Michelle Hoffman, editorial director of Pharmaceutical Technology.

Michelle Hoffman

-Sanofi-aventis entered into an agreement with Chinese authorities allowing Sanofi to construct a vaccine-manufacturing plant in Shenzhen municipality. The signing ceremony, which took place in Beijing, was attended by Hu Jintao, President of the People’s Republic of China, and Nicolas Sarkozy, President of France, who was in China for a state visit. 

Construction on the plant, which will be operated by Sanofi-Pasteur, the vaccine division of Sanofi-aventis, is scheduled to begin in 2008, with the goal of turning out “seasonal” influenza vaccine for the Chinese market by 2012. According to a company press release, the facility is “designed to be able to switch to pandemic vaccine manufacturing if a human pandemic influenza is declared and once a pandemic influenza strain is identified by the World Health Organization.” Influenza, or the “flu,” is caused by a virus.

“China is joining a growing number of countries focusing on prevention of diseases and recognizing the value of vaccines. The time is right for Sanofi-Pasteur to further invest in China and prepare to provide this fast growing market with the most modern vaccines to be produced in a state of the industry facility,” said Gerard Le Fur, Chief Executive Officer of Sanofi-aventis in the release. The release also notes that the facility can be expanded to keep pace with the growing Chinese vaccine market. The 

 reported that the new plant represents an investment of 70 million Euros for the company.

Articles

Sanofi-aventis entered into an agreement with Chinese authorities allowing Sanofi to construct a vaccine-manufacturing plant in Shenzhen municipality.

Sanofi-Aventis to Build Vaccine Facility in China

Gone are the days when drug making was the province of the lone pharmacist or herbalist. Today, drug making is a sprawling operation—functionally and geographically—requiring the joint efforts of hundreds of people separated by oceans and job titles to produce a single drug. How do they manage to operate together? The answer in a single acronym is IT, or information technology. Disparate workers' operational procedures become standardized when they all plug into a single platform brought to them by Oracle, or SAP, or IBM. In that way, business procedures, workflows, documentation, and reporting structures become uniform across the entire organization. Indeed, for better or worse, IT is probably the single most important factor in enabling corporate sprawl. Add to operational management, the drug business is also regulated, more than any other industry, and that entails documentation—a lot of documentation. So the software companies have also produced compliance packages, risk-management packages, and incident-reporting packages. The challenge for software producers and users is twofold. First, does the software program do what it's supposed to? But second, and more critical for the overall success of an enterprise, is how seamless is the software? Whether it's a single package to manage every function and aspect of the business—which to date just does not exist, or whether it's a number of software applications—how well do they work together to maximize organizational efficiency and productivity while minimizing regulatory and financial risk?

Illustration by Melissa McEvoy. Photography: photos.com

To learn a little bit more about the software landscape for the pharmaceutical industry, I sat down with Roger Bottum, vice-president of marketing at  Axentis, Ran Flam, president and chief executive officer of Sparta Systems, and Jim Sabogal, vice-president for industry solutions for the Life Sciences Product Technology Unit at SAP. Our conversations focused on the present and future of software for enterprise and risk management, regulatory compliance, and incidence tracking. Arvindh Balakrishnan, senior director of the Life Sciences Industries Business Unit at Oracle, was unable to attend the live event, but responded to my questions later—virtually, of course. (For the flow of this article, I have inserted his comments where they seem appropriate.) What follows is an excerpted transcript of our discussion. 

The organization is the palette on which the entire operation is drawn. So it makes sense to look at the software that manages the entire enterprise. As we started talking about enterprise software, I found myself remembering a theory I'd studied in a linguistics class—the Sapir-Whorf theory, which says:  

"We dissect nature along lines laid down by our native languages. The categories and types that we isolate from the world of phenomena we do not find there because they stare every observer in the face; on the contrary, the world is presented in a kaleidoscopic flux of impressions which has to be organized by our minds—and this means largely by the linguistic systems in our minds. We cut nature up, organize it into concepts, and ascribe significances as we do, largely because we are parties to an agreement to organize it this way—an agreement that holds throughout our speech community and is codified in the patterns of our language."

