Upcoming CCTS Events
CEI 2018 drew more than 150 participants from a variety of disciplines and sectors, all interested in building bridges to better health.
The 5th Annual Community Engagement Institute (CEI) took place on Friday, October 12, drawing more than 150 participants from across the Deep South as well as a robust virtual audience comprising three CCTS Partner institutions (UA, USA, UMMC) who watched livestreamed sessions and interacted via social media. The full-day symposium, which took place at the Hyatt Regency (The Wyndham) in Hoover, Alabama, explored ways to reach across sectoral divides to work synergistically on our region’s greatest health challenges.
The morning began with a thought-provoking panel discussion moderated by OGC Council Member Lyord Watson, Jr., M.Div., Minister of Education at the Birmingham Tabernacle Baptist Church. Joining him were four panelists representing distinct sectors that focus on community health needs, including David Hicks, DO, Deputy Health Officer, Jefferson County Department of Health (JCDH); Nadia Richardson, PhD, CEO and Founder, No More Martyrs; Reverend Fred Witt, Pastor, Agape Missionary Baptist Church; and Andrea Cherrington, MD, MPH, UAB Division of Preventive Medicine and Co-Director of the Community Engagement Core for the Diabetes Research and Training Center at Cooper Green Mercy Hospital. Their topic was “Who Contributes to the Health of Our Communities?” It ended with a lively Q&A session, including several questions sent via Twitter from virtual attendees.
The panel discussion set the stage for breakout sessions that examined the role of different sectors in addressing community health needs. Attendees selected the sector (e.g., philanthropy, government, social justice, and education) that most closely aligned with their interests and backgrounds.
This year’s keynote speaker, Dr. Derek M. Griffith, PhD, Founder and Director of the Center for Research on Men’s Health and Professor of Medicine, Health, and Society at Vanderbilt University, explored determinants of health and their role in racial and gender health disparities. He discussed racism’s role as a factor that helps explain the differences in mortality between Blacks and Whites in the U.S. The majority of his talk, however, focused on “within group” issues that hurt the health of all men. “This year thousands of men will die from stubbornness,” he said, not seeking health care until it is too late.
Attendees broke into small groups in the afternoon—the World Café session stimulated “group think” and lively discussions about ways to bring the morning’s bridge building ideas to life. Each group had a flip chart to capture responses to the following questions, which they shared with the broader group during the Harvest Café session:
- What are specific ways we can create safe places and spaces for dialogue to strengthen the health of our communities?
- What are the barriers to strengthening the health of our communities?
- Who are the leaders that need to be engaged?
- Which public and private organizations are responsible for the resources to strengthen the health (physical, mental, spiritual, and socioeconomic) of our many diverse communities?
The symposium also featured a poster session and multiple opportunities for attendees to network with each other as well as with speakers and poster presenters. Congratulations to the authors of the six posters that won awards:
1st Place
Innovative Strategies to Improve Living Kidney Donation (Alexis Carter & Markayla Peoples)
2nd Place (three-way tie)
Utilizing Facilitated Deliberation to Inform Genomic Screening Initiatives (Jamie Richards)
ATLAS: Alabama Teens Learn About Substance (Use) (Michelle Kung)
A Systematic Review of Splenic Infarction in Individuals with Sickle Cell Trait (Wynston Sims)
3rd place (two-way tie)
Utilizing Physician Referrals to Increase Community Engagement of School-Aged Children and Their Parents in a Family-Based Behavioral Treatment for Pediatric Overweight/Obesity (Caroline Keller and Marissa Gowey)
Dispensing Hope to Improve Medication Adherence (Connie White-Williams and Alysia Campbell)
About the CEI
CEI is a joint activity of CCTS and its One Great Community Council and the Center for the Study of Community Health and its Jefferson County Community Participation Board. Together we extend a hearty thank you to the Alabama Public Health Institute and Protective Life for their sponsorship of CEI 2018. We also thank our CEI 2018 Planning Committee: Shauntice Allen, Andria Cimino, Mary Evans, Max Michael (chair), and Lyord Watson.
Dr. Laura James, University of Arkansas Medical Center (UAMS) Associate Vice Chancellor of Clinical and Translational Research and Translational Research Institute Director, shared her team's success story in leveraging NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants to fund their research and commercialize a new diagnostic test for acetaminophen toxicity.
What are SBIR/STTR Grants?
James reviewed the purpose of these NIH funding mechanisms, which represent one of the largest sources of early-stage technology financing in the country. The goal of SBIRs is to strengthen the role of innovative small business concerns in federally funded research and development (R&D). STTRs facilitate technology transfer developed by a research institution through the entrepreneurship of a small business concern.
Phase I and II, James explained, are when you build and test your prototype via a clinical trial or some similar study design. Small businesses that have performed Phase I-type research through other funding sources may submit a Direct-to-Phase II SBIR application. Phase IIB, which used to be called Phase III, is the final phase, when an investigator moves a discovery validated by earlier phases into commercialization.
