The Present and Future of Personalized Medicine in Saudi Arabia - Essay Example

The present and the future of personalized medicine in Saudi Arabia By Name () University () Date () DECLARATION This Dissertation is my original work and has not been presented for a degree in any other University. ……………………… …………………… Signature Date NAME…… ADM NO… Student This dissertation has been submitted for examination with my approval as University Supervisor. …………………….. …………………… Signature Date NAME ……… University Supervisor ACKNOWLEDGEMENT I wish to thank the Almighty God for giving me this noble chance in life, my family members and friends for their support and my supervisor, NAME()., for all the feedback, guidance and support he has given me throughout the writing of this dissertation. DEDICATIONS This work is dedicated to my () for his/her () passion and support ABSTRACT Medical treatments for various ailments have in the past become very in effective leading to the ban of some drugs from being used because of their toxicity or adverse reaction to some patients. However, after the human genome project completion a lot of focus has been put to personalized genomic medicine, which involves the utilization of the genome technology to assess individual risk so that delivery of the right treatment at the right time is achieved. Although the genome wide information is very vital, it is recognized that gene expression is important than the genome sequence hence the utilization of the proteomic strategies could enhance tracking of the gene products leading to a more advanced personalized treatment. In the recent years there have been numerous partnerships forged between the biotechnology companies and pharmaceutical companies signaling the end of an era of blockbuster model of drug production. The incorporation of the phamacogenomics has also enhanced focused treatment since it does not only focus on drug metabolism but also the drug delivery process, which includes transporters that affect absorption, distribution and excretion of drug. In this regard, this research paper seeks to study personalized medicine and its present and the future in the kingdom of Saudi Arabia. The paper is divided into five major chapters, the chapter one introduces personalized medicine discussing its application, the advantages and the disadvantages and the business view associated with personalized medicine thus developing the objective of he research and the research questions that guides the study. The second chapter provides the literature of the previous studies and articles on personalized medicine looking into the foundation of personalized medicine, the current practices in this mode of treatment, the use of personalized mode of treatment in cancer. In addition, this chapter also looks into the single nucleotide polymorphism (SNPs), the drug response, the pahmacogenomics and the ADME genes. This chapter concludes by looking into the risk assessment tools and the integration of the genomic testing into the clinical practices. The third chapter focuses on the application of personalized medicine in the treatment of various cancers such as the breast cancer and the neurodegenerative diseases such as the Parkinson disease. The fourth chapter studies the present and the future application of the personalized medicine in Saudi Arabia paving the way for the chapter five, which provides with the methods used to facilitate the study and to collect data .this chapter also provides the results of the data and the analysis using table, pie charts and bar charts. The last major chapter’s chapter six which discuses the results obtained makes conclusion and gives recommendations for the study. Key words: phamacogenomics, proteomics, personalized medicine, genomic medicine, SNPs ABBREVIATIONS SNPs single nucleotide polymorphism DNA deoxyribonucleic acid RNA ribonucleic acid ADME absorption, distribution, metabolism and elimination FDA food and drug administrators CT colon test EGFR epidermal growth factor VEGF vascular endothelial factor FNAB fine -needle aspiration biopsy CNV copy number variation GWAS genome wide studies IGMC international genome conference Table of Contents DECLARATION ACKNOWLEDGEMENT DEDICATIONS ABSTRACT ABBREVIATIONS CHAPTER ONE 1.0 Introduction 1.1 Advantages of personalized medicine 1.2 The disadvantages of personalized medication 1.3 Business point of view on personalized medicine 1.3 Research objectives 1.4 Research questions 1.5 Research hypothesis 1.6 Justification 1.8 Scope 1.9 Limitations of the study CHAPTER 2: LITERATURE REVIEW 2.0 Introductions 2.1 Foundation of personalized medicine 2.3 Current personalized medicine 2.4 Personalized medicine in cancer 2.5 Commercial direct-to-costumer SNP analysis 2.6 Drug response 2.6.1 Pharmacogenomics and ADME genes 2.7 Risk assessment tools and prediction 2.8 Integration of genomic testing into clinical practice 2.9 Summary CHAPTER 3: DISEASES RELATED TO PERSONALIZED MEDICINE 3.0 Introduction 3.1 Cancer diseases 3.1.1Breast cancer 3.1.2 Lung cancer 3.1.3 Colon cancer 3.1.4 Pancreases cancer 3.2 Neurodegenerative diseases 3.2.1 Alzheimer’s disease 3.2.2 Parkinson’s disease CHAPTER 4: Present of personalized medicine and SNPs in Saudi Arabia CHAPTER 5: Methodology of the research, Results and data analysis 5.1 Introduction 5.2 Research Design 5.3 Population 5.4 Sampling frame 5.5 Instruments 5.6 Primary and secondary data 5.6.1Primary Data 5.6.2 Secondary Data 5.7 Data Processing and Analysis 5.8 Characteristics of employees studied 5.8.1. Response rate 5.8.2. Years of service of employees in the health care CHAPTER 6: Summary of objective, conclusion, recommendation on the present and future of personalised medicine in Saudi Arabia 6.1 Introduction 6.2 Summary of the Major Findings H1 personalized medicine has improved health care provision in Saudi Arabia H2 the pharmaceutical companies have to design a new business portfolio that is in line with the personalized medicine requirement H3 personalized medicine is the way for the future health care provision in Saudi Arabia 6.3 Conclusions 6.4 Recommendations REFERENCES APPENDIX 1 questionnaire List of tables Table 2.0: Biomarkers of established or potential clinical utility to guide therapy Table 2: The Sampling Frame Table 5.1: Response rate List of figures Figure 5.1 Employees years of service Fig 5.2 rating the performance and growth of the current health care system Fig 5.3 drug effectiveness Fig 5.4 effects of personalized approach to drug response Figure 5.5 showing the involvement of government, healthcare provides and pharmaceutical companies in personalized medicine Fig 5.6 effective treatment of cancer and neurodegenerative diseases through personalized approach Fig 5.7 Employees propose the ways for integrating personalized medicine in the current healthcare Fig 5.8 whether the Saudi Arabians were aware any company providing single nucleotide polymorphism (SNPs) services Fig 5.9 role of the pharmaceutical company in enabling the adoption of personalized medicine Fig 5.10 the need to integrate genomic medicine and the pharmaceutical companies Fig 5.11 -business threat in adopting personalized medicine Fig 5.12 whether pharmaceutical companies should adopt new business tactics Fig 5.13 need to regulate genomic medicine Fig 5.14 current personalize, medicine is efficient and effective to gain trust from more patients Fig 1.15 whether there is adequate facilities to support personalized medicine Fig 5.16 presence of adequate health care policies to allow the adoption of the personalized medicine in Saudi Arabia CHAPTER ONE 1.0 Introduction In the recent past, there has been increased need to improve drug safety and efficacy. According to the study by Aspinall and Hamermesh (2007, p.110), the innovation of the new technologies in personalized therapies is in highly required in order to increase the number of people who benefit from the pharmacological medications. The adoption of personalized medicine that relies on the pharmacogenetics is eyed to provide informations that can help to customize the patients’ health care. Personalized medicine is actually a modern medical model that concentrates on individual genetic profile so that the best medical outcome is realized through selection of treatment that is effective to an individual patient genetic profile (Kalow, 2009, p. 163). Personalize medicine extends traditional approaches which tend to base their treatment on observation in order to come up with the diagnosis or drug prescription. Therefore, in personalized medicine prescribing and dosing is actually carefully tailored and customized to fit individual genetic variant (Jain 2009, p.250). To make personalized testing possible pharmacogenetics testing is done to ascertain the availability of validated genetic tests, this validated genetic tests have data that links the availability or absence of a specific variant which has specific outcome (Lazarou, Pomeranz and Corey 1998,p. 280). This data has also to have an updated connection that is able to link appropriately and without error the genetic variation and drug response. Therefore, personalized medicine goes beyond the normal physical appearance to the genes that are proven responsible for the variation in chemical reactions in response to medication (Lesko, 2007, p.808). Furthermore, variation in the genetic coding that is responsible for the level at which one is predisposed to a certain disease and it determines how a particular individual would response to treatment of that particular disease. In addition, personalized medicine utilizes the genetic mapping in the investigation of some specific diseases, which involves the genetic profile of the patient. Therefore, genetic mapping gives also the required information that allows appropriate selection of medication for treatment. Personalized medicine also uses the strategy that checks the genetic predisposition of patients (Kalow, 2009, p. 168). The employment of micro arrays techniques to test for genetic mutations that help to make a classification of patients in different categories of metabolizes. As a result, there is always a higher possibility for abolishing or reducing the side effects of various medications and development of a specific kind of disease treatment. Consequently, because there are different pharmaceutical companies that make drugs it could lead to a more collaboration with the medical laboratories in order to develop drugs that are personalized in order for the personalized medicine to be realized (Shurin, and Nabel, 2008, p. 402) 1.1 Advantages of personalized medicine Personalized medicine at its peak will lead to a more accurate means for disease diagnosis and treatment thus reducing the possibilities for faulty diagnosis because of the individual care that the patient receives while under treatment. Personalized medicine is evolutions of disease treatment scheme that has shifted from the traditional model that used observation and assumed that all patients could be treated with the same drug for the same disease, by emphasizing on individual gene profile as the basis for treatment of disease could lead to eradication of vary many diseases at individual level. According to Aspinal and Hamermesh in their article (2007, p.128) the clinical trial of targeted therapies usually are not such expensive as the broad based medication. Thus, the personalized therapies could be cheaper and effective than the older methods for treatment. Personalized treatment notifies the patients the possibilities of them being susceptible to disease and thus end up improving the disease detection and preventing its possible progression. This is through single nucleotide polymorphism (SNPs) services that is provided for individual by various companies which is bale to predict a possible susceptibility to certain disease due to the type of genetic make up .this prediction enable one to avoid things that may further expose them to risk for instance in the case of cigarettes for lung cancer. Personalized medicine also abolishes the use of trial and error in administering of medication to patients thus bringing in a specific mode of drug prescription for a particular disease for the particular patient (Lazarou, Pomeranz and Corey, 1998, p. 286). Another advantage of personalized medicine is that there were some drugs which were withdrawn from the market or failed clinical trials ,these drugs could be revived and found useful for certain patients. Personalized medication also prevents a complete withdrawal of a drug from the market. These drugs are revived on the basis that these drugs did not have an adverse reaction to all the patients that used it. Since personalized medicine is a selective form of prescription to drug with regard to predicted reaction, and then it becomes possible to use these formally withdrawn drugs for patients who do not develop adverse reaction or toxicity after use. By embracing personalized medicine, there is a projection that it will lead to an overall reduction of healthcare cost and lead to a more control and patient centered access to medical records. Thus, in the end medical health would be affordable to all. Personalized medicine will also make people to be more aware of their genetic risks and advantages, thus shaping peoples lifestyles (Lazarou, Pomeranz and Corey, 1998, p. 289). 1.2 The disadvantages of personalized medication Despite the fact that personalized medication could be a great breakthrough in disease treatment compared to the traditional method of approach. It cannot be presumed accurate by noting genotype of a person before administering medication this is because the human metabolism is also varying in micro periods where it is determined by the environmental conditions, nutrition, attitude and their history. In addition, human genetics is not the only factor to consider when assessing for any disease drug response or cause but there are other factors such as proteomics and environment, which should also be considered before making any decision. Therefore, personalized medicine is not a simple model but a complex one that require high skilled professionals to interpret. Personalized medicine is still being established and therefore, it might not be readily advanced for use because it also requires legislations that allow for the medical laboratories and the pharmaceutical companies to work in unison, thus this is hindered by the business notion or orientation of the pharmaceutical companies. In addition, at its present young state, there is no mechanism in place, which can help to confirm that the genetic tests are in deed true before they are marketed since inappropriate test may lead to deceiving a health care provider and subsequently the patient. There is also possibility of misleading marketing claims by various drug manufacturers because the tests are directly sold to the patients or consumers this is because there is no established health care provider who serves as regulators of genomic medicine to block misinterpretation and of test results or even inappropriate test ordering (Heymann 2006, p. 672). 