Technology Transfer in the Context of Responsible Research

“Transcending Boundaries” was the 2019 theme for the American Association for the Advancement of Science (AAAS) annual meeting in Washington DC promoting the idea that Science is a global enterprise. Representatives from all over the world attended scientific talks as well as talks about the uneasy relationship between Science and Society. The European Commission funded several academic consortia to investigate this problem.  The University of Maryland, Baltimore (UMB), is a member of an EU-funded consortium espousing “Responsible Research and Innovation (RRI)”.  The "STARBIOS" consortium (standing for Structural Transformation to Attain Responsible BIOScience) held a symposium at the AAAS meeting and a Workshop on the UMB campus.

Members of the STARBIOS consortium visited the UMB Campus to conduct a workshop on “Technology Transfer in the context of Responsible Research and Innovation (RRI)”.   The goal of the Workshop was to highlight the various forms of tech-transfer opportunities on the UMB campus and the UMB culture of “Responsible Research”. Tech-Transfer was defined as the commercialization of university discoveries, as well as the direct translation of knowledge without commercialization through engagement of both local and global communities.

The Workshop began with Vittorio Colizzi, MD PhD, Professor and Director of the University of Rome. As principal investigator of the STARBIOS grant, he described the culture of RRI that must be fostered in a university and in global outreach activities [1].  For over 30 years Dr. Colizzi has conducted tech-transfer from Europe to less-developed countries in West Africa under the auspices of the United Nations (UN) or the European Union (EU). He brought laboratory scientists as educators to Cameroon, Sierra Leone and Burkina Faso, and, during the Ebola epidemic, he brought medical laboratory support.  He studies host:microbe interactions, including microbiome analysis, and the effects of plant microRNA acquired through diet on the epigenetics of the host. His STARBIOS program promotes 5 key efforts to Engage Society in scientific research, increase Open Access to scientific results, ensure Gender Equity in both research processes and content, promote Ethical procedures, and promote science Education.

Claire Fraser, PhD, and Director of UMB’s Institute of Genome Sciences spoke of her experiences with tech transfer and responsible research.  She has been a pioneer in comparative genomics and microbiome analysis. At this year’s AAAS meeting, she noted the large representation of foreign scientists and the big interest in responsible research.  In the 1990’s she had appealed to several funding agencies to support research on a bacterial disease decimating cattle in Kenya, Theilaria parva, and found there was little interest in funding something that did not affect the USA.  Luckily she was at a private institute (TIGR) and had discretionary funds to complete this project and make a vaccine for Kenya [2]. With the first successful vaccine trial, World Bank and commercial involvement soon followed. Recently, Dr. Fraser has been instated as AAAS President-Elect for 2020.  During her 3-year term she will promote the RRI culture to improve the relationship between science and society.

A social scientist on the STARBIOS team, Andrea Declich, MSc spoke of “Guidelines for responsible research and innovation (RRI).” Since every bioscience institution is different, the first step to formulating an Action Plan is “contextualization”, or describing the context of an institution (e.g. UMB has 7 post-graduate schools, a hospital, and a large indigent patient population). UMB has identified obstacles, and mobilized its own strategic plan with strong efforts in Public Engagement and Technology Transfer.  In general, bioscience institutions waste social capital by failing to mentor and promote women and minorities; UMB is addressing its own challenges through the Women in Science organization and Cultural Change initiatives. The STARBIOS team has published an article describing guidelines for RRI [1]. Changing values in the post-modern society make it difficult for university scientists to establish credibility and value.

