IPI Summer 2020

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Editor's Letter We are now in the middle of 2020. This first half of the year has certainly made us realise that the world changes and we have to be adaptable; as everyone everywhere has been affected by COVID, I want to look at the reality of what the virus has brought to our sector. Certainly within our lifetime, our world has become accustomed to accessible vaccines that enable us to live longer and more healthily than we would have 100 years ago. However, over the past 10 years, antimicrobial resistance has been widely talked about, with few antibiotics and new vaccines being found, so I do wonder how the world thinks it is going to locate a silver bullet for the COVID virus. Alan White at The Translation People reveals more about how Cononavirus has presented a whole new challenge in regard to translation within pharmaceuticals.

This is also very important when there are ethnic minorities living in communities where they do not understand the local language, thus presenting a challenge in ensuring they adhere to the local COVID rules to stop the spread of the virus. Graham Mills at Techspert.io talks about why pharma firms will need academic expertise like never before in the post-COVID world, as $985 million has been put towards funding from both public and private sources to support innovation projects. In the first half of the 20th century, science fiction familiarised the world with the concept of artificially intelligent robots. The life science sector has talked about this and how it is going to revolutionise the way we can work. Benedict Irwin, Matthew Segall at Optibrium Ltd. and Alexander Wade of University of Cambridge explain that there is increasing evidence we have entered the hype cycle “trough of disillusionment” due to the gap in

understanding the route from traditional and well-understood statistical modelling methods to the poorly-defined promises of Artificial Intelligence. Natalie Balanovsky and Gillian Wilson at Almac Clinical Service discuss why flexibility actually feeds innovation and the evolution of clinical trial supply chain flexibility. This will also be interesting the further we move towards individual healthcare and personalised medicine, along with directto-patient distribution. I hope you enjoy reading this edition of the magazine and I am looking forward to seeing how the second half of 2020 continues; will we be any nearer to finding a vaccine and will we be able to find a new normality in our everyday lives?

T he out br eak o f Coronavirus Disease 2019 (COVID-19) has caused enormous challenges to worldwide’s economy and people’s lives. With the epidemic on the rise, society has paid more attention to the healthcare and pharmaceutical industries, which will impose both positive and negative consequences across different sub-sectors. Pharmaceutical companies have deep scientific knowledge gained from decades of experience with similar viruses. Companies are researching

vaccine candidates and undertaking inventories of research por t folio libraries to identify additional potential treatments for R&D. Some have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV. Others are exploring ways to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified. In the coming weeks and months, life sciences companies will take the lessons learned from this crisis, as the industry

has with other events in the past, and work to improve their agility and resiliency. The impact on clinical trials and the drug approval pipeline will also come into focus and underscores the need for the same energ y, collaboration, and commitment by industry and governments to minimize disruption and provide patients with new medicines and treatments. I wish you all a safe and health summer, and I look forward to bringing you more informative articles in the autumn issue.

Georg Mathis Founder and Managing Director, Appletree AG

Steve Heath, Head of EMEA – Medidata Solutions, Inc

Catherine Lund, Vice Chairman, OnQ Consulting

Jagdish Unni, Vice President – Beroe Risk and Industry Delivery Lead – Healthcare, Beroe Inc.

Patrice Hugo, Chief Scientific Officer, Clearstone Central Laboratories

Deborah A. Komlos, Senior Medical & Regulatory Writer, Thomson Reuters

Jeffrey Litwin, M.D., F.A.C.C. Executive Vice President and Chief Medical Officer of ERT

Heinrich Klech, Professor of Medicine, CEO and Executive Vice President, Vienna School of Clinical Research

Diana L. Anderson, Ph.D president and CEO of D. Anderson & Company

Jeffrey W. Sherman, Chief Medical Officer and Senior Vice President, IDM Pharma

Franz Buchholzer, Director Regulatory Operations worldwide, PharmaNet development Group

Jim James DeSantihas, Chief Executive Officer, PharmaVigilant

Francis Crawley. Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and a World Health Organization (WHO) Expert in ethics

Mark Goldberg, Chief Operating Officer, PAREXEL International Corporation

Have a lovely summer. Lucy Robertshaw Director, Lucy J.Robertshow Consulting

Virginia Toteva Editorial Manager – IPI

Editorial Advisory Board Bakhyt Sarymsakova, Head of Department of International Cooperation, National Research, Center of MCH, Astana, Kazakhstan

Rick Turner, Senior Scientific Director, Quintiles Cardiac Safety Services & Affiliate Clinical Associate Professor, University of Florida College of Pharmacy 6 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Robert Reekie, Snr. Executive Vice President Operations, Europe, Asia-Pacific at PharmaNet Development Group Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting

Maha Al-Farhan, Chair of the GCC Chapter of the ACRP

Stefan Astrom, Founder and CEO of Astrom Research International HB

Stanley Tam, General Manager, Eurofins MEDINET (Singapore, Shanghai)

T S Jaishankar, Managing Director, QUEST Life Sciences Summer 2020 Volume 12 Issue 2


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