Future Of Pharmaceutical Industry, Clinical Research, And Product Development Pipeline

Introduction

The future of pharmaceutical industry, clinical research and product development pipeline is promising. Due to need for overcoming numerous diseases being experienced across the world, various countries have come together in conducting researches on drugs and disease control mechanisms. There have also been establishment of laws and regulations facilitating cooperation between different countries. Improvement in technology has also boosted researches within clinics giving hopes for eradication of numerous diseases. The rate at which pharmaceutical industries and product development are evolving leaves no doubt for a brighter future of these industries.

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Future of clinical research

Today, clinical research is suffering from scarce resources and financial constraints. Despite the problems, future of clinical research looks more promising than ever. Laxity from young doctors in conducting research also hampers its development. With outbreak of strange diseases every day, clinics have no choice but to embark on research. This will not only help in eradicating the diseases but will also educate future generations on measure to take in case of such incidences. One of the best means to enhance future of clinical research is by integrating research centers with medical schools. There is no doubt that research will be successful depending on the commitment of those involved in research. With increased awareness among consumers on importance of clinical research, it shows that in the next ten years clinical research will have made great progress. Development of international laws is helping researchers in coming up with research that prioritize on world wide health making it accepted globally. Limited benefits and lack of incentives in clinical research has discouraged many people from getting involved in clinical research.

Inadequate finance in for research conduction has been one of the reasons why research staffs are paid poorly. This has made most of research experts opt to occupy themselves with other jobs. For a long time, governments have failed to increase fund allocated on research despite increase in disease outbreaks. Promises have been made of increasing fund but never fulfilled. In spite of all the hardships, there is hope for improvement in clinical research in most countries. Countries are coming up with plans to boost their research projects. Government institutions are cooperating with private research institutions to improve clinical research. Fund is being set aside for research with better pact being promised to those who accept to conduct research. With this inclination, it is believed that in the next ten years health conditions of most countries will have improved as well as invention of new methods of conducting and analyzing clinical researches.

Many people believe that clinical research is geared towards alleviating human suffering, controlling and treating diseases as well as fostering health. Its failure in meeting these has made many people not trust in it. Advance in technology as well as biology is providing greater opportunity for research improvement. There are varied information sources that can be effective in providing necessary research information. In addition, there are ranges of health systems; such as health maintenance organizations (HMOs) that can help in paving way for effective healthcare. Pharmaceutical companies are continuing to invest on clinical research. However, most researches have been faced with financial constraints. With increased demand in protecting and maintaining health in countries, there is great need for pharmaceutical companies to take advantage of scientific opportunities currently available. Several workshops have been convened by companies involving all stakeholders in bid to highlight some of the problems that have hindered growth of clinical research in the world.

It has been discovered that there has been little awareness among the public on importance of clinical research leading to most of them declining to rely required information to researchers. Inadequate acquisition of data has bee another problem that has rocked clinical research. Lack of qualified personnel in research work has also been another problem (Hughes 2002, Par. 2-4).Due to all the above problems, pharmaceutical industry has decided to come up with action plan to ensure that all problems are addressed. The public is being educated on importance of clinical research to help in ensuring that they participate in preliminary trials required during research. Researchers are being educated on better methods of conducting research and data collection. Some promising initiatives have been established where research education is conducted on every health practitioner starting with nurses and physicians. Researchers have also been categorized to conduct research on specific diseases to ensure that all fields are addressed (Hughes 2002, Par. 6). In future, there is hope that research will have been conducted on all disease fields.

Other hardships being faced by research institutes at the moment includes hardships in storing data electronically, communicating gathered information and consistency of records. Currently, clinics employ an intricate method in storing and conveying patient information. There is inconsistency in clinical and charging system and in recovery and storage of data collected in clinical research. With development in medical industry, it will be possible to predict likelihood of various disease outbreaks before they occur and to devise appropriate measures to counter them. Companies are merging and organizing research information on specific patients in a manner that it will facilitate in establishing disease protection mechanisms easily. There is increase in development of data storage systems that ensure privacy of the patients. Every institute is switching to use of electronic health records. Research data gathered electronically is greatly being used in clinical trials. Through this technology clinical research is being improved as efficiency and accuracy of collected data is being observed. It is believed that clinical research will significantly help in reduction of death cases. Most deaths result due to lack of reliable information regarding patients’ illnesses and trend of their recovery. With their information being stored electronically, it will be possible for medical staffs to monitor their progress and responding in advance (U.K. Medicines and Healthcare products Regulatory Agency 2009, Par. 2).

