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Problem Solving

: Describe your role at Medidata, and how it has changed over the last few years.

Andrew Newbigging: In my current role as Senior Vice President of R&D, I lead a global team of 350 people in developing, supporting and operating all of the solutions and applications in the Medidata Clinical Cloud®. Essentially, I am responsible for technical and product strategies, and developing current and new products to fulfi ll those strategies, as well as heading the support services and technical operation of the Medidata platform.

My role has broadened over the years with the company’s rapid growth, as both the number of trials conducted via our solution and the functionality we offer has increased. Today, my responsibilities also include ensuring that we provide the highest standards of security, quality and reliability to support our customers worldwide.

It has been extremely rewarding to see our platform of cloud-based solutions help life sciences companies modernise drug development and bring needed therapies to patients faster, and with lower cost and risk.

What are the biggest challenges currently facing this sector?

There is growing pressure from a range of environmental issues, including dramatic loss of revenue due to patent expirations, increasingly cost-constrained healthcare systems and more demanding regulatory requirements. The good news is there is widespread recognition that business models need to change, and that the life sciences industry must adapt to new methods and a fresh way of thinking. This transition to more proficient, innovative processes – that still meet high standards of quality and regulatory compliance – requires good software system support and a willingness to embrace change.

As an industry, we now have the opportunity to transform clinical trial processes and make drug development more efficient with new technology and data-based insights. Broad adoption of platform technology will enable better decision-making and fewer, less redundant procedures, helping to drive faster, less expensive and safer clinical trials.

Another major hurdle will be the management of the oncoming data tsunami from genomics, wearable devices and continuous patient monitoring activities. Analytics are only worthwhile if they can be used to glean real insight, and our job is to help the global life sciences industry manage – and make sense of – potentially overwhelming amounts of data.

What is Medidata’s business philosophy?

Our mission has always been to make the science of drug development better and to help bring needed new therapies to patients, faster and with lower cost and risk. In 2015, our focus remains to deliver value to our life sciences customers and users, and help them navigate through the changes in our industry. Continuous innovation is key to our business as we fi nd new ways to improve the clinical trial process – and Medidata’s investment in R&D reflects that belief.

Professionally, what has been your proudest moment?

Medidata was founded 15 years ago, and we are very proud to be able to say that, of the 10 highest grossing drugs (from a revenue perspective) in the US last year, seven of them were developed on our platform.

For me personally, one of the first trials I worked on at Medidata led to the successful development of a drug that is now in clinical use, saving lives every day. That is an incredibly inspiring feeling and one that makes me excited about the work we do here.

How can companies get the most out of their data?

Historically, life sciences firms made substantial investments in customised internal IT systems and a range of technology solutions from third-party vendors. However, the many different and proprietary systems used to run clinical trials are hindering the implementation of common standards, such as those established by the Clinical Data Interchange Standards Consortium. As a result, the R&D environment does not effectively support cross-industry collaboration.

Cloud-based technology solutions are helping the industry overcome this challenge. They offer an interoperable model based on service-oriented and standards-based architecture, as well as the flexibility to interface with legacy systems. Today, we are seeing such platforms enable knowledge sharing and collaboration that is stimulating innovation across the industry. The need to improve patient care and management of clinical trial sites has resulted in recent introductions of better and more effi cient ways to share data among R&D teams, CRO partners and vendors.

However, having access to more data does not necessarily make that information more useful. Focus needs to be placed on instituting practices that enhance the quality of the data captured. For example, we have conducted several analyses – with industry bodies such as TransCelerate BioPharma Inc and PhUSE – which have demonstrated that copious quality checks and 100% source data verification does not lead to any change in data, and therefore any variation in quality. Targeting efforts, via risk-based monitoring and other strategies, can achieve the same standards of quality but with lower effort.

Taking full advantage of the right data in real-time will result in tremendous time and money savings, as well as lower risk to patients. Implementing complementary infrastructure and procedural changes that streamline processes and eliminate data silos are necessary to capitalise on the opportunities presented by such datadriven models. When meaningful data can be viewed across multiple studies and evaluated together, organisations will have the ability to explore possibilities never previously considered.

You have also been working on the use of mobile health devices combined with cloud-based technologies in trials – what benefits can this approach bring?

At Medidata we believe incorporating digital technologies into clinical trials will result in better data, enhanced patient experiences and more efficient trials.

Mobile health (mHealth) technologies can provide a much richer, more accurate picture of patients’ health and wellness in the real world – not just at scheduled visits, but at all times. In the future, this will help with earlier adverse event detection, better profiles of treatment benefits, and reduce the need for in-clinic appointments.

In bringing mHealth solutions into early clinical development, companies can examine and enhance techniques for patient engagement and compliance, prior to a drug’s commercialisation. This means that interventions and recommendations can be introduced that will allow patients to gain more optimal therapeutic value earlier in the therapy lifecycle. Devices and monitoring technology that can connect with participants’ existing mobile phones will significantly further these efforts by allowing patients to interact with technology with which they are already familiar.

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Andrew Newbigging is Senior Vice President of R&D at Medidata, and has over 25 years of healthcare and pharma IT experience. Previously, he founded InferMed, a UK company providing software products for health and life sciences organisations. Andrew has also held positions with the UK’s NHS and PricewaterhouseCoopers, and received his BA from the University of Cambridge.
Andrew Newbigging
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