Pharmaceutical breakthroughs of 2015: Editor's Picks

As always innovation has been a key element in this year’s pharmaceutical sector. Lu Rahman handpicks her favourite stories showing the breakthroughs that have taken place over the last 12 months

Delivery service

Drug delivery is a key aspect of pharmaceutical manufacture. The list of breakthroughs in this field is immense. At the start of the year we heard that researchers from the Wyss Institute had created 3D structures using a minimally invasive technique to enrich and activate a host’s immune cells, attacking harmful one in vivo.

Owen Mumford discussed the growth in biologics and how this will be a key driver for the emergence of large volume injectors, with around 50% of the top 100 selling drugs expected to be biologics by 2016. Biologics are estimated to contribute 27% of the total drugs market by 2020, causing pharmaceutical companies to focus on developing drug delivery devices that allow self-administration of high viscosity, large volume drugs and/or biologics.

Craig Thompson, Owen Mumford commented: “There are multiple ways in which you can add value to the end user; alterations can be made to the injection devices to change the method of administration, making it more of a comfortable experience when injecting. Involving human factors experts during the design and development stages can help steer the design to make the process of injecting less intimidating for the user and can provide insights to improve adherence.”

Meanwhile 3M’s Hollow Microstructured Transdermal System (hMTS) was designed to be patient-friendly and easy to use while opening up opportunities for pharmaceutical companies. The device became available  for clinical trials comes after 3M conducted a number of studies and design verification tests. Based on 3M microreplication technology, pharmaceutical and biotech companies were able to take advantage of this patient-friendly hollow microneedle device for difficult-to-deliver biologics.

Other breakthroughs included the team of researchers at Washington University School of Medicine​ in St. Louis and the University of Illinois which developed a wireless device the width of a human hair that can be implanted in the brain and activated by remote control to deliver drugs.

Meanwhile Novo Nordisk announced a research collaboration with the Langer Laboratory at the Massachusetts Institute of Technology (MIT) for the next generation of drug delivery devices for the administration of peptides.

The aim of the research collaboration, conducted at both MIT in Boston, US and at Novo Nordisk’s research facilities in Måløv and Hillerød, Denmark, is to develop the next generation of drug delivery devices as an alternative to parenteral or injection-based delivery of peptides.

We also had US researchers at the Purdue University, who had reportedly developed an electronic smart capsule that could deliver medication directly to the colon. This would be ideal for conditions such as Crohn’s disease and Irritable Bowel Syndrome which need medication to reach the large colon in order to work. As well as being more effective, this development could also prove to be more cost-effective.

And the drug delivery innovation didn’t stop there. According to Graham Reynolds, West Pharmaceutical Services, one of the most promising options in drug delivery is wearable drug delivery technology. West Pharmaceutical Services’ SmartDose electronic wearable injector system is a single-use, electronic wearable injector that adheres to the patient’s body, usually on the abdomen and is pre-programmed to deliver high volumes of viscous or complex drug products. The system incorporates a polymer-based drug container system with a drug delivery device that controls the delivery of large doses over time, making it easier for patients to self-administer medication outside of the clinical setting.

Finding solutions

Mike Straw, Achieve Breakthrough highlighted some of the challenges that the industry faced such as the influx of

generics onto the market. In his opinion middle managers are reluctant to take risks are are adapting to change rather than capitalising on it. On top of this, pharmaceuticals are finding it hard to attract the new talent needed. Straw believed that senior management within pharma companies are missing a trick. The talent they need is there all around them – but they need to unlock it from what he calls the ‘frozen’ middle. The task for senior leadership is to find ways to enable the layers of middle management to work to its full potential and reach new heights of productivity.

Let’s Get Digital

Digital health was a key feature of the year. It would have been difficult to miss plethora of digital health devices and wearables to hit the sector in the last year. The EPM team launched a sister website dedicated to this important and growing market – www.digitalhealthage.com – as well as the #Let’s Get digital campaign to support the work being done in this field by medtech companies.

Let’s Get Digital was launched in August this year and part of its aims is to look at the way digital health is playing an increasingly major role in the pharma sector – moving ‘beyond the pill’ to revolutionise clinical trials. Making use of social media, surveys and other online forums, the project’s founders are busy compiling a list of the most important things for the pharma sector to consider in this market.

