DOCSLIB.ORG

Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile PREVIEW Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile [email protected] ©2014 Industry Standard Research www.ISRreports.com act with confidence Report Overview Finding patients to participate in clinical trials is a constant struggle in the pharmaceutical industry. The challenging nature of recruitment leads both sponsors and service providers to consistently explore new geographies to find appropriate patient populations. The largest CROs have made several recent acquisitions and agreements in the Middle East and North Africa region which may indicate that clinical trial activity in the area is poised to increase. In this report, ISR provides insight into the clinical trial regulation and development environment, sponsor and service provider activities, and population “health status” for Egypt, Israel, Lebanon, and Saudi Arabia. Consider this report a “primer” for learning about clinical trials in the region. Methodologies: ISR gathered content for this report via an exhaustive secondary research effort and from company profile questionnaires that were distributed to CROs profiled in this report. 46 Report Structure: Charts and Graphs 1. Introduction 2. Health Statistics Q3, 2014 3. Clinical Trial Overview and Trial Metrics Publication Date 4. Domestic CROs capabilities 62 5. Profile of Domestic Clinical Service Providers Pages 6. Domestic Service Provider Contact List What you will learn in this report: • How population health status, regulations, organizations on conducting clinical trials clinical trial activity, and international and in Egypt, Israel, Lebanon and Saudi Arabia domestic company partnerships make Egypt, • Clinical trial operational metrics for country- Israel, Lebanon, and Saudi Arabia some of the specific clinical studies top emerging global pharmaceutical markets • Compiled lists and contact details for domestic • Insights from domestic service provider and international service providers How you can use this report: • Understand how Egypt, Israel, Lebanon, and • Understand the legal, logistical, and regulatory Saudi Arabi compare to other countries on details for conducting clinicals trials, and a variety of health condition scales so the illustrate the benefits and drawbacks of reader can consider the areas in which they conducting trials in Egypt, Israel, Lebanon, and may be beneficial as trial sites Saudi Arabia NEXT: Table of contents and sample pages www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 2 act with confidence Table of Contents Copyright and Usage Guidelines Company profile responses Methodology and Sources Geographic reach Introduction Therapeutic expertise Egypt Experience by Phase Israel Triumpharma Lebanon Background / History Saudi Arabia IPRC Health Statistics Background / History Clinical Trial Activity Acdima BioCenter Egypt Background / History Clinical trials, by Phase Pharmaceutical Research Unit Study type distribution Background / History Industry-funded study type distribution Molecule CRO Average trial length, by Phase Background / History Average enrollment, by Phase MEK Consulting Israel Background / History Clinical trials, by Phase Therapeutic experience Study type distribution Therapeutic experience by Phase Industry-funded study type distribution Regional experience Average trial length, by Phase Organizational structure Average enrollment, by Phase Clients and studies Lebanon CRA education Clinical trials, by Phase CRA experience Study type distribution ClinServ Industry-funded study type distribution Background / History Average trial length, by Phase Nagy Research Average enrollment, by Phase Background / History Saudi Arabia Examples of clients Clinical trials, by Phase SCIDRE Co. Study type distribution (i.e. interventional) Background / History Industry-funded study type distribution Clinart MENA Average trial length, by Phase Background / History Average enrollment, by Phase Company progress Domestic CROs capabilities chart Interventional studies Domestic Clinical Service Providers Observational studies Atlas Medical Services Domestic Service Provider Contact List Background / History About Industry Standard Research Jordan