MHS).
Beginning in 2010, MHS partnered with the YMCA of Greater New York to provide the YMCA’s 1-year Diabetes Prevention Program (DPP) to patients in Bronx-based primary care clinics. During an office visit, eligible patients were told of their risk for developing diabetes and asked whether they were interested in participating. Physicians referred patients who said yes. Schedule and location for 16 core sessions were based on availability of coaches, space for the sessions, and patient demand.
Over the study period, 1,249 patients were referred to the DPP. For up to 1 year after referral, MHS placed patients in 66 core groups. “Placed” meant they were scheduled to attend a session. Patients who attended ≥ 3 sessions were considered “enrolled.” Of MHS patients referred to the YMCA’s DPP, only 34% were placed. Of those, 47% attended ≥ 3 sessions.
More than half (53%) of placed patients were never enrolled. But when they do enroll the study shows patients have good results. One-third of patients lost ≥ 5% of their body weight during their enrollment. The average weight loss was 3.4%.
The study points to some areas for improvement, the researchers say. Reducing the lag time between referral and the start of the sessions, for instance, would maximize the likelihood of enrollment. Patients who started their sessions within 2 months of their referral date were more often enrolled compared with those who had to wait ≥ 4 months (54% vs 22%). The researchers also note that the timing of referrals and sessions are important considerations, and efforts should be made to coordinate them.
Targeting younger patients and Spanish-speaking adults also would help. Attrition among younger participants is of “particular concern,” the researchers say, given that about 26% of adults aged < 60 years have prediabetes. Patients aged 18 to 44 years, the bulk of the patients referred, were least often placed compared with patients aged ≥ 45 years. Patients who preferred sessions in Spanish were less often placed than those who preferred English.
Finally, the researchers point out that health care providers have an important role in placing patients: The number of referrals that a provider made was associated with whether or not the patient was placed.
Zika virus spread undetected in the Americas, team says
New research suggests the Zika virus spread quickly in the Americas and then diverged into distinct genetic groups.
Researchers performed genetic analysis on samples collected as the virus spread throughout the Americas after its introduction in 2013 or 2014.
The team found that Zika circulated undetected for up to a year in some regions before it came to the attention of public health authorities.
Genetic sequencing also enabled the researchers to recreate the epidemiological and evolutionary paths the virus took as it spread and split into the distinct subtypes—or clades—that have been detected in the Americas.
Hayden C. Metsky, a PhD student at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported these findings in Nature.
The researchers reconstructed Zika’s dispersal by sequencing genetic material collected from hundreds of patients in 10 countries and territories.
The team eventually amassed a database of 110 complete or partial Zika virus genomes—the largest collection to date—which they analyzed along with 64 published and publicly shared genomes.
Based on changes to the viral genome that accumulated as the disease moved through new populations, the researchers concluded that Zika virus spread rapidly upon its initial introduction in Brazil, likely sometime in 2013.
Later, at several points in early to mid-2015, the virus separated into at least 3 clades—distinct genetic groups whose members share a common ancestor—in Colombia, Honduras, and Puerto Rico, as well as a fourth type found in parts of the Caribbean and the continental US.
The researchers believe these findings could have a direct impact on public health, informing disease surveillance and the development of diagnostic tests. 
New research suggests the Zika virus spread quickly in the Americas and then diverged into distinct genetic groups.
Researchers performed genetic analysis on samples collected as the virus spread throughout the Americas after its introduction in 2013 or 2014.
The team found that Zika circulated undetected for up to a year in some regions before it came to the attention of public health authorities.
Genetic sequencing also enabled the researchers to recreate the epidemiological and evolutionary paths the virus took as it spread and split into the distinct subtypes—or clades—that have been detected in the Americas.
Hayden C. Metsky, a PhD student at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported these findings in Nature.
The researchers reconstructed Zika’s dispersal by sequencing genetic material collected from hundreds of patients in 10 countries and territories.
The team eventually amassed a database of 110 complete or partial Zika virus genomes—the largest collection to date—which they analyzed along with 64 published and publicly shared genomes.
Based on changes to the viral genome that accumulated as the disease moved through new populations, the researchers concluded that Zika virus spread rapidly upon its initial introduction in Brazil, likely sometime in 2013.
Later, at several points in early to mid-2015, the virus separated into at least 3 clades—distinct genetic groups whose members share a common ancestor—in Colombia, Honduras, and Puerto Rico, as well as a fourth type found in parts of the Caribbean and the continental US.
The researchers believe these findings could have a direct impact on public health, informing disease surveillance and the development of diagnostic tests.
New research suggests the Zika virus spread quickly in the Americas and then diverged into distinct genetic groups.
Researchers performed genetic analysis on samples collected as the virus spread throughout the Americas after its introduction in 2013 or 2014.
The team found that Zika circulated undetected for up to a year in some regions before it came to the attention of public health authorities.
Genetic sequencing also enabled the researchers to recreate the epidemiological and evolutionary paths the virus took as it spread and split into the distinct subtypes—or clades—that have been detected in the Americas.
Hayden C. Metsky, a PhD student at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported these findings in Nature.
The researchers reconstructed Zika’s dispersal by sequencing genetic material collected from hundreds of patients in 10 countries and territories.
The team eventually amassed a database of 110 complete or partial Zika virus genomes—the largest collection to date—which they analyzed along with 64 published and publicly shared genomes.
Based on changes to the viral genome that accumulated as the disease moved through new populations, the researchers concluded that Zika virus spread rapidly upon its initial introduction in Brazil, likely sometime in 2013.
Later, at several points in early to mid-2015, the virus separated into at least 3 clades—distinct genetic groups whose members share a common ancestor—in Colombia, Honduras, and Puerto Rico, as well as a fourth type found in parts of the Caribbean and the continental US.
The researchers believe these findings could have a direct impact on public health, informing disease surveillance and the development of diagnostic tests.
Before the Parade Passes By, Be Sure to Cross the Street
Are we in Pamplona, Spain, or San Diego, California?
The differences might blur Saturday morning; it won’t be Pamplona’s running of the bulls in front of the San Diego Convention Center, but a cattle drive of long-horned cattle. And this frontier drive may create a few difficulties getting to and from the Vascular Annual Meeting.
The cattle will travel on Harbor Drive, the street directly in front of the San Diego Convention Center, VAM’s home and the VAM headquarters hotel, the Marriot Marquis San Diego Marina.
The route will affect the ability to cross Harbor Drive (from other hotels, for example) and will delay anyone attempting to leave the Marriott via car or taxi while the parade is passing by.
For those staying in San Diego after VAM, the fair opens June 2 and runs through July 4. Fun includes panning for gold, a Wild West saloon with an old-fashioned player piano, and chance encounters with notorious outlaws such as Jesse James and Black Bart.
Are we in Pamplona, Spain, or San Diego, California?
The differences might blur Saturday morning; it won’t be Pamplona’s running of the bulls in front of the San Diego Convention Center, but a cattle drive of long-horned cattle. And this frontier drive may create a few difficulties getting to and from the Vascular Annual Meeting.
The cattle will travel on Harbor Drive, the street directly in front of the San Diego Convention Center, VAM’s home and the VAM headquarters hotel, the Marriot Marquis San Diego Marina.
The route will affect the ability to cross Harbor Drive (from other hotels, for example) and will delay anyone attempting to leave the Marriott via car or taxi while the parade is passing by.
For those staying in San Diego after VAM, the fair opens June 2 and runs through July 4. Fun includes panning for gold, a Wild West saloon with an old-fashioned player piano, and chance encounters with notorious outlaws such as Jesse James and Black Bart.
Are we in Pamplona, Spain, or San Diego, California?
The differences might blur Saturday morning; it won’t be Pamplona’s running of the bulls in front of the San Diego Convention Center, but a cattle drive of long-horned cattle. And this frontier drive may create a few difficulties getting to and from the Vascular Annual Meeting.
The cattle will travel on Harbor Drive, the street directly in front of the San Diego Convention Center, VAM’s home and the VAM headquarters hotel, the Marriot Marquis San Diego Marina.
The route will affect the ability to cross Harbor Drive (from other hotels, for example) and will delay anyone attempting to leave the Marriott via car or taxi while the parade is passing by.
