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StrategyAug 17, 2020

Leveraging Times of Change to Reassess Content Approval Processes in Regulated Industries

Sayli Kulkarni

Every industry feels the need to communicate clearly and quickly with customers. However, companies in regulated industries such as Pharmaceuticals and Financial Services must deal with additional processes that make this even more challenging. The Pharma industry in particular must follow rigorous processes to approve and distribute marketing messages. While digital technologies provide additional avenues for communications, these too must follow time-consuming regulatory processes. And now that the global pandemic is forcing companies to react quickly to changing circumstances in the economy and public health, some of these regulatory processes are facing a tipping point.

digital acceleration in the pharmaceutical industry

In this article, we will specifically look at the Pharmaceutical industry to see how they can overcome these burdens and speed up approvals for faster time-to-market. The slide below is from the June 2020 Veeva Summit. Veeva is a market leader in regulatory and CRM software for the Pharma and Life Sciences industry. As we can see, the quantity and necessity of digital communications are only accelerating during the pandemic.

Figure 1

The data clearly indicates that patients and Health Care Professionals (HCP’s) have changed their behavior to be more digital-friendly. In most industries this is just business-as-usual. However, the Pharmaceutical industry faces additional hurdles that can limit the effectiveness of such communications.

the medical-legal-regulatory process

The biggest bottleneck for all Life Science companies is the Medical-Legal-Regulatory (MLR) process. Every piece of marketing content that is published by a Pharma company has to be MLR-reviewed, and FDA-approved.  This could be a webpage, an email, an IVA (Interactive Visual Aid), or a printed brochure.  And in the COVID-19 economy, it is even more critical to get content quickly out to target audiences. Pharma companies cannot afford to take weeks to put relevant content out to their patients and HCP’s. This is not just a competitive advantage question – it is a question of survival in this rapidly evolving digital environment.

cresanda case study

Let’s take an example of a piece of content that needs to be published as quickly as possible after some research results have been uncovered. Cresanda is a fictional weight loss prescription drug sold by a Pharma company. After one year of research and clinical trials with patients, they have concluded that the majority of patients achieved a clinically meaningful weight loss of ≥5% with Cresanda.

Figure 2

The marketing department wants to share the content in Figure 2 with their HCP's and patients through various channels like websites, emails, IVAs, and brochures. In today’s world, the MLR team will only approve the content when presented as distinct and separate submissions.

So, they would have a different submission for IVA’s, a webpage, and an email even though they all rely on the same chart. This causes two issues: first, it increases the cost per piece of content, and second, it also hinders coordinated communications. In some cases, patients will get the research information before the HCP’s have seen it because the webpage was approved before the IVA!

an opportunity for growth

The pandemic has two major consequences in this environment. Companies need to publish content rapidly through various channels, which also opens a door for Pharma’s to take a closer look at the MLR process that is archaic and has not changed with the times. Pharma’s will have to make some fundamental changes in the way they think about regulatory approval, and that alone will create a quantum change in the speed to market for relevant content.

So how can companies go about making this change? One area where the regulatory process can be accelerated is through approvals of modular content. Today, Pharmaceutical companies upload each channel-specific piece of content for individual review. As mentioned before, this causes a variety of problems for effective communication. With the concept of modular content, Pharma companies can upload one core component of content for approval, such as the graph above. Then, when they need to leverage that asset for channel-specific communications, they can re-upload the materials while specifying that the critical data has already been approved. While this may seem like a straightforward change, it can have big impacts in the industry.

wide ranging application

This article showcases an example in the Pharma industry, but the principles apply to all other regulated industries like Financial Services, Insurance, and Healthcare as well. While systems such as the regulatory process have long been bottlenecks for these industries, the necessities of communicating during an ongoing crisis force change like this.

To learn more about Credera’s process improvement experience and offerings, please contact us at findoutmore@credera.com.