The OTT POC Fund: A Little Goes a Long Way

What’s one of the biggest hurdles to startup success? Finding enough money to start.

Seed funding is absolutely critical to getting new technologies on the market. It’s the money that can help give an idea a physical shape, put it on the path to becoming a full-fledged product. The POC fund is a simple idea reflected in its simple acronym: proof of concept. The fund is meant to give Emory inventors enough money to develop their product with as little bureaucratic stalling as possible. By getting funds into the hands of innovators quickly and effectively, and by helping provide follow-up funding opportunities, we’ve been able to push the growth of multiple startups. Today, we highlight two teams that have used our POC funding to full effect: CorAmi and Covanos, both focused on finding new ways to treat heart disease. (Our previous blog describing the POC fund.)

CorAmi

Scientists have made leaps and bounds in finding new ways to heal our organs when they break. New medicines promise to restore damaged tissues in the heart, intestines, pancreas and beyond by physically attaching regenerative cells or drugs onto them using substances called hydrogels. But how do we get those drugs to hard-to-reach areas – for example, the surface of the heart?

Rebecca Levit photo

Rebecca Levit, MD

That’s where CorAmi comes in, with a proprietary device designed to deliver these hydrogels and related medications straight to the heart without requiring invasive surgery. Rebecca Levit, MD, is the inventor of this technology and CSO of CorAmi Therapeutics. She came up with the idea for her solution while working as a resident/ research fellow studying regenerative medicine. Levit was well aware of the technical challenges surrounding hydrogels, but was also interested in how to get them there. If a patient happened to need open heart surgery, delivery wouldn’t be a significant concern – but most patients don’t.

The challenge, then, is to create a device that can be inserted into the chest, through the sac that keeps your heart suspended in liquid called the pericardium, and on top of the surface of the damaged heart tissue – all without breaking blood vessels or interrupting the electrical signals that control the heart. After coming up with an initial design, Levit went to the Coulter Foundation and the OTT, who awarded her thirty thousand dollars from the POC fund to develop proof of concept for her device. She used the funding to hire an engineer, and with him created a design that could lay a hydrogel onto the heart without leaking out.

But many hydrogels are still waiting for FDA approval. “It’s like having a gun with no bullets,” Levit says.

So today, CorAmi is soliciting their hydrogel delivery device along with their own medication: a formulation of amiodarone, a drug that can treat irregular beating of the heart. With many hydrogels awaiting approval by the FDA, delivery systems like CorAmi’s could be part of a new frontier in treating patients.

Covanos

About 1 million cardiac catheterizations (or caths) are performed in the United States every year. It’s a common procedure, but only a few steps short of surgery – it involves threading a long tube from outside the body through an artery in the leg and into the coronary arteries that supply blood to the heart. A contrast agent is injected and visualized using X-rays to see whether there are atherosclerotic plaques that are obstructing blood flow. This information is used to decide on further treatment, such as placing stents in the arteries or performing bypass surgery. About 50% of those caths, however, turn up negative results for obstructive coronary artery disease, so there was no need to have the cath procedure. Because of this, there’s a real need for a noninvasive but accurate way of screening for those people who actually should have the cath procedure performed – a need that can be fulfilled using 3D imaging technology and computational fluid dynamics.

Samady & Veneziani photo

Deborah Bruner; Habib Samady & Alessandro Veneziani; Raj Guddneppanavar

Don P. Giddens, PhD is the former dean of the College of Engineering at Georgia Tech and COO of Covanos, Inc., a start-up company that grew out of Emory research. He’s an expert in the fields of fluid dynamics and biomechanics – two fields that find their natural intersection in our circulatory system. Along with Emory cardiologist Habib Samady, MD and mathematics and computer science professor Alessandro Veneziani, PhD, the Covanos team recognized the need for a sea change in the way cardiac diseases were detected and set their interdisciplinary knowledge to the task.

CT scans have been a mainstay of medical imaging since the 1970s. By using X-rays to fire energy beams from many different angles, computers can receive and transform signals into three-dimensional images that doctors can use to diagnose disease. But it takes sensitive equipment and a lot of computing power to generate accurate pictures of spaces the size of the blood vessels in your heart. And images of the arteries alone don’t tell the whole story, and that’s where the fluid dynamics comes in – the images generated by CT scans form models for computing blood flow characteristics with mathematics similar to that used in aerospace engineering. A related technology has been approved by the FDA – but those systems don’t deliver services at the point of care for patients and also require supercomputers. To overcome those hurdles, Covanos optimized the relevant calculations to create a technology that can deliver results to the physician in less than an hour when used by a trained CT technician.