1.3 Business point of view on personalized medicine The core business aim is to maximize profit and to remain in business. However, the business owners also will require personalized medicine that is centered at a personal level. In this regard, there are several businesses, which now offer genotyping services (Kewal 2009, p. 84). According to The economics (2009, P.3), some pharmaceutical companies acknowledge that the blockbuster era of drug production is gone and the companies have to be innovative, informed, cheaper and targeted drugs. However, full adoption of the personalized medicine is very challenging and the companies must look for a suitable business model since personalized medicine could lead the pharmaceutical companies being unable to make fully a certain economic calculation of drug production and marketing. In addition, a legislation to regulate the drug companies could affect their development of budgets and their market plans and in overall affect the product lifecycle. According to The economics (2009,P.4) there is a change in focus from marketing and sales of pharmaceutical products to an emphatic focus on the patient education that lays more emphasis on the proactive care, targeted treatments and prevention. The businesses have to increase their emphasis on proactive testing for various pre-symptomatic individuals; the business sector will have to find a way to educate their physicians and patients to focus on their latest genetic tests. Some view that that personalized medicine would not translate into fewer cases of disease arguing that targeted therapies could still have a large revenue potential for the pharmaceutical companies (The economics, 2009, p 2). Therefore, there is need for businesses to make new strategies since initial investment by the biopharmaceutical companies in personalized medicine are expensive since the various forms of medications have to be in line with the variations of genetic information. The setting up of laboratories as well as the equipment to carry out the change by biopharmaceutical companies in order to produce drugs that are in line with personalized medicine is expensive since it requires the collection of a large number of data in relation to genetics and the drugs to be made. The production costs are also to go up since the individualization of health care in personalized medicine will require variations in the medications to be used from one individual to another. Hence, the drugs will be produced on individual basis rather than the previous ways in which drugs were produced on a mass scale without special considerations given to variances from one individual to another. The pharmaceutical companies also have to spend more especially on their marketing due to the changes in terms of medication, which have been instituted by the introduction of personalized medicine. Since the drugs to be used will now be based on, individuals and the marketing will also now need to focus on individuals rather than the olden way of focusing on masses. With a large database in the future, the biopharmaceutical companies will be able to meet the demands of the new population that is embracing rapidly personalized medicine. Therefore, this study will look into the development of present and the future personal medicine in Saudi Arabia as the main objective. 1.3 Research objectives General Objectives To evaluate the present and the future of personalized medicine in Saudi Arabia Specific Objectives 1. To evaluate the effects of the present personalized medicine practice to health care in Saudi Arabia 2. To evaluate the effects of personalized medicine on pharmaceutical companies in Saudi Arabia 3. To determine the future of personalized medicine in Saudi Arabia 1.4 Research questions 1. How does personalized medicine affect the provision of health care in Saudi Arabia? 2. What are the effects of personalized medicine to pharmaceutical companies in Saudi Arabia? 3. What are effects of personalized medicine to the future healthcare provision in Saudi Arabia? 1.5 Research hypothesis H1 personalized medicine has improved health care provision in Saudi Arabia H2 the pharmaceutical companies have to design a new business portfolio that is in line with the personalized medicine requirement H3 personalized medicine is the way for the future health care provision in Saudi Arabia 1.6 Justification Health care effectiveness and drug efficacy remains a major problem in Saudi Arabia. The Governments in the attempt to provide medical health to its citizens is still challenged by the effectiveness of the health care provided especially in cancers diseases and neurodegenerative diseases. As a result, a lot of money goes into waste while treating drug side effects and the treatment of diseases that have unpredictable trends of response to drug ending up with unintended consequences for the performance of drugs and therapies. Therefore, government agencies, pharmaceutical companies and public can utilize the findings of this study after understanding the level and function o personalized medicine in the country. 1.7 Scope The scope of this study shall be on the Saudi Arabia. The respondents shall come from within the organizations that provide health care in Saudi Arabia and the government agencies. This therefore, shall imply that the information obtained shall not be limited to those interviewed. 1.8 Limitations of the study The survey might face a challenge due to few similar studies; this will limit the room for comparisons. The next challenge that the researcher might face is lack of cooperation from the administrators and in this case, the information to be collected may not be sufficient to give a good conclusion for the study. Finally, the researcher might face the problem of lack of enough time to collect the information thus narrowing the findings of the study CHAPTER 2: LITERATURE REVIEW 2.0 Introductions This chapter review relevant literature to this research. It puts more focus on cancer and neudegenerative diseases in personalized medicine. 2.1 Foundation of personalized medicine The foundation of the personalized medicine is pahamacogenomics; this is study concentrates on the effect of the genetic make up to the body’s response to drugs. Over the past years, there have been many studies on the gene ushering a good understanding of the DNA and RNA (Langreth and Waldholz 1999, p.426). This research has been to understand various human diseases, which then has ushered in the development of another form of disease treatment and therapies using this genetic information. the concept of personalized medicine was initiated by sir William Osler in 1849-1991,he was able to deduce that there is a very great variation between human bodies each with distinct reaction under abnormal conditions like diseases (Willard and Ginsburg 2009, p.214). Furthermore, when Framingham heart study in 1960 (Lander, Linton and Birren et al., 2001, p.870), elucidated the ‘factors of risk’ became the first population based that found out that there were individual in the population who were at a higher risk of developing heart conditions. Thereafter, the developments in the human genome project became the tool for understanding the complexities of disease biology and variation. These tools enabled a more precise prediction of risk and response to therapies (Lander, Linton and Birren et al., 2001, p.870). Thus, these tools gave way for the genomic and personalized medicine that enables the health care providers and patients to utilize this proactive and preventive health planning (Langreth and Waldholz 1999, p.427). In 2007,the then senator for Illinois Obama tabled a legislation in the genomic and personalized medicine Act of 2007 whose aim was to enable allocation of necessary resources and integrate the government and other stakeholders to advance to partner in the advancement of this new medicine field. Thus, the last 10 years have seen many government officials, the public, the health care provides and industry leadership accepting and embracing personalized medicine (Willard and Ginsburg 2009, p. 216). According to the translational research (2009, p.68), the tools for personal medicine practices are being developed which will lead to a major transformation of the health care system. However, the foundation supporting the scientific and the technological application that allow for the individualized approach to health care are still developed. Although a proper ground has not yet been laid down fully for this system of health care, there is also the economic and policy issues that still have to be considered (Davis, Furstenthal, Desai, Norris, and Sutaria, 2009, p. 280) 2.3 Current personalized medicine Personalized medicine is just becoming steadily known among the public although it has not been well understood by many, and even if it has, there has not been enough development and policy framework to allow health care providers both in public and in private sector to embrace it fully (Willard 2009, p.224). However, initial benefits from several treatments based on predictive factors have already been taking place. For instance cancer, several targeted therapies that is aimed at specific cancerous causing cell mutations. A number of cancers, including the Gleevec for chronic myelogenous leukemia and Herceptin for some forms of breast cancer have been very successful in the use of the predictive factors (Hanahan and Weinberg 2000, p.58). However, the health care providers are still basing their treatment of some forms of cancer on the body tumor instead of using the molecular aberrations that could be the cause. On the other hand, according to Bild, Potti & Nevins (2006, p.735) it has been deduced that cancer develops because of multiple genetic defects and that person with the same type of cancer would not have the same genetic defects in their tumors. This is why patients with the same type of cancer do have different response to anticancer agents, which is clearly the main obstacle in the cancer treatment. However, in the past decade there has been a great shift from the ‘one size fit all’ kind of therapy for cancer to a more personalized approach. This new approach is enabled by determining each patient’s specific genetic defects in their tumor (Emery, Kumar & Smith 1998, p.79) In drug tasting, it has been demonstrated by Apostolia-Maria Tsimberidou of the university of Texas MD Anderson cancer centre, in Houston (Garber 2009, p.137). That using targeted therapies in the three phase trials by use of the volunteers genetic profile to the drugs being tested saved a lot of time and money. This aspect has been highly embraced by drug companies because it shows that the drug developer could skip phase II and jump straight to phase III which is the test for efficacy of the drug which is prospected to save the company several years of clinical studies and money (Garber 2009,p.137). On the other hand, scientists in royal Marsden hospital, in London, have come up with the method of probing tumors directly as they are able to test bits of DNA that floats on the blood stream (Xenidis , Perraki and Kafousi et al.2006,p.3757). The recent advances in the molecular diagnostics have also enabled the understanding of the link that is between the telomere length (this is the sequence of DNA that repeats at the end of the chromosome whose function is to protect them from damage) maintenance deficiencies. In addition to, the increased pathologies, which are not, related to the hematopoietic system or in other words the blood cellular components (Harry, Semple, Parkin and Gilbert 2010, p. 100). Blood clots was formally treated by warfarin before the emergent of the genome based molecular screening, this drug was dangerous because it could lead to excessive bleeding. However, after genotyping for patients undergoing warfarin, it allowed the prescription of drug therapy regimens on to patients that were likely to benefit from the drug at specific dosage (Xenidis , Perraki and Kafousi et al.2006, p.3758). Colorectal cancer is the most severe among the population than the breast cancer. This cancer was normally treated using cetuximab. The biomarkers for colon cancer a protein encoded by the KRAS gene predict the characteristic of response that the cancer tumor would respond to specific therapeutic drug. However, it was found that cetuximab was only effective to colon cancer patients that had a normal KRAS gene and for other patients it could be ineffective thus, alternative therapy could be sought (Harris, et al. 2007, p. 1200). For breast cancer, the molecular diagnostics have been applied to women breast screening to determine the type of receptor that their tumor cell contains (Harris et al.2007, p.1230). Additionally, tissue typing during tissue transplant such as that of the bone marrow has been personalized to allow the donor and the recipient link to offer the most accurate genetic match; this has enabled the reduction of the risk of adverse immune response (Harris, et al. 2007, p. 1200). Furthermore, diabetes treatment has been utilizing personalized, where the patients rapidly analyses their blood sugar level to determine the amount of insulin to be injected with. The molecular diagnostic tests are also being used to help the HIV/AIDS patients to determine their type of HIV infection at individual level, since there are two types of HIV;HIV-I and HIV-II with their subtypes groups and strains (Harry, Semple, Parkin and Gilbert 2010, p. 110). This leads to a more specific and precise treatment. This genetic testing can also be used to determine the adverse drug reaction for the HIV patients thus reducing the risks. 