Translational Science by Public Biotechnology Companies in the IPO“Class of 2000”: The Impact of Technological Maturity

Each year our Clinical and Translational Science Award pilot projects program awards approximately $500,000 in translational pilot funding to advance health in South Texas. We identified needs to improve the timeliness, transparency, and efficiency of the review process by surveying applicants. Lean six sigma methodologies, following a “Define, Measure, Analyze, Improve, Control” approach, were used to streamline the pilot project application and review by identifying and removing bottlenecks from process flows. We evaluated the impact of our reorganized review process by surveying applicants and reviewers. Process mapping identified pilot project review as the main source of delay, leading to the implementation of a study section-style review mechanism. After one cycle, 90.3% of pilot applicants and 100% of reviewers were highly satisfied with the new processes and time to award notice was reduced by 2 months. All reviewers familiar with both review processes preferred the study section. We demonstrated how lean six sigma, a methodology not commonly applied in research administration, can be used to evaluate processes in translational science in academic health centers. Through our efforts, we were able to improve timeliness, transparency, and efficiency of the review process.

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2305

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.171 ◽

2017 ◽

Vol 1 (S1) ◽

pp. 47-47

Author(s):

Gayathri Devi ◽

Ranjan Sudan ◽

Stephanie Freel ◽

Laura Fish

Keyword(s):

Focus Groups ◽

Translational Research ◽

Interdisciplinary Approach ◽

Health Care Research ◽

Assessment Tools ◽

Grant Writing ◽

Team Science ◽

Translational Science ◽

Duke University ◽

The Impact

OBJECTIVES/SPECIFIC AIMS: To improve translational research, we have developed a program called Duke Multidisciplinary Education and Research in Translational Sciences (Duke MERITS). Duke MERITS will facilitate cross-disciplinary collaboration among faculty involved in foundational, clinical and/or health care research and in turn also prepare them to train the next generation of translational researchers. METHODS/STUDY POPULATION: The program aims are (1) to define metrics and outcomes measures so faculty can track their progress and identify impact of their collaborative research in translational sciences; (2) to offer a multi-modal faculty development series to promote team science, improve didactic teaching, and incorporate innovative resources to promote interdisciplinary approach to translational research; (3) to provide module-based hands-on-training sessions in bench to bedside research and training in translational grant writing to facilitate the development of multidisciplinary research collaborations. The present study describes results from Aim 1 and includes (a) development of baseline outcome assessment tools necessary to gauge the impact of our programs on both the participating faculty and the research culture within Duke University, (b) impact of a specific course offering in Translational Medicine. In order to achieve this, we conducted multiple focus group sessions with faculty self-identified as junior-, mid-, or advanced-career, a mixed group at any career level and included a group of graduate students and postdoctoral trainees to study the impact of a graduate level course in Translational Aspects of Pathobiology. The activities during these translational science focus groups were designed to define what successful translational science is, to determine what resources support translational Science at Duke, and to decide what resources we need in order to enhance Duke’s position as a leader in research and scientific education. RESULTS/ANTICIPATED RESULTS: We identified that translational science is changing standards while incorporating leadership, teamwork, collaborations, and movement primarily focusing on the overall goal of improving all aspects of health. Participants categorized their field of study and the fields of their coparticipants most frequently as basic discovery and a combination of intervention and health services. The most frequently identified pros/benefits of performing translational science at Duke include industry connections, collaborations with other departments resulting in disciplines being bridged, improving patient care, and access to resources as well as money. The most frequently identified cons/barriers of performing translational science includes the expensiveness, silos, and lack of resources willing to absorb risks. DISCUSSION/SIGNIFICANCE OF IMPACT: The identification of these defined factors from the focus groups has allowed us to issue a comprehensive, sliding Likert scale-based anonymous survey from the secure RedCap system and is being rolled out throughout Duke University, including schools of medicine, nursing, Trinity, biomedical engineering. We envision that Duke MERITS education program will facilitate interprofessional efforts, which we define as a team science approach to identify the clinical “roadblock” and then seek an innovative approach or technology to help overcome this “roadblock”? It can facilitate institutional and departmental recognition in faculty career development. The common goal is to gain fundamental new insights that will result in significant improvement of the existing “standard of care” and meet the challenges of dwindling extramural support.