The initial Proof-of-Concept grant the Covanos team received from Emory’s Office of Technology Transfer allowed them to test their central question: can we make those computations faster?

“Our first test,” said Giddens, “was to see if we could simplify [the mathematics] without sacrificing accuracy … and that was successful.”

The information received from the CT scans allows for the calculation of a patient’s BFPi, or blood flow physiology indices – a set of metrics doctors use to determine whether a patient’s blood flow is healthy. Thanks to Covanos’ work, these programs can now “do the calculations in less than an hour on a laptop or desktop computer, by comparison to many hours on a supercomputer.”

Giddens credits the OTT for helping Covanos build important relationships among new partners and for helping to file patents for the technology. Recently, the OTT awarded Covanos its 2018 Deal of the Year Award after Emory entered into a licensing agreement for their software. With further support from the Coulter Foundation and the Georgia Research Alliance, Covanos has since expanded its team of innovators, moving closer to developing a product that could significantly improve the quality of cardiac care.

Read more about CorAmi and Covanos on their websites.

From the Director: IP Policy Q&A

Many people are unaware, but most universities, including Emory, have formal intellectual property (IP) policies. At first glance it might seem counterintuitive to the university mission of creating and sharing knowledge, but the policies are written in a way that both encourage scholarly activity and the open exchange of ideas while balancing the potential to commercialize new inventions. What these polices say is that if one happens to make an invention that could end up as a new product then the institution owns the invention – but in return, as part of the deal, the institution fronts various costs associated with protecting the IP and gives the inventor a share of the revenue. At Emory, it’s not only a personal share of revenue to the inventor, but also a share that goes to the individual’s lab, department and their school. The IP policy breaks down how this revenue is distributed within the University. Surprisingly, researchers often get excited not about the personal share of revenue but about the research funds that can support the lab that can come from it. This is largely because these funds don’t come with requirements on what kind of research they are put towards. IP policies are meant to be an incentive for the people and support behind innovation at the institution.

Can I divert/re-assign my personal share?

Yes you can. It comes back to the fact that we are trying to motivate faculty as much as possible. Sometimes employees divert their personal share to their research, for at least a set amount of time.

Can I appeal the distribution formula for my technology?

Cliff Michaels photo

Cliff Michaels

Yes, it is possible, but by and large the general split between the inventors, department, school and university is adhered to except in special circumstances. At Emory there are mechanisms for handling the most common disagreements over a distribution; most often the disagreements have to do with split of the personal share among the inventors. If the inventors are unable to agree amongst themselves on how to divide the personal share, then what the policy says is in the absence of an agreed upon distribution all inventors get treated equally. Most often though, we end with an unequal distribution that is agreed upon among by the inventors depending on who contributed the most. If this is still deemed unfair by someone they can appeal for review by senior administration

Does Emory assert ownership over student IP?

Emory does not assert ownership over undergraduate student IP, unless they are working in a lab or under a grant.

Can/How do I request a release of my IP so that I can pursue commercialization personally?

You can – at Emory you have to petition/request it to be released/assigned to you, and while we do have this happen it’s uncommon. OTT may look at an invention and decide not to pursue patenting. If the inventor still wants to pursue commercialization, we give them the ability to petition to have the invention released and then they can pursue as they choose. Any release/assignment also has to take into account any obligations Emory may have to a funding source, like the federal government.

What happens to my revenue/ownership when I die?

The revenue will then get passed on to your heirs. We have had cases where this happens, and the revenue was passed on to the spouse. It is an ongoing obligation on our part.

What happens to my revenue/ownership when I leave Emory?

If researchers leave Emory they will continue to receive their personal share, although the lab share must stay within the university and is typically shifted to their department.

How can I bring my previous IP from another institution when I come to Emory?

If it wasn’t invented here, then OTT can work out an arrangement a previous employer or former university to manage that IP. This is done through something called an inter-institutional agreement (IIA). We typically don’t manage other’s IP unless Emory owns at least a portion of it, but often new faculty will come with prior inventions, and then they add to it or make a new invention here the best way to commercialize the IP is to bundle all of those inventions together. That’s the most common situation, one where we enter into an IIA to manage former IP along with current/new IP.

What is a scholarly work in layman’s terms?

