Posted on Tue, Jun 11, 2013 @ 08:05 AM
In order to enhance and accelerate drug discovery, human bio specimens are widely used by researchers to study the efficacy, reproducibility, and safety of new drug compounds. Pre-clinical use of human tissues provides valuable insight into the likely success or failure of novel drug therapy compound candidates. This process relies heavily on well-annotated tissue samples.
Let’s briefly define the term “well-annotated”. Basically, annotation describes the clinical and demographic data that is provided with each tissue sample. A well-annotated tissue sample will have a wide range of information that details the “who, what, when and where” of that specific specimen.
Why is it important to have such detailed data on a human tissue sample? Disease researchers equate their efforts to those of a detective. As they chase down the core molecular basis for diseases such as cancer, they need clues that tell them why certain patients develop cancer. These clues are contained inside human tumors, tissue, and blood specimens. Access to human tissues with specific diseases provides the opportunity for researchers to identify, for example, disease-related biomarkers and to enhance the selection accuracy of new compounds most likely to succeed in a human clinical trial. Because the biospecimen represents both the biology of the patient and of the disease, it’s critical to know as much as possible about that patient and their specific disease.
Without access to well-annotated tissue samples, drug discovery can go down the wrong path. When that happens, time is lost, money is misspent, drug candidates have to be withdrawn because of unforeseen side-effects, or a promising compound never gets green-lighted because decisions were based on faulty data. Saddest of all, patients with life-threatening diseases are kept waiting for better treatment therapies.
This is unacceptable for those involved in critical drug research, and it’s the reason why companies who spend millions and millions of dollars in clinical research are demanding reliable and well-annotated tissue samples. Top-rate tissue banks work very hard to supply such samples because they know it can help lead to advancements in disease treatments and cures. When seeking to partner with a tissue bank, look carefully at the quality of their sample annotation. It should include:
- In-depth and highly detailed demographic patient profiles
- Precise and meticulous clinical notations
- Exhaustive treatment history
- Accurate, methodically recorded disease information.
Access to well-annotated tissue samples is critical for drug discovery, so make sure your biospecimen provider has the skills, knowledge, resources and procedures in place to provide you with critically important annotation data. Contact Conversant Bio with any questions regarding well-annotated tissue samples.
How can we help catalyze your drug discovery?
Posted on Tue, Jun 04, 2013 @ 08:04 AM
The availability of well-characterized and properly-handled human tissue samples is a necessity for today’s drug discovery and scientific research programs. One of the most important areas where the tissue bank helps in disease research is in the study of inflammatory diseases. A tissue bank can help accelerate the development of drugs and companion biomarkers for these chronic and often progressive diseases.
Crohn’s Disease
Inflammation anywhere in the gastrointestinal tract is a marker for this disease. There are several subtypes which are identified by the location of inflammation. Patients with Crohn’s disease have periodic flare-ups and remissions and require a combination of dietary and medication therapy to manage the disease. It’s thought that genetics, autoimmunity or infectious agents are the main causes for this chronic disease that affects about 500,000 Americans of all ages and both genders.
Tissue bank specimens are invaluable for further investigation of the disease mechanism of Crohn’s. Biospecimens used for research into this disease include fresh tissue shipped overnight as well as FFPE tissue. Bone marrow or peripheral blood samples containing lymphocytes (the cellular organs of the immune system) also prove useful for research into Crohn’s disease.
Sarcoidosis
There are estimated to be about 54,000 sarcoidosis cases per year in the U.S. This disease is characterized by chronically inflamed cells that form lumps on the interior or exterior of the body, but mainly in the lungs and lymph nodes. It’s been linked to a propensity for developing certain cancers such as lymphomas and lung cancer. The causes are varied, and are thought to include BTNL2 genes, infectious agents, and thyroid disease. One of the biomarkers for sarcoidosis is the angiotensin-converting enzyme; elevated levels indicate disease progress.
Obtaining well-characterized biospecimens on an ongoing basis from a tissue bank partner is helping researchers better understand sarcoidosis.
Rheumatoid arthritis (RA)
This autoimmune disease is marked by chronic inflammation of many tissues, especially the (synovial) joints. The disease is destructive to the connective tissues, causing red and painfully swollen joints. About 1.3 million Americans have RA and early diagnosis is important for reducing long-term joint damage. Genetic inheritance and infectious agents are among the suspected causes. Current research has linked some genetic markers to the disease. Researchers believe that a combination of these markers and infectious agents may cause RA; however, not all patients have these markers.
