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Genetics - BrainPOP
Genetics is the future and the past. The history and the promise of every organism is written in its DNA.
Geneticists are leading one of the major scientific revolutions of humankind, delving into the distant past and providing an unprecedented understanding of the biological world.
Our department offers a supportive and unique training environment across the full spectrum of genetics, bridging the disciplines of molecular genetics, development, genomics, and evolutionary biology.
The Department of Genetics is in UGA'sFranklin College of Arts and Sciences.
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Welcome to the Department of Genetics | Department of Genetics
The first major-specific course required of freshman genetics majors is Careers in Genetics and Biochemistry. This introductory course brings in professionals to aid students in discovering the diversity of career opportunities available from this degree. This course also helps you become aware of professional organizations, ethical issues and the requirements for advanced studies.
In the first two years at Clemson, youll take various science courses such as general and organic chemistry, biology, physics and mathematics. These will prepare you for upper-level course work that includes molecular biochemistry, molecular and general genetics, comparative genetics and population genetics. Additionally, youll be able to tailor your degree to your specific interests by selecting from approved scientific courses such as microbiology, immunology, and human anatomy and physiology.
Genetics students spend quite a bit of time in Clemsons laboratories with our nationally recognized faculty. Our faculty have diverse research interests from alternative fuel to molecular parasitology. You also have a chance to participate in internships and study abroad, as well as join any of Clemsons hundreds of student organizations.
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Genetics (B.S.) | Degree Programs | Clemson University ...
Genetic and genomic research has improved our understanding of the genetic origin of growth, development and disease and affects all areas of healthcare. There is also mounting evidence that many complex conditions are the result of interactions between genes. These include diabetes and hypertension.
Genomics has become increasingly important to oral health too. Dentists regularly come across obvious expressions of genetic disorders or genetic-based diseases in the oral and head and neck region. There are approximately 5,500 known inherited conditions. More than 700 of these have abnormalities which involve the oral and dental region of the face.
These insights have been gained through continued and concerted efforts to understand the genetic aspects of diseases. This understanding, in turn, has generated novel approaches to prevent, diagnose and manage them.
In the area of dentistry, teaching has unfortunately not kept up with the science, particularly in Africa. This places dentists at a disadvantage. They cant or find it difficult to contribute to the overall health of patients with genetic disorders because they dont have the necessary knowledge. This would include the ability to recognise the indicators of genetic disorders and the confidence to manage these patients.
This is why dentists need a sound understanding of genetics. And its why genetics and genomics should be included in the undergraduate and postgraduate curriculum. Investing in structured dental genetics programmes in dental schools in Africa would ensure an increase in the dental genetics workforce. This would ultimately improve the management of patients with inherited conditions with oral and dental manifestations.
To evaluate the need for human genetics in the dentistry curriculum my colleagues and I conducted a survey at the dental school at a South African university. Academic staff, 4th and 5th-year undergraduate dental students as well as postgraduate dental students participated in the survey.
The results indicated that students and clinicians had limited training and experience pertaining to the diagnosis and management of individuals with genetic disorders.
Currently, there are no plans in place to train dentists with a sound understanding of genetics. There are also no programmes in place to allow trained African dentists to choose such a career pathway.
As a result, there is an over-dependence of African clinical practice on research findings from technologically advanced Western countries. Secondly, it means that clinical research capacity building isnt happening. And finally, it means that patients arent being offered the best possible diagnosis and treatment.
There are several factors responsible for the lack of dental genetics in Africa. Among a few challenges are poor biomedical research infrastructure, minimal funding and an absence of a structured dentist genetics career pathways.
To address these challenges, African universities and dental schools need to develop and include dental genetics courses in undergraduate and postgraduate programmes. These should be designed to ensure they help members of the dental fraternity to treat patients with hereditary conditions.
The dental genetics workforce would, in turn, increase trained dentists some of whom could have the option of following a research career. This would enhance networking among African dental researchers and lead to better dental research output across the continent.