A work product developed by faculty in pursuit of scholarly activities. What faculty write and publish, and opinions that they put forth are exempt from the IP policy as part of academic freedom. We want to encourage academic activity, we don’t want the IP policy to become a barrier or impediment. It isn’t always 100% clear as to whether certain IP is a scholarly work or not. For example, a book that took $20,000 dollars of administered time at the institution or maybe even had a $100,000 grant supporting it poses the question of whether it is a scholarly work or not and may require a case by case review.

What is considered Emory support?

This can be more challenging than it might seem to define. Someone sitting in their office using an Emory computer is not considered Emory support for the purposes of determining whether or not the IP is a scholarly work. Good examples of Emory support are when faculty are commissioned to do the work, or there is a sponsor who has paid the institution, and this money went into research in the form of a grant supporting the work. Just using Emory resources, like the library or computers, is not typically the kind of Emory support that would change the definition of scholarly work.

What is considered part of my duties?

Generally, Emory owns two types of intellectual property for an employee. One is intellectual property related to one’s normal course of duties at the institution, and the other is where they utilize Emory support. The former is what can be the most difficult, figuring out what is deemed related to one’s normal course of duties. It isn’t frequent but it can be challenging. Once, a biochemist at Emory invented a ping pong paddle. That was clearly not part of their duties and therefore Emory did not own that IP. Emory is only trying to own IP that is related to one’s work (including their area of expertise), resources, and facilities here at Emory.

IdeaGate: Submit Your Disclosures On-line

Technology Transfer Offices receive invention disclosure forms for new innovations daily. These forms are the way that Emory personnel let the Office of Technology Transfer (OTT) know about their innovative ideas, so that OTT can explore the commercial potential of their idea or invention. Emory’s OTT continuously has an influx of these, as the faculty and researchers on campus are always creating new innovations. Faculty submitted over 250 invention disclosures last year. Once OTT receives the forms, they research whether the idea is protectable, if the idea has already been protected, what the market around the idea looks like, or if a comparable product already exists.

To do all this research, the office first needs to actually acquire the disclosure forms. In the past, faculty, staff, and researchers had to complete the appropriate form for their technology in either PDF or Word form, collect signatures manually on a printed copy or electronically for every contributor, and finally email it back to the office to be processed.

While this tried and true system has worked well, OTT is rolling out an efficient and convenient alternative for submitting disclosure forms called “IdeaGate.” The platform is essentially an online version of the old forms (try it here: http://bit.ly/Emory_IdeaGate). The system requires a valid Emory netid. The system has undergone several months of beta testing and is now publicly available according to Patrick Reynolds, Assistant Director of Faculty and Start-up Services. Reynolds explained that one simple but handy improvement that IdeaGate provides is the ease of obtaining contributor signatures. When a form is submitted through the platform, the names and emails of all contributors must be included. This is so the platform can send each Emory contributor an email requesting their electronic signature, and the platform will even send them occasional reminders should they forget to sign. Previously, Reynolds says that collecting signatures from all of the contributors on a project was one of the most difficult and time-consuming parts of the disclosure submission process. An additional benefit for faculty is that they will be able to go back into the system after a disclosure is submitted and see some basic status and patent information related to that disclosure.

In addition to the convenience that IdeaGate will provide to the contributors, it is also convenient for OTT. IdeaGate is automatically linked to Inteum, the database that OTT uses. Reynolds appreciates that with the portal, once someone works on a draft, he can see their timeline: when they started the form, how many contributors they have, and what the idea is about. Previously the only timeline would be the end: the submittal of the form. But now Reynolds can check in with the researchers who have started forms but not turned them in after an extended period.

This new platform helps faculty and members of OTT get “great ideas to the office so they can start looking at their potential”, in the words of Reynolds. It appears to be a more efficient and convenient method of submitting invention disclosure forms—for everyone involved.

Evolution of an Epidemic: Taming a Killer Virus

AIDS—acquired immunity deficiency syndrome—was named in 1982, at the beginning of the epidemic in the U.S. It was another two years before it was known that human immunodeficiency virus (HIV) was the cause of this strange new disease. Death rates rose steadily and steeply over the next decade. By the mid-1990s, AIDS was the leading cause of death for Americans ages 25 to 44 and more than 250,000 people had died from AIDS or AIDS-related causes.

“Some of our most creative people were taken away from us by this terrible disease,” says Emory synthetic chemist Dennis Liotta. “I became increasingly convinced that I had to do something that would make a difference, even though I didn’t know anything about virology. That was my driving force for getting into it and I never looked back.”

