Editor’s Letter

So, 2020 has been a bit like living inside a sci-fi movie, strange and fantastical, in all the wrong ways. However, if a year ago you had told me about the pandemic and told me that we had already had six vaccines developed and being rolled out, less than a year since we made ‘first contact’ with the virus, then I really would have thought you had taken leave of your senses and entered a parallel universe. The global response, particularly from the pharmaceutical industry, has been nothing short of phenomenal. The previous record for developing a vaccine against a new pathogen was held by the Ebola virus vaccine, which took five years to develop. A decade is more commonplace. But instead of 10 years, we did this in 10 months. As a result, we can see a light at the end of the tunnel. The US government even borrowed a Star Trek term to help us to get here, calling its COVID-19 vaccine acceleration programme ‘Operation Warp Speed’.

One effect of this most science fiction-like of years has been to put the pharmaceutical industry centre stage like it never has been before. Who would have thought a year ago that we had all become such experts on vaccine types, cytokine storms and R numbers? While the likes of Pfizer and AstraZeneca were probably household names beforehand, few outside of our industry would have heard of BioNTech and Moderna a year ago. The pharma industry, which, by and large, did not have the greatest of public images, is now riding to all our rescues. Whereas previously, many viewed big pharma as a nefarious shadowy enterprise, now it is coming together to save the world. It is to be hoped that it can continue to build on its enhanced reputation in the months ahead as the vaccine challenge moves to be one which is more logistical than scientific. But we should not underestimate the enormity of that challenge, for both pharma and governments. It is a sobering thought that tuberculosis, a disease for which there have been not only vaccines but drug treatments for decades, still manages to kill.

So, on this quest for a greater and good pharma industry, IPI has bought you a vivid array of articles, which will help our executives to boldly venture into uncharted territories.

Our Regulatory section begins with Richard Ettl at SkyCell describing how technology can help build a fairer, healthier world, and Nadine Kasidas-Neale at Recipharm explaining the incoming changes to EU medical device regulations and their impact on pharmaceutical companies developing drug delivery devices, including autoinjectors for the EU market.

The Asian market has seen a rapid onslaught by this COVID 19 predicament. Roshel Jayasundera at Axios International reveals that Thailand, much like the rest of the region, has been busy expanding its in-patient hospital capacity to accommodate the surge of COVID-19 patients and minimise the damage caused by the virus.

The Drug Discovery and Development Section starts looking at the role of multifactorial disease models in de-risking topical formulation development. Dr. Jon Lenn and Prof Marc Brown at MedPharm

Our world was disrupted during 2020. Are you ready to gain a deeper understanding of the year that changed our perceptions of possibility? Much like the real universe then, it seems that the pharma R&D universe continues to swell inexorably and that not even evil alien invaders from the planet Corona can halt the expansion of its empire.

In an atmosphere of mounting pricing pressure and changing regulatory requirements, global pharmaceutical and life sciences companies face increasing challenges to achieve and maintain profitable growth. Global pharmaceutical outsourcing offers companies an opportunity to face these challenges. By forming strategic relationships with outsourcing partners, companies can focus on core competencies, access specialised expertise, achieve cost-saving benefits and reduce burn rates that lead directly to greater shareholder value.

Over the past two decades, the outsourcing of R&D and manufacturing processes has become increasingly prevalent and is now a major trend explain why, for these large companies, an early failure is much less expensive than a failure in the clinic.

Another topic of enormous importance in today’s online market environment is fake medications. What is being done to help ensure that patients and their family members are not left worrying?

Marietta Ulrich-Horn at Securikett discusses that with its Directive 62/2011, the EU has introduced stringent measures to ensure that prescription drugs can be traced back to their origin with a unique code for each package, allowing for tracking, and tamper-proof sealing for the package is intended to guarantee this.

I hope this issue of IPI keeps you entertained this glorious summer. Get your vaccines and look forward to meeting you all in person soon. Lucy Robertshaw, CEO LucyJRobertshaw

in the pharmaceutical industry. Pharmaceutical companies have moved up the value chain for outsourcing from non-core functions, such as IT and human resources, to secondary core functions, such as R&D and manufacturing. Even a small reduction in drug development time can yield substantial cost savings and significant benefits. Contract research or contract manufacturing (CRO/CMO) partners help eliminate bottlenecks, provide immediate access to advanced technologies and, ultimately, help reduce development cycles and time-to-market.

How can pharmaceutical and life sciences companies strategically engage global outsourcing?

I am delighted to bring you a wide array of articles in this issue of IPI, which will help you understand all the recent developments in the industry.

I look forward to meeting you with the next issue in October and hopefully see all of you in person at CPHI/ICSE, Pharmapack and others. Till then, stay safe. 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