2.4 Personalized medicine in cancer Cancer research is the leading field in personalized medicine. Oncologists have determined the uniqueness of cancer in every patient in prognosis, clinical presentation and the tumor response and tolerance to therapeutic drugs. In addition, differences second malignancy, risk of recurrence and long-term complications of therapies. According to Downward (2006, p.275), there is a very distinct difference between personalized medicines in cancer compared to other diseases. In cancer, the factors that are used to classify groups of patients are normally tumor specific factors while in other diseases they used somatic genetic variations. secondly, the approach for personalized medicine for cancer treatment is to determine prognosis of the disease while in other diseases personalized medicine is based on the improvement of drug efficacy, thus if it can perform effectively its function in a particular patient. According to Harry, Semple, Parkin, and Gilbert (2006, p.123) the reason for prognosis in cancer patients is to know the cause of the disease and help in making decision in cancer therapy. The development of a specialized field of medical genetics called cancer genetics that is currently dealing with the hereditary cancer risks. Has enabled some understanding of the cancer predisposing syndromes where the allele does segregate in an autosomal dominant mode that lead to high risks for some type of cancer. However, genetic variations have called for the need to a have a more distinct personal method in cancer risk assessment. Every type of cancer that is found in human beings is made up of a biological subset that is different in the clinical behavior and response to treatment (Mandrekar and Sargent 2009, p.4030). Therefore, these subsets must be recognized in order to produce a better result in the treatment of that cancer. For instance, some important tumor subtypes include oestrogen receptor HER2 that indicates a positive breast cancer. Another subtype is none small cell lung cancer (NSCLC) with the epidermal growth factor receptor (EGFR) indicates activating mutations, and colorectal cancer that has the KRAS gene mutations. And a summary biomarkers as shown of the table below Table 2.0: Biomarkers of established or potential clinical utility to guide therapy (Mandrekar, & Sargent 2009, p.4038) Tumor type Biomarker Potential clinical use Breast steroid hormone receptors select hormone therapy Breast Her2 select trastuzumab use Breast Oncotype Dx gene profile Assess prognosis; select chemotherapy Colon KrAs mutation status Guide eGFr-specific antibody use Colon Microsatellite instability Assess prognosis or utility of 5-fluoruracil adjuvant treatment Non-small cell lung eGFr mutation Guide selection or use of eGFr tyrosine kinase inhibitors Non-small cell lung erCC1 select platinum-based chemotherapy Glioblastoma MGMT methylation Guide temozolomide use Melanoma BrAF v600e mutation select therapy Key: eGFr, epidermal growth factor receptor; erCC1, excision repair cross-complementation group 1; Her2, also known as erBB2; MGMT, methyl guanine methyltransferase The use of biomarkers in the identification of the patient’s possible treatment out come is very cost effective. According to McMurray, Sampson and Compitello, et al., (2008, p. 1114) cancer progression characterization can also be done using system biology or networks of gene interaction that is found within the cell. This is based on the fact that cells in each molecular species is made functional by a very finely tuned set of homeostatic process that is able to react and respond to internal or external stimuli. The information within these molecules is usually propagated through very complex signaling networks, which may alter the transcriptional programs of some specific gene thus affecting the others downstream. It is evident that cancer is a multifaceted disease, which can originate in various tissues and become involved in the disruption of the normal cellular pathways. This complexity is made more complex by their variability. Understanding of these factors has been the foundation of the computational biology. 2.5 Commercial direct-to-costumer SNP analysis It is very possible in the modern technological era to screen an individual for disease status or carrier status characteristics. In order to achieve this one has to search for disease characteristic that is based on another person’s genotype. The requirement for this is the DNA and the analysis tools. however, in the modern days there are companies that have come up to help in the analysis and genotyping, an individuals sends saliva in which the persons genome is screened for inter human variants known as the single nucleotide polymorphism(SNPs) (Yoshiura, Kinoshita and Ishida et al.2006,p. 325). These DNA are very different in distinct individuals and it can be found all over the human genome. The SNPs are mapped using international Hapmap consortium, found in the Hapmap project. The use of this map is to link disease variations in individuals, carrier status, drug response and human traits. Presently there are about 23 diseases that an individual undertaking the SNPs mapping can be informed whether he or she is a carrier of any of these diseases. When one has two disease alleles is called a carrier, but this individual does not have disease phenotype) (Yoshiura, Kinoshita and Ishida et al.2006, p. 328). An individual taking SNPs mapping is also given information on how they can respond to 19 drugs, such as the metformin used in the treatment of type II diabetes. Despite the fact that this is the most prescribed drugs for treatment of the type II diabetes, various individuals respond differently to the treatment as under-treatment or over treatment. The drug can also result into very severe side effects. Therefore the information that this individual is given can be very helpful to health care providers in the adjustments of the dose given for this form of diabetes to particular individual (Yoshiura, Kinoshita and Ishida et al.2006, p. 330). 2.6 Drug response Drug researching and development has change tremendously since the publication of the human genome and the change from ‘one size fit all’ form of drug prescription and disease treatment. In the modern health care, there is individual need, which is based on the genetic background of an individual that must be considered before prescribing a therapy or treatment. This personalized drug prescription is based on the individual drug response that is derived from the phamacogenomics, which guide medical decision-making. 2.6.1 Pharmacogenomics and ADME genes The traditional mode of drug prescription was for large group of patients. However, the number of patients that the drug achieved the desired effect was very few. This indicated that there were patients who could not respond to the drug. Moreover, a number of patients could result in very server side effects. This could be attributed to the fact that the manufacturer does not establish most of the drugs moleculer mode of action and therefore it could be difficult to tell the severity of the side effect of the drug to certain patients. However all the drugs have a common kinetic factor. This kinetics can be utilized to predict the response of drug to an individual. All other factors held constant, a drug must be absorbed in the body for it to be distributed for metabolism. Therefore, the drug must undergo the four-pharmacokinetics processes, which include absorption, distribution, metabolism and elimination, which are put together and abbreviated as ADME (Grossman 2009, p. 450). Therefore, it is the inter–individual variations of the genes, which is involved in the process that brings about the observed variation in the drug response by different individuals. For instance, the mutation in the absorption protein that is found in the ileum could lead to variation in the efficiency f the drug due to variant concentration attributed to absorption. The ADME genes are categorized into four groups (Grossman 2009, p. 458). The phase I and phase II metabolizing enzymes. The phase I gene is responsible for the modification of the functional groups while the phase II genes are responsible for the conjugation of the endogenous moieties. Then the transporter protein genes are responsible for the transport that takes place in and outside the cell. The serum binding proteins, they bind proteins to enable their transportation through the circulation. Lastly, the transcription factors and modifiers are known to be involved in the transcription of other ADME genes (Grossman 2009, p. 460). Genetic variations in various ADME genes have already been established (Pasanen, Neuvonen and Niemi 2008, p. 20). This has enabled linking of the genetic variation to the drug response and thus it helps in the prescription of drugs to various patients. 2.7 Risk assessment tools and prediction The most crucial tool for the personalized medicine is to have a standard health risk assessment (HRA) that help in the determination of possibilities fro an individual developing the common chronic diseases. This tool is effective when it is coupled with predictive models that facilitates the assessments and concentrate on the patients risk to develop disease. There are several models but the most renowned model is the Framingham coronary heart disease model, this was developed by the Framingham heart studies (Kannel, Dawber, Kagan, Revotskie and Stokes 1961, p.37). However, the Gail model with its latest versions is the most accepted tool for the breast cancer risk assessment. Furthermore, HRAs is developing to the standard, it is known to be the initiator for the personalized medicine mode of disease treatment. Another important risk assessment tool is the family history (FHH).It is a very valuable tool in delivering a personals health risk information, the family history reflects a much intertwined combination of the shared genetics, lifestyle factors and the environment. It integrates the genomic risk information of the patient leading to preventive measures (Hariri, Yoon, Moonesinghe, Valdez and Khoury 2006, p. 758). The last vital tool is the genomic information; this has been highly facilitated by the completion of the human genomic sequence project, which has facilitated the cataloguing and discovery of variations among different individuals. 2.8 Integration of genomic testing into clinical practice There is a lot of optimism for this new mode of approach disease treatment. However, despite this optimism regarding the impact of genomic testing there are many obstacles that must be overcome in order to integrate this personalized medicine into the clinical practices (Jain 2009, p. 367). There are reasons that hinder the incorporation of the genomic into the patient’s treatment guidelines. One reason is that the researchers, pharmaceutical firms and the medical regulatory authority have not come up with the framework that can help to confirm the effectiveness of the drugs. In addition, the health care providers have not yet established ways that can allow this new mode of treatment to fit in their current model of care and risk assessment (Beitelshees and McLeod 2006, p.498). Furthermore, there is possibility of bringing in additional cost, which is not yet communicated or confirmed by the payers. In this regard, a framework has been developed and being proposed that could help genetic testing evaluation and establishing the technical capacity and the operational standards for the tests. In addition to , the diagnostic capacity and the effect on the clinical decision making, the mode of integrating the cost with the current physicians methods ,the cost effectiveness of the treatment and the health care outcomes for the patients (Beitelshees and McLeod 2006,p. 499). Therefore, there is need for health care policy change so as to accommodate a system wide adoption, there is also need for regulatory policy, the acceptance by FDA to embrace personalized medicine and genomicmedicne as a solution to the current unsustainable pharmaceutical industry model for drug manufacturing and development. This has led o a growing list of drugs approved by FDA and over 200 products are labeled as to recommended influence genetic testing and drug response safety. 2.9 Summary From the literature reviewed above we can deduce that the current practice of personalized medicine is has not been fully established and is currently facing various challenges. However, there is notable progress in personalized treatment of some diseases like cancer whose clinical assessments and management of patients has become a reality of the implementation of the personalized medicine. Consequently, it is expected that personalized medicine will improve treatment efficacy, minimize cost of health care and reduce prescribed drugs toxicity. The genome-profiling project holds the major stake in revealing more drug targets especially for cancer treatment. However, the challenges for fully adoption of this mode of disease treatment and drug are still to overcome. In addition, the framework policy has not been established thus hindering the full progress of adoption. Furthermore, there is still need for the integration of the drug companies with the healthcare laboratories, which is yet to be realized. CHAPTER 3: DISEASES RELATED TO PERSONALIZED MEDICINE 3.0 Introduction This chapter will discuss some of the diseases that are quickly and easily be treatable using the genomic or personalized medicine method. 