HIV virusDeath rates began to decline after multidrug therapy became widely available. Emory researchers were front and center in the discovery of this therapy.

“At the time, we didn’t know too much about HIV. We didn’t know if it was a respiratory virus, we didn’t know if it would affect us personally. But we worked on it because there was a need and an urgency,” says organic medicinal chemist Raymond Schinazi. “When you’re young, you want to save the world. We took the gamble and it paid off.”

HIV is now a chronic, not fatal, diagnosis, largely due to drugs made from compounds that emerged from Emory labs. More than 90 percent of people in the U.S. who have HIV, and many around the world, take at least one of the drugs invented by Emory researchers Liotta, Schinazi, and Woo-Baeg Choi.

Liotta, Professor of Chemistry and Executive Director of the Emory Institute for Drug Development, and Schinazi, Walters Professor of Pediatrics at Emory and Director of the Laboratory of Biochemical Pharmacology, are still hard at work, developing other novel therapeutic agents and furthering vaccine development.

Emtriva bottle“This is an incredible example of the impact that academic research can have on people’s lives,” says Todd Sherer, Emory Interim Vice President for Research Administration. “We are very proud that the work by Drs. Liotta, Schinazi and Choi has helped so many people.”

Untold numbers of people around the globe have benefitted from this basic research. Go here to watch the story of how the discovery unfolded, and to see patients whose lives were saved by a dark-horse drug regimen that became the most common HIV treatment in the world. Go here to read the full series of blog interviews with inventors, patients, and others.

What is HIPAA?

Losing your job is hard enough. But what if you lost your healthcare insurance along with it? And there were no standardized ways to keep or transfer your health information? Although this scenario may seem hard to fathom today, in the not-so-distant past the loss of employer-based health insurance and irregular recordkeeping were very real fears. The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 to address many concerns around health records and coverage. There are five sections (“titles”) to the act:

Title I: HIPAA Health Insurance Reform | Health care access, portability and renewability

Title I was implemented to address the availability of health insurance for individuals. In other words, it protects patients who might otherwise not have access to health insurance. It requires that during a change or loss of job, the employee may still have access to his insurance plan.

Title II: HIPAA Administrative Simplification| Preventing health care fraud and abuse; administrative simplification; medical liability reform

Title II requires the Department of Health and Human Services (HHS) to develop standards for the use and dissemination of healthcare information, a stipulation that resulted in the creation of the Privacy Rule and Security Rule. Both are intended to prevent health care fraud and abuse. The Privacy Rule establishes national standards for the protection of certain health information known as Protected Health Information (PHI). The Security Rule establishes a national set of security standards for ePHI, protected information that is stored or transferred electronically.

Title III: HIPAA Tax-Related Health Provisions

This title adjusts laws regarding health insurance and medical deductions. The most important example of this might be the standardization of the amount that may be saved per person in a pre-tax medical savings account (MSA). Since 1997, MSAs have been available to employees covered under an employer-sponsored high deductible plan of a small employer and self-employed individuals.

Title IV: Application and Enforcement of Group Health Plan Requirements

Title IV specifies that employees cannot be denied coverage due to preexisting conditions or medical history.

Title V: Revenue Offsets

This title makes special provisions regarding company-owned life insurance, treatment of expatriated individuals, and also repeals the IRC’s financial institution rule to interest allocation rules.

HIPAA affects all organizations that directly maintain and transmit protected health information. These include hospitals, healthcare providers, laboratories, health insurance companies, pharmacies and more. The Privacy and Security Rules have impacted the way these organizations operate and changed the landscape of healthcare treatment.

Some critics argue that HIPAA has built roadblocks that impede healthcare research, as healthcare organizations cannot perform studies based on patient chart data without consent. They claim that this has driven up costs of recruitment for studies and surveys.

Critics also point out that since patient data cannot be shared between healthcare providers without patient permission, some records are not transferred in a timely manner. Many people point to the complexity of implementing HIPAA as cause for increased expenses for healthcare providers.

On the other hand, many say HIPAA has bolstered information security in those same organizations. Standards for patient confidentiality and healthcare information have been established across organizations and information transfer is more secure and efficient. As a result of HIPAA, patients and their information are more protected than ever before.

HIPAA has become an ingrained part of the US healthcare system, impacting the millions who depend on hospitals, physicians, and other providers for life-saving treatments. Understanding HIPAA is key to understanding healthcare in America.

