Editor’s Letter

We are finally at the end of 2020. This year has already gone down in the history books because of the global pandemic of COVID; it is amazing to have seen the scientific community come together and that we have been able to achieve rolling out a vaccine, which has already been given to patients in the UK.

I have been thinking recently that have we started to see the real beginning of personalised medicine in the way that the virus infected people; we saw and understood the end point to the virus and we managed to make a vaccine that is 95% effective all within a year. The regulatory process has had to speed up, and what can this mean for the future of our industry?

There are obviously challenges which go with this: do we have enough resource to be able to deliver the vaccine to everyone on the planet? It is predicted that vaccinating Britain will come at a cost of £12 billion, with the NHS needing 46,000 new staff.

Vidya Subramanian at Roambee talks about the unique distribution challenge for unique monitoring that will leverage new distribution approaches and create fresh thinking.

Unfortunately, there are always going to be people who inevitably see an opportunity to create a counterfeit drug, and Alf Goebel at advanco analyses how pharmaceutical serialisation providers can step up the fight against drug counterfeiting by adopting a more open and agile supply-chain.

Marcelo Cruz at Tjoapack talks about how the introduction of new technologies that have paved the way for companies to explore more innovative solutions for packaging and building of strategic partnerships with specialised contract packaging organisations.

The delivery solutions of the drugs that we take today can come in all forms, whether that be injections, plasters, nasal sprays or of course tablets. Marianna D’Onghia at I Holland explains that there is an increasing demand for mass production of tablets but that there is a goal of reducing time to market, which is putting pressure on tablet manufacturers.

There are also challenges with the new drug candidates, of which approximately 70% fall into Class II, which have poor bioavailability due to low solubility. Kim Shepard at Lonza talks about how formulators are turning to amorphous stray-dried dispersions.

Kieran Connolly, Rosamund Round and Nick Darwall-Smith at Parexel talks about how COVID-19 has pushed decentralised clinical trials (DCTs) to the forefront of clinical research from telemedicine and wearable sensors to

Welcome to the last issue of IPI for 2020. What a significant and unforgettable year it has been. Within just twelve months since the COVID-19 outbreak, we have observed great changes, challenges, and scientific discoveries. From the first vaccine on the market, and another eight candidates currently in Phase II or Phase III clinical trials, the pharmaceutical industry has surpassed its own expectation.

While the pharma industry is still trying to deal with the current situation, the British government announced the appearance of a new mutated variant of the coronavirus that appears to be spreading rapidly. home health visits and direct-to-patient drug shipments.

George I’ons at Owen Mumford Pharmaceutical Services has identified where there is a need for innovative drug delivery devices that accommodate higher viscosity and higher volume formulations, typical of new biologics.

There are also some other major questions about how sustainable our industry is and what the beginning of the production chain looks like from bulk product right down to the delivery of the drug to the patient. Are we going to be able to reach our global goals which need to be delivered in the way of cutting our carbon footprint amongst other things?

I wish you a very safe and Merry Christmas, as I am extremely excited to see what 2021 will deliver to us all on this amazing planet that we live on.

Lucy Robertshaw, CEO LucyJRobertshaw

Although scientists do not know much about the new strain, the fact that it appears to increase in prevalence rapidly, even during lockdown is causing serious concern among the wider community.

It seems that challenges still lie ahead for the scientists and pharma industry as well as for all of us.

Stay with us in 2021 to keep yourself well informed about the latest news through our articles.

I wish you and your loved ones a warm and lovely Christmas and a Happy New Year! Virginia Toteva, Editorial Manager – IPI

Editorial Advisory Board

Bakhyt Sarymsakova, Head of Department of International Cooperation, National Research, Center of MCH, Astana, Kazakhstan Catherine Lund, Vice Chairman, OnQ Consulting Deborah A. Komlos, Senior Medical & Regulatory Writer, Thomson Reuters Diana L. Anderson, Ph.D president and CEO of D. Anderson & Company Franz Buchholzer, Director Regulatory Operations worldwide, PharmaNet development Group Francis Crawley. Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and a World Health Organization (WHO) Expert in ethics

Rick Turner, Senior Scientific Director, Quintiles Cardiac Safety Services & Affiliate Clinical Associate Professor, University of Florida College of Pharmacy Georg Mathis Founder and Managing Director, Appletree AG Jagdish Unni, Vice President – Beroe Risk and Industry Delivery Lead – Healthcare, Beroe Inc. Jeffrey Litwin, M.D., F.A.C.C. Executive Vice President and Chief Medical Officer of ERT

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

Jim James DeSantihas, Chief Executive Officer, PharmaVigilant

Mark Goldberg, Chief Operating Officer, PAREXEL International Corporation Maha Al-Farhan, Chair of the GCC Chapter of the ACRP (Singapore, Shanghai) Steve Heath, Head of EMEA – Medidata Solutions, Inc

Patrice Hugo, Chief Scientific Officer, Clearstone Central Laboratories Heinrich Klech, Professor of Medicine, CEO and Executive Vice President, Vienna School of Clinical Research 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