For those staying in San Diego after VAM, the fair opens June 2 and runs through July 4. Fun includes panning for gold, a Wild West saloon with an old-fashioned player piano, and chance encounters with notorious outlaws such as Jesse James and Black Bart.
How to Welcome a Patient Advisor to Your Research Team
When it comes to caring for those with vascular disease, who better to tell surgeons and researchers the effects of various treatments than … patients?
Patients who have completed a comprehensive Patient Advisors Course will provide their perspective Thursday afternoon in “Patient Advisors Program,” 2:30 to 3:30 p.m., with a reception to further the conversation immediately afterward, from 3:30 to 4:30 p.m.
This session has been more than a year in the making, the fruition of a project funded by the Patient-Centered Outcomes Research Institute on “Connecting Patients and Researchers to Engage in Patient-Centered Vascular Disease Research.” Adrienne Faerber, PhD, at the Dartmouth Institute for Health Policy and Clinical Research is leading the project in partnership with SVS member Philip Goodney, MD.
The patients attending VAM have completed an online course aimed at patient collaboration with researchers and clinicians. Researchers, clinicians, and clinical leaders all should find the session valuable, said Dr. Faerber. Major funding agencies are moving toward requiring patients to give their input on research proposals, she said.
“And clinicians who want to improve their care of patients and clinical leaders who want to learn about leading change initiatives will want to listen to what they have to say as well.
“Patients are the experts in living with vascular diseases and we should be listening to them.”
Their experience encompasses far more than just their treatment, Dr. Faerber said of patients, with questions – even if they don’t know to ask them – that involve far more than “stent or surgery.”
“Surgeons tend to think of risks and benefits of procedures. But patients find the post-operative recovery a really important part of the experience,” she said. Surgeons should discuss pain management and any lifestyle restrictions; for example, a patient might not know until after surgery that he cannot drive for six or eight weeks.
“In the patient-centered view, that’s a huge issue,” she said.
“Providing good care goes beyond recommending a treatment,” said Dr. Faerber. “Clinicians need their patients’ input as to what they want, their values and beliefs.” Considering all those factors, plus lifestyle, “may change your thinking on the treatment decision.”
The Thursday session includes an orientation to patient-centered research and patient advisors, conversations with patients about their experiences and how clinics and hospitals can improve the patient experience of those with vascular care plus clinician and researcher reactions.
Dr. Matthew Corriere will discuss parallels between the patients’ stories to his work evaluating what matters to patients undergoing treatment, and Dr. Philip Goodney will describe how patient advisors have helped him improve his research portfolio.
The reception following the session will provide an opportunity to talk with the patient advisors and find out more about adding a Patient Advisor to a research or quality improvement team.
For more information, visit patientadvisorscourse.com.
Thursday, June 1
2:30 – 3:30 p.m.
SDCC, Room 17B
Patient Advisors Program
Moderators: Adrienne Faerber, PhD and Philip Goodney, MD
3:30 – 4:30 p.m.
SDCC, Room 17B
Patient Advisors Program Reception
When it comes to caring for those with vascular disease, who better to tell surgeons and researchers the effects of various treatments than … patients?
Patients who have completed a comprehensive Patient Advisors Course will provide their perspective Thursday afternoon in “Patient Advisors Program,” 2:30 to 3:30 p.m., with a reception to further the conversation immediately afterward, from 3:30 to 4:30 p.m.
This session has been more than a year in the making, the fruition of a project funded by the Patient-Centered Outcomes Research Institute on “Connecting Patients and Researchers to Engage in Patient-Centered Vascular Disease Research.” Adrienne Faerber, PhD, at the Dartmouth Institute for Health Policy and Clinical Research is leading the project in partnership with SVS member Philip Goodney, MD.
The patients attending VAM have completed an online course aimed at patient collaboration with researchers and clinicians. Researchers, clinicians, and clinical leaders all should find the session valuable, said Dr. Faerber. Major funding agencies are moving toward requiring patients to give their input on research proposals, she said.
“And clinicians who want to improve their care of patients and clinical leaders who want to learn about leading change initiatives will want to listen to what they have to say as well.
“Patients are the experts in living with vascular diseases and we should be listening to them.”
Their experience encompasses far more than just their treatment, Dr. Faerber said of patients, with questions – even if they don’t know to ask them – that involve far more than “stent or surgery.”
“Surgeons tend to think of risks and benefits of procedures. But patients find the post-operative recovery a really important part of the experience,” she said. Surgeons should discuss pain management and any lifestyle restrictions; for example, a patient might not know until after surgery that he cannot drive for six or eight weeks.
“In the patient-centered view, that’s a huge issue,” she said.
“Providing good care goes beyond recommending a treatment,” said Dr. Faerber. “Clinicians need their patients’ input as to what they want, their values and beliefs.” Considering all those factors, plus lifestyle, “may change your thinking on the treatment decision.”
The Thursday session includes an orientation to patient-centered research and patient advisors, conversations with patients about their experiences and how clinics and hospitals can improve the patient experience of those with vascular care plus clinician and researcher reactions.
Dr. Matthew Corriere will discuss parallels between the patients’ stories to his work evaluating what matters to patients undergoing treatment, and Dr. Philip Goodney will describe how patient advisors have helped him improve his research portfolio.
The reception following the session will provide an opportunity to talk with the patient advisors and find out more about adding a Patient Advisor to a research or quality improvement team.
For more information, visit patientadvisorscourse.com.
Thursday, June 1
2:30 – 3:30 p.m.
SDCC, Room 17B
Patient Advisors Program
Moderators: Adrienne Faerber, PhD and Philip Goodney, MD
3:30 – 4:30 p.m.
SDCC, Room 17B
Patient Advisors Program Reception
When it comes to caring for those with vascular disease, who better to tell surgeons and researchers the effects of various treatments than … patients?
Patients who have completed a comprehensive Patient Advisors Course will provide their perspective Thursday afternoon in “Patient Advisors Program,” 2:30 to 3:30 p.m., with a reception to further the conversation immediately afterward, from 3:30 to 4:30 p.m.
This session has been more than a year in the making, the fruition of a project funded by the Patient-Centered Outcomes Research Institute on “Connecting Patients and Researchers to Engage in Patient-Centered Vascular Disease Research.” Adrienne Faerber, PhD, at the Dartmouth Institute for Health Policy and Clinical Research is leading the project in partnership with SVS member Philip Goodney, MD.
The patients attending VAM have completed an online course aimed at patient collaboration with researchers and clinicians. Researchers, clinicians, and clinical leaders all should find the session valuable, said Dr. Faerber. Major funding agencies are moving toward requiring patients to give their input on research proposals, she said.
“And clinicians who want to improve their care of patients and clinical leaders who want to learn about leading change initiatives will want to listen to what they have to say as well.
“Patients are the experts in living with vascular diseases and we should be listening to them.”
Their experience encompasses far more than just their treatment, Dr. Faerber said of patients, with questions – even if they don’t know to ask them – that involve far more than “stent or surgery.”
“Surgeons tend to think of risks and benefits of procedures. But patients find the post-operative recovery a really important part of the experience,” she said. Surgeons should discuss pain management and any lifestyle restrictions; for example, a patient might not know until after surgery that he cannot drive for six or eight weeks.
“In the patient-centered view, that’s a huge issue,” she said.
“Providing good care goes beyond recommending a treatment,” said Dr. Faerber. “Clinicians need their patients’ input as to what they want, their values and beliefs.” Considering all those factors, plus lifestyle, “may change your thinking on the treatment decision.”
The Thursday session includes an orientation to patient-centered research and patient advisors, conversations with patients about their experiences and how clinics and hospitals can improve the patient experience of those with vascular care plus clinician and researcher reactions.
Dr. Matthew Corriere will discuss parallels between the patients’ stories to his work evaluating what matters to patients undergoing treatment, and Dr. Philip Goodney will describe how patient advisors have helped him improve his research portfolio.
The reception following the session will provide an opportunity to talk with the patient advisors and find out more about adding a Patient Advisor to a research or quality improvement team.
For more information, visit patientadvisorscourse.com.
Thursday, June 1
2:30 – 3:30 p.m.
SDCC, Room 17B
Patient Advisors Program
Moderators: Adrienne Faerber, PhD and Philip Goodney, MD
3:30 – 4:30 p.m.
