Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs

2014 ◽  
Vol 42 (4) ◽  
pp. 564-575 ◽  
Author(s):  
Shuai Xu ◽  
Aaron S. Kesselheim
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Patient Outcomes ◽  
New Drugs ◽  
Medical Innovation ◽  
Phase 3 ◽  
Current State ◽  
Innovation Output ◽  
The Cost ◽  
Ongoing Concern

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment.

The Economics of New Drugs: Can We Afford to Make Progress in a Common Disease?

2013 ◽  
pp. e126-e130
Author(s):  
Bradford R. Hirsch ◽  
Kevin A. Schulman
Keyword(s):  
Drug Development ◽  
Cost Of Capital ◽  
New Drugs ◽  
Common Disease ◽  
Target Market ◽  
Sustainable Business ◽  
Product Pricing ◽  
Grant Support ◽  
To Come ◽  
The Cost

The concept of personalized medicine is beginning to come to fruition, but the cost of drug development is untenable today. To identify new initiatives that would support a more sustainable business model, the economics of drug development are analyzed, including the cost of drug development, cost of capital, target market size, returns to innovators at the product and firm levels, and, finally, product pricing. We argue that a quick fix is not available. Instead, a rethinking of the entire pharmaceutical development process is needed from the way that clinical trials are conducted, to the role of biomarkers in segmenting markets, to the use of grant support, and conditional approval to decrease the cost of capital. In aggregate, the opportunities abound.

scholarly journals An expanding role for cell biologists in drug discovery and pharmacology

2012 ◽  
Vol 23 (21) ◽  
pp. 4162-4164 ◽  
Author(s):  
Peter K. Sorger ◽  
Birgit Schoeberl
Keyword(s):  
Drug Discovery ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Basic Structure ◽  
Healthcare Systems ◽  
New Drugs ◽  
Conceptual Basis ◽  
The Face ◽  
Programming Skills ◽  
In Cells

The profound challenges facing clinicians, who must prescribe drugs in the face of dramatic variability in response, and the pharmaceutical industry, which must develop new drugs despite ever-rising costs, represent opportunities for cell biologists interested in rethinking the conceptual basis of pharmacology and drug discovery. Much better understanding is required of the quantitative behaviors of networks targeted by drugs in cells, tissues, and organisms. Cell biologists interested in these topics should learn more about the basic structure of drug development campaigns and hone their quantitative and programming skills. A world of conceptual challenges and engaging industry–academic collaborations awaits, all with the promise of delivering real benefit to patients and strained healthcare systems.

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.

New pharmaceutical product development: Barriers to overcome and opportunities to exploit

2008 ◽  
Vol 14 (3) ◽  
Author(s):  
Nic S Terblanche
Keyword(s):  
Pharmaceutical Industry ◽  
Biotechnology Industry ◽  
Pharmaceutical Product ◽  
New Drugs ◽  
New Approach ◽  
Pharmaceutical Product Development ◽  
Sales And Marketing ◽  
Rate Of Increase ◽  
State Of Affairs ◽  
The Cost

The pharmaceutical industry experienced an unprecedented rate of increase in the cost of developing new drugs while the number of new drugs that were approved and accepted in the marketplace has reached a very low level. Various factors are responsible for this state of affairs. One of the major opportunities available to the pharmaceutical industry to improve this situation is to collaborate with the biotechnology industry. The future solutions to a host of current diseases as well new strains of existing ones lie in the cooperation between these two industries. The pharmaceutical industry will, however, have to carefully manage challenges such as increased governmental control and the damaged image of the industry. There are many opportunities offered by offshoring, advanced application of information technology, climate change and a new approach to sales and marketing, all of which the pharmaceutical industry can exploit. Should the pharmaceutical industry manage to address the issues responsible for the high costs prevalent in the industry, its role as partner with the biotechnology industry could prove to be very beneficial for both these industries.

scholarly journals Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development

2020 ◽  
Vol 38 (10) ◽  
pp. 1031-1042 ◽  
Author(s):  
Meenakshi Srinivasan ◽  
Annesha White ◽  
Ayyappa Chaturvedula ◽  
Valvanera Vozmediano ◽  
Stephan Schmidt ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Drug Development ◽  
Economic Value ◽  
New Drugs ◽  
Specific Patient ◽  
Dose Concentration ◽  
Mechanistic Basis ◽  
Pricing And Reimbursement ◽  
The Cost ◽  
The Impact

