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This year brings new challenges to the life sciences industry, but many of the challenges from last year remain. While data integrity observations from the regulatory bodies are experiencing a decrease, incidents of hacking, data theft, and new challenges to security remain high. For example, by early 2018, crytomining had replaced ransomware, a prevalent threat in 2017. However, old problems remain; more than 90% of malware gets delivered by email. As fileless malware becomes more common, the days when you could tell that your email was a phishing attack or contained a virus by the .exe file attached are fading fast.

Artificial Intelligence (AI) offers promises that could not have been imagined even a decade ago, yet it brings additional challenges to a highly regulated industry. These advancements in technology rely on the quality of the data available; the old ‘garbage in; garbage out’ still remains. Regulations continue to change and adapt, but they aren’t always able to keep pace with the rapid changes in technology.

Last year we reflected on technological advancements like the cloud, internet of things (IoT), artificial intelligence (AI), and blockchain. We discussed how these were disrupting the way the life sciences industry has operated for the last two decades. In 2018, the use of cloud-based systems was just ramping up throughout the life sciences industry, but this year we’ve seen ever-increasing levels of acceptance of this technology. In fact, the benefits to R&D, innovation, operational improvements, etc., make the migration to the cloud inevitable. Indeed, 2018 saw much advancement in the ability of these technologies to change the way we think and do business.

The continuing (and potentially increasing) vulnerability of data provides hackers with plenty of tempting targets. This combined with less than stellar security around critical data systems, increases the probability for data loss or theft. There is a steep price to pay as fines for breaches of personally identifiable information (GDPR, HIPPA, PIPA, CCPA) become real, creating even greater concerns for data security.

Where are we going in 2019? One thing is for sure, technology will continue to evolve rapidly. And with that, we will need new ways to secure and protect our data.

#1 - The Promise of the Cloud for Life Sciences

It’s undeniable that the need for digital transformation has disrupted the life sciences industry. It is not only critical, but necessary to grow your business and stay competitive in today’s technology landscape. No longer is the cloud simply about cost savings and data storage. Today’s cloud technology is at the forefront of R&D and innovation, bringing new products to market faster than ever, as well as driving continuous organizational and process improvements that enable life sciences companies to collaborate more efficiently and remove fragmented silos.

Consumer expectations for transparency, speed, technical innovation, and integrated solutions ensure the cloud table-stakes for any technology-driven business serious about growth. Yet finding a cloud vendor that can be nimble and innovative, and skillfully navigate the complex requirements of regulators like the FDA, EMA, and Health Canada CFDA, creates a significant challenge for life sciences companies.

“The selection of cloud vendors capable and willing to provide evidence of their qualification and compliance efforts is crucial. Leveraging these efforts is the first step to establishing that your requirements – both business and regulatory, have been met. It is also imperative to ensure that the vendors you select (including any third parties related to compliance maintenance) can continue to provide high-quality information and risk mitigation evidence once you are live, to keep up with the high frequency of changes that are part and parcel of the advantages of cloud computing.”

- David Blewitt, VP of Cloud Compliance, USDM Life Sciences

What this means to you:

Life science customers’ ability to adopt cloud applications with a higher frequency and move off the multiple on-premise silos of data will allow them to better leverage their investments, innovate faster, and harvest more from the data they have stored. These customers must balance the constant push for innovation (which is the norm when it comes to the cloud) with traditional compliance and change management paradigms. The potential of using cloud solutions designed to integrate readily with multiple applications creates the possibility of a fully integrated, collaborative system landscape.  

For instance, by linking your content management system with your clinical trials management system and electronic signatures solutions, and establishing real-time workflows into your marketing, supply chain management and planning systems truly enable you to take a holistic approach to manage your business – and this can all be done in a transparent and compliant manner.

How USDM can help:

USDM’s Cloud Assurance is a managed service where USDM handles the entire compliance workload, from cloud vendor selection to compliance establishment to ongoing maintenance of the validated state. This provides our customers with a harmonized, consistent and fully transparent compliance experience across all their cloud vendors. USDM also offers services for automated risk mitigation, change management and change control processes, workflow as a service, and many other digitally transformative capabilities beyond compliance management, thereby maximizing our customer’s IT dollar.

#2 - Real-World Data & Real-World Evidence

Real-World Data (RWD) refers to data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence regarding the use and potential benefits or risks of a medical product derived from analysis of RWD. Both RWD and RWE are beginning to have a significant impact on the life sciences industry.

  • FDA uses RWD and RWE to monitor post-market safety and adverse events and to make regulatory decisions.
  • The healthcare community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
  • Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches (1).

Additionally, the 21st Century Cures Act, passed in 2016, puts greater focus on the use of these types of data to support regulatory decision making. RWD and RWE have the potential to ensure regulators, scientists, doctors, and patients alike have better information to make more informed, effective, and efficient medical and health care decisions. While this all sounds promising, life sciences organizations will find it challenging to optimally access and mine RWD sources and develop RWE to utilize in clinical and safety reporting. As these data and the extract and analytical tools are used for clinical and safety reporting the processes and systems must be validated.

