scholarly journals Drug Discovery over the Past Thirty Years: Why Aren’t There More New Drugs?

2016 ◽  
Vol 29 (1) ◽  
pp. 61
Author(s):  
Lloyd Fricker
Keyword(s):  
Drug Discovery ◽  
Translational Research ◽  
Basic Science ◽  
Science Studies ◽  
Disease Process ◽  
Science Research ◽  
The United States ◽  
New Drugs ◽  
Biomedical Knowledge ◽  
The Past

The rate of drug discovery has not kept pace with the exponential increase in biomedical knowledge. For the past 30 years, the number of new molecular enti- ties approved by the United States Food and Drug Administration has averaged 20 to 30 drugs per year, except for a peak in the mid-1990s that briefly doubled this rate. This modest productivity cannot be explained by lack of funding, as the research budgets of government and industry-funded programs have increased threefold to fivefold over the past three decades. Various arguments have been proposed to account for the relative lack of innovative new drugs, but little consideration has been given to the focus on hypothesis-driven translational research. In theory, the emphasis on translational research should have led to an increase in the number of new drugs. However, in considering the historical perspective of drug discovery and the role of serendipity, it can be argued that the emphasis on translational research diverts scientists from pursuing basic-science studies that give rise to fundamental discoveries. In many cases, retro-translational research (from clinic to basic science) is necessary before the disease process can be understood well enough for scientists to develop therapeutics. Ultimately, a balance of disease-oriented and basic-science research on fundamental processes is optimal. 

scholarly journals Drug Discovery over the Past Thirty Years: Why Aren’t There More New Drugs?

2016 ◽  
Vol 29 (1) ◽  
pp. 61 ◽  
Author(s):  
Lloyd Fricker
Keyword(s):  
Drug Discovery ◽  
Translational Research ◽  
Basic Science ◽  
Science Studies ◽  
Disease Process ◽  
Science Research ◽  
The United States ◽  
New Drugs ◽  
Biomedical Knowledge ◽  
The Past

The rate of drug discovery has not kept pace with the exponential increase in biomedical knowledge. For the past 30 years, the number of new molecular enti- ties approved by the United States Food and Drug Administration has averaged 20 to 30 drugs per year, except for a peak in the mid-1990s that briefly doubled this rate. This modest productivity cannot be explained by lack of funding, as the research budgets of government and industry-funded programs have increased threefold to fivefold over the past three decades. Various arguments have been proposed to account for the relative lack of innovative new drugs, but little consideration has been given to the focus on hypothesis-driven translational research. In theory, the emphasis on translational research should have led to an increase in the number of new drugs. However, in considering the historical perspective of drug discovery and the role of serendipity, it can be argued that the emphasis on translational research diverts scientists from pursuing basic-science studies that give rise to fundamental discoveries. In many cases, retro-translational research (from clinic to basic science) is necessary before the disease process can be understood well enough for scientists to develop therapeutics. Ultimately, a balance of disease-oriented and basic-science research on fundamental processes is optimal.

Male bias in ACE2 basic science research: Missed opportunity for discovery in the time of COVID-19

2021 ◽  
Author(s):  
Branka Stanic ◽  
Sydney Maddox ◽  
Aline Maria Arlindo de Souza ◽  
Xie Wu ◽  
Danial Mehranfard ◽  
...  
Keyword(s):  
Sex Differences ◽  
Basic Science ◽  
Science Studies ◽  
Renin Angiotensin System ◽  
Science Research ◽  
The United States ◽  
Original Research ◽  
Experimental Conditions ◽  
Biological Variable ◽  
The Impact

Throughout the world, including the United States, men have worse outcomes from COVID-19 than women. SARS-CoV-2, the causative virus of the COVID-19 pandemic, uses angiotensin-converting-enzyme-2 (ACE2) to gain cellular entry. ACE2 is a member of the renin-angiotensin-system (RAS) and plays an important role in counteracting the harmful effects mediated by the angiotensin-type-1-receptor. Therefore, we conducted Ovid MEDLINE and Embase database searches of basic science studies investigating the impact of the biological variable of sex on ACE2 expression and regulation from 2000, the year ACE2 was discovered, through December 31, 2020. Out of 2131 publications, we identified 853 original research articles on ACE2 conducted in primary cells, tissues and/or whole mammals excluding humans. The majority (68.7%) of these studies that cited the sex of the animal were conducted in males, while 11.2% were conducted solely in females; 9.26% compared ACE2 between the sexes, while 10.8% did not report the sex of the animals used. General findings are that sex-differences are tissue-specific and when present, are dependent-upon gonadal state. Renal, cardiac and adipose ACE2 is increased in both sexes under experimental conditions that model co-morbidities associated with worse COVID-19 outcomes including hypertension, obesity, and renal and cardiovascular diseases; however, ACE2 protein was generally higher in the males. Studies in Ace2- knockout-mice indicate ACE2 plays a greater role protecting the female from developing hypertension than the male. Studying the biological variable of sex in ACE2 research provides an opportunity for discovery in conditions involving RAS-dysfunction and will shed light on sex-differences in COVID-19-severity.

