Competitive Intelligence in an Agile World
Adapting intelligence functions to an increasingly complex pharma landscape
This thought piece explores the concept of agile working for the pharma world, delving into the opportunities and challenges that arise for CI teams and managers as working environments adapt to find success in a more dynamic, uncertain, and fast-paced environment.
If agile is the answer, what is the question?
At the heart of pharma stands the monolith that is the clinical trial protocol: three phases; strict regulations governing every aspect of each; enormous quantities of clinical study report data to be captured and translated into coherence. This is the template that pharmaceutical companies have incorporated into every aspect of their decision-making process. Upon these three cascading phased tiers are all pharma workflow decisions made. This structure is immutable, and pharma companies monkey with it at their peril.
Except… recent guidance from the FDA practically begs them to monkey with it. Consider the September 2018 guidance for industry, Adaptive Designs for Clinical Trials of Drugs and Biologics:
“Adaptive designs can provide a variety of advantages over non-adaptive designs. These advantages arise from the fundamental property of clinical trials with an adaptive design: they allow the trial to adjust to information that was not available when the trial began.”1
To anyone familiar with the plethora of modern workflow and productivity systems, that last sentence – allowing the trial to adjust to information not available at the beginning – can only mean one thing:
Somebody at the FDA knows – and cares – about agile.
As COVID-19 continues to disrupt normalcy across the globe, China is responding with innovation in online health delivery and telemedicine. How has China encouraged telemedicine uptake? What are the factors contributing to China’s relatively quick utilization of telemedicine in the face of COVID-19? And what learnings can we gain from taking a closer look? We explore these questions in our latest addition to our COVID-19+Pharma Series.
COVID-19 is throwing a wrench in years’ worth of launch planning, introducing complications and delays into the regulatory process and severely constricting promotional and educational opportunities for new products. How is the pharmaceutical industry responding to these changes in well-laid plans? How are regulatory bodies responding? We consider the potential impact of the pandemic on launch timing and strategy here.
As the impact of COVID-19 pandemic continues to expand globally, pharmaceutical and biotech players are beginning to feel the disruptive effects of the outbreak. New clinical trials will be significantly delayed as companies continue to face challenges arising from COVID-19, from potential patient quarantines, to site closures, travel limitations or interruptions to the supply chain for new investigational products.
Deallus is excited to announce that Jenny Cummins will be partnering with Deallus as a Strategic Advisor. Jenny’s experience in formulating strategic direction within and outside of pharmaceutical companies is something we are excited to add to our panel of strategic advisors. Our clients will benefit from her expertise in the healthcare sector as well as her impressive leadership, communication, and facilitation skills.