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Home | Newsletter | UPDATE 1 | 2018 | Life Sciences Trend Radar 2018
February 26, 2018

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.

Life Sciences Trends 2018

(You can download the ARCONDIS Life Sciences Trend Radar 2018 as a PDF file here)

 

 

The market environment

Three ever-more relevant market players are emerging with new or extended requirements that have a direct effect on life sciences, forcing the industry to face developments and to develop responses, including for itself:

 

Life Sciences Trends 2018 - Global Environment

 

The bearers of healthcare costs, such as governments or insurance providers, are sticking to their cutback policies. For industrial nations, this means providing medical care to an aging population with the same financial means. Japan is already looking to nursing robots, for example, which as a new technology cut down on nursing costs only slightly – not the perfect solution. In addition, global access to medical care must be established at an affordable price. Sponsors today

 

 

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.

 


New technologies

Following risk-averse years with conservative investments in innovation, the second half of the decade can be compared with a technology boom: Sensors that detect illnesses, 3D-printed pills and medical robots that navigate patients through hospitals, among other things. These are not speculations for the future, but rather a reality today; Even so, it remains to be seen what technologies will prevail. With just under one-hundred consultants that support life sciences companies in facing current challenges and taking advantage of future opportunities each and every day, ARCONDIS is at the forefront of the industry. And we see major potential in the following technologies:

 

Life Sciences Trends 2018 - Technology

 

Digital biomarkers – the jack-of-all-trades

In the context of clinical studies, predictive and diagnostic biomarkers (genes, proteins, etc.) are continuing to gain in importance. With the help of wearables, health trackers and health apps, digital biomarkers such as pulse, heart rate, skin elasticity, etc. can be added to the mix. For example, ARCONDIS is currently assisting one of the world’s largest pharmaceutical companies in using digital biomarkers in clinical studies in the area of neurology. As a result, considerably more research data can be obtained and analyzed, leading to a lower error rate and higher quality products.

 

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.

 


 

The regulatory environment

Regulatory authorities have always been responsible for ensuring patient welfare. This is why current regulatory trends are responding to opportunities and risks arising from the globalization, digitization and technologization of the industry.

 

Life Sciences Trends 2018 - Regulation

 

When it comes to globalization, regulations on product safety and counterfeit prevention are high on the agenda, primarily:

 

  • Medical Device Regulation (MDR) for medical devices: In May 2017, the new European regulation for medical devices took effect, with stricter guidelines for product classification and market monitoring, especially for high-risk products (see also GxP Compliance). The transition period for affected companies will expire in May 2020.
  • Unique device identifier (UDI) for medical devices: The MDR has also made mandatory the introduction of the UDI, a unique identifier for medical devices. It is intended to ensure the traceability of products and to prevent counterfeiting. The US Food and Drug Administration (FDA) already passed a corresponding act for the US market in 2013.
  • Serialization of medicines: The serialization of licensed medications will become a statutory requirement for all companies in the EU starting in February 2019 in accordance with the Falsified Medicines Directive (EU FMD). The American equivalent, the Drug Supply Chain Security Act (US DSCSA), will become mandatory even earlier, in November 2018. Serialization is also obligatory in Turkey, Brazil and China.

 

Digitalization – on principle a blessing – also results in an increase in regulations for data security and privacy, for example:

 

  • GDPR in Life Sciences & Healthcare: In May, the two-year transition period for the new European General Data Protection Regulation GDPR (German: EU-DSGVO) will be up. GDPR is especially relevant to the life sciences industry, as health data is considered particularly sensitive. Many companies are currently still in the implementation phase (see also our article GDPR: The final spurt from this edition of UPDATE).

 

  • 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.

 

Life Sciences Trends 2018 - Outlook

More than a forecast: An urgent need for action can be seen already today.
(click the image to enlarge)

 


 

The result: A new healthcare ecosystem

In the wake of trends in various areas, the image of a new healthcare ecosystem is emerging, with a spotlight on the collaboration and connectivity of patients, manufacturers, authorities, service providers and sponsors in the healthcare industry.

Major focal points of this network include the following developments:

 

  • From treatment to prevention: This goal has never before been as realistic as it is today. After all, the combination of digital biomarkers, progress in genome research and predictive analyses are paving the way for the detection and prevention of illnesses before they actually occur.
  • From healthcare to self care: In the new ecosystem, patients play a key role, as direct and unfiltered contact is possible – in both directions. For life sciences companies, this development is an opportunity to concentrate on the actual consumers and allow them to participate in the development and optimization of treatments. Of course, this also goes hand in hand with a major shift in the patient’s voice.
  • From unit price to value orientation: With increasing pricing pressure, the trend towards value-oriented healthcare will continue to grow. Technologies such as predictive analyses, genomics and biomarkers help predict the effectiveness of treatments in specific patient groups more accurately than ever, making them ideal for delivering relevant information for valuation.

 

Life Sciences Trends 2018 - Healthcare Ecosystem

 

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


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