Translational Research

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Translational Research

The term "translational research" has been used since the early 90s as a result of the lack of research applications in healthcare. Its main objective is to increase health performance in the general population. More information regarding what is translational research is provided below.

History and Definition

  • The term "translational research" first appeared in the early 1990s. This term emerged as a result of considerable increases "in basic or clinical science discoveries" and not many advances in "health care and health outcomes."
  • Translational research came to be because of the long time it takes to bring medical discoveries into practice and the need to transform research into practice more quickly. According to studies, it takes an average of 17 years for 14% of new discoveries to enter clinical practice.
  • The term has been defined differently by scholars and professionals. Despite these variations, in every definition three attributes are highlighted: it adopts a scientific approach, it includes innovative investigation, and it is directed toward improved performance. One example is the definition by nature.com: "Translational research involves the application of knowledge gained through basic research to studies that could support the development of new products."

Objectives

  • Translational research is aimed toward bonding "practical laboratory practices and performance related issues" in the health profession. It has been recently seen as a scientific discipline that bounds basic and clinical science.
  • It adopts a scientific investigation into a given health problem which eventually helps to increase health performance.

Relevance

  • Translational research reduces health disparity (when a proportion of people are unable to get equal medical treatment) as it makes use of realistic approaches for health sector problems and takes into consideration factors such as "income level, educational level, marital status, political affiliation, social status, and economic power."
  • It promotes partnership in research as it uses partnership, often public-private, as a tool for ensuring that relevant stakeholders are involved in the research process, which ensures that the process of investigation is explored by a wide range of different groups of participants and a lasting solution is achieved.
  • Also, it helps research to be patient-oriented as translational research considers the patients’ needs, aspirations and problems in all the research process.

How It Differs from Clinical Research

  • Clinical research involves studying subjects through surveys, health services research, or clinical trials by testing regulated hypotheses in controlled environments. Through it, scientists and physicians are able to find new methods of diagnosis, prevention, and treatment.
  • In the other hand, translational research serves as a bridge between science and practice and, ultimately, patients' needs. It translates research results into strategies for improving healthcare and community health,
  • Additionally, clinical research is usually done at "academic medical centers and their affiliated research sites," while translational research is mostly done at dedicated university science departments and research centers because it requires various sets of skills, tools, and resources that sometimes are not found at a typical laboratory or clinic.

How It Works

  • In translational research, "academia and industry work together" to improve health outcomes. Its success does not depend only on the science and its application, but also on the informatics needed to connect them.
  • Translational research informatics is the bridge between biomedical informatics and translational research and enables researchers to store and analyze their data to make possible the application in the clinic.
  • It involves four phases: translation to humans (find a use for a scientific discovery in human health), translation to clinical settings (understand the value of the potential health use), translation to practice (move evidence-based guidelines into practice), and translation to populations (evaluate the real-world outcomes).
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Translational Research - Current State

The current state of translational research, including facts and figures related to its funding and its applications, is provided in this report. Calculations are outlined below in the Research Strategy section.

Insights on Translational Research

  • Translational research is relatively new and does not have widely accepted credentialing pathways in the United States.
  • Used for applied research: 3.9 percent of publications produced by basic research awards between 2008-2014 were based in translational research, according to a 2018 paper. Comparatively, 7.4 percent of publications for applied research were based in translational research.
  • In 2016, the National Institute of Health allocated $500 million to the Clinical and Translational Science Awards program.
  • In FY2018, the National Institute of Health allocated $1 billion of its overall $36 billion budget to translational research.
  • Of the $1 billion in funding for translational research that National Institute of Health committed in FY2018, most of it went toward researching commonalities underlying medicinal practice as a whole rather than specific diseases.
  • Global adoption: The European Union's Innovative Medicines Initiative has a $6 billion budget, all of which is dedicated toward translational research.
  • Global adoption: Germany began a focused translational research effort in 2010 and has since dedicated $14.74 billion in funds to the program.
  • Global adoption: Australia has declared translational research to be its second-highest priority for the National Health and Medical Research Council, next to investment in research. The council dedicated $586.2 million to translational research in 2016-2017.
  • Global adoption: In the UK, 20 translational research facilities have been established, generating nearly 100 patents and attracting more than $1.5 billion from private charities.
  • Preferred for alcohol research: The National Institute on Alcohol Abuse and Alcoholism specifically identified translational research as being a preferred method for the National Institute of Health in researching alcohol misuse.
  • Increasing number of references: The number of publications referring to translational research has increased from 15,062 in 2014 to 20,718 in 2016.
  • Increasing citations for related journal: The impact factor of the journal Translational Research has increased from approximately 4.0 in 2014 to 4.516 in 2018, according to Clarivate Analytics. The impact factor measures the number of citations received by articles published in the journal.
  • Research center profile: Of the top 10 largest projects funded at Indiana University's School of Medicine in 2017 by the National Institute of Health, three were based in translational research. The amount funded for translational research represented 26.76 percent of total funding.

Research Strategy

The research team began by looking through academic articles on Science Direct pertaining to translational research to find statistics on how often translational research is utilized. Ten articles published between 2009-2018 were found, however, none of them offered statistical information on its frequency of usage.

While a 2018 paper providing a detailed snapshot of translational research was found, the data was for 2008-2014. Newer information could not be located following a search for similar academic articles.

To determine the percentage of funds awarded to Indiana University's School of Medicine for translational research by the National Institute of Health in 2017, the amounts awarded to translational research were added and totaled, as follows:
5.2 + 2.2 + 2.18 = $9.58 million
The total amount awarded to the top 10 projects was then added, as follows:
7.6 + 5.2 + 5 + 4.8 + 2.5 + 2.3 + 2.2 + 2.18 + 2.12 + 1.9 = $35.8 million
The amount received by translational research projects (9.58) was then divided by the total amount received (35.8), as follows:
9.58 / 35.8 = ~0.2676, or 26.76 percent

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Translational Research - Barriers

The complexity of the regulatory processes during the translational phase of the research frustrates and defies scientists. At the same time, the difficulty to reproduce studies due to misleading or wrong information is widely recognized as a problem by academic researchers.