Center for Pharmaceutical Research Background / History MCT Background / History www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 3 act with confidence Sample Page Introduction act with confidence Introduction Finding patients to participate in clinical trials is a constant struggle in the pharmaceutical industry� The challenging nature of recruitment leads both sponsors and service providers to consistently explore new geographies to find appropriate patient populations� The largest CROs have made several recent acquisitions and agreements in the Middle East and North Africa region which may indicate that clinical trial activity in the area is poised to increase� • PAREXEL acquired Istanbul-based service provider Atlas Medical Services in July 2014 with the goal of serving clients who see increasing importance in the region and who are seeking broad range of patient populations and market access� • In March 2014, INC Research expanded its presence in the region by purchasing MEK Consulting, a clinical-monitoring focused CRO based in Lebanon� • Quintiles formed an agreement in February 2012 with Dayarn Pharma, a company specializing in pharmaceutical sales, marketing, regulatory services� The partnership allowed Quintiles and its partners to supply contract sales forces and sales promotion outsourcing services in the region� Quintiles cited growing healthcare spend and demand for services in the region as the primary reasons for forming the partnership� Industry Standard Research has compiled secondary research and statistics in this new report Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile to provide readers with a primer on clinical trial activity in the aforementioned countries� A high-level overview of current clinical trial figures is provided below: TrialsTrials conductedconducted TrialsTrials conductedconducted TrialsTrials conductedconducted TrialsTrials conductedconducted only in only in only in onlyonly inin only in only in only in EgyptEgypt IsraelIsrael LebanonLebanon SaudiSaudi ArabiaArabia # of Ongoing TrialsTrials 8585 1,2191,219 1313 6969 # of Ongoing Trials by Phase Phase 0: 4 Phase 0: 7 Phase 0: 0 Phase 0: 2 Phase I: 3 Phase I: 47 Phase I: 0 Phase I: 2 # of Ongoing Industry- Data available in full report Phase II: 13 Phase II: 168 Phase II: 2 Phase II: 11 # of OngoingFunded Trials Trials by Phase Phase III: 16 Phase III: 83 Phase III: 2 Phase III: 12 # of Patients Currently Phase IV: 13 Phase IV: 92 Phase IV: 4 Phase IV: 4 Enrolled in Trials No Phase: 36 No Phase: 822 No Phase: 5 No Phase: 38 # of Ongoing Industry- 9 150 2 1 Funded Trials # of Patients Currently ~30,000 ~208,000 ~1,900 ~16,000 Enrolled in Trials © Industry Standard Research www.ISRreports.com ©2014 | Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 7 www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 4 act with confidence Sample Page Clinical Trial Activity act with confidence Egypt Clinical trials, by Phase Percentages are based on the number of ongoing and recently completed (past two years) trials conducted only in Egypt (N=203)� How to read the table: 3 (4%) of the 85 ongoing trials conducted only in Egypt are Phase I trials� Egypt Ongoing Recently Total Completed Trials (past two years) Total 85 118 203 Phase 0 4 (5%) 3 (3%) 7 (3%) Phase I 3 (4%) 5 (4%) 8 (4%) Phase II 13 (15%) 20 (17%) 33 (16%) Phase III 16 (19%) 26 (22%) 42 (21%) Phase IV 13 (15%) 14 (12%) 27 (13%) No Phase 36 (42%) 50 (42%) 86 (42%) © Industry Standard Research Study type distribution The table represents the number of ongoing and recently completed (past two years) trials conducted only in Egypt by the type of study type listed in ClinicalTrials�gov� How to read the table: 70 (82%) of the 85 ongoing trials are classified in ClinicalTrials�gov as “interventional” trials� Egypt Ongoing Recently Total Completed Trials (past two years) Total 85 118 203 Interventional 70 (82%) 92 (78%) 162 (80%) Observational 15 (18%) 26 (22%) 41 (20%) Expanded Access - - - © Industry Standard Research www.ISRreports.com ©2014 | Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 19 www.ISRreports.com ©2014 | Preview of: Egypt, Israel, Lebanon & Saudi Arabia: Clinical Development Profile 5 act with confidence Sample