Question: What drew you to combine your interest with engineering and medicine? Padala: I got my mechanical engineering degree in India, and did a 1 year internship at the hypersonic propulsion lab at the Indian defense laboratories, where I got my first introduction to putting theory into practice . When I came to Georgia Tech to get my PhD, I began focusing on heart valves and fluid mechanics, plainly the study of blood flow through the heart. After finishing my PhD, I started my independent lab in the division of cardiothoracic surgery at Emory, where our focus was on applied translational research – i.e., apply engineering concepts to viable medical solutions. The cardiothoracic surgery division here has a unique mix of clinical practice and research enterprise, and this environment provided me the opportunity to identify the right medical problems, and develop solutions that a clinician would want to use to treat their patients. Question: How do you balance the goal between research and commercialization? Padala: For me, research and commercialization are not really two different things. From its start, my lab had developed parallel paths: (a) a research path where we study a disease and develop the necessary models to
Continue readingAuthor: Linda Kesselring
T3 Labs: Helping Move Healthcare Forward
In 1999, a group of interventional cardiologists got together in Norcross, Georgia with the goal to translate ideas for medical devices, biologics, and drugs into cutting-edge technologies. They collaborated with sponsors to test product designs and formulations and to train physicians, health professionals, and company representatives and ultimately formed Saint Joseph’s Translational Research Institute (SJTRI). Their mission was simple – to get medical devices and therapies to patients faster and safely with the hope of changing the face of modern medicine. By 2009, SJTRI, as part of the Saint Joseph’s Health System (SJHS), had expanded to over 35 employees in a multi-million dollar facility with full-equipped operating rooms, wet labs, and office space. In 2012, SJHS entered into a partnership with Emory Healthcare in which Emory acquired majority ownership. Recently, they changed their name to T3 Labs or Translational Testing and Training Laboratories, Inc. T3 Labs manages studies in a number of fields, including cardiovascular, orthopedic, urology, and regenerative medicine. With Emory, they are working to streamline pre-clinical device development cycles and leverage the expertise of both industry and academia. By partnering with Emory, T3 Labs has the ability to function as a private institution with its industry sponsors while
Continue readingHow are Medical Device Patents Different?
A medical device is defined as an instrument, application, or implant that is used in the diagnosis or treatment of a disease or other medical condition. Medical device patents differ from patents on biologics or pharmaceutical products in that there is less need to establish the efficacy of the device, actually build a prototype, or provide supporting data. In many cases, once the inventor has thought of the idea and how it would be implemented, a patent application for a medical device can be pursued. When a new medical device is disclosed to the Office of Technology Transfer, our case managers analyze the potential market for the product, what development still needs to occur for the product to be commercially viable, and perform a preliminary prior art search. Subsequently, if the market and initial patent analyses suggest that the idea is commercially feasible, the Emory Patent Group will get involved to develop a patent strategy, perform additional prior art searches, and draft a patent application. From an intellectual property (IP) standpoint, there are different options to protect a medical device when compared to a biologic or small molecule therapeutic. For any of these products, a utility patent application that covers
Continue readingSoutheastern Medical Device Association (SEMDA)
Join us throughout January as we feature medical devices; this week’s post highlights the Southeastern Medical Device Association. The Southeastern Medical Device Association (SEMDA) is a regional non-profit trade association that supports and promotes medical device and medical device data system (MDDS) companies in the Southeast. Created in 2004, SEMDA helps such companies accelerate device development and achieve commercial success, through educational resources and access to funding and networking opportunities. SEMDA members gain access to quarterly meetings, regional and national affiliate joint events, and SEMDA’s annual conference. Such opportunities allow members to obtain development skills, learn from experts in the industry, and network with others who can help companies achieve their business and medical device objectives. In addition, SEMDA seeks to provide educational content around issues that a medical device company needs from the start-up phase to the post-market launch. It brings in experts on topics such as grant-writing, presentation, and the business aspects of the medical industry. It also produces original content about the medical device industry. “We’re constantly updating our website, putting up data, and working with other device advocacy groups to make sure that our content is current, relevant and meaningful,” SEMDA President Robert Crutchfield says. According to