SDCC, Room 17B
Patient Advisors Program Reception
On Tap – Thursday
Here are some of the events your colleagues will be talking about later. You won’t want to miss:
Thursday, June 1
Stop by the Exhibit Hall, opening at noon, and its popular Vascular Live presentations.
8:00 to 8:30 a.m. – Opening Ceremony. Don’t miss the kickoff of our 2017 Vascular Annual Meeting events. Find out who is here and what you’ll want to attend. SDCC, Room 6 A/B.
8:30-10:15 a.m. – William J. von Liebig Forum. The first big event in our opening day lineup. Top issues moderated by Drs. Ronald Fairman and Ronald Dalman. SDCC, Room A/B.
10:30 a.m. to 12:00 p.m. – The E. Stanley Crawford Critical Issues Forum. “How to Navigate a Value-Based Reimbursement System: What you Need to Know,” the event will bring in experts on the changing reimbursements landscape. SVS President-Elect Dr. R. Clement Darling III, will moderate. SDCC, Room A/B.
2:30 - 3:30 p.m. – Patient Advisors Program. New this year! Patients advisors, trained in an innovative new program, will share stories of their diagnoses and treatments and discuss how patients and researchers can collaborate on patient-centered research projects. SDCC, Room 17B, with a reception to further the conversation following from 3:30 to 4:30 p.m.
3:00 to 3:30 p.m. – The Roy Greenberg Distinguished Lecture. “Aneurysms Don’t Know Borders” will be delivered by Dr. Tara Mastracci, of the Royal Free Foundation Trust in London. SDCC, Room 6 A/B.
6:30-7:30 p.m. – The Networking Reception for Women, Diversity and Young Surgeons, Marriott, Santa Rosa room, followed by the popular Alumni Receptions (see Program Book or the VAM mobile app for times and rooms).
Here are some of the events your colleagues will be talking about later. You won’t want to miss:
Thursday, June 1
Stop by the Exhibit Hall, opening at noon, and its popular Vascular Live presentations.
8:00 to 8:30 a.m. – Opening Ceremony. Don’t miss the kickoff of our 2017 Vascular Annual Meeting events. Find out who is here and what you’ll want to attend. SDCC, Room 6 A/B.
8:30-10:15 a.m. – William J. von Liebig Forum. The first big event in our opening day lineup. Top issues moderated by Drs. Ronald Fairman and Ronald Dalman. SDCC, Room A/B.
10:30 a.m. to 12:00 p.m. – The E. Stanley Crawford Critical Issues Forum. “How to Navigate a Value-Based Reimbursement System: What you Need to Know,” the event will bring in experts on the changing reimbursements landscape. SVS President-Elect Dr. R. Clement Darling III, will moderate. SDCC, Room A/B.
2:30 - 3:30 p.m. – Patient Advisors Program. New this year! Patients advisors, trained in an innovative new program, will share stories of their diagnoses and treatments and discuss how patients and researchers can collaborate on patient-centered research projects. SDCC, Room 17B, with a reception to further the conversation following from 3:30 to 4:30 p.m.
3:00 to 3:30 p.m. – The Roy Greenberg Distinguished Lecture. “Aneurysms Don’t Know Borders” will be delivered by Dr. Tara Mastracci, of the Royal Free Foundation Trust in London. SDCC, Room 6 A/B.
6:30-7:30 p.m. – The Networking Reception for Women, Diversity and Young Surgeons, Marriott, Santa Rosa room, followed by the popular Alumni Receptions (see Program Book or the VAM mobile app for times and rooms).
Here are some of the events your colleagues will be talking about later. You won’t want to miss:
Thursday, June 1
Stop by the Exhibit Hall, opening at noon, and its popular Vascular Live presentations.
8:00 to 8:30 a.m. – Opening Ceremony. Don’t miss the kickoff of our 2017 Vascular Annual Meeting events. Find out who is here and what you’ll want to attend. SDCC, Room 6 A/B.
8:30-10:15 a.m. – William J. von Liebig Forum. The first big event in our opening day lineup. Top issues moderated by Drs. Ronald Fairman and Ronald Dalman. SDCC, Room A/B.
10:30 a.m. to 12:00 p.m. – The E. Stanley Crawford Critical Issues Forum. “How to Navigate a Value-Based Reimbursement System: What you Need to Know,” the event will bring in experts on the changing reimbursements landscape. SVS President-Elect Dr. R. Clement Darling III, will moderate. SDCC, Room A/B.
2:30 - 3:30 p.m. – Patient Advisors Program. New this year! Patients advisors, trained in an innovative new program, will share stories of their diagnoses and treatments and discuss how patients and researchers can collaborate on patient-centered research projects. SDCC, Room 17B, with a reception to further the conversation following from 3:30 to 4:30 p.m.
3:00 to 3:30 p.m. – The Roy Greenberg Distinguished Lecture. “Aneurysms Don’t Know Borders” will be delivered by Dr. Tara Mastracci, of the Royal Free Foundation Trust in London. SDCC, Room 6 A/B.
6:30-7:30 p.m. – The Networking Reception for Women, Diversity and Young Surgeons, Marriott, Santa Rosa room, followed by the popular Alumni Receptions (see Program Book or the VAM mobile app for times and rooms).
2017 Resident Research Award: Epigenetic Mechanisms in Type 2 Diabetic Wound Healing
The issue of impaired wound healing in type 2 diabetes is a serious one and the leading cause of lower extremity amputation in the United States. The level of morbidity and mortality associated with diabetic foot ulcers has remained under the radar and, as a result, this important area of research has been understudied.
This year’s Resident Research Award winner, Andrew S. Kimball, MD, of the University of Michigan, will report on the research he and his colleagues performed on the immunologic and epigenetic mechanisms of wound healing in both physiologic and pathophysiologic states.
Dr. Kimball will present the research on Friday, June 2, at 10:00 a.m., discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing.
“Our lab specifically looks at the role of monocyte/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – as occurs in diabetes – affects monocyte/macrophage phenotype, and ultimately, wound healing,” said Dr. Kimball.
He is a PGY5 general surgery resident who will be applying for a vascular surgery fellowship this year.
“This specific project looks at epigenetic changes,” she continued. “It is a newer field, which looks at how variations in the environment can affect changes in the cell. We have found that a particular enzyme, SETDB2, is needed in macrophages for normal wound healing. Diabetics don’t have enough of the enzyme, which results in chronic inflammation.”
The research is important because the at-risk population is vast, and the opportunity for breakthrough research to have an impact has never been greater.
“Despite this,” said Dr. Kimball, “there are no effective treatments for abrogating the impaired wound healing seen in diabetes. And patients continue to suffer significant morbidity and mortality as a result.”
He added, “We hope our fundamental research will identify novel targets for the treatment of impaired wound healing in diabetes.”
Those attending the presentation, Epigenetic Mechanisms of Macrophage Phenotype Regulation in Diabetic Wound Healing, will learn about the immune system’s role in the early stages of wound healing. They will receive a better understanding of the role of epigenetics in influencing the wound cell inflammatory phenotype, and its effect on wound healing. They will also begin to realize how epigenetics influences a cell’s inflammatory phenotype.
Hopefully, the research will be an important first step – leading to new future therapies that target the enzyme and improve macrophage function in diabetic wounds.
“Andrew worked very hard, and I am very proud of his efforts,” said Dr. Gallagher. “He has done a phenomenal job in the lab, and his diligent work has advanced this field tremendously.”
She continued, “I have no doubt that Andrew will continue to make important scientific discoveries in our field in the future. He is certainly deserving of this award.”
Dr. Kimball and his coauthors have no relevant financial disclosures.
Friday, June 2
10:00 a.m.
SDCC, Room 6 A/B
Plenary 5, 2017 Resident Research Award
The issue of impaired wound healing in type 2 diabetes is a serious one and the leading cause of lower extremity amputation in the United States. The level of morbidity and mortality associated with diabetic foot ulcers has remained under the radar and, as a result, this important area of research has been understudied.
This year’s Resident Research Award winner, Andrew S. Kimball, MD, of the University of Michigan, will report on the research he and his colleagues performed on the immunologic and epigenetic mechanisms of wound healing in both physiologic and pathophysiologic states.
Dr. Kimball will present the research on Friday, June 2, at 10:00 a.m., discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing.