Human blood and tissue samples are invaluable for studying RA and developing better drug therapies with fewer side-effects.
Biorepository aids inflammatory disease research
One good way to accelerate inflammatory disease research and discovery is through the creation of a global biorepository of qualified patient samples. Some companies partner with a tissue bank that can help them with the study design, population profile and biospecimen collection. For example, a researcher may want 100 samples each of RA, Crohn’s disease, sarcoidosis and scleroderma collected from serum, plasma and peripheral blood mononuclear cells. Or maybe immune cells (especially B- and T-cells) are desired by the client; these can be isolated by the tissue bank using immunomagnetic cell sorting. Some tissue banks can serve as a long-term biobank for their clients; this is a convenient approach for large sample collections, as the client can focus on research rather than biospecimen storage and maintenance.
Since the handling of human tissues must follow regulations designed to protect patients through proper consenting and sample sourcing procedures, it’s critical that the tissue bank you select as your partner in inflammatory disease research are experts in the ethical and legal issues involved in handling of human tissues. Learn more about how Conversant Bio can help your research.
How can we help catalyze your inflammatory disease discovery?
Posted on Tue, May 28, 2013 @ 08:05 AM
It’s an astounding number. According to the World Health Organization, 347 million people worldwide have some form of diabetes, which WHO says is due to rapid increases in weight, obesity and physical inactivity. By 2030, it’s predicted to be the 7th leading cause of death worldwide. In the U.S. alone, there will be 30 million people with diabetes by 2030.
There are two major types of diabetes – type 1 and type 2. Type 1 diabetes results from a lack of insulin production and type 2 diabetes, which accounts for 90 percent of worldwide cases, is caused by our body's inability to effectively use insulin.
Given the exploding incidence of diabetes across the globe, there is a great need for new drug therapies to manage and treat diabetes. The tissue bank with well-annotated human biospecimens has an important role to play in diabetes research. There are many ongoing studies of all aspects of diabetes utilizing human biospecimens. Here are four ways the tissue bank is helping to accelerate diabetes research.
Diabetes and cardiovascular disease
People with type 2 diabetes have a high frequency of cardiovascular disease (CVD), though studies have shown that the traditional factors, such as hypertension and dyslipidemia, don’t explain this increased incidence. A study published in 2012 investigated the molecular characteristics of diffuse pre-atherosclerotic changes that are often seen in diabetics with CVD. Using tissue samples from age-matched diabetic and non-diabetic men scheduled for a coronary bypass operation, gene expression profiles indicated that there are pathways and networks implicated in the diffuse vasculopathy that is present in arterial tissue of people with type 2 diabetes, and according to study authors, “these abnormalities may play a role for the arterial response to injury and putatively for the accelerated atherogenesis among patients with diabetes.”
Type 2 diabetes and pancreatic beta-cell gene expression
Using human biospecimens obtained from a tissue bank, researchers studied the changes in gene expression in pancreatic beta-cells from type 2 diabetes (T2D) patients. According to study authors, pancreatic beta-cells play a large role in T2D development and progression. Frozen tissue sections from the tissue bank were control (non-T2D) and T2D specimens. Beta-cell enriched samples were obtained by laser capture microdissection, the RNA was extracted and amplified, then underwent microarray analysis. The study has “identified many novel changes in gene expression that enhance understanding of the pathogenesis of T2D.”
Type 2 diabetes and microRNA changes in skeletal muscle tissue
Skeletal muscle insulin resistance, say this study’s authors, is an early feature of the progression toward T2D and is considered a risk factor for cardiovascular disease. Using muscle tissue samples obtained from a pre-qualified donor population, thousands of microRNA target genes were stratified and ranked. The authors “provided evidence that insulin resistance may be related to coordinated changes in multiple microRNAs, which act to target relevant signaling pathways. Thus, miRNA detection represents a new molecular biomarker strategy for insulin resistance.”
Skin inflammation in type 2 diabetics
Persistent skin inflammation in people with T2D is a common and vexing symptom. A global gene expression profile was performed on isolated lymphatic endothelial cells from both normal and T2D patients. Results revealed “aberrant dermal lymphangiogenesis and provide insight into its role in the pathogenesis of persistent skin inflammation in type 2 diabetes.”
