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UntitledFor reprint orders, please contact:firstname.lastname@example.org Lawrence Shih-Hsin
Vita Genomics, Inc., centered in Taiwan and China, aims to be a premier genomics-based WuS
biotechnological and biopharmaceutical company in the Asia–Pacific region. The company Ellson Che
focuses on conducting pharmacogenomics research, in vitro diagnosis product †Author for correspondence1Vita Genomics, Inc., development and specialty contract research services in both genomics and pharmacogenomics fields. We are now initiating a drug rescue program designed to resurrect drugs that have failed in the previous clinical trials owing to low efficacies. This program applies pharmacogenomics approaches using biomarkers to screen subsets of Tel.: +886 289 769 123;E-mail: ellson.chen@ patients who may respond better or avoid adverse responses to the test drugs. Vita Genomics, Inc. has envisioned itself as an important player in the healthcare industry offering advanced molecular diagnostic products and services, revolutionizing the drug-development process and providing pharmacogenomic solutions.
As a pharmacogenomics service provider, Vita metabolic reactions. The technology is generally Genomics, Inc. offers streamlined and customized applicable both to drugs with well-characterized pharmacogenomics contract services and solu- effects and those that require subjective eval- tions for pharmaceutical and biotechnological genomics research are prepared to be ready for We focus on conducting clinical research, diag- nostic product development and specialty con- tract research organization (CRO) services with alaboratory certified by ISO 17025:2005. We also establish good manufacture practice (GMP)- Since the sequencing of the human genome in compliant manufacturing, state-of-the-art tech- the 1990s, the association of genetic poly- nology and cost-effective and speedy solutions to morphisms and susceptibility to disease are fulfill all the requirements of our global clients in establishing a new paradigm for the understand- the genomics and pharmacogenomics fields. ing of genetic risk factors. Many complex dis- Pharmacogenomics holds promise in improv- ing drug safety and efficacy. In 2003, the environmental elements and genetic factors US FDA issued a draft guideline on pharmaco- (Figure 1). Genetic variations of intense interest
genomics data submission, encouraging drug include those that cause disease susceptibility or developers to include genomic data in clinical tri- are correlated with efficacy of certain drugs for als. In addition, they published the draft of certain patients. Association studies on personal drug–diagnostics codevelopment in 2005, as well genetic information with various genomic tools as the draft guidance on pharmacogenetic tests are the key to providing comprehensive solu- and genetic tests for heritable markers in 2006. tions that lead to the ultimate goals of medicine: Vita Genomics has expertise in using genom- prediction, prevention and protection.
ics and bioinformatics tools to select appropriate Pharmacogenomics thus plays an increasingly patient groups for clinical trials or in Phase IV important role in current development of new market clinical analysis, and has built strategic therapeutic agents in 21st century medicine.
alliances with prominent partners. The com- pany has also established strong collaborations efficacy and safety by finding the adequate treat- Keywords: contract research
with research institutions and major medical organizations throughout Taiwan and China.
Our proprietary technologies have allowed us to select patients prior to drug treatment who research on polymorphisms of drug-metabolizing may suffer from adverse drug reactions (ADR), enzymes in Asian populations, and the critical insufficient efficacy/potency and negative correlations between polymorphic subgroups and 10.2217/146224188.8.131.529 2007 Future Medicine Ltd ISSN 1462-2416 Pharmacogenomics (2007) 8(6), 669–673
COMPANY PROFILE – Shih-Hsin Wu, Su & Chen Figure 1. General concept scheme of personalized medicine.
certain drugs. The results have shown that specific conducted genetic mapping studies to investigate predisposing genotypes in Asian populations may locally prevalent diseases including liver hepatitis be different from those in ethnic groups elsewhere (hepatitis B and C viruses, fibrosis/cirrhosis and in the world. For example, responsiveness and hepatocellular carcinoma study), immune diseases safety of methylphenidate (Ritalin®) can be (asthma and allergy), metabolic disorders (diabe- assessed by cytochrome P450 2D6 poly- tes and diabetic nephropathy), cancer (liver can- morphisms; and of azathioprine, by thiopurine cer, non-small-cell lung cancer), familial S-methyltransferase (TPMT) polymorphisms.