“Our lab specifically looks at the role of monocyte/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – as occurs in diabetes – affects monocyte/macrophage phenotype, and ultimately, wound healing,” said Dr. Kimball.
He is a PGY5 general surgery resident who will be applying for a vascular surgery fellowship this year.
“This specific project looks at epigenetic changes,” she continued. “It is a newer field, which looks at how variations in the environment can affect changes in the cell. We have found that a particular enzyme, SETDB2, is needed in macrophages for normal wound healing. Diabetics don’t have enough of the enzyme, which results in chronic inflammation.”
The research is important because the at-risk population is vast, and the opportunity for breakthrough research to have an impact has never been greater.
“Despite this,” said Dr. Kimball, “there are no effective treatments for abrogating the impaired wound healing seen in diabetes. And patients continue to suffer significant morbidity and mortality as a result.”
He added, “We hope our fundamental research will identify novel targets for the treatment of impaired wound healing in diabetes.”
Those attending the presentation, Epigenetic Mechanisms of Macrophage Phenotype Regulation in Diabetic Wound Healing, will learn about the immune system’s role in the early stages of wound healing. They will receive a better understanding of the role of epigenetics in influencing the wound cell inflammatory phenotype, and its effect on wound healing. They will also begin to realize how epigenetics influences a cell’s inflammatory phenotype.
Hopefully, the research will be an important first step – leading to new future therapies that target the enzyme and improve macrophage function in diabetic wounds.
“Andrew worked very hard, and I am very proud of his efforts,” said Dr. Gallagher. “He has done a phenomenal job in the lab, and his diligent work has advanced this field tremendously.”
She continued, “I have no doubt that Andrew will continue to make important scientific discoveries in our field in the future. He is certainly deserving of this award.”
Dr. Kimball and his coauthors have no relevant financial disclosures.
Friday, June 2
10:00 a.m.
SDCC, Room 6 A/B
Plenary 5, 2017 Resident Research Award
The issue of impaired wound healing in type 2 diabetes is a serious one and the leading cause of lower extremity amputation in the United States. The level of morbidity and mortality associated with diabetic foot ulcers has remained under the radar and, as a result, this important area of research has been understudied.
This year’s Resident Research Award winner, Andrew S. Kimball, MD, of the University of Michigan, will report on the research he and his colleagues performed on the immunologic and epigenetic mechanisms of wound healing in both physiologic and pathophysiologic states.
Dr. Kimball will present the research on Friday, June 2, at 10:00 a.m., discussing the role of specific epigenetic enzymes in the dictation of macrophage phenotype in wound tissue. The talk will cover how diabetes alters those enzymes to influence a deleterious phenotype that promotes inflammation and delays wound healing.
“Our lab specifically looks at the role of monocyte/macrophages in the inflammatory phase of wound healing and how perturbation in the local environment – as occurs in diabetes – affects monocyte/macrophage phenotype, and ultimately, wound healing,” said Dr. Kimball.
He is a PGY5 general surgery resident who will be applying for a vascular surgery fellowship this year.
“This specific project looks at epigenetic changes,” she continued. “It is a newer field, which looks at how variations in the environment can affect changes in the cell. We have found that a particular enzyme, SETDB2, is needed in macrophages for normal wound healing. Diabetics don’t have enough of the enzyme, which results in chronic inflammation.”
The research is important because the at-risk population is vast, and the opportunity for breakthrough research to have an impact has never been greater.
“Despite this,” said Dr. Kimball, “there are no effective treatments for abrogating the impaired wound healing seen in diabetes. And patients continue to suffer significant morbidity and mortality as a result.”
He added, “We hope our fundamental research will identify novel targets for the treatment of impaired wound healing in diabetes.”
Those attending the presentation, Epigenetic Mechanisms of Macrophage Phenotype Regulation in Diabetic Wound Healing, will learn about the immune system’s role in the early stages of wound healing. They will receive a better understanding of the role of epigenetics in influencing the wound cell inflammatory phenotype, and its effect on wound healing. They will also begin to realize how epigenetics influences a cell’s inflammatory phenotype.
Hopefully, the research will be an important first step – leading to new future therapies that target the enzyme and improve macrophage function in diabetic wounds.
“Andrew worked very hard, and I am very proud of his efforts,” said Dr. Gallagher. “He has done a phenomenal job in the lab, and his diligent work has advanced this field tremendously.”
She continued, “I have no doubt that Andrew will continue to make important scientific discoveries in our field in the future. He is certainly deserving of this award.”
Dr. Kimball and his coauthors have no relevant financial disclosures.
Friday, June 2
10:00 a.m.
SDCC, Room 6 A/B
Plenary 5, 2017 Resident Research Award
Defining Pharmacy Leadership in the VA
Ashley L. Adams, PharmD. What are the key leadership attributes of pharmacy leaders?
Julie A. Groppi, PharmD. As a pharmacy leader, you have to be confident in what you do as a pharmacist and not only look at what you are doing now but what you can do in the future. You always have to look for that next apple to pick, because you have to be willing to accept change and help influence change, even though many people do not like change. As a supervisor, I ran a large and growing clinical pharmacy program. I remember many colleagues saying, “You mean, I have to do this now?” I would always try to bring the conversation around with staff to ensure that the benefit of the change or ‘what is in it for you’ was included in the approach. If you are a leader, communicating with physicians, pharmacists, or VA leadership, you just need to sell it to show why it is important and how the change will improve the process. If you don’t, then you won’t be able facilitate or sustain the momentum needed for change.
One important aspect of being a change leader is to make sure you listen (and talk) to those working in the area on a daily basis when you are going through your processes and trying to create change on what is going happen. It is important to make sure your stakeholders are involved and heard while you think about all of your potential obstacles; this is something that I always have tried to do. Also, reflecting on where you have been and what you have done will help you to think differently and is something you should do both professionally and personally. I may not need to know every aspect of the process, but I need to know the obstacles to figure out ways to prevent or break down those walls and solve those underlying issues.
Dr. Adams. What are some of the challenges and opportunities you have found in pharmacy leadership
Dr. Groppi. I think the challenges [are related to] the sheer volume of work that is out there. Having the ability to be able to separate and think about where you want your team to go is the challenge of any leader. When you are right in the middle of it, you tend to focus on the task at hand to get the work done. One week, it is pain management, and then the next week it is hepatitis C, and then it’s assessing acute care services, then gaps or problems somewhere else. There are always different obstacles and different initiatives (pressures) coming at you. You have to not lose your sense of where you want to go. Often, many people cannot stop and look at the whole picture.
I joined the Clinical Pharmacy Practice office in 2011, and one of the first things we were challenged with when the office started was to write guidelines, create policies, and develop tools that would help guide the practice. However, when we started sending out resources to the field, many people were too busy with what was going on at their local facility to focus on what we had developed, so we had to step back. We brainstormed some ideas and looked at our peers in other offices who had demonstrated success. When we started discussing pharmacist scope of practice agreements, I looked at nursing service and their movement related to scope of practice and how it had impacted change in the profession over the past several years.
Nursing has great infrastructure and support for its program. They created many different types of clinical practice councils within nursing, and they were able to institute a lot of changes and spread their initiatives. We thought, “Why don’t we do this for clinical pharmacy?” So we started doing more outreach to the different sites and had discussions with our advisory board, which resulted in the development of the National Clinical Pharmacy Practice Council (NCPPC). We promoted facility and VISN councils to start talking about practice issues and regularly discussing our initiatives as a part of teleconferences, so we could gain support and keep the momentum. Now the NCPPC has grown and everyone is excited about what is happening. It is having a multipronged effect to impact clinical practice.
Dr. Adams. When you are starting on a new project, how do you and your fellow coworkers decide which one is the best to pursue?
Dr. Groppi. We just do them all—I’m joking... sometimes it feels that way. It’s really hard. There are a lot of different things happening at once and many competing priorities, so we try to do as many things as possible. We will assist with requests that come through the Central Office or questions coming from other program offices related to clinical pharmacy practice and we try to get involved and help support and share the success stories of our pharmacist roles as much as possible. For example, the National Nephrology Office contacted us, about the anticoagulation directive. They wanted to do something similar for nephrology since so many pharmacists were effectively and safely managing erythropoietin stimulating agents. This started a conversation.
