Morrisville, N.C. (July 26, 2010) – Gentris Corporation, a global leader in applied clinical pharmacogenomics, announced today that they have appointed Karen Weck, M.D., as a consulting Medical Director.  Dr. Weck replaces the previous medical director to continue Gentris’ CLIA program and help expand opportunities to develop new biomarkers.

“Gentris is very fortunate to have Dr. Weck join us as a consulting Medical Director,” said Dawn Bordeaux, Chief Operating Officer of Gentris.  “She will be an invaluable asset to our Quality Program as we continue to transition into a CLIA regulatory environment.”

Dr. Weck brings over 20 years of experience to Gentris, including certified expertise in both clinical and molecular genetic pathology, which help the company to continue, and expand upon, its notable successes.  Dr. Weck’s distinguished professional history includes numerous research grants, a variety of honors and awards, multiple inventions, dozens of publications, and membership in several national organizations including the American Society of Human Genetics, the Association for Molecular Pathology, and the Academy of Clinical Laboratory Physicians and Scientists.

Currently, Dr. Weck is affiliated with the University of North Carolina, serving as the Director for Molecular Genetics, Associate Director of Molecular Pathology for the School of Medicine, and Associate Director of the UNC Institute of Pharmacogenomics and Individualized Therapy.  She also holds positions as Associate Professor of both Genetics and Pathology and Laboratory Medicine.

Dr. Karen Weck received both her Bachelor of Science degree and Medical Degree from Duke University, and completed her residency at Washington University School of Medicine.  Dr. Weck has also received board certification in molecular genetic pathology and clinical pathology from the American Board of Pathology.

###

About Gentris Corporation:
Founded in 2001, Gentris is a leading global provider of applied clinical pharmacogenomics, an emerging field that addresses how drug response is influenced by human genetic variations.  Gentris offers SNP genotyping, custom assay design and validation, expression analysis, toxicogenomics, and clinical sample bio-storage, all of which adhere to rigorous Good Laboratory Practice (GLP) and CLIA regulations.  The Company maintains a strong commitment to scientific excellence, regulatory compliance, and innovative pharmacogenomics applications.  Gentris is headquartered in Research Triangle Park, NC.  For additional information, please visit www.gentris.com or call 919.465.0100.

Contact:
Scott Clark, Ph.D.
Chief Scientific Officer
Gentris Corporation
133 Southcenter Ct., Ste. 400
Morrisville, NC 27560
919.653.5534
Scott.Clark@gentris.com
www.gentris.com

What is Project Management?  The term is bounced around businesses these days as much as any other industry jargon.  Every company has teams and personnel dedicated to project management, but what does it mean and why is it so vital to Gentris?

Project management at Gentris is composed of four key components:
1. Accountability of Service
2. On-time Delivery
3. Risk Management
4. Channel of Communication

Accountability of Service 

First and foremost, the Project Manager acts as a lifeline for our clients.  Available as a single point of contact for even the most complex studies, the Project Manager can monitor the critical points as each study progresses both internally and externally.  Ultimately, the goal is to follow each project through successful completion with timely results and the quality that Gentris is known for.

On-Time Delivery 

Delivery of data is of utmost importance to clients as clinical trials are increasingly dependent on results for enrollment of subjects.  Gentris’ focus on delivery of high quality data within established timelines has been a continued focus through its evolution.

Risk Management

Through proper project management, risks are identified early and can be mitigated before the consequences are great.  Gentris’ focus on cross-training Project Managers in areas such as contracts and sample logistics reduces the possibility that timeline and finances will derail a project.

Channel of Communication

Communication is key.  Continuous communication between team members and across teams, ensures a cohesive approach to project management at Gentris.  Having a clearly defined manager for each project means clients always have a single point of contact with which to communicate.

In reality, successful project management offers important benefits to ensure goals are effectively accomplished for the benefit of our clients.

Customer Service (n) – assistance and other resources that a company provides to the people who buy or use its products or services.

