TAKE Life Sciences: Transformation through Transparency, Virtualization, Collaboration and Process O

Mike Lewis, EVP
Regulatory scrutiny, demand for transparency, patent cliffs, M&A, emerging markets, stagnate markets, pressure from generics, and focus on patient outcomes drives an industry to look for new ways to capture, analyze, and process data. An organization’s success is highly dependent on their ability to adapt to rapidly growing sources of structured and unstructured data and effectively discover and react to data. The time from discovery of “golden nuggets” to enabling a business decision has to be in real-time for companies to stay competitive. There is also an additional challenge to managing data being driven by the need to take cost out of the organization. This is causing a push for a move towards SaaS, Cloud, IaaS, PaaS, and new business models like Fully Integrated Pharmaceutical Networks (FIPNet). These models require companies to reassess their view of data in terms of security, integration, and standardization within and outside the firewall. “There is philosophical shift required to deal with data sharing in an open manner across clouds and the FIPNet which includes regulators, partners, payors, and providers. The payoff has better outcomes,” says Mike Lewis, EVP, TAKE.

With 20 years of experience in the Life Sciences industry, Lewis’s key focus lies in building solutions that solve regulatory, clinical, safety, and manufacturing challenges within the industry. “TAKE is making strategic acquisitions that support our values of industry insight, client intimacy, pragmatic innovation, delivery excellence, and people centric approach,” notes Lewis. Today, TAKE has global offices in the U.S., U.K., India, and Singapore.

To help clients navigate business and data transformation initiatives, TAKE has four horizontal offerings—Industry Forums, Strategy and Change Management, Technology Innovation, and Life Sciences Operations. TAKE’s Industry forums focus on Pharma covigilance, Regulatory, Labeling, Technology, and the Chief Medical Officer. (PN Net, PV Connect, LabelNet, CMONet, CIONet and RIM Roundtable). Through these forums, TAKE has been generating unique insight and best practice approaches to the common challenges of clients.

The ability to discover data, share it, redefine its ownership and enable transparency and trust is at the heart of transforming the life sciences industry

These forums enable informed peer-to-peer discussion in key areas of interest and provide an opportunity to discuss and develop potential solutions. TAKE’s Strategy and Change Management and Technology Innovations offerings focus on assessing the data requirements of the organization to develop future state processes that will enable better business outcomes. And lastly, through Life Sciences Operations, TAKE supports a FIPNet model providing both a collaboration oriented architecture for secure data exchange as well FIPNet endpoints for Regulatory and Clinical outsourcing services.TAKE applied all four to help a major client to address the challenge of growing regulatory scrutiny, cost take-out, lost revenues due to patent cliffs and increased submission volume due to expansion into emerging markets and acquisitions. With TAKE’s help, the client developed a Regulatory Information Management (RIM) solution providing transparency into submission and registration management, end-to-labeling, publishing and commitment tracking. As a result, the client was able to handle increased submission volumes without any impact to quality, saving millions.

TAKE exclusively focuses on the life sciences industry, including sub verticals such as Biotech, Animal Health, Medical Devices, Consumer Health Agrochemicals, and Tobacco. “We are collaborating with a number of technology partners to address the data challenges across the value chain, with a belief that it is possible to use analytics, collaboration, content, and orchestration tools to enable real time analysis of structured and unstructured data. This will create an event driven architecture that will automate business decisions and actions and truly improve patient outcomes,” notes Lewis.

Going forward, TAKE Life Sciences will continue to build end-to-end RIM, IDMP, Quality Management, and Labeling solutions by not only using off-the-shelf technologies, but also utilizing service and collaboration oriented architectures that process secure data exchange between trusted partners.

TAKE Life Sciences

Princeton, NJ

Mike Lewis, EVP

TAKE Life Sciences is a global consulting, technology solutions and service provider, with significant focus across three principal business areas–Clinical, Regulatory and Safety