Often, the priorities come from patient demand such as in primary care. When VA was implementing patient aligned care teams (PACTs), PBM had to ensure that we had conversations ready to describe clinical pharmacy practice in this area. The same thing occurred with hepatitis C. There were new drugs approved and roles for pharmacists, and often there were not enough providers to care for patients. It became an opportunity.
Frequently, choices are based on what we think will be the largest yield and the biggest gaps in care. Other times, it is based on national priorities. We look at the strategic plan for VA and develop our initiatives accordingly. What’s a new priority or component of the strategic plan for this year? What’s the plan for next year or moving forward? Telepharmacy a few years ago or telehealth is an example. We were making sure to describe our practice in the area and then set goals that are going to sustain the profession.
We focused on PACTs during the first few years as we had hundreds of pharmacists practicing. The next big area was specialty and acute care. We started leading workgroups and focused on policies and guidance to share strong practices. The past several years the focus has been on pain management because everyone is struggling with the number of veterans on opioids. When there is a big crisis, you have to hit it full force and look for opportunities that exist. Antimicrobial stewardship was another great example where we were able to provide help and describe the important role of pharmacists based on the strong practices we have across VA. Many times prioritization is on demand, but always keeping in mind what is happening around you and how it supports our VHA strategic plan.
Dr. Adams. What would be your main advice for future pharmacy leaders? Just taking those opportunities and going with them?
Dr. Groppi. Yes. Look for the spot where you might be able to make a positive im
Ashley L. Adams, PharmD. What are the key leadership attributes of pharmacy leaders?
Julie A. Groppi, PharmD. As a pharmacy leader, you have to be confident in what you do as a pharmacist and not only look at what you are doing now but what you can do in the future. You always have to look for that next apple to pick, because you have to be willing to accept change and help influence change, even though many people do not like change. As a supervisor, I ran a large and growing clinical pharmacy program. I remember many colleagues saying, “You mean, I have to do this now?” I would always try to bring the conversation around with staff to ensure that the benefit of the change or ‘what is in it for you’ was included in the approach. If you are a leader, communicating with physicians, pharmacists, or VA leadership, you just need to sell it to show why it is important and how the change will improve the process. If you don’t, then you won’t be able facilitate or sustain the momentum needed for change.
One important aspect of being a change leader is to make sure you listen (and talk) to those working in the area on a daily basis when you are going through your processes and trying to create change on what is going happen. It is important to make sure your stakeholders are involved and heard while you think about all of your potential obstacles; this is something that I always have tried to do. Also, reflecting on where you have been and what you have done will help you to think differently and is something you should do both professionally and personally. I may not need to know every aspect of the process, but I need to know the obstacles to figure out ways to prevent or break down those walls and solve those underlying issues.
Dr. Adams. What are some of the challenges and opportunities you have found in pharmacy leadership
Dr. Groppi. I think the challenges [are related to] the sheer volume of work that is out there. Having the ability to be able to separate and think about where you want your team to go is the challenge of any leader. When you are right in the middle of it, you tend to focus on the task at hand to get the work done. One week, it is pain management, and then the next week it is hepatitis C, and then it’s assessing acute care services, then gaps or problems somewhere else. There are always different obstacles and different initiatives (pressures) coming at you. You have to not lose your sense of where you want to go. Often, many people cannot stop and look at the whole picture.
I joined the Clinical Pharmacy Practice office in 2011, and one of the first things we were challenged with when the office started was to write guidelines, create policies, and develop tools that would help guide the practice. However, when we started sending out resources to the field, many people were too busy with what was going on at their local facility to focus on what we had developed, so we had to step back. We brainstormed some ideas and looked at our peers in other offices who had demonstrated success. When we started discussing pharmacist scope of practice agreements, I looked at nursing service and their movement related to scope of practice and how it had impacted change in the profession over the past several years.
Nursing has great infrastructure and support for its program. They created many different types of clinical practice councils within nursing, and they were able to institute a lot of changes and spread their initiatives. We thought, “Why don’t we do this for clinical pharmacy?” So we started doing more outreach to the different sites and had discussions with our advisory board, which resulted in the development of the National Clinical Pharmacy Practice Council (NCPPC). We promoted facility and VISN councils to start talking about practice issues and regularly discussing our initiatives as a part of teleconferences, so we could gain support and keep the momentum. Now the NCPPC has grown and everyone is excited about what is happening. It is having a multipronged effect to impact clinical practice.
Dr. Adams. When you are starting on a new project, how do you and your fellow coworkers decide which one is the best to pursue?
Dr. Groppi. We just do them all—I’m joking... sometimes it feels that way. It’s really hard. There are a lot of different things happening at once and many competing priorities, so we try to do as many things as possible. We will assist with requests that come through the Central Office or questions coming from other program offices related to clinical pharmacy practice and we try to get involved and help support and share the success stories of our pharmacist roles as much as possible. For example, the National Nephrology Office contacted us, about the anticoagulation directive. They wanted to do something similar for nephrology since so many pharmacists were effectively and safely managing erythropoietin stimulating agents. This started a conversation.
Often, the priorities come from patient demand such as in primary care. When VA was implementing patient aligned care teams (PACTs), PBM had to ensure that we had conversations ready to describe clinical pharmacy practice in this area. The same thing occurred with hepatitis C. There were new drugs approved and roles for pharmacists, and often there were not enough providers to care for patients. It became an opportunity.
Frequently, choices are based on what we think will be the largest yield and the biggest gaps in care. Other times, it is based on national priorities. We look at the strategic plan for VA and develop our initiatives accordingly. What’s a new priority or component of the strategic plan for this year? What’s the plan for next year or moving forward? Telepharmacy a few years ago or telehealth is an example. We were making sure to describe our practice in the area and then set goals that are going to sustain the profession.
We focused on PACTs during the first few years as we had hundreds of pharmacists practicing. The next big area was specialty and acute care. We started leading workgroups and focused on policies and guidance to share strong practices. The past several years the focus has been on pain management because everyone is struggling with the number of veterans on opioids. When there is a big crisis, you have to hit it full force and look for opportunities that exist. Antimicrobial stewardship was another great example where we were able to provide help and describe the important role of pharmacists based on the strong practices we have across VA. Many times prioritization is on demand, but always keeping in mind what is happening around you and how it supports our VHA strategic plan.
Dr. Adams. What would be your main advice for future pharmacy leaders? Just taking those opportunities and going with them?
Dr. Groppi. Yes. Look for the spot where you might be able to make a positive im
Ashley L. Adams, PharmD. What are the key leadership attributes of pharmacy leaders?
Julie A. Groppi, PharmD. As a pharmacy leader, you have to be confident in what you do as a pharmacist and not only look at what you are doing now but what you can do in the future. You always have to look for that next apple to pick, because you have to be willing to accept change and help influence change, even though many people do not like change. As a supervisor, I ran a large and growing clinical pharmacy program. I remember many colleagues saying, “You mean, I have to do this now?” I would always try to bring the conversation around with staff to ensure that the benefit of the change or ‘what is in it for you’ was included in the approach. If you are a leader, communicating with physicians, pharmacists, or VA leadership, you just need to sell it to show why it is important and how the change will improve the process. If you don’t, then you won’t be able facilitate or sustain the momentum needed for change.
One important aspect of being a change leader is to make sure you listen (and talk) to those working in the area on a daily basis when you are going through your processes and trying to create change on what is going happen. It is important to make sure your stakeholders are involved and heard while you think about all of your potential obstacles; this is something that I always have tried to do. Also, reflecting on where you have been and what you have done will help you to think differently and is something you should do both professionally and personally. I may not need to know every aspect of the process, but I need to know the obstacles to figure out ways to prevent or break down those walls and solve those underlying issues.
Dr. Adams. What are some of the challenges and opportunities you have found in pharmacy leadership
Dr. Groppi. I think the challenges [are related to] the sheer volume of work that is out there. Having the ability to be able to separate and think about where you want your team to go is the challenge of any leader. When you are right in the middle of it, you tend to focus on the task at hand to get the work done. One week, it is pain management, and then the next week it is hepatitis C, and then it’s assessing acute care services, then gaps or problems somewhere else. There are always different obstacles and different initiatives (pressures) coming at you. You have to not lose your sense of where you want to go. Often, many people cannot stop and look at the whole picture.
