Development and Regulatory Challenges for Peptide Therapeutics

2020 ◽  
pp. 109158182097784
Author(s):  
Doris Zane ◽  
Paul L. Feldman ◽  
Tomi Sawyer ◽  
Zhanna Sobol ◽  
Jessica Hawes
Keyword(s):  
Health And Environmental Sciences ◽  
Panel Discussion ◽  
Technical Committee ◽  
Peptide Therapeutics ◽  
Genetic Toxicology ◽  
Future Directions ◽  
The Past ◽  
Genotoxicity Testing ◽  
Nonclinical Study ◽  
Regulatory Challenges

There has been an increased interest in and activity for the use of peptide therapeutics to treat a variety of human diseases. The number of peptide drugs entering clinical development and the market has increased significantly over the past decade despite inherent challenges of peptide therapeutic discovery, development, and patient-friendly delivery. Disparities in interpretation and application of existing regulatory guidances to innovative synthetic and conjugated peptide assets have resulted in challenges for both regulators and sponsors. The Symposium on Development and Regulatory Challenges for Peptide Therapeutics at the 40th Annual Meeting of the American College of Toxicology held in November of 2019 focused on the following specific topics: (1) peptide therapeutic progress and future directions, and approaches to discover, optimize, assess, and deliver combination peptide therapeutics for treatment of diseases; (2) toxicological considerations to advance peptide drug-device combination products for efficient development and optimal patient benefit and adherence; (3) industry and regulatory perspectives on the regulation of synthetic and conjugated peptide products, including exploration of regulatory classifications, interpretations, and application of the existing guidances International Council for Harmonisation (ICH) M3(R2) and ICH S6(R1) in determining nonclinical study recommendations; and (4) presentation of the 2016 Health and Environmental Sciences Institute’s Genetic Toxicology Technical Committee working group assessment of genotoxicity testing requirements. Perspectives were shared from industry and regulatory scientists working in the peptide therapeutics field followed by an open forum panel discussion to discuss questions drafted for the peptide therapeutics scientific community, which will be discussed in more detail.

General Aviation Weather Hazards:Current Human Factors Research, Pilot Practices, and Tools

2020 ◽  
Vol 64 (1) ◽  
pp. 123-126
Author(s):  
Beth Blickensderfer ◽  
Lori J Brown ◽  
Alyssa Greenman ◽  
Jayde King ◽  
Brandon Pitts
Keyword(s):  
Human Factors ◽  
Panel Discussion ◽  
General Aviation ◽  
Transportation Safety ◽  
Laboratory Research ◽  
Related Factors ◽  
Future Directions ◽  
The Past ◽  
Flight Operations ◽  
Human Factors Research

When General Aviation (GA) pilots encounter unexpected weather hazards in-flight, the results are typically deadly. It is unsurprising that the National Transportation Safety Board repeatedly lists weather related factors in GA flight operations as an unsolved aviation safety challenge. Solving this problem requires multidisciplinary perspectives. Fortunately, in the past several years innovative laboratory research and industry products have become available. This panel discussion brings together Human Factors and Ergonomics researchers and practitioners to discuss and describe the current work and future directions to avoid weather related accidents in GA.

On Future Directions in Pathology

1982 ◽  
Vol 40 ◽  
pp. 274-277
Author(s):  
Benjamin F. Trump ◽  
Irene K. Berezesky ◽  
Raymond T. Jones
Keyword(s):  
Electron Microscopy ◽  
Transmission Electron Microscopy ◽  
Clinical Pathology ◽  
Future Directions ◽  
Diagnostic Pathology ◽  
The Past ◽  
Transmission Electron ◽  
Organ Systems ◽  
The Many

The role of electron microscopy and associated techniques is assured in diagnostic pathology. At the present time, most of the progress has been made on tissues examined by transmission electron microscopy (TEM) and correlated with light microscopy (LM) and by cytochemistry using both plastic and paraffin-embedded materials. As mentioned elsewhere in this symposium, this has revolutionized many fields of pathology including diagnostic, anatomic and clinical pathology. It began with the kidney; however, it has now been extended to most other organ systems and to tumor diagnosis in general. The results of the past few years tend to indicate the future directions and needs of this expanding field. Now, in addition to routine EM, pathologists have access to the many newly developed methods and instruments mentioned below which should aid considerably not only in diagnostic pathology but in investigative pathology as well.