hypercholesterolemia (FH) and CNS disorders Recently we have initiated a drug rescue pro- gram to identify genotype association with drugs Pediatric asthma and diabetic nephropathy that are effective or have severe side effects only are common diseases with a high prevalence for a subset of patients by concomitant develop- worldwide. We carried out genetic mapping by ment of genetic tests to stratify patient sub- whole-genome screening and a candidate gene populations. This is especially useful for drugs approach to identify susceptibility genes that are that have failed in trials due to low efficacy or candidates for both prognostic markers and strong side effects. Stratifying the etiology of dis- drug targets. We have performed not only func- ease in groups of patients based on genetic differ- tional genomics studies, but also pathway analy- ences sets the stage for the development of sis to find genes correlated to the diseases.
Furthermore, pharmacogenetic studies for iden- leading advantages with years of devotion in tifying responsive genotypes of asthma drugs developing advanced genomics technologies.
such as β2-agonist and leucotriene antagonistare ongoing.
FH has been identified as a major risk factor Working together with experienced physicians in for coronary vascular disease, which is associated with mutations in a number of genes, including Pharmacogenomics (2007) 8(6)
the low-density lipoprotein receptor (LDLR), pipelines are integrative and robust from start to apolipoprotein B (APOB) and the recently end. Our work flow starts with clinical sample reported proprotein convertase sutilisin/kexin 9 collection and an archiving system, followed by a (PCSK9). Genetic testing for these hypercholes- genotyping core and functional genomic core.
terolemia-associated mutations helps diagnose Data generated from both patient demography FH at any age, allowing early intervention to and genomic researches are streamed into an prevent or delay the development of cardio- integrated database processed by our bioinfor- vascular disease. Due to high genetic heterogene- maticians and statisticians. Genomic association ity of autosomal dominant hypercholesterolemia studies have been conducted on many collabora- (ADH), mutation screening requires sequencing of these genes. The direct sequencing process is These technologies sustain Vita Genomics’ cumbersome and inefficient for diagnostic pur- development of innovative and intellectual prop- poses. We designed the oligonucleotide-based erty-protected products that are moving through microarray, called FHChip, which covers the clinical trials and field testing. Some of our coding and promoter regions of three FH-related research is further developed into diagnostic or genes (LDLR, APOB and PCSK9).
prognostic kits that are commercially available in The FHChip provides base calling with accu- racy greater than 99.98% and reproducibility For example, one of our products, INFor, is reaching 99.99%, which is comparable with the an in vitro diagnostic test to predict the efficacy conventional sequencing method. To facilitate of interferon (IFN)/ribavirin combination data analysis and to generate diagnostic reports from these arrays, we have also developed a web- patients. Therapy for CHC patients using IFN based informatics platform that allows for data has a response rate of approximately 50%, and submission and generation of reports. It auto- the treatment is expensive and the process pain- matically lines up array results, helps users to ful. Together with viral load and virus types, locate each mutation and amino acid change patient SNP profiles provide high accuracy in predicting the treatment outcome. Therefore, this test is very useful for CHC patients, physi- Viral hepatitis has higher prevalence in Taiwan cians and healthcare systems to make a proper and Southeast Asia than in any other regions in decision prior to treatment. Benefits include the world. Hepatitis develops in patients for years the ability to tailor therapeutic protocols to in silence. Treatments for chronic hepatitis, type reach maximal efficacy of IFN/ribavirin combi- B and type C, are often ineffective and expensive.