The Complexity of the Regulatory Processes

  • Research evidence is not always the driver of health guidelines. Health guideline methodologists observed that financial constraints, trade-offs between desirable and undesirable outcomes, preferences, and stability of effect are all determinant factors to whether research evidence is transformed into health policy.
  • Stakeholder values and preferences add even more complexity to the landscape. Partisan politics, donations to policy-makers from industries threatened by new regulations, and agendas promoted by interest groups may impact health guidelines and policies.
  • For instance, in 2015, 45 new drugs were approved in the US, while 1.3 million medical papers were published in trade journals during the same period. The National Institute of Health (NIH) estimates that 80% of research projects never reach the clinical trial phase and that only one in every 1000 drugs gains FDA approval.
  • A 2015 study examined numerous papers reporting scientists’ views of the aspects they perceive as hindering the conduct of translational research. The complexity of regulations, the study discovered, is a common issue for researchers. For instance, surveys conducted with senior researchers in the U.S. unveiled that regulatory requirements are particularly challenging for translational research, thus limiting the success of biomedical innovation being translated into benefits for patients."
  • Regulatory processes vary according to the country. There are additional provincial or state requirements in Canada and the USA as well as additional national requirements in countries of the European Union.
  • Even when researchers manage to reach the proper agency, uncertainty still exists regarding the regulations that are in place since documentation often lacks clarity. Some say that the lack of transparency is intentional, as the regulatory policy is performance-based by nature.
  • Interacting with medical authorities and regulatory agencies is challenging by itself due to the organizational complexity of these entities. The information available online is often not user-friendly, time-consuming, and websites are not always updated regularly.
  • For those in the field of stem cell research the challenge is even more prevalent, as stem cell research is yet to be properly defined. "Scientific and technological developments and their accompanying 'imagined futures' therefore created uncertainty on the part of both scientists and regulators as both parties sought to develop and refine interpretations of rules and regulations."
  • Ethical and social implications add an extra layer of complexity, as exemplified by scientists working on stem cells as potential therapy for leukemia and diabetes, who reported making a deliberate effort to follow the strict regulatory processes to ensure acceptance and legitimacy of their research. They argue that public attention to the ethical and social implications of stem cell research breakthroughs would limit the "move from bench to bedside."
  • The public scrutiny often carries weight when it comes to scientific breakthroughs. In the stem cell field, legislators place tighter restrictions on specific stem cell therapies in favor of less controversial treatments, regardless of the outcomes for patients. The biopharmaceutical industry is focusing on drugs that are more likely to succeed in the regulatory approvals now than it was before.

What is being done to overcome the barrier

  • Many international harmonization initiatives are trying to reduce the burden of regulation on researchers, such as the International Pharmaceutical Regulator's Forum Cell Therapy Group, International Council on Harmonization (ICH), International Pharmaceutical Regulator's Forum Gene Therapy Group, Pharmaceutical Inspection Cooperation Scheme (PIC/s), and Regional Cooperation Council (RCC).
  • The academic community is also pushing for national databases containing the clinical data that is used to support the approval of drug or medical device applications. Health Canada, for example, is considering policy changes to make this information publicly available.
  • Some institutions are increasing their efforts to navigate the regulatory difficulties by implementing project management and project leadership to address scientific and regulatory issues. The NIH and other organizations are supporting these multidisciplinary, translational teams.
  • Furthermore, academic institutions, such as Penn State Clinical and Translational Science Institute, are hiring regulatory impact leaders to support policy-relevant research and foster its translation between researchers and regulators.

Reproducibility

  • The quality of research is related to the quality of the input data and the methods for processing and interpretation. Unfortunately, most research findings cannot be replicated. Even those that are successfully replicated often have no immediate impact or utility.
  • Research suggests that several published researches in the biomedical field are "misleading, not as robust as they claim, or cannot be reproduced." For that reason, the reproducibility of findings and their translatability to human studies is widely acknowledged as an issue by the industry and academic researchers.
  • A survey conducted by the journal Nature reported that 90% of respondents believe there is a slight or significant reproducibility crisis in science. Between 40% to 70% agreed that fraud, selective reporting, and pressure to publish contribute to irreproducible research.
  • Simple divergences such as type of coating tubes, how cells are stirred in culture, what temperature cells are grown, or subtle pH differences can result in complete failure to replicate the results.
  • Methodological flaws and poor experimental designs in preclinical "in nitro" and "in vivo" animal studies can lead to the inefficiency of the translational research, as they may lead to systematic bias, which in turn leads to irreproducible and unreliable data and inaccurate conclusions.

What is being done to overcome the barrier

  • Scientists are more mindful of the importance of open and transparent science now than they were before. A recent study discovered promising improvements in transparency and openness in biomedical research.
  • Dr. John Ioannidis, professor of medicine, health research and policy, biomedical data science and statistics at Stanford University, explains that there is still much room for improvement in terms of transparency and reproducibility for the average paper. However, there were many advancements in the last few years.
  • Initiatives such as the Brazilian Reproducibility Initiative are emerging to address this issue by conducting systematic and multicenter efforts to repeat experiments.
  • The NIH revised application instructions and strengthened review criteria to improve reproducibility through increased scientific rigor and transparency in grant applications and publications in 2016.
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Translational Research - Barriers 2

Patient recruitment for translational research, as well as sample collection from human research subjects, poses a challenge to translational research. Additionally, translation researchers face operational barriers, including not having enough equipment and skills to undertake research.