Resources:
https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
https://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act

Antibodies as Biomarkers in the Detection of Cancer

The early detection of cancer is vital for successful treatment as well as increasing survival rates, and the ability to come up with a reliable way to determine cancer phenotypes early could potentially save many lives. Identification of new serum antibodies as biomarkers in cancer phenotypes could prove to be an effective and precise method of detecting cancer. Tumors, specifically, tend to release into the circulatory system proteins, hormones, and other markers that can be detected in serum blood.

Despite this knowledge, there are few genomic and proteomic methods that have produced a standardized and noninvasive method of cancer screening and early detection. A vast majority of proteins released by tumor tend to be in low, if not undetectable, quantities, and have a rapid clearance rate due to the rapid metabolic rate of cancer cells.

Due to this inability to accurately quantify the secretions of cancer tumors, many scientists have turned to autoantibodies – antibodies produced by the patient’s own immune system. These antibodies have shown promise in becoming a biomarker for the detection of cancer phenotypes. Autoantibodies are produced in large quantities despite the corresponding low concentrations of antigens found among cancer cells.

New methods have emerged for the discovery of new autoantibody targets; these new methods include phage-splay libraries, recombinant cDNA expression cloning, and self-assembling protein arrays. The specificity of these targets have proved to be an issue in these novel methods because scientists must avoid targets identified by antibodies present in patients that do not have cancer or have benign tumors. These methods are being refined to improve their sensitivity and specificity.

Exploring alternative, novel biomarkers for diagnostic potential is a rapidly growing field, and one that Emory researchers have not shied away from. Emory University has pioneered several biomarker assays to predict cancer phenotypes. Many of these cancers are known to be more chemotherapy-resistant than others, and this resistance is attributable to the expression of certain genes in cancer cells. Emory University researchers identified the expression of certain genes in small cell lung cancer. By assaying the expression of these genes in tumors, cancers can be identified quickly and more targeted, individualized therapies can be developed.

Emory researchers have identified RNA biomarkers to detect prostate cancers that could not only screen, but accurately predict recurrence of certain prostate cancers reliably. Researchers have also identified DNA biomarkers in the form of cell-free DNA to accurately identify and diagnose renal cell carcinomas.

Although Emory has not yet delved into the biomarker potential of antibodies, researchers have identified antibodies in the treatment of certain cancers, such as myelomas (Elotuzumab) and mesotheliomas (Durvalumab). At the forefront of biomedical research and discovery, it will not be long before Emory further explores the multipurpose of antibodies in the rapidly growing field of oncology.

Johannes W. Pedersen, Hans H. Wandall; Autoantibodies as Biomarkers in Cancer, Laboratory Medicine, Volume 42, Issue 10, 1 October 2011, Pages 623–628, https://doi.org/10.1309/LM2T3OU3RZRTHKSN

The Promise of Biomarkers and Antibodies

Biomarkers, an abbreviation of “biological markers,” serve as medical indicators for the disease state observed from outside the patient. This measure is both precise and replicable, and accounts for a chemical, physical, or biological response. [1]

Biomarkers have been around for quite some time, and we see examples of them in our everyday lives. Blood pressure, for example, can serve as a biomarker for the physiological state of a patient or a patient population. Similarly, body temperature, or presence of a fever, can indicate to us a change in a person’s state of being, from diseased to healthy or vice versa.

Biomarkers are often used as clinical endpoints while measuring biological processes, especially as a function of disease. Biomarkers are often surrogate endpoints in clinical trials; that is, they serve as substitutes when a clinically relevant endpoint cannot be identified. The advantage to this is that many clinical endpoints, such as survival (a measure of death), are not reliable predictors due to infrequency of occurrence or unethical practices, such as manipulating the survival of individuals. By using a biomarker, researchers can reduce harm and risk to a subject while still producing clinically relevant conclusions. [1]

Biomarkers play a large role in the drug development process; they bridge the gap between the measurable biological outcomes and clinical outcomes. However, biomarkers are limited in how well they can reproduce physiological consequences of disease.[1]

On the other hand, antibodies are abundant, stable-in-serum biomarkers that can predict a variety of pathologies. Many comparable biomarkers have a tendency to run dilute, and detection can prove difficult, particularly over extended periods of time. [2]

Natural antibodies are the body’s biomarkers, and help the immune system monitor the body. Antibodies in the body can serve as biomarkers that indicate the functional changes of the body system that they are functioning in. [3] Antibodies are the body’s way of detecting a change in the expression of a protein, which in turn can indicate the progression of a disease or infection. Harnessing the natural properties of antibodies as biomarkers, or clinical indicators, could prove to be successful on a larger scale in the future. The ability for antibodies to remain stable in blood serum over extended periods of time could change the way clinical trials are conducted.