Continue readingSocial Media Lessons Learned & Take-Homes for TTOs – Part 2
Twitter, Facebook, YouTube, LinkedIn, Pinterest, oh my! So many options, so little time and it appears like everyone else is jumping on the social media train, what is my office to do? We don’t want to be left at the station! On one hand social media can be a powerful tool for building your brand and much can be gained, but on the other hand, if done poorly or without realistic expectations, it can be a great deal of effort with little reward. In this two-part blog post we will share our lessons learned as well as snippets gathered from a recent social media event we attended featuring thought leaders in the social media/marketing fields. (Read part one of the blog series here.) Part 2 Recently we had a chance to attend Entrepreneur Magazine’s “Thought Leaders Live” Event here in Atlanta covering “The Mathematics of Social Media.” This half-day event featured a panel of leaders in the fields of social media and marketing. They discussed how to use social media platforms effectively and how to measure its success, among other relevant topics. While not every point was necessarily applicable to our business as TTOs, we did come away with some
Continue readingSocial Media Lessons Learned & Take-Homes for TTOs – Part 1
Twitter, Facebook, YouTube, LinkedIn, Pinterest, oh my! So many options, so little time and it appears like everyone else is jumping on the social media train, what is my office to do? We don’t want to be left at the station! On one hand social media can be a powerful tool for building your brand and much can be gained, but on the other hand, if done poorly or without realistic expectations, it can be a great deal of effort with little reward. In this two-part blog post we will share our lessons learned as well as snippets gathered from a recent social media event we attended featuring thought leaders in the social media/marketing fields. Part 1 Our office jumped into the social media fray in 2010 when we recognized the increasing importance of communicating with our colleagues, customers, and community via online channels. Since that time, the number of users within our industry has grown exponentially; in fact, our friends at Fuentek™ recently conducted a survey of TTOs and found two-thirds of respondents used social media in some capacity.* While much has been written about metrics and strategies for effectively using social media to build your brand, we thought
Continue readingTI:GER: The Next Generation
The Technological Innovation: Generating Economic Results, or TI:GER program, is a unique collaboration between Emory University and the Georgia Institute of Technology (GA Tech) that brings together business, law, and science. TI:GER organizes students into teams comprised of two GA Tech MBA students, two Emory Law students, and a PhD candidate in the field of science or engineering. During the TI:GER program, students are directly involved in the innovation process and work together to bring discoveries to the marketplace. Teams are challenged with the task of preparing a commercialization strategy and business plan based around the PhD candidate’s research. One of the hallmarks of the program is that the economic, regulatory, and legal issues are considered prior to the research being completed. These considerations can then be incorporated into the research plan and commercial development strategy. The two year program includes multiple components, ranging from classroom instruction and guest lectures, to internships and networking. Students also have the opportunity to directly engage with start-up companies in GA Tech’s incubator, the Advanced Technology Development Center (ATDC). Tyler Dutton, an Emory Law student in the program, explained that TI:GER helps students learn about and apply patent law, contract law, venture capital, angel investors,
Continue readingFrom the Director: Emory Breakfast Club
We sat down with Executive Director Todd Sherer to talk about one of OTT’s signature events – the Emory Breakfast Club. Started in 2010, OTT’s Breakfast Club is an early morning networking breakfast during which OTT’s licensing associates briefly pitch new innovations. Also, take a look at our video about the Breakfast Club events. What was the inspiration for creating the event? We realized we needed a better way to engage the business community with regards to licensing opportunities we had in the office. We created this event so that we could find a way to more regularly bring the business community together and pitch technologies to them. What do you feel the audience gets out of the event? I think the audience gets a chance to come and sit down and hear more about Emory and not just what is going on in the Tech Transfer Office. We will occasionally have speakers and provide background information about other things across campus. They get a chance to hear about business opportunities and to network. Since this event is invitation only, how was the invitee list created? We thought a lot about who to invite. We wanted it to be a fairly
Continue readingInterns: How the Emerging Leaders Network Creates Opportunities
