Ted Bosworth, AGA Tech Summit News

 

BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.

One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.

Mastering new skills

The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”

Simulation-based mastery learning is already in widespread use, has been associated with improved quality of care, and is increasingly employed to ensure high standards of performance for health care delivery. During the meeting, which was sponsored by the AGA Center for GI Innovation and Technology, Dr. Ritter cited studies showing improved outcomes and reduced costs in such diverse settings as placement of central lines for infection control in the intensive care unit, inguinal hernia repair, and cholecystectomy. Conversely, traditional learning practices are being questioned.

“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.

“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.

“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.

Identifying problems more quickly

To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.

“There are many examples, such as surgical mesh products and new devices, which have become widely used before serious problems are identified. The goal is to develop better methods for identifying unexpected issues in real time,” Dr. Telem explained.

One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.

As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.

“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.

Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.

“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.

Improving learning through telementoring

 

Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.

“We have known for some time that a weekend course is often insufficient to dependably result in adequate surgical skill,” Dr. Schlachta noted. Providing mentors to assist in difficult procedures during the steep part of the learning curve is effective but not always practical. According to Dr. Schlachta, this has drawn attention to alternatives such as telementoring.

The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.

“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.

There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.

Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.

“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.

“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.

 

BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.

One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.

Mastering new skills

The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”

Simulation-based mastery learning is already in widespread use, has been associated with improved quality of care, and is increasingly employed to ensure high standards of performance for health care delivery. During the meeting, which was sponsored by the AGA Center for GI Innovation and Technology, Dr. Ritter cited studies showing improved outcomes and reduced costs in such diverse settings as placement of central lines for infection control in the intensive care unit, inguinal hernia repair, and cholecystectomy. Conversely, traditional learning practices are being questioned.

“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.

“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.

“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.

Identifying problems more quickly

To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.

“There are many examples, such as surgical mesh products and new devices, which have become widely used before serious problems are identified. The goal is to develop better methods for identifying unexpected issues in real time,” Dr. Telem explained.

One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.

As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.

“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.

Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.

“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.

Improving learning through telementoring

 

Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.

“We have known for some time that a weekend course is often insufficient to dependably result in adequate surgical skill,” Dr. Schlachta noted. Providing mentors to assist in difficult procedures during the steep part of the learning curve is effective but not always practical. According to Dr. Schlachta, this has drawn attention to alternatives such as telementoring.

The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.

“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.

There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.

Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.

“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.

“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.

 

BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.

One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.

Mastering new skills

The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”

Simulation-based mastery learning is already in widespread use, has been associated with improved quality of care, and is increasingly employed to ensure high standards of performance for health care delivery. During the meeting, which was sponsored by the AGA Center for GI Innovation and Technology, Dr. Ritter cited studies showing improved outcomes and reduced costs in such diverse settings as placement of central lines for infection control in the intensive care unit, inguinal hernia repair, and cholecystectomy. Conversely, traditional learning practices are being questioned.

“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.

“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.

“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.

Identifying problems more quickly

To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.

“There are many examples, such as surgical mesh products and new devices, which have become widely used before serious problems are identified. The goal is to develop better methods for identifying unexpected issues in real time,” Dr. Telem explained.

One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.

As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.

“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.

Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.

“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.

Improving learning through telementoring

 

Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.

“We have known for some time that a weekend course is often insufficient to dependably result in adequate surgical skill,” Dr. Schlachta noted. Providing mentors to assist in difficult procedures during the steep part of the learning curve is effective but not always practical. According to Dr. Schlachta, this has drawn attention to alternatives such as telementoring.

The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.

“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.

There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.

Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.

“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.

“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.

BOSTON – A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News

Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

BOSTON – A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News

Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

BOSTON – A series of important technological advances in cloning stem cells of the gastrointestinal tract is rewriting the basic concepts surrounding these cells and has the potential to advance understanding of GI conditions such as Barrett’s esophagus and Crohn’s disease, according to the winner of the 2016 AGA-Medtronic Research and Development Pilot Award in Technology.

The award is sponsored by Medtronic and administered through the AGA Research Foundation. “Medtronic is pleased to partner with the AGA Research Foundation in supporting research to improve patient outcomes,” said Vafa Jamali, president of Early Technologies’ business with Medtronic. “We are dedicated to support patient-friendly innovations enabling the early detection and treatment of chronic GI diseases and cancers.”

Eli Zimmerman/Frontline Medical News

Award winner Wa Xian, PhD, gave an update on her research at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

“The enabling technology we developed is the means of cloning and propagating single mucosal stem cells from discrete regions of the gastrointestinal tract in their most immature form. What we have shown is that these stem cells from normal individuals are essentially immortal, are genetically stable, and, critically, are rigorously regiospecific,” Dr. Xian of the Institute of Molecular Medicine for the Prevention of Human Diseases, University of Texas Health Science Center, Houston, said in an interview.

“This regiospecificity – duodenum stem cells always yield duodenum epithelia, ascending colon stem cells produce ascending colon epithelia – has important implications for both regenerative medicine and drug discovery,” she added.

With regard to the dominant stem cell technologies in use today, including induced pluripotent stem cells and organoid cultures of the gastrointestinal tract, Dr. Xian’s technology represents a paradigm shift.

Dr. Xian’s system generates pure “ground state” stem cells that differentiate in 3-D culture to an epithelium indistinguishable from textbook images of in situ epithelia, at rates 250 times faster than intestinal organoid systems.

This system is being applied in major investigations into Barrett’s esophagus and inflammatory bowel disease in collaboration with investigators at multiple centers in the United States and Singapore.