[1] Strimbu, K., & Tavel, J. A. (2010). What are Biomarkers? Current Opinion in HIV and AIDS 5(6), 463–466. http://doi.org/10.1097/COH.0b013e32833ed177

[2] Sabatino, A. D., Biagi, F., Lenzi, M., Frulloni, L., Lenti, M. V., Giuffrida, P., & Corazza, G. R. (2017). Clinical usefulness of serum antibodies as biomarkers of gastrointestinal and liver diseases. Digestive and Liver Disease,49(9), 947-956. doi:10.1016/j.dld.2017.06.010

[3] Xu, X., Ng, S. M., Hassouna, E., Warrington, A., Oh, S. H., & Rodriguez, M. (2015). Human-derived natural antibodies: biomarkers and potential therapeutics. Future Neurol, 10(1), 25-39. doi:10.2217/fnl.14.62

The Benefit of Master Agreements

Master agreements help set standard terms between two parties of a contractual, reciprocal agreement. The process of two parties having to repeatedly enter into a separate agreement of the same type can be tedious, time consuming and potentially detrimental to a business relationship, especially if the parties find themselves constantly revising and renegotiating agreement terms. Doing so can significantly slow down the time it takes to initiate sponsored research projects or productization of licensed inventions.

The master agreement specifically covers standard terms that apply to a particular type of transaction between two parties. These agreements set out the basic framework of the working relationship between the two parties. Emory University, specifically, negotiates master agreements that cover the terms of clinical trials, sponsored research, research tools, and confidentiality. By agreeing to standard terms upfront, the parties save a significant amount of time when a new project or engagement is initiated. With the umbrella agreement in place, a relatively short addendum, work order, or similar is executed for a specific item/project. There are some terms that need to be agreed upon for each project under a master agreement such as project scope of work, finances, and IP rights.

Master agreements themselves can cover a broad spectrum of terms; for example, indemnification, which is a part of an agreement that stipulates that one party in the agreement will absorb monetary costs for losses that a second party may incur. Other terms can be items such as termination, confidentiality, data ownership, publication and reporting.

Creating a large, comprehensive agreement is not without its pitfalls. Parties involved must be incredibly thorough and make sure that they can live with the terms, as once a master agreement has been signed off on, making changes can be difficult.

Master agreements are generally a benefit to both parties. Investigators are extremely supportive of master agreements, given they can significantly shorten the waiting time before a research project can begin. The university and company save on personnel time and resources by engaging in one extensive negotiation rather than multiple negotiations, which is a much more inefficient process. Putting several agreements under one master agreement saves time and effort while simultaneously establishing a working business relationship. Streamlining the process makes companies and institutions more willing to work with one another.

While the investment it takes to negotiate the initial agreement can be significant, once the master agreement is in place, individual agreements covering a research study or commercial license can be finalized within a matter of a few days. The time it takes to develop the initial master agreement can vary greatly and depends on the level of priority a company assigns to such an agreement, but one thing remains for sure: master agreements are almost universally appreciated and preferred in the industry.

Monte Eaves’ a Kauffman Success Story

Monte Eaves is a professor of surgery at Emory University and Medical Director at Emory Aesthetic Center. He is also the man behind EMRGE, a company developing products that are revolutionizing the wound closure industry. EMRGE challenges the traditional needle and thread wound closure procedure with noninvasive and cost-effective technology that promotes healing and minimizes scarring. For this, Eaves was recently awarded the Office of Technology Transfer (OTT) award for 2017 Startup of The Year, one of many achievements. Shortly after, we got to talk with him about how he got there and the role OTT and Emory’s Kauffman Foundation FastTrac® TechVenture™ course for entrepreneurs played in helping him along the way.

Monte Eaves

Tell me a little about the origins of your startup company.

So I was a resident here at Emory in the ‘90s. I worked with one of the surgeons named Alan Lumsden and we were co-inventors of the first endoscopic vein harvesting system. Through the OTT we licensed that to Endosurgery Johnson & Johnson, and that product is still made today, more than 20 years later. It was eventually sold to Sorin, and it’s called ClearGlide®. That technology and its derivative products are now used in about 70 percent of heart bypasses. It’s really cool that one product could make such a difference, and that’s what gave me the bug.