Several first world universities, such as the universities of Pittsburg, Manchester and Oslo have included dental genetics into their curricula. Their vast research capacity has resulted in evidence-based dentistry being offered to patients in those countries.
Another way to foster an interest and understanding of genetics in the dental community is by developing collaborative relationships. One already exists in South Africa between the division of human genetics at the University of Cape Town and the dental faculty at the University of the Western Cape. This partnership runs a dental genetics clinic which serves patients with genetic disorders from across the Western Cape province. Postgraduate students also rotate through the clinic and are mentored in the dental management of children with genetic disorders and congenital abnormalities.
Adding courses on human genetics in the curriculum at dental schools would be a first step to ensuring that more dentists have an understanding of the field.
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Dentists in South Africa aren't being taught genetics. Why they should - The Conversation Africa
A reporter examines a 23andMe DNA genetic testing kit in Oakland, California.
Cayce Clifford | Bloomberg | Getty Images
It has not been a good year for consumer DNA testing companies.
In January, Silicon Valley-based 23andMe laid off 100 employees, about 14% of its workforce. A month later, Ancestry, which has offices in Utah and San Francisco, also cut 100 jobs, representing about 6% of its staff.
The major reason for the downsizing? Simply put, consumers aren't buying as many at-home DNA tests as they used to.
The first sign came in the summer, when Illumina, maker of the DNA sequencing machines that are used by Ancestry and 23andMe, acknowledged in an earnings call to investors that the category had hit a lull. CEO Francis DeSouza didn't share an explanation for that, but noted that Illumina was taking a "cautious view" of the opportunity in the near term. Orasure, maker of the spit tubes used by consumer DNA testing companies, has also seen its stock take a hit.
At that time, some smaller companies were already feeling the impact. Helix, a start-up that spun out of Illumina to build an "app store" model for DNA tests, cut staff in May. The company revealed to Bloomberg that it was shifting its focus away from consumers to population health, meaning it would work with health industry partners. A few months later, Veritas Genetics another company focused on consumers that sold more expensive but more detailed whole genome sequencing tests shuttered its U.S. operations.
So what happened? There hasn't yet been a detailed study to understand the shift in consumer thinking around these tests. But CNBC spoke with some of the leading genetics experts and doctors, who shared a few theories.
Dawn Barry, a former Illumina executive with a start-up in the space called LunaDNA, blames a few factors, especially privacy concerns.
Consumers have seen a slew of reports in the past few years about how companies are using their personal data for targeted advertising, without their knowledge, and might be feeling particularly sensitive about their health information.
Anne Wojcicki, CEO of 23andMe, has previously referred to these concerns as the "Facebook effect." In her view, consumers are increasingly freaked out about stories they're reading in the media about privacy, mostly about Facebook and other technology companies, and are reacting by feeling anxious about getting DNA tests.
Companies like 23andMe do make money off this information. Her company does ask for consent from users and it has publicly explained its revenue model, but a big part of its business involves its relationships with pharmaceutical companies like GlaxoSmithKline. 23andMe also has a therapeutics arm, where it is hoping to leverage its database of millions of people's DNA to develop new drugs.
Making matters worse for these companies, suggests Barry, is the Golden State Killer case. Law enforcement honed in on a suspect after running DNA from a decades-old crime scene through a free online database, where anyone can upload their genetic information.
A suspect was found through a distant relative who might have paid for a test via Ancestry or 23andMe, and then uploaded it into the database.
The case raised all sorts of complicated questions about whether genetic information is fundamentally different than other types of data because it implicates family members and not just individuals.
Other experts suspect that consumer DNA testing companies might have run out of early adopters. The theory goes that there's about 20 million or 30 million consumers who are naturally interested in learning more about their family background, and it's not that challenging or expensive to sell tests to them. At this point, many of these people have already been sold to, and there's no reason for them to buy a second test. Ancestry has sold about 14 million tests, and 23andMe has sold some 9 million.
But many people are wary about learning information they might not want to know like the father who raised them isn't their biological father or that they have a risk for a genetic disease that they can't take a pill to prevent.