Page Domestic CROs capabilities act with confidence Domestic CROs capabilities Atlas Medical Atlas Pharmac Research for Center Jordan PharmaquestJo Pharma Poseidon MCT Triumpharma IPRC BioCenter Acdima Unit Research Pharmaceutical CRO Molecule MEK Consulting ClinServ Ergomed Research Nagy Scidreco Clinart MENA Atlas Medical Atlas Research Pharmac for Center Jordan PharmaquestJo Poseidon Pharma MCT Triumpharma IPRC Acdima BioCenter Unit Pharmaceutical Research Molecule CRO MEK Consulting ClinServ Ergomed Nagy Research Scidreco Clinart MENA RegionRegion AustraliaAustralia MENAMENA EuropeEurope N.N �Americas Americas RestRest of of Asia Asia JapanJapan RussiaRussia S.S �America America WorldwideWorldwide PhasePhase PreclinicalPreclinical PhasePhase I I PhasePhase II II Phase III Data available in full report Phase III Phase IV Phase IV Post launch Post launch No mention No mention Services Bio Analysis Services Bio Analysis Biostatistics Biostatistics
Load more

Recommended publications
  • Presentation Title 1 – Arial Bold 45Pt
    Parexel Academy Overview May 2019 © 2019 Parexel International Corporation / CONFIDENTIAL Parexel Academy is not the training institute for PAREXEL employees Parexel’s learning & development department © 2019 Parexel International Corporation / CONFIDENTIAL Parexel Academy is providing trainings and education for Professionals with a training need in Clinical Research Professionals who want to start a career in Clinical Research Clinical Research professionals who want to get an academic degree Physicians who want to become an investigator Nurses who want to become a study nurse Students at pharmaceutical universities Companies with a training need in Clinical Research https://parexel-academy.com/SGP/industrieseminare/ 3 © 2019 Parexel International Corporation / CONFIDENTIAL Parexel Academy’s program portfolio Duration: 6 months, full time PGC government-funded Live classroom teaching and project work for Germany Postgraduate Audience: Graduates from the life sciences, German skills certificate programs (PGC) PGC Clinical Trial Duration: 6 months, part-time Management for global Blended learning (online and face-to-face training) audience Audience: Graduates from the life sciences, English skills Duration: 4 months, part-time PGC with the National “Flipped classroom“ mode (online & face-to-face) University of Singapore Audience: Graduates from the life sciences Duration: 5 weeks University KPU undergraduate program Instructor-led by Parexel Academy faculty, English language in Clinical Trial Management partnerships Audience: Pharmacology
    [Show full text]
  • The TGN 1412 Phase I Trial (Very Preliminary Draft) Illustrations by Julia Berman Notes by Steve Simon
    The TGN 1412 Phase I trial (very preliminary draft) Illustrations by Julia Berman Notes by Steve Simon This presentation is licensed under a Creative Commons Attribution 3.0 license. You are free: to Share — to copy, distribute, display, and perform the work; to Remix — to make derivative works under the following conditions: Attribution. You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). For any reuse or distribution, you must make clear to others the license terms of this work. Any of the above conditions can be waived if you get permission from the copyright holder. Apart from the remix rights granted under this license, nothing in this license impairs or restricts the author's moral rights. Your fair use and other rights are in no way affected by the above. 1 (What is TGN 1412) TGN1412 (also known as CD28-SuperMAB) is the working name of an immunomodulatory drug which was withdrawn from development, originally intended for the treatment of B cell chronic lymphocytic leukemia (B-CLL) and rheumatoid arthritis.[1] It is a humanised monoclonal antibody that not only binds, but is a strong agonist for the CD28 receptor of the immune system's T cells. Mice of the inbred strain BALB/c were immunized with recombinant human CD28-Fc fusion proteins and boosted with a B lymphoma cell line transfected to express human CD28. Hybridomas were obtained by fusing B cells with the hybridoma partner X63Ag8.653 and screened for reactivity with human CD28 and TCR-independent mitogenic activity.