A tissue bank with a diverse network of partner clinics can be an invaluable asset when you need well-annotated samples to advance drug discovery for diabetes. Hundreds of millions of diabetic sufferers around the globe are waiting for new therapies to fight this deadly disease. Contact Conversant Bio for the right tissues samples for your research.
How can we help advance your diabetes research?
Posted on Tue, May 21, 2013 @ 08:22 AM
Formalin fixed paraffin embedded (FFPE) tissue is the most common method of tissue preparation, found in archival collections all around the globe. FFPE tissue specimens provide a sizeable information source for large-scale drug discovery and biomedical research efforts. Indications include biomarker identification/ validation, genetic studies, and visualization of tissue structure. FFPE samples are important for ongoing studies involving many types of cancer, including breast, lung and colon cancer as well as inflammatory diseases such as rheumatoid arthritis and systemic lupus erythematosus (SLE).
FFPE tissue preparation is a critical factor so that the outcome of research studies can be relied upon as clinically valid. Because there is currently no universal standard for FFPE tissue preparation, variability in sample quality exists and has been a challenge for users of FFPE tissue. This is just one reason why it’s important to seek out a reliable source of FFPE tissue and to find out how the specimen is collected, processed and assessed as to its viability and quality.
One of the biggest concerns over the years has been the impact of FFPE fixation on RNA degradation. It has been widely documented that improper FFPE tissue preparation techniques cause a loss of quality nucleic acids from the tissue, limiting their use for expression profiling. One large study concluded that development of RNA-based assays from FFPE tissue is possible; however, study authors recommend that “greater attention to tissue handling and processing is essential to improve the quality of biospecimens for the development of robust RNA-based assays.”
When you’re seeking FFPE tissues samples for your research, one important question you need answered is whether a licensed pathologist oversaw the tissue collection and processing procedure. Pathologists play a key role in making sure that tissue samples collected are appropriate for testing and research. They evaluate tumor tissue sections for the frequency of tumor cells to ensure that sufficient quantity of extracted tumor cell DNA is available. Without the oversight of a pathologist, tissue specimens may be basically useless and a waste of valuable research time and funds.
Another important consideration when you acquire FFPE specimens is the quality control of samples procured by biobanks. As you surely know, good data is dependent on good sample quality. Find out whether your human tissue supplier routinely performs both a gross and microscopic review of FFPE tissue blocks to ensure that samples will meet your specific research criteria. Ask if you can review the specific sample fixation protocols.
The bottom line is this: because there are no fixed standards for FFPE tissue preparation, it’s very important for you to find a reliable and trustworthy partner to help you source high-quality, hyper-annotated specimens for your critical research projects. Contact Conversant Bio to learn more about why we're different.
Where can we help accelerate your research?
Posted on Tue, May 14, 2013 @ 08:52 AM
Breast cancer is the most common cancer among women in the U.S. (when non-melanoma skin cancer is excluded), reports the CDC. It causes hundreds of thousands of deaths among women each year. Estimates from the National Cancer Institute (NCI) are that in 2013, there will be over 232,000 new cases in women and over 2,200 in men; 39,000+ women will die as will over 400 men. About 85 percent of breast cancers occur in women with no family history of breast cancer, a surprising statistic for many women. Breast cancer is found in women of any age and rarely in men. The prognosis varies depending on the subtype, stage, and patient treatment options.
The many subtypes of breast cancer (including ductal carcinoma in situ, lobular carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma, inflammatory, triple negative) make it a very challenging cancer for researchers seeking better therapeutic options. One important tool is the use of FFPE tissue for breast cancer research.
Formalin fixed paraffin embedded (FFPE) biospecimens are widely available in tissue archives and allow scientists to pursue many promising drug discovery programs. Human tissue banks can help researchers procure samples that are highly annotated and come only from individuals who were properly consented. Many biobanks will work with the research team to prospectively gather samples for pre-clinical test regimens. They may also have an extensive existing biorepository of FFPE tissue.
Here are just a few clinical studies utilizing FFPE tissue for breast cancer research:
- A current clinical trial for patients with advanced solid tumors is investigating an agent called NUC-1031 that may work on breast cancer by preventing cancer cells from dividing by attacking their DNA.
- It’s estimated that 40 to 50 percent of estrogen receptor (ER) positive breast tumors resist endocrine therapy, which has been shown to reduce recurrence risk and even death. By performing proteomic screening of FFPE tissues, a recent study found a novel new protein known as FKBP4 that may play an important role in endocrine-responsive breast cancers.