Jim Kaper, PhD, is Chairman of the Department of Microbiology and Immunology and University of Maryland, School of Medicine's (UMSOM) Vice Dean for Academic Affairs. He told a riveting story about bringing his live-attenuated cholera vaccine to market [3]. In the 1980’s, his lab genetically attenuated the virulent Vibrio cholerae. The Director of UMSOM’s Center for Vaccine Development (CVD), Mike Levine, MD, was instrumental in getting this attenuated vaccine to market, with its first release in Switzerland in 1993.  Unfortunately, European laws against genetically modified organisms (GMO) prevented licensure in other European countries. Although initially sold in Australia and New Zealand, anti-GMO sentiment forced the withdrawal of the vaccine from these markets as well. Although the World Health Organization distributed the vaccine (gratis from the manufacturer) during some outbreaks, production stopped in 2004. While the vaccine sat for years in cold storage, cholera outbreaks in war-torn regions of the world caused the demand for this vaccine to resurge. In 2009 it was licensed to PaxVax in San Diego and in 2016 it was issued an FDA license to be produced as Vaxchlora. A single oral dose delivers 90% protection within 10 days and serves as the only US-licensed vaccine against an infection that sickens as many as 4 million people a year. This is a remarkable tale of a persistent scientific team delivering valuable technology to a resistant society.

Phil Robilotto, DO MBA, Associate Vice President of ORD and the head of Technology Transfer (now UM Ventures, Baltimore) described the process for determining whether UMB discoveries are patentable and could be further developed, marketed, and licensed to industrial partners.  Every year through UM Ventures, UMB faculty and staff disclose approximately 140 new inventions and UM Ventures will file 80-90 provisional patents, execute 40-45 licenses and help launch 8 to 10 new start-up companies based on UMB intellectual property. After licensing, UMB often retains rights so that research can be sustained.  Any potential conflicts of interest between researchers and their industrial partners are addressed early in the licensing process and a management plan is put in place prior to executing a license.  New government money is supporting an expansion of UMB incubator lab space at the BioPark: Programs such as Anchor Ventures (supported by the state of Maryland) and the UMB BioPark's Science in the City provide numerous opportunities for networking and collaboration.

Stephen Davis, MBBS FRCP FACE MACP is Chairman of the Department of Medicine at UMSOM, and Vice President of Clinical and Translational Science at UMB.  He also directs the new Institute of Clinical and Translational Research (ICTR), a transformative university-wide, interdisciplinary hub for clinical translational research and training. ICTR Cores provide support for bioinformatics, biostatistics, and community engagement as well as financial support for research in the form of pilot and feasibility awards and micro-grants to be used at UMB scientific core services. The data generated with this support is meant to contribute to new publications, grant submissions, and to assist in the development of UMB intellectual property (IP). ICTR currently offers programmatic support for pre- and post-doctoral scholars and has launched a mentored career development award for junior faculty engaged in clinical research. In 2018, twelve Accelerated Translational Incubator Pilot (ATIP) awards of up to $50,000 each were given to multi-disciplinary teams across five UMB professional schools.  Additionally, 86 vouchers (worth $5000 - $10,000 each) were awarded to UMB investigators to use the translational cores on campus. An obstacle to commercialization is often the lack of validated data, that a translational core is able to provide (e.g. testing in small animal models). The ICTR effort is in line with the RRI concepts of Educating young investigators facilitating Open Access to research data, and fostering Research Integrity in training. They also promote Community Engagement by providing researchers access to expert patient- and community-centered services, resources and partnerships along with partnerships with other clinical and translational entities.  Dr. Davis recently received NIH funding in the form of a Clinical and Translational Science Award  (~$9 million) to support ongoing collaborations with Johns Hopkins.  

