In my previous blog, I discussed some of the data challenges pharmaceutical companies face during the clinical phase of drug and product development. After a drug has been approved for availability in the market, manufacturing and supply chain requirements come into focus and that phase too can be plagued with integration and data management issues.
With the increased focus on product development and R&D, we are seeing a significant shift in what pharma companies focus on as their core competencies and how they address changes to improve their time to market. Trends include: selling assets (business lines, manufacturing plants, etc.) to fund new drug development and the need to retool their facilities much more frequently than in the past to address the needs of personalized medicine, for instance. When combined with other factors such as the Affordable Care Act (ACA), many pharma companies are outsourcing to Contract Manufacturing Organizations (CMOs).
CMOs are becoming increasingly popular as they focus on manufacturing specific drugs for a portfolio of clients. However, each CMO has a unique focus that frequently complicates the business relationship between CMOs and their pharma clients. While there are many issues, here’s one example.
When a company decides to outsource the manufacturing of a drug, the firm no longer has the supply chain visibility that it would have with in-house manufacturing. Normally, a firm would have complete “source-to-settle” visibility from the sourcing of raw materials all the way through to the finished product. Data that would typically be entered into the internal system is now spread out across many different partners. So centralized visibility of information about drug manufacturing across multiple levels and firms is a key requirement. And as you can imagine, integration of data is a key requirement for success.
We’re actually presenting information about this in an upcoming webinar, “Pharma IBPM Done right – A Game Changing Approach” with our partners from Activ Technologies and Operations, Transformation & Transition Specialists (OTTS) on July 26 at 1pm EST. If you can make it, I think you will find it educational.
Learning about real case studies can also be helpful. Here’s one where ”Lupin Solves Paper Metastasis using Liaison Healthcare’s Cloud-based Data Integration and Harmonization”
As the complexity of developing and manufacturing new drugs grows with time, so will the challenge of managing FDA compliant data. I’m interested to hear what our community has experienced:
- What challenges are you facing with drug manufacturing data?
- How has the rise of CMOs affected your organization?
- What steps have you taken to address new challenges?
Until next time,
Gary Palgon, VP Healthcare and Life Sciences Solutions