The talk was all about convergence and mashups at this week's annual Rockwell Automation Fair in Nashville. In case you haven't heard, a mashup is a web application that combines data from more than one source into a single integrated tool--at least that's how Wikipedia defines it.

George Laszlo has been keeping tabs on the technology offerings in his blog.  For access to this very handy list, a work-in-progress, read on.  Also note posts on open-source code (technology is ready, but is the industry ready for it, he asks) and the changing role of the Pharma CIO.

A storm, complete with hail, thunder and generous amounts of lightning, appeared to follow me through Connecticut and Rhode Island as I drove to Boston on Wednesday for the DIA meeting.  Didn't make it until almost 4 PM, only to have the storm break out in Boston at 6 PM in all its glory.  Although I'd missed the presentation on global regulatory harmonization (which included Japan's top pharma regulatory official), the few hours were very well spent.

Flagging a cab was quite difficult, with very long lines at the convention center, so we found a kindly trolley car driver who took us to one appointment, and gave us an impromptu tour of the North Side along the way. 

One highlight of the trip was a visit with two top executives with Microsoft's Life Sciences division (in order of their appearance: Les Jordan, Industry Technology Strategist and Michael Naimoli, Director) to learn more about SharePoint, its manufacturing and drug development platforms, and a new clinical trial data management platform developed by TranSenda (whose CEO, Robert Webber explains the system) but powered by Office.  For the die-hard Microsoft fans, here's a brief audio clip (which isn't on our web site yet)

AMS

At a meeting at DIA in Boston yesterday, Mike Svinte, President of Global Life Sciences at IBM provided a sneak peek and insights into a new report probing CEO challenges and concerns and their implications. The report, which is due to be released next month, will distill interviews with more than 1,100 CEOs from around the world, 40 of them heading life sciences companies, including mid-sized companies, in North America, Europe and Asia. Not that their individual names can or will be disclosed, but the CEO’s appeared very willing to engage in open dialogue and creative discussion of issues. "The interviews were a bit like therapy for some,” Svinte said.

Nearly a quarter of the life sciences CEOs interviewed admit that they have had no, or only minimal success at managing change within their organizations.  At the same time, IBM analysts found, they are hungry for change.  The study suggests that CEOs need to “seed” their organizations with challenges and to gain inspiration by examples from other industries that have already undergone transformation. They will then need to convince their companies that change is necessary, and cultivate enthusiasm for it

IBM’s research shows that life sciences companies’ financial performance tends to be better when CEOs encourage change and invest in new areas, Svinte said. The questions are where to invest and why, and how will pharma’s industry model and business model need to change for the future. Will pharma companies be the "dinosaurs" predicted years ago---holding companies that outsource all key functions?

Not enough CEO’s have actively wrestled with these questions, the survey suggests.

Talent shortages top the list of their concerns---63% of pharma CEOs named this the major problem (compared with 48% in other industries. Regulatory issues, as one might expect, came in second (53% vs. 45% for other industries).

One factor driving change, CEO respondents say, is a better informed consumer, who demands more as he or she pays more."We’re experiencing increased pressure related to environmental initiatives,” wrote one anonymous CEO from
North America.“Transparency is being driven by the government as well as by consumers. There is great risk in not focusing on rising consumer expectations."

As pharma moves from the old multinational model to a globally integrated one, Svinte said, issues of global regulation, intellectual property protection and talent shortages in India, China and other regions of the world may pose risk but more CEO's say they are investing there.

Three quarters of pharma CEOs are pursuing innovations in business models. More than half are focused on enterprise model innovation or reconfiguring the breakdown between what work is done inhouse and what is outsourced. Only 17% were focused on new industry model innovations, including those that will involve diagnostics and targeted or personalized medicine, and will require new revenue and enterprise models.  Among blue sky possibilities discussed was the concept of consumers paying for a therapy only if it worked.  (Ha! Don’t hold your breath waiting for this to happen – brief editorial interjection)

62% of the life sciences CEOs surveyed also see rising expectations of corporate social responsibility as a positive, rather than a negative one. But nearly a quarter of respondents don’t expect such work to have any impact on their corporate bottom lines. IBM analysts suspect that new dimensions of corporate responsibility may not yet have reached pharma CEOs’ radar screens.Pharma CEO’s may recognize the drug industry’s duty to “do no harm,” but they may not be able to measure the footprint that pharma has on society, analysts suggest, pointing to the issue of drug residues in the world’s municipal water supplies.