There's likely a larger consumer segment that's interested, but still wary about these tests. They might not believe that the information is valuable enough to warrant the price tag. The cheapest tests sell for $99, and they'll cover ancestry and some health risks but lack truly actionable health information, like whether an individual might respond poorly to a drug based on their genetic makeup.
"The ancestry market is a finite market," said David Mittelman, CEO of Othram, a genomics start-up and a molecular physicist. A decade or so in, "these companies are beginning to tap out the market."
Mittelman notes that customer acquisition costs, including ad dollars these companies need to spend on sites like Facebook, will increase over time.
"I think the companies know this," he said. "The investment in health shows that they are working to appeal to a broader market."
What's noteworthy about the recent round of layoffs is that Ancestry kept all of its employees at its Ancestry Health business. And 23andMe is still highly focused on its drug development business. That suggests that both companies are indeed hinging their future on developing powerful health applications.
In light of that, some geneticists are optimistic about their future.
"First of all, a slowdown isn't a stoppage," said Dr. Robert Green, a professor of genetics at Harvard Medical School. "Our research is finding that genetics is about to take its rightful place in medical care for the world."
As Green explains, it's been a challenge for doctors to understand how genetics can inform their patient care. Many haven't had the education about genetics to understand how to talk about it with their patients or recommend tests that might be beneficial. But that's starting to change.
For instance, 23andMe is starting to roll out new tests that can identify people's risk for chronic diseases like diabetes, called polygenic risk scores. These results could be used by doctors to help steer their patients toward making healthier lifestyle choices to help them avoid getting the disease.
And for these companies, which already have genetic databases of millions of people, they might not need to keep spending ample marketing dollars to acquire new customers. Instead, they could focus on developing new insights from their existing databases. if they succeed at that, they can forge partnerships to the medical industry.
As Mittelman puts it, there's no need to "force people down an ancestry funnel."
Green agrees, saying companies like 23andMe and Ancestry might double down on more expensive but more detailed sequencing tests that provide a lot more relevant health information. 23andMe has dabbled with those kinds of tests but has been reluctant to roll out higher-priced tests while its main focus has been growth.
"The direct-to-consumer phenomenon will give way to a more of a proper integration of genomics into the day-to-day care of patients," said Green. "What we're seeing is a course correction, and consumers are waking up to the potential limitations of a $99 test."
CNBC Evolve will return, this time to Los Angeles, on June 8. Visit cnbcevents.com/evolve to apply to attend.
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Consumer DNA testing is a bust: Here's how companies like Ancestry and 23andMe can survive - CNBC
Chromosomes prepared from a malignant glioblastoma visualized by spectral karyotyping (SKY) reveal an enormous degree of chromosomal instability a hallmark of cancer. Credit: NCI Center for Cancer Research (CCR)
Mutations in 38 different types of cancer have been mapped by means of whole genome analysis by an international team of researchers from, amongst others, the University of Copenhagen, Aarhus University, Aarhus University Hospital, and Rigshospitalet. The researchers have compiled a catalog of the cancer mutations that will be available worldwide to doctors and researchers.
Globally, cancer is one of the biggest killers and in 2018, an estimated 9.6 million people died of the disease. In order to provide the best treatment for the disease, it is essential to find out which mutations are driving the cancer.
We have studied and analyzed the whole genome, and our analyses of mutations that are affecting cancer genes have enabled us to genetically explain 95 percent of the cancer occurrences we have studied by means of mutations. Joachim Weischenfeldt
In a major international collaboration called Pan-Cancer Analysis of Whole Genomes (PCAWG), researchers from the University of Copenhagen, Aarhus University, Aarhus University Hospital, and Rigshospitalet have helped to map mutations in 38 different types of cancer.
The mutations have all been combined into a sort of catalog. The catalog, which is already available online, allows doctors and researchers from all over the world to look things up, consult with and find information about the cancer of a given patient.
