The biopharmaceutical (pharma) industry is undergoing major transformation. This transformation is being driven by the changing face of healthcare, characterized by demographic changes, rapid technological developments, and new healthcare expectations, all occurring at the same time as rising regulatory and compliance challenges.
The ability of pharma to respond successfully to these challenges depends on improving the use of information and data. Research by the McKinsey Global Institute estimates that applying big data strategies to improve decision-making could generate up to $100 million in value annually across the US healthcare system. Critical here is by improving their use of information, pharma can improve clinical-trial efficiency, improve collaboration, and use this data to improve their R&D processes. Ultimately this will help pharma find the insights necessary to drive personal or precision medicine, where patients are treated using individualized approaches. However within pharma, one department in particular is currently being dramatically impacted by, as well as tasked with using, insights, and that´s Medical Affairs.
In the past the responsibility of the Medical Affairs group in a pharmaceutical firm was simply to answer medical questions from healthcare providers. Typically the role was characterized by sharing timely information with key stakeholders, and combining and synthesizing relevant medical information or research.
However this role has significantly increased in scale and complexity. Because of the increasing importance of data, information and other factors, Medical Affairs has become the key agent in helping pharma overcome today’s challenges. In particular Medical Affairs has a key role to play in helping pharma in the following areas:
Graphic How Medical Affairs help pharma overcome today’s challenges
As pharma seeks to respond and adapt to today’s challenges, it therefore needs a Medical Affairs department with the capabilities to collect and analyze vast swathes of information. For Medical Affairs to be able to achieve this, they need dedicated tools to help them.
An innovative software company based in Silicon Valley, kernel, recognized early the fundamental shifts taking place in the pharma industry. The company saw the need for Medical Affairs leaders and medical science liaisons (MSLs) to have access to real-time information in order to provide insights and data to their colleagues whether in commercial or R&D, at their moment of need. They recognized the need to use data visualization and advanced analytics to provide insight in new ways, for new audiences.
It was clear that Medical Affairs was struggling with their existing CRM tools. Medical Affairs leaders are scientists, not salespeople. By providing them with the means to evaluate real-time data and analytics, we can help them make better decisions faster, and ultimately improve outcomes for patients.
Avikk Ghose, CEO and co-founder, kernel
Based on this understanding of the challenges faced by pharma, and the urgent need for real-time information that could be easily understood, digested, and shared, kernel created a user-friendly, intuitive software tool, which brought together different sources of data and information and put them in the hands of the experts in Medical Affairs.
Graphic kernel’s user friendly dashboard of medical insights
kernel launched its first prototype in December 2014. The product provided biotech and pharma companies the means by which to detect medical insights and trends. Faced with time-to-market pressures, kernel aimed to get the product quickly to market, and then iteratively improve it based on user-feedback. As a result kernel decided to use Agile development, because of the need to ship code rapidly.
However releasing software every few weeks, represents a fundamentally different approach to software development. In the past software companies would release software once every 2-3 years. But recognizing the need to move quickly depending on business requirements, kernel, despite not initially being experts in Agile development, looked to the expertise of Agile trainers and Belatrix Software, an Agile specialist, to rapidly build up expertise. The result is that since 2014, with Belatrix’s help, kernel has released over 23 software updates to its core product.
Our focus was on providing kernel with the Agile development and technological expertise they needed to ensure they met aggressive quality and time-to-market goals. Agile provided the framework for rapid iterations, and ensured the feedback of Medical Affairs leaders could be incorporated rapidly into the product design.
Alex Robbio, President and Co-Founder, Belatrix Software
Prior to the development of kernel’s product, Medical Affairs was reliant on unwieldy CRM systems, and traditional Microsoft Word and Excel documents. Information was collected and analyzed, before being presented to a variety of stakeholders from physicians, to commercial, to R&D. The difficulty was that this information was not shared in real-time, or even close to it. Medical Affairs may not have received feedback from customers and patients for a couple of weeks or even months.
Today, at this time of patient-centricity, where the patient’s voice needs to be considered throughout the drug development and approval process, real-time information is critical. kernel´s product makes this possible. Receiving information faster, means pharma can act upon feedback quicker and more effectively. This translates to better decisions and ultimately to better patient outcomes.
Java SDK and runtime (currently using Java 1.6.0_30), SSH, Git, Eclipse for Java, Eclipse add-ons (EGit, Java Web Developer Tools, Eclipse Web Developer Tools, Eclipse J2EE tools, 3 JST Server packages), Firefox with Poster and Firebug add-ons (for testing and debugging), MySql, WYSIWYG Component, Dynamic CSS, JQuery