scholarly journals A snapshot of biologic drug development

2015 ◽  
Vol 34 (12) ◽  
pp. 1279-1285 ◽  
Author(s):  
L Andrews ◽  
S Ralston ◽  
E Blomme ◽  
K Barnhart
Keyword(s):  
Drug Development ◽  
Fusion Proteins ◽  
Biologic Agents ◽  
Therapeutic Protein ◽  
Development Programs ◽  
Biologic Therapies ◽  
Medical Needs ◽  
Recombinant Therapeutic Protein ◽  
Unmet Medical Needs ◽  
Biologic Drug

Since the approval of insulin as the first recombinant therapeutic protein, the prominence of biologic therapies in drug development has grown significantly. Many modalities beyond traditional biologics are now being developed or explored for various indications with significant unmet medical needs. From early traditional replacement proteins to more recent, highly engineered antibodies, oligonucleotides, fusion proteins, and gene constructs, biologic agents have delivered life-changing therapies, despite often having scientifically and technically challenging development programs. This brief review outlines some of the major biotherapeutic classes and identifies the advantages and challenges with the development of these products.

scholarly journals PHP7 Orphan Drugs for Rare Diseases in the European Union: Bridging the Gap between Drug Development and Unmet Medical Needs?

2011 ◽  
Vol 14 (7) ◽  
pp. A334
Author(s):  
F. Catalá-López ◽  
S. Peiró ◽  
R. Gènova-Maleras ◽  
A. Garcia-Altés ◽  
G. Sanfélix-Gimeno ◽  
...  
Keyword(s):  
European Union ◽  
Drug Development ◽  
Rare Diseases ◽  
Orphan Drugs ◽  
The European Union ◽  
Medical Needs ◽  
Unmet Medical Needs

scholarly journals The Different Colors of mAbs in Solution

Antibodies ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 21
Author(s):  
Alexandre Ambrogelly
Keyword(s):  
Visual Inspection ◽  
Quantitative Methods ◽  
Geographical Area ◽  
Therapeutic Protein ◽  
Protein Solutions ◽  
Protein Solution ◽  
Critical Quality Attribute ◽  
Recombinant Therapeutic Protein ◽  
Protein Variants ◽  
Antibody Solution

The color of a therapeutic monoclonal antibody solution is a critical quality attribute. Consistency of color is typically assessed at time of release and during stability studies against preset criteria for late stage clinical and commercial products. A therapeutic protein solution’s color may be determined by visual inspection or by more quantitative methods as per the different geographical area compendia. The nature and intensity of the color of a therapeutic protein solution is typically determined relative to calibrated standards. This review covers the analytical methodologies used for determining the color of a protein solution and presents an overview of protein variants and impurities known to contribute to colored recombinant therapeutic protein solutions.

scholarly journals Factors Affecting Health-Related Quality of Life in Multimorbidity

Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 334
Author(s):  
Eunmi Lee ◽  
Sunkyung Cha ◽  
Geun Myun Kim
Keyword(s):  
Quality Of Life ◽  
Health Behaviors ◽  
Private Insurance ◽  
Subjective Health ◽  
Health Related Quality ◽  
Medical Needs ◽  
Related Quality ◽  
Health Related ◽  
Unmet Medical Needs

We investigated the effect of predisposing, enabling, need factors, and health behaviors on health-related quality of life (HRQoL) of patients with multimorbidity according to Andersen’s model. This study is a secondary analysis of population-based cross-sectional surveys. Data from 328 patients with multimorbidity (≥3 co-occurring chronic diseases) from the 6th/7th Korea National Health and Nutrition Examination Surveys were analyzed using logistic regression. Patients ≥65 years, without private insurance, with poor subjective health, unmet medical needs, and/or limited activity were more likely to experience mobility problems. Self-care problems were more likely among those without private insurance and/or with limited activity. Patients lacking living security, with poor subjective health, limited activity, and/or who smoked were more likely to experience problems performing usual activities. Pain/discomfort was more likely among females, Medicaid beneficiaries, and patients with limited activity and/or with poor subjective health. Patients with poor subjective health, limited activity, and/or unmet medical needs were more likely to experience anxiety/depression. The investigation of HRQoL in multimorbidity should consider predisposing, enabling, need factors, and health behaviors. Interventions addressing movement restrictions and personalized care based on HRQoL domains should be prioritized.