Applied to organizational management, I wondered whether the underlying structure dictated the software and its configuration, or whether it really was the other way around: The structure of the software determines the organization's structure. 

Jim Sabogal started off the discussion of the relation between software and organizational structure by noting that "Life sciences has been one of the [industries] where they have a varied IT landscape." And that, he says, is because the industry itself is so "fragmented." 

 There are different pieces.... When you look at a life science form, there's a whole world called research and development, there's a whole world called manufacturing, and there's a whole sales and marketing world. They've not been tied together. And our goal at SAP, at least, is to try and provide common business processes across all three areas, knowing that this is a regulated industry. Because at the same time what we're trying to do is look for ways to shorten that new product development time.... So the challenge really becomes: What's the formula for doing that? How do I grow the business? 

 Roger Bottum suggested that among Axentis customers that are "doing particularly well, they have put in place the organizational structure to support that." 

 [One can] boil it down to a couple of key things.... [One of these is the ability to] derive operational excellence. It's manufacturing on a global scale. It's supply chain on a global scale. So it doesn't matter if you're a biotech with one product, we want to have the same solution for you as a medium-size company with a couple of products to one of these large pharmaceutical companies with far-flung operations all over the place. What we're seeing in the market is they're all looking for the common platform, because [the company's management has] got to grab everybody's attention because [they're] trying to drive revenue for [the] company.... SAP's in  the business of solving that problem. That's really what it boils down to: a common business process with a business platform, with a lot of business applications. But what is the next step? What is the next thing that we have to get to if we're going to multiply this by 100 products, by 200 products, by 1000 products? The amount of paperwork and regulation we have to go through is astronomical. So that's the challenge.... And that is where I think [a] business platform and common business processes get to be ... what we want to focus on.  

 Ran Flam agreed that the common goal of all three software manufacturers at the table was that they offer their customers the means to "enable them to run their business in a systematic way." 

 Whatever the process is, [we want to use the software to] handle different business processes, as well as action to be taken [to assist employees to make decisions based on SOPs, to follow predefined enterprise business rules and guidelines.] I think we all share this. [Sparta's QMS software, TrackWise, does not] hard-code any of those behaviors in the software itself but rather enables the businesses themselves to [configure their database applications so that the software maps the desired business practices and forces users to follow the same].  

The factor that distinguishes the pharmaceutical industry from just about any other is the degree to which it is regulated. The US and foreign governments alike monitor drugs throughout their development and production life-cycle for safety, efficacy, and purity of ingredients and the final product. Needless to say, compliance software is of supreme importance to pharmaceutical manufacturers. Accordingly, we focused our discussion primarily there. 

Sabogal raised the notion that the compliance issues faced by a company with only one product will only grow in complexity when companies produce hundreds of products—as is likely once many targeted products replace the single blockbuster—in tens of countries, each with their own set of regulations. The paperwork alone, he notes, is staggering. 

 Bottum followed up by noting that in addition to the number of products managed in-house that, "Big Pharmas are being more aggressive about leveraging third parties for supporting services on clinical trials and sales and marketing." 

 The circle of the people that touch the development through the delivery of your product in any market is much more complex even than is inside your four walls. And so [Axentis] is specifically focused on risk management and compliance .... The risk a lot of times isn't  the person that's sitting next to you in the cubicle—it's the person that's sitting a city away in a totally different company and carries a different business card but for whatever reason is doing work for you on that day. In particular, what we do is provide an overall consistent way to manage all the elements of governance, risk, and compliance. 

 It's not uncommon for us to think about the problem in China being based in California.... You have to take compliance and you really have to push it to a point where you institutionalize it. Everybody must comply with the regulations. 

 We're definitely seeing more of the mid-market pharmaceutical companies and the medical device companies take a more aggressive view to government-regulated compliance.... And we see the big pharmaceutical companies take the more aggressive view about managing the risks of their business partners.... 

Flam notes that while software vendors should be current with regard to the regulatory landscape, most changes to regulations affect how companies conduct their business rather than the underlying software they use. 

