PLM the missing “Substance” for Pharma Industry

Product Lifecycle Management (PLM) has been around for over two decade now. Automotive, discrete manufacturing were the initial adopters, followed by CPG industries & Medical devices which embarked on PLM in the last decade. Pharma industry, so far, has been the slow adopter of PLM and only after only after International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Steering committee approved ICH Q12 “Lifecycle Management” in 2014, the focus on PLM has been increased.

As Pharma Industry being one of the last to embark on PLM Business transformation, they can leverage a lot lessons learnt from other industries that have implemented PLM and reaping the benefits.

However, PLM focus has also challenged pharma status quo considering the fact that pharma lifecycle is a lengthy and complex process. While on one side some pharma players are debating the true value realization from PLM, there are others who have envisaged the long term value, a formal system like PLM platform could bring to their information management. Also, pharma being one of last, the industry can see how to leverage “SMAC” (Social, Mobile, Analytics and Cloud) and leap towards “Digital PLM”.

The good news is that PLM solution could help manage the “lab to launch” drug development process thus bringing the standardization and harmonization across multi disciplines. The most critical piece to manage is the clinical trial process and commercialization process and effective management of ‘chains of custody” is pivotal with multiple hand-shakes and hands-off between various collaborative parties.

AMR reported “Lack of precise coordination of the clinical trial inventory within the trial management plan is disruptive, adding considerable cost and time to this phase of product development. Consequently, key clinical supplies metrics routinely result in less than 25% of their targeted performance objectives.”

Hence, an opportunity exists for leading companies looking for ways to transform their business that lead to profitability and growth. Some of the key considerations while embarking on the PLM business transformation should be:

• Model the current R&D process and how it impacts clinical supplies
• Build common development model for the enterprise and identify key challenges
• Formulate a business case to prioritize on initiatives which are most critical to address
• Identify specific transformation requirements for prioritized initiatives
• Define a deployment plan to manage the transformation of these key objectives

This approach also provides the foundation for “think big - start small – scale fast” for enterprise PLM transformation.

One of biggest challenges organization will face is selecting the right PLM platform as there are fewer vendors that focus on PLM for Pharma. One of few key things to look out from a PLM vendor perspective should be:

• Product vendor’s roadmap with respect industry
• Vendor’s roadmap for “SMAC” (Social, Mobile, Analytics & Cloud)
• How the vendor plans to address company and industry specific gaps / functions
• Ease of Use of system

You can reach more details about PLM vendor selection in the article.