The Emerging Leaders Network (ELN), a division of Georgia Bio consisting of students, postdoctoral fellows, and young professionals, has been instrumental in my personal and professional development during my graduate career, including introducing me to the intern program at OTT. ELN was established to provide resources and networking opportunities for students and early career professionals in an effort to retain locally educated talent. Specifically, ELN aids in initiating connections with seasoned professionals, making introductions to local companies in the biosciences, and providing educational opportunities for professional development. Since I became involved with ELN, I have learned a tremendous amount about my career interests and personal strengths through participation in ELN’s programming. There are several regular programs offered by ELN: Social networking events – mainly in the form of happy hours. ELN’s social events provide a great way to meet other young professionals in a casual environment. Small dinner series – a seasoned professional and leader in their field is invited to have dinner at a local restaurant with 8-10 attendees. The small dinners allow attendees to learn about a particular career field in depth and form authentic connections with the speaker and other attendees. Educational events – these events can have
Continue readingUSPTO After Final Consideration Pilot Program: A Success
Emory has successfully participated in the USPTO’s After Final Consideration Pilot (AFCP) 2.0 Program, which is available through December 14, 2013. The pilot is part of on-going efforts by the USPTO to further compact prosecution and increase collaboration between examiners and applicants. The pilot program provides a process for the applicant to have an after final response entered without having to file a request for continued examination (RCE). This initiative provides additional time, up to three hours for utility applications, for the examiner to consider whether the amendment places the application in condition for allowance.To be considered under the program, the response must include “an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect” and the transmittal form (USPTO Form SB 434). In our case, our office received a Final Rejection rejecting the claims under two rejections over new references in view of our previously filed response. In the Final Rejection, the Examiner suggested that we amend the claims to incorporate a dependent claim into each of the respective independent claims to address one of the rejections if we could overcome the other rejection by filing a Declaration. After consideration,
Continue readingAn ENTICeing Proposition: Neuromodulation Innovation Center
The advent of neuromodulation, the therapeutic alteration of neural activity via an implanted device, has revolutionized the treatment of neurological and neuropsychiatric disorders. Emory has long been at the forefront of this revolution with pioneering research on the pathophysiology of Parkinson’s disease and the identification of novel brain targets for ablation. At the same time, Emory has also been a leader in the development of innovative deep brain stimulation (DBS) techniques for psychiatric disorders (e.g., major depression), and the use of DBS for epilepsy and dystonia. The success of these programs has propelled the expansion of neuromodulation-related research at Emory, which now spans the Departments of Neurosurgery, Neurology, Psychiatry, Rehabilitation, Biomedical Engineering, Neuroscience, and Psychology as well as the Yerkes Primate Center and collaborations with our colleagues at Georgia Tech. Emory is now prepared to take the next step. By bringing together these clinicians, researchers, and engineers into a single center, Emory hopes to further develop these discoveries into practical solutions and products. This new center is called the Emory Neuromodulation and Technology Innovation Center (ENTICe). The goal of ENTICe is to advance the understanding and effectiveness of neuromodulation in order to reduce the burden of neurological and psychiatric disorders. The
Continue readingInterns: Choices Outside the Lab
When I first started my PhD program I was driven by my desire to learn more about neuroscience, pursue translational research that could eventually help people, and contribute to our growing knowledge of the brain. As I progressed through my program, I started to think more about my career after earning a doctoral degree. I first focused on the type of academic career track that would best suit me, but I began to realize that the life of a typical academic did not appeal to me. Although I did enjoy learning about new scientific discoveries and felt an immense sense of pride in being part of that discovery process, I realized I did not want to continue bench work as a life-long career. Unfortunately, I had a limited grasp of careers available to Ph.D. graduates and no idea for how best to make the leap from academia to ‘alt-ac’ careers. I did know that I wanted to find a career that matched both my experience as a trained scientist and my desire to promote new scientific ideas. I decided to pursue an internship with OTT because it seemed to align with my interests and desires in a career. The internship
Continue readingFrom the Director: Technology Transfer and Patent Reform
