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Translational medicine

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Last Updated: 02 July 2021

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General | Latest Info

In pharmaceutical research, there is a gap that promising therapeutic candidates often fall into on the path from biological discovery to clinical trials. When necessary resources and expertise are lacking, gap can seem overwhelming. 1 Enter our Translational Medicine Group. This global team of physician - scientists and researchers specializes in integrating findings from early drug discovery projects with their own deep knowledge of disease pathways and unmet medical needs. They offer insights on where novel therapy might have the highest impact on diseases and what research needs to be done prior to clinical testing. It really helps to have teams thinking about clinical opportunities along with research right from the beginning of the project, says Evan Beckman, Global Head of Translational Medicine at Novartis Institutes for BioMedical Research. It streamlines and gives focus to program and provides clarity on what team needs to produce. To maximize our impact on projects, group has adopted an open and flexible approach. Rather than committing candidate to one disease area early on, they carry out studies in multiple small, focused patient populations. They then follow Science to identify patient groups who show the most promising therapeutic response. Often this leads to exploration of Rare Diseases that are genetically well defined and have few effective treatment options. Small - scale studies also help streamline larger future efforts in more common diseases. They may, for example, provide critical safety and dosing information or establish biomarkers that allow the US to easily detect therapeutic response. Deeply understanding how drugs work in one disease, may allow the US to predict success in other conditions. For example, fully understanding inflammation pathways in patients with Juvenile Idiopathic Arthritis that were controlled by canakinumab, IL - 1b inhibitor, helps identify, and support, approval in patients with Adult Onset Stills Disease. We are not wed to, nor are we held down by, our disease focus areas, so we can really concentrate on capturing emerging science and driving it towards addressing unmet needs, explains Beckman. This helps the US move quickly in new directions and nimbly across disease areas. At times, this approach dictates that clinical trials are trials in diseases without an existing roadmap. For example, designing a clinical trial in sarcopeniathe age - related loss of skeletal muscle mass and strengthwas nearly impossible less than a decade ago, based on lack of consensus on disease characteristics. There had been no accepted definition of patient population, say Beckman. But Translational Medicine leadership works with academics and members of industry to push health authorities and expert communities to come up with some accepted definitions. These now exist for the first time in Europe. 2 in the US, these efforts have led to approval of the statistical classification code for Sarcopenia as well, advancing Research of Disease at Novartis and other organizations. 3 4 butler, D. Translational Research: Crossing the valley of death. Nature. 2008 Jun 12; 453: 840 - 2. Doi: 10. 1038 / 453840a. Cruz - Jentoft, AJ et al.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

History

Readers might be excused for thinking that the preceding account merely documents the process, in its modern form of new drug discovery, giving it a fancy name and cute slogan. Unfortunately, drug discovery process remains a slow and inefficient process. The formulation of the Translational Science concept, at very least, serves to focus our minds on how this process can be expedited and made more successful, by creating centers of excellence where basic and clinical scientists, government, academia, and industry, and entrepreneurs and investors can meet with reasonable expectation of giving process kick - start into more healthy future, putting into history some of more archaic constraints document by such authors as Cavalla and Ostholm. Formal identification of Translational Science can be expected over the next 10 years or so to: give a major boost to biomarker research in universities; cause modest transfer of early Clinical testing work into academic control; create better opportunities for universities to commercialize their discoveries; and catalyze an increase in efficiency and quality of process and its products. Scientific search should be for biomarkers that scale, figuratively speaking, with slope of zero from in vitro to patients and for drugs that interact predictably with systems highlighted by those biomarkers and that have predictable pharmacokinetic properties amenable to successful allometric scaling.