“The program continually builds upon itself. So if you apply for a Phase I grant, which is entry level, and you’re successful, then you are eligible to go on to Phase II, which is a bigger award for more years of funding, plus NIH mentoring that we found to be very helpful,” James said. She recommended investigators explore an interactive SBIR/STTR infographic that provides a tutorial for applicants taking them from “a good idea” through the different funding pathways and corresponding levels of support each phase provides for R&D or commercialization.
Benefits of SBIR/STTR Funding
Since James first heard of the SBIR/STTR grants in 2007, the program has grown and is now NIH-wide, with every Institute offering some funding via one or both of these mechanisms. She noted they represent a growing share of NIH Institute budgets. They are attractive for many reasons, including “they are generally less competitive, as fewer people know about them.” Other benefits include:
- Funding is stable, predictable, and not a loan
- Funding lines are generally higher than an R01
- Capital is non-dilutive (no need to give up an equity stake or share ownership as with private sources of capital funding)
- Small businesses and research organizations retain intellectual property rights
- SBIR and STTR grants confer eligibility to use other NIH support programs and resources
- NIH’s rigorous peer-review process for these grants provides recognition, validation, and visibility to early-stage biomedical companies
- The prestige associated with these awards can help attract more funding or other support (e.g., venture capital, strategic partners)
Of critical importance to James, who did not wish to leave academia, the STTR grants she received allowed her to maintain her academic career and even helped offset her academic salary. Indeed, the STTR grant requires that applicants have a partnership with an academic institution.
Acetaminophen Toxicity Diagnostics (ATD) LLC
James began her career as pediatrician and became involved in clinical trials, eventually joining a multidisciplinary team that wanted to improve the ability to diagnose liver injury (formation of adducts due to acetaminophen poisoning) at the point of care.
The team members formed a company in 2006 and received their first grant in 2007 to develop an assay that could detect acetaminophen protein adducts. They applied for a supplement in 2010 to develop instrumentation (a dipstick for the assay, similar to a urine pregnancy test), followed by grants to fund clinical testing of their product, AcetaSTAT®.
James emphasized that ATD “did not happen overnight, but grew out of a long-standing collaboration” and built with lots of “local support.” This was one of the keys to success, in addition to defining the clinical problem in a way that clearly elucidated “where is the pain?” and putting together a well-rounded team.
To hear James’ entire talk, which traces the journey of her team’s discovery, product development, and company in relation to the support they received, including collaborators and STTR funding, click here.
Current NCATS SBIR/STTR Opportunities
The National Center for Advancing Clinical and Translational Science (NCATS) bills its SBIR and STTR programs as “engines of innovation for developing and commercializing tools, technologies and intervention platforms to support the creation of new therapeutics and diagnostics.”
NCATS recently released two new SBIR/STTR funding opportunities through the 2018 Omnibus Solicitation. Representatives of small businesses and research organizations focused on commercializing innovative medical technologies are encouraged to submit applications to PA-18-574 and PA-18-575 by Jan. 7, 2019.
NCATS encourages applications that address research areas relevant to any stage of translation, from target validation through pre-clinical and clinical evaluation to intervention implementation and dissemination, including:
- Drug Discovery and Development
- Biomedical, Clinical and Health Research Informatics
- Clinical, Dissemination and Implementation Research
An updated SBIR/STTR Application Guide with additional instructions for the newly reinstated SBIR Direct Phase II application preparation and submission will be posted by Nov. 26, 2018.
Attendees broke into teams for an exercise during the CCTS Technology and Commercialization Pop-Up Course held at Auburn University on September 26, 2018.More than 30 faculty, postdocs, and students participated in our most recent pop-up course, conducted at Auburn University on Wednesday, September 26, 2018. The course was led by CCTS Executive Council Member and UAB Collat School of Business Associate Dean for Research, Innovation, and Faculty Success Dr. Molly Wasko; Auburn Site Lead and Mr. and Mrs. Bruce Donnellan & Family Endowed Professor, Dept. of Electrical and Computer Engineering, and Director, Auburn University MRI Research Center Dr. Thomas Denney Jr.; Lowder Center for Family Business and Entrepreneurship Managing Director and Raymond J. Harbert College of Business Associate Professor Dr. LaKami Baker; and Biological Sciences Professor Dr. Mark Liles.
Participants learned how to determine the commercial viability of their innovations, develop a successful business case for securing funding and attracting collaborators, and apply to NIH for an SBIR grant. They represented a wide range of disciplines—including engineering, pharmacy, veterinarian medicine, human sciences, biosystems, architecture, design and construction, and liberal arts—and career levels, including a few enterprising undergraduate engineering students.