    [Show full text]
  • 3 Steps to Middle East Success
    WHITE PAPER 3 STEPS TO MIDDLE EAST SUCCESS A roadmap for Phase IV, observational, and registry studies in the Middle East The need to access larger numbers of patients and qualified investigators for expanded late phase trials, combined with an already saturated field for patient recruitment, has created demand for a truly global approach to site recruitment. Ease of patient enrollment and high-quality, yet lower-cost clinical resources make the Middle East and Turkey a truly attractive region for late phase studies. THE MIDDLE EAST TURKEY • LEBANON • • JORDAN • KUWAIT EGYPT • • BAHRAIN SAUDI ARABIA • DUBAI • QATAR • • ABU DHABI UNITED ARAB EMIRATES • • OMAN YOUR JOURNEY. OUR MISSION.TM | 2 WHY CONDUCT TRIALS IN THE MIDDLE EAST AND TURKEY? ACCESS AND EAGERNESS The Middle East is an emerging region that is welcoming, sophisticated, and home to varied and accessible patient populations. In this white paper we will discuss the winning factors for study start-up, site initiation, and site management in the Middle Eastern region. EXCELLENT STUDY OPPORTUNITIES THAT MEET highly equipped than Western sites. Electronic systems URGENT MEDICAL NEEDS are also being implemented, with Turkey’s newly digitized submission process promising first feedback The countries of the Middle East are home to treatment- within 48 hours. naïve patients with a diversity of profiles including common indications such as diabetes mellitus, cardio- vascular disease, and psychiatric diseases. Additionally, REGIONAL COHERENCE there is a strong potential for genetic sub-studies. With Arabic as the Middle East’s most common From a high incidence of Hepatitis C in Egypt to Diabetes language, cross-border monitoring is easier and in the United Arab Emirates and Jordan, trials can translation costs are greatly reduced compared to provide adequate treatment that may not be available other regions.
    [Show full text]
  • PAREXEL INTERNATIONAL CORP (Form: 10-K, Filing Date: 09/25/1998)
    SECURITIES AND EXCHANGE COMMISSION FORM 10-K Annual report pursuant to section 13 and 15(d) Filing Date: 1998-09-25 | Period of Report: 1998-06-30 SEC Accession No. 0000799729-98-000030 (HTML Version on secdatabase.com) FILER PAREXEL INTERNATIONAL CORP Mailing Address Business Address 195 WEST ST 195 WEST ST CIK:799729| IRS No.: 042776269 | State of Incorp.:MA | Fiscal Year End: 0630 WALTHAM MA 02154 WALTHAM MA 02154 Type: 10-K | Act: 34 | File No.: 000-27058 | Film No.: 98715000 6174879900 SIC: 8731 Commercial physical & biological research Copyright © 2012 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document 39 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (MARK ONE) (X)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 1998 OR ( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number 0-27058 PAREXEL INTERNATIONAL CORPORATION (Exact name of registrant as specified in its Charter) Massachusetts 04-2776269 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 195 West Street Waltham, Massachusetts 02154 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (781) 487-9900 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value per share (Title of class) (Continued) Copyright © 2012 www.secdatabase.com.
    [Show full text]
  • Thesis Corrected.Pdf
    Understanding the transport mechanisms of BSEP to improve the prediction of DILI compounds Robbin de Kruijf Darwin College Department of Pharmacology University of Cambridge This thesis is submitted for the degree of Doctor of Philosophy September 2019 I II Ik wijd mijn thesis toe aan mijn mama en papa en aan mijn oma en opa. Zij zijn de oorsprong van mijn nieuwsgierigheid, De reden voor mijn stoerheid. III IV Declaration This thesis is the result of my own work and includes nothing which is the outcome of work done in collaboration except as declared in the Preface and specified in the text. It is not substantially the same as any that I have submitted, or, is being concurrently submitted for a degree or diploma or other qualification at the University of Cambridge or any other University or similar institution except as declared in the Preface and specified in the text. I further state that no substantial part of my thesis has already been submitted, or, is being concurrently submitted for any such degree, diploma or other qualification at the University of Cambridge or any other University or similar institution except as declared in the Preface and specified in the text. It does not exceed the prescribed word limit for the relevant Degree Committee. V VI VII Abstract Understanding the transport mechanisms of BSEP to improve the prediction of DILI compounds Robbin de Kruijf At present, Drug-Induced Liver Injury (DILI) is the most frequent cause of acute liver injury, with an incidence ranging from 0.023-1.5‰ in developed countries.
