The predominate goal of pharmaceutical and biotech drug development is to achieve approval of a “drug product” that meets an unmet medical need and is in agreement with the FDA, EMA, and/or other global healthcare authorities. But pushing forward development of these innovative medicines often results in a general acceptance of increased risk, but no corresponding increase in the probability of success (16%). However, failure events which occur at the most unanticipated and inopportune times, coupled with poor planning, lack of communication, and lack of development experience at senior levels, often drive many innovator companies to the point of self-destruction.
Corporate boards and investor demands generate a tremendous drive to provide these innovative drug products, but often with little regard for historic checkpoints and feedback, which are viewed as slowing the development process. But ultimately, this company stance has the potential to fail at multiple levels due to lack of proper assessment of the probability of failure or the means to fail successfully.
To this end, Inpernum is partnering with Atlee Risk Consulting, LLC in order to provide a new organizational risk assessment process, to pharma and biotech clients through iterative learning and drafting of concise plans that will define critical-path activities, set milestones, integrate timelines across all internal and external functional areas, assess medical/clinical program feasibility, and set regulatory strategy. Inpernum calls this far-reaching concept “Development Assurity,” which we define as security against broad losses or damage that a company may incur as part of the drug-development process. Our team will work directly with client leadership on how to assess those processes that may lead to failure, how to improve organizational systems to reduce the likelihood of failure, and then to detail how to assure that if failure does occur, the organization will have future opportunities to fuel improvements and provide openings for great innovation. What is unique is that each client will self-determine and define what a successful failure is, and client leadership will set in place a means to develop, monitor, and alter/evolve processes as ongoing collection of data and information are acquired throughout the drug development process.
So Inpernum and Atlee Risk Consulting, are looking to provide a clear solution and implementation process for companies working in this heavily regulated pharmaceutical environment and looking to achieve both drug-development and corporate success, even while facing a high potential for failure.