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Description Table of Contents. Summary Written with a broader perspective and knowledge, Cancer Supportive Care: Advances in Therapeutic Strategies presents state-of-the-art management options for the full range of symptoms, toxicities, and complications experienced by cancer patients. Written by key opinion leaders in the field, Cancer Supportive Care: Advances in Therapeutic Strategies : assembles and synthesizes state-of-the-art information into one convenient resource, helping busy clinicians learn the most effective supportive care strategies available discusses emerging therapies and approaches covers topics not included in other cancer supportive care books, such as measurement of symptoms, growth factors, thromboembolism, skeletal complications, fatigue, the elderly cancer patient, cancer survivorship, and alternative and integrative therapies.
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Bluestone, 2 and Wendell A. Lim, 3. Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases.
However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.
T cells , synthetic biology , cellular therapy , immunotherapy , cellular engineering. Allogeneic transplantation of foreign organs or tissues has lifesaving potential, but can lead to serious complications. After solid organ transplantation, immune-mediated rejection mandates the use of prolonged global immunosuppression and limits the Read More.
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Figure 1: Potential inflammatory or tolerogenic alloantigen-presenting cells after allogeneic transplantation. Center After allogeneic hematopoietic cell transplantation, donor T cells become activa ILC3s rele Figure 3: Overview of Notch signaling and sources of Notch signals in alloimmunity. Laura Baseler, Daniel S. Chertow, Karl M. Johnson, Heinz Feldmann, David M. Morens Vol. For almost 50 years, ebolaviruses and related filoviruses have been repeatedly reemerging across the vast equatorial belt of the African continent to cause epidemics of highly fatal hemorrhagic fever.
The West African epidemic, by far the most Figure 1: Ebolavirus structure indicating various proteins and the genes that code for them. The rationally designed analog with enhanced CD80 and CD86 binding, belatacept, a second-generation selective co-stimulation blocker, was approved by the FDA on June 15, , for the prophylaxis of kidney transplant rejection Rituximab binds to CD20 expressed on the surface of many B cells but not plasma cells , resulting in B-cell depletion via antibody-dependent cellular cytotoxicity ADCC , complement-mediated cytotoxicity CMA , and the induction of direct cell death apoptosis 68 , This second-generation medicine contains a CDbinding variable region introduced through protein engineering to take advantage of the potent induction of direct cell death and limited C1q binding typical of type II anti-CD20 antibodies This second-generation anti-CD20 mAb for treatment of chronic lymphocytic leukemia was also the first therapeutic protein to receive breakthrough therapy designation.
In addition, Gazyva was granted orphan designation upon approval and contains pharmacogenetics information included on the drug label. Over this examination of the recently approved therapeutic protein drug landscape, several emerging trends have become apparent. Pharmacogenetics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.
Drug labeling may contain information on genomic biomarkers and can describe drug exposure and clinical response variability, risk for adverse events, genotype-specific dosing, mechanisms of drug action, and polymorphic drug target and disposition genes. Therefore, pharmacogenetic profiling is of particular importance when potential drug candidates exhibit highly variable safety, efficacy, or pharmacokinetics profiles. Pharmacogenetic information and changes in drug labeling can lead to drugs targeted for different populations, personalized dosing regimens, and companion diagnostics.
Recent advances in (therapeutic protein) drug development
There have been 11 therapeutic proteins approved since that have included pharmacogenetic biomarkers in their drug labels Table 6. Comprehensive listing of all FDA-approved therapeutic proteins with pharmacogenetics biomarkers in drug labeling from January 1, , through August 31, , listed in chronological order of FDA approval.
In addition, the class of protein, a brief description, pharmacogenetics biomarker, and therapeutic area are included. It is reasonable to anticipate that proteins will be more extensively engineered in the future. This means that the new generation of therapeutic proteins will carry neo-sequences not found in nature. Thus, the potential risks of immunogenicity undesirable immune responses to therapeutic proteins 39 will also increase and, in turn, demand new technologies for immunogenicity risk assessment and mitigation 39 , Protein engineering is no longer restricted to altering the primary sequence of proteins.
On the other hand, the rapidly growing trend of codon optimization involves the substitution of synonymous codons to improve protein synthesis and increase protein production 41 , A growing scientific literature suggests that although synonymous codons do not alter protein sequence they can have profound effects on protein folding and function 43 — Consequently, these therapeutic proteins designed by using such strategies will have to be carefully evaluated. These opportunities do come with risks but rapid advances in new technologies as well as the underlying science suggest that these risks can be managed.
The authors declare that they have no competing interests. F Faculty Reviews are written by members of the prestigious F Faculty. They are commissioned and are peer reviewed before publication to ensure that the final, published version is comprehensive and accessible. The reviewers who approved the final version are listed with their names and affiliations. Alongside their report, reviewers assign a status to the article:. Competing interests: No competing interests were declared.
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Get XML. How to cite this article. NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details. Recent advances in therapeutic protein drug development [version 1; peer review: 2 approved]. Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies.
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