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.
Innovation in the biopharma industry is not going to get
any easier, or any less complex. Despite the challenges, is there hope for biopharma
companies to drive sustainable growth through innovation?
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.
– 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.
– 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:
If you are interested in learning
more about driving innovation with PLM, visit Kalypso at booth #113 at Oracle Value Chain Summit (VCS) 2014.
- Compliant product data record
- Product change control
- International product registrations
- Packaging and artwork management
- Quality management