FOREWORD CONTENTS
Outsourcing in Clinical Trials Handbook 2021
Portfolio lead Masood Jon +44 207 947 2771; +44 742 744 3533
masood.jon@
arena-international.com Editor Chloe Roberts Managing editor Phoebe Galbraith Group art director Henrik Williams Production Dave Stanford
Outsourcing in Clinical Trials Handbook is published by Arena International Events Group, a trading division of GlobalData. John Carpenter House, John Carpenter Street, London, EC4Y 0AN, UK. +44 207 936 6400
events@arena-international.com
www.clinicaltrialsarena.com
ISSN 2515-4559
© 2020 Arena International Events Group. Registered in England No. 06276344
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or any information storage or retrieval system without the express prior written consent of the publisher. References are available upon request.
The contents of the Outsourcing in Clinical Trials Handbook are subject to reproduction, storage and retrieval systems.
Printed by Stephens & George Print Group.
Masood Jon Portfolio lead
s the pharmaceutical industry grasps with unprecedented challenges due to the Covid-19 pandemic, it is now more important than ever to look at the latest innovations in outsourcing, technology, regulatory aff airs and medical devices. Arena international seeks to deliver cutting-edge content on how best to manage outsourcing strategies in the 2021 edition of the Outsourcing in Clinical Trials Handbook. Returning for its fourth year, the 2021 handbook will harness the insights of some of the industry’s leading voices. Doug Cary and Roger Nolan look at the funding of early-stage clinical trials; Paul Slater and Ryan Tubbs of Microsoft talk about new technology to optimise clinical research; and Frank Leu of Novapeutics gives us a blockchain 101 on how AI drives a hyper-effi cient clinical trial. New for this edition, we have a new Covid-19 chapter focusing on the impact the virus has had on the industry and its future responses, with Michael Breen of GlobalData discussing Gilead’s suspension of Covid-19 trials in China.
A
With this and so much more inside from our sponsors, we hope you enjoy the latest edition in Arena’s growing handbook series.
First in ELISPOT
Cellular Technology Limited (CTL) is the pioneer and industry leader in the development, use, and manufacturing of standardized cell mediated immune monitoring.
• Contract Laboratory: Immune monitoring with an emphasis on T and B cell evaluations within pre-clinical and clinical applications. Our CLIA/CLEP certified/approved, Part 11 compliant, laboratory specializes in custom client Laboratory Developed Tests in accordance with FDA guidance for Bioanalytical Method Validation; and capable of processing up to 450 samples per week. Assays include: ELISPOT, ELISA, NAb, CBA, FACS,, Proliferation, and more. Comprehensive solutions for sample processing: Whole blood processing with optimized PBMC
cryopreservation methods that ensure exceptional cell functionality. • ePBMC®
: Our extensive cryopreserved ePBMC library containing over 400 HLA-typed donors with established NK reactivity and T-cell reactivity to Mumps, Flu, CMV, EBV, CPI, CEF pool and PHA-P using CTL ImmunoSpot®
ELISPOT kits.
• ELISPOT Kits: Our extensive offerings of T & B cell kits combine high-sensitivity with proven, accurate, and consistent results rendering ELISPOT a simple and precise assay.
• Serum-free Solutions: For standardized PBMC cryopreservation and for sample testing of lymphocytes. • BioSpot®
and ImmunoSpot® • All-around ELISPOT: ImmunoSpot® Analyzers: Manufactured in our ISO 9001: 2015 certified facility; our Analyzers
accommodate for diverse assays including: Viral Plaque, PRNT, Viral ICA, Serum Neutralization, and Serum Bactericidal, all with multi-color capabilities and more.
Image Analyzers and software; Standardized ELISPOT Kits for proven, consistent results; Plate Scanning Services; Hands-on Training; Consultation.
Cellular Technology Limited 20521 Chagrin Boulevard
Shaker Heights, OH 44122-5350
+1 216-325-7235 Phone • +1 216-791-8814 Fax
info@immunospot.com •
www.immunospot.com
Outsourcing in Clinical Trials Handbook | 3
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120