Intellectual property protection, in particular patent protection, is an important aspect of university technology transfer. Such rights give the licensee a proprietary position that allows for investment in continued development and helps ensure that the public ultimately benefits from basic research that results in commercial product. In terms of patent rights, it will be important to watch in the coming years how new factors such as the Leahy-Smith America Invents Act (AIA) affect academic innovation. The law represents the most significant change to the U. S. patent system since 1952 and switches patent rights from a first-to-invent system to a first-inventor-to-file system. This change presents particularly challenges for us in academic technology transfer as our faculty function in a “publish or perish” environment. Under the new law, researchers are no longer protected through early conception of an invention, and disclosures to third parties can impair patentability. Most researchers are familiar with the role and necessity of lab notebooks, particularly in determining when an “invention” occurred. This note taking requirement was not eliminated with AIA, but in fact its importance is expanded. Although there are changes, AIA does retain certain protections for researchers, such as the grace period for an inventor’s
Continue readingA Successful Office Initiative: The Emory Patent Group (EPG)
One of the key responsibilities of the Office of Technology Transfer (OTT) is determining which form of intellectual property protection is most appropriate (and feasible) for inventions arising out of research, and other activities, at Emory. The Emory Patent Group (EPG), one of the pillars of our ReTechTran program, was created in 2009 as an innovative way to address budgetary constraints and improve our ability to pursue promising new technology. These constraints had started to impact our ability to protect new technologies effectively. Emory’s goal is to draft, manage, and prosecute all patents for unlicensed technologies in-house rather than working with an outside law firm. Bringing patent work in-house is very uncommon for university tech transfer offices. Two distinct challenges that often keep universities from creating an in-house patent counsel include 1) uncertainty whether there will be real cash savings, and 2) concern that a few in-house patent attorneys will not be able to cover the high variability in technology. OTT has carefully evaluated the implications of bringing our patent work in-house including the potential cost savings. Further, unlike many universities Emory’s focus in biomedical research makes it more practical to cover all relevant technical areas compared to many of
Continue readingInterns: Love Your “Other Projects as Assigned!”
Although the core duties of an intern, such as prior art assessments and writing non-confidential summaries, are key to developing your knowledge of technology transfer, embracing those unique opportunities with special projects can be a valuable experience as well. My first “other project as assigned” was to help prepare paperwork for a company that was looking for early stage, small molecule therapeutics for further development. The company had already identified technologies in which they were interested. The paperwork necessary was a blend of a non-confidential summary, prior art search, and market assessment, but with a focus on small molecule development. The task was not difficult, but it allowed me to gain a greater feel for how small molecule therapeutics are developed (skills I didn’t have from my science career) and to get a glimpse into how companies assess technologies for licensing and development. My second “other project” was to evaluate non-exclusively licensed technologies and identify any potential technologies that were generating reasonable revenue and had the potential to be more broadly licensed. I was allowed (forced) to use some creativity to determine the best way to present the massive volume of numbers I was working with and present the information
Continue readingFrom the Director: Research Drives Innovation
To maintain growth, strong and sustained funding for basic research is necessary to assemble a pipeline of great ideas. Basic research provides the building blocks and foundation for much of what we do in technology transfer. The origins of a great many inventions society depends on today can be traced back to a discovery made at the bench as a basic research project. Some outside observers however, assume that the amount of money we put into research should directly translate to money as licensing revenue. Over the last two decades, federal research funding has been on the rise each year with around $63.7B reported by 194 respondents in the FY12, AUTM Licensing Survey – up from $12B in 1991. If you were to plot research funding and number of new invention disclosures over time on the same graph, you would find that the two lines mirror each other amazingly well. In other words, research drives innovation. Some look at the $63.7B a year of federal money in research, compare that to the $2.6B of licensing revenue in FY12, and conclude that this outcome is a bad return on the investment in federal research. Although a tempting comparison to make, it
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