The project also hopes to work with government and policymakers to help improve digital switchovers and transition processes within hospitals.

Novartis launched the ‘Trials of the Future’ initiative to digitally connect and aggregate medical device data during clinical trials. Teaming up with Qualcomm Life, the pharma group said it aims to “leverage health care technology to improve the experience of clinical trial participants and patients using Novartis products, and provide connectivity with future products marketed by Novartis”.

Graham Reynolds, West Pharmaceutical Services looked at wearable technology and the concept of taking it one step further

by connecting injectable drug delivery systems with tools that can improve the user experience and drive adherence. The connected health movement has helped the pharmaceutical industry realise the potential of using consumer technology and electronic devices to further engage patients in their care and address the issue of non-compliance.

Rick Valencia, Qualcomm Life, explained how wearable technologies would be able to enhance the effectiveness of clinical trials. He described the way that wearables have grown in popularity in the last two years and are primarily known for smartwatches and fitness bands. But this new technology could save the US health care industry hundreds of billions of dollars.

One emerging area in which connected wearable devices may have the biggest potential impact is in the clinical trial space, he said. Valenica cited Kevin Patrick, a professor of family and preventive medicine at the UC San Diego School of Medicine, who discussed in an Xconomy piece, how clinical trials are growing into a multi-billion dollar global market for wearable health trackers and other related technologies – pharmaceutical companies are the primary customers.

Currently, trials are costly, time-consuming, demanding and come with an extremely high rate of failure. Because data during these trials is typically collected in paper form, much of it is lost; the remainder that isn’t lost is susceptible to concerns with accuracy and analysis. The industry needs an easier, more efficient and more reliable method of collecting data from clinical trials. Connected wearable devices could be the solution.

Looking ahead

As always, thought leadership in the pharmaceutical world is never in short supply. When we asked readers what they thought would be the key topics in 2015, the responses came flooding in. Peter Sheppard, Genpact, was clear that the industry’s winners will be defined by an ability to rapidly re-allocate resources to take advantage of new opportunities. He also said that companies that evolve their business architecture to innovate at speed and scale will out-compete the rest.

Adam Moorhouse, Onyx Scientific, said that on the CRO side, the sector would see the consolidation of the past few years across the industry. He commented: “In large pharma and the larger biotechs, there is a move towards re-evaluation of current CRO/CMO partnership, or a more strategic organisation of CRO/CMO partnerships respectively. Perhaps the time is right for them to poach a new big player before they cosy up into hibernation with their new strategic partners,” he says.

For Sven Stegemann, Capsugel, quality would be a big topic during 2015. He said: “A decade of cost-cutting in pharmaceutical development and manufacturing yielded some unintended consequences for many companies in 2014, as the quality of their products failed to meet established standards.”

Meanwhile Klaus Wassermann and Christa Janko, EMTRAIN, said that without competent researchers innovation processes in European medicines development would not be sustainable. They looked at the way in which during the past decade, the environment for medicines research and development had undergone unprecedented change. Core structures have shifted from big pharma to extensive collaborations between industry, academia and small and medium enterprises. Novel scientific discoveries have been made, with greater emphasis on the molecular basis of disease for stratified and personalised medicine. And the overall focus of the business is shifting to needs and priorities of patients and society.

Within all these dynamics the pharmaceutical industry continues to see a lack of new product emerging from their research and development departments. Licences for blockbuster medicines are phasing out and there are currently not enough new product lines to fully compensate. To provide patients and society with novel innovative medicines and equally sustain prosperity for the business in the future, something needs to be done, they commented.

According to Patheon’s Mike Mencer, innovation would continue essential to the pharmaceutical industry. “There needs to be consistent focus on innovative solutions that improve speed to market, not only for vaccines, but also for new drugs and drug-device combinations,” he said.

Natoli’s Dale Natoli believed that innovation in the pharmaceutical industry, where manufacturing is concerned, is almost always driven by the need to improve efficiency – to produce more, faster. He commented: “We’ve seen it with inquiries about continuous manufacturing in facilities, and with the advent of functionality being added to the electronic components on tablet presses. However, a very simple way to improve efficiency during tablet manufacturing is to consider multiple tip punches and dies.”