Most previous major studies have focused on the protein coding two percent of the genome. We have studied and analyzed the whole genome, and our analyses of mutations that are affecting cancer genes have enabled us to genetically explain 95 percent of the cancer occurrences we have studied by means of mutations, says co-author Joachim Weischenfeldt, Associate Professor at the Biotech Research & Innovation Centre, University of Copenhagen, and the Finsen Laboratory, Rigshospitalet.
So, if you know which mutations have caused cancer, the so-called driver mutations, you will be able to better tailor a treatment with the most suitable drugs or design new drugs against the cancer. Precision medicine is completely dependent on the mapping of driver mutations in each cancer, in relation to diagnosis, prognosis and improved treatment, says co-author Jakob Skou Pedersen, professor at Bioinformatics Research Centre and Department of Clinical Medicine, Aarhus University, and Aarhus University Hospital.
The new research results are published in a special edition of the scientific journal Nature with focus on PCAWG. To date, it is the largest whole genome study of primary cancer. This means that the analysis was performed based on material from the tissue in which the tumor originated and before the patient has received any treatment.
The researchers have mainly analyzed and had data on the most common types of cancer such as liver, breast, pancreas and prostate cancer. In total, they have analyzed whole genome-sequenced tumor samples from more than 2,600 patients.
Based on their analyses, they could see that the number of mutations in a cancer type varies a lot. Myeloid dysplasia and cancer in children have very few mutations, while there may be up to 100,000 mutations in lung cancer.
The infographic is an overview of the different cancer types studied in the Pan-Cancer Project. The lower part also lists the six cancer types (for men and women) for which the most samples were available. Credit: Rayne Zaayman-Gallant/EMBL
But even though the number of mutations spans widely, researchers could see that on average there were always 4-5 mutations that were driving the disease, the so-called drivers no matter what type of cancer it was.
It is quite surprising that almost all of them have the same number of driver mutations. However, it is consistent with theories that a cancerous tumor needs to change a certain number of mechanisms in the cell before things start to go wrong, says Jakob Skou Pedersen.
In the catalog, the researchers have divided the mutations into drivers and passengers. Driver mutations provide a growth benefit for the cancer, while passenger mutations cover all the others and are harmless. The vast majority of all mutations are passengers.
To store and process the vast amount of data, the research team has used so-called cloud computing, using 13 data centers spread across three continents. They have had centers in Europe, the US, and Asia.
The large data set has been necessary to establish what was common and unique to the different types of cancer. Today, cancer is divided according to the tissue in which the disease originates, for example breast, brain, and prostate.
The researchers found many things that were completely unique to each type of tissue. Conversely, they also found many common traits across the tissue types. According to Joachim Weischenfeldt, there is thus a need to rethink the way we think about cancer.
Cancer is a genetic disease, and the type of mutations is often more important than where the cancer originates in the body. This means that we need to think of cancer not just as a tissue-specific disease, but rather look at it based on genetics and the mutations it has.
For example, we may have a type of breast cancer and prostate cancer where the driver mutations are similar. This means that the patient with prostate cancer may benefit from the same treatment as the one you would give the breast cancer patient, because the two types share an important driver mutation, says Joachim Weischenfeldt.
Reference: Pan-cancer analysis of whole genomes by The ICGC/TCGA Pan-Cancer Analysis of Whole Genomes Consortium, 5 February 2020, Nature.DOI: 10.1038/s41586-020-1969-6
The International Cancer Genome Research Consortium has been supported by national foundations, including Independent Research Fund Denmark.
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Massive Genetic Map of Cancer Mutations Cataloged Available to Doctors and Researchers Worldwide - SciTechDaily
NEW YORK The American College of Medical Genetics and Genomics (ACMG) and five other national medical organizations said on Wednesday that they have partnered to create the Reproductive Genetics Technology Consortium in order to help develop consensus recommendations and consistency among various medical societies that issue recommendations and guidelines for prenatal genetic testing.
