Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2019

Bioanalysis ◽  
2019 ◽  
Vol 11 (24) ◽  
pp. 2245-2249
Author(s):  
Ryan Darling ◽  
Eric Bonner ◽  
Pei Li
Keyword(s):  
Gene Therapy ◽  
New Orleans ◽  
Regulatory Agencies ◽  
High Quality ◽  
Scientific Excellence ◽  
Contract Research ◽  
Research Organizations ◽  
Poster Award ◽  
The World

The 13th WRIB was held in New Orleans, LA, USA in April 2019. It drew over 1000 professionals representing large pharmas, biotechs, contract research organizations and multiple regulatory agencies from around the world. The Global Bioanalytical Community convened in New Orleans to discuss current topics of interest in bioanalysis, biomarkers, immunogenicity and gene therapy. High quality, better compliance to regulations and scientific excellence are always the foundations of this workshop.  Bioanalysis and Bioanalysis Zone are very proud to be supporting the WRIB Poster Awards again this year, and we feature the profiles of the authors of the winning posters. Visit www.bioanalysis-zone.com to see the winning posters in full.

Structure, Organization, and Knowledge Production of Clinical Trial Industry

2018 ◽  
pp. 178-201
Author(s):  
Roger Jeffery ◽  
Gerard Porter ◽  
Salla Sariola ◽  
Amar Jesani ◽  
Deapica Ravindran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
World Trade Organization ◽  
World Trade ◽  
Main Argument ◽  
Contract Research ◽  
Social Forms ◽  
Research Organizations ◽  
The World ◽  
To Come

This chapter reviews the evidence about the scale and significance of clinical trials in India. After describing some of the new social forms that service these trials it assesses the growth in their number from 2005 to 2012 and the reasons for—and implications of—a decline since then. The main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by reforms, linked to India’s accession to the TRIPs agreement and the World Trade Organization in 2005. By contrast, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated trial sponsors and contract research organizations.

Financial Conflict of Interest: an Unresolved Ethical Frontier

2001 ◽  
Vol 27 (2-3) ◽  
pp. 149-162 ◽  
Author(s):  
Jerome P. Kassirer
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Conflict Of Interest ◽  
Contract Research ◽  
Financial Conflict ◽  
Financial Gain ◽  
Research Protocols ◽  
Research Organizations ◽  
Medical Facilities ◽  
Medicine Today

Financial conflict of interest has become one of the most contentious issues in medicine today. Several decades ago studies disclosed that physicians who had investments in medical facilities were referring patients for more tests and procedures than physicians who had no such investments. More recently, physicians who forego expensive tests and treatments for patients have been accused of skimping on care for personal financial gain. Physicians who emphatically tout certain treatments have been criticized for possessing hidden financial ties to the manufacturer of the products. Some physicians engaged in clinical trials have been suspected of enrolling patients who do not strictly conform to the research protocols so that they can collect fees from contract research organizations. And in the aftermath of deaths and complications in gene therapy experiments, some scientists and their institutions have been criticized for possessing a financial stake in companies that are involved in the studies.

scholarly journals High Background Incidence of Spontaneous Subcapsular Adrenal Gland Hyperplasia of Tg.rasH2 Mice Used in 26-week Carcinogenicity Studies

2018 ◽  
Vol 46 (4) ◽  
pp. 444-448 ◽  
Author(s):  
Molly H. Boyle ◽  
Madhav G. Paranjpe ◽  
Dianne M. Creasy
Keyword(s):  
Adrenal Gland ◽  
Common Finding ◽  
Regulatory Agencies ◽  
Spontaneous Tumors ◽  
High Background ◽  
Male And Female ◽  
Contract Research ◽  
Research Organizations

The Tg.rasH2 model was accepted by regulatory agencies worldwide for 26-week carcinogenicity assays as an alternative to the standard 2-year assays in conventional mice in 2003. Several references documenting spontaneous nonneoplastic findings and incidences of spontaneous tumors in the Tg.rasH2 mice have been published. The purpose of this publication is to add adrenal gland subcapsular hyperplasia to the database pertaining to spontaneous lesions noted in Tg.rasH2 mice, review physiology related to this finding, and discuss its significance. The incidence of spontaneous subcapsular adrenal gland hyperplasia was determined in control Tg.rasH2 mice from nine 26-week carcinogenicity studies carried out within the last 5 years at two contract research organizations. Incidence of this finding ranged from 56% to 79% in males and 88% to 100% in females, with an incidence average of 62% in males and 93% in females. Adrenal gland subcapsular hyperplasia is a common finding in male and female Tg.rasH2 mice that did not progress to neoplasia in Tg.rasH2 mice. In general, it tends to be more frequent and severe in females in comparison to males.

