<![CDATA[Coulter Foundation Provides Translational Funding]]> 27513 The Wallace H. Coulter Foundation awarded $850,000 in total seed money to support five new biomedical research projects from Emory University and Georgia Tech with the goal of accelerating the translation of these technological innovations. Translational funding is used to bridge a gap in development between early stage university research and its commercialization.

 

The Coulter Foundation Translational Fund of the Wallace H. Coulter Department of Biomedical Engineering, provides annual awards to Emory and Georgia Tech research teams working on products with commercial potential that meet a significant unmet or underserved clinical need.

 

The projects are selected by an award committee composed of Emory doctors, Georgia Tech engineers, industry experts, venture capitalists, entrepreneurs, angel investors and technology transfer experts from each school.

 

“The award of funds is just the beginning of the program for these teams,” said Shawna Khouri, managing director of the Coulter Translational Fund. “Over the next year, our teams will work together to push these technologies from academia and into start-ups and industry. This marriage of PI (principal investigator) clinical and technical acumen with the industry and start-up experience from my team makes the distinct difference in translational success.”

 

Of the 60 projects evaluated during the funding cycle, five emerged as this year’s winners:

 

Antiviral Peptide: a therapeutic peptide, originally harvested from frog secretions, has shown broad-spectrum antiviral activity, including evidence of efficacy against Zika, Dengue serotypes 1-4, and Influenza H1N1, H3N2, H1N2 and H3N1 viruses. Principal Investigator: Joshy Jacobs (Emory).

 

Biological Pacemaker: a heart pacing treatment for pediatric patients; this RNA and small molecule combination therapy converts cardiomyocytes into pacemaking cells, eliminating the need for an implantable heart-pacing device. Principal investigators: Hee Cheol Cho (Coulter Department at Emory and Georgia Tech/Petit Institute researcher), Jonathan Langberg (Emory), Phil Santangelo (Coulter Department at Emory and Georgia Tech/Petit Institute researcher).

 

Inhaled GeneRegs: an antisense technology consisting of a topical gold nanoparticle coated with specific deoxyribozymes (DNAzymes), which regulate and silence pro-inflammatory cytokines that cause severe asthma exacerbations. Principal investigators: Cherry Wongtrakool (Emory) and Khalid Salaita (Emory).

 

Nephrogenic Diabetes Insipidus: a new therapeutic that restores water balance in pediatric patients with nephrogenic diabetes insipidus (NDI), an x-linked genetic disorder that can lead to mental retardation as a result of dehydration. Principal investigators: Janet Klein (Emory) and Jeff Sands (Emory).

 

Periurethral Targeting Device: a device that will allow direct, controlled placement of bulking agents into the female urethra thereby increasing the efficacy of stress urinary incontinence treatment. Principal Investigators: Niall Galloway (Emory).

 

The translational research program has fiscal roots in the $25 million grant the Wallace H. Coulter Foundation made to the Georgia Tech-Emory biomedical engineering program in 2001. This gift resulted in the naming of the Wallace H. Coulter Department of Biomedical Engineering, while also targeting $10 million toward the ongoing support of translational research.

 

“The Coulter Translational Program is a jewel in our crown, providing an individualized training program with an enviable track record in guiding innovative research teams to conquer translation challenges to successfully commercialization”, said Susan Margulies, chair of the Coulter Department, and a Georgia Research Alliance Eminent Scholar in Injury Biomechanics.

 

Including the Georgia Tech-Emory department, there are 15 universities with similar translational research partnership programs supported by the Coulter Foundation, including Columbia, Duke, Johns Hopkins, and Stanford universities.

 

 

Media Contacts:

Walter Rich

Communications Manager

Wallace H. Coulter Department of Biomedical Engineering

Georgia Institute of Technology

]]> Walter Rich 1 1506545916 2017-09-27 20:58:36 1506545916 2017-09-27 20:58:36 0 0 news 2017-09-27T00:00:00-04:00 2017-09-27T00:00:00-04:00 2017-09-27 00:00:00 Walter Rich

]]> 596590 596590 image <![CDATA[Multi Pipette]]> image/jpeg 1506545763 2017-09-27 20:56:03 1506545763 2017-09-27 20:56:03 <![CDATA[Starring Role for Atlantic Pediatric Device Consortium (APDC)]]> 27195 Atlanta-based consortium on leading edge of pediatric device development.

Most children are healthy, so they comprise a small percent of the healthcare industry’s profit base, which makes the development of purpose-driven pediatric devices very challenging.