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Medical Organizations Form Reproductive Genetics Technology Consortium - GenomeWeb
- After Median Follow-Up of 11.5 Months, 73 Percent of Patients Had Confirmed Tumor Response with Majority of Responses Still Ongoing; No New Safety Signals Observed for the Combination -
- Findings To Be Presented During an Oral Session at the 2020 Genitourinary Cancers Symposium -
BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ --Seattle Genetics, Inc.(Nasdaq: SGEN) and Astellas Pharma Inc.(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract #441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.
PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2
"Cisplatin-basedchemotherapy is the standard treatment for first-line advanced urothelial cancer; however, it isn't an option for many patients,"said Jonathan E. Rosenberg, M.D., Medical Oncologist and Chief, Genitourinary Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York."I'm encouraged by these interim results, including a median progression-free survival of a year for patients who received the platinum-free combination of PADCEV and pembrolizumab in the first-line setting."
In the study, 58 percent (26/45) of patients had a treatment-related adverse event greater than or equal to Grade 3: increase in lipase (18 percent; 8/45), rash (13 percent; 6/45), hyperglycemia (13 percent; 6/45) and peripheral neuropathy (4 percent; 2/45); these rates were similar to those observed with PADCEV monotherapy.3Eighteen percent (8/45) of patients had treatment-related immune-mediated adverse events of clinical interest greater than or equal to Grade 3 that required the use of systemic steroids (arthralgia, dermatitis bullous, pneumonitis, lipase increased, rash erythematous, rash maculo-papular, tubulointerstitial nephritis, myasthenia gravis). None of the adverse events of clinical interest were Grade 5 events. Six patients (13 percent) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. As previously reported, there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.
The data demonstrated the combination of PADCEV plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 73.3 percent (33/45; 95% Confidence Interval (CI): 58.1, 85.4) after a median follow-up of 11.5 months (range,0.7 to 19.2). Responses included 15.6 percent (7/45) of patients who had a complete response (CR)and 57.8 percent (26/45) of patients who had a partial response. Median duration of response has not yet been reached (range 1.2 to 12.9+ months). Eighteen (55%) of 33 responses were ongoing at the time of analysis, with 83.9% of responses lasting at least 6 months and 53.7% of responses lasting at least 12 months (Kaplan-Meier estimate).The median progression-free survival was 12.3 months (95% CI: 7.98, -) and the 12-month overall survival (OS) rate was 81.6 percent (95% CI: 62 to 91.8 percent); median OS has not been reached.
"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating PADCEV in this platinum-free combination in the first-line setting," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
"These additional results support continued evaluation of PADCEV in combination with other agents and at earlier stages of treatment for patients withurothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.
About the EV-103 TrialEV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.
The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. Patients were dosed in a 21-day cycle, receiving an intravenous (IV) infusion of enfortumab vedotin on Days 1 and 8 and pembrolizumab on Day 1. At the time of this initial analysis, 45 patients (5 from the dose-escalation cohort and 40 from the dose-expansion cohort A) with locally advanced and/or metastatic urothelial cancer had been treated with enfortumab vedotin (1.25 mg/kg) plus pembrolizumab in the first-line setting.
The primary outcome measure of the cohorts included in this analysis is safety. Key secondary objectives related to efficacy include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). DoR,PFS and OS are not yet mature.
Additional cohorts in the EV-103 study will evaluate enfortumab vedotin:
More information about PADCEV clinical trials can be found at clinicaltrials.gov.
About Bladder and Urothelial CancerIt is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.5 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.6 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.7
The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are ineligible for cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.8
About PADCEV PADCEV (enfortumabvedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.9
PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.2,9Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9PADCEV is co-developed by Astellas and Seattle Genetics.
Important Safety Information
Warnings and Precautions
Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).
Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).
The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).
Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.
Drug Interactions
Specific Populations
For more information, please see the full Prescribing Information for PADCEV here.
About Seattle GeneticsSeattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people's lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.comand follow @SeattleGenetics on Twitter.
About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.
About the Astellas and Seattle Genetics CollaborationSeattle Genetics and Astellas are co-developing enfortumab vedotin-ejfv under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.