Abstract Pharmacometrics is the science of quantifying the relationship between the pharmacokinetics and pharmacodynamics of drugs in combination with disease models and trial information to aid in drug development and dosing optimization for clinical practice. Considering the variability in the dose–concentration–effect relationship of drugs, an opportunity exists in linking pharmacokinetic and pharmacodynamic model-based estimates with pharmacoeconomic models. This link may provide early estimates of the cost effectiveness of drug therapies, thus informing late-stage drug development, pricing, and reimbursement decisions. Published case studies have demonstrated how integrated pharmacokinetic–pharmacodynamic–pharmacoeconomic models can complement traditional pharmacoeconomic analyses by identifying the impact of specific patient sub-groups, dose, dosing schedules, and adherence on the cost effectiveness of drugs, thus providing a mechanistic basis to predict the economic value of new drugs. Greater collaboration between the pharmacoeconomics and pharmacometrics community can enable methodological improvements in pharmacokinetic–pharmacodynamic–pharmacoeconomic models to support drug development.

scholarly journals Should we expect an increase in corporate espionage in the pharmaceutical industry of tomorrow?

Revizor ◽  
2020 ◽  
Vol 23 (91-92) ◽  
pp. 37-47
Author(s):  
Milorad Stamenović
Keyword(s):  
Cost Effectiveness ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Industry Growth ◽  
The Future ◽  
The Cost ◽  
Determining Factor

Corporate espionage is a process of obtaining classified information from business competitors for economic reasons and gaining an advantage over the competition. This paper is presenting an analysis of industry growth, investments in R&D and the total value of the investment estimating the possible existence of trends and activities of corporate espionage in the drug development industry. Some authors analyze the cost-effectiveness of corporate espionage compared to investing in R&D, which if shows efficient - might be determining factor in broadening prohibited activities. The results of the analysis show that growing of corporate espionage might be expected in the future due to the growing impact of these industries on society.

scholarly journals Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development

2018 ◽  
Vol 23 (8) ◽  
pp. 765-776 ◽  
Author(s):  
Bernard Fermini ◽  
Shawn T. Coyne ◽  
Kevin P. Coyne
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Clinical Development ◽  
New Drugs ◽  
Attrition Rate ◽  
Preclinical Drug Development ◽  
Current Article ◽  
Induced Pluripotent ◽  
The Cost ◽  
Further Development

The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development. Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs. The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population. This approach, termed “Clinical Trials in a Dish” (CTiD), allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition. The current article offers a perspective of this new model for “humanized” preclinical drug development.

Pharmaceutical Development Process

2019 ◽  
pp. 133-157
Author(s):  
Yaashikaa Ponnambalam Ragini
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
Development Process ◽  
Human Life ◽  
Drug Application ◽  
New Drugs ◽  
Pharmaceutical Drug ◽  
Pharmaceutical Development

The most significant attribute of the pharmaceutical industry is its creations and advancements. The innovation of new drugs is necessary for improving the quality of human life and duration. Pharmaceutical drug development is a time-consuming, costly, and crucial process. The essential goal of drug development is to discover a dosage or dosage scale of a drug application that is both efficient in curing the desired disease and safe. Clinical trials including newly developed drugs that are directed in a progression of successive steps called stages to decide the security and efficacy of the new drug moreover the viability against the targeted diseases. There are four phases through which clinical trials are conducted. An investigational item can be assessed in more than one stage all the while in various clinical trials, and some clinical trials may cover two unique stages.

scholarly journals Cell line access to revolutionize the biosimilars market

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 537
Author(s):  
Dzintars Gotham
Keyword(s):  
Drug Development ◽  
Reverse Engineering ◽  
Cell Line ◽  
High Income ◽  
Manufacturing Processes ◽  
Phase 3 ◽  
Biologic Drugs ◽  
Cost Of Production ◽  
The Cost

Biologic drugs are notoriously expensive. Biosimilars, though priced lower, are also costly. Analysis of the cost of production of biologics suggests that the cost of manufacture is in many cases less than 10% of the price in high-income countries, and less than a third of the price of biosimilars in India. This in turn implies that the relatively high prices of biosimilars are largely due to the need to undertake laborious reverse-engineering and phase 3 trials to demonstrate clinical similarity. In this article, it is proposed that originators could be required to submit cell line stocks to regulators and disclose details of manufacturing processes. These would be shared with prospective non-originator manufacturers to greatly reduce the investments needed to bring a non-originator biologic to market. This system would allow far greater price reductions for biologics after the expiry of monopoly rights (e.g. patents), while maintaining the monopoly rights used to incentivize drug development.

scholarly journals New drug and clinical trial rules, 2019: an overview

2020 ◽  
Vol 7 (4) ◽  
pp. 278
Author(s):  
Swathi A. Annapurna ◽  
Srinivasa Y. Rao
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
New Drugs ◽  
Development Method ◽  
New Drug ◽  
The Government

<p>Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.</p>

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