“There are many challenges, but two major ones, probably,” says David Ku, the Lawrence P. Huang Chair Professor of Engineering Entrepreneurship, who leads the Atlantic Pediatric Device Consortium (APDC), which is based at the Georgia Institute of Technology. “One is that the market size for all pediatric devices is small compared to adults. There is a lower return on investment, too low to garner much attention, so medical device companies or investors typically have less interest in pediatrics.”

Way less, in fact. According to the nonprofit Institute for Pediatric Innovation, about 6% of healthcare dollars are spent on children, who are overwhelmingly outnumbered by adults (by a 4-to-1 ratio), who tend to have a lot more health problems, making grown-up medicine a much safer and therefore more prevalent investment. Consequently, there aren’t many options designed explicitly for children, which gets to the second problem on Ku’s list.

“The second thing is, designing medical devices just for children isn’t easy,” he says. “Most devices are built with adults in mind, and we try to scale them down, but you almost have to create a different device, because it’s not just a matter of size and proportional scaling. Children’s bodies are growing, and they may have long-term needs that change over time.”

So, to address those specific pediatric needs, the U.S. Food and Drug Administration (FDA) created the Pediatric Device Consortia Grant Program in 2009. The effort has been inspiring medical device projects across the country, and the APDC (one of seven FDA consortia in the country) has taken a starring role, making the Georgia Institute of Technology a leader in the development of pediatric technologies.

APDC, founded in 2011, is a partnership between Georgia Tech, Emory University, Children’s Healthcare of Atlanta and the Virginia Commonwealth University (APDC’s founding leader, Barbara Boyan, former dean for research in Tech’s College of Engineering, is now dean of VCU’s School of Engineering).

The consortium exists to increase accessibility of pediatric medical devices by helping researchers and entrepreneurs develop and commercialize them more efficiently. Interest in the effort has manifested in the form of large investments, such as the $20 million joint venture by Tech and Children’s (announced in June 2012) for developing solutions to improve kids’ health, and more recently, a $3.5 million award from the FDA to the APDC announced early this year. In addition to that, APDC administers seed grants each year in its annual Pediatric Device Innovation Competition.

In April, APDC awarded seed grants (in the $30,000 to $50,000 range, according to Martha Willis, APDC program manager) to eight projects selected by a panel of physicians, scientists and business leaders. One of the most promising is an adaptable implant to treat cleft palate, developed by Ku at Georgia Tech.

Cleft palate is a congenital defect that causes major speech and swallowing problems for young children, with potential social implications, because it is unsightly. The usual best strategy is to repair the defect during infancy, before swallowing and speech problems develop. But surgical correction is a challenge because of growth issues.

“Early closure leads to growth restrictions, and late closure leads to defects in speech. So the question is, how do you get something that fits in there and grows with the child,” says Ku, who answered the question by using material developed at Georgia Tech about 15 years ago.

Polyvinyl alcohol cryogel (PVA-C) is a biocompatible material that is easily molded into a design that can resist pressure while allowing for growth of a child’s mouth. “This is a soft and compliant hydrogel, easy to clean and it can be molded in the physician’s office,” says Ku.

It’s a new, long-term version of the palatal obturator, which is typically a short-term prosthetic. And because Ku’s device is a more advanced and adaptable version of a device that already exists, the regulatory pathway to commercialization (and a child’s mouth) is less burdensome, thanks to a law passed almost 40 years ago.

In May 1976, the Federal Food, Drug and Cosmetic Act (FD&C) was amended to include medical devices. Specifically, section 510(k) of the FD&C allows the FDA to determine whether a new device is somehow equivalent to commercial devices that existed before May 1976. If deemed “substantially equivalent,” a new device doesn’t have to go through premarket approval.

“It’s possible to get this cleared and to the marketplace in two years, instead of the 10-year timeframe that is typical for some new devices. By appropriate design, the cost to bring this to market is on the order of $2 million to $5 million, versus $50 million to $75 million,” says Ku, who began his career as a surgeon before moving fulltime into research at the Parker H. Petit Institute of Bioengineering and Bioscience.

Ku’s device provides a physiological correction for cleft palate. Full correction through surgery comes around the age of 5, but by then, ideally, the child patient has learned to speak, and to create the hard, pressure consonant sounds (that a cleft palate hinders), thanks to an effective, efficient device. Ku, who is Regents' Professor in the George W. Woodruff School of Mechanical Engineering, will use the seed grant to provide design control documentation and prepare for FDA 510(k) application.

The idea behind the seed grant program is to kick start promising projects that have a good chance of securing larger sums of venture capital later on. It’s a strategy that has worked very well for one of APDC’s early seed grant recipients. When APDC was started in 2011, says Wilbur Lam, “we had to pitch a handful of ideas to the FDA to show that we here in Atlanta had the technologies and infrastructure, as well as the commercialization know how, to take a handful projects to the next round of development.”

