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.

Business versus science: High drug prices conspire against oncological research.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Approval ◽  
Point Of View ◽  
New Drugs ◽  
New Drug ◽  
Drug Registration ◽  
Ethical Point ◽  
Post Marketing ◽  
State Of Affairs ◽  
Drug Approval Process

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.

The basis of the discovery process for a new pharmaceutical product

Open Medicine ◽  
2012 ◽  
Vol 7 (6) ◽  
pp. 691-699
Author(s):  
Veselin Dickov
Keyword(s):  
Pharmaceutical Industry ◽  
Mechanism Of Action ◽  
Active Ingredient ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Discovery Process ◽  
Innovative Drug ◽  
Consumer Value ◽  
History Of ◽  
The Cost

AbstractThe basis of the discovery process for a new pharmaceutical product is in understanding the mechanism of action of a particular disease or processes in the organism related to the disease and/or its symptoms. The essence of a pharmaceutical is in the active ingredient capable of affecting processes within the organism beneficially. The discovery process includes a particular sequence of activities of various profiles of experts, about which various authors agree. The history of pharmaceutical industry (and pharmacy) is measured from one discovery of an innovative drug or approach to treatment of a particular disease to the next one. The cost of pharmaceutical products is one of the key causes of controversy related to this industry. Numerous cultures have proverbs expressing the opinion that health is priceless or that health is the greatest wealth. What if health does have a price? One of the basic premises of marketing is that price should reflect consumer value.

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.

Janus – A New Approach to Air Combat Pilot Training

2019 ◽  
Vol 2019 (4) ◽  
pp. 7-22
Author(s):  
Georges Bridel ◽  
Zdobyslaw Goraj ◽  
Lukasz Kiszkowiak ◽  
Jean-Georges Brévot ◽  
Jean-Pierre Devaux ◽  
...  
Keyword(s):  
Low Cost ◽  
Cost Effective ◽  
High Energy ◽  
Training System ◽  
Embedded Sensors ◽  
Pilot Training ◽  
New Approach ◽  
Combat Aircraft ◽  
Air Combat ◽  
The Cost

Abstract Advanced jet training still relies on old concepts and solutions that are no longer efficient when considering the current and forthcoming changes in air combat. The cost of those old solutions to develop and maintain combat pilot skills are important, adding even more constraints to the training limitations. The requirement of having a trainer aircraft able to perform also light combat aircraft operational mission is adding unnecessary complexity and cost without any real operational advantages to air combat mission training. Thanks to emerging technologies, the JANUS project will study the feasibility of a brand-new concept of agile manoeuvrable training aircraft and an integrated training system, able to provide a live, virtual and constructive environment. The JANUS concept is based on a lightweight, low-cost, high energy aircraft associated to a ground based Integrated Training System providing simulated and emulated signals, simulated and real opponents, combined with real-time feedback on pilot’s physiological characteristics: traditionally embedded sensors are replaced with emulated signals, simulated opponents are proposed to the pilot, enabling out of sight engagement. JANUS is also providing new cost effective and more realistic solutions for “Red air aircraft” missions, organised in so-called “Aggressor Squadrons”.

scholarly journals Advances in Applying Computer-Aided Drug Design for Neurodegenerative Diseases

2021 ◽  
Vol 22 (9) ◽  
pp. 4688
Author(s):  
Mootaz M. Salman ◽  
Zaid Al-Obaidi ◽  
Philip Kitchen ◽  
Andrea Loreto ◽  
Roslyn M. Bill ◽  
...  
Keyword(s):  
Drug Design ◽  
Neurodegenerative Diseases ◽  
Docking Studies ◽  
New Drugs ◽  
Computer Aided Drug Design ◽  
Biological Assays ◽  
Advantages And Disadvantages ◽  
Computer Aided ◽  
Research Challenge ◽  
The Cost

Neurodegenerative diseases (NDs) including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and Huntington’s disease are incurable and affect millions of people worldwide. The development of treatments for this unmet clinical need is a major global research challenge. Computer-aided drug design (CADD) methods minimize the huge number of ligands that could be screened in biological assays, reducing the cost, time, and effort required to develop new drugs. In this review, we provide an introduction to CADD and examine the progress in applying CADD and other molecular docking studies to NDs. We provide an updated overview of potential therapeutic targets for various NDs and discuss some of the advantages and disadvantages of these tools.