scholarly journals Therapeutic Antibodies for the Treatment of Respiratory Tract Infections—Current Overview and Perspectives

Vaccines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 151
Author(s):  
Alexie Mayor ◽  
Adélaïde Chesnay ◽  
Guillaume Desoubeaux ◽  
David Ternant ◽  
Nathalie Heuzé-Vourc’h ◽  
...  
Keyword(s):  
Respiratory Tract Infections ◽  
Inflammatory Diseases ◽  
Treatment Strategies ◽  
Candida Spp ◽  
Medical Needs ◽  
Life Threatening ◽  
Rsv Infection ◽  
Syncytial Virus ◽  
Tract Infections ◽  
Unmet Medical Needs

Respiratorytract infections (RTIs) are frequent and life-threatening diseases, accounting for several millions of deaths worldwide. RTIs implicate microorganisms, including viruses (influenza virus, coronavirus, respiratory syncytial virus (RSV)), bacteria (Pseudomonas aeruginosa, Streptococcus pneumoniae, Staphylococcus aureus and Bacillus anthracis) and fungi (Pneumocystis spp., Aspergillus spp. and very occasionally Candida spp.). The emergence of new pathogens, like the coronavirus SARS-CoV-2, and the substantial increase in drug resistance have highlighted the critical necessity to develop novel anti-infective molecules. In this context, antibodies (Abs) are becoming increasingly important in respiratory medicine and may fulfill the unmet medical needs of RTIs. However, development of Abs for treating infectious diseases is less advanced than for cancer and inflammatory diseases. Currently, only three Abs have been marketed for RTIs, namely, against pulmonary anthrax and RSV infection, while several clinical and preclinical studies are in progress. This article gives an overview of the advances in the use of Abs for the treatment of RTIs, based on the analysis of clinical studies in this field. It describes the Ab structure, function and pharmacokinetics, and discusses the opportunities offered by the various Ab formats, Ab engineering and co-treatment strategies. Including the most recent literature, it finally highlights the strengths, weaknesses and likely future trends of a novel anti-RTI Ab armamentarium.

Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections

2016 ◽  
Vol 42 (2-3) ◽  
pp. 429-450 ◽  
Author(s):  
Thomas J. Hwang ◽  
Aaron S. Kesselheim
Keyword(s):  
New Drugs ◽  
Resistant Bacteria ◽  
Drug Resistant ◽  
Regulatory Pathways ◽  
Medical Needs ◽  
The Past ◽  
Drug Resistant Bacteria ◽  
Patient Health ◽  
Life Threatening ◽  
Unmet Medical Needs

Accelerating the development and approval of novel therapeutics has emerged as a key public health priority given the mortality, morbidity, and economic costs associated with infections caused by drug-resistant bacteria. However, there is limited empirical evidence to guide policymaking, such as the factors that may disadvantage antibiotics compared to other classes of drugs. In this Article, we empirically examine characteristics of the key clinical trials underpinning FDA's approval of antibiotics and other drugs over the past decade. Despite perceptions that antibiotic trials are larger and more difficult to conduct, we find that antibiotic trials are no larger than those conducted for drugs approved in other disease areas with high unmet medical needs, suggesting that policymakers may need to target other levers to meaningfully stimulate innovation. We discuss the risks and benefits of harnessing new and existing regulatory pathways to speed the approval of new drugs, particularly those intended to treat patients with serious and life-threatening infections, and we evaluate ways that proposals for new regulatory pathways could be improved to better prioritize and expedite the approval of therapies with the greatest potential for patient health benefits.

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