PATIENT RECRUITMENT AND SAMPLE COLLECTION CHALLENGES

  • The recruitment of human research subjects for translational research is a key challenge to implementing clinical studies. About 34% of clinical scientists in a study identified the recruitment of research participants as a significant barrier to translational research.
  • Most clinical studies rely on animal studies before conducting human trials. Researchers prefer animal studies because obtaining tissue samples from animals is far easier than regularly acquiring tissue samples from humans. Additionally, sample collection methods used in animal trials may not be applicable in human trials.
  • Challenges surrounding human trials in translational research, including patient recruitment and sample collection, increases the research risk profile. It results in human trials being longer and more expensive than animal studies. Overall, it culminates in a reduced success rate of translational research.

What is being done to overcome the barrier

INSUFFICIENT RESEARCH SKILLS AND EQUIPMENT

  • Clinical scientists identify that deficiencies in research skills and access to equipment impends their capacity to undertake translational research. Additionally, translational research requires access to information technology systems for monitoring the research process.
  • Demanding clinical roles reduce the time available for researchers to undertake training for translation research. Such training often turns out to be too time-intensive and reduces the available time to undertake translational research.
  • Under-investment by universities, research institutions, and the government for research equipment and training of researchers has significantly curtailed the success of translational research. It has also reduced the growth of translational research culture across universities and research institutions.

What is being done to overcome the barrier

  • Translational researchers are actively seeking grants that offer the provision of research equipment within translational research funding. Stellenbosch University allocates translational research three grants that have research equipment funding, including the Faculty of Medicine and Health Sciences Strategic Equipment Fund and National Research Foundation Research Infrastructure Support Programme. Additionally, translational researchers are promoting the use of research equipment with functional uses across both translational research and regular lab work.
  • Duke University actively promotes the importance and benefits of translational research in advancing health care through the establishment of clinical and translational science enterprise to steer leadership and management of translational research. The organizational framework guides the support for allocating translational researchers training opportunities and equipment to cover translational research efforts.
  • Duke University has implemented a project leader model for translational research to improve the project management outcomes of translational research projects. Particularly, the project leader model creates opportunities for clinical scientists to be trained in translational research.

Research Strategy

While most of the research was straightforward, one of the sources we included in this brief was published in the year 2016, which is outside of the Wonder 24-month time frame. After searching through multiple reports, articles, research notes, etc. from credible sources, including the National Center for Biotechnology Information (NCBI), the University of North Carolina School of Medicine, and Researchgate, among others. After an exhaustive search, we found the 2016 report from the NCBI centered around the optimization of translational research, which contained useful information that was relevant to the topic of this request. It identifies numerous barriers to translational research, many of which were mentioned due to surveys/studies involving medical institution research leaders and various scientists.

Though the information was compiled in 2016, we decided to include this report as a source as we believed the data to have remained relevant to this date, and no other, more recent studies that we came across provided updated information.
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Translational Research 1

The only major supporter of translational research that seeks to reclaim abandoned research and bring it to market is the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. Through its programs and grant awards since 2012, NIH has stimulated academic institutions and hospitals to revisit abandoned research and drug trials, encouraged several dozen graduate schools to offer degree programs in translational medical research, and influenced the production of numerous research publications and conferences.

The National Institutes of Health (NIH)

  • In 2011, NIH established The Learning Collaborative. This organization was a collaboration among three programs: (1) the NIH Chemical Genomics Center (NCGC) and its Therapeutics for Rare and Neglected Diseases (TRND) program, (2) The Leukemia & Lymphoma Society (LLS), and (3) the University of Kansas Cancer Center (KUCC), whose purpose was "to discover and develop new drug therapies for rare blood cancers." No current information on The Learning Collaborative was found.
  • NIH established the National Center for Advancing Translational Sciences (NCATS) in 2011 to catalyze "technological and paradigmatic advances" in academia. The National NCATS was "the newest of 27 Institutes and Centers (ICs)" at the National Institutes of Health (NIH).
  • NCATS was expected to develop partnerships with nonprofits, biotechnological and pharmaceutical industries, government, and universities to advance translational science.
  • NCATS awarded about 250 grants per year between 2012 and 2017 in Clinical and Translational Science. The year 2017 is the most recent year for which grant information is available at the NCATs website, but more is available here.
  • NCATS's budget for fiscal 2019 was nearly $560 million.
  • More information on NCATs is available here.

Examples of Graduate School Degree Offerings in Translational Research

  • Harvard University Medical School developed a "Master of Medical Sciences in Clinical Investigation degree" to provide "world-class training in the methods and conduct of clinical discovery for future leaders in patient-oriented and translational research. This two-year program, which requires students to reside in Boston for its duration, combines innovative forms of pedagogy from leading Harvard faculty with an individual mentored research experience."
  • The University of Pennsylvania Perelman School of Medicine offers a Master of Science in Translational Research.
  • New York University Grossman Medical School's Clinical and Translational Science Institute "offers a variety of master’s-level science programs for students ... who are interested in pursuing translational and clinical research."

Universities and University Hospitals in Translational Research

  • Mayo Clinic and about 60 other academic institutions have obtained NCATS, NIH, and Center for Translational Science (CTSA) Award funding.
  • The University of Kansas Medical Center developed a drug discovery and development program with its NCATS and CTSA Award grant. The program is called "Frontiers: University of Kansas Clinical and Translational Science Institute. One of its components, the Institute for Advancing Medical Innovation (IAMI), works with academic investigators to conduct product development–focused translational research."