 [When the FDAdecides to update or change any of its GMP, GCP, or GLP regulations, such changes will most often impact the companies directly. However, it is our responsibility to ensure that additional requirements on our software are rapidly implemented so that our customers remain compliant. This is particularly relevant] when a company is using electronic records. 

 There's really two pieces [to what we do]. The first is: How do I manage my response to that regulation? [And second,] whether my response is to change a policy or procedure in the company or implement a whole new set of controls in an automated fashion.... Some of those decisions are enabled by software.... Fifteen years ago...one of the key things was lot traceability: How do I know ... what got made where, so if there's a problem, I could take it back? ... [companies at the time didn't have that feature producing software for enterprise resource planning (ERP)]. So it was a way through the inventory process...because it was a fundamental business process [it] was dealt with within software. But the decision ultimately of what to do is the business's decision... If [they're] doing a good job at running a compliance program...[they] need to assign somebody who's responsible. If there's a compliance issue, and there's nobody in the organization who is singularly responsible, that's a problem. 

 ....for the first time, the life sciences industry is feeling the need to manage regulatory compliance across regulations on a risk-based approach. Often, there is one officer in the company who is charged with regulatory compliance, and this officer is keenly interested in mitigating risk proactively in a unified governance framework for the company.  

 [Companies] need a way to communicate....[they] need a way to track issues that occur and manage them in a consistent way.... The very simple economics of doing the right things are ...  if I have an effective compliance program, and I can prove it, and this is where software comes into place.... So the elements of an effective compliance program is sort of the recipe to a process model that one, lets you have a clear view, and two, when the inevitable occurs and somebody comes after you, you have a defensible position that you can prove. 

 That is really the essence of keeping track of anything that happens. [The steps to be taken to investigate incidents, actions to be taken as a remedy, and what needs to be done to prevent incidents from happening again].  

At this point, I asked the discussants to talk about particular requirements that are most challenging. 

 For each company, a given regulation could impose challenges that are particularly difficult within their specific business. Sarbanes-Oxley provides great challenges because the extent to which companies interpret and implement regulatory compliance is sometimes subjective. As a result, companies usually go overboard in an attempt to remove regulatory risk altogether. On the other hand, with regulations such as 21 

 Part 11 and the like, the scope is well understood, but the challenge with these initiatives is the cost of validation. Often the cost and complexity of validation are extremely high, enough to thwart continuous improvement initiatives. 

 We've helped a number of the large pharmaceutical companies with corporate integrity agreements, and that is where they've gotten typically into trouble around Medicare–Medicaid billing fraud. 

 All the products that [pharmaceutical companies] make today require a certain amount of increased focus on product safety, increased focus on regulatory reporting. We have to meet the regulations, or else we're not sitting here as a vendor true to the market.... So from a SAP perspective, yep, we do electronic signature. Yep, we do [21 

] Part 11. Yep, we do Sarbanes-Oxley. Yes, we do all these different things, but at the end of the day, the cycle is still seven years, a billion dollars, to bring a new product to market. So how do we scrunch that down? 

 I think we all agree that consistency and the ability to put on the brakes, all of these are very important. But the challenge that we've seen as far as the FDA is concerned [is that] they put this little letter "c" in front of GXP [where the] "c" really means "current" [i.e., the agency's current expectations with regard to handling compliance]. The 

 has not changed that substantially or drastically, [however,] the interpretation by regulatory bodies [as to what is current] is changing. [For instance, one important aspect of compliance, about which] our customers [care very much] is the ability to automatically trend and keep track of incidents that may happen across their [organization]. [Customers need] the means to always have their fingers on the pulse and make sure that if something goes wrong, they can catch it as fast as possible. [This is] one way to [address such] challenges. [Take] corrective action and preventive actions in real time rather than [rely on individuals to run reports and independently determine appropriate actions].   

 Knowing that is not good enough.... At the end of the day, it's what business processes allow you to go back to product safety ? Several key customers...can manufacture products that are in compliance, that manage the risk aspects of it, but may I suggest to you that there are those types of players that are out there...that can actually counterfeit these products, introduce them to the market, and threaten product safety from that perspective. 