So, he pitched CellScope, Inc., and its mobile microscope product, the Remotoscope, a clip-on attachment and app combination that turns your iPhone into an otoscope. Lam, an assistant professor in the Wallace H. Coulter Dept. of Biomedical Engineering, started the project with his colleagues at the University of California, Berkeley, and brought it with him when he joined the faculty at Georgia Tech in 2011, when CellScope secured $50,000 in seed money from FDA through APDC.

“The bottom line is, APDC allowed CellScope to receive initial funding to develop the technology further, enabled us to work on the hardware and perhaps most importantly, gave us street cred, which enabled us to find venture capital funding and take our company to the next level,” says Lam, a pediatrician and researcher whose company is now supported by funding from Khosla Ventures, a Silicon Valley firm. “In terms of commercialization, we’re very close.”

The idea behind the Remotoscope is, basically, to allow parents at home to use their cell phone’s camera and flash to provide light for otoscopic images. Mom can take a snapshot of her child’s inner ear, then send it electronically to the pediatrician for a remote diagnosis. The devices have been distributed to physicians across the country for their initial testing.

“We’re about to do a study with our partners at Children’s Healthcare of Atlanta, in terms of getting these devices to families of children with chronic ear infections, to see if we can use the device to save healthcare expenditures by preventing emergency room visits,” says Lam, a Petit Institute researcher based at Emory, who treats patients at Children’s. “Over time, we hope it’ll also help reduce unnecessary antibiotic use.”

His thought is, because physicians will be able to check for infections more frequently now, they can cut back on prescribing drugs for infections that can improve on their own. Because time is usually pretty short during an office visit, pediatricians often prescribe an antibiotic whether the infection is caused by bacteria, or a virus (which antibiotics can’t fix), and this can eventually result in antibiotic resistance, therefore limiting the drug’s ability to fight bacterial infections (which antibiotics are designed to cure). “This is a big public health issue, the issue of antibiotic resistance,” says Lam, a co-director of APDC and one of the consortium’s principal investigators.

The seed grant program doesn’t guarantee a device’s commercialization and success, but it does provide an important boost for the researcher who is putting purpose ahead of profit on the development path.

“You know, $50,000 isn’t much in the scheme of things,” Lam says, “but sometimes that can be just enough to enable an inventor to take the next step. It allows creative people to move forward with great ideas that can have a big impact down the road.”

]]> Colly Mitchell 1 1401884437 2014-06-04 12:20:37 1475896593 2016-10-08 03:16:33 0 0 news Atlanta-based consortium on leading edge of pediatric device development.

]]> 2014-06-04T00:00:00-04:00 2014-06-04T00:00:00-04:00 2014-06-04 00:00:00 Jerry Grillo
Communications Officer II
Parker H. Petit Institute for 
Bioengineering & Bioscience

]]> 301281 301291 301281 image <![CDATA[David Ku, PhD - Executive Director, Atlantic Pediatric Device Consortium (APDC)]]> image/jpeg 1449244572 2015-12-04 15:56:12 1475895004 2016-10-08 02:50:04 301291 image <![CDATA[Wilbur Lam, MD, PhD - Professor, Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech & Emory University]]> image/jpeg 1449244572 2015-12-04 15:56:12 1490466440 2017-03-25 18:27:20 <![CDATA[Atlanta Pediatric Device Consortium]]> <![CDATA[Ku profile]]> <![CDATA[Lam lab]]> <![CDATA[iEAT Application Helps Treat Children with Feeding Disorders]]> 27303 For most of his life, four-year-old Carsten had required a feeding tube for his nourishment. Born with a chromosome abnormality known as translocation, he also had negative experiences with food as an infant. While he seemed to like the taste of food, he just didn’t eat enough to support his growth and development.

But after just six weeks in the feeding disorders program at the Marcus Autism Center, Carsten was able to stop using the feeding tube and now gets all his nourishment by mouth. And that thrills his mom, Lettitia Ussery.

“The program here gave us the structure and the rules to increase the amount that Carsten was eating,” she said. “He’s eating three or four meals a day now, and his teacher feeds him at school. He’s doing really well and seems to be happy with eating. It’s exciting, and a big change for us.”

As many as five percent of children suffer from severe feeding disorders. In many cases, the challenges arise with other health problems leading to negative experiences with food, such as food allergies or reflux disorder. Despite the best efforts of concerned parents, many of these children must be sustained by feeding tubes. Ironically, these interventions may further hinder appropriate feeding patterns and exacerbate an already fragile parent-child mealtime relationship.

