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Virtual Clinical Trials The new normal?

Across the world, one thing that has been a hot topic since the pandemic started is the arrival of a COVID-19 vaccine. COVID-19 led several pharma companies to pursue vaccine production with aggressive deadlines and a sense of urgency in developing and bringing to market. People around the world have closely followed the vaccine candidates advancing each phase of clinical trials.

Impacted by the COVID-19 pandemic, many in-person activities have turned virtual for obvious reasons. A report published by Informa on Decentralised & Hybrid trials indicates that COVID-19 and the country-wise lockdowns have in fact resulted in increased use of decentralised / virtual trials.

Recent numbers point to an increase in funding for technology startups that provide virtual trial platforms powered by Artificial Intelligence (AI) and Machine Learning (ML). The advent of digital technologies paved the way for clinical research organisations conducting trials virtually. Virtual clinical trials make use of digital health technologies for information collection at every stage, thus helping improve patient recruitment and retention, which is a major challenge for traditional clinical trials, and monitor patient safety along with real-time data tracking and measurement. Over the past few years, there were attempts to decentralise clinical trials laying a path for continued experimentation and potential adoption in the long-run.

In 2011, Pfizer pioneered the virtual clinical trial model when it conducted a randomised trial using mobile phones and web-based technologies, in a bid to validate virtual, patient-centred approach to clinical research. Patient enrolment was a major issue for this study, but Pfizer published the results indicating this approach was safe and equally effective as a traditional trial. Pharma companies like Sanofi also took up this approach a few years later by partnering with technology companies, albeit with limited success. Regulatory restrictions and various other reasons became a roadblock for companies to adopt virtual clinical trials on a wider scale.

The US Food and Drug Association (FDA) had early this year issued guidance on evaluating alternative assessment methods for clinical trials during public health emergencies. A recent update to the guidance suggests investigators consider alternative assessment methods for clinical trials, remote or virtual trials, while emphasising the need for patient safety. Adoption of virtual trials has been accelerated by the pandemic and it is worth noting that the shift to this has not been purely innovation-driven but rather a risk mitigation approach in the current global healthcare landscape.

With a focus on patient-centricity and increased use of digital health technologies for accurate data collection and real-time patient monitoring, benefits associated with virtual clinical trials outweigh the traditional model. But there’s little evidence to suggest the industry is in for a complete shift from conventional clinical trial approach. Clinical research and pharma organisations will do well to embrace hybrid models as the industry commits to bring about a meaningful change that benefits business and the global population at large.

This issue features an article by Ayaaz Khan, Global Head of Generics at Navitas Life Sciences, that revolves around how AI can play a key role in transformation of clinical trials into virtual mode for improved efficiency.

Prasanthi Sadhu Editor

CONTENTS

STRATEGY

06

13

16

20

23

32 Nanotechnology to Combat Covid-19

Joydip Sengupta, Department of Electronic Science, Jogesh Chandra Chaudhuri College (Affiliated to University of Calcutta) Chaudhery Mustansar Hussain, Department of Chemistry and Environmental Science, New Jersey Institute of Technology

Pharma Trade Terms in Asia-Pacific Time for a reset!

Aditya Agarwal, Principal, Roland Berger

The Swiss Cheese Strategy By copying the aviation industry, you can make sure your marketing strategy will fly

Brian D Smith, Principal Advisor, PragMedic

Health Canada New Validation Rules (Version 5.0) For eCTD and non-eCTD Submissions

S D Devendra Raj, Senior Manager, Freyr Software solutions Private Limited

Vietnam EU Pharma's strategic imperative

Aditya Agarwal, Principal, Roland Berger

Challenges and Solutions in HCP ELISA Development The importance of reliable Host Cell Protein (HCP) monitoring during manufacturing of biopharmaceutical drugs

Martin Föge, Business Development Manager, BioGenes

RESEARCH & DEVELOPMENT

36 Formulating Haematopoietic Stem Cell Transplantation for Practitioners A technology-based health service

S Dravida, Founder, CEO, Transcell Biologics Lakshman Varanasi, Scientist, Instructor

CLINICAL TRIALS

44 Moving Ahead with Intelligent Virtual Clinical Trials

Ayaaz Hussain Khan, Global Head Generics, Navitas Life Sciences (a TAKE Solutions Enterprise)

COVER STORY 26 Solving the toughest water SUEZ

and process challenges

Geert Verstraeten, General Manager, Analytical Instruments business and Sievers product line, SUEZ – Water Technologies & Solutions

MANUFACTURING

51

56

60 Continuous Manufacturing of Lipid-based Delivery Systems Using Melt Extrusion

Gautam Chauhan, Vivek Gupta* College of Pharmacy & Health Sciences, St. John’s University

Current Development and Future of Pharmaceutical 3D Printing

Yunong Yuan, Doctorate student, Sydney Pharmacy School Lifeng Kang, School of Pharmacy, Faculty of Medicine and Health, University of Sydney

Novel Drug Delivery Systems Industrial advancements

Farhan Jalees Ahmad, Professor, School of Pharmaceutical Education & Research, Jamia Hamdard

EXPERT TALK

64 Pharma Focus Asia Patient-centric Drug Delivery

Lonnie Barish, VP, Business development and marketing, Bora John Ross, President, Metrics Marc Brown, Chief Scientific Officer and Co-founder, MedPharm

SPECIAL FEATURES

39 BOOKS

Alan S Louie Research Director, Life Sciences IDC Health Insights, USA

Christopher-Paul Milne Director, Research and Research Associate Professor Tufts Center for the Study of Drug Development, US

Douglas Meyer Associate Director, Clinical Drug Supply Biogen, USA

Frank Jaeger Regional Sales Manager, AbbVie, US

Georg C Terstappen Head, Platform Technologies & Science China and PTS Neurosciences TA Portfolio Leader GSK's R&D Centre, Shanghai, China

Kenneth I Kaitin Professor of Medicine and Director Tufts Center for the Study of Drug Development Tufts University School of Medicine, US

Laurence Flint Pediatrician and Independent Consultant Greater New York City

Neil J Campbell Chairman, CEO and Founder Celios Corporation, USA

Phil Kaminsky Professor, Executive Associate Dean, College of Engineering, Ph.D. Northwestern University, Industrial Engineering and the Management Sciences, USA

Rustom Mody Senior Vice President and R&D Head Lupin Ltd., (Biotech Division), India

Sanjoy Ray Director, Scientific Data & Strategy and Chief Scientific Officer, Computer Sciences Merck Sharp & Dohme, US

Stella Stergiopoulos Research Fellow Tufts University School of Medicine, USA

EDITORIAL TEAM

Debi Jones Grace Jones

ART DIRECTOR M Abdul Hannan

PRODUCT MANAGER

Jeff Kenney

SENIOR PRODUCT ASSOCIATES

Ben Johnson David Nelson John Milton Peter Thomas Sussane Vincent

PRODUCT ASSOCIATE

Veronica Wilson

CIRCULATION TEAM

Naveen M Sam Smith

SUBSCRIPTIONS IN-CHARGE

Vijay Kumar Gaddam

HEAD-OPERATIONS

S V Nageswara Rao

In Association with A member of

Confederation of Indian Industry

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