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Increasing research mentor training among biomedical researchers at Clinical and Translational Science Award hubs: The impact of the facilitator training initiative

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.33 ◽

2018 ◽

Vol 2 (3) ◽

pp. 118-123 ◽

Cited By ~ 3

Author(s):

Jenna Rogers ◽

Christine A. Sorkness ◽

Kimberly Spencer ◽

Christine Pfund

Keyword(s):

Workforce Development ◽

Dissemination And Implementation ◽

Translational Science ◽

Mentor Training ◽

Facilitator Training ◽

University Of Wisconsin ◽

Development Interventions ◽

High Satisfaction ◽

Research Mentor ◽

The Impact

As part of their mission, Clinical and Translational Science Award (CTSA) hubs are charged with developing, testing, and disseminating evidence-based practices to other CTSA hubs. Over the past 7 years, the University of Wisconsin-Madison has answered this charge by implementing the facilitator training (FT) initiative for research mentors. Three elements to advance training across the CTSA hubs have been critical: (1) using an FT model to empower others to build research mentor training at their local institutions; (2) tracking implementation of training events across the CTSA hubs over time; and (3) partnering with implementation sites to build local capacity and evaluate the effectiveness and quality of training. Here we report that facilitators have been trained at 75% of CTSA hubs. These facilitators report high satisfaction with the training and increased confidence in their ability to implement mentor training, and plan to implement local mentor training. These findings demonstrate that the FT initiative can serve as a model for dissemination and implementation of other workforce development interventions across the CTSA hubs.

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Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264617752725 ◽

2018 ◽

Vol 13 (2) ◽

pp. 139-144

Author(s):

Susan Sonne ◽

Stephanie Gentilin ◽

Royce R. Sampson ◽

Leslie Bell ◽

Toni Mauney ◽

...

Keyword(s):

Junior Faculty ◽

Support Service ◽

Institutional Review Board ◽

Translational Science ◽

Research Teams ◽

Institutional Review ◽

Medical University ◽

The Impact ◽

Regulatory Knowledge

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.

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Toward a science of translational science

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.14 ◽

2017 ◽

Vol 1 (4) ◽

pp. 253-255 ◽

Cited By ~ 2

Author(s):

Caleb Smith ◽

Roohi Baveja ◽

Teri Grieb ◽

George A. Mashour

Keyword(s):

Translational Research ◽

Large Scale ◽

Network Science ◽

Systematic Investigation ◽

Industrial Engineering ◽

Translational Science ◽

Exponential Increase ◽

Large Scale Networks ◽

The Impact

Translational research as a discipline has experienced explosive growth over the last decade as evidenced by significant federal investment and the exponential increase in related publications. However, narrow project-focused or process-based measurement approaches have resulted in insufficient techniques to measure the translational progress of institutions or large-scale networks. A shift from traditional industrial engineering approaches to systematic investigation using the techniques of scientometrics and network science will be required to assess the impact of investments in translational research.

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THE PROFITABILITY DETERMINANTS OF THE GLOBAL PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES DURING THE COVID-19 PANDEMIC

DIEM: Dubrovnik International Economic Meeting ◽

10.17818/diem/2021/1.5 ◽

2021 ◽

Vol 6 (1) ◽

pp. 43-54

Author(s):

Boris Tušek ◽

◽

Ana Ježovita ◽

Petra Halar

Keyword(s):