An examination on data integrity auditing patterns in cloud computing

2018 ◽  
Vol 7 (1.9) ◽  
pp. 200
Author(s):  
T A.Mohanaprakash ◽  
J Andrews
Keyword(s):  
Cloud Computing ◽  
Information Security ◽  
Data Integrity ◽  
Cloud Service ◽  
New Approach ◽  
Computing Services ◽  
Security Challenges ◽  
Cloud Server ◽  
State Of Affairs ◽  
Dynamic Updates

Cloud computing is associate inclusive new approach on however computing services square measure made and utilized. Cloud computing is associate accomplishment of assorted styles of services that has attracted several users in today’s state of affairs. The foremost enticing service of cloud computing is information outsourcing, because of this the information homeowners will host any size of information on the cloud server and users will access the information from cloud server once needed. A dynamic outsourced auditing theme that cannot solely defend against any dishonest entity and collision, however conjointly support verifiable dynamic updates to outsourced information. The new epitome of information outsourcing conjointly faces the new security challenges. However, users might not totally trust the cloud service suppliers (CSPs) as a result of typically they may be dishonest. It's tough to work out whether or not the CSPs meet the customer’s expectations for information security. Therefore, to with success maintain the integrity of cloud information, several auditing schemes are projected. Some existing integrity ways will solely serve for statically archived information and a few auditing techniques is used for the dynamically updated information. The analyzed numerous existing information integrity auditing schemes together with their consequences.

scholarly journals Getting Prices Right: What Should Be Done?

1998 ◽  
Vol 12 (1) ◽  
pp. 37-46 ◽  
Author(s):  
Angus Deaton
Keyword(s):  
Cost Of Living ◽  
Identification Problems ◽  
Single Index ◽  
Rate Of Increase ◽  
Price Indexes ◽  
Short Run ◽  
The Cost ◽  
Heterogeneous Consumers

Much of the profession accepts that the CPI likely overstates the rate of increase of the cost-of-living. It is less clear that there are sound and feasible steps that the BLS can adopt to improve matters in the short run. There are unresolved conceptual and identification problems in the measurement of quality. Superlative price indexes are not feasible, and feasible approximations are not superlative, and may not even be better. The need for a single index that aggregates over heterogeneous consumers with different incomes, tastes, and needs casts serious doubt on the cost-of-living approach.

Inferring age from otolith measurements: a review and a new approach

2004 ◽  
Vol 61 (7) ◽  
pp. 1269-1284 ◽  
Author(s):  
RIC Chris Francis ◽  
Steven E Campana
Keyword(s):  
Simulation Experiment ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
New Method ◽  
Population Parameters ◽  
Benefit Analysis ◽  
Mixture Analysis ◽  
New Approach ◽  
Individual Fish ◽  
The Cost

In 1985, Boehlert (Fish. Bull. 83: 103–117) suggested that fish age could be estimated from otolith measurements. Since that time, a number of inferential techniques have been proposed and tested in a range of species. A review of these techniques shows that all are subject to at least one of four types of bias. In addition, they all focus on assigning ages to individual fish, whereas the estimation of population parameters (particularly proportions at age) is usually the goal. We propose a new flexible method of inference based on mixture analysis, which avoids these biases and makes better use of the data. We argue that the most appropriate technique for evaluating the performance of these methods is a cost–benefit analysis that compares the cost of the estimated ages with that of the traditional annulus count method. A simulation experiment is used to illustrate both the new method and the cost–benefit analysis.

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