A00-281 exam Dumps Source : Clinical Trials Programming Using SAS 9 Accelerated Version
Test Code : A00-281
Test name : Clinical Trials Programming Using SAS 9 Accelerated Version
Vendor name : SASInstitute
: 99 existent Questions
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The branch of Biostatistics within the school of Public health and health Professions these days launched a brand unique analysis software for undergraduates prerogative through the 2018-19 wintry weather smash.
The Biostatistics Epidemiology and research Design (BERD) Undergraduate wintry weather Institute for Biostatistics became designed to address the widening hole between the exact for qualified biostatisticians and the available give via pupil exposure to the self-discipline. This application provided 13 undergraduates with didactic lecture leeway instruction in simple biostatistical and epidemiological methodology, in addition to mentorship from individual BERD faculty, to abet college students breathe mindful the pass to effectively result the methodology in an actual clinical and translational research surroundings.
The inaugural BERD wintry weather Institute kicked off in December with every week of on-site classroom and guideline before the college students departed for the holidays. From Dec. 22 via Jan. 22, members worked remotely on analysis initiatives beneath school mentorship. prerogative through the path of the institute, members additionally discovered statistical programming the usage of R statistical application; explored graduate and career alternatives, and took fragment in networking activities; visited the UB scientific and Translational analysis seat on the Buffalo Niagara clinical Campus; and won firsthand insight from alumni in the box. When the college students returned to campus in January, the institute culminated with a poster presentation.
“for almost All of the college students, this is their first experience in analysis. a lot of them possess now expressed hobby in pursuing extra training and a profession in biostatistics after completion of their undergraduate reviews,” says Gregory E. Wilding, chair of the department of Biostatistics.
“we're so lucky to tender them this opportunity to participate and expose them to percentages for their future.”
The program is supported by pass of the UB scientific and Translational Science Institute (CTSI) through a award from the countrywide seat for Advancing Translational Sciences of the countrywide Institutes of health (UL1TR001412) and by pass of the UB department of Biostatistics. Participation in the program is offered at no cost, together with All vital tutorial substances, nutrients and a treasure trove of talents to select with them.
“Biostatisticians play a key role in the design and conduct of rigorous medical analysis stories,” says Timothy F. Murphy, director of the CTSI, SUNY individual Professor of medication and senior associate dean for scientific and translational analysis within the Jacobs college of drugs and Biomedical Sciences at UB. “This exciting program aligns well with an distinguished purpose of the CTSI to teach the subsequent generation of scientific and translational researchers. It changed into brilliant to peer the keenness of these talents future biostatisticians.”
besides Wilding, SPHHP faculty assisting with the institute included Dietrich Kuhlmann, Jeffrey Miecznikowski, Guan Yu, Jiwei Zhao, Austin Miller and Michael LaMonte.
skill degree: Intermediate status: lively
low-priced: $one hundred eighty (shortest song)
abstract:For programmers and statisticians who use SAS software to investigate clinical trials records to provide reviews for submission to regulatory authorities. compose certain to possess journey in the medical trials manner, getting access to, managing, and remodeling scientific trials facts, statistical tactics and macro programming, reporting medical trials outcomes, and validating scientific tribulation statistics reporting.
preliminary requirements:There are two the prerogative pass to merit this credential:
1) flux the scientific Trials Programming the usage of SAS 9 examination ($180). The examination consists of 99 questions and has a three hour closing date. A passing ranking of 70% is required.
2) in case you already cling the SAS basis Programmer credential, you could select the accelerated version of the scientific Trials Programming using SAS 9 examination ($180). This shorter exam does not reiterate cloth coated on the bottom programming exam.The accelerated examination carries seventy one questions and has a 2 hour deadline. A passing rating of 70% is required.
practicing is attainable but not required.
continuing necessities:The SAS international Certification application now considerations versioned credentials that don't expire. The version is indicated in the credential identify - for instance, SAS licensed basis Programmer for SAS 9. prior to now, SAS issued non-versioned credentials and required recertification every three years, however with the addition of versioning to the credential names, recertification necessities possess been dropped.
See All Sas Certifications
supplier's web page for this certification
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Skill Level: Intermediate Status: Active
Low Cost: $180 (shortest track)
Summary:For programmers and statisticians who use SAS software to analyze clinical trials data to bear reports for submission to regulatory authorities. You should possess experience in the clinical trials process, accessing, managing, and transforming clinical trials data, statistical procedures and macro programming, reporting clinical trials results, and validating clinical tribulation data reporting.
Initial Requirements:There are two ways to merit this credential:
1) Pass the Clinical Trials Programming Using SAS 9 exam ($180). The exam consists of 99 questions and has a 3 hour time limit. A passing score of 70% is required.