- Preliminary data on the association of the folate receptor alpha (FRA) expression with triple negative breast cancer (TNBC) suggests that this may be a new molecular subtype of breast cancer that could be a target for FRA therapy. In metastatic breast cancer, FRA was found to be expressed in 86 percent of TNBC patients.
Improving on breast cancer prognosis is vitally important for women and men all around the world. Utilizing top-quality, carefully-sourced FFPE tissue for breast cancer research can help move research forward and ultimately, provide new and better treatments for this devastating disease.
What breast cancer biospecimens can we source for you?
Posted on Tue, May 07, 2013 @ 08:05 AM
Human tissue specimens offer an invaluable source of information for scientific research into a wide variety of human diseases and potential cures. Fresh tissue is not always available, and so preserved tissue specimens are widely used; the most common is formalin-fixed paraffin-embedded (FFPE) tissues. Advances in scientific extraction and recovery methods in recent years are enabling researchers to gather more information from FFPE tissue samples that is clinically and scientifically reliable. Here are just a few interesting clinical indications for FFPE tissue samples - there are hundreds, if not thousands, of additional studies underway that utilize top-quality FFPE tissue samples.
Reverse phase protein array (RRPA)
Protein biomarker quantification in FFPE tissues is important for making better treatment decisions for diseases such as cancer, and for evaluating the success or failure of personalized molecular therapies. Reverse phase protein array (RRPA) is a new method for rapid and parallel analysis of large numbers of patient samples to obtain relative and absolute protein quantifications. One recent study looked at how protein extraction from FFPE tissue samples could aid in integrating RPPA into therapy decisions.
Clinical trial on biomarkers in thyroid neoplasms
The Mayo Clinic has begun a clinical trial protocol using both fresh and FFPE tissue to evaluate microRNA biomarkers from both blood and biopsy samples. The purpose is to be able to distinguish benign folliular adenoma from follicular carcinoma of the thyroid.
Mitochondrial DNA depletion syndrome
Research into quantifying mitochondrial DNA content is important for diagnosing mtDNAdepletion syndrome (MDS). Using FFPE muscle biopsy archival samples, one study concluded that FFPE muscle tissue samples are useful for screening patients thought to have MDS, especially when frozen biopsies aren't available.
Clinical trial on ONJ in patients with metastatic cancer
This ongoing trial uses two types of FFPE tissue samples to help researchers create a risk index that aids in estimating someone's risk of developing osteonecrosis of the jaw (ONJ) for patients who have been prescribed nitrogen-containing bisphosphonate therapy for metastatic bone disease.
Biomarker research into urological cancer
Because there is often a lack of adequate numbers of fresh tissue samples for biomarkerprofiling studies, there is great interest in using FFPE archival tissues for urological cancer biomarker studies. A recent review looked at new techniques that are emerging to overcome the degradation of tissue DNA that has been a concern with the FFPE process. It concludes that using FFPE archives for biomarker research and profiling is possible, given these new methodology advancements.
These are but a few of the important and interesting research projects now underway utilizing FFPE tissue samples. When fresh or frozen tissue specimens aren't available or available in sufficient numbers, FFPE tissues are a valuable resource for your drug discovery or diagnostic methodology research.
What project can we help you to catalyze?
Posted on Tue, Apr 30, 2013 @ 10:03 AM
Fixed and archived tissue specimens are stored in facilities all around the world and their research value cannot be overstated. The most commonly available preserved biospecimensare formalin-fixed paraffin embedded (FFPE) tissues. This method of tissue preservation entails fixing a biospecimen in neutral-buffered formalin soon after resection and then embedding it in paraffin. These samples are increasingly popular for molecular medicine and diagnostics research, including such areas as biomarker identification and validation, genetic studies and tissue structure visualization.
Unfortunately, not all FFPE tissues are created equal. Because no specific industry standards yet exist and regulatory documentation is hard to find, there is variability in the procedures used for tissue collection and fixation. To find top-quality FFPE tissues, here are a few suggestions that can help you ensure your samples are clinically useful:
Pathologist oversight – Quality is improved when fixation is supervised by a licensed pathologist. Why is this important? Pathologists are physicians specializing in the diagnosis and characterization of human disease by examining tissue specimens or bodily fluids such as blood. To become licensed, the individual must complete medical training, an approved residency program and be certified by an appropriate body; in the US, this is typically the American Board of Pathology. Licensed pathologists make sure that high standards are followed when biospecimens are procured and fixed.