I joined the Clinical Pharmacy Practice office in 2011, and one of the first things we were challenged with when the office started was to write guidelines, create policies, and develop tools that would help guide the practice. However, when we started sending out resources to the field, many people were too busy with what was going on at their local facility to focus on what we had developed, so we had to step back. We brainstormed some ideas and looked at our peers in other offices who had demonstrated success. When we started discussing pharmacist scope of practice agreements, I looked at nursing service and their movement related to scope of practice and how it had impacted change in the profession over the past several years.
Nursing has great infrastructure and support for its program. They created many different types of clinical practice councils within nursing, and they were able to institute a lot of changes and spread their initiatives. We thought, “Why don’t we do this for clinical pharmacy?” So we started doing more outreach to the different sites and had discussions with our advisory board, which resulted in the development of the National Clinical Pharmacy Practice Council (NCPPC). We promoted facility and VISN councils to start talking about practice issues and regularly discussing our initiatives as a part of teleconferences, so we could gain support and keep the momentum. Now the NCPPC has grown and everyone is excited about what is happening. It is having a multipronged effect to impact clinical practice.
Dr. Adams. When you are starting on a new project, how do you and your fellow coworkers decide which one is the best to pursue?
Dr. Groppi. We just do them all—I’m joking... sometimes it feels that way. It’s really hard. There are a lot of different things happening at once and many competing priorities, so we try to do as many things as possible. We will assist with requests that come through the Central Office or questions coming from other program offices related to clinical pharmacy practice and we try to get involved and help support and share the success stories of our pharmacist roles as much as possible. For example, the National Nephrology Office contacted us, about the anticoagulation directive. They wanted to do something similar for nephrology since so many pharmacists were effectively and safely managing erythropoietin stimulating agents. This started a conversation.
Often, the priorities come from patient demand such as in primary care. When VA was implementing patient aligned care teams (PACTs), PBM had to ensure that we had conversations ready to describe clinical pharmacy practice in this area. The same thing occurred with hepatitis C. There were new drugs approved and roles for pharmacists, and often there were not enough providers to care for patients. It became an opportunity.
Frequently, choices are based on what we think will be the largest yield and the biggest gaps in care. Other times, it is based on national priorities. We look at the strategic plan for VA and develop our initiatives accordingly. What’s a new priority or component of the strategic plan for this year? What’s the plan for next year or moving forward? Telepharmacy a few years ago or telehealth is an example. We were making sure to describe our practice in the area and then set goals that are going to sustain the profession.
We focused on PACTs during the first few years as we had hundreds of pharmacists practicing. The next big area was specialty and acute care. We started leading workgroups and focused on policies and guidance to share strong practices. The past several years the focus has been on pain management because everyone is struggling with the number of veterans on opioids. When there is a big crisis, you have to hit it full force and look for opportunities that exist. Antimicrobial stewardship was another great example where we were able to provide help and describe the important role of pharmacists based on the strong practices we have across VA. Many times prioritization is on demand, but always keeping in mind what is happening around you and how it supports our VHA strategic plan.
Dr. Adams. What would be your main advice for future pharmacy leaders? Just taking those opportunities and going with them?
Dr. Groppi. Yes. Look for the spot where you might be able to make a positive im
BLA for CAR T-cell therapy granted priority review
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for axicabtagene ciloleucel (formerly KTE-C19), a chimeric antigen receptor (CAR) T-cell therapy.
Kite Pharma, Inc. is seeking approval for axicabtagene ciloleucel as a treatment for patients with relapsed or refractory, aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA has set a review deadline of November 29, 2017, for the axicabtagene ciloleucel BLA.
Axicabtagene ciloleucel also has breakthrough therapy designation from the FDA as a treatment for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.
ZUMA-1 trial
The BLA for axicabtagene ciloleucel is supported by data from the phase 2 ZUMA-1 trial, which enrolled 111 patients with relapsed/refractory B-cell NHL.
After a single infusion of axicabtagene ciloleucel, the objective response rate was 82%. At a median follow-up of 8.7 months, 44% of patients were still in response, which included 39% of patients in complete response.
The most common grade 3 or higher adverse events were anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%).
There were 3 deaths during the trial that were not due to disease progression. Two of these deaths were deemed related to axicabtagene ciloleucel.
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for axicabtagene ciloleucel (formerly KTE-C19), a chimeric antigen receptor (CAR) T-cell therapy.
Kite Pharma, Inc. is seeking approval for axicabtagene ciloleucel as a treatment for patients with relapsed or refractory, aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA has set a review deadline of November 29, 2017, for the axicabtagene ciloleucel BLA.
Axicabtagene ciloleucel also has breakthrough therapy designation from the FDA as a treatment for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.
ZUMA-1 trial
The BLA for axicabtagene ciloleucel is supported by data from the phase 2 ZUMA-1 trial, which enrolled 111 patients with relapsed/refractory B-cell NHL.
After a single infusion of axicabtagene ciloleucel, the objective response rate was 82%. At a median follow-up of 8.7 months, 44% of patients were still in response, which included 39% of patients in complete response.
The most common grade 3 or higher adverse events were anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%).
There were 3 deaths during the trial that were not due to disease progression. Two of these deaths were deemed related to axicabtagene ciloleucel.
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for axicabtagene ciloleucel (formerly KTE-C19), a chimeric antigen receptor (CAR) T-cell therapy.
Kite Pharma, Inc. is seeking approval for axicabtagene ciloleucel as a treatment for patients with relapsed or refractory, aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA has set a review deadline of November 29, 2017, for the axicabtagene ciloleucel BLA.
Axicabtagene ciloleucel also has breakthrough therapy designation from the FDA as a treatment for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.
ZUMA-1 trial
The BLA for axicabtagene ciloleucel is supported by data from the phase 2 ZUMA-1 trial, which enrolled 111 patients with relapsed/refractory B-cell NHL.
After a single infusion of axicabtagene ciloleucel, the objective response rate was 82%. At a median follow-up of 8.7 months, 44% of patients were still in response, which included 39% of patients in complete response.
The most common grade 3 or higher adverse events were anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%).
There were 3 deaths during the trial that were not due to disease progression. Two of these deaths were deemed related to axicabtagene ciloleucel.
How Zika arrived and spread in Florida
A study published in Nature appears to explain how Zika virus entered the US via Florida in 2016 and how the virus might re-enter the country this year.
By sequencing the Zika virus genome at different points in the outbreak, researchers created a family tree showing where cases originated and how quickly they spread.
The team discovered that transmission of Zika virus began in Florida at least 4—and potentially up to 40—times last year.
The researchers also traced most of the Zika lineages back to strains of the virus in the Caribbean.
“Without these genomes, we wouldn’t be able to reconstruct the history of how the virus moved around,” said study author Kristian G. Andersen, PhD, of The Scripps Research Institute in La Jolla, California.
“Rapid viral genome sequencing during ongoing outbreaks is a new development that has only been made possible over the last couple of years.”
Why Miami?
By sequencing Zika virus genomes from humans and mosquitoes—and analyzing travel and mosquito abundance data—the researchers found that several factors created a “perfect storm” for the spread of Zika virus in Miami.
“This study shows why Miami is special,” said study author Nathan D. Grubaugh, PhD, of The Scripps Research Institute.
First, Dr Grubaugh explained, Miami is home to year-round populations of Aedes aegypti mosquitoes, the main species that transmits Zika virus.
The area is also a significant travel hub, bringing in more international air and sea traffic than any other city in the continental US in 2016. Finally, Miami is an especially popular destination for travelers who have visited Zika-afflicted areas.
The researchers found that travel from the Caribbean islands may have significantly contributed to cases of Zika reaching Miami.
Of the 5.7 million international travelers entering Miami by flights and cruise ships between January and June of 2016, more than half arrived from the Caribbean.
Killing mosquitos produces results
The researchers believe Zika virus may have started transmission in Miami up to 40 times, but most travel-related cases did not lead to any secondary infections locally. The virus was more likely to reach a dead end than keep spreading.
The researchers found that one reason for the dead-ends was a direct connection between mosquito control efforts and disease prevention.
