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
- Identify specific transformation requirements for prioritized initiatives
- Define a deployment plan to manage the transformation of these key objectives
- Formulate a business case to prioritize on initiatives which are most critical to address·
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. In 2014, Dassault Systems introduced
BIOVIA by combining Accelrys acquisition and BioPLM, and in 2010 Oracle introduces
PLM function /features in the Agile PLM platform.
One of few key things to look out from a PLM vendor perspective should be:
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.
#PLM #PharmaPLM # SMAC # PI #NPI
#PLM #PharmaPLM # SMAC # PI #NPI
