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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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