And here the conversation veers into what a company can do to prevent such events from happening and how to respond once they do. Bottum replied that the ability to prevent counterfeiting constituted a "very narrow view of risk." 

 What is relatively new in the life sciences companies and relatively new among vendors like us, is offering organized ways for management to manage risk... Your perspective is largely based on where you sit. Many of the risks we deal with are not risks that can be systematized. Risk cannot be eliminated. 

 Compliance is always a combination of process documentation and recording of deviations (potential or real) from such processes.  

 What do you do when the safety of a product has been compromised? What do you do if a drug...does not have the ingredients that it's supposed to have? [Nowadays, the automatic detection and trending is available ... it wasn't] 10 or 20 years ago.... [The quality system] needs to kick in and [raise a red flag], and say, '[You should apply] those brakes.' [The system may even automatically launch an investigation... [A good program should have a built-in 24/7] business rule engine [where companies configure] all their business rules [to enforce processes,] trending, and all actions to be taken.  

[An ERPtool] is an essential solution to do exactly what it's meant to do... introduce standard, predictable, and consistent processes. When you look at what we do, what TrackWise does, it's actually putting in place a quality system to manage all the actions to be taken [when incidents happen ... the products are really very complementary].   

Flam and the other participants noted that their software products work together. However, I have heard people in industry comment that some add-ins work very poorly with platform software (not necessarily with regard to the panelists' software). I asked the panelists to address the question of integration. 

 What SAP's done in the last  two years has been to provide infrastructure in terms of how we partner....The first tier is we publish, from our perspective, all the ways in which you can connect SAP. Second, we have a certified program that allows particular vendors to actually come in and say, 'OK, we're going to run our software on [SAP's] platform. And any time we have something that SAP doesn't do, we look for a partner that actually fills that space.' 

 There are a number of strategic systems out there: ERP lab information management systems (LIMS), document management systems... and QMS...[a term] we coined some years ago for quality management system. [QMS plays a core function as it] is getting feeds from numerous sources such as a problem with a certain batch number or lot number, etc. We have developed an open programming interface [which allows] other [software] systems to communicate directly with TrackWise, [for instance], to  create and update issues, [to query the status of an open issue, and to be able to make decisions based on such information. This takes the concept of quality management to an enterprise-wide level]. 

 Standards adoption is the most challenging aspect of integration projects. If two technologies adopt open standards, integration becomes a non-issue. On the other hand, if two proprietary standards-based technologies need to be integrated, the result is expensive and complex integration. Oracle [bases its] integration platform on open standards. Similarly, our application integration architecture, an open, standards-based platform for business process management across Oracle, third-party and custom applications, is based on open standards, and this makes it easy to integrate our products with others. 

The traditional point-to-point integration model has outlived its utility. In most industries, chief information officers are asking us for a hub-based integration framework that can incorporate an enterprise-wide common object model. Such an architecture makes it easy to plug and play applications over time, without undertaking massive integration projects. Pharmaceutical companies are beginning to adopt this model as well and are trying to understand the impact of regulatory constraints on the adoption of such models.  

Information technology is the glue that should unify a company while ironically, it enables further fragmentation. Experts talk about the successes and challenges for IT in helping a company function efficiently.

Programming a Seamless Supply Chain

Every time I go to the supermarket these days, I'm reminded that we're entering the fall–winter holiday season. Judging from the displays, the season starts with Halloween—for most people. But not for me. My favorite fall holiday started earlier this week with Columbus Day. And with all due respect to Christopher Columbus, my enthusiasm has nothing to do with his voyages to the New World. 

Rather, it's the day that the Nobel Foundation starts announcing the year's winners of the Nobel Prize, beginning with the biology prize (they like to call it the prize for physiology or medicine). I wait all year for that announcement the way other people wait for the finale of "The Bachelor," or "Survivor." But unlike the winners of those contests, the "contestants" in the Nobel showdown devote their entire lives to their prize-winning endeavors and for the most part, do so without looking for any prize at the end. Also in contrast to the winners of those other contests, Nobel Laureates are rarely interviewed on the news, the morning shows, or on talk shows—even though I think we could convincingly argue that their achievements are generally more impressive than, say, getting the final rose. Or aren't they? 