Publication of Translational Research Results

Research Strategy
We were unable to describe the success of efforts to reclaim abandoned translational research and bring it to market so far because the vast amounts of data are scattered in numerous reports within NIH, in professional journals, in nonprofit annual reports, in conference proceedings, and other locations. More than 1,500 grants have been awarded by NCATS for research and training in reclaiming translational research since 2012. More than 60 universities and university-affiliated hospitals are involved in this type of research. No single compilation of successful efforts has been published. It might be possible to gather a set of data about successful reclaiming of abandoned research on a single disease, such as Parkinson's disease, if desired.
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Translational Research 2

Examples of efforts that are used to advocate for an increase in U.S. federal funding for applied biomedical Research and Development (R&D) include federal legislation such as the 21st Century Cures Act and advocacy organizations such as the Federation of American Societies for Experimental Bodies (FASEB) and the Graduate Student Organization (GSO). An overview of the research findings follows below.

The National Institute of Health (NIH)

  • For the purpose of research, the NIH was considered as one of the main organization in the United States that takes part in applied biomedical research.
  • This is because one of NIH's main objective is to "ensure the future of U.S. competitiveness and innovation in biomedical research."
  • One of the goals of the NIH is to "foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health"
  • Consequently, the efforts to advocate for an increase in funding for government agencies that are involved in biomedical research such as the NIH were considered in research.
  • Over the last three years, Congress has been increasing the NIH budget as a result of federal legislation and advocacy. In the 2016/2017 financial year, NIH's funding was increased by $2 billion while in the 2018 financial year, the funding was increased by $3 billion.

Federal Legislation

  • A major strategy for advocating for an increase in federal funding for applied biomedical R&D is the use of legislation.
  • The 21st Century Cures Act, which was passed in December 2016 was used to advocate for an increase in federal funding for biomedical research.
  • Consequently, the NIH received a 6.2% increase in funding to $34 billion as a result of additional funds that came to the NIH because of the act.
  • Specifically, $352 million was provided under the 21st Century Cures Act as a measure to boost biomedical innovation through research and development.
  • After incorporating the funds that were provided for the 21st Century Cures Act, the NIH's base budget increased by $1.6 billion.
  • The law also "established an NIH Innovation Account that authorized $4.796 billion to fund several large projects over the next 10 years."
  • The funded projects, which included the Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Cancer Moonshot Initiative, and clinical research in regenerative medicine are all involved in research within the applied biomedical space.

Advocacy Organizations

  • Another major effort in advocating for an increase in federal funding for applied biomedical R&D is by advocacy organizations.
  • In 2019, the leadership of Stony Brook University's Graduate Student Organization (GSO) met with congressional staff to advocate for increased funding for scientific research and the creation of policies to support green technologies.
  • GSO's President, Xiaoqing Zhang noted that "it is crucial that students and researchers urge Congress to increase federal funding for major science agencies including the National Science Foundation, Department of Energy, Department of Defense, and National Institutes of Health." This is because robust, long-term investments in scientific research ensures researchers across the United States can work to grow the economy, discover new life saving treatments, and secure the country.
  • Another organization that advocates for an increase in funding for applied biomedical research is the Federation of American Societies for Experimental Bodies (FASEB).
  • FASEB's mission statement is to "advance health and well-being by promoting research and education in biological and biomedical sciences through collaborative advocacy and service to our societies and their members."
  • FASEB recently put out a new advocacy resource titled the Value of Federally Funded Biological Research. The slide deck shows how biomedical research improves the health, quality of life and the economy of the United States.
  • The slide deck encourages Americans to be advocates for biomedical research by contacting their members of Congress and asking them to support increases to federal research budgets, writing a letter to local newspapers, tweeting about science funding, and volunteering at a local science museum.
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Translational Research 3

Partnerships in translational research include health practitioners, private individuals, government entities, and non-governmental agencies. The new thinking around potential public-private coalitions or partnerships in translational research is that it can help reform existing drug development, bridge the translational gap, increase access to resources, and expand the pre-competitive field.

Reforming Existing Drug Development

Bridging the Translational Gap

Access to Resources

Expansion of Pre-Competitive Field

Research Strategy

The research team consulted published journals, trusted online articles, websites, health reports, and blogs to find information about the new ideologies around potential public-private (or nonprofit) coalitions or partnerships in translational research. An element was considered a new ideology if it is currently changing the view on partnerships in translational research. From these resources, reforming existing drug development, bridging the translational gap, increasing access to resources, and expanding the pre-competitive field are among the new thoughts regarding potential public-private coalitions or partnerships in translational research.



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Translational Research 4

Four conferences that are addressing the subject of translational research include the 13th UK Neuromuscular Translational Research Conference, Translational Science 2020, International Sarcopenia Translational Research Conference, and the 5th Translational Research Conference: Multiple Myeloma. Two prominent media outlets that are addressing the subject of translational research include the American Association for the Advancement of Science (AAAS) and Brown University.

CONFERENCES

1. UK Neuromuscular Translational Research Conference 2020

  • The 13th UK Neuromuscular Translational Research Conference is scheduled to be hosted on 22 and 23rd April 2020 in London, United Kingdom.
  • According to the website, the conference is "designed to engage neuromuscular clinicians and scientists, and showcases the best and latest developments in neuromuscular science, and highlights their translation into patient benefit."
  • The full program for the conference can be found here.

2. Translational Science 2020

  • Translational Science 2020 is an international conference hosted in Washington, DC, on April 14-17, 2020.
  • The conference is hosted by the Association for Clinical and Translational Science, and is focused on education over 1,100 trainees, researchers and federal officers on the latest developments in translational science.

3. International Sarcopenia Translational Research Conference

  • The International Sarcopenia Translational Research Conference is scheduled to be hosted in Newcastle-Upon-Tyne, United Kingdom, on 11 – 12 June 2020.
  • The conference will be focused on sarcopenia as a growing area of clinical and research activity, with translational research being the key to the research activity: "Great strides are being made in our scientific understanding of sarcopenia and muscle health, and the challenge now is to translate these advances into better care and better treatments for older people."