The FDA acknowledges the numerous sources of RWD including patient reported outcomes, paper or electronic patient medical records and case histories, diagnostic laboratory and imaging data, and medical device data within the device such as self-diagnostics, error codes, and patient diagnoses. Many of these efforts are becoming more and more possible in the medical device sector through the global initiative to utilize unique device identifiers (UDIs).

Outside the US, the imminent EU MDR and EU IVDR regulations will require proactive surveillance to maintain approvals. RWD/RWE will also be useful to create clinical effectiveness reports (CER) and post-market clinical follow-up (PMCF) reports. How RWE supports these regulations is just beginning to be understood, but it certainly substantiates the need to understand and position your company to adopt capabilities with RWE.

“RWD and RWE have the potential to ensure regulators, scientists, doctors and patients alike have better information to make more informed, effective, and efficient medical and healthcare decisions. USDM Life Sciences is ready to help you establish the processes and technologies to accrue the power and benefits of RWD analysis and RWE, as always in a compliant manner.” 

- Jim Macdonell, VP of Medical Device Services and Solutions, USDM Life Sciences

What this means to you:

As an organization continues its initiatives to support pharmaceutical and medical device approvals and safety improvement, the use of RWD and RWE will continue to grow in importance and application. Ensuring companies are prepared with compliant processes, technologies, and data sources will be a strategic and necessary initiative. For instance, by linking your content management system with your clinical trials management system and electronic signatures solutions, and establishing real-time workflows into your marketing, supply chain management and planning systems truly enable you to take a holistic approach to manage your business – and this can all be done in a transparent and compliant manner.

How USDM can help:

USDM Life Sciences can help pharmaceutical and medical device companies structure and manage their access to and analysis of RWD and RWE to better support their clinical studies, submissions, and post-marketing safety reporting. The proven leadership capabilities of USDM’s talent has helped hundreds of clients to create modern, world-class regulatory, clinical and safety organizations, systems, and processes.

#3 - AI in Life Sciences and Drug Discovery

A recent press release headlined “Sky High Growth of Artificial intelligence in Life Sciences Market 2019 Expected to Witness a Sustainable Growth with +22% CAGR and USD 15 billion in 2025 (2)." The challenges to bring Artifical Intelligence (AI) to life sciences organizations are multifaceted, but at this point in time, they are focused on two areas: talent and data. From legacy organizational and technical challenges of data being fragmented in silos to the gap in human talent (i.e. biological and medical scientists versus computer and big data scientists), the life sciences industry is under the gun to find data scientists who are familiar with AI but also possess a background in life science industries.

The conservative nature of life sciences combined with the highly competitive space creates further resistance to new generation data opportunities. Strict regulatory compliance standards often bring progress in advanced technology implementation to a halt. The opportunity is greatest for the larger pharmaceutical companies that have bigger budgets to invest in strategic partnerships and outsource IT and AI experts in order to move faster (i.e. Alcon and Google). The potential of AI to identify previously unknown causes of disease to accelerate the trend towards treatments designed for patients with specific biological profiles is the future. Technology provides a means to discover cures and treatments we’ve only dreamed of and life sciences companies who embrace more advanced technologies will make history.

“AI, machine learning, natural language processing, blockchain, and other emerging technologies driving digital transformation will fundamentally reshape how life sciences companies operate in future. Availability of large volume of data, cheap compute and storage, cloud adoption, pace of innovation and algorithm improvements, will accelerate adoption of these disruptive technologies to drive high impact outcomes.” 

- Vishal Sharma, VP of Digital Trust and Transformation, USDM Life Sciences

What this means to you:

Companies that have shown early success indicators have started by removing barriers and silos in the organization to think more about an ecosystem approach than traditional functional departments. Furthermore, when thinking through the option to build an internal IT or AI expertise  or outsource it, realize the challenges in the organizational transformation management are significant. To hire the best and brightest AI minds, you are competing with the technology giants of the world, and very few deep-learning data experts have experience in the biomedical sciences (3).

How USDM can help:

USDM Life Sciences can help pharmaceutical and medical device companies structure and manage their access to and analysis of RWD and RWE to better support their clinical studies, submissions, and post-marketing safety reporting. The proven leadership capabilities of USDM’s talent has helped hundreds of clients to create modern, world-class regulatory, clinical and safety organizations, systems, and processes.

#4 - Personalized Medicine

Personalized medicine is a set of procedures and processes used by doctors that separates patients into different groups with medical decisions, practices, and products being tailored to the individual patient based on their genome or unique disease susceptibility. This medical model is most notably growing in importance to the area of oncology, as cancer is not a single disease but hundreds of different diseases. Personalized medicine will utilize CAR-T and CRISPR/gene therapy to treat maladies specific to each patient. Instead of taking medicines developed for millions of people, everyone will eventually be treated per their DNA makeup. Technology advances will be critical to progressing personalized medicine – technology will enable the confirmation of patient DNA, RNA, or protein, which will ultimately lead to confirming or preventing diseases.