2) If you already hold the SAS basis Programmer credential, you can select the accelerated version of the Clinical Trials Programming Using SAS 9 exam ($180). This shorter exam doesn't reiterate material covered on the basis programming exam.The accelerated exam consists of 71 questions and has a 2 hour time limit. A passing score of 70% is required.
Training is available but not required.
Continuing Requirements:The SAS Global Certification Program now issues versioned credentials that execute not expire. The version is indicated in the credential name - for example, SAS Certified basis Programmer for SAS 9. Previously, SAS issued non-versioned credentials and required recertification every 3 years, but with the addition of versioning to the credential names, recertification requirements were dropped.
See All Sas Certifications
Vendor's page for this certification
Completed Enrollment of matter Cohort to champion BLA Submission Through Accelerated Approval (AA) Pathway for Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A
CHMP persuasion for Palynziq® (pegvaliase) Injection for Patients 16 and older with PKU Anticipated in 1Q 2019 and Potential Approval in EU in 2Q 2019
SAN RAFAEL, Calif., Jan. 7, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN), a company focused on innovative therapies to handle rare diseases, provided highlights to the investment community on its key milestones for 2019 at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.
"With multiple evolution and regulatory milestones expected in 2019, BioMarin maintains sturdy pipeline momentum. They are looking forward to advancing multiple product candidates in parallel through the evolution process," said Jean-Jacques Bienaimé, BioMarin Chairman and CEO. "Our focus on the unmet needs in rare genetic diseases and demonstrating meaningful clinical benefits provides the foundation to crawl rapidly through product evolution and commercialization."
During the company's presentation at the conference, Bienaimé provided information on the company's evolution program for valoctocogene roxaparvovec gene therapy for stern hemophilia A. BioMarin has completed enrollment of the initial cohort of patients in its aspect 3 program intended to champion a BLA submission through the accelerated approval pathway. A decision to submit a BLA through an accelerated approval pathway is tracking for the second half of 2019. If the company submits a BLA using the accelerated approval pathway, it will disclose additional information on the timing of its plans regarding the BLA submission. The complete aspect 3 study is targeting enrollment of 130 patients by mid-year 2019.
Valoctocogene roxaparvovec has Orphan Drug designation from the FDA and the European Medicines Agency (EMA). Valoctocogene roxaparvovec has too been accepted for Priority Medicines (PRIME) scheme from the EMA. Additionally, the FDA has granted valoctocogene roxaparvovec Breakthrough Therapy designation.
BioMarin too provided an update on its clinical program for vosoritide, an analog of C-type Natriuretic Peptide (CNP), in children with achondroplasia, the most common contour of disproportionate short stature in humans.
BioMarin expects top line results from the fully enrolled aspect 3 study of vosoritide in children by year End 2019. The aspect 2 study in infants and juvenile children up to age 5 with achondroplasia study enrollment is on track, and in this early fragment of the study, vosoritide is generally well-tolerated. espy "About Vosoritide aspect 3 Study" and "About Vosoritide aspect 2 Infant and juvenile Children Study" below for more information on the studies.
In addition, Bienaimé noted during the presentation that the company is anticipating an persuasion from the Committee for Medicinal Products for Human use (CHMP), the scientific committee of the European Medicines Agency (EMA) on Palynziq® (pegvaliase) Injection for the treatment of patients 16 and older with PKU in 1Q 2019. If the CHMP provides a positive persuasion in 1Q 2019, then in 2Q 2019, it is workable that the European Commission (EC) could provide marketing authorization in the European Union. In addition, the company provided 2019 global revenue guidance for Palynziq of between $70 and $100 million.
Palynziq, a PEGylated recombinant phenylalanine ammonia lyase enzyme approved in the United States in May 2018, is the first approved enzyme substitution therapy to target the underlying reason of phenylketonuria (PKU) by helping the corpse to fracture down Phe. PKU is a rare genetic disease that manifests at birth and results in a variety of cumulative toxic effects on the brain. Palynziq is BioMarin's second approved treatment for this grave condition. In March 2018, the European Medicines Agency accepted BioMarin's submission of a Marketing Authorization Application for Palynziq.
Gene Therapy Manufacturing
BioMarin has constructed one of the largest gene therapy manufacturing facilities of its kind, which is located in Novato, California. genuine Manufacturing Practices (GMP) production of valoctocogene roxaparvovec has commenced supporting clinical evolution activities and will champion any anticipated commercial demand. This facility is capable of supporting approximately 4,000 doses per year, and the production process was developed in accordance with International Conference on Harmonisation guidance for Pharmaceuticals for Human use to facilitate worldwide registration with health authorities. Clinical supplies for valoctocogene roxaparvovec for Hemophilia A and BMN 307, a pre-clinical gene therapy for PKU, are produced in this facility.
