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.

DOWNLOAD WHITE PAPER

You may also be interested in…

  • China Pharma Market Access

China Pharma Market Access (CPMA)

Since the establishment of the China National Medical Insurance Bureau in 2018, the goal has been to strengthen public health and medical service levels, achieve maximum utilisation of the national medical insurance fund, and to enhance the strategic purchasing capability of medical insurance funds. Significant tools in achieving this are the National Reimbursement Drug List (NRDL) and drug Volume Based Procurement (VBP), which have opened a new chapter in China’s medical reform. Meanwhile, the new drug registration process is improved, simplified, and accelerated.

  • George Gu attends DIA meeting in Suzhou 2023

George Gu attends DIA meeting in Suzhou

George Gu, Principal and Head of China at Deallus, recently attended the 2023 DIA China Annual Conference where he participated in an expert panel discussion on "Post-Marketing Medical Activities Based on Specialty Drug Pharmacy Management Platform".

  • Medical Insights to Maximise Product Value

Maximise product value through Medical Insights

Medical Insights is emerging as a transformative organisational capability within Medical Affairs that aims to capture real-world insights through medical channels and use them to maximise product and portfolio value.

Deallus sponsoring and speaking at the Pharma CI EU Conference

We are excited to be sponsoring and speaking at the Pharma CI EU conference, held in Rome on 30-31 March 2023. Julie Munch Khan, COO, and Stephen Small, Senior Principal at Deallus will be joining other Competitive Intelligence experts across Pharma, Biotech and Medical Devices.