3.1 Cancer diseases 3.1.1Breast cancer The incidence of breast cancer is very high n the United States females, in the year 2010 28% of every female patient in the US who had cancer suffered from breast cancer (Jemal, Siegel, Xu and Ward 2010, p. 280).It is the most common form of cancer and the second world leading form of cancer death in women. There are certain heritable genetic factors that lead to breast cancer risk. However, breast cancer is said to be a heterogeneous disease that manifests it self as different molecular subtypes, which respond to chemotherapy agents and radiation differently. There are several chemotherapy drugs that are available today, which includes tamoxifen, aromatase inhibitos, anthracyclines, fulverstrant, cyclophosphamide, taxanes, platinum, vinorelbine, lapatinib, bevacizumab, trastuzumab and others. There are very many clinical decisions that have to be made from the time the cancer is diagnosed to the time it is cured or undergoing palliative treatment. These clinical decisions are concerned with the type, the combination and the severity of treatment that is to be applied (Goldhirsch, Ingle, Gelber, Coates, Thürlimann, and Senn 2009, p. 1320). The traditional treatment of the cancer used the microscopic evaluation to determine the type of treatment by utilizing the histology of the tumor, the size of the tumor the status of the tumor auxiliary node and the metastasation of the tumor to a distant location. In addition, there is the surgical removal of small tumor patients (lumpectomy) if the tumor is below 5 centimeters. However, if the tumor is above 5 centimeters the whole breast is surgically removed (mastectomy) (Gebauer, Fehm, Lang, Jäger 2002, p. 1670). It is through the surgical removal of the lymph node that allows for the analysis for the presence or absence of the lymph node metastasis. After the analysis, the information gathered is used to make the appropriate decision on treatment, whether the patient should start with the adjuvant chemotherapy. However, only the patients who indicate a positive lymph node metastasis that are advised to start chemotherapy. The patient’s tumor size and the lymph node status plays a very crucial role in the prognostic results of treatment and the survival, however, this factor are said to have low sensitivity and specificity (Dunnwald, Rossing, and Li 2007, p.9). This indicates that the health care providers have been doing lots of research to characterize tumors in order to increase effectiveness of certain therapies. The tumor characteristic search has resulted in more factors that are used to determine the adjuvant treatment of the breast cancer. The tissues that make up the tumor are stained after surgery to express the estrogen (ER) and the progesterone (PR) receptors. However, there has been treatment using receptors inhibitors, which inhibit the functions of these receptors, the drugs work by competitively binding their steroid binding domain (Gebauer, Fehm, Lang, Jäger 2002, p. 1674). This is because all the cancerous breast tumors are analyzed for the expressions of ER and PR as a result all those patients whose tumor express either ER or PR are treated using the adjuvant endocrine (tamoxifen) therapy which is usually combined with the cytostatics. On the other hand, the patients whose tumor does not show any expression for the ER and PR are treated using cytostatics alone (Dunnwald, Rossing, and Li 2007, p.11). Furthermore, the ER positive tumour cells not to represent a single entity they can be graded as low grade ER-positive and high grade ER-positive (Morales, Canney and Dyczka, et al 2007,p.335). These two grades can be differentiated using the immunohistochemistry (IHC) through FOXA1 and GATA-3. In addition, Oncotype DX, MGH2-gene signatures, the intrinsic gene signatures or even MapQuant Dx through limited molecular profiling, can also differentiate it. However, the ER biology is still under research and many scientists are trying very best to understand it. As a result, this would enable proper classification and thus a better-personalized approach to the ER –positive breast cancer. The development of this receptor expression to distinguish between the cancers has enabled adjuvant treatment and reducing the number of relapse and side effects that were experienced before. This is because; they are able to treat patients who can only respond well to this kind of therapy thus increasing therapy efficacy. It is also because by treating only the expressed receptor patients it reduced the side effect posed to none expressed receptor patients. Moreover, the developments from the studies seeking to identify other factors have been positive with a new predictive factor coming into place. It has been identified that the aggressive tumors and poor prognosis are associated with the over expression of the human epidermal growth factor receptor Her-2/neu by certain tumor tissues (Slamon, Leyland-Jones and Shak, et al.2001, p.785). As a result, anew drug for Her-2/neu has been developed for the patients with the tumors that overexpress this factor. This drug is a monoclonal antibody that is set against the extracellular domain of the Her-2/neu receptor this drug is known as Trastuzumab (hercepacine). The treatment with this drug also is very effective for the patients of this classification. For those patients that may show negative for estrogen, progesterone and HER2 receptors, which is classically called the triple negative breast cancer. This cancer does not respond to therapies such as tamoxifen or herceptin, therefore the health providers use other therapies to treat this cancer. In most cases a combined therapy that comprises of radiation, surgery and chemotherapy are used. However, the treatment for this type of breast cancer is still under studies and may take the genomic medicine approach. For the post menopausal women with receptor-positive metastatic breast cancer Faslodex and Raloxifene are drug options for treatment (West, Blanchette and Dressman, et al.2001, p.11465). Therefore, breast cancer treatment has always taken the personalized dimension by using various prognostic and predictive factors in its treatment to determine the appropriate treatment for individual patient. In this regard, during the patients classification, the number of groups are usually very few than the number of patients per group. However, still, there are patients that do not respond well to treatment in these groups thus calling for further classification through personalization to treat patients in basing on evidence. by the use of the published human genome the expression profiling method for many different mRNAs of the breast tumor tissues which can further be used to determine subsets of the genes that can give predictive value with regard to treatment and prognosis of the breast cancer (Morales, Canney and Dyczka, et al., 2007,p.332). Therefore, the use of genomic profiling to asses the probable risk of tumor recurrence, drug toxicity and drug resistance is very useful in the treatment of the breast cancer. The application of the pahamacogenomics in the treatment of the breast cancer is vital. For it uses the genome wide approach to understand and study the inheritable and inherited basis for the various drug responses with the aim of developing drugs that are more effective and efficient. Therefore, an understanding of the way genetics influence drug efficacy and toxicity has a great potential in the development of a personalized drug treatment system that is based on an individual genetic make up. Therefore, the promise for the phamacogenomics in the breast cancer research is to help in the improvement in drug safety and efficacy (Morales, Canney and Dyczka, et al., 2007, p.332). . 3.1.2 Lung cancer This is a heterogeneous group of disorders and often posing many challenges in determination of its treatment. Lung cancer is the most prevalent form of cancer among men worldwide. The risk factors of this cancer include those caused by chemical compounds. Generally, it is caused by a long exposure to the environmental carcinogenic mixtures and also life style, diet and factors that are unique to the host (Pope; Burnett; Thun; Calle; Krewski; Ito and Thurston, 2002, p. 1136). the host factors include ,carcinogenic exposure ,the genetic pattern of the host, the DNA repair activities, nutritional status, carcinogenic metabolism, oncogene and tumor suppressors expressions The current treatment is based on the surgical resection for early-stage diseases which is then followed by a chemotherapy that has radiation or without in the latter stages of the disease. The use of personalized approach in the treatment of the disease has shown a lot of promise. the most utilized biomarkers which are observed for molecular abnormalities include the KRAS gene ,EGFR, MET,ALK,COX2 and CBL, which has come in the first line as therapeutic targets (Adonis; Martinez; Riquelme; Ancic; González; Tapia; Castro; Lucas; Berthou and Gil,2003,p. 8). The most promising application of genomic medicine to lung cancer treatment is derived from the gene expression of the cancer cells (Salgia, Hensing , Campbell , Salama , Maitland, Hoffman , Villaflor , Vokes 2011,p.278) . therefore ,this expressions of the gene, cDNA arrays and oligonucleotide arrays analysis have become vital tools in which the researchers are using to enable understanding on selected clones and the genes that are over expressed in some type of lung cancers and do identify some therapeutic targets (Irarrázabal; Rojas; Aracena; Márquez and Gil,2009,p.70). 3.1.3 Colon cancer Colorectal cancer is a major killer cancer in the United States. The most important biomarkers for colon cancer is the KRAS gene that is responsible with the response to certain therapies. Subgroups analysis when employed reveals that the drug cetuximab is efficient and cost effective to patients who have a high epidermal growth factor receptor (EGFR) copy number. Therefore cetuximab is only limited to those patients with EGFR – overexpressed colorectal tumors (Dube, Heyen, and Jenicek, 1997, p.38). The latest studies indicates that the colorectal tumors that have the KRAS mutation do not respond to cetuximab and any other related treatment therefore these patients do not benefit from the treatment. Hence, the EGFR-directed monoclonal antibodies were disbanded for these patients (Weiser et al.2008, p.382). The studies for early detection of the cancer led to the improvement of therapies for the early but limited stage of the cancer. Because there are different, methods employed for the treatment of the colon cancer. The use of adjuvant therapy for the resectal limited stage colon cancer has three stages involved. However, in the present day imaging techniques it is advisable to patients that they have to undergo an evaluation with the CT (colon test) scans before being administered curative surgery after being diagnosed with this cancer. 3.1.4 Pancreases cancer Pancreatic cancer (PC) kills more people than any other cancer known. Despite the strides made in its chemotherapy, the death rate has not changed meaning that there has not been effective chemo treatment of this cancer (Farrell, Elsaleh, Garcia, Lai, Ammar and Regine et al.2009, p.189). However, there are research being carried out using therapies that target the epidermal growth factor (EGFR), various specific mutation in proteins such as the KRAS gene ,vascular endothelial growth factor (VEGF),immunotherapy which utilizes the tumor associated antigens and other biological therapies (Dong , Javle, Hess, Shroff, Abbruzzese, Li 2010,p.465). However, all these trials therapies have not bore any fruits in the treatment of the pancreatic cancer. Therefore, since pancreatic cancer is a heterogeneous disease a personalized genomic approach would provide an avenue for tailoring treatment to fit the unique modifications of individual patients and their tumors. This is boosted by the fact that the human genome has already been sequenced thus offering the required information on the human genome readily. However, early detection of pancreatic cancer through the application of the personalized technology, its localization and treatment would not be easy (Rozenblum, Schutte, Goggins, Hahn, Panzer and Zahurak et al.1997, p.1732). Despite this, there is hope that personalized genome approach to this cancer would finally lead to very significant improvement of therapy treatments. The most common life span for the patients with pancreatic cancer is not more than six months (Han 2010, p.40). This is because there is no early detection, diagnosis and effective treatment for patients with advanced disease condition. For this to be averted and increase the survival period of the advanced patients ,precise tumor markers for the disease diagnosis and modern molecular targets have to be quickly developed and thus it calls for personalized approach to treatment of this cancer (Han 2010,p.42). There has been a lot of effort in the research for the genes that are associated with this cancer and those that are associated with the progression with the malignant characteristic of the pancreatic cancer. Therefore, this has resulted with the identification of the alterations in the expressions of various cancer related genes found in the pancreatic tumors (Han 2010, p.42). This identification and hence characterization of these cancer genes have increased the information that has helped better understanding of the cancer. Many models have been used to determine the best drug for this cancer. The advancement of the genomics and the proteomics research has generated the greatest impact in the drug discovery for the pancreatic cancer, which includes the model system tools in the research (Han 2010, p.43). The development of the assay technique that helps in the predicting of the tumor response to treatment was impossible in the past because there were no good methods to acquire tissues from the tumor. In the past large tumor, specimens were required for the chemo sensitivity assays. The adoption of the fine- needle aspiration biopsy (FNAB) enhanced the acquisition of the tumor rich cells that was ideal for the analytic molecular tests (Han 2010, p.43). In this regard, using the freshly acquired heterotranspalnted human tumor xenograf resulted in adequate tumor cells and proteins quantities that are ideal for the analysis of the efficacy of the drugs before the and during systemic treatment of this cancer (Han 2010, p.44). The personalized treatment where the optimal agent is identified for individual patients, This is based on the fact that each patients tumor does respond to drugs that is in other wise active to against other patients . Consequently, the tumor pancreases xenografts from those patients who have resectable pancreases edenocarcinoma are usually treated with a battery of different acceptable anticancer agents with the aim of making the priority of the best treatment incase of the recurrence of the disease after being treated with gemcitabine (Han 2010, p.40). This method is ideal for the resected pancreatic cancer due to the fact that patients are treated with the adjuvant chemotherapy after resection. However, this personalized medication for pancreatic cancer should not be generalized for there are shortcomings thus this is restricted to patients who are undergoing surgical resection and there is availability of excess tissues from their tumor. In addition, there must be successful propagation in both in-vitro and in vivo conditions (Han 2010, p.40). This form of personalized treatment of the pancreatic cancer is tailor made and the restrictions must be strictly adhered to for any success to be achieved. 