Quality Control – Not all FFPE tissue suppliers do additional quality control on received tissue blocks. Look for a tissue lab that does both a gross and microscopic review to make sure only top-quality FFPE tissues are procured for your research requirements.
Reliable sourcing – Certainly, there are many reliable organizations who have high standards when it comes to collection and fixation of biospecimens. And sadly, there are other organizations with substandard QC procedures and unreliable fixation procedures. When seeking a source of FFPE specimens, find out where the biolab gets their samples, and inquire about the reliability of samples that come from non-U.S. sources.
Transparency – Your research relies on well-annotated biospecimens, properly collected and fixed. A top-rate tissue lab should not hesitate to provide specific details on the fixation protocols followed by its collection team.
Patient and genetic history – The more data you have on patient treatment, the better it is for your research protocol and progress. Finding the right patient cohort is often a challenge. Look for an FFPE tissue lab that is able to provide newly diagnosed, refractory, or metastatic details, as well as genetic profile information on the most commononcogenes.
Make sure you find a trustworthy biospecimen partner, so you find answers faster to today’s challenging medical mysteries. What kind of top-quality FFPE tissues can we locate for you?
Posted on Fri, Apr 26, 2013 @ 09:50 AM
Customized Medicine and Breast Cancer
There are numerous subtypes of breast cancer. Generally, ductal carcinomas occur in the ducts while lobular carcinomas occur in the lobules. The subtypes of breast cancer include ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), inflammatory breast cancer, triple negative breast cancer (TNBC), Paget’s disease of the nipple, Phyllodes tumor, angiosarcoma, and male breast cancer. Usually, breast cancer occurs in women at any age and rarely occurs in men. There were 226,870 new invasive breast cancer cases and 63,300 new non-invasive breast cancer cases in the United States last year. Prognosis varies according to the type and stage of breast cancer, as well as the patient’s location. Patients in developing countries have poorer prognoses.
Characteristics
Patients may notice a palpable lump in the breast or lymph node. They may also notice a change in breast shape, size, and position. There may be a change in the nipple’s appearance, a rash around the nipple, or discharge from the nipple. Some patients experience chronic pain in the breast and/ or armpit region. There may be swelling in the armpit or collarbone region. Some patients may experience itching, warmth, or redness around the breast. Patients suffering from inflammatory breast cancer may experience an orange-peel texture of the breast, termed peau d’orange. Patients suffering from Paget’s disease may experience redness and flaking of the nipple as well as burning and tingling. More general physiological symptoms include fever, weight loss, jaundice, and neurological symptoms.
Diagnosis
Breast cancer is diagnosed in symptomatic individuals and in asymptomatic individuals that undergo regular health screenings. Lumps are usually sighted by imaging technology such as mammography, and are palpated during clinical breast exams. These lumps are further investigated by a number of biopsy techniques. These techniques include fine needle aspiration (FNA), core needle biopsy, vacuum-assisted biopsy, incisional biopsy, and excisional biopsy. FNA is the least invasive procedure and usually leaves no scar. Core needle biopsy involves a larger needle than FNA, but usually leaves no scar. Both FNA and core needle biopsy can result in a false negative since both tests use smaller tissue samples. Vacuum-assisted biopsy is one of the newest techniques; it uses a probe and a rotating cutting device to suction out tissue samples. This allows for larger tissue samples than FNA and core needle biopsy. Incisional biopsy is more invasive than other biopsy techniques. A surgeon makes an incision to remove a tissue sample. Excisional biopsy is the most invasive technique, involving a surgeon removing the entire lump as well as a margin of normal tissue. This technique has the lowest false negative rate. After a lump or a part of a lump is removed by biopsy, it is tested microscopically for cancerous growth.
Causes
There are a number of suspected causes of breast cancer, which include genetic inheritance, disease, and environmental agents. Genetic markers have been linked to a patient’s susceptibility to breast cancer. These markers include BRCA1, BRCA2, ATM, CHEK2, PTEN, CDH1, STK11, HER2, ER, and PR. By indentifying these markers, researchers make patient risk assessments available. Patients can understand their risk level and follow their own specific health regimen. Patients are equipped to make better healthcare choices by closely monitoring their health risks.
