Heather Oebel, NPI enterprise solutions manager at Winshuttle examines the changing drug landscape and why pharmaceutical companies need to go digital with their data.
Data
The last 20 years have seen rapid development of personalised medication, higher levels of public engagement with health issues and increased demand for safe over-the-counter drugs.
New market dynamics are causing an explosion in demand for product variations and fierce competition as small, agile brands enter the market. Pharmaceutical manufacturers risk becoming irrelevant if they do not keep up with the race to market while consumers will miss out on low prices if monopolies continue to dominate for newly introduced products.
Unfortunately for large pharmaceutical manufacturers, introducing new products to market is a complicated process. Extensive safety measures, new legislation or even a product rebrand, can lead to a product being taken off the shelf and reintroduced in a new package, perhaps without any need to change the product inside.
In international markets where each country adheres to its equivalent to the Medicines and Healthcare products Regulatory Agency (MHRA), product and packaging requirements are likely to differ.
In production terms, each new product variant, even a simple packaging change, kicks off what can be a lengthy launch or new product introduction (NPI) process. For large manufacturers who run their business on an SAP Enterprise Resource Planning (ERP) system, hundreds of data points may be collected for each new product.
We recently surveyed manufacturing professionals from around the globe to understand the challenges with their NPI processes. We found that over half are hindered with slow, manual data collection processes. We also discovered that 75% are under pressure to speed up launches—no surprise given the increasingly intense market competition in the sector.
A combination of rapidly changing market dynamics and slow, manual launch processes may cause pharmaceutical companies to “hedge their bets” and start the launch process for over-the-counter (OTC) product variations that may never get released. This involves collecting as much data as possible upfront, and often guessing at some data elements to move the process along.
This game of chance can have a couple of major negative consequences. Firstly, time and resources are wasted if a product is never released, and secondly, placeholder data is often not replaced with the right data, leading to possibly dangerous and costly downstream consequences, such as inaccurate dosage instructions or the omission of allergens.
Digitising data collection and entry can reduce launch cycles by 50% or more, reducing or eliminating the need to start launches for unapproved products. Another benefit to a digitised launch process is the ability to build in data guardrails and approval processes that improve data quality and minimise errors.
In today’s fast-paced OTC markets, large pharmaceutical manufacturers must balance speed and agility with strict regulatory guidelines and product quality standards. Digitising manual launch processes can be an important step towards meeting these important goals.