4. 5th Translational Research Conference: Multiple Myeloma

  • The 5th Translational Research Conference: Multiple Myeloma will be hosted between October 09 and October 11, 2020, in Mandelieu-La Napoule, France.
  • The conference will be focusing on update on the pathophysiology of myeloma and how the disease is evolving from MGUS and SMM, update on the diagnostic criteria and the use of new assessments in the diagnostic process, treatment of young myeloma patients, treatment of elderly and frail myeloma patients, optimal sequencing at the relapse, the role of new immunotherapic approaches and how will they fit in the landscape, the role of novel drugs under development, and latest updates in other plasma cell disorders beyond myeloma.

MEDIA OUTLETS

1. American Association for the Advancement of Science (AAAS)

  • The American Association for the Advancement of Science (AAAS) operates a news alert website called Eureka that delivers news on different scientific topics, including translational research.
  • The most recent topic the outlet reported on was that NIH provided $23 million for statewide translational research institute.

2. Brown University News

  • Brown University operates an online news website regarding scientific research, and has a dedicated page of translational research.
  • The page gives information into the newest publications, courses, seminars, and ideas put forward in the field, including the most recently published article titled "Big Data, Small State: RI Database Offers the Potential for Efficient, Improved Healthcare".
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Translational Research - Key Players

The National Center for Advancing Translational Science, the U.S. Food and Drug Administration's Office of Translational Science, The Translational Institute for Space Health, The Division of Translational Research, and the Initiative for Translational Research are five key U.S. government agencies that support translational research. The five agencies focus either on a specific health issue/disease or on developing innovations to help accelerate different phases of the translational science process.

The National Center for Advancing Translational Science

  • The National Center for Advancing Translational Science (NCATS) is one of the 27 divisions of the government agency, the National Institutes of Health (NIH).
  • NCATS doesn't focus on a specific disease or health problem, but rather the entire process of translational research; the goal is to catalyze innovative approaches to various steps in the process, such as target validation (provide confidence that the correct molecular target has been identified as the cause of disease), that helps treatments get to patients faster.
  • NCATS identifies bottlenecks in the translational science process with the goal of either removing, reducing or bypassing them altogether.
  • The center offers funding opportunities, including a small business program that works with start-ups trying to develop technologies or methods for overcoming bottlenecks in translational research.
  • Also, crucial to NCATS work is to provide funding to translational researchers working on diseases where significant gaps exist between understanding the molecular pathways of illness and finding treatments for those illnesses.
  • In addition, the NCATS provides expertise, education, and training (including software tools) to help translational research teams.

The Office of Translational Sciences

  • The Office of Translational Sciences (OTS) is housed in the U.S. Food and Drug Administration (FDA).
  • The OTS primarily supports translational medical research for the consumer watchdog, the Center for Drug Evaluation and Research (CDER). In particular, OTS focuses on innovations in the area of regulation of drug development (e.g., testing efficacy, quality, and performance) to speeding up drug development.
  • The office created the Critical Path Initiative, which focuses on finding more modern scientific and research tools, as well as productively using information technology and data, to help one part of the translational research process move faster, namely, the regulatory aspect.
  • OTS has also spearheaded the Critical Path Innovation Meetings (CPIM) that regularly convenes meetings of scientists, industry, patient-advocacy and government agencies to collaborate around improving the efficiency and success rates of drug development. Among issues discussed are biomarkers for disease, computer-based predictive models, and new clinical evaluation techniques.

The Translational Research Institute for Space Health

  • The Translational Research Institute for Space Health (TRISH) is a branch of the National Aeronautics and Space Administration (NASA).
  • TRISH focuses on discovering, and funding discoveries of, innovative and disruptive treatments, technologies, and preventive therapies to address health risks, human performance issues, or health problems resulting from space travel. In other words, TRISH specializes in translational research for space medicine.

Division of Translational Research

  • The Division of Translational Research (DTR) is a branch of the National Institutes of Mental Health (NIMH).
  • The DTR specializes in translating neuroscientific and molecular knowledge into understanding the etiology, neurochemical basis, and trajectory of mental disorders.
  • The division is actively engaged in a variety of translational research projects, including identifying the neural networks involved in psychopathology, looking for ways to ameliorate negative side-effects of current psychiatric medications and determine the specific mechanisms affected by pharmacological treatments of mental disorders.
  • The DTR/NIMH provides both a Small Business Innovation Research (SBIR) Program and Small Business Technology Transfer (STTR) Program for those start-ups or small companies working on child psychopathology.
  • Similar SBIR and STTR programs are offered to support translational research into adult psychopathology.

Initiative for Translational Discoveries

  • The Initiative for Translational Discoveries focuses on using machine learning to better identify promising basic, scientific studies that should be explored for human applications in the treatment of disease.
  • The focus of this initiative is on the early stages of the translational research process, namely, more efficiently mining databases of studies with potential application to treating disease; much translational research is hindered by the consuming process of identifying promising studies, hence using machine learning technologies, the goal is to accelerate this step.
  • In addition, the Initiative for Translational Discoveries utilizes other HHS initiatives to spark innovation in this- particular translational research project-and other priorities for public health. For example, HHS created the Ignite Accelerator Project, which draws on entrepreneurial practices and coaching.
  • One translational research project benefiting from the Ignite Accelerator Project is the "Web-based Knowledge Integration System of the U.S. Clinical and Translational Science Enterprise to Support Public Health Response Coordination."


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Translational Research - Key Players 1

The most impactful nonprofit institutions in the field of translational research are Oregon Clinical and Translational Research Institute (US), Translational Research Institute (Australia) and Eureka Institute for Translational Medicine (Singapore). All these institutions value research collaboration in their efforts to promote translational research.