I find myself wondering about this every single year during Nobel Prize Week. Each fall, I hope that the winners will be in the media, describing their prize-winning work and its applications,  and every year I'm disappointed. My expectations are so diminished that I'm grateful when a newscaster mentions the prize at all. They frequently mention the winning scientist's nationality. Sometimes they even  mention their name(s), or offer a phrase describing the prize-winning work, but they never, ever interview the person. And I can't understand that. 

Young scientists fare a little better. On a few occasions, I have seen high-school students interviewed for winning prestigious contests such as the Intel Science Talent Search (formerly the Westinghouse Science Talent Search). The interviews, however, are less than satisfying. In almost every case, the young scientist is questioned by a giddy journalist, who, more than anything, seems to want to know whether the interviewee is "still a regular kid." The conclusion we're to draw, I guess, is that having scientific talent is irregular. Or, to put it another way, "uncool."  

Here we come to a circular problem, the Catch-22 of "coolness," which is achieved in large part by appearing on television. But if you're considered uncool, there's no chance you'll appear on TV in the first place. Many people have become famous and admired for merely appearing on TV (or worse, for having their mugshot appear on TV). So, by the same reasoning, wouldn't scientists become more accessible, more valued, and more cool by appearing on TV once in a while? And then we have to ask, what would it take to make winning the Nobel Prize seem cool enough to merit an appearance on TV in order to convey to the public just how cool it is to win a Nobel Prize? 

My concern is not to garner publicity for scientists per se. Nor do I want to emphasize the Prize-winning over the work that won the prize. Rather, I'm concerned about our values as a nation. By promoting the images of success and fame that we do, we reflect the current values and shape the values of the future. So, if kids see people who become more famous for leaving rehab than for curing a disease, what do you think they'll be motivated to do? 

Will kids think about studying the sciences or go into science if they're not presented images of a culture celebrating scientific achievement? And will adults be interested in funding scientific research without having some exposure to the work their tax money is funding? 

If anyone out there reading this books interviews for TV news or talk shows, please, make my Nobel Prize Week a really good one next year. Book a Nobel Laureate for your show.

Send your comments or story ideas to Editor-in-Chief 

Thanks to the media, Nobel Laureates are underrated, undervalued, and simply uncool.

What Good is Winning a Prize if No One Cares?

Q. How has information technology (IT) dealt with regulatory issues (e.g., Sarbanes-Oxley, the Health Insurance Portability and Accountability Act, 21 

 Part 11 have been well understood (and implemented) by the industry for several years. However, for the first time, the life sciences industry is feeling the need to manage regulatory compliance across regulations on a risk-based approach.  Often, there is one officer in the company who is charged with regulatory compliance, and this officer is keenly interested in mitigating risk proactively in a unified governance framework for the company. 

The cost of noncompliance has become almost unfathomable in the pharmaceutical industry. Companies that are affected by noncompliance (be it a SOX [Sarbanes-Oxley] associated restatement or an FDA consent decree) suffer far beyond the superficial commercial aspects.  Corporate culture, leadership, confidence in management, and even the capability to recruit and maintain talent are severely challenged.  As a result, chief regulatory officers in the life sciences industry are at a very strategic helm, and their direct relevance to business continuity and growth is becoming well understood by boards of directors and investors. 

Q. Which regulatory requirements are the most challenging and why?

For each company, a given regulation could impose challenges that are particularly difficult within their specific business. Sarbanes-Oxley provides great challenges because the extent to which companies interpret and implement regulatory compliance is sometimes subjective. As a result, companies usually go overboard in an attempt to remove regulatory risk altogether. On the other hand, with regulations such as 21 

Part 11 and the like, the scope is well understood, but the challenge with these initiatives is the cost of validation. Often the cost and complexity of validation is extremely high, enough to thwart continuous improvement initiatives. 

Q. What industry (outside life sciences) that you know of has a good handle in dealing with regulatory compliance, and why?