At Gentris, the importance of a satisfied customer is understood and highly valued, which is why we continue to strive to go above and beyond to redefine what we believe customer service should be. Customer service is a vital element to every business that enables the company to continuously improve their products and services to satisfy the changing demands of their clients. It is achieved by enhancing the level of customer satisfaction and overall service that has been the distinguishing staple of Gentris. We offer experience, talent, and dedication that provides unparalleled quality and outstanding customer service. We strive to enhance the personal experience of each project while making the process more efficient from our quote request through study completion. Gentris attributes its success in achieving and exceeding our clients’ expectations to our focus on customer-oriented principles and motivated employees. Our customer-oriented approach allows us to remain flexible to the needs of our clients and ensures that we provide customized solutions that are specific to the customer’s requests. Employee satisfaction is also key to exemplary customer service.  Employees are commonly at the front lines, and the success of most organizations is based on employee loyalty and dedication, so it is imperative to have a positive and supportive workplace that helps motivate workers to do their jobs better. At Gentris, we understand that a satisfied customer is the lifeblood of any business, so our relentless focus on customer service begins with happy employees and ends with happy customers.

?

Gentris attended the 2010 DIA conference in Washington, D.C. We had significant interaction with current customers, attendees from pharmaceutical companies and from the FDA, both in the exhibit hall and in the scientific sessions.
Seminar sessions pertinent to pharmacogenomics included one on the Critical Path initiative. The speakers mentioned that the Critical Path Initiative has four consortiums:

1) Predictive Safety Testing Consortium that focuses on Drug Safety. The specific areas of interest are nephrotoxicity, hepatotoxicity, myopathy, vacular injury, and carcinogenicity.

2) Patient Related Outcomes which is focused on Drug Efficacy. The therapeutic areas that they are focusing on are Irritable Bowel Syndrome, Cognition, Depression, Asthma, NSCLC, and advanced breast cancer.

3) Coalition Against Major Disease which is focused on sharing Clinical Data.

4) Critical path to TB drug regimens which focuses on new drug combinations.

Another session, entitled, Personalized medicine: “Are we there yet?” featured three talks related to the incorporation of pharmacogenomics into drug development and clinical practice. Dr. Walter Bradley, Professor and Chairman Emeritus, Department of Neurology at the University of Miami discussed how environmental factors involving cyanobacteria lead to very high rates of ALS in a population on Guam, and how these same factors in lower doses worldwide might lead to ALS in only genetically susceptible individuals. Dr. Mark Curran (Centocor/J&J) illustrated how strategies involving PGx can benefit a pharmaceutical company’s bottom line revenue for a particular drug, and on Centocor/J&J’s participation in a consortium to determine whether PGx can guide the course of treatment for TNF? inhibitors in the treatment of rheumatoid arthritis. Dr. Francis Kalush of the FDA summarized the FDA perspective on diagnostics and personalized medicine from her position as Network Leader, Diagnostics and Personalized Medicine.
In a session entitled 21st Century Genomics Reviews at the US FDA, chaired by Dr. Frederico Goodsaid of the FDA, three speakers from the FDA’s Genomics Group reviewed the reasons that biomarkers are of increasing interest to pharma companies, the increasing number of voluntary genomic data submissions, and how the FDA reviews genomic information, including some case studies, and how the FDA considers pharmacogenomic information with regard to drug label updates.
Overall good meeting for PGx!

Cancers are thought to arise from de novo (newly arisen) mutations in genes that regulate cell growth and death. For example p53 mutations occur in the tumor, the nearby tissue does not have measurable p53 mutations or they occur in 1 out if every 1,000,000 cells. However, a SNP is inherited from either mom or pop so it is in your genome and present in every cell. A SNP in a gene (e.g. CYP450) occurs in 100% of the cells in the body and will also occur in 100% of the cell that make up the tumor, i.e., blood vessels, fibroblast and the cancer cells that are all part of the tumor.

So a SNP occurs in 100% of all cells, mutation only happen in tumors (100%) or in normal tissue in 0.00001%

Gentris has developed methods to detect mutations in tumor tissue including formalin fixed paraffin embedded tissues.