Multinational Corporations ◽

Financial Management ◽

Financial Stability ◽

Panel Data Analysis ◽

Stress Test ◽

Business Environment ◽

Sustainable Operations ◽

The World ◽

Biotechnology Companies ◽

The Impact

In today's chaotic, complex, unpredictable, and extremely dynamic business environment, it is more than ever essential to operate in a way that will ensure sustainable operations and demand for companies’ goods or services. Employing contemporary corporate governance, advanced information technology, and adequate financial management are significant foundations for sustaining high profitability and adequate financial stability as crucial objectives that ensure adding value for companies' owners. Covid-19 is an excellent stress test for every entity, as for micro-companies, so for the largest multinational corporations. Nowadays, in the era of the world Covid-19 pandemic, companies challenge to maintain business operations and going concern assumption. However, in every crisis or adverse situation, some companies take enormous benefits of it. Pharmaceutical and biotechnology companies can be characterized as the major players during this last, still actual crisis. Their role can be observed from two angles, first as a provider of necessary drugs for curing Covid-19 patients and from the other side, as a developer of effective and efficient vaccine which will ‘save the world’ and brought us back to the ‘old normal’. This paper seeks to investigate financial determinants that are the most significant for the profitability of the pharmaceutical and biotechnology companies. The question is how those companies coped with the Covid-19 crisis, and what is the impact on their profitability in 2020 compared to previous operating years? Another question is how is the development of the vaccine financed and are R&D expenses significantly increased in 2020? Therefore, the objective of the paper is to investigate the impact of the Covid-19 crisis on the profitability of global pharmaceutical and biotechnology companies. The research covers 52 entities on the global level for the period from 2010 to 2020. Data will be analysed by applying adequate panel data analysis and moderator regression analysis. Keywords: profitability ratios, pharmaceutical and biotechnology companies, Covid-19

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4015 Evaluation of the Impact of a Clinical and Translational Science Predoctoral Program on Post-Graduate Outcomes

Journal of Clinical and Translational Science ◽

10.1017/cts.2020.212 ◽

2020 ◽

Vol 4 (s1) ◽

pp. 62-62

Author(s):

Alexandra Joelle Greenberg-Worisek ◽

Katherine Cornelius ◽

Becca Gas ◽

Carmen Silvano ◽

Karen Marie Weavers ◽

...

Keyword(s):

Mayo Clinic ◽

Healthcare Delivery ◽

Structured Interview ◽

Professional Organization ◽

Translational Science ◽

Leadership Positions ◽

Making A Difference ◽

Study Population ◽

New Research ◽

The Impact

OBJECTIVES/GOALS: The Mayo Clinic Clinical and Translational Science (CTS) Predoctoral program aims to develop independent researchers capable of leading multi-disciplinary teams to accelerate the translation of discovery to application. Here, we detail the outcomes of our graduates over the past ten years (2010-2019). METHODS/STUDY POPULATION:): A survey was fielded with all CTS graduates whose degrees were conferred since the program’s inception to 2019. Items addressed their current position, whether they were still involved in research, what type of research they were involved in, and whether they stayed involved with education. They also submitted a recent CV, from which data were collected about publications and grants. A subset were then contacted for a semi-structured interview. Items included questions addressing motivation for pursuing a PhD in CTS, whether the program prepared them for their current work, gaps they felt they had in training, and whether they felt they were making a difference in the lives of patients. RESULTS/ANTICIPATED RESULTS: Of the 41 alumni, 34 responded (83% response rate). Of these, 19 (56%) are at Mayo Clinic, 9 (26%) work for other academic institutions, and 6 (21%) do not work for an academic institution. Most have remained in research (33/34, 97%). The majority (22/33, 67%) are involved in clinical research, 30% (10/33) in basic science, and 24% (8/33) in healthcare delivery research. Most (23/34, 68%) are engaged in educational activities. When asked about changes they have led, 67% (18/27) led quality improvement projects and 44% (12/27) designed a new research method. Several hold leadership positions either in their organization (12/16, 75%) or in a professional organization (10/16, 63%). DISCUSSION/SIGNIFICANCE OF IMPACT: The CTS Predoctoral program successfully prepares scholars for careers involving clinical and translational research; furthermore, alumni remain in research-oriented careers after graduation. We will continue to gather longitudinal data alumni move forward in their careers.

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Assessing Participant Group Affiliation and Attitudes Towards CTSI Services

The Qualitative Report ◽

10.46743/2160-3715/2019.3815 ◽

2019 ◽

Author(s):

Linda Behar-Horenstein ◽

Huibin Zhang

Keyword(s):

Mixed Methods ◽

Translational Research ◽

Sentiment Analysis ◽

Frequency Function ◽

Translational Science ◽

Group Affiliation ◽

Survey Question ◽

Participant Group ◽

Participant Perspectives ◽

The Impact

Analyzing open-ended survey text responses holds the capacity to yield greater insight about participants’ perceptions of clinical translational science institute (CTSI) initiatives. Few translational research studies have explored their effectiveness. The aim of this mixed methods analysis was to assess participant perspectives of the impact and effectiveness of our CTSI program and services. We selected two open-ended survey question items (how CTSI benefitted research, and the most important impact of the research facilitated by the CTSI) from a larger set and compared responses by participant affiliations (clinical/non-clinical; lab/non-lab). We used a three-step analysis. First, nodes were generated using NVivo word frequency function. Next, with the aid of Python, we used sentiment analysis to classify each node (as positive, negative, or neutral) to indicate participant ratings toward their experiences with the CTSI and computed the average differences between groups. Third, we selected nodes that met pre-established criteria and report the qualitative distinctions. We recommend using precisely worded open-ended questions in future annual surveys or administering a survey using only opened-ended questions every six months.