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Future of pharmaceutical companies

With improvement in technology, there has been creation of new possibilities for industry. By researchers having wide source of information and better understanding of molecular foundation of human illnesses, they are capable of improving on the quality of drugs. There has been improved understanding about markers such as glucose and cholesterol. These markers are being used in manufacturing drugs. With past knowledge on drug metabolizing agents, pharmaceutical companies are now concentrating on development of tools to facilitate in testing doses before being administered on patients or changing patient’s dose. This knowledge is at the moment being advanced trough conduction of numerous researches by clinical researchers. To attain their target goals, pharmaceutical companies are conducting thorough analysis on people’s perception with respect to biomarkers. Various staffs are being enrolled for training to improve their knowledge on use of biomarkers in dose testing and drug production. More people with knowledge on genetics are being assimilated into the companies in bid to come up with effective drugs. As complex diseases continue to appear together with monogenic disorders, companies are coming up with new methods to meet the needs of such patients (U.S. Department of Health and Human Services FDA 2003, Par. 6).

Pharmaceutical companies are vigorously conducting research aimed at improving their services. One of the major breakthroughs in this industry is development of adoptive design. This uses accumulated data about patient’s conditions to modify the mode of treatment of similar patients. Some of the modifications include bringing to an end the treatment, increasing or changing the dose administered to patients and determining the kind of treatment to be provided to various patients. Pharmaceutical and clinical research companies recognize that as new diseases continue to surface, research and production of drugs and other products will continue. By conducting numerous trials on diseases, they will be able to come up with the most effective drugs hence managing to contain most of the emerging diseases. For a long time it has been hard for doctors to get the right drugs to fight specific disease. Doctors have been subjecting patients to trial drugs leading to increment in death rates among the patients. There have been cases of people being prescribed to drugs only to be asked to stop using them later. This has reduced the trust patients had on doctors. Through adoptive dose design, doctors will be able to introduce or stop using various drugs on patients on time reducing their suffering. It will also smooth the progress of in administering extra patients to some doses. The development will help in identifying various drugs for different diseases in advance leading to reduction of death cases (The Economist Technology Quarterly 2009, Par. 4).

Economic crisis have affected most of the world’s economic sectors; pharmaceutical industry, clinical research and product development pipeline being among them. Stakeholders in these sectors have claimed that their companies have been left with little to sustain their growth. Despite the challenges, these companies are coming up with alternatives that provide opportunities for their growth. To reduce on operation cost and maximize on provision of services, companies have opted to outsource. Pharmaceutical industry is coming up with novel methods of operations across the world. They aim at improving their image as well as services for them to improve their profits. The current mode of operations is very intricate. They greatly rely on human knowledge in coming up with new discoveries and development of drugs. As a result, companies have decided to come up with worldwide biotechnological techniques that will help them gain market globally. These include product qualification methods, alteration of regulatory mechanisms and other scientific techniques. There has bee a decline in rate of pharmaceutical products approval for monoclonal and recombinant proteins. However, the trend is changing with time and there is hope for it to improve in the next ten years. In the year 2008, ten new products were approved. There has been an upward trend in development of biosimilars. Through development in technology, reduction in production cost and establishment of favorable healthcare policies the trend is hoped to improve (The Economist Technology Quarterly 2009, Par. 6).

There is a universal believe by pharmaceutical companies that by the year 2012, a lot of drugs will lose exclusive rights to protection leading to emergence of competition from basic manufacturers. This together with other uncertainties within the industry has made various pharmaceutical companies merge and come up with new development strategies. Companies are not only bringing together their resources but are also looking for viable means to improve their research and development pipelines.

Discovery of biomarkers in the pharmaceutical industry has revitalized hopes for its growth. Biomarker is accountable of evaluating the ordinary genetic processes, pharmacologic activities to healthcare intercessions and infective responses. In past, the industry has been blamed for not making progress. Various reasons have been attributed to its slow development. These include domination by merger and acquisition activities. In-stead of focusing on research and development, companies have been concentrating on improving the size and value of product pipeline. It has been noted that for newly merged companies, it can take them as long as four years to improve their productivity in research and development. The industry has also been introducing non-effective drugs in the market for the past ten years making it hard to progress. These drugs have been found to only heal approximately thirty percent of diseases. As many people could not benefit from the drugs, they did not have trust n the industry (U.S. Department of Health and Human Services FDA 2003, Par. 2). Current progress in drug production is giving hopes for growth of the industry in years to come.

Efforts are underway with pharmaceutical industry conducting thorough analysis on need for biomarkers. They are identifying various areas where they need use of new biomarkers. Today, many pharmaceutical companies are storing biomarkers for use in case of re-occurrence of past problems. They are coming up with laboratories and research programs to help in developing new biomarkers for use in identifying various diseases in future. Due to experience that patients respond differently to drugs, it is becoming possible to comprehend how various categories of patients respond to specific drugs. Through this knowledge pharmaceutical industry is expected to make great contribution in developing different drugs to curb some of uncommon diseases.