1. Oregon Clinical and Translational Research Institute


2. The Translational Research Institute

  • The Translational Research Institute (TRI) is a nonprofit medical institute in Brisbane, Australia.
  • TRI promotes medical research and aims to contribute positively to the society.
  • Their work involves patients, clinicians, and researchers collaborating to address health issues promptly.
  • The needs of patients are very important at TRI. Scientists work together to produce better solutions for patients and transfer knowledge. Medical collaborations promote better communication and reduces the need for long written reports which can be difficult to read. Other benefits include measurable outcomes and better monitoring.
  • TRI has several translational research projects in progress which include HPV vaccine, breast cancer spectroscopy and theranostic prostate cancer research.


3. Eureka Institute for Translational Medicine

  • Eureka Institute for Translational Medicine (Eureka) is a nonprofit medical organization based in Singapore.
  • The goals of Eureka include promoting translational medicine and strengthening translational research.
  • One of the chief goals of Eureka is to develop a research community of medicine professionals who can produce valuable medical discoveries.
  • Eureka aims to achieve this goal by providing educational lessons which includes certificate courses and workshops.
  • The certificate course has been a success because 240 researchers from various countries have finished the programme.
  • Eureka plans to form a network of alumni who will further educate others.

Research Strategy

To determine the major nonprofit institutions, we examined the top 45 academic journals (based on impact factors) on translational research. We looked for highly cited papers and authors’ affiliations. The academic databases used were Springer, Elsevier, Wiley and Oxford University Press. Many authors were affiliated with universities only. However, we found that OCTRI, TRI and Eureka were the most common nonprofit organizations appearing as affiliates on the research papers. In addition, we considered the websites of the above-mentioned institutions and examined their annual reports, visions, missions and blogs. The following web sources were important in finding additional information, San Diego School of Medicine, Business wire and Thermo Fisher Scientific.

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Part
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Translational Research - Key Players 2

Translational research transforms scientific discoveries found in the laboratory into ways to prevent, diagnosis or treat disease. Three academic institutions and/or academic coalitions supporting translational research are The Duke Clinical and Translational Science Institute (CTSI), The Clinical and Translational Science Center at UC Davis Health, and The Harvard Catalyst at Harvard University. Details surrounding what they are, and what they are doing in support of translational research, are detailed below.

The Duke Clinical and Translational Science Institute (CTSI)

  • The CTSI is part of Duke University School of Medicine which is ranked eighth both in research and in primary care among all medical schools in the United States, according to new U.S. News & World Report rankings.
  • Not only is Duke University School of Medicine home to the Duke Clinical Research Institute, the world's largest academic clinical research organization, it houses one of the first and most prominent Clinical and Translational Science Award (CTSA) sites.
  • The Duke Clinical and Translational Science Institute (CTSI) is an academic hub for accelerating the translation and implementation of scientific discoveries into health benefits for patients and communities.
  • According to their website, The Duke Clinical and Translational Science Institute (CTSI) makes the research process faster and easier by connecting Duke investigators to funding, project management, datasets, and other critical resources to move their ideas from the lab to the real world.
  • Their experts provide guidance and specialized knowledge at all stages of the research process, linking potential collaborators, facilitating studies and clinical trials, and navigating the administrative and regulatory landscape.
  • They also provide researchers with a variety of workforce development and early career programs.
  • Duke Clinical & Translational Science Institute and BioLabs North Carolina have awarded the first ever Duke Golden Ticket to Dr. Eric Benner to advance a novel therapy for infant brain injuries. Previously, Duke CTSI Accelerator supported this research with its Translational Accelerator Funding Award and by providing project management through its team of Project Leaders.
  • With support from the NIH Clinical and Translational Science Award and Duke Health, CTSI accelerates real-world translational research at Duke with funding, innovative resources, and nationwide collaborations.
  • "Dr. Donald Lo of Duke and Dr. Al Baldwin of the University of North Carolina used support from the Clinical and Translational Science Award (CTSA) to collaborate on a new approach for growing and characterizing human brain tumors in a lab, producing insights that could help fight recurrence of tumors in patients."

The Clinical and Translational Science Center at UC Davis Health

  • The University of California, Davis's is ranked, according to the 2020 edition of Best Colleges in National Universities, 39th in the United States. Further, The University of California, Davis, School of Veterinary Medicine is, for the fifth year in a row, ranked number one in the United States according to the annual 2019 QS World University subject rankings.
  • The UC Davis School of Veterinary Medicine leads scientific studies, provides clinical services and trains the next generation of veterinary doctors to cross boundaries for timely solutions. View their approach to translational research medicine here.
  • The Clinical and Translational Science Center at UC Davis Health offers a full-fledged toolbox of resources that faculty and staff across the spectrum of scientific research can use to improve health and health care delivery.
  • "Physicians and veterinarians have already teamed up at UC Davis to fight cancer, treat facial disorders and alleviate pain. These promising starts improve quality of life for patients now and lay a foundation for more collaboration and innovation to come."
  • According to their website, the CTSC at UC Davis Health "serves as a catalyst to support biomedical research projects by providing services and resources to investigators, staff, scholars and trainees, and community partners."
  • "As an honest and resourceful broker, the CTSC partners with UC Davis schools and colleges engaged in life science and translational research to support collaborative projects with the potential to improve health care."
  • All under one roof, the CTSC administers resources committed to promoting biomedical research through "innovation, collaboration, and expertise." Aided by its programs and resources, the UC Davis CTSC provides the necessary infrastructure for establishing research teams of the future to improve human health.
  • According to their website, the CTSC's research activities span a broad spectrum beginning with basic laboratory research into the mechanisms of disease and extending into correlative research that examines laboratory observations alongside clinical observations, clinical trials of new therapies, and research looking at the health of populations.