    [Show full text]
  • Program of the MDC Career Day 2019 (PDF, 4.26
    CareerDay MDC.C | Campus Berlin-Buch Robert-Rössle-Str. 10 · 13125 Berlin April 11 2019 www.mdc-careerday.de 1 Dear early-career researchers, We warmly welcome you to the MDC Career Day 2019! ABSCHLUSS IN NATURWISSENSCHAFTEN? Along with our sponsoring companies, Bayer, PAREXEL and Pharmaakadamie, the Max Delbrück Center for Molecular Medicine is delighted to showcase the Machen Sie mit der PAREXEL® Academy den Sprung career options available to life scientists, both within and outside of academia. aus der Wissenschaft in die Klinische Forschung! We are honoured to have keynote presentations from Dr. Keely Bumsted-O’Brien and Prof. Dr. Chiara Romagnani. The difference in the career paths taken by our presenters is a clear indication of the diversity in career options open to early Während die biopharmazeutische Industrie weiter expandiert, wächst auch der Bedarf an career life scientists today, and a great way to kick-off the MDC Career Day. hochqualifizierten Mitarbeitern. Unsere Postgraduierten-Programme sind Ihr Weg zum Experten in die Klinische Forschung: This years’ program includes a sample of the career options open to life scien- tists, both within the areas of Berlin and Brandenburg and beyond. Our round Postgraduate Certificate in Weiterbildung Clinical Monitoring - table sessions will allow you to dive-deeper into the different career pathways Clinical Trial Management Clinical Trial Management available to you, ranging from, but not exclusive to, progressing in academia, (Remote) (Berlin) moving into science management and founding your own company. • Five months part-time: Online training • Sechs Monate Vollzeit: Drei Monate You are encouraged to take advantage of the many offers available to you to- plus six face-to-face weekend- Theorie und drei Monate Projektarbeit day, including CV checks, presentations from leading companies and informa- sessions in Berlin in einer der PAREXEL-Abteilungen tion sessions on funding opportunities for early career scientists.
    [Show full text]
  • TGN1412-HV PAREXEL Project Number: 68419
    This document was scanned and processed through optical character recognition. Spelling and punctuation errors have been corrected where found. Some formatting is a bit different than in the original. - NMG Protocol Number: TGN1412-HV PAREXEL Project Number: 68419 PAREXEL International Ltd (PAREXEL) Clinical Pharmacology Research Unit Northwick Park Hospital INFORMED CONSENT FORM Please initial each box [boxes not shown] 1. I confirm that I have read and understood the informed consent form (version 02, dated 9 February 2008, pages 1-2) and separate information sheet (version 02, dated 9 February 2008, pages 1-11) and have been given the opportunity to ask questions and agree to participate in the above study, which is being conducted on behalf of TeGenero AG (who is the Sponsor of this study). I understand that an independent Research Ethics Committee and the Medicines and Healthcare Products Regulatory Agency (MHRA) have approved this study. 2. Dr Daniel Bradford, the Principal Investigator, or his deputy has explained the nature and purpose of the study and has provided me with the information sheet. 3. I have read the information sheet relating to blood borne viruses (HIV and hepatitis B and C) (version 4, dated 8 June 2005) and consent to be tested for these viruses. 4. I authorise you to contact other drug trial units and enquire about my participation in/registration for studies elsewhere. 5. I agree that one of the Unit’s Physicians may contact my General Practitioner and I authorise my General Practitioner to divulge, to one of the Unit Physicians, any information deemed relevant regarding my suitability to participate in volunteer drug trials.