About BioMarin and Disease Information
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with grave and life-threatening rare and ultra-rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates. For additional information, delight visit www.biomarin.com. Information on such website is not incorporated by reference into this press release.
About Hemophilia A
Hemophilia A, too called factor VIII (FVIII) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII, a clotting protein. Although it can breathe passed down from parents to children, about 1/3 of cases are caused by a automatic mutation, a unique mutation that was not inherited. Approximately 1 in 10,000 people predominantly male is born with Hemophilia A. People vital with the disease are not able to contour blood clots efficiently and are at risk for immoderate bleeding from modest injuries, potentially endangering their lives. People with stern hemophilia often bleed spontaneously into their muscles or joints. The standard of keeping for the 49% of individuals with hemophilia A who are severely affected is a prophylactic regimen of Factor VIII infusions two to three times per week. Even with prophylactic regimens, many people silent experience automatic bleeding events that result in progressive and debilitating joint damage.
Valoctocogene Roxaparvovec aspect 1/2 Study Safety
Overall, valoctocogene roxaparvovec has been well-tolerated by patients across All doses. No patients developed inhibitors to Factor VIII and no patients withdrew from the study. The most common AEs across All dose cohorts were alanine aminotransferase (ALT) height (11 patients, 73%); arthralgia, aspartate aminotransferase elevation, and headache (7 patients each, 47%); back ache and fatigue (5 patients each, 33%). Two patients reported SAEs during the study. One patient was hospitalized for observation after developing Grade 2 pyrexia with myalgia and headache within 24 hours of receiving valoctocogene roxaparvovec. The event resolved within 48 hours following treatment with paracetamol, an over-the-counter treatment for ache and fever. The event was assessed as related to valoctocogene roxaparvovec. The other AE was assessed as not related to the therapy, attributed to a planned knee surgery to handle hemophilic arthropathy, and Grade 1 in severity. No complications were reported.
Achondroplasia, the most common contour of disproportionate short stature in humans, is characterized by failure of modest conversion of cartilage into bone, which results in disproportionate short stature. This condition is caused by a mutation in the fibroblast growth factor receptor 3 gene (FGFR3), a negative regulator of bone growth. Beyond disproportionate short stature, people with achondroplasia can experience grave health complications, including foramen magnum compression, sleep apnea, bowed legs, mid-face hypoplasia, permanent sway of the lower back, spinal stenosis and recurrent ear infections. Some of these complications can result in invasive surgeries such as spinal cord decompression and straightening of bowed legs. In addition, studies display increased mortality at every age.
More than 80% of children with achondroplasia possess parents of tolerable stature and possess the condition as the result of a automatic gene mutation. The worldwide incidence rate of achondroplasia is about one in 25,000 live births. Vosoritide is being tested in children whose growth plates are silent "open," typically those under 18 years of age. This is approximately 25% of people with achondroplasia. In the U.S., Europe, Latin America and the Middle East, there is currently no licensed medicines for achondroplasia.
About Vosoritide aspect 3 Study
The global aspect 3 study is a randomized, placebo-controlled study of vosoritide in approximately 110 children with achondroplasia ages 5-14 for 52 weeks. The study will breathe followed by a subsequent open-label extension. Children in this study will possess completed a minimum six-month baseline study to determine their respective baseline growth velocity prior to entering the aspect 3 study. Vosoritide is being tested in children whose growth plates are silent open. This is approximately 25% of people with achondroplasia.
The primary endpoint of the study is the change in growth velocity from baseline over one year in children treated compared to placebo. The company too plans to augment the growth velocity data with assessments of proportionality and functionality.
About Vosoritide aspect 2 Infant and juvenile Children Study
The aspect 2 vosoritide study is a randomized, placebo-controlled study of vosoritide in approximately 70 infants and juvenile children with achondroplasia ages zero to less than 60 months for 52 weeks. The study will breathe followed by a subsequent open-label extension. Children in this study will possess completed a minimum three-month baseline study to determine their respective baseline growth prior to entering the aspect 2 study. The primary objectives of the study are to evaluate safety, tolerability, and the upshot of vosoritide on height Z-scores, which is the number of standard deviations in relation to the impress height of age-matched, tolerable stature children. The company too plans to augment the height Z-score data with assessments including proportionality, functionality, quality of life, sleep apnea, and foramen magnum dimension, as well as the advent of major illnesses and surgeries.