Comparison and Analysis of Computational Methods for Identifying N6 - methyladenosine Sites in Saccharomyces Cerevisiae

2020 ◽  
Vol 26 ◽  
Author(s):  
Pengmian Feng ◽  
Lijing Feng ◽  
Chaohui Tang
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Computational Methods ◽  
Computational Analysis ◽  
Computational Prediction ◽  
Experimental Methods ◽  
Biological Processes ◽  
Biological Functions ◽  
Precise Location ◽  
Future Directions ◽  
The Past

Background and Purpose: N 6 -methyladenosine (m6A) plays critical roles in a broad set of biological processes. Knowledge about the precise location of m6A site in the transcriptome is vital for deciphering its biological functions. Although experimental techniques have made substantial contributions to identify m6A, they are still labor intensive and time consuming. As good complements to experimental methods, in the past few years, a series of computational approaches have been proposed to identify m6A sites. Methods: In order to facilitate researchers to select appropriate methods for identifying m6A sites, it is necessary to give a comprehensive review and comparison on existing methods. Results: Since researches on m6A in Saccharomyces cerevisiae are relatively clear, in this review, we summarized recent progresses on computational prediction of m6A sites in S. cerevisiae and assessed the performance of existing computational methods. Finally, future directions of computationally identifying m6A sites were presented. Conclusion: Taken together, we anticipate that this review will provide important guides for computational analysis of m 6A modifications.

scholarly journals The Use of Autogenous Teeth for Alveolar Ridge Preservation: A Literature Review

2021 ◽  
Vol 11 (4) ◽  
pp. 1853
Author(s):  
João Cenicante ◽  
João Botelho ◽  
Vanessa Machado ◽  
José João Mendes ◽  
Paulo Mascarenhas ◽  
...  
Keyword(s):  
Ridge Preservation ◽  
Graft Material ◽  
Alveolar Ridge ◽  
Natural Consequence ◽  
Oral Rehabilitation ◽  
Future Directions ◽  
The Past ◽  
Alveolar Ridge Preservation ◽  
Functional Consequences ◽  
Teeth Extraction

Alveolar ridge resorption is a natural consequence of teeth extraction, with unpleasant aesthetic and functional consequences that might compromise a future oral rehabilitation. To minimize the biological consequences of alveolar ridge resorption, several surgical procedures have been designed, the so-called alveolar ridge preservation (ARP) techniques. One important characteristic is the concomitant use of biomaterial in ARP. In the past decade, autogenous teeth as a bone graft material in post-extraction sockets have been proposed with very interesting outcomes, yet with different protocols of preparation. Here we summarize the available evidence on autogenous teeth as a biomaterial in ARP, its different protocols and future directions.

scholarly journals Small Molecule Inhibitors of Influenza Virus Entry

2021 ◽  
Vol 14 (6) ◽  
pp. 587
Author(s):  
Zhaoyu Chen ◽  
Qinghua Cui ◽  
Michael Caffrey ◽  
Lijun Rong ◽  
Ruikun Du
Keyword(s):  
Influenza Virus ◽  
Membrane Fusion ◽  
Small Molecule ◽  
Drug Target ◽  
Small Molecule Inhibitors ◽  
Virus Entry ◽  
Critical Role ◽  
Structural Basis ◽  
Future Directions ◽  
The Past

Hemagglutinin (HA) plays a critical role during influenza virus receptor binding and subsequent membrane fusion process, thus HA has become a promising drug target. For the past several decades, we and other researchers have discovered a series of HA inhibitors mainly targeting its fusion machinery. In this review, we summarize the advances in HA-targeted development of small molecule inhibitors. Moreover, we discuss the structural basis and mode of action of these inhibitors, and speculate upon future directions toward more potent inhibitors of membrane fusion and potential anti-influenza drugs.

scholarly journals The Past, Present and Future of Cannabis sativa Tissue Culture

Plants ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 185
Author(s):  
Adrian S. Monthony ◽  
Serena R. Page ◽  
Mohsen Hesami ◽  
Andrew Maxwell P. Jones
Keyword(s):  
Tissue Culture ◽  
Disease Virus ◽  
Cannabis Sativa ◽  
Clonal Plants ◽  
Future Directions ◽  
The Past ◽  
Recent Developments ◽  
History Of ◽  
Drug Type

The recent legalization of Cannabis sativa L. in many regions has revealed a need for effective propagation and biotechnologies for the species. Micropropagation affords researchers and producers methods to rapidly propagate insect-/disease-/virus-free clonal plants and store germplasm and forms the basis for other biotechnologies. Despite this need, research in the area is limited due to the long history of prohibitions and restrictions. Existing literature has multiple limitations: many publications use hemp as a proxy for drug-type Cannabis when it is well established that there is significant genotype specificity; studies using drug-type cultivars are predominantly optimized using a single cultivar; most protocols have not been replicated by independent groups, and some attempts demonstrate a lack of reproducibility across genotypes. Due to culture decline and other problems, the multiplication phase of micropropagation (Stage 2) has not been fully developed in many reports. This review will provide a brief background on the history and botany of Cannabis as well as a comprehensive and critical summary of Cannabis tissue culture. Special attention will be paid to current challenges faced by researchers, the limitations of existing Cannabis micropropagation studies, and recent developments and future directions of Cannabis tissue culture technologies.

scholarly journals Bioinsecticides based on plant essential oils: a short overview

2020 ◽  
Vol 75 (7-8) ◽  
pp. 179-182
Author(s):  
Murray B. Isman
Keyword(s):  
Essential Oils ◽  
Crop Protection ◽  
Large Body ◽  
Regulatory Agencies ◽  
The European Union ◽  
Plant Essential Oils ◽  
The Past ◽  
Wide Range ◽  
The Usa ◽  
Regulatory Challenges

