By Terri Hiskey-Oracle on Jan 28, 2014
Kalypso is one of our PLM Premier Sponsors of the 2014 Oracle Value Chain Summit. Attending the Summit? Be sure to visit Kalypso at Booth #113 and learn more about what Kalypso has to offer in the guest blog below authored by Horst Groesser, Partner, Kalypso.
With 2014 underway, biopharma companies continue to face a variety of industry factors: patent expirations, generic competition and pricing pressure from payers that are demanding clearer demonstration of product value. The complexity that results from the drug development process, mergers and acquisitions, and ever-changing and increasing regulatory compliance requirements only adds to the list of challenges.
But the biggest challenge for the biopharma industry continues to be driving sustainable innovation and successfully commercializing new products. To address this, companies have tried various strategies including mergers and acquisitions, scientific partnering and collaborations, and expansion into emerging markets, but have yet to realize their growth targets.
The answer is yes, but not without a caveat, of course. Innovation in biopharma is often understood as scientific breakthroughs in basic research and discovery. Biopharma companies must change this mindset. While the discovery of new molecular entities is the lifeline for companies, true innovation is not just about the science – it also requires transforming those breakthrough discoveries into marketable products and successfully launching them in highly regulated markets.
Product lifecycle management (PLM) has transformed how products are developed and commercialized in many industries over the last two decades. Can it do the same for biopharma?
Based on our experience working with other regulated, complex industries, we believe that product lifecycle management (PLM) can be instrumental in driving innovation in biopharma.
PLM can help biopharma companies (1) effectively manage product data from discovery through commercialization, and (2) efficiently register and launch new products in multiple markets while assuring regulatory compliance at every stage of the process. PLM can also enable three core capabilities that enhance innovation performance:
- Visibility – Scientists with better visibility into one another’s work improve the chances of “connecting the dots.” Better visibility helps management set priorities and ensure resources are allocated in line with those priorities. It can also smooth the transition from research to manufacturing and commercialization.
- Traceability – Better traceability improves the organization’s ability to maintain compliance and address regulatory inquiries. Traceability is at the center of addressing the complexity challenge. Consider how much faster a new drug product could be launched in multiple countries in various strengths or forms if product data was globally accessible in an integrated repository for core product and product packaging data. Such a central repository would allow accelerated changes to the core product and its packaging while maintaining compliance in different regional markets. It also enables improved reuse of knowledge assets by allowing product development teams to retrace development decisions made in the past.
- Collaboration – Drug development is a complex, cross-functional endeavor. Increasingly, it involves partnering with researchers from many different organizations. Better collaboration enables a richer understanding of scientific challenges and more innovative product solutions.
Visibility, traceability and collaboration can have a significant impact on business processes such as regulatory submission and product launches, regulatory compliance, product packaging and labeling, and portfolio prioritization – all keys for driving product innovation success in biopharma.
What does the PLM platform look like for biopharma?
To fully describe how PLM can help enable these capabilities, we first defined the PLM platform for the biopharma industry here. Then, we explored how PLM can support a compliant product dataset; facilitate change control, packaging, labeling and artwork changes; and manage new product submissions and international registrations in a series of white papers and publications.
To help biopharma companies get started on their PLM journeys, we also offer and implement Oracle Value Chain capabilities and accelerator solutions that enable them to successfully respond to the industry challenges and sharpen their competitive edge, including:
- Compliant product data record
- Product change control
- International product registrations
- Packaging and artwork management
- Quality management