Then I left Emory for about 15 years from 1997 to 2013. I had six additional patents that were licensed, but what I found was very frequently this intellectual property (IP) had a hard time actually getting significant and ultimately are just mothballed. I began developing the wound closure technology in 2010, but I was at a loss about how to move it forward until I came back to Emory where OTT really helped me get started and connected me to people in the community. They helped me sign up for the Kauffman course which was quite helpful, and got me into a southeast bio business plan competition. That’s what got me moving toward creating a company.

How did you realize there was this niche opportunity for you in the medical marketplace? What was your thinking process when first developing your products?

Our technology addresses a pretty well recognized need. I actually worked for two years with Johnson and Johnson in the field; I had an inventor’s agreement with them to try and develop new wound closure technology. They were always looking for things that would be faster, less invasive, and would improve scars. And yet, if you look at the majority of the way we close wounds it’s the same way we closed wounds 5,000 years ago; a needle and thread.

I’ve been aware that this was an area in need for a while now. As I was exploring the possibilities I probably tried 50 different technologies, trying to do it internally or trying to do it on the surface. Then one night I was thinking “Okay, I’ve really got to think outside the box. Well… what is the box?” I had to first figure out what box I had put myself in.

I started thinking, the box was that it had to be flat to the surface, or it had to be underneath. I kept examining, “If I can’t be underneath and I can’t be on top, what’s left?” Then I started thinking about Breathe Right® nasal strips and how they bend and flex. We took that concept but reversed it. This creates the forces that can push, turn, and twist tissues, but do it externally.

It’s a dynamic device that has two arcs of rotation, one opens it up and one pushes down this little footplate that’s like a strut, and between those two they create the right action to bring it all together. The process was, for me, a very interesting learning experience; when we’re trying to be creative and original we have to figure out what box we’ve put ourselves into.

Was there any other specific event or experience that got you thinking about creating your own startup?

After a certain point of getting IP mothballed and having projects that just don’t take off, you realize that sometimes you’re just going to have to do it yourself. I think the world has changed from 20 years ago when companies would frequently use internal product development and had the right researchers and engineers inside the company itself. Now, they want to go buy innovation. These days if you want to develop technology you might have to do it yourself.

The other thing that got me interested was being president of the American Society for Plastic Surgery. I think the experience of helping to run an organization made me realize how much I enjoy building teams, having projects, bringing people and concepts together, and figuring out how to pay for it. That’s exactly what you do with a startup.

Did the Kauffman course help you decide on a direction, or did you already know exactly what you wanted to do by the time you took the course?

Before I showed up here in 2013 I spent three years thinking through the technology, filing the original patent, and building what I could with models, but I didn’t have connections to any resources. When I came to Emory I knew I needed to move this forward, I just had no idea how. The Kauffman course was eye-opening in helping me know how to take the first steps.

Was there a specific moment in the course where you realized a startup was actually something you could do, or a particular session where something clicked?

Before the Kauffman course I knew I needed to do this, I just didn’t know how. Even just looking at the course material and its sections gave me an idea of what path to take. I went there knowing I was going to do this, I just needed guidance.

Were there any sessions that continue to provide guidance?

I think the most illuminating sessions were on regulatory processes. That, and understanding finances: what are your options, what are you going to do; that starts you thinking about what your best path is to get there.

Tell me about networking for your startup.

Networking isn’t just something that happens when you go to an event and walk around. That can certainly be helpful, but really what you have to do is just be hungry for it. And it’s amazing, when you start to cold call people asking if they know anyone who could help with a particular thing, if you do it enough you’ll eventually end up talking to the same people again. You get to know people, and then you become a resource for them as well. It’s a two-way street.

It’s amazing, one of my biggest lessons during this process was realizing how many people will help if you approach them with humility, and often after that it starts clicking. You just have to make that call or send that email.

Did any particular speakers from the Kauffman Course stand out to you?

Tom Calloway, he gave the talk on funding. There were a couple of things he said that stuck in my mind. Like, “Time is the enemy, money is the weapon.” I thought through that several different ways, and think it is a very important truism.

When you look back, do you see anything missing from the Kauffman course?

I think one thing that could be helpful is having someone who has gone through the process like me, talking about how to do this and still balance it with other responsibilities. It’s very much a learning curve, you can get so overwhelmed with clinical responsibilities or other research activities. You have to make decisions about priorities. That’s something that would be helpful: information on how to manage it, how to make connections and get the right contacts, how to be a good partner to your manufacturers, things like that.

The Kauffmann course tells you the steps, finances, regulatory, the legal details. It tells you what to do, but if I were teaching a course, I’d talk about how to do it.