Ductal and lobular hyperplasias, alcoholism, and obesity are also linked to breast cancer. Hyperplasia is a non-cancerous abnormal growth in the ductal or lobular areas of the breast. Atypical ductal hyperplasia (ADH) is an abnormal growth in the breast ducts. Patients with ADH experience increased risks of developing breast cancer. Alcohol has been classified as a Group 1 carcinogen by the IARC. The Million Women Study conducted between 1996 and 2001 concluded that low to moderate alcohol consumption in women increases their risk of developing certain cancers.[1] According to the study, the incidence of breast cancer increases by 11 out of 1000 women for each alcoholic drink consumed per day. The incidences of other cancer types are also increased, resulting in 15 different cancer types per 1000 women. Obesity is also linked to higher incidences of breast cancer as well as the reoccurrence of breast cancer following treatment. A research team from Tulane has studied adipose-derived stromal/ stem cells (ASCs), which were taken from both lean and obese patients undergoing plastic surgery.[2] The team found that stem cells originating from obese patients were much more invasive. These stem cells invade neighboring tissues, feeding cancerous cell growth.2This team’s findings could revolutionize how we treat breast cancer. Instead of targeting breast cancer cells, we can target the phenotypes that cause these stem cells to invade tissues to feed the cancer.2
Radiation exposure, oral contraceptives (DMPA), and estrogen therapy are more causes linked to breast cancer. Radiation exposure comes in many different forms from X-ray exposure to sun exposure. Some patients receiving radiation treatment for other types of cancer may develop secondary cancers, including breast cancer. Oral contraceptives, especially depot-medroxyprogesterone (DMPA), have been linked to increased incidences of breast cancer. Carcinogenicity studies have focused their testing on monkeys, rats, mice, and dogs. In these studies, the incidence of cancer increased with DMPA dosage concentration.[3] DMPA, however, cannot be directly linked to breast cancer. It is difficult to prove DMPA as the sole initiator of breast cancer in patients due to the various effects of progesterone on breast tissue.
Treatments
Standard methods of treatment include surgery, radiation, chemotherapy, and targeted therapy. Available treatment options vary according to the breast cancer’s stage. Surgery is more effective for early stage breast cancer cases. Later stage breast cancer cases require radiation and chemotherapy treatments to treat metastatic growths. The prognosis for stage 0 breast cancer for 5 years post-diagnosis is 92%; 87% for stage I; 75% for stage II; 46% for stage III; and 13% for stage IV. Epidemiological studies can drastically improve treatment options by studying what increases breast cancer incidences. Customized medicine that prevents breast cancer before it occurs is the way of the future.
[1] J Green., et al. “Moderate Alcohol Intake and Cancer Incidence in Women.” Journal of the National Cancer Institute 101.5 (n.d.): 296-305. Science Citation Index. Web. 15 Apr. 2013.
[2] Bruce A Brunnell, et al. “Obesity-associated Dysregulation of Calpastatin and MMP-15 in Adipose-derived Stromal Cells Results in their Enhanced Invasion.” Stem Cells (Dayton, Ohio) 30.12 (2012): 2774-2783. Medline. Web. 17 Apr. 2013.
[3] “Depot-Medroxyprogesterone Acetate (DMPA) and Cancer: Memorandum from a WHO Meeting.” Bulletin of the World Health Organization 71.6 (1993): 669-676. Medline. Web. 17 Apr. 2013
Posted on Tue, Apr 23, 2013 @ 08:00 AM
Drug discovery relies more and more on high-quality human tissue specimens. Such biospecimens may be from fresh and frozen human primary cells, cancerous tumors removed during surgery; bone marrow; processed and whole tissue; or xenograft tumor cells. Whatever the type of biospecimen, rigorous ethical standards related to tissue sample consent and sourcing protocols must be a top concern for scientists who need these samples.
When biospecimen suppliers get sloppy and don’t follow consent standards, the entire industry suffers. Imagine what would happen to drug discovery if patients stopped consenting to donating their tissue specimens for research. It would be a huge setback for all companies seeking to bring better therapies to sick patients.
This is not just a theoretical “what-if” proposition. A recent article about biopiracy in The Scientist reports on the struggle of U.S. scientists to complete studies in Ecuador due to biopiracy accusations. The complaint alleges that researchers drew blood from indigenous people without proper consent and under the false pretense that the samples would be used as part of a medical exam. While the case is as yet unresolved and the researchers claim they received no commercial benefit from the specimens, this situation nevertheless serves to highlight the value of partnering only with the most ethical biobanks.