Introduction

From time to time, there are paradigm shifts in the way in which new drug products are invented and in the underlying science on which inventions are base. The Advent of Translational science is one of those paradigm shifts. At its core is identification of funding category for making public money available to facilitate movement of ideas from bench to bedside. Seemingly, for decades, there has been criticism of the drug discovery and development process, as practice by biotechnology and pharmaceutical industries, as too slow and too inefficient. These are obviously related issuesthe current conventional wisdom is that up to 15 years are needed to take the original idea to first product introduction, that approximately one billion dollars of expenditure will be involve, and that only one in every 5000 - 10 000 compounds synthesize will become products. There is a general idea that time of seven years and a success rate of more like 1 in 250 compounds is feasible. Unfortunately, changes in process evolve over many years, albeit with occasional signal event causing specific, instant change. Measurement of the impact of change is difficultbasically,. Changes in process are followed by further changes before their impact can be measure. The Process of Discovery of new drugs and their full evaluation in patients for whom they are designed involves at least five crucial extrapolations: from physicochemical properties to biology; from in vitro to in vivo; from animals to healthy human volunteers; from single doses to multiple doses; and from healthy volunteers to patients. Of these, extrapolation from animals to humans is probably most significant. This step is now viewed as a critical component of broader area of interest, term Translational science, which potentially embraces four of five extrapolations listed above, excluding only structure - activity relationships.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

International organizations

Singapore since the late 1990s has transformed from being an information Technology Development powerhouse to one that is now focus on Government sponsor partnerships with biotechnology and pharmaceutical companies, including significant educational partnerships. Singapore has become life Science knowledge economy and in doing so, Singapore has invested in academic PIs and Clinical Research. Strategic University investments in the early part of last decade 2000 - 2004 had focused on supporting new innovations arising from experimental Medicine units that could be commercialized by investigators lead spin - off companies. During previous decade many Singapore graduates wished to train in both undergraduate Science and postgraduate MBA courses, however there has been a recent explosion of Singapore scientists training to PhD level. This is the opposite to what was happening 10 years ago, where it was difficult to recruit Singapore PhD students, and significant shortfall being made up of students from China, India and Malaysia. This transition in Singapore to local PhD Training was likely, in part, result of start - up companies spinning out of the university system finding it difficult to attract funding without patient translational data - This led to adjustment of the model, where the Singapore Government formed partnerships with large pharmaceutical companies and expanded number of * STAR Institutes. Partnerships have also been formed with National University of Singapore and Duke University, with a focus on graduate Medical Training and Translational Research with Duke - NUS being located on the same site as Singapore General Hospital. Because Singapore has close ties with sponsored biotechnology and pharmaceutical industry, educational internships are possible. Additionally, Singapore has developed key talent development initiatives including NUS Academy of GxP Excellence that offers post - graduate Training in Pharmaceutical manufacturing, and the GSKEDB partnership to build up capabilities in sustainable manufacturing. Early exposure to Research Training is encouraged during undergraduate Science courses at NUS, with the undergraduate Research Opportunities Programme in Science. * Star drives a significant component of Singapore Translational Medical Science PhD Training. Recent development of Singapore Institute for Clinical Science in 2007 has resulted in flagship programs in neuroscience, metabolic Medicine, Diabetes and developmental epigenetic studies. Sics also has a strong pharmacological Translational Medicine Program in partnership with the Center for Clinical Pharmacology at National University Hospital and Pharmaceutical companies. China has no formal Translational educational Program, although last year a number of expanded PI positions were created for Translational scientist appointments. This has in part been regulated by the government to promote Biotechnology Development through strategic support in its Medium and Long Term S & T Development Plan, overseas talent - attraction programmes, commercialization initiatives, and development of high - Technology and Science parks. All of the leading global pharmaceutical companies have established a presence in China and many have established R & D units. Global Pharmaceutical companies in China are well placed to offer practical placements for PhD graduates and clinicians wishing to gain industry experience. Additionally, presence of pharmaceutical companies supports the central mandate for Translational Research outcomes.


