Life Sciences Overview

• Diminishing new drug pipeline
• Lawsuits from drugs with extreme adverse effects
• Pricing pressure insurance companies and illegally imported drugs
• Poor public relations image in the eyes of the consumers; seen largely as putting profits ahead of the greater good of mankind
• Increasing regulatory compliance requirements add significant overhead cost to the drug development process
• Numerous inefficient, outdated and manual tasks during the drug development process that weigh the process unnecessarily

For most Pharmaceuticals and Biotechs, the majority of the focus on improving their general business outlook has gone towards improving the health of their new drug pipeline. Since organic growth takes time, most Pharmaceuticals and Biotechs have turned to acquisition of smaller (and sometimes not so small) players with healthy pipelines, but insufficient funding to withstand the long drawn out and heavily regulated clinical trial processes.

Given the current state of the financial markets and the lack of credit available, we do believe this will create a frenzy around the acquisition of the smaller Pharmaceuticals and Biotechs. The ones with promising drugs in late stage of the development cycle will likely get acquired by bigger players looking to build healthier new drug pipelines, while the remaining smaller players will be weeded out – survival of the fittest. Such Mergers & Acquisitions will lead to elimination of redundancies including supply chain and back office integration requirements. Princeton Blue can help define the integration strategy around these process integrations, IT platform consolidations, system retirement and dual application platform support, and help you execute on that strategy too – with the objective of delivering a seamless experience for customers.

The area within these Pharmaceutical and Biotechs (large or small) that has been largely neglected is the efficiency of the Research & Development process within these organizations. With clinical trials costing upwards of $750,000 per day during Phase III, there is a huge incentive to run these R&D processes as efficiently as possible, however most R&D organizations fail to take advantage of the real-time integration and process management technologies introduced over the past 10 years. Improving the efficiency and productivity of the R&D processes, such as protocol authoring, field data synchronization between EDC and IVRS and CTMS applications, adverse event reporting, etc, can lead to greater visibility and better control over the clinical trial and consequently, the ability to make timely decisions and take appropriate actions to amend or cancel the trial if necessary. Clinical trial cost savings are clearly a benefit here; however, the more important benefit is the longer monopoly marketing period for that drug.

With experience in pharmaceuticals, medical devices and consumer goods, Princeton Blue has been working with its Life Sciences clients to help them build a shared services framework that facilitates rapid integration between the various internal clinical trial applications and external 3rd party vendors involved in the clinical trials. Princeton Blue can assist you in building process-based solutions so you can better handle new FDA regulatory and compliance requirements as they are introduced. These process centric solutions allow your business decision makers to track, review, monitor and react to the process information in real-time, saving months in the process.