3.2 Neurodegenerative diseases 3.2.1 Alzheimer’s disease Alzheimer disease is very complex and difficult to diagnose, the current diagnosis is based on the suspecting though the disease cannot be detected an early stages. A robust based system biomarkers panel that is used could help in the in the modification of the drugs for therapy. Since this disease is neurodegenerative, it is heterogeneous thus there is need to apply a personalized approach mode of treatment in order to slow down further progression of the disease(Camberg, Woods, Ooi, Hurley, Volicer, Ashley, Odenheimer and McIntyre 1999,p.447). The biomarker that is observed is the CSF, which enables the classification of the patient into groups that have different response to treatments (Jain 2009, p.250). The CSF AB1-42, P-Tau18P and total CSF tau protein are the three levels of the biomarkers that allow the health care givers to identify early stages of the Alzheimer’s disease including other neurodegenerative diseases pathogenic progression (Spector, Thorgrimsen, Woods, et al.2003, p.250). In Alzheimer disease, the scientists have been able to combine both genetic and molecular approaches for them to be able to identify and group individual patients. Thus, they are able to come up with a more predictive, personalized, preventive and participatory health care design that is helpful in the improvement of the elderly patients. 3.2.2 Parkinson’s disease Parkinson’s disease is a progressive, multisystem neurodegenerative disorder that results in motor and non-motor symptoms in very many people around the world. Its prevalence increases with age thus impairing the quality of life of the patient. The disease therapy is aimed at early detection and alleviation of motor and non-motor symptoms and hence the improvement of the quality of life of the patient (Chaudhuri and Schapira 2009, p.468). However, most healthcare providers do not recognize non-motor symptoms as in any way related to the Parkinson disease. The current treatment of the disease after accurate and comprehensive assessment is by the use of dopamine replacement therapy, which is combined with carbidopa, dopamine agonist, levodopa, catechol-o-methyltransferase inhibitors, monoamine oxidase type B inhibitors and amantadine. However, in the recent genomic studies, it has been deduced that mutations in the parkin gene and the PINK 1 gene could be the source of recessive inheritance of the Parkinson disease (Fisher 2011, p.1768). Therefore, the a availability of a single parkin or the PINK 1 gene mutation is normally associated with a dopaminegic nigrostriatal dysfunction which has a higher risk in enabling the development of the Parkinson disease. Consequently, neurimaging of the non-manifesting persons with a mutant parkin or PINK1 allele enables an early phase detection and investigation of the Parkinson disease (Eeberger, VanderArk, and Robinson 2010, p. 8). CHAPTER 4: Present of personalized medicine and SNPs in Saudi Arabia The Saudi bioscience company is the largest and most equipped with modern technological equipment in the whole of Middle East. The basic aim of the company is to initiate the development and implementation of the personalized medicine concept by documenting the variations exhibited in the Arabic population (Saudi Biosciences. 2010). Therefore, Saudi Bioscience Company was able to initiate sequencing 100 Arab genomes ,it also explores copy-number variations (CNV) and also perform genome wide studies (GWAS) as they collaborate with major middle east institutions. In this regard, in the year 2008 at Riyadh in Saudi Arabia, the Saudi bioscience company in collaboration with Beijing genomics institute Shenzhen and CLC bio performed the first and the initial sequencing of the Arab human genome and its analysis as part of the main project aimed at sequencing 100 Arab human genome. The sequencing could help to map the unique genetic variation displayed in the Arab world population. As stated by his royal highness prince Ahmad bin sultan bin Abdul-Aziz who is the head of directors at the Saudi bioscience that the genome sequencing marked the first milestone in their goal to pioneer the personalized medicine concept in Saudi Arabia and the Arab world at large(Saudi Biosciences.2010). Henceforth, this will enable the achievement of the modern medicine and genetic research that will enable tailoring of medical care to fit and individual genetic make up of profile. Furthermore, on 16th and 17th of February 2011, the Saudi Arabians hosted the first international genomic conference (IGMC), thus enabling the country scientists to interact with the world top grade scientists in various fields of genomics. The Arab genome database being developed will play a major role in the advancement of the personalized medicine. In addition, the recent advertisement for international services by the center of excellence in genomic medicine research at king Abdulaziz University situated in Jeddah, Saudi Arabia. It seek to fill created vacancies for researchers and experts in the cancer genomic research program, stem cell research program and many others is a sign that the country is prepare ring it self for a major shift in the mode of disease treatment and therapies (G.I.Z,2010). This can further be confirmed by the fact that the center of excellence in genomic medicine research is owned by the most reputable, recognized university in Saudi Arabia, and is highly supported by the ministry of high education of the country (MOHE). The vision of this institution also should be considered as it reiterates that its aim is to become a leading location in the region for advanced research in human genetics and make advancement in fight against the genetically determined diseases (G.I.Z, 2010). Personalized medicine is also a newly established mode of treatment program at king fahad medical city. This program is situated at badir biotechnology incubators laboratories with the aim of providing advice and guidance to those patients seeking personalized medicine thus enabling the physicians find the correct drug for treatment (Rofaiel, Muo and Mousa1 2010, p 131). The most common form of DNA variation in the human genome of the Saudi Arabians population is also found in the single nucleotide polymorphism (SNP). The SNPs is known to present the natural genetic variability in the human genome and is considered the main source of the phenotypic variability that brings about the differences within different species of individuals. The SNPs are found in the non-coding and the coding regions (Rofaiel, Muo and Mousa 2010, p 136). When it takes place in the coding region, it generates polymorphic variations observed in the expressed proteins, resulting in altered functionality of the protein. The allelic occurrences of any SNP differ across populations. This is because an SNP is found in every 300 to 1000 bases for the humans, as there are extreme level of possibilities that the nucleotide can position in the human genome at which could generate a certain level of natural variation. The studies being undertaken by the scientists in Saudi Arabia is based on the belief that SNPs could be used to identify genes that contribute to the population wide polygenic disease. Their main aim is to identify genes that contribute to disease and develop disease therapies that target these genes and be can used to predict the possible disease occurrence and drug reaction (Rofaiel, Muo and Mousa 2010, p 139). According to Al Mashni (2009) post, Genetika is Acibadem Health care Group’s Genetic Diagnosis Center and Treatment Center, which is the largest genetic center in Turkey and among he largest in Europe. This center (Genetika) provides genetic services to al people around the world including Saudi Arabia. Therefore, this implies that there are people in Saudi Arabia who have been in the past receiving services for the personalized medicine from foreign companies abroad. According to oxford business group (2009), there is great expansion of healthcare facilities in the kingdom of Saudi Arabia posing a great challenge to the ministry of health (MOH) officials. The need for doctors is overwhelming and thus the ministry opt for oversee doctors. Furthermore, the ministry is geared towards the development of personalized medicine in the kingdom (Oxford Business Group 2009, p. 225). According to Aida (2011), personalized genomics and stem cell research is very vital in the development of a knowledge-based diagnosis, prevention and the treatment of various diseases. Since the Saudi Arabia has been able to develop a high-density single nucleotide polymorphism, (SNP) information for clinical application that is available to many people due to the affordable prices charged. However, it has been understood that genome sequencing is not in whole the only in formation required to enable the application of the personalized medicine but it is just a part of the required information which is added to other information’s such as the epignomics and transcription which must also be integrated with the genomic information. This information should be associated with the data of the large or entire population so that there may be sufficient predictive and personalized diagnostic information at hand. Saudi Arabia has a culture that allow for the first cousin marriage. These marriages tend to lead to a very unique but common genetic disorders such as the sickle cell anemia and thalassaemia and other whose proper treatment is not yet been established . Therefore, it is projected that these diagnostic challenges would be overcome by adoption of the genomic or personalized medicine in the kingdom. However, just like in other cultures the ethical issue also is an issue of concern in the Saudi Arabia kingdom concerning the use of human genetic techniques. In countries like Saudi Arabia, whose religion has a strong influence on the political decisions processes, genomic medicine is also the center of debate, which would lead to development of the policies that are in line with the cultural or religious believes Linjawi (2010) reiterated that it is the basic science, which has been the backbone of the development of the personalized medicine. Linjawi (2010) says that his company would integrate the genome 1000 project and the future sequencers in Saudi Arabia in order to come up with definite variance of the entire population to identify the specific genetic factors that are related to a variety of diseases such as cancer, especially the drug resistance to breast cancer and diabetes. According to Runges and Patterson (2006, p48) the kingdom of Saudi Arabia also has established program that help to educate, manage and counsel various individuals and families on their genetics issues. Therefore, the genetic counselor discipline is mainly concerned with the human genetics and counseling skills at the masters level of the health professionals. Adopted and revised in 1993 and 2006 respectively. The code of ethics of the national society of genetic counselor main role is respect for client’s autonomy and the patient’s advocacy. For phamacogenomics to be fully realized in the kingdom for various diseases the clinical and the epidemiologic studies are still required to assess the way the drug respond among various persons of different genotypes . The prevalence of the specific genotype in the population and subpopulations and the level at which the environmental factors influence the drug response among the various genotypes individuals in the population. However, despite the recent rapid genomic technology progress in the field of supporting personalized medicine in Saudi Arabia all the way from the discovery of the biomarkers and the genome sequencing being done by the Saudi bioscience center .there has been little progress that has translated to clinical benefits for the personalized patients. For instance, the biotechnology sector has been un able to come up with other biomarkers for the breast cancer other than the human epidermal factor 2 (HER 2). The use of the drug hercepatin had shown great breakthrough in the treatment of breast cancer. The personalized medicine research advances being produced by the Saudi bioscience include tests to determine the best treatment for patients with hepatitis C and genotyping of cancers to match with the best therapies . The Saudi Arabia food and drug administrators (FDA) approved the use of hercepatin that targets the human epidermal factor 2 (HER 2) of breast cancer patients and has shown to be very effective against cancers that test positive for HER2 overexpression (Saudi Biosciences. 2010). The common difficulties faced by the companies as if Saudi bioscience is the regulatory oversight. This is so because the clinical rout for the development of the diagnostic tests are to properly marked and regulated. Therefore, the laboratory-based tests are not subject to food and drug administrator of the Saudi Arabian country (FDA) premarket approval. However, the tests that are marketed must undergo the premarket approval process although the rule has not been clearly set. According to Runges and Patterson (2006, p50) getting drug for the right people at the right time is the main principle and ultimately what personalized medicine is all about. In addition, personalized medicine implementation would require more than just a push of technology development and commercialization but it needs the health care providers to fully involvement in the drug administration and progress monitoring. CHAPTER 5: Methodology of the research, Results and data analysis 5.1 Introduction This chapter provided an explanation of the methods used in carrying out this study, emphasizing the data analysis. Various methods are used in the conduction of research. The aim of this research methodology is to give reliable and valid reasons behind the conclusions obtained with regard to the research questions. This chapter relates to a justified and very informed account of the manner in which the research was approached. Thereafter, the chapter will present data, which was obtained using 100 questionnaires from 100 respondent’s working at security forces hospital, collage of pharmacy at king Saudi university. Others are pharmacists working in various hospitals and drug companies’ addition to lecturers and associate professors at universities in Saudi Arabia. The data was analyzed using SPSS chi-square and then the resulting percentages were tabulated and illustrated by the use of tables and figures. 5.2 Research Design The research used descriptive case study design, which enables a clear presentation of the variables under investigation. This is because the research utilized both the qualitative and quantitative data. The data was collected, edited, summarized and reduced to basic representative values that helped to present the findings in tables, pie chart and graphs 5.3 Population Population refers to the entire group of individuals, events or objects having common observable characteristics. The aggregate of all conforms to a given specification. For the purpose of this research, the Saudi Arabian health care providers, pharmaceutical companies and government representatives in the health sector, lecturers and professors of the universities will be chosen. The sample population comprises of 100 employees. 