Financial services firms, by the nature of their business, have incorporated risk-based strategies in their regulatory compliance initiatives for years. This makes them extremely resilient to sporadic noncompliance, changing regulations, changing market conditions, and changing customer requirements. 

Q. How creative can software makers be when providing compliance solutions? Is there room for 'out-of-the-box' thinking?

Compliance is always a combination of process documentation and recording of deviations (potential, or real) from such processes. Scientifically speaking, unless all processes can be standardized across the industry, it would be impossible for any company to develop an out-of-the-box compliance solution. However, there are some process areas that are reasonably standard in the life sciences industry, and we are working toward some prebuilt compliance tools for some standard business processes and functions. 

Q. Do you have any comments on regulatory requirements outside the United States?

Local regulations (or "localizations") are the cost of doing business globally. In today's economy, this is a need that cannot be ignored. We, at Oracle, have seen a trend toward incorporating local financial regulations in shared service transaction processing environments.  

Q. Do you foresee unified global regulatory requirements?

To some extent, there already are unified world regulatory requirements. Market-leading regulatory bodies, such as FDA and the USDA, assume leadership roles in implementing world-wide regulations. Their regulations are immediately adopted with little or no variations by regulatory bodies in other countries. Often individual countries might adopt a superset of FDA regulations by combining FDA regulations with country-specific codes developed by their regulatory bodies. The cost of not doing business with the US is so great, that we believe that bodies such as FDA and USDA truly have a global impact. 

Q. What advice do you have for drug makers in meeting the regulatory requirements?

'Be ahead of the curve' is the best advice we could give the industry. If possible, work with regulatory bodies to understand key regulatory initiatives that are in progress and the potential impact of these regulations on the real world. Attempt to influence the regulations by positive collaborative efforts across the industry. Undertake research and development efforts to implement (or simulate), in a small laboratory environment, regulatory compliance before regulations are enacted. 

Q. What challenges do you have in integrating technology from different vendors with your product (for example, with a Windows server)?

Standards adoption is the most challenging aspect of integration projects.  If two technologies adopt open standards, integration becomes a nonissue. On the other hand, if two proprietary standards-based technologies need to be integrated, the result is expensive and complex integration. Oracle is doing its part to enable low-cost integration by basing its integration platform (Oracle Fusion Middleware) on open standards. Similarly, our application integration architecture (AIA), an open, standards-based platform for business process management across Oracle, third-party and custom applications make it easy to integrate our products with others. 

Q. What integration issues do you see up and coming in all type of industries, and any specific challenges in the pharmaceutical industry?

The traditional point-to-point integration model has outlived its utility.  In most industries, chief information officers are asking us for a hub-based integration framework that can incorporate an enterprise-wide common object model. Such an architecture makes it easy to plug and play applications over time, without undertaking massive integration projects. Pharmaceutical companies are beginning to adopt this model as well and are trying to understand the impact of regulatory constraints on the adoption of such models. 

Q. What are the top three applications that are typically interfaced with your products? And what are the challenges in interfacing with applications with different languages (character sets)?

1. Factory-level shop floor (such as process control and process scheduling applications) 

2. Statistical packages for highly advanced and specific data analysis  

3. Third-party (legacy) business intelligence products. As long as all these applications accept unicode characters, integration with these applications should not be an issue.  However, some applications are less "internationally robust" than others, and unique character sets, such as the Japanese character set, can pose a problem. 

Q. Some companies face challenges in integrating MES (Manufacturing Execution Systems) to Enterprise Resource Planning (ERP) applications. What is your company doing to help ease this integration?

Oracle is adopting the S95 standard aggressively and using this standard to guide our AIA strategy and approach, where appropriate. 

Q. Do you have any thoughts on virtualization (e.g., virtual servers) and the impact of this to your business and to the pharmaceutical industry?

[A few years ago, Oracle introduced] real application clusters, which support the deployment of a single database across a cluster of servers—providing strong fault tolerance, performance, and scalability. We aggressively promote the virtualization of an application environment through the implementation of machine clusters. This drastically lowers the cost of ownership, as a group of several smaller machines is often a small fraction of the cost of a much larger machine, and the risk of failure of a cluster is infinitesimal, as well. The adoption of this approach by the industry has been a strong validation of our commitment to lower total cost of ownership for our customers. 

