Life Sciences Trend Radar 2018
In the life sciences industry, we can look back at a turbulent year. Accompanied by successes in both technology and research, 2017 was characterized by uncertainties regarding regulatory and economic processes. What topics and developments will dominate agendas in 2018 and beyond?
Our look at the three most important influences – the market environment, new technologies and regulations – will shed some light on the matter.
(You can download the ARCONDIS Life Sciences Trend Radar 2018 as a PDF file here)
already expect flexible pricing for high-cost treatments. The life sciences industry would be wise to take the lead, and so ARCONDIS supported a globally active pharmaceuticals company in conceptualizing innovative price models based on individual patient data.
To meet the outlined challenges and others, renowned and new technology companies are edging into the market, attempting to stir up the traditional life sciences pot with innovative products. Some examples include glucose-sensing contact lenses from “Verily” (formerly Google Life Sciences) or an augmented reality iPad app developed by Fraunhofer Institut MEVIS for surgical operations. The range of examples is virtually endless, and even includes until now small startups with disruptive forces and convincing approaches. Established companies are responding with think tanks, increased research expenses (often including streamlining of current processes) or by purchasing promising startups or forming a joint venture with them.
Last but not least, one more protagonist is emerging from the shadows to steal the limelight: patients themselves. Awareness of health has been growing for many years, proven by ever-increasing private health expenses. Better informed than ever thanks to health trackers, platforms and medical apps, patients are demanding more individual treatments, active participation in the “management” of their own health and faster access to better networked healthcare.
But this applies to more than just research. After all, digital biomarkers provide “real world data” for monitoring products on the market and validating claims made in clinical studies. Furthermore, biomarkers offer the potential to continuously monitor human health for the long term and to detect possible illnesses in early stages, making them essential aids for manufacturers, patients, doctors and authorities alike.
When computers are capable of learning: Artificial intelligence
Researchers across the world use artificial intelligence (AI) and predictive analyses to predict illnesses prevent break-outs or optimize treatment plans. In this context, Basel-based pharmaceutical company Novartis announced a partnership with IBM Watson just a few months ago. Based on real world patient data and deploying a self-learning computer system, the project aims to support medical personnel in selecting the best suited therapies for breast cancer patients. The London Institute of Medical Science has also celebrated its first successes in the area of cardiology: As part of a study, its AI system detected which heart patients would die within a year with an accuracy of 80%, while real doctors only made a correct prediction in 60% of cases. Using technology enables better detection and treatment of high-risk patients.
Blockchain as a disruptive force
Using distributed databases and cryptographic mechanisms, blockchain creates an invariable, manipulation-proof history (chain of blocks) that generates data and values. The life sciences are considered one of most prospective applications. After all, blockchain offers the foundation required for data privacy and product safety, which is vital for the necessary trust between parties. For example, a Swiss pharmaceuticals company is working on a pilot project with Zurich-based technology startup Modum, investigating the blockchain applications in the supply chain. Sensors constantly monitor the product temperature during transport, writing the data straight to the blockchain by generating a smart contract. The health authorities in Estonia are one step ahead: since 2008, every Estonian has a digital patient file standardized at the national level. But that’s not all: the patient data is also stored encrypted in a blockchain.
- Data integrity: Looking at the statistics for FDA warning letters reveals a major need for action among industrial companies: In the previous fiscal year, 45 warnings were issued due to data management and data integrity violations, corresponding to 65% of all drug GMP warning letters. In 2016, the FDA, like the British MHRA, published its own guidelines for handling GxP data.
- Cybersecurity: The spread of networked medical devices is accompanied by growing security concerns. Data theft, extortion by holding back or publishing health data and even manipulation of treatment plans are all conceivable threats. The FDA has recognized this risk, dealing with the topic in webinars and fact sheets. The authority has summarized its expectations for manufacturers in its guidance documents on “Pre- and Post-Market Cybersecurity.” Industrial groups such as the AAMI (Association for the Advancement of Medical Instrumentation) are also taking action.
Tighter regulations are intended to improve patient safety, but governments and authorities are also investing to take advantage of the opportunities brought about by new technologies:
- 21st Century Cures Act: Adopted at the end of 2016, this US law addresses current challenges in the industry and aims to break down barriers in research and approval, involve patients more closely and encourage more precise treatments. Over the next ten years, the American government will provide a grant of over 6 billion USD that will be allocated to relevant initiatives by the national health authorities.
- Mutual Recognition Agreement (MRA) and Medical Device Single Audit Program (MDSAP): These two programs are in pursuit of common recognition of inspections from other countries in the pharmaceutical and medical device industries. This will reduce the burden on authorities and manufacturers while ensuring faster processing.
More than a forecast: An urgent need for action can be seen already today.
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All the trends described here have one thing in common: they are based on or dependent on data. They form the foundation for successful business models and are an essential asset in the exchange and collaboration with others involved in the healthcare ecosystem. As a result, they are considered the new currency in the life sciences.
Practice with initiatives such as serialization, UDI (unique device identifier) or IDMP (identification of medicinal product) also shows that at present it is still difficult for companies to establish consistency, integrity and transparency in their data. Overarching data management strategies and the standardization of data formats for exchange in the ecosystem generally trail behind. This not least makes life difficult for the Chief Digital Officer, who is supposed to foster new, digital business models and innovative products. Appointing a Chief Data Officer in order to ensure modern data management following the example of the financial sector is an important first step in actively shaping developments in the industry.
■ Sonja Fix, Nikolas Sideris