5.4 Sampling frame Table 2: The Sampling Frame Cluster No. Cluster Type Business Population percentage Representation Sample Size 01 02 Managers Other staffs 30 70 100% 100% 30 70 Total 100 100 5.5 Instruments The main instruments for data collection in this research will be through questionnaires. The research questionnaire will be used for all administration staffs. The choice of questionnaires as a data collection tool was arrived at after a close and in-depth consideration of the research goals and the target group. Random method of sampling was to a large extent employed in order to ensure that the most reliable information that would be a representative of the whole population is arrived at. Managers, government representatives and other staffs in the health sectors opinions would be collected through the planned distributive questionnaires among random groups. In addition to the questionnaires, other online sources of information, journals, books, written articles and magazines have also been utilized in the data collection process (Vogt 2001,p.16).The method was applied because it provides a link between the theoretical perspectives, research purposes and the data collected which in turn elicits the research findings (Miller & Neil 2002,p.148). 5.6 Primary and secondary data Based on the research paradigm and the chosen research method, there are a series of data generation methods that can be used. Most of the times, several data generation methods are used for the same study; 5.6.1Primary Data Like any research work, the role of primary data is very significant and can therefore, not be negated whatsoever. Thus, regarding primary sources, the research shall make immense usage of questionnaires. All these instruments shall be used in extracting useful information from all stakeholders in the health care sector, especially at the decision-making levels in the healthcare agencies. There shall be questionnaire structured in both open-ended and closed-ended format. The decision to use open-ended questions is because of the quest to find more information besides the general questions posed. Open-ended questionnaires are able to give room to respondents to present more information compared to the one they could have given had they been provided with closed-ended questions. Secondly, the use of open-ended questions to level mangers and other tactical level managers and staffs is vital because, these people are able to access huge information in the health care compared to other lower level employees and the public. Furthermore, by providing them with open-ended questionnaires, they can be able to fill in information that could assist in the final recommendations of the research regarding the impact of personalized medicine and SNPs in Saudi Arabia. Other people that shall be interviewed shall be customers of various occupations in order to find out their feelings regarding the adoption of personalized medicine and SNPs in the healthcare provision. 5.6.2 Secondary Data The use of secondary data shall be equally important in this research. This is because; it is through studying the existing literature regarding personalised medicine that the researcher is going to understand the overall conception and impact of it in the all sector. Therefore, various books, journals, and websites shall be utilized in order to understand better the use of personalized medicine and SNPs in Saudi Arabia. The researcher shall also use secondary sources of information in order to design the necessary questions based on the previous studies so that such answers shall be evaluated alongside the research findings. Secondary sources shall also be used in examining and understanding the manner in which health care providers in Saudi Arabia have embraced the usage of personalised medicine and SNPs. The research shall as well utilize both the qualitative and quantitative measures in research in studying the secondary sources. Therefore, it shall utilize the SPSS programs in analyzing the statistical findings of the all usage. This is a very important approach owing to the nature of all in dealing with numbers as well as statistical information. 5.7 Data Processing and Analysis Data will be analyzed by both qualitative and quantitative approaches. The data that will be obtained from questionnaire will be analyzed using Statistical Package for Social Sciences software (SPSS) by using the chi-square test. Chi-square is a one variable test that in this case will be used to determine the Saudi Arabia people’s interest or feelings towards the implementation of personalized medicine and do away with the traditional model of disease treatment. In addition, this test will determine whether the data normally distributed or not. This will enable an effective testing of the research hypothesis. This software was chosen in this research because it is able to handle large quantities of data and is thus efficient for the data processing and analysis. The data will be summarized and presented using tables, bars and pie charts. This study will be using secondary data that has been published in accordance with accountability measures. However, in keeping with ethical standards in the conduct of research with human participants, and respect for copyright of the published data, respect, consent, and confidentiality will be accorded to respondents (Arthurs, 2005, p.58). 5.8 Characteristics of employees studied 5.8.1. Response rate The target sample was 100 respondents for the study. However, 82 respondents participated fully and gave their response through the questionnaires of the study. This constituted of 82% response rate, which is considered adequate for this study. This is represented in the table below. Table 5.1: Response rate Test Statistics Respondent Number Chi-Square(a) .000 df 81 Asymptotic Significance 1.000 a 82 Cells 100.0% low freqs 1.0 expected low... 5.8.2 Years of service of employees in the health care The question sought to establish the number of years that the employees have been in the health organization. Most 56.8% of the employees have been working in the organization for one year; 33% have been in the organization for two years; 10.2 % have been in the organization at most 3 years. Therefore, these are people with experience and their contribution in this study could give valid sentiment of the entire population. This is as expressed in the test below NPar Tests Chi-Square Test Frequencies Figure 5.1 Employees years of service 5.8.3 The question on rating the performance and growth of the current health care system, this question was aimed at assessing the projection that the current system of health care is taking, if it is taking advantage of the enhanced technology in treatment and in its expansion of services and health care providers. The response on growth in its provision of health care 22 % rated it high 68.3% medium and 9.7 % low. On the provision of adequate drug information to the patient, this question seek to know whether the service providers gave enough information to the patients on the prescribed drugs concerning its adverse reaction or possible side effects the response was 9.7% rated it high 36.6 % medium while 53.7% rated it low. On the creation of genomic medicine awareness, this was aimed at determining whether the new mode of treatment has reached a level that patients could be notified about, the services 7.3% rated it high 28% medium 64.7% low. As depicted by the chi-square analysis NPar Tests Chi-Square Test Frequencies Fig 5.2 rating the performance and growth of the current health care system 5.8.4 This question required rating of the drug effectiveness in disease treatment; it was aimed at assessing the efficacy of the prescribed drugs. These blockbuster drugs are traditionally prescribed in the health centers in Saudi Arabia. In addition, whether most of the patients got well after using the prescribed drugs, the response was that 20% rated it high, 76.8% rated it medium while 3.2% rated it low. As indicated in the test below NPar Tests Chi-Square Test Frequencies Fig 5.3 drug effectiveness 5.8.5 When asked whether personalized approach would affect drug response by patient, the question seek to know the level of understanding of what personalized medicine is and the perception that the public in the Saudi Arabia have on this new treatment model. The response was 96% of the respondents agreed 4% disagreed. When asked to rate their response 25.6% neutral 41.5% agrees while 29.2 % strongly agreed. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.4 effects of personalized approach to drug response 5.8.5 The question asking whether the government, healthcare providers and pharmaceutical companies do work together to promote personalized medicine. These three major stakeholders in health care and their individual role could affect the establishment and development of personalized medicine in the country. Therefore, this question aimed at determining whether there is willingness in participation by all the stakeholders and whether they are ready to bring all the vital components of personalized medicine in place. Response was 11 % of the respondents agree while 89% disagree. NPar Tests Chi-Square Test Frequencies 5.5 Figure showing the involvement of government, healthcare provides and pharmaceutical companies in personalized medicine 5.8.6 The question on whether personalized approach to medication has helped in the treatment of cancer and other neurodegenerative diseases such as Parkinson disease. This question was aimed at determining whether the application of personalized medicine was gaining recognition as effective in treatment of diseases. Response was 63% agreed while 37% disagreed. On the rating of their agreement response, 2% neutral 65% agree while 33% strongly agreed. NPar Tests Chi-Square Test Frequencies Fig 5.6 effective treatment of cancer and neurodegenerative diseases through personalized approach 5.8.7 On the open-ended question on how personalized medicine can be integrated in the health care this question was aimed at assessing what the respondents believe as the best way to bring to effect this model of treatment into an already existing traditional model. Some respondents suggested that the food and drug administrators (FDA) in the country are in a better position to integrate the two. Others suggest development of genetic database for patients, which should also be, enacted in the general population national ID cards. There are those who suggest civic education as the best way to integrate the system. Others see the need to start with high-risk patients or creation of special clinics for this kind of treatment, which should be regulated by the government. There are those who think that the government should enact laws that enable this integration and enhance communication between the hospitals and the health care agencies. Development of trust is the main thing that some respondents cite for the integration to be efficient and effective. 5.8.8 The question seeking to know whether the Saudi Arabians were aware any company providing single nucleotide polymorphism (SNPs) services. This question seeks to know the participation of the public in understanding their genetic risks and assessing the number of service providers for human genetic. The response was 12.5% of the respondents agreed while 87.5 % disagreed. NPar Tests Chi-Square Test Frequencies Fig 5.7 Saudi Arabians awareness SNPS services 5.8.9 The question seeking to rate the role of the pharmaceutical company in enabling the adoption of personalized medicine, this question seek to know whether the pharmaceutical companies acted for or as an impediment to the adoption of this mode of treatment that does not favor their business. The response was 3.6% of the respondents rated it high, 54.9% medium while 41.5% low. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.8 role of pharmaceutical companies in enabling adoption of personalized medicine 5.9.0 The question seeking whether there was need to integrate genomic medicine and the pharmaceutical companies. This question seek to assess the understanding of the important role that each play in the development of the genomic medicine and the need for this stakeholders to integrate their components to enhance this model. The response was 92% of the respondents agreed while 8% disagreed. NPar Tests Chi-Square Test Frequencies Fig 5.9 need to integrate genomic medicine and drug manufacturing companies 5.9.1 On the business, angle of the pharmaceutical company the question seeking to know if there is business, threat in adopting personalized medicine. The question seeks to know whether the pharmaceutical companies are hesitant in participating in the enhancement of this mode of treatment that is thought to end the era of blockbuster drug production. The response rate was 68.3% of the respondents agreed while 31.7% disagree. NPar Tests Chi-Square Test Frequencies Fig 5.10 business threat in adoption of personalized medicine 5.9.2 On the suggestive question on the rout that the pharmaceutical companies should take in order to remain in business by adopting new business portfolio, this seek to find the general opinion on what the public thinks that the pharmaceutical companies should do to remain in active business. Moreover, assess their understanding of the role of these companies in enhancing personalized medicine. The response was 2.6% strongly disagree 12.9% disagree 44.2% were neutral 30% agree while 10.4% strongly agree. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.11 pharmaceutical companies should adopt new business tactics 5.9.3 The question seeking to rate the government effort in encouraging personalized medicine adoption, this question was aimed at assessing whether the government of the kingdom of Saudi Arabia is keen on funding the new healthcare or its participation has been overshadowed by the private sector. The response was 20.7% strongly disagreed, 34.1% disagreed, 33% nutral, 9.8 agree and 2.5% strongly agree. NPar Tests Chi-Square Test Frequencies Fig 5.12 rating the government effort in encouraging personalized medicine 5.9.4 On the question, seeking whether there is needed to regulate genomic medicine, this question aimed at elucidating the ethical and religious consideration on this mode of treatment. Considering that, Saudi Arabia population has a profound religious background, which could not be tolerant to some scientific research on human body. In addition, whether there is any foreseen danger in the adoption of personalized medicine. The response was 100% agree while 0% disagrees. NPar Tests Chi-Square Test Frequencies 5.9.5 Whether the current personalize, medicine is efficient and effective to gain trust from more patients. This question was aimed at getting information whether there was any success story in personalized medicine for those who are known to have sought this mode of treatment. The response was 30.8% agree while 69.2% disagree. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.13 current personalized medicine is efficient and effective to gain trust from more patients 5.9.6 The question seeking to know whether there is adequate facilities to support personalized medicine. This question seeks to know whether the service providers and stakeholders such as the government have taken the initiative to purchase modern equipment that can help in the personalized treatment. The response was 20.3% agree while 79.7% disagree. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.14 there is adequate facilities to support personalized medicine 5.9.7 The presence of adequate health care policies to allow the adoption of the personalized medicine in Saudi Arabia, This question seek to know whether the country is ready or is getting prepared seriously for the adoption of personalized medicine. It also seeks to know whether the public is interested in personalized medicine by being keen on the progress that is taking place in the health sector. Therefore, the response was as indicated 6% of the respondents agrees while 94 % of the respondents disagree. As indicated by the test below NPar Tests Chi-Square Test Frequencies Fig 5.15 adequate healthcare policies to allow the adoption of the personalized medicine are in place 5.9.8 On the open-ended question seeking reasons, which may affect the adoption of personalized medicine in the country. This question was aimed at elucidation some of the factors or issues that need to be taken care of so that the adoption of personalized medicine in the country is not hindered. Some of the respondents cited inadequate professional work force and lack of proper knowledge in the field of personalized medicine. other respondents cited cost could hinder the application of this model because it is a fact that the initial cost are high for the companies and thus would tend to pass this cost burden on the patients by increasing medical charges. There were some who cited lack of policies and set out laws that could help to regulate and control this mode of treatment as there are many loopholes that can be used by criminals to swindle the public. Others lack of funds could hinder the initial starting of the project. There are some of the respondents who felt that lack of public awareness and information, which should be provided by the health sector and other players in the sector or ignorance and the inertia exhibited by the current professionals who are used to traditional mode of treatment, could become an obstacle in the establishment of the personalized medicine. 5.9.9 The question on whether there is future for personalized medicine in the country. This question seeks to know whether the country is taking the right path towards the adoption of personalized medicine. The response rate was 82.7% agreed while 17.3% disagreed. NPar Tests Chi-Square Test Frequencies Fig 5.16 the future for personalized medicine in the kingdom of Saudi Arabia CHAPTER 6: Summary of objective, conclusion, recommendation on the present and future of personalised medicine in Saudi Arabia 6.1 Introduction This chapter seeks to answer the research questions/test the validity of the hypothesis that were put forward in order to guide the researcher into meeting the main objective of the study. The main objective of this study was evaluating the present and the future of personalized medicine in Saudi Arabia. Therefore, the chapter represents the summary of he main findings and observations made by the research. 6.2 Summary of the Major Findings The findings show that 82% of the sampled respondents participated in the study where they responded to the questions on present and the future of personalized medicine in Saudi Arabia. The study participants comprised of employee working at security forces hospital, collage of pharmacy at King Saudi University, pharmacists working at hospitals and drug companies, lecturer, and assistant professors and other administrative staffs. The majority of respondents had over 3 years of experience in the organization. These findings were as presented below to test for the hypothesis of the study. H1 personalized medicine has improved health care provision in Saudi Arabia According to the result obtained from the survey questionnaires, Majority of the respondents as indicated by fig 5.2 moderately faulted the current health care system on the ground of its performance and growth. In the provision of adequate drug information 53.7% of the respondents indicated that they were not satisfied with the information given to patients concerning the prescribed medicine that they receive from the hospital. Although this can be attributed to the drug, manufacturers not putting enough labels that probably would further inform the patient concerning the medicine they buy over the counter. The current health system ahs also been faulted for not providing with enough information on the provision of the genomic medicine ,how it works and how to access it thus many patients could have been locked out of this treatment due to lack of information of its existence ,this is indicated by the 67.7% respondents in fir 5.2. However, as this is a very new model of treatment the efforts of the health care as generally indicated by respondents rating the recent growth of health care as indicating that there is some progress. As indicated by oxford business group (2009) there is a lot of expansion in healthcare facilities leading to the employment of the oversea doctors, additionally this literature indicates that the ministry of health in Saudi Arabia is also moving towards personalized medicine. Furthermore, a great number of respondents as indicated by fig 5.3 still view that the current drug mode being used has moderate effectiveness to disease treatment although a small percentage 3.2% find the drugs being in effective in the disease treatment. This could be an attribute of personal experience or valid knowledge that a few people have positive results from this medication thus suggesting that there must be factors that the drug prescribers must consider at individual level before prescribing therapies to patients as a result the one size fit all has to be forgotten. Therefore, 96% as indicated by fig 5.4 of the respondents feel that the current practices and the future adoption of personalized medicine has and could have great affect on the effectiveness of prescribed drugs this is because it is based on the individual genetic composition, which has characteristics that determine how the patient is to respond to certain medication. Therefore, when the drug was prescribed with predicted reaction the success rate of these drugs is very high compared to the traditional mode of drug prescription in addition, the cases of side effect is reduced completely. Thus 29.2% of the respondents strongly fell that adoption of personalized medicine is long overdue in the country. However, 98% as indicated by fig 5.5 indicate that the government, the healthcare sector, and the pharmaceutical companies are hindering the adoption of the genomic medicine by not working together. This is because each party has vested interest and none of them would want to lose out in business especially with the knowledge that the pharmaceutical companies would be highly affected by this change of drug production. The current practices of personalized medicine though inadequate has positive results in the treatment of neurodegenerative diseases and cancer as indicated by fig 5.6.as a fact that neurodegenerative diseases such as the Parkinson disease is a progressive, multisystem neurodegenerative disorder. The genomic mode of treatment is able asses the presence of the mutations in the parkin gene and the PINK1 gene which are said to be the source of the recessive inheritance of the Parkinson disease thus enabling early phase detection and treatment of the disease. In addition cancers such as the breast cancer whose traditional method has not been very successful. The use of tumor characteristics has resulted in the determination of the more factors that are used to determine the type of adjuvant treatment of the breast cancer. In addition, the tissues that make up the tumor are assessed for the estrogen receptors (ER) or progesterone receptors (PR) which determines the type of the adjuvant to be used. Therefore, this has resulted in a high success rate for the treatment of the terminal illness among the Saudi Arabian people. The continued research on the use of personals medicine could bring out much better results in the treatment of various diseases and thus the current treatment mode would be substituted completely with the personalized mode of treatment in the near future. Therefore, the hypothesis that the current practice of personalized medicine has had effect of the treatment of various diseases by enhancing drug response is valid. H2 the pharmaceutical companies have to design a new business portfolio that is in line with the personalized medicine requirement The integration of the current healthcare programs with genomic medicine could be highly welcomed as majority of the respondents were of the view that there should be the involvement of the food and drug administrators (FDA) in the integration as this agency is able to regulate and asses the drugs produced and license drug companies. The view could be because of the fact that none of the companies or agencies can go it alone in the full implementation and effective treatment using personalized mode. In addition, considering the fact that each one of the groups have a separate role to play, the merging of this component roles of the hospitals, health care agencies and the pharmaceutical companies would enable a quick and effective adoption of personalized medicine in the country harmoniously. This is because this integration could enable the patients to have access to an effective treatment. Since as indicated before that this mode of treatment is new and has not taken root well in this country compared to countries like the US and other European countries such as turkey, the Majority of the Saudi Arabians 85% are not ware of companies that offer SNPs services in the country as indicated by fig 5.7. However, as the literature indicates the only company in the Saudi Arabia that could be offering such services is the Saudi bioscience facility. Although some of the Saudi people have also been seeking to know their SNPs services form oversea companies such as the Genetika, which is the largest genetic center in Turkey that provides genetic services to all people around the world. This could be the reason why most of the drug companies will have to seek new business opportunities by capitalizing in such services in the country. However, the cost of these services was of concern to majority of the respondents. Nevertheless, majority of the respondents 41.5% as indicated by fig 5.8 felt that the pharmaceutical companies are standing on the way for personalized medicine adoption. This is because of the business factor that the companies are trying to protect. In addition, there are no clear policies in place to allow for adoption of the genomic drug production; since this is a very young project; it is only time and more research that could lessen the companies from standing on the way for the genomic medicine. However, the companies are adjusting accordingly to make sure that they are in line with the advances in medicine. Therefore, majority of the respondents 92% are calling for the integration of the genomic medicine with the pharmaceutical companies as indicated by fig 5.9. To allow for a cost effective and efficient treatment that does not become ambiguously expensive for the citizens. This will also allow the pharmaceutical companies to continue investing in country’s health care and thus will not have to shut down but play its part effecting the adoption of personalized medicine. However, the pharmaceutical business will be threatened by the adoption of personalized medicine as indicated by fig 5.10, although after the adjustment, there is potential business that is there for the pharmaceutical companies in the production of the personalized drugs. Therefore, this worry expressed by the pharmaceutical companies is just a normal resistance to change, which will be overcome once the medication is properly advanced. As the companies will have to rely or merge with hospital laboratories or other, genomic facilities so that, they may produce customized drugs to patients that could not lead to adverse effects but effective treatment of their ailments. Thus, this in deed will develop a huge business potential for the companies, as there will be no three phase of drug testing thus saving on the cost of production of the new drugs. In addition to the fact that there will be no withdrawal of drugs from the market due to claims of blanket adverse effect, thus costing the companies a lot of investment. Therefore, the pharmaceutical companies will be affected in the initial adoption stages and thus they will have to go back on the drawing board as indicated by fig 5.11 in order to develop a new business tactic and define their role in the new treatment model and thus the hypothesis is valid. H3 personalized medicine is the way for the future health care provision in Saudi Arabia From the previous understanding of the role of the personalized medication, there is a lot that the Saudi Arabians could gain from the adoption of personalized model of disease treatment. However, the government role would be very crucial in the enhancing and facilitating ground for the adoption of this model of treatment in the current provision of health care. As indicated by fig 5.12 majority of the respondent felt that there is a lot of laxity in the side of the authority in the encouraging and funding this new mode of treatment in the current health care model. However, the government has left it for the private