    [Show full text]
  • TGN1412 Case in March 2006, a Phase I Study of a Humanized Monoclonal Antibody Design
    Ethical Considerations in Phase I studies: TGN1412 Case In March 2006, a Phase I study of a humanized monoclonal antibody designed to treat leukemia and rheumatoid arthritis captured the attention of not only the biomedical world, but also that of the public. The trial received intense and long-lasting media coverage because all six of the healthy male volunteers given the treatment in the trial suffered from immediate adverse reactions. All were hospitalized, at least four suffered from multiple organ dysfunction. “SuperMAB” TGN1412 (trademarked “superMAB”) is the first product of a small German pharmaceutical company TeGenero. It belongs to a novel class of synthetic antibodies; specifically, it is a humanized monoclonal antibody that is a strong agonist for the CD28 receptor of T cells. TGN1412 was thought to have the potential to revolutionize the treatment of leukemia and rheumatoid arthritis. The drug trial was carried out by Parexel, a Massachusetts-based company that helps bring new therapeutics to market for pharmaceutical and biotechnology firms. Clinical Trial Parexel began conducting the Phase I trials for “SuperMAB” in Northwick Park and St. Mark’s Hospital, London in March 20061. The plan was to recruit healthy male volunteers into the study and offer compensation of £2,000 (approximately $3,200 USD) per participant, with an expected commitment to a three-day inpatient stay and a dozen outpatient visits over the period of a month2. The trial was a double-blind, randomized, placebo-controlled study. On March 13th, the treatment for the first cohort of eight healthy volunteers began: two received placebo and six received 1/500th of the highest dose used in previous animal experiments.
    [Show full text]
  • Connecting Perfectly at Every Stage
    2010 ANNUAL REPORT Connecting perfectly at every stage Right where you need us ™ About PAREXEL PAREXEL International, a leading global biopharmaceutical services provider, continues to be a premier, trusted partner to clients who rely on the Company for expertise and fl exibility, as well as the effi ciencies of a worldwide infrastructure, to help them more quickly achieve their goals. PAREXEL complements client organizations with strategic insight, in-depth scientifi c knowledge, tactical expertise, and a wealth of experience throughout the product development process, including worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and medical communications services, as well as reimbursement and market access services. PAREXEL is focused on providing tailored solutions that match a client’s specifi c needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality, needed to help clients bring safe and effective treatments to patients sooner. During the past year, PAREXEL has been recognized as a “Best 10 Outsourcing Company to the Pharmaceutical Industry” as part of the Global Outsourcing 100® and as “Best Performing CRO in Asia” by the BioSingapore Association. Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 54 countries and has 9,720 employees worldwide. Financial Highlights FISCAL YEAR ENDED JUNE 30 2010 2009 2008 (In Thousands Except Per Share Data) Total Service Revenue
    [Show full text]
  • A Report on the Clinical Research Industry Cluster in Southeastern North Carolina
    A Report on the Clinical Research Industry Cluster in Southeastern North Carolina Updated December 2016 The southeastern region’s North Carolina Coast Clinical Research Initiative is a collaborative, cluster development effort between clinical research companies, healthcare providers, economic developers, University of North Carolina Wilmington, and the North Carolina Biotechnology Center Southeastern Office, who work together to strengthen and grow the clinical research industry cluster in our area. The goals of the NC Coast Clinical Research Initiative, an economic development initiative, are to help existing companies grow and to attract additional talent and companies to the region by creating greater cohesiveness between members of the clinical research community, by enhancing the local clinical research workforce, by increasing physician-led clinical research trials in the region, and by promoting the local clinical research cluster in the region and beyond, all for the economic, societal, and health benefit to the southeastern region of North Carolina. The North Carolina Biotechnology Center provides long-term economic and societal benefits to North Carolina through support of biotechnology research, business, education and strategic policy statewide. Headquartered in Research Triangle Park, the Center has five regional offices, including the Southeastern Office in Wilmington, focused on regional biotechnology economic development. A Report on the Clinical Research Industry Cluster in Southeastern NC The Clinical Research industry cluster is vital to Southeastern North Carolina, supporting over 3,200 knowledge-sector jobs to strengthen the region’s diverse economy. The Wilmington area is home to a wide range of clinical research companies, including small entrepreneurial ventures and large, multinational companies, such as PPD, the third largest clinical research organization (CRO) in the world, headquartered in downtown Wilmington.