AbstractInterest in the discovery and development of plant essential oils for use as bioinsecticides has grown enormously in the past 20 years. However, successful commercialization and utilization of crop protection products based on essential oils has thus far lagged far behind their promise based on this large body of research, most notably because with the exceptions of the USA and Australia, such products receive no special status from regulatory agencies that approve new pesticides for use. Essential oil-based insecticides have now been used in the USA for well over a decade, and more recently have seen use in the European Union (EU), Korea, and about a dozen other countries, with demonstrated efficacy against a wide range of pests and in numerous crop systems. For the most part these products are based on commodity essential oils developed as flavor and fragrance agents for the food and cosmetic industries, as there are formidable logistic, economic, and regulatory challenges to the use of many other essential oils that otherwise possess potentially useful bioactivity against pests. In spite of these limitations, the overall prospects for biopesticides, including those based on essential oils, are encouraging as the demand for sustainably-produced and/or organic food continues to increase worldwide.

scholarly journals A Technical Study on UAV Characteristics for Precision Agriculture Applications and Associated Practical Challenges

2021 ◽  
Vol 13 (6) ◽  
pp. 1204
Author(s):  
Nadia Delavarpour ◽  
Cengiz Koparan ◽  
John Nowatzki ◽  
Sreekala Bajwa ◽  
Xin Sun
Keyword(s):  
Precision Agriculture ◽  
Weather Conditions ◽  
Future Directions ◽  
Radiometric Correction ◽  
Practical Applications ◽  
The Past ◽  
Field Crops ◽  
Advanced Technologies ◽  
Technical Study ◽  
Agricultural Operations

The incorporation of advanced technologies into Unmanned Aerial Vehicles (UAVs) platforms have enabled many practical applications in Precision Agriculture (PA) over the past decade. These PA tools offer capabilities that increase agricultural productivity and inputs’ efficiency and minimize operational costs simultaneously. However, these platforms also have some constraints that limit the application of UAVs in agricultural operations. The constraints include limitations in providing imagery of adequate spatial and temporal resolutions, dependency on weather conditions, and geometric and radiometric correction requirements. In this paper, a practical guide on technical characterizations of common types of UAVs used in PA is presented. This paper helps select the most suitable UAVs and on-board sensors for different agricultural operations by considering all the possible constraints. Over a hundred research studies were reviewed on UAVs applications in PA and practical challenges in monitoring and mapping field crops. We concluded by providing suggestions and future directions to overcome challenges in optimizing operational proficiency.

scholarly journals Evolution of Cancer Vaccines—Challenges, Achievements and Future Directions

Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 535
Author(s):  
Ban Qi Tay ◽  
Quentin Wright ◽  
Rahul Ladwa ◽  
Christopher Perry ◽  
Graham Leggatt ◽  
...  
Keyword(s):  
Cancer Vaccines ◽  
New Drugs ◽  
Delivery Methods ◽  
Future Directions ◽  
The Past ◽  
New Directions ◽  
Tumour Antigens ◽  
Target Characteristics ◽  
Toxic Responses ◽  
Shed Light

The development of cancer vaccines has been intensively pursued over the past 50 years with modest success. However, recent advancements in the fields of genetics, molecular biology, biochemistry, and immunology have renewed interest in these immunotherapies and allowed the development of promising cancer vaccine candidates. Numerous clinical trials testing the response evoked by tumour antigens, differing in origin and nature, have shed light on the desirable target characteristics capable of inducing strong tumour-specific non-toxic responses with increased potential to bring clinical benefit to patients. Novel delivery methods, ranging from a patient’s autologous dendritic cells to liposome nanoparticles, have exponentially increased the abundance and exposure of the antigenic payloads. Furthermore, growing knowledge of the mechanisms by which tumours evade the immune response has led to new approaches to reverse these roadblocks and to re-invigorate previously suppressed anti-tumour surveillance. The use of new drugs in combination with antigen-based therapies is highly targeted and may represent the future of cancer vaccines. In this review, we address the main antigens and delivery methods used to develop cancer vaccines, their clinical outcomes, and the new directions that the vaccine immunotherapy field is taking.

The Founding, Evolution, and Impact of the American Council on Rural Special Education

2019 ◽  
Vol 38 (2) ◽  
pp. 67-78
Author(s):  
Melinda Jones Ault ◽  
Britt Tatman Ferguson ◽  
Ann B. Berry ◽  
Sarah Hawkins-Lear ◽  
Kathleen Magiera
Keyword(s):  
Special Education ◽  
Future Directions ◽  
American Council ◽  
The Past ◽  
Rural Environments

Interest in documenting the history and evolution of the American Council for Rural Special Education (ACRES), from the perspective of its original members, resulted in distribution of a survey and interviews. The data collected recount the original mission of ACRES and describe the organization’s impact over the past 37 years. Overarching themes that emerged from the data include the unique needs of rural special education, ACRES’s voice for rural environments, people with a passion for rural special education, and friendliness of the organization. The results identified future directions of the organization.

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