Have your experiences in business given you insight into its relationship with medicine, and how the marketplace affects the evolution of the medical world?

Both fields are definitely mutually beneficial. Part of it for me was being the director of the Emory Aesthetic Center, which is a retail medical department, so it’s a business. You have a product, you have to manage people, you only have a certain amount of resources, there are barriers to overcome. There is a lot of beneficial crossover, particularly because I’m in a management position at the center.

What is Neuroethics?

In the 1990s, developments in the field of human genetic engineering opened the possibility of modifying inheritable genes. If the technology advanced, genetically engineered children, known as “designer babies”, could be altered in order to decrease risk for developing disorders such as Alzheimer’s, Huntington’s, and Down syndrome.

However, this development also spurred controversial debates about the ethical concerns of genetic manipulation. For instance, genes for physical characteristics such as eye color and hair can also be manipulated. Would the ability to select our children’s traits lead to a future society obsessed with creating the ‘perfect’ child? Or, as the procedure is expensive, could this development create a gap within society by splitting “designer” and “non-designer” babies?

Similar to how genetic engineering has inspired controversial ethical debates, the field of neuroethics, which emerged from the realization that neuroscience research was advancing at a very rapid pace, also had profound implications.

“There were profound ethical problems in neuroscience that were not being addressed. The nature of those problems were more immediate and more far reaching than those in genetics”, Paul Wolpe, PhD, Director of the Center for Ethics at Emory University and one of the 12 original founders of the field of neuroethics, explained.

Some ethicists maintained neuroethics was merely bioethics applied to the brain and thus, the creation of a separate field wasn’t necessary. It is true that some traditional bioethical concerns can be applied to the brain. For instance, a researcher may discover during a research study that his neuroimaging patient may show signs of a disease. This ethical dilemma can be difficult. Does the researcher have the responsibility to inform the patient? But what if the patient does not feel the same way? Some may prefer living without the knowledge of possessing a life-changing condition.

Other ethicists believe that neuroethics, which encompasses ethical, legal, and social impact of neuroscience, merits its own professional identity. “Neuroscience was beginning to question fundamental human principles like free will, agency, and personality”, explains Wolpe.

To many people, the idea that humans do not possess free will may seem absurd. After all, we make  decisions everyday on what we eat, where we go, and who we speak to. However, a legal case concerning a 40-year-old American schoolteacher convicted of pedophilia in 2002 may question this principle. After his conviction, magnetic resonance imaging (MRI) scans revealed a tumor in the part of his brain involved in impulse control and decision making. Once the tumor was removed, remarkably, the man’s pedophilic behavior disappeared. Scientists speculated that the tumor may have impaired his ability to control his impulses.

Such neuroscience findings challenge our current understanding of human behavior and may also impact jurisprudence. For example, if this man is not capable of self-control, is he still guilty? Was he responsible for failing to seek professional help for his impulses?

Recognizing the importance of these questions, Wolpe, along with the other 11 founders of neuroethics, founded the International Neuroethics Society (INS) in 2006. This provided an environment where scientists, ethicists, lawyers, policymakers, and educators could share their professional perspectives and discuss their concerns. In addition, the INS also informs the non-scientific community about neuroethical implications through engaging in public forums and discussions with journalists and the general public.

Despite some concerns that people would not recognize the growing importance of neuroethics, the INS now has over 300 members. There are also other organizations that have been established to investigate neuroethical issues. For example, the McArthur Foundation at Vanderbilt focuses on issues at the intersection of neuroscience and the criminal justice system.

As the field of neuroscience continues to advance, it’s important that the scientific community, as well as the general public, stay informed about new developments and their possible neuroethical implications. The Center for Ethics at Emory provides an abundance of resources to become informed and participate in discussions. The center regularly hosts events address pressing ethical issues from human enhancement to human rights. The Director of the Center for Ethics, Wolpe, is also the Editor-in-Chief of the American Journal of Bioethics Neuroscience (AJOBN), a peer-reviewed academic journal which explores the ethical, social, and legal dimensions of neuroscience. AJOBN’s official blog, The Neuroethics Blog, started at Emory by Karen Rommelfanger, PhD, the Neuroethics Program Director at the Center for Ethics, is also available to Emory students and the general public interested in neuroethics. Emory students can participate through writing for the blog or joining the Bioethics Society, a student interest group. With so many resources available on the Emory campus, students can engage in healthy discourse, gain new perspectives, and become better equipped to anticipate potential future changes.