Meriem Gaval-Cruz, PhD works as a liaison between ICTR and the Office of Technology Transfer.  She is able to identify potential IP from ICTR-supported projects and refer investigators to the services provided by OTT, such as patent filings, state and national commercialization grants, education on new company formation, and opportunities to partner with industry for co-development of UMB IP. In the near future, ICTR will expand their services to include coordination between other clinical and translational sites to facilitate the initiation and implementation of multicenter research projects. Other future efforts will focus on building the capacity to enhance the recruitment and integration of special populations into our research, e.g. shock trauma patients and Old Order Amish individuals. Some of these recruitment efforts will be done through the ICTR Community and Collaboration Core (CCC). The CCC is integral in giving a voice to community members so they can weigh in on what makes an effective, successful research collaboration. Among the services CCC provides are: assistance with developing communication strategies to aid subject recruitment in university studies and creating focus groups or community advisory boards to gauge opinion from community members themselves on specific issues related to community-based participatory research. The CCC can also help connect our faculty with citizen scientists that can effectively and respectfully explain to laypersons the nature of the work being performed by our faculty and the implications it has for their community.  In collaboration with Johns Hopkins, UMB expects to receive funding this spring to expand these endeavors with the goal of translating basic research findings into novel therapies and diagnostics and on to their implementation into routine clinical use. ICTR is currently thinking more about their metrics of success beyond publications and grant applications; keeping track of IP filings, commercialization advances, licensing successes, and ways to measure knowledge transfer to the public as well as community and patient engagement.

Rana Quraishi, PhD is the Director of New Ventures and teaches UMB’s post-graduate course in Entrepreneurship. Approximately 12 graduate students a year have the chance to take this course to learn how to make a business plan, submit provisional patents, and directly experience commercializing discoveries made by UMB faculty. Her goal is for students to become familiar with Baltimore’s innovation ecosystem and make an impact on it. Unique skills for life-science innovation include understanding safety issues and the regulatory environment, understanding intellectual property and licensing, and having deep technical knowledge of genetic analyses and other biomedical methods.  Other Entrepreneurship programs led by Dr. Quraishi on the campus include the President’s Entrepreneurial Fellowships supporting graduate students from all 7 schools to obtain hands-on experience with starting a company.  The current group of fellows is designing a clinical trial for a startup company to test the safety and efficacy of inhibitors of triple-negative breast cancer. Dr. Quraishi interacts with the student-lead entrepreneurship network, and the GRID start-up space in the BioPark where Entrepreneurship students can intern. In addition, the I Corps and the President’s Student Leadership Institute are all activities that Dr. Quraishi supports under the New Ventures and the Entrepreneurship initiatives.

Maria S Salvato, PhD is a professor at UMB’s Institute of Human Virology, and a member of the STARBIOS consortium.  She stepped in at this part of the Workshop to say that the Jacques Initiative (JI) that supports AIDS care for the surrounding Baltimore community, had to withdraw from the Workshop agenda because its director Jamie Mignano, MSN MPH RN, was just hired by Gilead to run their drug-delivery programs. The Jacques Initiative has tested approximately 70,000 individuals in the last few years and found over 10,000 seropositive for HIV. 80% of those were also seropositive for Hepatitis C. Approximately 5,000 individuals were linked to care and approximately 300 high-risk individuals enrolled in PrEP (AIDS-prevention). Each year approximately 75 people stop their medications due to homelessness, addiction, or mental illness and are given intensive attention to return them to wellness.  Under the leadership of Anthony Amoroso, MD, the Jacques Initiative will continue its much-needed Community Engagement and delivery of AIDS/hepatitis testing and care.

Next, a panel on “Integrating Community Engagement at UMB” presented an overview of Community Engagement, then examples of global engagement, then local engagement, and concluded with a specific UMB program to attract Baltimore youth to scientific research. Karen Matthews, DM MPA, is UMB’s Director of Strategic Planning and Assessment and gave the overview.  She made the point that universities are currently expanding their mission to improve the region’s economic development by educating and training the workforce, by helping government solve complex problems (like health care delivery to needy populations), by incubating new enterprises, and by collecting and disseminating information about the local economic ecosystem.  She summarized the factors that promote or inhibit community engagement.  Positive factors include stakeholder networks and a transformative leadership, such as President Perman’s efforts to listen to the local people and the lower echelons of UMB society. Barriers to community engagement include limited resources, bureaucratic red tape, and too few inducements for Faculty to become involved in outreach.