“We show that if you decrease the mosquito population in an area, the number of Zika infections goes down proportionally,” Dr Andersen said. “This means we can significantly limit the risk of Zika virus by focusing on mosquito control. This is not too surprising, but it’s important to show that there is an almost perfect correlation between the number of mosquitos and the number of human infections.”
Based on data from the outbreak, the researchers see potential in stopping the virus through mosquito control efforts in the US and other infected countries, instead of, for example, through travel restrictions.
“Given how many times the introductions happened, trying to restrict traffic or movement of people obviously isn’t a solution,” Dr Andersen said. “Focusing on disease prevention and mosquito control in endemic areas is likely to be a much more successful strategy.”
When the virus did spread, the researchers found that splitting Miami into designated Zika zones—often done by neighborhood or city block—didn’t accurately represent how the virus was moving.
Within each Zika zone, the researchers discovered a mixing of multiple Zika lineages, suggesting the virus wasn’t well-confined, likely moving around with infected people.
Drs Andersen and Grubaugh hope these lessons from the 2016 epidemic will help researchers and health officials respond even faster to prevent Zika’s spread in 2017.
Behind the data
Understanding Zika’s timeline required an international team of researchers and partnerships with several health agencies.
The researchers also designed a new method of genomic sequencing just to study the Zika virus. Because Zika is hard to collect in the blood of those infected, it was a challenge for the researchers to isolate enough of its genetic material for sequencing.
To solve this problem, the researchers developed 2 different protocols to break apart the genetic material they could find and reassemble it in a useful way for analysis.
With these new protocols, the researchers sequenced the virus from 28 of the reported 256 Zika cases in Florida, as well as 7 mosquito pools, to model what happened in the larger patient group.
As they worked, the researchers released their data immediately publicly to help other researchers. They hope to release more data—and analysis—in real time as cases mount in 2017.
The research was supported by the National Institutes of Health, The Pew Charitable Trusts, The Ray Thomas Foundation, a Mahan Postdoctoral Fellowship from the Computational Biology Program at Fred Hutchinson Cancer Research Center, the US Centers for Disease Control and Prevention, the European Union Seventh Framework Programme, the United States Agency for International Development Emerging Pandemic Threats Program-2 PREDICT-2, and the Defense Advanced Research Projects Agency.
A study published in Nature appears to explain how Zika virus entered the US via Florida in 2016 and how the virus might re-enter the country this year.
By sequencing the Zika virus genome at different points in the outbreak, researchers created a family tree showing where cases originated and how quickly they spread.
The team discovered that transmission of Zika virus began in Florida at least 4—and potentially up to 40—times last year.
The researchers also traced most of the Zika lineages back to strains of the virus in the Caribbean.
“Without these genomes, we wouldn’t be able to reconstruct the history of how the virus moved around,” said study author Kristian G. Andersen, PhD, of The Scripps Research Institute in La Jolla, California.
“Rapid viral genome sequencing during ongoing outbreaks is a new development that has only been made possible over the last couple of years.”
Why Miami?
By sequencing Zika virus genomes from humans and mosquitoes—and analyzing travel and mosquito abundance data—the researchers found that several factors created a “perfect storm” for the spread of Zika virus in Miami.
“This study shows why Miami is special,” said study author Nathan D. Grubaugh, PhD, of The Scripps Research Institute.
First, Dr Grubaugh explained, Miami is home to year-round populations of Aedes aegypti mosquitoes, the main species that transmits Zika virus.
The area is also a significant travel hub, bringing in more international air and sea traffic than any other city in the continental US in 2016. Finally, Miami is an especially popular destination for travelers who have visited Zika-afflicted areas.
The researchers found that travel from the Caribbean islands may have significantly contributed to cases of Zika reaching Miami.
Of the 5.7 million international travelers entering Miami by flights and cruise ships between January and June of 2016, more than half arrived from the Caribbean.
Killing mosquitos produces results
The researchers believe Zika virus may have started transmission in Miami up to 40 times, but most travel-related cases did not lead to any secondary infections locally. The virus was more likely to reach a dead end than keep spreading.
The researchers found that one reason for the dead-ends was a direct connection between mosquito control efforts and disease prevention.
“We show that if you decrease the mosquito population in an area, the number of Zika infections goes down proportionally,” Dr Andersen said. “This means we can significantly limit the risk of Zika virus by focusing on mosquito control. This is not too surprising, but it’s important to show that there is an almost perfect correlation between the number of mosquitos and the number of human infections.”
Based on data from the outbreak, the researchers see potential in stopping the virus through mosquito control efforts in the US and other infected countries, instead of, for example, through travel restrictions.
“Given how many times the introductions happened, trying to restrict traffic or movement of people obviously isn’t a solution,” Dr Andersen said. “Focusing on disease prevention and mosquito control in endemic areas is likely to be a much more successful strategy.”
When the virus did spread, the researchers found that splitting Miami into designated Zika zones—often done by neighborhood or city block—didn’t accurately represent how the virus was moving.
Within each Zika zone, the researchers discovered a mixing of multiple Zika lineages, suggesting the virus wasn’t well-confined, likely moving around with infected people.
Drs Andersen and Grubaugh hope these lessons from the 2016 epidemic will help researchers and health officials respond even faster to prevent Zika’s spread in 2017.
Behind the data
Understanding Zika’s timeline required an international team of researchers and partnerships with several health agencies.
The researchers also designed a new method of genomic sequencing just to study the Zika virus. Because Zika is hard to collect in the blood of those infected, it was a challenge for the researchers to isolate enough of its genetic material for sequencing.
To solve this problem, the researchers developed 2 different protocols to break apart the genetic material they could find and reassemble it in a useful way for analysis.
With these new protocols, the researchers sequenced the virus from 28 of the reported 256 Zika cases in Florida, as well as 7 mosquito pools, to model what happened in the larger patient group.
As they worked, the researchers released their data immediately publicly to help other researchers. They hope to release more data—and analysis—in real time as cases mount in 2017.
The research was supported by the National Institutes of Health, The Pew Charitable Trusts, The Ray Thomas Foundation, a Mahan Postdoctoral Fellowship from the Computational Biology Program at Fred Hutchinson Cancer Research Center, the US Centers for Disease Control and Prevention, the European Union Seventh Framework Programme, the United States Agency for International Development Emerging Pandemic Threats Program-2 PREDICT-2, and the Defense Advanced Research Projects Agency.
A study published in Nature appears to explain how Zika virus entered the US via Florida in 2016 and how the virus might re-enter the country this year.
By sequencing the Zika virus genome at different points in the outbreak, researchers created a family tree showing where cases originated and how quickly they spread.
The team discovered that transmission of Zika virus began in Florida at least 4—and potentially up to 40—times last year.
The researchers also traced most of the Zika lineages back to strains of the virus in the Caribbean.
“Without these genomes, we wouldn’t be able to reconstruct the history of how the virus moved around,” said study author Kristian G. Andersen, PhD, of The Scripps Research Institute in La Jolla, California.
“Rapid viral genome sequencing during ongoing outbreaks is a new development that has only been made possible over the last couple of years.”
Why Miami?
By sequencing Zika virus genomes from humans and mosquitoes—and analyzing travel and mosquito abundance data—the researchers found that several factors created a “perfect storm” for the spread of Zika virus in Miami.
“This study shows why Miami is special,” said study author Nathan D. Grubaugh, PhD, of The Scripps Research Institute.
First, Dr Grubaugh explained, Miami is home to year-round populations of Aedes aegypti mosquitoes, the main species that transmits Zika virus.
The area is also a significant travel hub, bringing in more international air and sea traffic than any other city in the continental US in 2016. Finally, Miami is an especially popular destination for travelers who have visited Zika-afflicted areas.
The researchers found that travel from the Caribbean islands may have significantly contributed to cases of Zika reaching Miami.
Of the 5.7 million international travelers entering Miami by flights and cruise ships between January and June of 2016, more than half arrived from the Caribbean.
Killing mosquitos produces results
The researchers believe Zika virus may have started transmission in Miami up to 40 times, but most travel-related cases did not lead to any secondary infections locally. The virus was more likely to reach a dead end than keep spreading.
The researchers found that one reason for the dead-ends was a direct connection between mosquito control efforts and disease prevention.
