Becoming Nimble - It's no secret that Big Pharma is facing some of the biggest changes in the history of the industry. The looming patent cliff is now forcing companies to reexamine the way they do business from the ground up: According to IDC Health Insights, between now and 2012, 19 of the industry's blockbuster drugs will come off patent, for approximately $60 billion in annual industry revenue. A "one size fits all" approach to drug development is outdated; the companies that are coming out on top in the pharma industry are the ones who can react quickly and with agility to their customers' needs.

The multinational technology company Oracle works "up front" with its customers when developing software, and within their close work with pharma companies, they learned that the top management do indeed realize that there is a significant need for them to completely change the way they are developing, said Denis Senpere, vice president of Product Lifecycle Management Solutions EMEA at Oracle. The company said the pharma industry needs to improve its paradigm for innovation in three different ways: by forming orchestrated drug-development networks; by supporting a more integrated R&D and regulatory process; and doing all of this within the framework of a globalized, scalable and secure supply chain.

"Ironically," Senpere said, "we saw this same situation 20 years ago in the automobile industry."

So why is the pharma industry lagging behind? Senpere said its due in part to the huge amounts of money that pharma companies were able to bring in through their blockbuster drugs over the last decades. However, he said the trends should have been visible back then, but in light of the profits that were being made, pharma companies placed more priority on acquisitions.

"The wake-up call came about three years ago," he said. And while companies are ready to "clean house," they are struggling to find the root cause of their woes and how to go about transforming their businesses. Senpere said many pharma companies wrongly believe they have departmental issues.

"They don't have department issues," he said. "They have enterprise issues."

‘Siloization'

Senpere said the most common structure that can be found within pharma companies can be likened to silos, meaning every department works independently for themselves without much consultation or contact with other units.

"If you have different silos for clinical trials, R&D, commercialization, this leads to a proliferation of new processes that have never been consolidated within an enterprise management system," he said.

This leads to gaps throughout the entire process chain. The formation of the products and processes that go into developing drugs are exploding, as well as the knowledge capture that goes into behind these products and processes.

"But when you explode and have no infrastructure to control information, you have a massive proliferation of problems," Senpere said.

"That means the situation today has become absolutely abysmal in many companies," he said, citing a myriad pharma companies who have been fined for compliance issues. "These companies would've been better served by investing the money into internal process optimization systems."

From Lab to Launch

This is where Oracle comes in with its product lifecycle management system Oracle Agile PLM for Pharma that can help all players in the industry - large, small and all those in between - to more effectively develop products; eliminate waste; create a secure ecosystem of networked partners; and enable Quality by Design (QbD) practices. The software system, which can be tailored to fit the specific needs of a company, helps to eliminate the siloization and makes communication possible across all parts of the production chain - from lab to launch. The software touches many different functions across the chain, too: R&D; quality; production; clinical trials; packaging; regulatory affairs; and marketing.

In order to develop software to assist with this transition within the pharma industry, Oracle worked together with 15 leading industry players - members of the Oracle Pharmaceutical Strategic Council - to identify the seven common enabling elements needed for change. The Agile PLM is based on these elements:

1. Drug development portfolio management: This enables the user to enforce critical program
deliverables and regulatory requirements by improving drug development execution, program
management and cross function collaboration.

2. Comprehensive drug development records: Structured drug development records facilitate the re-use of Common Technical Documents (CTD) by capturing complex multi-dimensional data from material, equipment, process/recipes and analytical methods in one system.

3. Efficient clinical supply management: This enables faster clinical trials by allowing users to easily allocate materials and make equipment reservations as well as the efficient and effective management of recipe variations during the all clinical trials phases.

4. Faster technology transfer: The software facilitates the scale-up to commercial drug production
volumes simplifying the analysis of the entire drug product development value chain, from suppliers to materials, equipment and processes.

5. Integrated quality and risk management: This assists the user in building quality into the development from the beginning and offers a comprehensive enterprise quality management solution that supports QbD and other quality programs. This results in faster and more efficient regulatory submissions.

6. Integrated packaging and label management: This is to improve the regulatory integrity
of commercial content by providing a global repository for all packaging components, digital
assets and marketing collateral that are linked back to development evidence.

7. Global product registration: This makes it possible to create a single product registry to maintain the
content required to support regulatory submissions and product rollout.

Satisfied Customers

Oracle boasts over 170 customers in life sciences, making it the enterprise PLM leader in that market. Companies such as Eli Lilly, Bayer, GlaxoSmithKline and Abbott have already implemented parts of the Agile PLM - part of the flexibility of the software is that not all seven elements need to be put into place at the same time, giving users the possibility to start with the area of their business where the need is most dire.

Wolfram von Ehren likes to use Bayer as an example of a successful user of the Agile PLM for Pharmaceutical. Von Ehren is a strategy and operations consultant at Deloitte, a professional services organization who is working together with Oracle.

"In our work with Bayer over the last 10-15 years, they have always been the first to try out new technologies and approaches. Part of their success is that they are willing to take the risk to be one of the first, but then they are also one of the first to reap the benefits."

After implementing several elements of the Agile PLM, Bayer HealthCare was able to reduce cycle times for packaging by one third; saw a 50% reduction in packaging/labeling errors and a 50% reduction in rework costs; is able to consistently track ingredient data per country; has seen improvement in quality and compliance; and has won overall global viability of data.

Senpere, however, stresses that Oracle's Agile PLM is not something companies can just download in order to make their enterprise problems disappear.

"If someone wants to change their whole company, then they will apply all seven initiatives over time of five to 10 years, depending on their size," Senpere said. "Transformation is a journey."

Members of Oracle's Agile Pharma PLM Strategy Council
Bayer
Eli Lilly
Glaxosmithkline
Novartis
Boehringer Ingelheim
Invitrogen
Merck & Co
Abbott Diabetes Care
Pfizer
Ranbaxy
Dr. Reddy's
Takeda
GE Medical Systems
Symyx
USDM
Sierra Atlantic