Novel New Drug Approvals in 2011: A Succinct Analysis of Drug Discovery Trends in the United States

2012 ◽  
Vol 5 (2) ◽  
pp. 1661-1665
Author(s):  
D Samba Reddy
Keyword(s):  
United States ◽  
Drug Discovery ◽  
Lupus Erythematosus ◽  
Lymphoblastic Leukemia ◽  
The United States ◽  
New Drugs ◽  
Chronic Obstructive ◽  
The Past ◽  
New Drug ◽  
Drug Approvals

Thirty (30) new drugs have been approved by the FDA in 2011 for marketing in the United States. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new indications for drugs already approved. Eleven of the 30 NMEs were new drugs approved for orphan diseases, while twelve are considered first-in-class drugs with a unique new mechanism of action. During 2011, the FDA approved many unique and new drugs for chronic obstructive pulmonary disease, deep vein thrombosis, systemic lupus erythematosus (SLE), and epilepsy. In addition,  several new biologicals were approved in the past year for the treatment of macular degeneration, acute lymphoblastic leukemia, Hodgkin lymphoma, melanoma, chronic hepatitis C, and SLE. The introduction of 30 NMEs in 2011 underscores a robust success rate. It confirms that innovation is once again beginning to pay off. Analysis of drug approvals reveals a unique new trend in drug discovery in the face of stiff competition from generic products and declining revenues. In the existing climate of reduced pipeline for NMEs, the future and survival of big companies rests heavily on their unique niche products and biologics with relatively less competition from generic manufacturers. However, the competition for biosimilars is growing by the hour and therefore, crafting innovative generic biologicals is vital for generic biotech companies. Although the number of NMEs approved in the past 10 years has been declining, there is a substantial increase in R&D expenditure for drug discovery. Overall, the new drug approval list unveils unique and emerging trends in drug discovery especially in the current generics era. 

scholarly journals STATEMENT FROM THE DIRECTOR OF THE W. E. B. DU BOIS INSTITUTE

2004 ◽  
Vol 1 (1) ◽  
pp. 1-2 ◽  
Author(s):  
Henry Louis Gates
Keyword(s):  
Social Science Research ◽  
Science Research ◽  
The United States ◽  
First Century ◽  
Past Century ◽  
Color Line ◽  
Du Bois ◽  
The Past ◽  
Considerable Work ◽  
Public Policy Decisions

In 1903, William Edward Burghardt Du Bois famously predicted that the problem of the twentieth century would be the problem of the color line. Indeed, during the past century, matters of race were frequently the cause of intense conflict and the stimulus for public policy decisions not only in the United States, but throughout the world. The founding of the Du Bois Review: Social Science Research on Race at the beginning of the twenty-first century acknowledges the continuing impact of Du Bois's prophecy, his pioneering role as one of the founders of the discipline of sociology in the American academy, and the considerable work that remains to be done as we confront the “problem” that Du Bois identified over a century ago.

scholarly journals Advances in Proteomic Technologies and Its Contribution to the Field of Cancer

2014 ◽  
Vol 2014 ◽  
pp. 1-25 ◽  
Author(s):  
Mehdi Mesri
Keyword(s):  
Basic Science ◽  
Tumor Development ◽  
Treatment Strategies ◽  
Science Research ◽  
Biological Processes ◽  
Cancer Genes ◽  
Cancer Genetic ◽  
Care Plans ◽  
The Past ◽  
To Come