Important to note, the FDA is planning a new 52-person Office of Drug Evaluation Science (ODES) to improve the review of new medicines and to standardize the approach for using personalized medicine, digital data, and patient reporting (4). Life sciences companies that intend to utilize personalized medicine and thus millions of clinical electric medical records that need to be converted into research-grade data, must also think though their overall data governance strategy to control this density of data. Data governance will be critical to validating and trusting the data.

“Complete, consistent, and accurate data for personalized medicine can only be achieved through the initiation, planning, execution, monitoring, and control of a Data Governance program.”

- Armand Mintanciyan, Engagement Lead, USDM Life Sciences

What this means to you:

Technology advances that will enable personalized medicine are beginning to disrupt the health care and life sciences industry. This scale of technological advancement requires a focused data governance and digital transformation strategy along with culture change, organizational change management, and new leadership approaches to enable the use of intelligent data and modern technology to create value in an organization. Often, it is difficult to execute this magnitude of change without a 3rd party partner who shares your values, understands your goals, and has the experience to deliver meaningful results.

How USDM can help:

Companies that capture genetic information from patients for personalized medicine would benefit from a Data Governance program. USDM can implement a Data Governance program to provide assurance of data consistency, improve data quality, and promote data accuracy. The Data Governance Institute defines data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. USDM’s senior consultants have the expertise and experience to assess your company and implement the needed technical and procedural controls for your Data Governance program.

#5 - Cybersecurity and Digital Trust

Cybersecurity and data integrity breaches and violations continue to remain a concern for life sciences companies and most industries. Underlying these concerns and the digitization of the industry is the concept of digital trust – an organization’s ability to trust that 3rd party vendors will protect and secure their data when it’s ultimately the organization’s responsibility to their customers. Industrial and National cyber espionage and hacking are becoming commonplace. The complex and ever-evolving technological landscape further exposes unwitting companies to cyber threats. To add additional strain to the system, there are myriad consumer protection laws by different governing bodies (e.g. GDPR, HIPAA, PIPA etc.) with more rules slated to come.
The life sciences industry typically operates in a standardized and methodical way at the mercy of controlled regulatory requirements, and fears the volatile patent protection system. The speed that is required to drive growth across life science organizations is quickly translating into strategic partnerships and investments in mergers and acquisitions with tech companies whose foundations have been built on open-source code environments and who move at the speed of light.

Merging these two drastically different engrained business processes and cultures of life sciences and big tech poses risks to the entire organization as technologies and data become shared assets and control of systems and system security become shared responsibilities. This rapid increase in technology and the pressures to adopt it creates serious concern and hesitation that updates to software and computer systems and the increased use of cloud-based systems will cause significant risks and testing requirements (and therefore significant costs) to maintain both system security and compliance.

“In an era of rapid technological evolution, immense cost and speed pressures, and proliferation of regulations and rules, it is paramount to have a partner like USDM that is at the crossroads of business, technology, and regulations.” 

- Subbu Viswanathan, Strategic Advisor, USDM Life Sciences

What this means to you:

Companies can stay in the game by 1) selecting the right technology partners, 2) having strong governance and process controls to manage data flow and information flow between the company and the various technology partners, and 3) creating an overarching compliance framework that can manage how data is classified, how and where data is stored and managed, what is done to the data, how and why is it retained, what is the minimum possible information that needs to be stored at any point in the data flow, and what processes and tools need to be in place to secure, retain, and purge the data. Furthermore, it is necessary to establish robust change management processes to ensure that when any part of the data flow “chain” is modified, the appropriate level of impact analysis is conducted, and to take appropriate measures to preserve sensitive data and information.

How USDM can help:

USDM has implemented thousands of compliance projects and is acutely aware of their customer’s security concerns and hesitations using a 3rd party. With a track record of more than 80% of customers renewing and increasing their cloud subscriptions services from USDM, the proof is in the numbers and the length of the deeply embedded partnerships. USDM reins in the seemingly competing priorities of technology (innovation/agile) and regulations (standardization/control) to provide our customers a harmonious experience where we maximize the potential of the latest in technologies without suffering from regulatory “gotchas.” Our regulatory agency veterans teamed with our technology experts form a unique nexus of talent that allows our customers to constantly stay ahead of the curve. 

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(1) Real World Evidence.  (2019, February 6). Retrieved from https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm
(2) Sky high growth of Artificial intelligence in life sciences market 2019 Expected to Witness a Sustainable Growth with +22% CAGR and USD 15 billion in 2025. (2019, February 14). Retrieved from https://www.marketwatch.com/press-release/sky-high-growth-of-artificial-intelligence-in-life-sciences-market-2019-expected-to-witness-a-sustainable-growth-with-22-cagr-and-usd-15-billion-in-2025-2019-02-14
(3) Raghav Bharadwaj. (2019, February 12). AI in Life Sciences Trends and Terms that Executives Need to Know. Retrieved from https://emerj.com/partner-content/ai-in-life-sciences-trends-and-terms/
(4) Matthew Herper. (2019, January 7). FDA plans to create a new office to leverage cutting-edge science. Retrieved from https://www.statnews.com/2019/01/07/fda-plans-to-create-a-new-office-to-leverage-cutting-edge-science/ 

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