International Society for Translational Medicine (ISTM)

The International Society of Translational Medicine has been fully incorporated and declared establishment on 26 May, 2011 in Beijing, China. Society was co - initiate by a group of researchers who participated in the Bio - X 2010 International Symposium on Translation Medicine that took place in May 2010. The exclusive purpose of this Society shall be to develop and foster Translational Medicine into clinical practice, from bedside to bench to bedside. The primary purpose of society is to promote study of Translational Medicine and its interactions with living systems. The International Society for Translational Medicine is a non - profit organization dedicated to communication and cross - fertilization among clinicians and researchers from all science fields with interest in Translational Medicine. Istm provides a platform to bring together clinicians, scientists and researchers from all biomedical fields, as well as providing a forum for interdisciplinary exchange of current knowledge and concepts on Translational Medicine through social membership, professional development programs and conferences. Istm accelerates development and clinical application of new therapeutic strategies and diagnostic tools. Istm promotes interaction and co - operation among physicians, scientists, researchers, policy makers, investors, business developers in academics, industries, funding agencies and governments. Istm also provides professional recognition for engagement in Translational Medicine and promotes outstanding and innovative studies in the field of Translational Medicine. Istm mainly focuses on cellular & molecular Medicine, applied immunology, molecular imaging, regenerative Medicine, drug discovery and development, biomaterials & clinical application, neurosciences, OMICS science, and oncology. The following is a list of scholars from the International Society for Translational Medicine who contribute and / or serve as editors for one or more OMICS International journals and conferences.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Need for translational medicine

Translational science is a novel concept, whose main purpose is to categorize practical, outcome - oriented research. In healthcare, Translational Research can be viewed as research on human specimens, whose findings may inform basic science research and lead to transfer of results towards clinical therapeutics and novel healthcare policies; its definition seems, however, to be an ever evolving phenomenon; if initially IT refers to bench - to - bedside enterprise of using information from basic sciences to produce new treatment alternatives for patients, nowadays IT is define by process that start with fundamental Research and end at macro level. Moreover, some authors consider that the translational process should not start with fundamental research, as this approach rarely succeed, but rather from clinical medicine so - call bedside to bench to bedside approach. A classical example to show the usefulness of this approach is represented by the development of balloon angioplasty by Gruentzig. More recent example is represented by T Cell therapyT. Cells have various roles in Cell - mediate immunity, being able, among others, to differentiate between healthy and abnormal cells, and is involved in HIV infection. This clinical knowledge has recently been brought to the bench by a research team led by Dr. Marson, who, by editing the genome of human T cells using the CRISPR / Cas9 ribonucleoprotein delivery method, caused up to 40% of cells to lose high level Cell surface expression of CXCR4, which could open new therapeutic possibilities in oncology, autoimmunity or infectious diseases. For purposes of this article we will try to define Translational process as containing three main elements: phases, gaps, and data transfer; Therefore, when analysing ethical issues determined by Translational Research, we will consider them as appertaining to either element of Translational process, or the process of Translational Research itself. Initially, Translational Research was considered as containing two main phases: T1bench - to - bedside, in which new discoveries from laboratory could be translated towards clinical Research and T2, in which these applications were translated into clinical Practice. Recently, process was further developed by the addition of other stages;. Therefore, most recent models contain either four or six translational phases and may or may not include bedside - to - bench approach. For the purpose of this article, we will use the six - phase approach shown in Fig. 1. The Six - Phase approach considers that Translational Research starts with fundamental research and ends with developing and implementing social / economic policies determined by results obtained in the process. Between each adjacent set of phases is a gap, or roadblock, which refers to lack of funding / support needed for progression to the next. The most important gap is between T0 and T1, called the valley of death, because most fundamental research studies do not go beyond IT. According to Pienta, these translational gaps are dependent upon successful management of four main risks: scientific, intellectual property, regulatory, and market. In the translation process, transfer of information from one study to the next one characterizes data transfer. These transfers occur either within phases or between phases.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Challenges in translational medicine

