IPI Autumn 2020

Page 8

Editor's Letter We are now eight months into the pandemic in Europe and is there a light at the end of the tunnel for delivering a vaccine? Well, Bill Gates says that “the rich world could be close to normal by late 2021”, but what does this say for world equality? With any disease or infection diagnosis, it is so important to ensure a patient understands why they are feeling the way they are. Subhajit Hazra, an experienced medical writer, reviews the current array of diagnostic techniques available for the detection of SARS-CoV-2 (COVID-19). How we are going to be able to receive drugs in the future is also an interesting question, as there are many patients who are unable to swallow medicine. Brennan Miles at Team Consulting looks back at some of the recent defining moments for the respiratory drug delivery sector, and The COVID-19 pandemic has stretched healthcare suppliers, organisations, governments, and healthcare professionals to their very limits, locking down the world like never. Healthcare industries, which were already under huge strain across the world, have been placed under unprecedented pressure. Sadly, when the pandemic hit, we quickly discovered that many nations and their health services were underprepared when it came to having the right equipment and infrastructure in place to respond rapidly. Demand change, supply shortages, panic

looks at what the future holds for the industry. COVID-19 really has been a wake-up call to the world on what our future may hold for humanity, but surely we can’t keep going down the same path each time this happens. That’s why we need to ensure the pharmaceutical industry is prepared for a future pandemic. Vladimir Tkachenko at Amaxa Pharma talks about ensuring that we are prepared, and he believes that we are starting to see positive signs, and sees a light at the end of the tunnel. Vanessa Fachada Oliveira, Pharmacovigilance Manager & EU QPPV at Arriello, discusses where companies are falling short and where they need to focus their attention to stay on the right side of inspectors. One of the challenges that the industry faces is the barriers in medical device

innovation. Knowing how medical devices interact with humans is a critical problem that needs to be discussed. Tarun Nag S S, Balamuralidhara V and M P Gowrav at JSS College of Pharmacy look at this issue, which influences both the design and acceptance of innovative new technologies and regulation. We must also ensure we create a fitfor-purpose supply chain for the COVD-19 vaccine. This means that every patient who needs a vaccine, whatever country they live in, should be vaccinated. Rich Quelch at Origin explains why this ambitious timeline presents a huge challenge for pharmaceutical supply chains and healthcare systems. I hope that you enjoy reading this edition of the magazine and keep well. Lucy Robertshaw CEO LucyJRobertshaw

buying and stocking, regulation changes and shift of communication and promotions to remote interactions through technology and research and development (R&D) process changes can be seen as short-term impacts of COVID-19 on the pharmaceutical market. However, while the pandemic continues, it is beginning to ease out, and pharma is becoming more adept at responding to the crisis. Companies are collaborating with each other to form partnerships to help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19. Others have donated a variety of crucial medical supplies including advanced surgical equipment, antibiotics, disinfection equipment, masks,

gloves and more. In addition, antibacterial medicines that have been approved to treat secondary infections such as pneumonia are being used. Companies have also 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. While the fight is far from over, we as a pharma industry can work together to beat COVID-19 head on and forge a better future for our people.

Georg Mathis Founder and Managing Director, Appletree AG

(Singapore, Shanghai) 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

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

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

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

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

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

Maha Al-Farhan, Chair of the GCC Chapter of the ACRP Stanley Tam, General Manager, Eurofins MEDINET

Robert Reekie, Snr. Executive Vice President Operations, Europe, Asia-Pacific at PharmaNet Development Group Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting Stefan Astrom, Founder and CEO of Astrom Research International HB T S Jaishankar, Managing Director, QUEST Life Sciences Autumn 2020 Volume 12 Issue 3


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Articles inside

End-to-end Visibility – The Foundation of Addressing Today’s Challenges in Pharmaceutical Distribution

15min
pages 100-288

Automated Quality Control of Pharmaceutical Packaging Materials

7min
pages 92-95

Advanced Capsule Development for Today’s Needs: HPMC

24min
pages 82-91

Using Phase-appropriate Delivery to Accelerate Inhaled Product Development

10min
pages 78-81

Creating a Fit-for-purpose Supply Chain for the COVID-19 Vaccine

10min
pages 96-99

Calcium Bioavailability is Key

5min
pages 74-77

Trapped Ion Mobility Mass Spectrometry (TIMS) Drives High-throughput Phosphoproteomics Research

9min
pages 70-73

Pharma’s Quantum Leap: Launching New Medicine in the Age of AI

11min
pages 66-69

Respiratory Drug Delivery – What has Happened and What Might the Future Hold?

11min
pages 48-53

Returning to Basics of siRNA Design to Fulfil Therapeutic Potential

11min
pages 58-61

The Role of Connected Inhalers in Improving Usability and Adherence in Respiratory Disease

18min
pages 42-47

Optimising HPAPI Value Chain to Achieve Maximised Product Value

14min
pages 36-41

Regeneron v Kymab: Transgenic Mice Claims Found Insufficient

14min
pages 54-57

Pre-filled Safety Syringes and the Self-administration Trend A Mutually Reinforcing Relationship

7min
pages 32-35

Barriers in Medical Device Innovation

12min
pages 14-19

Agile and Flexible – A Fitness Check for the Pandemic Era

5min
pages 26-27

Editor’s Letter

4min
pages 8-9

The Patent Landscape Behind COVID-19 Vaccines

9min
pages 22-25

Successful Marketing of Medicinal Cannabis and Cannabis-derived Products – Part II

10min
pages 28-31

Pharmacovigilance: Why are so Many Companies Failing their Regulated Audits?

6min
pages 10-11

Building Solid Foundations for Regulatory Data Automation

6min
pages 12-13

Ensuring the Pharmaceutical Industry is Prepared for a Future Pandemic

9min
pages 20-21
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