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Massacre, Earthquake, Flood

International Perspectives in Psychology Research Practice Consultation ◽

10.1027/2157-3891/a000003 ◽

2021 ◽

Vol 10 (1) ◽

pp. 39-54 ◽

Cited By ~ 1

Author(s):

Julia J. Rucklidge ◽

M. Usman Afzali ◽

Bonnie J. Kaplan ◽

Oindrila Bhattacharya ◽

F. Meredith Blampied ◽

...

Keyword(s):

Clinical Results ◽

Ease Of Use ◽

Translational Science ◽

Post Traumatic Stress ◽

Impact Of Event Scale ◽

Event Scale ◽

Disaster Survivors ◽

Mass Shooting ◽

Clinically Significant ◽

The Impact

Abstract. Natural (e.g., earthquake, flood, wildfires) and human-made (e.g., terrorism, civil strife) disasters are inevitable, can cause extensive disruption, and produce chronic and disabling psychological injuries leading to formal diagnoses (e.g., post-traumatic stress disorder [PTSD]). Following natural disasters of earthquake (Christchurch, Aotearoa/New Zealand, 2010–11) and flood (Calgary, Canada, 2013), controlled research showed statistically and clinically significant reductions in psychological distress for survivors who consumed minerals and vitamins (micronutrients) in the following months. Following a mass shooting in Christchurch (March 15, 2019), where a gunman entered mosques during Friday prayers and killed and injured many people, micronutrients were offered to survivors as a clinical service based on translational science principles and adapted to be culturally appropriate. In this first translational science study in the area of nutrition and disasters, clinical results were reported for 24 clients who completed the Impact of Event Scale – Revised (IES-R), the Depression Anxiety Stress Scales (DASS), and the Modified-Clinical Global Impression (M-CGI-I). The findings clearly replicated prior controlled research. The IES-R Cohen’s d ESs were 1.1 (earthquake), 1.2 (flood), and 1.13 (massacre). Effect sizes (ESs) for the DASS subscales were also consistently positive across all three events. The M-CGI-I identified 58% of the survivors as “responders” (i.e., self-reported as “much” to “very much” improved), in line with those reported in the earthquake (42%) and flood (57%) randomized controlled trials, and PTSD risk reduced from 75% to 17%. Given ease of use and large ESs, this evidence supports the routine use of micronutrients by disaster survivors as part of governmental response.

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Expand the scorecard for health-care reform to achieve a better result and enhance clinical and translational science

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.333 ◽

2018 ◽

Vol 2 (5) ◽

pp. 276-279

Author(s):

Barry S. Coller

Keyword(s):

Health Care ◽

Medical Education ◽

Care Delivery ◽

Universal Coverage ◽

Care Physician ◽

Translational Science ◽

Personnel Decisions ◽

Administrative Costs ◽

Policies And Programs ◽

The Impact

Clinical and translational science is vitally dependent on the nation’s underlying health-care policies and programs. In a reciprocal fashion, data generated by clinical and translational research can inform both health policy and health-care delivery. It is important, therefore, to rate health reform proposals comprehensively on a set of criteria that reflect the broad goals of reform, including the potential impact on clinical and translational science and medical education. I propose that the criteria include achieving universal coverage, reducing administrative costs, retaining one’s chosen primary care physician, encouraging care coordination, empowering physicians, freeing industry from choosing and administering health plans, providing choice of specialists and hospitals, providing patient education, preventing patient overuse of services, rationalizing resource allocation, encouraging competition, limiting government’s role, supporting medical education, training, and research, and freeing industry to make personnel decisions based on business criteria rather than the impact on health-care costs to the company. I discuss the rationale for each element and offer a rating of current proposals relative to a proposal previously made.

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