Knowledge management and the drive to turn data into information are becoming more important to a growing number of CEOs, the study found, since these establish a framework for more collaboration and cross-functional product development.

Manufacturing and supply chain management are becoming a priority for more CEO’s, Svinte said, although they were not probed in depth, by themselves, in this survey.

Among other subjects that came up at this discussion was IBM’s patient-centered healthcare project,

Also talked about was the MidEast Consortium on Infectious Diseases, a program underway in the
Middle East that is using supercomputers to predict future pandemics and the potential impact of changes within patient population.

Look for more detailed reporting on the research and trends in future issues of our magazine and online.

And now for something completely different (for any opera fans or Italophiles out there).

AMS

Microsoft's Life Sciences Group has certainly grown, from 5 people when it was established seven years ago to 800 people today. The SharePoint platform, which allows users to customize solutions without having to play programmer is finding increased acceptance. Among new developments:

At the DIA conference in Boston this week, TranSenda International LLC launched the beta of Office Smart Clinical Trials OSCT) Manager, incorporating SharePoint, which allows clinical trial professionals to use Microsoft Office tools, eliminating some of the drudgery of data entry and allowing remote, but secure access. "When conducting clinical trials, life sciences professionals often struggle with toggling in and out of different systems to input their data, and there's an ongoing challenge of knowing which spreadsheet is the 'single version of the truth," said Michael Naimoli US life sciences industry director, in the official press release. Mr. Naimoli comes, not from an IT background but from the industry.

As Robert Webber, CEO of TranSenda International, developer of the software, explains in a recent white paper, the biggest challenges are:

More on some specifics soon.

In the meantime, Microsoft announced winners of the Pharma and Life Sciences Innovation Award. They are :

Discovery and Product Innovation: AstraZeneca and Thermo Fisher Scientific Inc. , for harmonizing disparate processes to record, track and manage a growing number of requests for compound screening. AstraZeneca implemented Thermo Scientific Nautilus Laboratory Information Management Systems (LIMS) to centralize biochemical screenings, map laboratory workflows and dramatically drive efficiency through superior data management. Built on Microsoft’s Visual Studio .NET, Thermo Scientific Nautilus LIMS helped coordinate global requests, automate workflows and standardize screening. Within six months of the deployment, AstraZeneca reportedly realized a 180 percent efficiency gain across its laboratories from the centralized screening process.

Sales and Marketing: Sanofi-Aventis and Brimstone are delivering real-time product information and clinical and patient support materials to communicate with physicians and other stakeholders across multiple channels.

Clinical Development: The Scripps Research Institute and InterKnowlogy for a customized solution based on .NET Framework 3.0, SharePoint and Windows Vista, to display cellular, molecular and atomic levels in 2-D and 3-D, while providing tools for annotations. The result, judges say, was a newfound ability to link multiple kinds of data to an image, making it easier and faster to send information from experiments across the organization. Researchers now spend less time searching for data and more time developing potential treatment solutions.

QC and drug safety demand quick information access, but the drug industy still has some issues in managing data, the precursor to managing knowledge.  

A recent survey of 1000 professionals (228 of them working for the drug industry) by the software firm, QKnow Technologies, found that retrieving information was a major problem across all industries, but particularly in pharma.

71% of pharma respondents say they keep critical information mainly in electronic files. However, an equal number  find that searching hard drives/network drives for electronic documents and emails that they have "read but cannot find" hurts their productivity at work. This was the largest percentage compared to all other industries including Financial (57%), Insurance (56%) and manufacturing (39%).