Systematic studies of the cancer genome have generated a wealth of knowledge in recent years. These studies have uncovered a number of new cancer genes not previously known to be causal targets in cancer. Genetic markers can be used to determine predisposition to tumor development, but molecularly targeted treatment strategies are not widely available for most cancers. Precision care plans still must be developed by understanding and implementing basic science research into clinical treatment. Proteomics is continuing to make major strides in the discovery of fundamental biological processes as well as more recent transition into an assay platform capable of measuring hundreds of proteins in any biological system. As such, proteomics can translate basic science discoveries into the clinical practice of precision medicine. The proteomic field has progressed at a fast rate over the past five years in technology, breadth and depth of applications in all areas of the bioscience. Some of the previously experimental technical approaches are considered the gold standard today, and the community is now trying to come to terms with the volume and complexity of the data generated. Here I describe contribution of proteomics in general and biological mass spectrometry in particular to cancer research, as well as related major technical and conceptual developments in the field.

Surviving in the Valley of Death: Opportunities and Challenges in Translating Academic Drug Discoveries

2019 ◽  
Vol 59 (1) ◽  
pp. 405-421 ◽  
Author(s):  
Marcus C. Parrish ◽  
Yuan Jin Tan ◽  
Kevin V. Grimes ◽  
Daria Mochly-Rosen
Keyword(s):  
Drug Discovery ◽  
Translational Research ◽  
Early Stage ◽  
The United States ◽  
Academic Programs ◽  
Government Policies ◽  
Pharmaceutical Companies ◽  
Financial Return ◽  
Know How ◽  
Valley Of Death

With pharmaceutical companies shrinking their research departments and exiting out of efforts related to unprofitable diseases, society has become increasingly dependent on academic institutions to perform drug discovery and early-stage translational research. Academic drug discovery and translational research programs assist in shepherding promising therapeutic opportunities through the so-called valley of death in the hope that a successful new drug will result in saved lives, improved health, economic growth, and financial return. We have interviewed directors of 16 such academic programs in the United States and found that these programs and the projects therein face numerous challenges in reaching the clinic, including limited funding, lack of know-how, and lack of a regional drug development ecosystem. If these issues can be addressed through novel industry partnerships, the revision of government policies, and expanded programs in translational education, more effective new therapies are more likely to reach patients in need.

scholarly journals SMALL MOLECULES SOLVING BIG PROBLEMS: PRESENT AND FUTURE OF DRUG DISCOVERY

2018 ◽  
Vol 9 (1) ◽  
Author(s):  
Anna Lucia Fallacara ◽  
Iuni Margaret Laura Tris ◽  
Amalia Belfiore ◽  
Maurizio Botta
Keyword(s):  
Drug Discovery ◽  
Drug Development ◽  
Small Molecules ◽  
Rational Design ◽  
Development Process ◽  
New Drugs ◽  
Drug Development Process ◽  
Development Models ◽  
The Past ◽  
The Cost

The Drug development process has undergone a great change over the years. The way, from haphazard discovery of new natural products with a potent biological activity to a rational design of small molecule effective against a selected target, has been long and sprinkled with difficulties. The oldest drug development models are widely perceived as opaque and inefficient, with the cost of research and development continuing to rise even if the production of new drugs remains constant. The present paper, will give an overview of the principles, approaches, processes, and status of drug discovery today with an eye towards the past and the future.

scholarly journals Recent advances in the development of protein–protein interactions modulators: mechanisms and clinical trials

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Haiying Lu ◽  
Qiaodan Zhou ◽  
Jun He ◽  
Zhongliang Jiang ◽  
Cheng Peng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Discovery ◽  
Small Molecules ◽  
Protein Interactions ◽  
Clinical Studies ◽  
New Drugs ◽  
Protein Protein Interactions ◽  
The Past ◽  
Recent Advances ◽  
Novel Drugs

Abstract Protein–protein interactions (PPIs) have pivotal roles in life processes. The studies showed that aberrant PPIs are associated with various diseases, including cancer, infectious diseases, and neurodegenerative diseases. Therefore, targeting PPIs is a direction in treating diseases and an essential strategy for the development of new drugs. In the past few decades, the modulation of PPIs has been recognized as one of the most challenging drug discovery tasks. In recent years, some PPIs modulators have entered clinical studies, some of which been approved for marketing, indicating that the modulators targeting PPIs have broad prospects. Here, we summarize the recent advances in PPIs modulators, including small molecules, peptides, and antibodies, hoping to provide some guidance to the design of novel drugs targeting PPIs in the future.

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