Seattle Genetics Forward-Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the EV-103 and EV-302 clinical trials; clinical development plans relating to enfortumab vedotin; the therapeutic potential of enfortumab vedotin; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of enfortumab vedotin may fail to establish sufficient efficacy; that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.
1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.3 Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.4 ClinicalTrials.gov. A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103). https://clinicaltrials.gov/ct2/show/NCT03288545.5 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.6National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.7International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow. 8 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.9 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.
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Clinical vs. DTC Genetic Testing
When 23andMe laid off roughly 100 employees last month, it was another admission that direct-to-consumer, or at-home, genetic testing sales are down at some leading companies. The reasons, however, while varied, have nothing to do with the interest in genetic testing. People want the information but it seems many prefer to get it from their doctors.
Theres reason for the interest: The field of genetics is booming.
Since the 1990s when we started testing for BRCA1, BRCA2 [which most notably increase the risk of breastandovarian cancers]and TP53 [which regulates cell division and keeps tumors from forming], the number of indications, or signs for cancer and the number of genes we can identify has expanded. And it will only continue to grow, Dr. Banu Arun, co-medical director of the Clinical Cancer Genetics Program at MD Anderson Cancer Center, tells SurvivorNet.
She notes that clinical genetic tests can aid in making recommendations for surveillance, determine prognosis and assist in treatment decision-making for cancer patients. Direct-to-consumer genetic tests dont offer that proverbial microscope.
When trying to understand your hereditary cancer risk, saysDr. Arun, clinical testing is the way to go.
Comparing DTC to clinical testing for cancer is actually a bit like apples to oranges.
Direct-to-consumer tests, which are relatively inexpensive ($99 and up), can make predictions about peoples health and ancestry. But theyre limited when it comes to offering tests for cancer risk. Currently, theFood and Drug Administration (FDA) has allowed at least one direct-to-consumer genetic testing company, 23andMe, to offer a test for cancer risk; it looks for three specific variations in BRCA1andBRCA2.
With direct-to-consumer testing, its only a very small piece of the puzzle, Megan Frone, board certified genetic counselor in the Clinical Genetics Branch at the National Cancer Institute, tells SurvivorNet. I think about it like a typo somewhere in a novel, she says. Theyre only looking at three pages, she says. You could have a typo anywhere else in the novel thats breaking that gene and giving you a higher risk for cancer, and theyre just not looking.
Clinical-grade testing can analyze the risk of 50 different types of cancer, according to The National Cancer Institute.
A study last year from the National Center for Biotechnology Informationnotes some other drawbacks, including how DTC tests frequently do notprovide conclusive results.
Most genetic tests performed by DTC companies are limited to few major genetic variants related to the phenotypes of interest, which leads to poor discriminatory power, it notes.
This means DTC genetic testing does not guarantee that a consumer with a high genetic risk score will suffer from a certain disease, it only indicates a genetic propensity.
Plus, test results could reveal other, unexpected, health risks.
You have to ask, Are they going to tell me about specific results I might not want to know about?' Frone says. Some at-home tests will tell you your risk for carrying certain Alzheimer gene variants. We dont have any particular treatment for Alzheimers. Some people dont want to know about that stuff because theres nothing they can do about it. They dont necessarily realize that theyre going to get that back on a test report.
All of which points to that important ingredient: an expert who can interpret and make an action plan.
DTC tests are often conducted without the involvement of a healthcare provider and without an understanding of clinical validity and utility, notes theCenters for Disease Control.
A recent study based on anonline survey of 1,001 adultsrepresentative of the population, found that public awareness of genomics and personalized medicine was not increasing in line with advancements in the industry. Seventy-three percent of the survey respondents had not heard of genetic counseling which is conducted by certified health professionals to advise consumers/patients on how to interpret genetic test results.
The first step for someone interested in learning about their risk for developing cancer, according to Frone, is to speak with a health care provider or genetic counselor to learn about options. Then, a risk assessment can be conducted by a certified genetic counselor.
In this type of consult, theyll look at personal medical history and family medical history. And, if youre female, theyll look at your hormonal risk factors, Frone explains. There are computer models to identify risks and patterns within someones personal and family history.