11% of the pharmaceutical professionals found themselves most frustrated when trying to locate emails, attachments and documents they need to perform daily tasks. This was the largest percentage compared to all other industries including Financial (5%), Insurance (9%) and Manufacturing (3%).

Out of all the industries, QKnow found that professionals in the pharmaceutical industry spent more time searching for their misplaced and lost emails and electronic documents – 14% spent more than 2 hrs (per day) compared to 11% in Financial and Insurance and 8% in Manufacturing.

Makes one wonder what the numbers for FDA, which is modernizing its IT infrastructure, would be.. (Or, for that matter, for those of us working in the publishing industry?)

AMS

The three groups are still disconnected at many drug companies today, as we learned in a very informal survey and touched on in a very brief article recently (click here to read , with insights from Gawayne Mahboubian-Jones (PRODUCT, not Process Development Manager as identified in the article, at Optimal Automation LLP....we need some PAT for editorial processes, it seems) Jacobs Engineering's Scott Sommer and Conformia's Anjali Kataria.

Rockwell Automation's recent White Paper analyzed the situation with the memorable title "Come Together."

Charlie Gifford, who established the ISA 95 integration best practices working group, has a more to-the-point suggestion: "Grow Up!"

He describes the situation that exists at many drug manufacturing facilities in a recent column and addresses them in his new blog, "Hitchhiking Through Manufacturing." One recent post asks why end user groups aren't more involved in developing standards. This leaves "their best interests" to vendors, and, as Scott Sommer will reveal at Interphex, they aren't always being served.

Of course, few people have the time or the inclination to get involved, but, it could be that, if they work for pharma companies, they may not even know what 88 and 95 are, if they're like 30+% of respondents to our survey last year, or, if they're like the similarly sized chunk of respondents who found that they weren't important).

Below, an excerpt from the full op-ed. (Does it remind you of anything you're seeing at your workplace?)

This is all by way of introduction to today’s subject—the bloody war zone in manufacturing operations management (MOM) systems. These applications sit between corporate IT (top management and the folks who crunch the financial and planning numbers) and process control systems (performing the role of diplomat, facilitator and translator for the plant’s workflow. They translate operations data into triggers and alerts, and business process and financial metrics). In the other direction, MOM systems translate enterprise work orders and planning into product definitions for detailed scheduling, work dispatching, work execution and process control. The product definition in this case is manufacturing workflow in the form of discrete routes and batch recipes.

This MOM bidirectional translation is much harder and expensive than it needs to be because of culture and system language differences. The language gap between the financial side and plant process side of the business is so wide that it is the #1 barrier to successful globalization and transitioning to adaptable manufacturing for North American manufacturers. The cultural problem cannot be solved until the language barrier is addressed.

The problem is plants have been and are viewed as cost centers by businesses, which consequently cause finance and planners to run plants in a bare-bones manner—a bad practice, since, as the manufacturing form must adapt to global pull make-to-order supply chains, no money is invested in plants unless it’s less than 12 months to ROI.

Furthermore, most plants currently run disparate/stand-alone operations IT or paper systems in production, quality, inventory and maintenance, all of which apply distinct languages in their systems, requiring paper-based workflow transactions between departments. That makes for lots of paper calling one item by many names—not to mention much non-value added work and error creation.

No common language exists even at the plant level. So when the business folks, who speak the language of accounting ledgers and material planning, want information exchange from these disparate systems, the Sandbox War ensues. The folks on the business side say, “Give me real-time visibility to work order and financial activity-based costing in my language. (I pay the bills!)” Then the plant person says (not so loudly), “I will only give you visibility to my operations in a black-box format because corporate IT people have no clue about our daily firefights, and we do not need their uninformed opinions.”

Neither side realizes how large and complex job it is to integrate and translate between the plant and business in real-time. So the walls go up, and turf and ego wars erupt, leading to bad compromises with which no one is happy...