The National Cancer Institute (NCI) has published a “Best Practices for Biospecimens Resources”; it’s a good guide for researchers seeking to better understand tissue sample consent and sourcing procedures. Here are some highlights:
Informed consent, says NCI, is designed to offer potential human donors with sufficient information— such as anticipated procedures, risks, and benefits—to make an informed decision about whether to participate in research studies. It notes that obtaining informed consent for the collection, storage, and future research use of biospecimens can be challenging because the specifics of the future research is not always known. That’s why it’s a good idea to have a process in place that ensures both adherence to the highest ethics of sample consent, while providing for some flexibility in the consent language so that researchers don’t have their hands tied when they need those biospecimens for uses that could not be forecasted at the time consent was provided.
The Federal Government’s Office for Human Research Protection also has written guidelines relating to tissue sample consent and sourcing procedures. They include:
· A description of the operation of the biospecimen resource (i.e. hospital, clinic, biobank)
· Conditions under which samples and data will be released to recipient investigators
· Procedures for protecting the privacy of human research participants and data confidentiality
· Specific descriptions of the nature and purpose of the research.
· Information about the consequences of DNA typing if human genetic research is anticipated.
NCI guidelines also stress the importance of respecting “personal, religious, and culturally held beliefs and traditions.” It notes that, for example, some cultures believe that the body is sacred and cannot be disturbed.
The Best Practices document further suggests that when tissue samples are obtained, a pathologist or his/her trained designate should be involved in collecting and processing biospecimens to ensure that patient care is never compromised. It recommends oversight procedures and a detailed SOP manual outlining the procedures for obtaining informed consent and for protecting the privacy of identifiable human research participants.
When you’re in search of the next blockbuster cancer therapy, rely on a partner that will deliver only the highest-quality, well-annotated biospecimens, while still adhering to rigorous ethical sourcing and consent standards.
How can we help advance your research?
Posted on Tue, Apr 16, 2013 @ 08:00 AM
Researchers are making great progress in developing effective treatments for cancer. As drug therapy has become more targeted, cancer survival rates are on the rise for many types of cancer. Yet, there is still much work to be done, as many cancers still have a poor prognosis and a high mortality rate. Hepatocellular carcinoma, for example, is the third leading cause of worldwide cancer deaths and has a mortality rate approximating its incidence. To improve and accelerate the development of effective cancer therapies, scientists increasingly rely on human tissue specimens for preclinical drug discovery. Partnering with a top-quality tissue bank is an essential part of the complex, lengthy and expensive cancer drug development process.
Why use tissue banks for cancer research
There are many reasons that researchers increasingly turn to tissue banks for cancer research, including the following:
1. It’s increasingly obvious to many cancer researchers that using animal models for drug research is inefficient and often generates results that don’t correlate very well to the human body’s response.
2. High-quality cancer tissue is important for the growing field of molecular medicine. Nucleic acids and proteins obtained from tissue are useful for a wide range of molecular analyses, including comparative genomic hybridization and quantifying gene expression. Human tissue specimens enable cancer researchers to zero in on the molecular mechanisms underlying human cellular activity and to better understand why and how cancer cells develop and proliferate.
3. Human tissue specimens that are stringently sourced, collected, preserved and annotated help to accelerate cancer drug discovery programs, by providing a repository of samples that scientists can quickly access for research projects. Such biobanks usually have hundreds of thousands of specimens representing all types of diseases.
4. Prospective sample collection is increasingly useful for drug research efforts. In these situations, the tissue bank is an active partner with their drug research client, seeking out samples that meet project criteria. The biobank has a diverse network of partner clinical institutions that can help to identify patients based on specific and customized demographic and clinical information criteria targeted specifically to researchers' needs.
5. A top-quality biobank adheres to the most stringent ethical standards so that all samples they collect are properly sourced and consented. Without such documentation, important and time-consuming drug candidate research can be lost.
6. When researchers use tissue banks for cancer research, they need to have confidence that the samples were properly prepared and stored after their extraction. Proper quality control procedures ensure that specimens maintain high cellular viability and are therefore reliable and translatable models for drug discovery research.
Collaboration among companies involved in cancer research and drug discovery helps speed answers to the big challenge of cancer. Let us be your partner in research and development and help provide your scientists and researchers with the highest quality specimens so they can create life-saving patient therapies. What cancer research project can we help you with?
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