“We show that if you decrease the mosquito population in an area, the number of Zika infections goes down proportionally,” Dr Andersen said. “This means we can significantly limit the risk of Zika virus by focusing on mosquito control. This is not too surprising, but it’s important to show that there is an almost perfect correlation between the number of mosquitos and the number of human infections.”
Based on data from the outbreak, the researchers see potential in stopping the virus through mosquito control efforts in the US and other infected countries, instead of, for example, through travel restrictions.
“Given how many times the introductions happened, trying to restrict traffic or movement of people obviously isn’t a solution,” Dr Andersen said. “Focusing on disease prevention and mosquito control in endemic areas is likely to be a much more successful strategy.”
When the virus did spread, the researchers found that splitting Miami into designated Zika zones—often done by neighborhood or city block—didn’t accurately represent how the virus was moving.
Within each Zika zone, the researchers discovered a mixing of multiple Zika lineages, suggesting the virus wasn’t well-confined, likely moving around with infected people.
Drs Andersen and Grubaugh hope these lessons from the 2016 epidemic will help researchers and health officials respond even faster to prevent Zika’s spread in 2017.
Behind the data
Understanding Zika’s timeline required an international team of researchers and partnerships with several health agencies.
The researchers also designed a new method of genomic sequencing just to study the Zika virus. Because Zika is hard to collect in the blood of those infected, it was a challenge for the researchers to isolate enough of its genetic material for sequencing.
To solve this problem, the researchers developed 2 different protocols to break apart the genetic material they could find and reassemble it in a useful way for analysis.
With these new protocols, the researchers sequenced the virus from 28 of the reported 256 Zika cases in Florida, as well as 7 mosquito pools, to model what happened in the larger patient group.
As they worked, the researchers released their data immediately publicly to help other researchers. They hope to release more data—and analysis—in real time as cases mount in 2017.
The research was supported by the National Institutes of Health, The Pew Charitable Trusts, The Ray Thomas Foundation, a Mahan Postdoctoral Fellowship from the Computational Biology Program at Fred Hutchinson Cancer Research Center, the US Centers for Disease Control and Prevention, the European Union Seventh Framework Programme, the United States Agency for International Development Emerging Pandemic Threats Program-2 PREDICT-2, and the Defense Advanced Research Projects Agency.
AstraZeneca recalls lot of Brilinta in US
AstraZeneca has announced a voluntary recall of 1 lot of professional (physician) sample bottles containing 8 tablets of Brilinta® (ticagrelor).
This recall follows a report that a professional sample bottle containing 8 tablets of Brilinta 90 mg also contained Zurampic® (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca.
The company said this precautionary measure is limited to 1 lot of Brilinta (Brilinta lot #JB5047) distributed to physicians in the US between March and April of 2017.
Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this recall. And this recall does not affect Zurampic.
Potential risks
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects, including acute renal failure, which is more common when Zurampic is given alone, as it should be used in combination with a xanthine oxidase inhibitor.
Missed doses of Brilinta increase the risk of heart attack and stroke. People with a stent who miss doses of Brilinta have a higher risk of stent thrombosis, heart attack, and death. Patients should not stop taking Brilinta without talking to their prescribing doctor.
To date, AstraZeneca has not received any reports of adverse events related to this recall.
Next steps
AstraZeneca is notifying physicians by recall letter and is arranging for the return of all recalled products. Consumers who have medicine that is being recalled should contact their physician.
Consumers with questions regarding this recall can contact the AstraZeneca Information Center at 1-800-236-9933 between the hours of 8 am and 6 pm (Eastern time) Monday to Friday, excluding holidays.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Brilinta.
Adverse reactions or quality problems related to Brilinta may also be reported to the FDA’s MedWatch Adverse Event Reporting Program.
About Brilinta and Zurampic
Brilinta is intended for use to reduce the rate of cardiovascular death, heart attack, and stroke in patients with acute coronary syndrome or a history of heart attack.
Brilinta is also intended to reduce the rate of stent thrombosis in patients who have been stented for treatment of acute coronary syndrome.
Zurampic is used together with a xanthine oxidase inhibitor, such as allopurinol or Uloric, in adults with gout who still have a high uric acid level.
Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with a “90” above a “T” on one side of the pill.
Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with “LES200” on one side of the pill.
AstraZeneca has announced a voluntary recall of 1 lot of professional (physician) sample bottles containing 8 tablets of Brilinta® (ticagrelor).
This recall follows a report that a professional sample bottle containing 8 tablets of Brilinta 90 mg also contained Zurampic® (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca.
The company said this precautionary measure is limited to 1 lot of Brilinta (Brilinta lot #JB5047) distributed to physicians in the US between March and April of 2017.
Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this recall. And this recall does not affect Zurampic.
Potential risks
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects, including acute renal failure, which is more common when Zurampic is given alone, as it should be used in combination with a xanthine oxidase inhibitor.
Missed doses of Brilinta increase the risk of heart attack and stroke. People with a stent who miss doses of Brilinta have a higher risk of stent thrombosis, heart attack, and death. Patients should not stop taking Brilinta without talking to their prescribing doctor.
To date, AstraZeneca has not received any reports of adverse events related to this recall.
Next steps
AstraZeneca is notifying physicians by recall letter and is arranging for the return of all recalled products. Consumers who have medicine that is being recalled should contact their physician.
Consumers with questions regarding this recall can contact the AstraZeneca Information Center at 1-800-236-9933 between the hours of 8 am and 6 pm (Eastern time) Monday to Friday, excluding holidays.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Brilinta.
Adverse reactions or quality problems related to Brilinta may also be reported to the FDA’s MedWatch Adverse Event Reporting Program.
About Brilinta and Zurampic
Brilinta is intended for use to reduce the rate of cardiovascular death, heart attack, and stroke in patients with acute coronary syndrome or a history of heart attack.
Brilinta is also intended to reduce the rate of stent thrombosis in patients who have been stented for treatment of acute coronary syndrome.
Zurampic is used together with a xanthine oxidase inhibitor, such as allopurinol or Uloric, in adults with gout who still have a high uric acid level.
Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with a “90” above a “T” on one side of the pill.
Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with “LES200” on one side of the pill.
AstraZeneca has announced a voluntary recall of 1 lot of professional (physician) sample bottles containing 8 tablets of Brilinta® (ticagrelor).
This recall follows a report that a professional sample bottle containing 8 tablets of Brilinta 90 mg also contained Zurampic® (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca.
The company said this precautionary measure is limited to 1 lot of Brilinta (Brilinta lot #JB5047) distributed to physicians in the US between March and April of 2017.
Other forms and dosage strengths of Brilinta, including medicine obtained via US retail or mail order pharmacies, are not affected by this recall. And this recall does not affect Zurampic.
Potential risks
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects, including acute renal failure, which is more common when Zurampic is given alone, as it should be used in combination with a xanthine oxidase inhibitor.
Missed doses of Brilinta increase the risk of heart attack and stroke. People with a stent who miss doses of Brilinta have a higher risk of stent thrombosis, heart attack, and death. Patients should not stop taking Brilinta without talking to their prescribing doctor.
To date, AstraZeneca has not received any reports of adverse events related to this recall.
Next steps
AstraZeneca is notifying physicians by recall letter and is arranging for the return of all recalled products. Consumers who have medicine that is being recalled should contact their physician.
Consumers with questions regarding this recall can contact the AstraZeneca Information Center at 1-800-236-9933 between the hours of 8 am and 6 pm (Eastern time) Monday to Friday, excluding holidays.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Brilinta.
Adverse reactions or quality problems related to Brilinta may also be reported to the FDA’s MedWatch Adverse Event Reporting Program.
About Brilinta and Zurampic
Brilinta is intended for use to reduce the rate of cardiovascular death, heart attack, and stroke in patients with acute coronary syndrome or a history of heart attack.
Brilinta is also intended to reduce the rate of stent thrombosis in patients who have been stented for treatment of acute coronary syndrome.
Zurampic is used together with a xanthine oxidase inhibitor, such as allopurinol or Uloric, in adults with gout who still have a high uric acid level.
Brilinta 90 mg tablets are supplied as a round, biconvex, yellow, film-coated tablet, and imprinted with a “90” above a “T” on one side of the pill.
Zurampic tablets 200 mg are blue in color and elliptical/oval in shape. They are imprinted with “LES200” on one side of the pill.