One of the important questions surrounding pharmacogenomics is its value. Many skeptics think that while pharmacogenomics has its place, it has failed to deliver the greatness that was anticipated. I would tend to disagree. While many of the valid biomarkers today are single gene associations, advanced technology such as microarray analysis and next generation sequencing can generate data to reveal more complex associations. The current biomarkers should not be easily dismissed because they are single gene associations. These biomarkers are important for both safety and efficacy. The FDA’s Table of Valid Biomarkers In the Context of Approved Drug Labels list several genes that can pose significant health risks to patients/subjects if given a certain medication. For example, polymorphisms in TMPT or thiopurine methyltransferase can cause an increase in myelotoxicity when patients are given azothioprine, mercaptopurine, or thioguanine. The reaction can be quite severe in children. In addition, patients on abacavir that have a genotype of HLA-B*5701 can present with lactic acidosis and severe hepatomegaly. Preventing severe adverse drug reactions of patients and helping reduce costs in clinical trials by omission of therapeutic dose monitoring, poor metabolizer patient withdrawal, and treatment for adverse reactions does not seem like a failure to deliver.

     Gentris attended the 2010 AACR meeting in Washington, DC this April. While attendance was low due to the eruption of the Eyjafjallajökull volcano in Iceland, the meeting was informative. Burt Vogelstein, from Johns Hopkins, gave a great overview on what was revealed in 78 cancer exomes. In particular, a group of scientists from Johns Hopkins, Washington University, British Columbia and the Sanger Institute examined the sequence of all 185,000 coding exons in each of 100 human tumors. They found that of the tumors, 3142 genes were mutated. Of the 3142 human genes mutated, 286 were in tumor suppressor genes, and 33 were in oncogenes. So, of the driver genes (tumor suppression genes and oncogenes) 90% of the drivers were tumor suppressors. . Using next generation sequence technology, they were able to see more genes because of increased sensitivity. More information regarding this study is available in Cancer Research (2009) 69. Many other discussions: Stephen Chanock’s (NCI) talk “Genome-wide association studies in cancer: What have we found and what next” and Levi Garraway’s (Dana-Farber Cancer Institute) discussion “From cancer genomics to personalized oncology” are also noteworthy.
     Many pharmaceutical companies such as AstraZeneca, Novartis, Eil Lilly, Pfizer, Sanofi-Aventis, Takeda/Millenium, and Merck, to name a few, outlined their Oncology programs at their exhibitor booths. Many of the pharmaceutical companies studies in Phase I through Phase III listed target genes for which we (Gentris) have genotyping or gene expression assays.

Gentris attended the 2010 Partnerships in Clinical Trials meeting in Orlando earlier this April.  The purpose of this meeting was to encourage Pharma, biotech, and contract research organizations to work with Gentris.  We met with several CROs and initiated discussions.

By partnering with Gentris they will receive:

• A partner dedicated solely to Pharmacogenomics.
• A partner with the most advanced technology.
• A partner that delivers personalized service.

Benefits of partnering with Gentris:

• Vast Array of Services: Protocol Development, Assay Development, Nucleic Acid Purification, Genotyping, qRT-PCR, Microarray Analysis, Tumor Profiling, Sample Management and Biostorage.
• Regulatory Expertise.
• Experience.

Gentris attended and exhibited at the American Society of Clinical Pharmacology and Therapeutics Conference in Atlanta. The meeting was fantastic and we would recommend anyone interested in pharmacogenomics to attend. There was much discussion on the pharmacogenomics in Hepatitis C (HCV) therapy. IL28B is a gene that seems to be involved in the efficacy of HCV treatment. Gentris has the expertise in this testing as we already have assays developed for the detection of IL28B polymorphisms.
In the drug metabolism and transporter world, polymorphisms in CYP2C19 and their association in safety and efficacy with clopidogrel was also discussed. Patients who have polymorphisms in CYP2C19 and convey a poor metabolizer phenotype have a greater cardiac risk than those patients homozygous for the wild-type alleles. A polymorphism in ABCB1 (C3435T) has also been associated with clopidogrel efficacy. As an employee of Gentris, it’s great to know that we have these tests already developed and validated. Robert Epstein gave a great talk on Private Sector Interests in Personalized Medicine-What’s there and What’s Missing. There were several great posters including a poster from the Center for Environmental Health Sciences and the University of Montana where they examined the “Genetic components of predicting drug adverse reactions in the Confederated Salish and Kootenai Tribal (CSKT) Population. The data presented is important is as this group is not well-defined nor represented in typical studies. Overall, the meeting was very informative.