Q. Do you outsource application development outside the US? Do you have any comments on the trend toward outsourcing?

Oracle has software development teams in several countries around the world. We have aggressively embraced globalization as a key option for attracting the required talent to fuel our research and development engine.  However, we do not typically call this outsourcing, as software development is undertaken by Oracle employees in these countries who are trained on our methodologies and standards and are subject to extremely stringent hiring criteria. So, we leverage a global pool of talent without having to outsource a key business function.

Q. What are the top three questions that your helpdesk gets from users in the pharmaceutical industry? And why do you think those are the most-asked questions?

Of the number of service requests logged in our support applications, very few actually require a software "patch." The vast majority of issues can be resolved by more aggressive end-user training.  We are attempting to integrate end-user training with the application footprint with products such as the Oracle User Productivity Kit, a synchronized, customizable solution that helps organizations quickly create the critical documentation, training, and support materials needed to drive project team and user productivity throughout the life cycle of a user's software.  

Q. What technology should be used more by members of the pharmaceutical industry in their 'supply-chain' business? Do you see the 'auto replenishment' feature being used in drug making?

Understanding downstream supply chain and 'demand' more accurately is a key area of focus for the pharmaceutical industry.  Auto-replenishment (loosely called 'KanBan') is already used for various direct materials and will continue to be adopted by the industry.   

Q. What advice can you offer the pharmaceutical industry about facing the challenges of counterfeiting?

Electronic pedigrees and RFID [radio frequency identification] solutions will greatly reduce the problems of counterfeits, grey-market sales, diversions and so on. In addition, product recalls, returns, chargebacks, and the like are all simplified and can be sources of significant savings through the adoption of such technology.  

Q. Can you talk more about how RFID is used in the pharmaceutical industry?

RFID is important from two perspectives. First, it is an efficient technology that can allow a large pallet of finished products to be "scanned" in a single pass without having to unpack boxes and scan bottles one by one. Secondly, RFID is accurate, and can enable supply-chain accuracy by automating supply-chain inventory information management. As the cost of RFID chips and scanners drop, we anticipate worldwide adoption of these technologies—not just across the supply chain, but also within manufacturing plants. 

Q. How is software being used in clinical trials? 

Companies are looking for a clinical platform that can manage all clinical operations in a consolidated and integrated technology base. This is becoming even more important as companies are buying pipeline from others (or are licensing them from biotechs), or are merging with and acquiring other companies.  Because clinical operations are the vital bloodline of these companies, it is strategically important to support this area with a comprehensive solution footprint and an overarching business intelligence approach. Our customers are asking the software industry for a comprehensive solution footprint that includes clinical trial management, clinical supplies management, financial management, investigator relationship management, remote data capture and clinical data management, product safety management, and overall clinical intelligence.  

Arvindh Balakrishnan is senior director of the Life Sciences Business Unit at Oracle, 

The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward virtualization, among other things. Do you have something to ask Arvindh Balakrishnan? Click here to submit your questions.

Tech Talk: A Q&A with Oracle's Arvindh Balakrishnan

-Novartis opened a new $180-million tableting facility in late October in Singapore and announced its intention to construct a $700-million cell-culture facility in the country. According to various printed sources, the announcement was made by Novartis officials at the inauguration of the tableting facility.

The cell-culture facility, which is expected to be operational sometime in 2012, will manufacture cells for clinical and commercial production of potential new biopharmaceutically based therapies for indications ranging from asthma to oncology. The move, said several reports, signals Novartis’ intention to place an increased emphasis on biological drugs in its product pipeline.

Novartis joins several other large pharmaceutical companies, GlaxoSmithKline, Genentech, Abbott, and Lonza, who have also put biopharmaceutical manufacturing plants in Singapore.  