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Bioanalysis ◽  
2021 ◽  
Author(s):  
Susan Spitz ◽  
Yan Zhang ◽  
Sally Fischer ◽  
Kristina McGuire ◽  
Ulrike Sommer ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Regulatory Compliance ◽  
White Paper ◽  
Regulatory Agencies ◽  
Scientific Excellence ◽  
Large Molecules ◽  
Research Organizations ◽  
International Industry ◽  
Regulatory Input ◽  
Biotechnology Companies

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

Gene therapy for the central nervous system has been initiated. This expansion will require some degree of simplicity in delivery processes

2021 ◽  
Author(s):  
Moataz Dowaidar
Keyword(s):  
Gene Therapy ◽  
Central Nervous System ◽  
Nervous System ◽  
Treatment Strategies ◽  
High Quality ◽  
Number Of Patients ◽  
New Development ◽  
The World ◽  
The Central Nervous System ◽  
Development Paradigm

In the new development paradigm, gene therapy for the central nervous system has been initiated as a result of the recent successes in phase I–II clinical trials of human patients, as well as superior vector technology. These treatment strategies are no longer confined to diseases with hereditary components, but may now be utilized for a wider array of disease indications and pathways, considerably broadening the scope of gene therapy for the central nervous system (CNS) indications. This expansion will require some degree of simplicity in delivery processes as well as foresight into future IV production requirements, particularly for target-specific delivery. Because of the need for consistent delivery procedures to serve an increasing number of patients, universal delivery procedures which may be used in different locations across the world are necessary. Moreover, manufacturability is critical in the development of the GT sector, as it has a direct impact on the supply of high-quality, large-quantity vectors that are required to meet future clinical demand, as well as the price and ability to introduce novel gene therapy products to the general population.

Analysis Criteria for Choosing Energy Efficient High-Quality Light Sources and Luminaires

2018 ◽  
pp. 113-119
Author(s):  
Gennady Ya. Vagin ◽  
Eugene B. Solntsev ◽  
Oleg Yu. Malafeev
Keyword(s):  
Energy Efficiency ◽  
Energy Efficient ◽  
National Standards ◽  
Light Sources ◽  
The European Union ◽  
High Quality ◽  
Eu Directive ◽  
The World ◽  
A New Technique ◽  
Energy Labelling

The article analyses critera applying to the choice of energy efficient high quality light sources and luminaires, which are used in Russian domestic and international practice. It is found that national standards GOST P 54993–2012 and GOST P 54992– 2012 contain outdated criteria for determining indices and classes of energy efficiency of light sources and luminaires. They are taken from the 1998 EU Directive #98/11/EU “Electric lamps”, in which LED light sources and discharge lamps of high intensity were not included. A new Regulation of the European Union #874/2012/EU on energy labelling of electric lamps and luminaires, in which these light sources are taken into consideration, contains a new technique of determining classes of energy efficiency and new, higher classes are added. The article has carried out a comparison of calculations of the energy efficiency classes in accordance with GOST P 54993 and with Regulation #874/2012/EU, and it is found out that a calculation using GOST P 54993 gives underrated energy efficiency classes. This can lead to interdiction of export for certain light sources and luminaires, can discredit Russian domestic manufacturer light sources and does not correspond to the rules of the World Trade Organization (WTO).

BROADCASTING PRODUCTS OF THE RADIO STATION «LVIVSKA KHVYLYA»: THE GENRE AND THEMATIC CHARACTERISTICS

2019 ◽  
Vol 25242644 ◽  
pp. 54-57
Author(s):  
Vitalii Handziuk
Keyword(s):  
Radio Station ◽  
High Quality ◽  
Fm Radio ◽  
The World

The main principles of developing of a program concept, target, genre-thematic and audience intended purposes of the Ukrainian FM-radio station «Lvivska khvylya» radio series are considered. It’s concluded that the radio «Lvivskа khvylya» successfully creates the actual, original content of the broadcast, hold onto the genres of radio journalism and the formula of radio success – a beautiful and cheerful mood, a friendly and relaxed atmosphere, a lively conversation; promptly informs the audience about current and important events in the country and in the world; journalists create high-quality content – informational, analytical, entertainment and musical radio series.

A Bibliometric Analysis of Global Research on Lophomonas sp. in Scopus (1933-2019)

2020 ◽  
Vol 20 ◽  
Author(s):  
Masoud Keighobadi ◽  
Maryam Nakhaei ◽  
Ali Sharifpour ◽  
Ali Akbar Khasseh ◽  
Sepideh Safanavaei ◽  
...  
Keyword(s):  
Bibliometric Analysis ◽  
International Collaboration ◽  
Research Articles ◽  
High Quality ◽  
The Real ◽  
The Us ◽  
The World ◽  
Scopus Database ◽  
Number Of Publications ◽  
Global Research

Background: This study was designed to analyze the global research on Lophomonas spp. using bibliometric techniques. Methods: A bibliometric research was carried out using the Scopus database. The analysis unit was the research articles conducted on Lophomonas spp. Results: Totally, 56 articles about Lophomonas spp. were indexed in the Scopus throughout 1933-2019 ( 87 years ) with the following information: (A) The first article was published in 1933; (B) 21 different countries contributed in studies related to Lophomonas spp.; (C) China ranked first with 16 publications about Lophomonas spp.; and (D) “Brugerolle, G” and “Beams, H.W.” from France and the US participated in 4 articles respectively, as the highest number of publications in the Lophomonas spp. network. Discussion: After 87 years, Lophomonas still remains unknown for many researchers and physicians around the world. Further studies with high quality and international collaboration are urgently needed to determine different epidemiological aspects and the real burden of the mysterious parasite worldwide.

New Orleans Jazz in the World

2018 ◽  
Vol 103 (4) ◽  
pp. 664-674
Author(s):  
Clyde C. Robertson
Keyword(s):  
New Orleans ◽  
The World ◽  
New Orleans Jazz
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