For Barrett’s, Dr. Xian has developed patient-matched stem cells from endoscopic biopsies of esophageal, Barrett’s, and gastric cardia to show that each arises from distinct lineages, and that the Barrett’s stem cells accumulate genetic alterations not found in those of the matched normal epithelia. These stem cells have been adapted to a drug-screening platform to identify leads that specifically eliminate Barrett’s with an eye on preemptive therapies.

Her work on mucosal stem cells in patients with Crohn’s and ulcerative colitis is revealing a coexistence of normal and pathogenic stem cells in these patients that may alter concepts of both the etiology and treatment of these conditions.

Dr. Xian suggests that treatment of Crohn’s may become analogous to treatment of cancer – emphasizing preservation of healthy cells while eliminating diseased cells – and move therapy from the current effort to induce a quiescent inflammatory state to one in which the goal is cure.

“These findings appear to indicate that some of the chronic inflammatory conditions so prevalent in gastroenterology, as well as the cancers arising from them, may have as their basis profound alterations in mucosal stem cell biology,” she added.

Though it’s still early days with this technology, its single-cell resolution naturally melds with other emerging genomic and genome editing technologies into a powerful means of dissecting the molecular basis of disease and realizing the potential of autologous regenerative medicine, according to Dr. Xian.

Following Dr. Xian’s presentation, Michael L. Kochman, MD, who is executive committee chair of the AGA Center for GI Innovation and Technology, announced the winner of the 2017 AGA-Medtronic Research and Development Pilot Award in Technology. The award was presented to Bani Chander Roland, MD, of Lenox Hill Hospital & Northwell Health System, New York. Her research will involve assessment of the ileocecal valve.

“She has several aims in this proposal to really understand better the causes of ileosphincter dysfunction using a novel method of measuring ileocecal junction pressures,” reported Dr. Kochman. He explained that other parts of the proposal included ileocecal evaluation with wireless capsule endoscopy as well as an evaluation of flora across the GI tract.

A new award to foster innovation in GI medtech is also planned. In partnership with Boston Scientific, the AGA has established the AGA-Boston Scientific Technology and Innovation Pilot Award. This $30,000 research grant will support investigators at any career stage who are developing and testing new medical devices and technologies with applications in gastroenterology and hepatology. The details of the award will be available on the AGA’s website in May. Applications for the award will be accepted beginning in the fall.

 

BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.

“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.

Eli Zimmerman/Frontline Medical News

“One major obstacle for gastroenterologists to participate in the new technology is the enduring focus on colonoscopy. So far, the message that gastroenterologists must expand their skills and expertise in the event that colonoscopy is no longer a major revenue generator has not been resonating with practicing clinicians,” Dr. Pasricha cautioned.

The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.

“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.

He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.

The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).

Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”

While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.

In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.

“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.

Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.

“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.

“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.

“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”

Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.

For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.

“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.

However, he believes that there is enormous room for successful innovation in GI medtech.

“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”

BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.

“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.

Eli Zimmerman/Frontline Medical News

“One major obstacle for gastroenterologists to participate in the new technology is the enduring focus on colonoscopy. So far, the message that gastroenterologists must expand their skills and expertise in the event that colonoscopy is no longer a major revenue generator has not been resonating with practicing clinicians,” Dr. Pasricha cautioned.

The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.

“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.

He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.

The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).

Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”

While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.

In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.

“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.

Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.

“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.

“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.

“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”

Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.

For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.

“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.

However, he believes that there is enormous room for successful innovation in GI medtech.

“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”

BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.

“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.

Eli Zimmerman/Frontline Medical News

“One major obstacle for gastroenterologists to participate in the new technology is the enduring focus on colonoscopy. So far, the message that gastroenterologists must expand their skills and expertise in the event that colonoscopy is no longer a major revenue generator has not been resonating with practicing clinicians,” Dr. Pasricha cautioned.

The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.

“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.

He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.

The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).

Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”

While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.

In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.

“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.

Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.

“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.

“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.

“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”

Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.

For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.

“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.

However, he believes that there is enormous room for successful innovation in GI medtech.

“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”

BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.

“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.

Eli Zimmerman/Frontline Medical News

“In regard to its impact on the FDA, one of the intents of this Act was to accelerate the pathway to bring drugs and devices to market, but it is fair to say that there is some confusion about how this will be implemented under the new administration. One uncertainty is the impact of the large budget cuts promised for the U.S. Department of Health and Human Services,” added Dr. Lerner, who was deputy director of the Division of Reproductive, Gastro-Renal, and Urological Devices at the FDA before joining Hogan Lovells last year.

In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.

“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.

“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.

Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.

“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.

Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.

Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.

“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.

AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.

BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.

“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.

Eli Zimmerman/Frontline Medical News

“In regard to its impact on the FDA, one of the intents of this Act was to accelerate the pathway to bring drugs and devices to market, but it is fair to say that there is some confusion about how this will be implemented under the new administration. One uncertainty is the impact of the large budget cuts promised for the U.S. Department of Health and Human Services,” added Dr. Lerner, who was deputy director of the Division of Reproductive, Gastro-Renal, and Urological Devices at the FDA before joining Hogan Lovells last year.

In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.

“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.

“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.

Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.

“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.

Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.

Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.

“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.

AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.

BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.

“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.

Eli Zimmerman/Frontline Medical News

“In regard to its impact on the FDA, one of the intents of this Act was to accelerate the pathway to bring drugs and devices to market, but it is fair to say that there is some confusion about how this will be implemented under the new administration. One uncertainty is the impact of the large budget cuts promised for the U.S. Department of Health and Human Services,” added Dr. Lerner, who was deputy director of the Division of Reproductive, Gastro-Renal, and Urological Devices at the FDA before joining Hogan Lovells last year.

In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.

“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.

“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.

Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.

“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.

Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.

Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.

“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.

AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.