Lori Edwards, DrPH RN MPH, is Senior Director of the Center for Global Education Initiatives. She spoke of a borderless world where communities all over the world collaborate on health care programs. Through student exchange and faculty scholarships, experiential learning experiences are created to address specific problems such as housing for the elderly or dealing with mental health emergencies.  Dr. Edwards engaged the UMB Law School to investigate human rights violations and the cultural violence that tends to accompany dilapidated buildings both in Baltimore and the Gambia. Her program, called GLOBALtimore, conducted a city tour and found that most people in the community are in need of jobs, childcare, better transportation, and healthcare.  She wants to promote neighborhood visits, and a campus-wide database so all people on the UMB campus working in Community Engagement can network.

Kelly Quinn, PhD, is a Senior Manager in the Office of Community Engagement. She made the point that UMB investigators should not only try to engage the community when they want to start a clinical trial, but they should make efforts to visit their neighbors and listen to people expressing their views to gain their trust.  UMB’s Community Engagement Center (CEC) is located within a new BioPark in a dangerously underprivileged and red-lined neighborhood to the west of Martin Luther King Blvd.  The CEC hosts free exercise classes and job-readiness classes.  This center seems to be an oasis of hope and safety in a sea of drug addiction, crime, and poverty. Dr. Quinn called for a better network of people on campus who are seeking resources for Community Engagement, and she mentioned the current need for a member of the lay community on the campus IRB.  

Robin Saunders, EdD, is Executive Director of the CURE Scholars Program on UMB campus.  CURE stands for Continuing Umbrella of Research Experiences and is funded by the National Cancer Institute.  This program represents just one successful example of UMB's efforts to engage with its local community, in conjunction with Baltimore City Public Schools, to address the socio-economic gap occurring in many disadvantaged communities across the globe. Its focus is to provide better access to STEM education and to introduce students to professionals in the health sciences. To date, UMB has engaged 75 youngsters from middle school, and continues to follow 30 successful participants who are now in high school. CURE engages UMB faculty, staff, and students to provide mentoring, hands-on lab experiences, and tutoring while assisting their guardians with social services, job placement, and other resources to engender a holistic working environment. UMB's efforts thus far have resulted in, on average, grades and school attendance improvement, while increasing students' aspirations to pursue STEM careers. Students receive education about healthy life-styles; they also receive home visits and an Emergency Response Plan to help them with complex family issues. Newspaper and TV coverage of this CURE program frequently occurred in 2017/2018. For every successful child in the CURE program, there are 1000 more in Baltimore needing special attention to succeed; as such, UMB has taken on a significant and essential mission.   

Jim Hughes, MBA is the UMB Vice President as well as Director of UM Ventures and Chief Enterprise and Development Officer for UMB.  He commented on this university’s efforts to connect with our public through business development. His office oversees several vital functions of UMB:

*the agreements made between researchers and their corporate partners

*the agreements made between researchers and government funding agencies,

*the many clinical trials conducted on this campus.

*the development of the BioPark and its tenants (some are non-university).

*marketing of University assets

The UMB President and Vice President’s offices oversee much of the Strategic Planning and Community Engagement efforts, and they have the capacity to promote the formation of new companies (for profit as well as non-profits). They have also co-sponsored this Workshop.

References

1) Colizzi V, et al.  Structural transformation to attain responsible biosciences (STARBIOS2) : protocol for a Horizon 2020 funded European multicenter project to promote responsible research and innovation.  JMIR Res Protoc 2019, vol8, e11745. http://www.researchprotocols.org/2019/1/e11745/

2) Graham SP, et al, Theileria parva candidate vaccine antigens recognized by immune bovine cytotoxic T lymphocytes. Proc Natl Acad Sci U S A. 2006 Feb 28;103(9):3286-91. 

3) C Herzog. Successful comeback of the single-dose live oral cholera vaccine CVD 103-HgR.  Travel Med Infect Dis 2016 Jul-Aug; 14(4):373-7. doi: 10.1016/j.tmaid.2016.07.003.