No room for luddites
By: Naz Haji | October 04, 2016
Today’s technology has given us the power to transform lives – but as an industry, do we have the courage to use it?
I recently read an article in the Bangalore Mirror about a Phase II pediatric clinical trial involving a wearable sensor. India has one of the highest neonatal mortality rates in the world and most rural hospitals do not have adequate facilities, which means neonates are not receiving timely and appropriate care. The wearable sensor, which picks up temperature abnormalities, is placed on the abdomen of newborn babies and raises an audible alarm for a family member to be alerted, or transmits these alerts remotely to the phone of a health worker. The potential of a device like this to save lives is immense.
This is just one example of the giant leaps forward we’ve taken into an era of disruptive information technology and data-driven, intelligent drug development. These technologies are giving us the power to save and transform lives, while driving a better understanding of the management of healthcare and disease overall. They are also playing a transformational role in addressing the escalating cost of drug development, and the need of biopharma companies to reduce time to market. Various estimates have put the cost of developing a new drug from anywhere between US$ 2.5 to US $ 5 billion. According to the Tufts Center for the Study of Drug Development, the cost to develop and win marketing approval for a new drug has increased by 145% between 2003 and 2013.
In response, biopharma companies are seeking partnerships that are much more transformational where risks are shared and partners are expected to play a more strategic role. They want to make faster, better-informed decisions and are seeking early signs of drug success or failure. Both these trends reaffirm the immense need for and value of technology in the biopharma industry. And we are making incredible strides in the implementation of technology across the drug development lifecycle.
Consider a few recent innovations in biopharma technology that are quickly becoming mainstream:
Risk-based Monitoring: Developments in the area of risk-based monitoring are indicative of the growing role that technology is playing in clinical research. RBM moves away from the traditional approach of frequent on-site visits and 100 percent source data verification towards a combination of activities, including centralized data collection and monitoring. Guidance by the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) has provided a stimulus for investments in RBM and we have seen and will continue to see a lot of developments in this area. In our business, RBM provides early triggers that enables sponsors to manage clinical trials more effectively and economically while ensuring enhanced patient safety. By harnessing the power of integrated, holistic data, we are able to respond to signals and trends that could affect patient safety and operational performance to help make smarter decisions about which sites to select and how to deploy monitoring resources.
Predictive Analytics: In this era of personalized healthcare, predictive analytics can play an important role in foretelling outcomes for individual patients leading to improved patient care, chronic disease management, better hospital administration and improved supply chain efficiencies. While physicians have historically always relied on just data, this abundant availability of data, combined with diagnostic and analytical tools has catalyzed and advanced predictive modeling in health care.
Now the industry needs to figure out how to create a regulatory environment that can balance privacy concerns while the need for innovation so that we can unlock the incredible potential of data analytics. The success and future of predictive analytics has a great dependency on how well we interpret and analyze the data to deliver insightful information.
Wearable Devices: Mobile and wearable technologies are changing the way we capture information and engage with patients. These devices produce data that, when enabled with analytics, can be used by consumers and healthcare organizations to improve care and potentially reduce costs through systems such as remote patient monitoring.
Global Industry Analysts Inc. estimates that the global market for medical wearable devices will reach US$ 41.3 billion by 2020 driven by the growing need for effective management of chronic diseases, rising healthcare awareness and launch of innovative health management devices. The evolution of wearable technology goes beyond just the gadget (although it's always cool to have a nice looking gadget). The importance is in how it encompasses the data it collects, the significance of this data, and how the data is interpreted. Organizations that are able to integrate all of this seamlessly into their research methodologies will be able to harness the power of data across the drug development continuum.
Telemedicine/Telehealth: In India we are all too familiar with the use of telemedicine to improve and advance the health of individuals and communities in remote areas of the country. In rural and inaccessible areas, the Ministry of Health & Family Welfare is committed to promoting tele-health solutions to deliver basic and specialized health care services nearest to the end user. Yet, as much as we have read about the benefits of telemedicine there continue to be challenges, most notable being the lack of access to even a simple technology infrastructure in remote areas.
These technologies have the power to transform the way we conduct research and develop drugs, but we have to continue pushing the innovation forward – and we need more than deep domain expertise and regulatory understanding to make that happen. At a local level, we need a commitment among all stakeholders to collaboratively develop technologies that will address our country’s healthcare needs and economic growth. At Quintiles, we have taken several steps toward this goal, including the development of our new global Solution Design Studio where expert teams will collaborate to create technologies that tackle some of healthcare’s biggest challenges. The Studio is a highly interactive technology-driven environment featuring digital-simulation capabilities and proven early development processes that drive innovation and rapid problem-solving. Our customers, therapeutic and domain experts, and key healthcare stakeholders will join our Studio’s team of simulation analysts, wearable and virtual-reality experts, user-interface designers and app developers to create technology solutions.
We need to lead
With nearly endless wireless bandwidth, gesture-sensitive touch screens, and handheld form factors packed with accelerometers and GPS synchronization, the ability to capture data from any person or location in the world is seemingly unbounded. These exponential advances in mobile, social, cloud and data will certainly continue to evolve introducing new opportunities for healthcare, in forms and ways we have yet to imagine. The question now is whether the industry will be able to embrace these advancements. Certainly a deeper understanding of the benefits and pitfalls of these technologies must be well understood and delivered not by technology experts alone, but by industry leaders who have a deep understanding of the needs of healthcare and life sciences.
Without expertise and a partnership in these areas, as well as the need and passion to continually re-invent ourselves, the true potential of technology to transform the healthcare industry will be only partially realized.