Both sides must now grow up and work together, since the 21st-century plant and its role have changed dramatically. The plant is now the dynamic, adaptable asset in a global distributed supply-chain network. Real-time visibility of capacity and capabilities are essential to global competitiveness. The plant is now in a pull, not push, role in the global supply chain. More products are make-to-order, not make-to-stock.

Manufacturing systems must be built to support adaptable business and workflow processes. To do this, we must make the business case to corporate IT, business and plant management that they have apply the manufacturing operation standards such as ISA-88/95, OMAC, OAGIS, MIMOSA and OPC across the enterprise in a simple form to lower the life cost of integrated systems and make those systems adaptable to business process. This business case has not been make at the CIO and CFO level of most American manufacturers, as it has been in Europe and Asia. Common manufacturing language is the barrier to 21st-century success for American manufacturing...

 Installment 6

Wyeth Pharmaceuticals has been through several transformations. Over the past few years, the company has quietly emphasized outsourcing operations, but established robust quality management practices for its contract partners and suppliers. (Click here and here (scroll down to the article on ICE Team for more on these efforts). 

Wyeth has also built up its pipeline in Japan and Asia Pacific, and, after some struggles, including a 483 for its facility in Guayama, Puerto Rico last year (since resolved), the company is striving to build a culture of operational excellence and compliance. 

With its Prevnar vaccine, one of several "Class of 1999" blockbusters, the company faced production, GMP training and compliance problems, culminating in a Consent Decree with FDA in October, 2000.

Charles Portwood, President of Tech Ops and Product Supply, who joined Wyeth during these challenging years, took ISPE's audience through some of this history, and described the company's Operational Excellence initiatives and the impact they are having, as well as Wyeth's new standardized IT platform,  DART, which he modestly called the "Star Wars of pharmaceutical manufacturing." 

Wyeth's now embarking on a new initiative to improve supply chain management (more on that in a brief interview with Mr. Portwood). He attributes Wyeth's success so far in reshaping its priorities to the vision and strategy of CEO-elect Bernard Poussot (photo), who sharpened the company's focus and redefined a new structure based on its key product groups: small molecules, large molecules, vaccines and nutritionals 

His keynote speech noted the dramatic change in communications and information management that has occurred within the past few decades. Unlike the media and retail industries, the pharmaceutical industry  isn't reaping the benefits of data access, Mr. Portwood suggested. He would like to change that. 

Wyeth sees leveraging integrated standards as the way to go.  This seemed a rather nebulous IT phrase (like so many of the IT terms thrown about by consultants) but it, presumably, denotes the use of open, service oriented architecture and redeployable standard procedures. 

Mr. Portwood has high praise for the Quality by Design initiative.  "Quality by Design and ICH guidelines offer incredible opportunities to change the way we do business," he said, "so do new technologies such as disposibles, microcreactors, and the continuous processing of solid dosage materials." 

He also mentioned the role that robust IT tools and systems could play.

His aims are ambitious. "My passion is to change the entire paradigm, to learn to leverage data into wisdom and perfection in everything that we do." Mr. Portwood sketched a pyramid based on systems such as LIMS, MES, EDMS, ERP , and using integrated standard systems to collect and store data, gather and integrate, and then analyze it to drive improvement….

Mr. Portwood then went on to tell the Wyeth story. "We had significant challenges with compliance six or seven years ago.  We had a network of very old plants and an aging product portfolio, and many issues that were difficult to sort out," he said.  Then, in 1999, he said, Wyeth gained approval for several blockbuster drugs, and operation became incredibly difficult to deliver, he recalled, "We had to change our paradigm."

Wyeth's new vision focused on very simple principles, he said. "Focus on product quality first, be leaders in cGMP (that "c" means you’re either leading or losing) and focus on compliance…."

Change involved making deliberate and strategic choices, he said, and the company rolled out sustainable compliance initiatives, redesigned organization for manufacturing, developed operating units for biomolecules, vaccines, nutritionals, and used the concept of primary process units to divide large facilities into smaller ones.