The Harvard Catalyst at Harvard University

  • The Harvard Catalyst is part of Harvard University, which is ranked, according to the 2020 edition of Best Colleges in National Universities, 2nd.
  • According to their website, The Harvard Catalyst works with "Harvard University’s schools and affiliate academic healthcare centers to build and grow an environment focused on team science, where discoveries are rapidly and efficiently translated to improve human health."
  • They "catalyze research across all clinical and translational domains by providing investigators with opportunities such as pilot funding, free resources such as biostatistics consultations, training and mentoring programs, and numerous courses."
  • "Founded in 2008 by principal investigator Lee Nadler, MD, the center is a shared enterprise of Harvard University and is funded by the NIH National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards Program."
  • Harvard Catalyst also receives support from Harvard University, Harvard Medical School, Harvard T.H. Chan School of Public Health, Dana-Farber Cancer Institute, Boston Children’s Hospital, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and Massachusetts General Hospital.
  • Supporting a diverse clinical and translational research workforce is a top priority for Harvard Catalyst through its governance, programming, training, and resource allocation.
  • Harvard Catalyst is committed to partnering with departments and divisions to provide education, core resources, project management, mentorship committees, grant training, and support for protected time.
  • The Translational Innovator leverages partnerships and collaborations within and outside of Harvard to evaluate, and ultimately improve, the conduct of research.
  • Harvard Catalyst has, for the past ten years, offered a three-week summer program to help ease the transition for biomedical scientists as they return to the laboratory as translational research fellows. Every summer, Models of Disease Boot Camp "features updates on advances in biomedical science, lectures by prominent scientists about their discoveries, and panel discussions on topics ranging from academic-industry interactions to strategies for translational research."
  • Harvard Catalyst awarded pilot funding for five projects that investigate the role of the microbiome in human disease.
Part
12
of twelve
Part
12

Translational Research - Funding

Several institutions provide funding for translational research. This includes the Innovative Medicines Initiative (IMI), the Clinical and Translational Science Awards (CTSA), and the UK Research and Innovation (UKRI) Medical Research Council (MRC).

There are also several academic journals publishing specifically about translational research. These include Science Translational Medicine, Translational Medicine, and the American Journal of Translational Research.

Major Funders of Translational Research

  • The Innovative Medicines Initiative (IMI) is the world's largest public-private partnership focusing on translational research. For 2019, the total budget of the IMI was ‎€585 million. This includes both commitment and payment appropriations. These appropriations are both from public and private organizations.
  • The Medical Research Council (MRC) is part of the UK Research Innovation (UKRI) agency that focuses on funding scientific research and innovation. As of 2017-2018, the MRC had a budget of £814.1 million. This had a £58.6 million increase from the previous year. From this budget, £380.2 million went to research grants and £150 million was allocated to MRC's internal research programs.
  • Funded by Germany's federal government, the Health Research Framework Programme is under the Federal Ministry of Education and Research. As of 2018, the Health Research Framework Programme has allocated €1.75 billion in translational research funding.

Translational Research Journals

Research Strategy

  • We computed the total budget of the IMI by adding the commitment appropriations (€387,573,739 and €197,930,919). €387,573,739 + €197,930,919 = €585,504,658.
  • We computed the budget increase for the UKRI MRC by deducting the budget of the previous year (£755.5 million) from the current year (£814.1 million.) £814.1 million - £755.5 million = £58.6 million.