Singapore has made a concerted effort to boost its attractiveness to pharmaceutical concerns-especially those in the biopharmaceutical sector. In a report released by the Singapore Economic Development Board, Mr. Lim Hng Khiang, the country’s minister for trade and industry was quoted as saying, “The biologics facility further reinforces Singapore’s position as a leading location for world-class biopharmaceuticals manufacturing. Within two years, we have attracted five biologics manufacturing investments.”

Novartis opened a new $180-million tableting facility in late October in Singapore and announced its intention to construct a $700-million cell-culture facility in the country.

Novartis Expands Operations in Singapore

An anthropologist of the future studying 21st–century America might be forgiven if she failed to understand our true position on the sanctity of life. On one hand, our future anthropologist would find groups of people passionate about the right-to-life of the unborn. Yet, the same anthropologist might find a shocking disregard for the life rights of those already born. I live here, and I don't understand it. 

A few months ago, I expressed my confusion over policies that forestall research on human embryonic stem cells that might result in treatments for very ill people. Now, I'm confused about a recent District Court decision denying the terminally ill access to experimental drugs. On Aug. 7, the US Court of Appeals for the District of Columbia decided, in 

Abigail Alliance v. Andrew Von Eschenbach

, that the due process clause of the Fifth Amendment does not extend to terminally ill patients who seek experimental drugs to save their lives.  

In previous decisions, this clause has been interpreted by the US Supreme Court to extend to "the rights to marry, to have children, to direct the education and uprbringing of one's children, to marital privacy, to use contraception, to bodily integrity, and to abortion." The Abigail Alliance, an advocacy group for terminally ill patients, argued that due process could also protect "persons in mortal peril" to "try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks." The court rejected that argument. 

In the opinion of dissenting Judge Judith Rogers, the majority opinion relied on "tragic wordplay." Judge Rogers wrote: "In the end, it is startling that the oft-limited rights to marry, ... , to have children, to control the education and upbringing of children, ... , and to control one's own body even if it results in one's own death or the death of a fetus have all been deemed fundamental rights ... but the right to try to save one's life is left out in the cold ...." 

There exists, it's important to note, a mechanism for terminally ill patients to obtain experimental drugs under a "compassionate use" provision. However, in a very passionate editorial in the 

(Aug. 14, 2007), Ronald Trowbridge and Steven Walker, volunteers with the Abigail Alliance, maintain that many people die while waiting to learn whether they will be given access to a drug for compassionate use. The math, if they are correct, is staggering. More than 520,000 people died while waiting to learn whether they might be able to use some 12 experimental cancer drugs. On the other hand, the US Food and Drug Administration grants some 650 people per year access to investigational drugs for all diseases and drugs, a number that Trowbridge and Walker call "a pathetic, even cruel, pittance." 

California attorney Alex Coolman is not involved in the case but keeps a close eye on it for his blog dedicated to pharmaceutical and drug issues  

). His May 19, 2006, entry notes that, "Industry itself seems somewhat unclear about the opportunities and requirements related to expanded access, which likely leads to delays in the development and implementation of such programs." In order to have the compassionate use provision applied more evenly for all terminally ill patients, the Abigail Alliance argued that these patients were guaranteed access under the Constitution. 

I am not a Constitutional scholar, so I will leave a discussion of the correctness of this approach to those who are. My thoughts are more simple-minded. Why, I wonder, are terminally ill patients not good subjects for clinical trials? Wouldn't it be useful to know how the most refractory of patients respond to a given drug? After all, if a drug can be effective on patients who are resistant to available treatments, wouldn't that bode well for patients with less severe disease? 

I understand that clinical trials are highly controlled; enrollees must meet very strict criteria in order for the data to be meaningful. However, this is a time when the drug industry is rethinking its approach to clinical trials, in many cases favoring evidence-based trials in real-world situations, as opposed to the more highly controlled (and contrived) trials that are currently the norm. Including the most severely ill patients in these trials could, I think, only add to an understanding of the efficacy of a drug, while also providing some desperately ill people with a possible second chance.  

There must be some way to provide the gravely ill with drugs that might improve their lives, and possibly save them. And that goes back to my original question. Who are we, really, with respect to an individual's right to life? 

Courts are denying the terminally ill access to experimental drugs, leaving many with no options.