    [Show full text]
  • Rising to the Challenges of Developing Treatments for Rare Diseases
    Rising to the challenges of developing treatments for rare diseases A Rare Disease is a disorder affecting a small Authors: Zizi Imatorbhebhe, fraction of the population compared with Cecil Nick, Sarah Glass, Arlene Hughes, Sylvain other prevalent diseases (Richter 2015). A Berthelot, Richard Macaulay, Darko significant number of rare diseases are severe, Dabic, Kemi Olugemo progressive, life-threatening or chronically debilitating. © 2019 Parexel International Corporation. There are 7,000 known rare diseases affecting hence there is a huge unmet need in this area. an estimated 350 million people worldwide (The The US Food and Drug Administration (FDA) and Global Genes Project, 2015). Most rare diseases the European Union (EU) define a drug or biologic are genetic in origin, and a large proportion (65- intended to treat a rare disease or condition as an 75%) of rare diseases have their onset in childhood. Orphan Drug. Only 5% of rare diseases have effective treatment, EU and US orphan drug Rare disease clinical trials face many challenges, and in 2018, 59 orphan drugs were approved. A some of which include: number of breakthrough therapies have recently regulations been introduced for diseases that previously had no small populations with limited opportunity for treatment. These include two products for lysosomal study participation and replication of results in storage disorders (Brineura® and Mepsevli®), for Both US and EU regulatory agencies have initiated which is just over 6/10,000. This compares with clinical trials spinal muscular atrophy (Spinraza®), the first gene programs to encourage development of treatments 4/10,000 for Japan. The alternative in both EU heterogeneous manifestation of disease and therapy for biallelic mutation-associated retinal for orphan diseases, as have other major regulatory and US is that the product is unlikely to generate phenotypic presentations dystrophy (Luxturna), and a novel treatment for bodies such as in Japan.
    [Show full text]
  • Entry-Level Positions Overview
    ENTRY-LEVEL PAREXEL has many entry-level opportunities across the globe! Please visit the Graduate POSITIONS Talent Gateway to read full job descriptions and OVERVIEW see what is available in your area. Examples of entry-level opportunities include: • IT/Technical – Student IT Development and PAREXEL Informatics Scheme • Statistical Programming – Student SAS Programmer, Placement Statistical Programmer UK and Biostatistics Internship Program • Clinical Operations – Clinical Logistics, Clinical Research Trainee, Research Assistant • Quality Control – QC Assistant Temp For any questions, please email: [email protected] THE CLEAREST PATH TO CAREER FULFILLMENT STARTS WITH PAREXEL Come on board and join our team at PAREXEL as a Student/ IT development assistant (f/m) in Berlin, Germany. JOB DESCRIPTION • Experienced with Microsoft based applications and general knowledge of PC functions You support our IT group within the framework of programming, support, and development of our clinical • Fluency in German and good English skills. computing systems. Moreover you contribute to the software development of OUR KEY BENEFITS new systems. At PAREXEL, we will provide you with an exciting insight You assist experts with the management of support into the world of Clinical Research within the field of requests within the area of 3rd level support. PAREXEL Informatics. Expect a very successful, highly qualified, and dynamic team. We offer you the opportunity You support our team with quality control, to grow and develop within our global organization. You software/technology tool evaluation to guarantee best can look forward to a competitive compensation and service, and continuously optimize our application benefits package and flexible working hours within a development processes.
    [Show full text]