He charted some success stories and overall progress. "In 2007, we are running at 0.1 major observations for inspections, down from over 0.7 in 2004….in 2002, at the height of the C.D.,  you couldn’t fit it on this Powerpoint page," he joked. "We’ve come a long way….but it is a challenge every day," he said.

Wyeth has also seen a 40% net sales efficiency improvement per employee over this period, he said.

With Prevnar manufacturing, the challenges were significant, yet improvements have been dramatic, Mr. Portwood said, and end-to-end cycle times have been dramatically reduced across sites. "In 2004, we were running 456 days.  This year, we're at 197.  That means lives saved.  We've doubled our doses in the last three years."

It wasn't easy. The vaccine is "the most complex product I've ever worked on," he acknowledged, involving  seven serotypes, each of which requires fermentation, activation, and conjugation, then the process must be run through five different sites. "It’s like manufacturing 22 different products," he said. 

Another drive has been to better utilize data.  "We've learned that it takes 0.6 metric tons of paper to produce 13.56 kg of protein," he said.  Eliminating documentation errors was critical.  Last year, Mr. Portwood said, Wyeth completed 217 million Prevnar batch record entries, at failure rate of 0.01

"But that wasn't good enough for what we do," he said.  The next move involved implementing MES and LIMS to reduce use of paper processes.  "We now achieve over 95% first-time quality all the time."

Mr. Portwood sketched a pyramid based on systems such as LIMS, MES, EDMS, ERP , and using integrated standard systems to collect and store data, gather and integrate it and then analyze to drive improvement….

The company built on four systems: ERP, MES, LIMS and EDMs, he said, adding ancillary systems,...such as CAPA and MRP to its ERP, data historians, SCADA systems, calibration tools, EBR and BMS to its MES, CDMS to its LIMS, and SOPs and registration documentation systems to its EDMS.

 "For years, the industry has used point solutions, such as LIMS, often as single-site solutions," Mr. Portwood said. "At some sites we used integrated point solutions, but they were usually hard to transfer between sites and costs were high."

Today, he went on, Wyeth's goal is to use integrated standard systems tied together with an integrated service bus. One key part of this system will be a data acquisition and reporting tool, providing a single version of the truth, so that any operator or engineer can go to any site and operate a standard process.

To implement the vision, Mr. Portwood says, Wyeth uses off-the-shelf solutions, and has rolled the platform out from site to site, using subject matter experts from the last implementation site to drive programs at the next. "You achieve tremendous knowledge from doing that," he said.

Wyeth's DART platform has been implemented at four sites so far, and the company plans to have it running at 70% of all Wyeth sites within the next few years.

Mr. Portwood sees integrated standards as the way to "fully capture the power of data to change the world." Biotech, which will be 40% of the company's total revenue, also promises to be a key part of Wyeth's future.

We will plan to elucidate more of DART (including what those letters stand for---Genentech has a similar IT acronym for Design and Review tool) in future articles, and will feature interviews with Wyeth's teams at Pearl River, including the Prevnar fill-and-finish team, which won our 2007 Team of the Year award, on our web site soon.

AMS

Remember Leonard Read's classic, "I, Pencil," which told the full story of the life cycle of an ordinary pencil? 

Mark Wade, an intrepid analyst at Computer Associates has done the same for Spam.  He recently followed the trail of a single spam advertisement, by posing as a consumer...fascinating reading, and likely describes the path of the pharma spam that's clogging so many of our inboxes.  Click here to access.

AMS

Perhaps it wasn't all as "revolutionary" as this local Carolina press clip states , but clearly Conformia and FDA are doing some groundbreaking work that promises to change the status quo for drug development and manufacturing.

We interviewed Conformia's cofounder Anjali Kataria and CDER Director Helen Winkle on the CRADA's progress recently and will provide an update next month.  The joint team also won one of our 2007 Teams of the Year awards for their work in bringing both industry and regulators to the table and opening up communication and dialogue within and between both groups.

We'd like to hear more from FDA's other CRADA partners as well, and promise to pursue them.

-AMS