nation therapy, including adjusting treatment The consequences of chronic hepatitis left untreated are devastating, with high morbidity Another genomic test, SmaPhile, can be used and mortality such as liver fibrosis, cirrhosis and to help predict the possibility of early onset cancer. Gene-expression profiles on liver tissues childhood asthma, that is, aged between 3 and with various stages of fibrosis are compared with 5 years. We have identified a handful of genes microarray tool followed by pathway and pro- related to asthma and allergic asthma, including teomic analysis. Liver cancer is not only the lead- a group that dominantly contributes to disease ing cause of death in Taiwan, but has been found symptoms. The test gives parents an early warn- to be genetically heterogeneous and, therefore, ing of susceptibility to asthma, cueing possible cancer patients tend to show different response preventive action. These genes are also possible rates and tolerance to different therapies. Early candidates for drug targets to develop new detection assays for heHCC and cirrhosis are We offer pharmacogenomics CRO services. We Vita Genomics has successfully implemented six continue to enlist pharmaceutical partners who technology platforms, including high-through- can benefit by identifying patients for drug put sequencing, short tandem repeat geno- responsiveness prior to treatment; partners who typing, SNP genotyping, clinical genomics, functional genomics and bioinformatics to pharmacogenomics; and partners who want to become one of the top leaders among Asia bio- expand pharmacogenomics studies into DNA- tech companies (Figure 2). Our genomic research
based molecular diagnostic products.
COMPANY PROFILE – Shih-Hsin Wu, Su & Chen Figure 2. Integrated genomic solutions in Vita Genomics, Inc.
In 2005, Affymetrix, Inc. and Vita Genomics assays we have developed to predict drug effi- announced collaboration on in vitro diagnostic cacy prior to treatment and to assess risks and product development using microarray tech- nology. The resulting microarray-based in vitro We have built a strong bioinformatics team diagnostic products can provide clinicians with to manage high-throughput analyses of large better diagnostic methods and more efficient data sets. Bioinformatics is an integrated disci- pline that merges biology and computational technology. Our bioinformatics core laboratory As part of the Powered by Affymetrix™ pro- facilitates the biological research processes by gram, Vita Genomics incorporates Affymetrix- providing proper tools and solutions for data patented arrays into the molecular diagnostic processing and statistical model building.
• The results from the international HapMap project opened the gate to genetically differentiate patients in order to assess disease susceptibility and drug efficacy. Furthermore, the US FDA has recently issued guidelines to encourage the use of genomics data for drug development. Toward this goal, we offer pharmacogenomics contract research organization services to drug companies interested in stratifying patients to optimize responses in clinical trials.
• We have identified potential high-risk genetic components for early-onset asthma. An account was published by Wang JY, Lin CG, Bey MS et al. in the Journal of Human Genetics. • We have studied genetic polymorphisms that influence the efficacy of interferon (IFN)/ribavirin combination therapy for chronic hepatitis C (CHC) patients. Results were published by Hwang Y, Chen EY, Gu ZJ et al. in Pharmacogenomics. A diagnostic test was developed to benefit chronic HCV patients eligible for IFN therapy. • Using an Affymetrix platform, Vita Genomics has developed a resequencing chip to identify genetic polymorphisms for familial hypercholesterolemia patients. Results were published by Charng MJ, Chiou KR, Chang HM et al. in the European Journal of Clinical Investigation.
• We have initiated a drug rescue program designed to resurrect drugs that have failed previous Phase III clinical trials. New trials focus on identified subsets of patients who can respond better to the tested drugs. Pharmacogenomics (2007) 8(6)
Bioinformatics tools are incorporated into an and therapeutic efficiency. In addition, Vita analysis pipeline, and also integrate databases Genomics can act as a conduit between west- ern enterprises and the burgeoning China mar- researchers and for outside customers.
ket, with half of our employees operating froma wholly owned subsidiary, GeneCore, in Shanghai, China. Committed to be the pro- Understanding the relation of genetic poly- vider of future solutions, in health manage- morphisms to diseases is critical for clinical ment, Vita Genomics ensures the worldwide diagnosis and proper treatment. We are primed applicability of its efforts and products by to continue to capitalize on the use of genomic maintaining the high standards of FDA guide- information, which promises to revolutionize lines in collecting samples and conducting
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