Translational Research, also referred to as Translational Medicine or Translational Science, refers to a bench - to - bedside process that harnesses knowledge from basic scientific Research into Clinical Research to create novel treatments and treatment options devices, Medical procedures, preventions, and diagnostics, essentially forming a bridge between basic Research and Clinical Research. For clinical researchers and other health workers, Translational Research refers to translating research into clinical practice in the form of new treatments and knowledge that actually reaches patients or populations. Despite differences in semantics, basic Science is the earliest stage of research, conducted for advancement of knowledge, often without any concern for its practical applications, whereas Translational Research is the process of applying these discoveries generated through basic scientific inquiry to treatment and prevention of human disease. Thus, Translational Research acts as a bridge between basic and Clinical Research. Despite significant investments in basic science, advances in technology and enhanced knowledge of human disease, translation of these findings into therapeutic advances has been far slower than expected and return on this investment has been limited in terms of clinical impact. There is consensus both in academia and industry that there is a crisis involving translatability of preclinical Science to Human applications and that most research findings are irreproducible or false. In time of increased cost, high - attrition rates, and length of time required for new drug development, and constrained resources, Translational Research needs to renew its outlook. For example, should funds be moved from preclinical to Translational Research projects more specifically linked to human disease, especially for those involving discovery and preclinical development of new Drugs? Would such a strategy in the long term improve translatability of preclinical findings and result in better long - term Patient Outcomes? One way to address these outstanding questions would be to evaluate potential culprits leading to failure of translating preclinical findings into human studies. In this article, I provide a fresh perspective on challenges of Translational Research, present examples of potential weak links that might be contributing to failures, and potential strategies to mitigate those problems. Of many known human diseases, approximately 500 have treatment approved by regulatory agencies. Even when a new treatment is shown to be effective, it can take several years to identify and serve all patients who could benefit. Furthermore, as discussed by Zeggini et al. Most common human diseases are highly complex chronic diseases and exhibit variable disease course and response to therapy. For example, it was reported in literature that 10 of the best - selling drugs in the United States, to achieve one patient with good response, between 4 to 25 patients must be treat. This carries a significant burden on health risks and resources by exposing those patients who are treated without achieving clinically significant response or to risk of harm through development of unnecessary side effects of drug.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

New Section: Translational Cancer Biology

TRACO Course Schedule

DateTopicsFaculty
Sept. 8Introduction Cervical cancerT. Moody J. Schiller
Sept. 14Cancer disparities Immune checkpointsB. Ryan S. Goff
Sept. 21Ovarian cancer TGFC. Annunziata S. Jakowlew
Sept. 28Clinical trials Small MoleculesJ. Smith A. Simeonov
Oct. 8Radiation oncology CAR-T cellsE. Nichols L. Mikkelneni
Oct. 15Prostate cancer Tumor imagingR. Madan P. Choyke
Oct. 19Genomics EpidemiologyJ. Wei N. Caporaso
Oct. 26Breast Cancer HIVF Zia F. Maldarelli
Nov. 2K-RAS SCLCJ. Luo H. Chen
Nov. 9NSCLC Case ReportsE. Szabo O. Olaku
Nov. 16Epigenetics Brain CancerM. Verma Timmer
Nov. 23Precision medicine TopoisomeraseC. Harris Y. Pommier
Nov. 30Pancreatic cancer NanotechnologyP. Hussain M. Dobrovolskaia

We are excited to announce the addition of a new section to the Journal of Translational Medicine entitled Translational Cancer Biology. Lead by Section Editor Cristina Maccalli, this exciting new section aims to provide a platform for communication and dissemination of advances in Cancer Biology and their Translational applications. The section will focus on mechanisms of transformation, progression and metastatization, Biology of Cancer stem cells and their immunological properties, mechanisms undergoing epithelial - to mesenchymal transition and Tumor dormancy, their relationship with immune functions and mechanisms undergoing Cancer resistance to therapies. The section also welcomes research on translational aspects and development of novel therapies relate to aforementioned themes and identification of patients ' responsiveness and outcome to therapies.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What is Translational Research?

Sometimes referred to as bench to bedside Medicine, Translational Research translates those discoveries made in research laboratory into a clinical setting so patients can benefit from research quicker. Translational Research is also referred to as Translational Medicine. Our researchers are leaders in discoveries that advance science and pave the way for new therapies and procedures to improve human health. Basic and clinical research findings emerging from our laboratories and hospitals improve treatment of a wide range of medical conditions and provide the foundation of knowledge on which many of Medicine's next generation of cures will be develop. The Institute for Translational Medicine and Therapeutics at Penn supports research at the interface of basic and clinical research focusing on developing new and safer medicines. Itmat laboratories are house within the Smilow Center for Translational Research. Learn more about the Institute for Translational Medicine and Therapeutics.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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