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For many years doctors have been prescribing grapefruit and other drugs as a remedy for heart problems. Despite grape fruit being a good component of balanced diet, it has proved to bring about complications when it reacts with some drugs. Researchers have noted this as one of the reasons why patients suffering from heart problems claim to have other complications whenever they are prescribed to use grapefruits in combination with other drugs. This has led to pharmaceutical companies embarking on a research for new drugs to be used as alternative for grapefruit (Stump, Mayo & Blum 2006, Par. 1&2). It is believed that by 2020 this problem will have been solved.

Establishment of trade communities is also acting as a booster to future of pharmaceutical companies. There has been a hindrance for trade and exchange of ideas among companies from different countries. One of the main reasons had been variation in mode of operations among states. Laws and regulations within countries have also hindered exchange of products among different countries. For a long time different countries had varied laws regarding health safety, medical devices and practices. There has also been variation in inspection and validation of medical products in different countries making it hard for pharmaceutical companies to borrow ideas from companies outside their countries. Trade unions are coming up with common laws facilitating in exchange of ideas among pharmaceutical companies from various countries. With emergence of common diseases in different countries, companies are willing to collaborate in conduction of clinical research. As every member country is willing to contribute its knowledge on research there is hope for a great breakthrough in clinical research field (Cheng 2003, Par. 1-3).

High cost in clinical development coupled with reduced rate of drugs discovery are leading to decline in productivity of most pharmaceutical companies worldwide. Upsurge of numerous generic drugs and expiry of exclusive rights of some drugs is further making the situation severe. In spite of these, pharmaceutical industry poses great growth opportunity for those adapting new techniques. Companies are concentrating on coming up with drugs for curing diseases that have been neglected for along time. Dynamic world population is expected to compel pharmaceutical companies focus on manufacturing drugs to counter the various up coming lifestyle disorders. As patient categories become more split and treatment methods more advanced, it is likely that there will be an increase in need for private treatment. Companies are shifting from depending on one drug to focus on developing drugs for specific diseases and groups of people. Use of computer posturing and biomarker invention is helping companies in developing new drugs. They are also becoming conversant with clinical expansion processes and in making informed decisions. Companies will reduce cost incurred in investing on ineffective drugs as they will be able to conduct numerous clinical researches. More new methods of identifying ineffective and harmful drugs in advance will reduce manufacturing cost and improve their productivity. In bid to improve drug development pipelines, pharmaceutical companies will result to merging, coming up with licensing accords as well as acquisition (U.K. Medicines and Healthcare products Regulatory Agency 2009, Par. 3).

Future of product development pipeline

Improving drug production pipeline is one of the major problems experienced by pharmaceutical and biotechnology companies throughout the world. Its impacts are not only perceived in pharmaceutical firms but also in medical researches and health care institutions. Various programs have been established to facilitate in alleviating this problem. Companies have embarked on developing drugs that focus on specific group of people who have been deserted for a long time in bid to increase their influence in the market. Companies are shifting from reliance on blockbuster drugs to development of new drugs to fight emerging diseases. Various pharmaceutical companies are merging to help in supply of drugs in the market. It is predicted that in the next ten years companies will be seen to concentrate on developing new drugs to fight new diseases and at the same time to acquire new market shares.

Conclusion

In ten years to come, pharmaceutical industry, clinical research and product development pipeline will have improved greatly with respect to the state they are in currently. Improvement in technology and availability of information research is attracting many people to clinical research. The public has also been enlightened on importance of research. Government and private institutions are readily willing to fund research institutions. With all stakeholders willing to combine effort in conduction of research it is predicted that that many people will embark on research leading to improvement in medical field. With discovery of biomarkers there are great hopes in reduction of human suffering as well as eradication of various diseases in the world. This is because doctors will be able to predict effects of administering specific drugs to patients in advance. Prediction of disease outbreak will also be made easy making countries to arm themselves in preparation to counter the disease. With establishment of laws applying to various countries, pharmaceutical companies will be able to share ideas as well as supplying their drugs to these countries.

Reference list

Cheng, M., 2003. Medical device regulations: global overview and guiding principles WHO, 2003. Web.

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Hughes, M.D., 2002. Surrogate Endpoints as Measures of Efficacy: Complexities & Limitations, Presentation to FDA Advisory Committee. Web.

Stump, A.L., Mayo, T. & Blum, A., 2006. Management of Grapefruit-Drug Interactions, American Family Physician, Web.

The Economist Technology Quarterly, 2009. Case History – The Rhythm of Life. Web.

U.K. Medicines and Healthcare products Regulatory Agency, 2009. Medical Devices Classification. Web.

U.S. Department of Health and Human Services FDA, 2003. Guidance for Industry – Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications. Web.

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