A key take-away message was “get out of the building” to connect with potential customers, find collaborators, better understand institutional commercialization processes, and avoid wasting time and resources.The free half-day session introduced attendees to the Lean Startup Methodology championed by the National Science Foundation’s (NSF) I-Corps™ program, which takes a scientific approach to business planning. Presenters led the audience through exercises in generating hypotheses about the commercial viability of products and developing and practicing their pitch to potential customers.
CCTS will travel next to New Orleans on Wednesday, November 28, to conduct a technology and commercialization pop-up for faculty, postdocs, and students at several Partner Network institutions: LSUHSC, PBRC, and Tulane. Stay tuned to CCTS Digest and our Events page for a link to register for the half-day training, coming soon.
Photos and story by Kate Matthews
Taking on the lingering summer heat, CCTS came together and put up the first walls for UAB Benevolent Fund’s Fifth Annual Habitat House in September. This home is being built for Ames Farrell, a life-time resident of Birmingham, Alabama. The build will run from September 20th to October 27th with volunteers on site every Thursday, Friday, and Saturday. Follow along via #UABBuilds on Twitter to see this house turn into a home! Special thank you to everyone who came out and volunteered their morning in 90-degree heat.
For the past five years, the UAB Benevolent Fund has collaborated with Habitat for Humanity of Greater Birmingham. During that time of service more than 2,500 UAB employees have given over 10,000 hours of their time as well as close to $250,000 in supporting contributions.
Habitat for Humanity is a non-profit committed to providing safe and affordable housing to individuals in need across our community and country. The most common misconception regarding Habitat is that the homes it provides are free, but on the contrary, all Habitat recipients are actually homeowners and manage a 0% interest 20-year mortgage rate. They also must meet a detailed set of criteria to be considered, including putting a down payment on the home and contributing 300 hours’ worth of “sweat equity.”
Rise and Shine! The 2018 CCTS Habitat for Humanity team. 
CCTS Director Dr. Robert Kimberly (l) hammering in nails for a doorway. 
CCTS Project Manager Brian Wallace setting up the first wall.
CCTS BERD Director Dr. David Redden overlooking his handy work. 
CCTS provides the framework for UAB School of Medicine to build on…for houses as well as scientific discovery! Kudos to Dr. Kimberly, who twice volunteered his skills to the Habitat for Humanity House.
(l to r): A panel discussion featuring CTSA representatives, including Signe Denmark (MUSC), Liz Grodin (TriNetX moderator), Madeline Gibson (UAB), and Pam Christie (UAMS)Research Commons Program Manager and CCTS TriNetX Liaison Madeline J. Gibson, MPH, traveled to Boston to share informatics-based tips to empower study recruitment and enrollment at the second annual TriNetX conference, an invitation-only event that took place September 25-26 in Boston, MA. Representatives from across the CTSA consortium, healthcare organizations, Contract Research Organizations (CROs) and industry sponsors attended.
The CCTS Hub uses TriNetX’s Trial Connect platform to leverage informatics in bringing industry-sponsored clinical study opportunities to UAB. Sponsors and CROs looking for study sites query TriNetX members’ de-identified medical records to determine which have the patient population of interest. If the Hub offers a feasible cohort, CCTS Research Commons and CCTS Informatics receive a notification about the potential study opportunity.
Gibson participated in a panel discussion on “Recruitment: From Patient Count to Enrolled Subject,” which focused on procedures for translating a TriNetX query on de-identified patients into an identified patient set that can be used by clinical teams to improve the Hub’s success with enrollment. She described how CCTS uses informatics to identify both potential patients and their treating physicians.
“Our informatics team translates TriNetX queries into internal i2b2 queries to provide an exact patient count and a list of treating physicians who are then contacted about their interest in pursuing the opportunity. Once study teams are activated and IRB approval is in place, CCTS Informatics provides the study team with a corresponding list of medical record numbers.”
Other CTSA representatives contributed to a panel discussion addressing best practices for approaching healthcare organizations about new trial opportunities through the Trial Connect platform. The brainstorming session was dedicated to the informational and operational needs of CTSAs to better engage them via the platform.
TriNetX rolled out several new features at Summit 2018, including:
- new analytics for propensity scores
- a visual depiction of patient treatment pathways
- front-end techniques that make protocols more efficient and feasible once they are adopted at study sites
Inspired by the meeting, Gibson will work with the CCTS Informatics team to further refine the patient data sets provided to study teams at the Hub.
Congratulations to our CCTS Informatics Team, which is leading the way in i2b2 integration with TriNetX. To learn more about TriNetX and i2b2 integration at the Hub, see “Following the Data to Tee Up Clinical Trial Opportunities for Investigators.” Contact Research Commons to learn more about i2b2 and how to participate in TriNetX studies.
Editor’s Note: Many thanks to Madeline Gibson for her representation of CCTS at the TriNetX Summit and her contributions to this news brief.