The next step, she says, is to discuss what needs to be done to test for the potential hereditary cancer syndrome.
People need to go into it understanding that genetic testing is really complicated, Frone says. To achieve the full value of it, weve got to apply the genetic test results in the context of their family health history and their other risk factors to understand final risk. Direct-to-consumer testing is very different from that. Its more recreational.
For those identified during the consult as being higher risk, insurance typically covers clinical testing. For people at a lower risk, they may be advised to skip testing altogether, or, they can pay out-of-pocket (costs can vary from $250 or more depending on whether a single gene or the entire genome is being tested).
For example, the BRCA1 and BRCA2 test 23andMe runs has been given the green light from the FDA, meaning the agency has determined that the benefits of the product outweigh the known risks for the intended use.
This specific test looks at three variants to determine if a woman is at an increased risk for developing breast and ovarian cancer, or if a man is at a higher risk for developing breast and prostate cancer.
It really is most relevant for individuals with Ashkenazi Jewish background because it can only look at three variants that can occur in these genes, when there are thousands possible, Frone says.
The actual test has been put in the Medical Devices class II risk category by the FDA. Class I devices, such as dental floss, are lowest risk. Class II, which includes condoms and powered wheelchairs, are moderate risk. Class III devices, such as pacemakers, require FDA approval in order to be marketed, while class I and II do not.
These mutations are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population, the FDA cautions.
Researchers estimate that roughly 5-10 percent of all cancers have a known genetic element, so while DNA tells a story, it doesnt write the entire script. External factors, like environmental nutrients or toxins, and lifestyle choices also influence risk for developing cancer.
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Kim Constantinesco is a freelance writer who specializes in health and founder ofPurpose2Play, which reports on positive and inspiring stories in sports. Read More
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Genetic Testing Is on the Rise Heres Why to Get it Done Through a Health Care Provider - SurvivorNet
Contract TypePermanentHoursFull TimeJob TypeAcademicSalary41,526 - 51,034 per annumVacancy TypeAcademic / Research VacanciesClosing Date05/03/2020Documents2913 JD LSL Football Physiology (Coaching).pdf(PDF, 528.13kb)
The School of Sport and Exercise Sciences seeks to strategically develop its world-leading profile of teaching and research excellence by the appointment of leading academics across the core disciplines of Sport and Exercise Sciences. The appointee to this post will be expected to contribute to the academic work of the School of Sport and Exercise Sciences across undergraduate and postgraduate levels within Science and Football through teaching and research.
You will be expected to develop and deliver research-informed/led teaching within the Schools well-established BSc (Hons) Science and Football programme, and contribute to its highly successful curricula at undergraduate, postgraduate and Professional Doctorate level.
You will also be expected to contribute to the supervision and tutorial support of Science and Football and Strength and Conditioning students in the School, including pastoral and academic (research and applied placement based learning) guidance.
The post also requires you to extend and enhance the football physiology research activity within the School of Sport and Exercise Sciences. Specifically to contribute to the Exercise Metabolism Adaptation research group. In this regard, the emphasis of this post is to extend our world-leading research outputs and impact within applied football physiology including strength training theory and its application into coaching, and its translation via the Football Exchange.
For informal discussions regarding the post or the School, please contact Professor Dave Richardson, Director of School, e:d.j.richardson@ljmu.ac.ukor Dr Rebecca Murphy, Subject Head,r.c.murphy@ljmu.ac.uk
The School/ department is committed to promoting equality and diversity, including the Athena SWAN Gender Equality charter for promoting the career of Women in STEM (science, technology, engineering, mathematics) in higher education. We particularly welcome applications from women for this post and all appointments will be made on merit.
Please note all of our vacancies will beclosed to applications at midnight on the advertised closing date, unless otherwise stated.
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Lecturer/Senior Lecturer in Football Physiology, Coaching job with LIVERPOOL JOHN MOORES UNIVERSITY | 195977 - Times Higher Education (THE)