Vosoritide, administered in over 28,000 injections, was generally well tolerated at All doses. The majority of adverse events (AEs) were mild and no grave adverse events (SAEs) were reported as study drug-related. Across All doses, injection site reactions and hypotension were the most common drug-related AEs. All injection site reaction events were transient. AEs of hypotension were mild, evanescent and resolved without medical intervention, and the majority were asymptomatic and reported in context of routine blood pressure measurements. No unique safety findings were observed at the 30 µg/kg/day dose.
PKU, or PAH deficiency, is a genetic disorder affecting approximately 90,000 diagnosed patients in the regions of the world where BioMarin operates and is caused by a deficiency of the enzyme PAH. This enzyme is required for the metabolism of Phe, an essential amino acid establish in most protein-containing foods. If the vigorous enzyme is not present in sufficient quantities, Phe accumulates to abnormally towering levels in the blood and becomes toxic to the brain, resulting in a variety of complications including stern intellectual disability, seizures, tremors, behavioral problems and psychiatric symptoms. As a result of newborn screening efforts implemented in the 1960s and early 1970s, virtually All individuals with PKU under the age of 40 in countries with newborn screening programs are diagnosed at birth and treatment is implemented soon after. PKU can breathe managed with a Phe-restricted diet, which is supplemented by low-protein modified foods and Phe-free medical foods; however, the strict diet is difficult for most adult patients to adhere to the extent needed for achieving adequate control of blood Phe levels.
To learn more about PKU and PAH deficiency, delight visit www.PKU.com. Information on such website is not incorporated by reference into this press release.
Palynziq substitutes the deficient phenylalanine hydroxylase (PAH) enzyme in PKU with the PEGylated version of the enzyme phenylalanine ammonia lyase to fracture down Phe. Palynziq is administered using a dosing regimen designed to facilitate tolerability; Palynziq's safety profile consists primarily of immune-mediated responses, including anaphylaxis, for which robust risk management measures efficient in clinical trials are in place.
The dosing and administration of Palynziq follows an induction, titration, and maintenance paradigm. Treatment is individualized to the lowest efficient and tolerated dosage. Prescribers may reckon increasing to a maximum of 40 mg once daily in patients who possess not achieved a response with 20 mg once daily for at least 24 weeks. Prescribers are instructed to discontinue treatment in patients who possess not responded after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily. Periodic blood Phe monitoring is recommended, and patients should breathe counseled on how to adjust their dietary intake, as needed, based on blood Phe concentrations.
Palynziq (pegvaliase-pqpz) Injection is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with PKUwho possess uncontrolled blood phenylalanine concentrations greater than 600 µmol/L on existing management.
Important Safety Information
BOXED WARNING: RISK OF ANAPHYLAXIS
WARNINGS AND PRECAUTIONS
Other hypersensitivity reactions
Blood Phenylalanine Monitoring and Diet
Effect of PALYNZIQ on other PEGylated products
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
You are encouraged to report side effects to report suspected adverse events to BioMarin at 1-877-695-8826 and the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please espy complete Prescribing Information, including Boxed Warning, at PALYNZIQ.com/hcp, which will breathe available in 24 hours.
Forward Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about its evolution programs and regulatory actions related to these programs, including the timing of (i) decisions by regulators, including the EMA's decision regarding BioMarin's MAA for Palynziq, (ii) BioMarin's global revenue guidance for Palyzniq in 2019 ( iii) BioMarin's preclinical studies and clinical studies and trials, (iv) completion of enrollment of those studies and trials, and (v) announcements of data from those studies and trials; the production capacity of BioMarin's gene therapy manufacturing facility; the continued clinical evolution and commercialization of BioMarin's commercial products and product candidates, including BioMarin's plans to complete the aspect 3 study enrollment of valoctocogene roxaparvovec by mid-year 2019 and potentially resolve in the second half of 2019 whether to submit a BLA for valoctocogene roxaparvovec for accelerated approval and the workable approval and commercialization of BioMarin's product candidates. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may vary materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of their product candidates, the continued clinical experiences of the patients in the current clinical studies; the content and timing of decisions by the FDA, the European Commission and other regulatory authorities; their talent to successfully manufacture their product candidates for the preclinical and clinical trials; and those factors circumstantial in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on contour 10-Q for the quarter ended September 30, 2018 as such factors may breathe updated by any subsequent reports. Stockholders are urged not to plot undue reliance on forward-looking statements, which talk only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any responsibility to update or alter any forward-looking statement, whether as a result of unique information, future events or otherwise.
BioMarin®, Palynziq®, and BioMarin are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates.
BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc.
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