At Marcus, which is part of Children’s Healthcare of Atlanta, Dr. Will Sharp is the director of a feeding therapy program that helps these children establish a developmentally appropriate relationship with food. The approach is very successful, but Marcus is one of only a handful of programs in the United States – and the only one in the Southeast – offering this kind of help.

“Traditionally, this kind of therapy is at specialty centers spread out geographically and not available in all communities,” said Sharp, who is also an assistant professor of pediatrics at Emory University. “There are only a handful of really well-known programs.”

Sharp’s therapy depends on a customized protocol determined by each child’s individual response to food. For example, the child’s behavior when one type of food is offered determines which food to try next. The goal is to help each child get past the negative association that led to the feeding disorder in the first place.

Sharp has worked to standardize the Marcus treatment model in an effort to increase access to care. The resulting intervention involves more than 140 possible pathways that were delineated on a paper-based flowchart that only Sharp and his team of trained therapists were able to use. The waiting list of children – and their anxious parents – was long.

About two years ago, Sharp met Leanne West, chief engineer for pediatric technologies in the collaborative research program operated by Children’s and the Georgia Institute of Technology. West heard Sharp’s presentation on the successful therapy program, and saw an opportunity to apply computer technology to the complex decisions that are made in treating the children.

The result of their collaboration is iEAT, an app developed for the iPad.

“The idea behind the app is that we bottle up some of the clinical knowledge and techniques into a comprehensive computer program that will allow others to treat children with severe feeding problems in community settings,” explained Sharp. “The goal is to serve many more children than we are able to reach now.”

The app recently underwent a successful clinical trial in which all children exposed to intervention experienced significant improvement in accepting and swallowing food. Carsten was among the first children to use the app in the clinic, and now Sharp hopes to make it available to other clinicians – and to develop a version that parents can use in the home.

“We put the flowchart from his paper-based manual into a computerized decision-support tool,” explained West, who is also a principal research scientist in the Georgia Tech Research Institute (GTRI). “The intelligence behind this program all came from Dr. Sharp’s knowledge developed over years of experience. Using the iPad, we made it easier and faster to use the protocol.”

In addition to helping clinicians decide the next step in feeding therapy, the iPad application, which was written by GTRI research scientist Heyward Adams, also captures information about each treatment session. This data capture reduces the time therapists must spend keeping paper records, and allows them to immediately review a session’s progress with parents.

“It worked, and now they are using it clinically,” said West. “It’s really rewarding to see a child go from negative behavior to keep food out of their mouths to starting to accept food on a spoon. We are very excited about helping Dr. Sharp and his staff make a difference for children and their parents.”

Sharp, West and Adams now hope to develop a version of iEAT that could be used by parents in the home. By combining therapy sessions at the clinic with meal activities at home, they hope to serve even more children and make the program both more convenient and less expensive.

The iEAT app was among the first projects of the “Quick Wins” program established as part of the collaboration between Georgia Tech and Children’s. West says it demonstrates the benefits of bringing doctors together with engineers to develop new solutions to clinical challenges.

“This type of project works because you have a multidisciplinary team in which engineers and scientists work with clinicians,” she said. “When you have people with different training and expertise working together, you can go well beyond what each group could think about on its own.”

For West, whose background is in educational and mobile health technology, the experience of working with Sharp and others at Children’s has been rewarding. “I think this will be truly life-changing for the parents of children with severe feeding disorders,” she said.

Research News
Georgia Institute of Technology
177 North Avenue
Atlanta, Georgia 30332-0181 USA

Media Relations Contact: John Toon (404-894-6986) (jtoon@gatech.edu).
Writer: John Toon

]]> John Toon 1 1446643898 2015-11-04 13:31:38 1475896794 2016-10-08 03:19:54 0 0 news Researchers at the Georgia Tech Research Institute and Children's Healthcare of Atlanta have developed an iPad app that helps therapists treat children who have severe feeding disorders.

]]> 2015-11-04T00:00:00-05:00 2015-11-04T00:00:00-05:00 2015-11-04 00:00:00 John Toon

Research News

jtoon@gatech.edu

(404) 894-6986

]]> 466121 466131 466151 466121 image <![CDATA[iEAT Therapy]]> image/jpeg 1449256408 2015-12-04 19:13:28 1475895213 2016-10-08 02:53:33 466131 image <![CDATA[iEAT Screen]]> image/jpeg 1449256408 2015-12-04 19:13:28 1475895213 2016-10-08 02:53:33 466151 image <![CDATA[Leanne West]]> image/jpeg 1449256408 2015-12-04 19:13:28 1475895213 2016-10-08 02:53:33