sector to practice this. The majority of respondents as seen in fig 5.13 think that the government should take the initiative and create laws that could govern this mode of treatment this is with regard to the religious and cultural profile of the Saudi Arabian people. In addition, as there will be no room for the traditional mode of drug production as the new mode of disease treatment continues to encroach in the system and the government should not burry its head in the sand. The blame is laid on the pharmaceutical companies for concentrating on the business profits rather than the well-being of the patients treated with their manufactured drugs. Therefore, to regulate genomic medicine to safeguard it from being misused by misrepresentation as indicated. This is because this country religion has a lot of influence in the political decision. Therefore, religious and ethical issues are of great concern thus the regulation must be in the development of policies that are in line with the cultural or religious believes of the Saudi Arabian people. Although majority of the respondents still feel that the current personalized medicine being practiced in the country as not being effective and efficient to bring more patients on board as shown by fig 5.13. There is still room because compared to the whole population, the number of people who could have had access to personalized medicine is quite small and could not be noticed by majority of the population. In addition, due to the fact that personalized medicine has not been advertised to the public or there been any form of civic education to inform the public on this new model of treatment. Furthermore, lack of adequate facility may hinder the growth and implementation of the genomic medicine as indicated by fig 5.14. However, the country companies such as the Saudi bioscience company have the most modern facilities in the region and it is not enough if it were to serve all the Saudi Arabian population. Moreover, there is still need for enough experts and health officers who are trained professionally on this new field of disease treatment and thus more experts should be trained. In addition, for the future efficiency of this new system, policies have to be put in place to facilitate smooth running as indicated by majority 94 % who feel that there is no adequate policies in place as indicated by fig 5.15. Which also help to regulate business competition among various companies and to prevent false creation of perceptions to genomic drugs developed by companies. Thus making sure that the drugs are what they indicate to be. Although this is a new model, proper framework should be developed to avoid future flop of the system and thus policies are highly needed in this sector. however, as indicated by the majority of the respondents ,there are other factors that could hinder the application and adoption of the personalized medicine in Saudi Arabia ranging from inadequate work force to high initial costs of development of facilities which could in turn be passed on to the patients. Lack of public awareness is also a factor that is cited by the respondents, which could indeed derail the adoption of personalized medicine in Saudi Arabia. As there are challenges in the implementation of the new model of treatment ,this challenges can not be compared to the future benefits of the adoption of this model of treatment in Saudi Arabia .the initial cost may be high but once the model is in place a lot of lives and money will be saved by this genomic medicine. This could be the reason why the majority of the respondents feel that personalized medicine is the way to go for the country and the future is personalized medicine for the Saudi Arabian people. thus 82.7% are optimistic that there will be a way out in the adoption of this treatment model as indicated by fig 5.16.tus this hypothesis is therefore valid that there is future for personalized medicine in Saudi Arabia. 6.3 Conclusions The study examined the present and the future of personalized medicine in Saudi Arabia ,the findings revealed that there is a progressive adoption of personalized medicine in this country and is projected to play a major role in the transformation of healthcare provisions in the country. Through establishment of predictive medicine approach, many Saudi Arabians will have access to safe and effective medicine that is cost effective. The study suggests that the adoption of personalized medicine ,though it could for a while affect the business structure of drug manufacturers in the long run it could also lead to a lot of benefit to the drug researching companies through reduced cost of production. The confirmation of the validity of the hypothesis and answering of the research questions has in deed helped to rank the Saudi Arabia country among the countries that are gearing up for the new mode of disease treatment through personalized medicine. Thus, many companies are gradually transforming towards understanding further the functions and implications of adoption of personalized medicine in their business practice. There is a common believe that the implementation of the personalized genomic medicine would benefit the patients and the health care system in Saudi Arabia in various ways. first it is presumed by majority of the Saudi that the new genome sequencing technology would improve individual risk assessment which will lead to disease prevention, early diagnosis and more personalized medication for many patients as a result this will raise the overall quality and effectiveness of the health care and lead to an improved health care outcomes. Secondly, the Saudis believe that the main goal for the personalized genomic medicine or specifically the phamacogenomics is to improve the drug safety by reducing partially or completely the adverse reaction to pharmacotherapy and enhance the overall rational prescription and dosing capabilities in other words enhance drug efficacy for the Saudi patients. Lastly, has also been elucidated that the Saudis believe that the adoption of personalized medicine has a potential to reduce costs that is associated with health care. This is attributed to two major changes anticipated. first, the adoption of personalized medicine will enable health care providers to provide a more effective treatment thus making it un necessary for the patient to have frequent treatments for the same illness due to lack of efficacy in prescribed drugs. Secondly, the adoption of the personalized genomic medicine will also be projected to improve pharmaceutical research and development thus reducing the cost for research and development thus reduced cost could be considerably important in the reduction of the overall cost for the health care in the kingdom of Saudi Arabia. From the study is understood that the patiently are not adequately given information about their genetic risks and the meaning and utility of genomic information thus making them have very inaccurate genetic information. this could be attributed to the fact that the genetic information is complex and there are not many people who have the clear understanding of the probabilities and statistics which are very vital in the discernment of the patients genetic risks. It is also reasoned that the largest worrier to the public understanding of the genetics is to become a victim of the genetics determinism, which has a lot of media influence. Finally, the study suggests that there is dire need for establishment of the policies that will guide the system thus preserving the beliefs and the ethical values of the Saudi Arabian people. In addition, all the stakeholders are required to pull together to facilitate effective adoption of this modern method of disease treatment. The government should take the leading role in the development of laws that could guide the functions of this model of treatment and also play part by funding studies and enactment of modern facilities in the health care facilities so that this model of treatment becomes effective. Furthermore, there is still more studies that is required in this field of medicine for it has been clearly indicated that human genomic is not the only factor to be considered in the understanding of various disease condition but there are other factors such as transcription and the environment factors that must be put into consideration before making conclusions. The public has not been fully informed of what personalized treatment or genomic treatment means and there have not been any civic education on the benefits of personalized medicine. Thus, majority of the people are still not aware of such mode of treatment being offered in Saudi Arabia. Therefore, the health care sector should develop plan that will educate the people on personalized medicine as this ignorance could lead to wrong perception to personalized medicine and in the acquiring of ones genomic profile. 6.4 Recommendations There is need for the government to fund the establishment of modern facilities that will enable the adoption-personalized medicine in its healthcare system. Although Saudi Bioscience Company has a lot of support from the ministry of health, more companies should be encouraged. There is also need for technological exchange programs with the most advanced programs such as those found in the United States and turkey in order to have more knowledge on steps towards full adoption of personalized medicine in healthcare. Therefore, from the various genetic techniques that is available. Saudi Arabia should allow the establishment of the strategies that best suit its genetic needs and thus should emphasize on the programs that are consistent with the ethical, religious and social values of its people thus averting conflicts in the adoption of this new genetic mode of treatment. If the personalized medicine adoption will lead to improved health care and drug efficacy while decreasing the cost of health care then it is worth its investment and the Saudi healthcare providers should embrace this model of treatment in their system if it will transform the delivery of health care in the kingdom. However, evidence regarding the validity and the clinical utility of this new genomic technology and personalized genomic medicine is required so that there are no obstacles that could hinder the implementation of this model to the health care system. As a result, for the researchers in Saudi Arabia to build this evidence there is need for investing in the areas of health technology assessment (HTA) and health outcome research. The work of the health technology assessment (HTA) is it self a form of policy research that helps to identify the validity and utility of the personalized medical diagnostics, preventive care and treatment in form of outcome research. Educational reform in the clinical practice guideline should be developed and implemented to assist in the determination on how and when the personalized genomic medicine can be utilized in the health care centers and the credible way to interpret results and findings. In addition, the government should increase the number of genetic counselors to meet the growing demand for the personalized medicine. 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Nat Genet, 38:324-330 APPENDIX 1 QUESTIONAIRE APPENDICES APPENDIX I: QUESTIONNAIRE ABOUT THE QUESTIONNAIRE The question is based on the requirement of an academic research project entitled: “The present and the future of personalized medicine and SNPs in Saudi Arabia” The questionnaire is divided in the following segments: 1. the present status of personalized medicine 2. effect of personalized medicine on pharmaceutical companies 3. the future of personalized medicine Background information of surveyee Name (optional)………………………………………………………………… Designation……………………………………………………………………………… Duties……………………………………………………………………………… Contacts…………………………………………………………………………… How long have you worked in health care sector? 0- 3years 3-5years above 5 years SECTION ONE: Present status of personalized medicine 1. How do you rate the current healthcare performance and growth in the country? HIGH MEDIUM LOW Growth of provision of health care activities Providing adequate drug information to patients Creating genomic medicine awareness 2. How do you rate drug effectiveness in disease treatment? HIGH MEDIUM LOW 3. Do you think the personalized approach to treatment affect a patient’s response to medication? YES NO 3.1. If yes in Q3 above how much do you agrees? Neutral Agree Strongly Agree 4. Do you think that government, healthcare providers and pharmaceutical agencies are working together in the country to allow for adoption of personalized medicine? YES NO 5. Has personalized medicine approach improved the treatment of cancer and other neurodegenerative diseases like Parkinson disease? YES NO 5.1. If yes in Q5 above how much do you agrees? Neutral Agree Strongly Agree 6. In your opinion, how can personalized medicine policy be fully integrated into current healthcare procedures in the country? ……………………………………………………………………………………………………………………………………………………………………………… 7. Are you aware of any SNP companies in the country? YES NO SECTION TWO: Effect of personalized medicine on pharmaceutical companies 1. How would you rate the role of pharmaceutical companies in personalized medicine? HIGH MEDIUM LOW 2. Is there need to integrate genomic medicine with pharmaceutical companies? YES NO 3. Is there any business threat that adoption of personalized medicine is posing to drug production companies? YES NO 4. Traditional mode of drug production will soon be outdated, thus pharmaceutical companies must adopt a new business portfolio if they want to remain in business. Strongly disagree Disagree Neutral Agree Strongly Agree 1 2 3 4 5 5. How would you rate the government effort to encourage personalized medicine? Strongly disagree Disagree Neutral Agree Strongly Agree 1 2 3 4 5 SECTION THREE: The future of personalized medicine 1. Do you think there is a need to regulate/streamline the use of genomic medicine in the country? YES NO 2. Is the practice of current personalized medicine in the country effective and efficient to attract more patients? YES NO 3. Are there adequate facilities to support the growth of genomic medicine in the country? YES NO 4. Is there an adequate healthcare policy framework for adoption of personalized medicine in the country? YES NO 5. State reasons which may affect the adoption of personalized medicine in the country. ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 6. Is there a future for personalized medicine in the country? YES NO THANK YOU Read More