Sources
Sources

From Part 02
Quotes
  • "Translational research is a bidirectional process that involves multidisciplinary integration among basic, clinical, practice, population, and policy-based research."
Quotes
  • "As a relatively new research discipline, translational research does not yet have any widely-accepted credentialing pathways beyond the degrees and certificates available at higher education institutions."
Quotes
  • "We found that 3.9% of publications produced by basic research awards were translational; that the percent of translational research publications produced by applied research awards is approximately double that of basic research awards (7.4%); and that targeted translational research awards from the CTSA program produced the highest percentage of translational research publications (13.4%)."
  • "Translational research continues to be a priority for NIH and in fiscal year 2016, NIH allocated $500 million to the CTSA program [19]."
Quotes
  • "Impact Factor based on 5 years of history."
Quotes
  • "Translational Research (formerly The Journal of Laboratory and Clinical Medicine) delivers original investigations in the broad fields of laboratory, clinical, and public health research."
Quotes
  • "Read on to see which research projects and initiatives were awarded the largest NIH grant awards of the year."
Quotes
  • "Translational research is the process of turning observations made in the laboratory, clinic, and community into interventions that improve health—from diagnostics and therapeutics to medical procedures and behavior change.3 Although translational research has long been a goal of the National Institutes of Health (NIH), in recent years, NIH has expanded its focus on this research area."
Quotes
  • "A nonsystematic search with the term “TR” in PubMed shows that the term came in biomedical journals around 1950 and grew exponentially from about the year 2000 onward [Figure 1]."
Quotes
  • "Basic science has significant public funding in the U.S. – NIH’s FY2018 budget was over $36 billion, with a large percentage of this dedicated to basic science – but total public funding for all aspects of translational research – including support functions – in the same year totaled less than $1 billion."
Quotes
  • "Similarly, the UK National Institute for Health Research has invested in 20 translational research facilities, with the new NIHR Imperial Biomedical Research Centre recently announced (https://imperialbrc.nihr.ac.uk/); such investments have produced nearly 100 patents, quadrupled intellectual property revenue of £120 million and attracted over £1.5 billion in funding from private charities1."
From Part 03
From Part 05
Quotes
  • "In January 2011, Secretary Sebelius further called for strategic partnerships between industry, government, academia and non-profit organizations to build “a stronger foundation for a new century of treatments and cures.”(4) Responding to this challenge, three organizations with forward-thinking strategies and unique respective drug repurposing experiences established The Learning Collaborative to advance therapies for blood cancers more efficiently than any of the component organizations could do alone. This collaboration represents the future in cancer drug development—a team effort that brings together unparalleled strengths in the various disciplines needed to advance a treatment from the laboratory to regulatory approval as rapidly as possible."
  • "The Learning Collaborative is a dedicated collaboration between the NIH Chemical Genomics Center (NCGC) and its Therapeutics for Rare and Neglected Diseases (TRND) program, The Leukemia & Lymphoma Society (LLS), and KUCC to discover and develop new drug therapies for rare blood cancers. Specifically, The Learning Collaborative combines the disease expertise and network of the LLS, the cancer drug repurposing and drug development expertise of the KUCC, and the drug discovery expertise of the NCGC to create a pipeline of new therapies to treat blood cancers using less traditional forms of drug discovery and development."
  • "the new National Center for Advancing Translational Sciences (NCATS) at NIH is envisioned as catalyzing just such technological and paradigmatic advances in the academic sector (6)."
  • "Members of The Learning Collaborative continue to explore solutions to barriers that include addressing regulatory science issues (with particular focus on repurposing off patent and abandoned drugs for rare and neglected diseases) and defining exclusivity path(s) to interest future for-profit partners. The Learning Collaborative is currently evaluating and selecting additional blood cancer drug discovery and development projects. Additional projects will employ drug discovery and drug repurposing strategies. Projects are being identified based on research conducted by the three collaborating organizations as well as research conducted by other academic institutions."
  • "A particular development challenge exists in repurposing off-patent drugs for rare cancers: regulatory approval often requires expensive and complex clinical trials, but limited returns on investment make it difficult to attract private sector financing and expertise. New paths to exclusivity and pricing/reimbursement strategies are needed to promote private sector engagement. In addition, it will be critical to create innovative public policy solutions that incentivize repurposing off patent drugs for rare cancers—particularly for small biotechnology companies, which may find opportunities in lower-margin and small (but well-defined) markets attractive."
Quotes
  • "Who is translating science into cures? National Institutes of Health. NIH has made tremendous progress, within its existing structures and with limited funding, toward promoting translational research with the creation of the National Center for Advancing Translational Sciences (NCATS) in December 2011. NCATS provides our nation with an opportunity to forge a new paradigm for translational research that involves government, academia, industry, philanthropy, and patient advocacy groups. The Center convenes expert teams from diverse scientific disciplines to reduce, remove or bypass significant bottlenecks across the entire continuum of translation. NCATS is intended to complement, not compete with, the private sector."
  • "Additionally, NCATS’ Clinical and Translational Science Awards (CTSA) program seeks to strengthen the full spectrum of translational research. Currently, approximately 60 medical research institutions in 30 states and the District of Columbia are active members of the CTSA Consortium."
  • "Nonprofits. Forward‐thinking philanthropic funders of disease research– foundations such as the Michael J. Fox Foundation for Parkinson’s Research, the Cystic Fibrosis Foundation, and a growing number of others–can play an absolutely critical role in stimulating research in under‐resourced disease areas, and helping to bridge the Valley of Death."
  • "Biotechnology and pharmaceutical industries. Within the pharmaceutical industry, the realization i s sinking in that the productivity gap i s unsustainable and that the blockbuster model of drug development can no longer be relied upon. Experts are advocating for a “quick win, fast fail”paradigm for drug development that would result in earlier proofs‐of‐concept and fe wer therapeutic candidates advancing into Phases II and III. Companies are also demonstrating themselves to be interested in new and more partnerships with other funders, including government, universities, and nonprofits–and even with other companies."
  • "The National Center for Advancing Translational Sciences (NCATS) is the newest of 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). NCATS was established in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster."
Quotes
  • "Harvard Medical School’s Master of Medical Sciences in Clinical Investigation degree provides world-class training in the methods and conduct of clinical discovery for future leaders in patient-oriented and translational research. This two-year program, which requires students to reside in Boston for its duration, combines innovative forms of pedagogy from leading Harvard faculty with an individual mentored research experience. To complement individual learning and development, the program provides students the choice of a Clinical Investigation or a Translational Investigation track, and places a core emphasis on practical skills and team-based approaches in each track’s training. "
  • "This track is co-led by Harvard Medical School faculty Rosalyn Adam, PhD, and Martina McGrath, MBBCh, who both have extensive experience in bench and translational research. "
Quotes
  • "The 2019 Translational Research Grant will fund high priority pancreatic cancer research, which is poised for important translational next steps to help move scientific discovery to application in patients through a $500,000 award over two years."
Quotes
  • "At Mayo Clinic, and at approximately 60 other academic institutions around the country that have obtained National Center for Advancing Translational Science, National Institutes of Health, and Center for Translational Science Award funding, these awards have been transformational in how health care research is carried out.5, 6"
  • "We at the University of Kansas Medical Center have also developed a drug discovery and development program as a result of our National Center for Advancing Translational Science and Center for Translational Science Award grant Frontiers: University of Kansas Clinical and Translational Science Institute. One if its components, the Institute for Advancing Medical Innovation (IAMI), works with academic investigators to conduct product development–focused translational research. By bringing industry-experienced drug discovery and development veterans to the university and establishing innovative public-private partnerships, IAMI has enabled projects traversing the valley of death through a few different resources."
Quotes
  • "Researchers have identified a promising two-drug combination to treat deadly childhood brain cancers known as diffuse midline gliomas. The drugs work together to kill cancer cells and counter the effects of a genetic mutation that causes the diseases."
Quotes
  • "The objective of the Master of Science in Translational Research (MSTR) program is to provide students with in-depth instruction in the fundamental skills, methodology and principles necessary to become a well trained translational investigator."
Quotes
  • "The Clinical and Translational Science Institute offers a variety of master’s-level science programs for students at NYU Grossman School of Medicine who are interested in pursuing translational and clinical research."
Quotes
  • "Clinical & Translational Research Resource Library is offered online by Thermo Fisher Scientific - US."
Quotes
  • "As per available reports about 700+ journals, 1000+ Conferences, 300+ workshops are presently dedicated exclusively to Translational Research and about 90000+ articles are being published on the current trends in Translational Research. "
From Part 09
From Part 11
From Part 12