Analysis on Lowering the Drug Development Cost while Improving the Manufactured Medicine's Quality

ROLE OF EFFECTIVE PROJECT MANAGEMENT IN REDUCING DRUG DEVELOPMENT COST

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i3.16186 ◽

2017 ◽

Vol 10 (3) ◽

pp. 53

Author(s):

Faisal B A Zaidi ◽

Salma Ahmed ◽

Munish Makkad

Keyword(s):

Project Management ◽

Drug Development ◽

Site Selection ◽

Late Phase ◽

Critical Role ◽

Project Manager ◽

Development Cost ◽

The Cost ◽

Patient Enrollment

ABSTRACTPharmaceuticals are passing through the difficult phase due to increasing numbers of patents expiry along with increasing cost of drug development.Protocol design, regulatory cycle time, site selection, patient enrollment and monitoring are some of the cost contributing elements for late phaseclinical trials. This paper applies the principles of project management and suggests means to reduce the cost of late phase drug development. It alsothrows light on the critical role that a project manager can play in overall drug development process.Keywords: Cost of drug development, Effective project management, Reduction in cost of drug development.

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Cancer drug development: The missing links

Experimental Biology and Medicine ◽

10.1177/1535370219839163 ◽

2019 ◽

Vol 244 (8) ◽

pp. 663-689 ◽

Cited By ~ 11

Author(s):

Ajaikumar B Kunnumakkara ◽

Devivasha Bordoloi ◽

Bethsebie Lalduhsaki Sailo ◽

Nand Kishor Roy ◽

Krishan Kumar Thakur ◽

...

Keyword(s):

Overall Survival ◽

Clinical Trials ◽

Drug Development ◽

Targeted Therapies ◽

Science And Technology ◽

Development Cost ◽

Phase I Clinical Trials ◽

Drug Benefits ◽

Number Of Patients ◽

Pharmaceutical Industries

Although better science and technology has been linked with better health care, however, reality is much different. Although America and most of Europe are equipped with most advanced science and technology, paradoxically cancer incidence is highest in the world. This indicates that science and technology alone is not sufficient in treating diseases like cancer. It is also now well recognized that more than 95% of the drugs/compounds that kill either cancer cells in culture or regress the tumors in animals, fail in phase I clinical trials in humans, indicating that most pre-clinical models of cancer are inadequate. In addition, most of the anticancer drugs that are approved by the regulatory agencies such as FDA either has no effect on the overall survival of the cancer patient or may provide an increase in few months in overall survival. This is despite the fact that most targeted therapies that are currently available are highly expensive; thus suggesting the lack of affordability. This review is meant to focus on some of these problems in detail and then provide potential solutions since most cancers are caused by multiple genes, and thus multi-targeted therapies are needed such as natural products which are inexpensive, safe and have been used for thousands of years for both prevention and treatment of cancer. Impact statement The success rate for cancer drugs which enter into phase 1 clinical trials is utterly less. Why the vast majority of drugs fail is not understood but suggests that pre-clinical studies are not adequate for human diseases. In 1975, as per the Tufts Center for the Study of Drug Development, pharmaceutical industries expended 100 million dollars for research and development of the average FDA approved drug. By 2005, this figure had more than quadrupled, to $1.3 billion. In order to recover their high and risky investment cost, pharmaceutical companies charge more for their products. However, there exists no correlation between drug development cost and actual sale of the drug. This high drug development cost could be due to the reason that all patients might not respond to the drug. Hence, a given drug has to be tested in large number of patients to show drug benefits and obtain significant results.

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Drug repositoning or target repositioning: a structural perspective of drug-target-indication relationship for available repurposed drugs

10.1101/715094 ◽

2019 ◽

Cited By ~ 2

Author(s):

Daniele Parisi ◽

Melissa F. Adasme ◽

Anastasia Sveshnikova ◽

Yves Moreau ◽

Michael Schroeder

Keyword(s):

Drug Development ◽

Drug Target ◽

Drug Repositioning ◽

Close Relation ◽

Full Potential ◽

Development Cost ◽

Computational Power ◽

Future Developments ◽

Current Drug ◽

Repurposed Drugs

ABSTRACTDrug repositioning aims to find new indications for existing drugs, in order to reduce drug development cost and time. Currently, numerous successful stories of drug repositioning have been reported and many drugs are already available on the market. Although many of those cases are products of serendipitous findings, repositioning opportunities can be uncovered systematically by following either a disease-centric approach, as a result of a close relation between an old and new indication, a target-centric one, which links a known target and its established drug to a new indication, or a drug-centric approach, which connects a known drug to a new target and its associated indication. The three approaches differ in their complexity, potential, and limits, and most important the necessary starting information and computational power. Which one is predominant in current drug repositioning and what does this imply for future developments? To address these questions, we systematically evaluated over 100 drugs, 200 targets structures and over 300 indications from the Drug Repositioning Database. Each of the analysed cases has been classified based on one of the three repositioning approaches, showing that the majority, more than 60%, falls within the disease-centric definition, around 30% within the target-centric, and only less than 10% within the drug-centric. We therefore concluded that so far repositioning has mainly been disease and target repositioning and not, as drug repositioning, as expected by definition. We discuss the reasons and suggest directions to exploit the full potential of techniques useful for drug-centric in order to sustain future rationale repositioning pipelines.

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