VIEW on E-Solutions October 2006 E-Solutions Adoption is a Marathon not a Sprint By Daniel Limbach Any mention of e-solutions involves a wide range of technologies. For the purposes of continuity and this publication, we view e-solutions as any electronically based, interactive technology that assists in communication, data collection, data integration, and data analysis. Most companies are examining and/or implementing strategies that would allow them to forgo their paper-based clinical-research methods and move their processes into the electronic world. E-tools save time; information can travel electronically at near-light speed, while FedEx can only manage overnight service at best. E-tools also can analyze hundreds of thousands of pieces of paper associated with a clinical trial in minutes. With all of these advantages, it begs the question as to why every pharmaceutical and biotech company hasn’t moved completely into the world of e-solutions. Because companies have relied on their paper systems for so long, many are evaluating whether the “pain” involved with changing outweighs any downside of their manual processes. Integration is another issue. A change in one system could very well impact several others, creating a hornet’s nest of problems. In many cases, this may be true, but ultimately e-solutions save time, save money, and provide more accurate information in more diverse ways. The adoption of e-solutions or e-technologies within traditional life- sciences companies could be likened to the Tortoise and the Hare fable. Pharmaceutical and biotech companies have adopted the tortoise mentality; they know that slow and steady wins the race. While it would be nice to think that in a few years every R&D project, every drug development effort, and every clinical trial would be managed electronically, this is just not practical today. It may take another decade before the last of the mountains of paper generated by these processes is but a distant memory, but the industry is moving toward that goal, make no mistake. E-solutions for marketing purposes are divided between patients and physicians, much like traditional marketing. The tactics for reaching each of these audiences vary greatly, too. On the patient side, the list of e-solutions includes Websites, discussion forums, e-mail, blogs, Podcasts, Wikis, CD-ROMs, DVDs, and more. Websites are proving to be excellent tools for providing consumers with useful information and a way to contact companies for more information. On the physician side, prescribers are embracing e-detailing and e-sampling technologies in increasing numbers.The new breed of technology has given the user — consumer or physician — control of the dialogue. Consumers and physicians are blogging in record numbers, and the adoption curve is still in its adolescence. A 2006 Forrester report gives four pieces of advice for marketing to consumers: discover and open new channels, embrace the experience economy, relinquish control, and share responsibilities. The Forrester report also describes how innovation in this sector has been turned upside down. In the old economy, executives were the sources of inspiration; now, customers provide most of the sparks. Customer involvement used to be structured and controlled; now, it’s spontaneous and completely unpredictable. Corporations reached out to customers; now they must invite them in and see what happens. Yesterday’s market-research tools were surveys and focus groups; today’s conversations are facilitated through search engines, e-mail, and blogs. At the end of the day, it is clear that innovation in the technology arena will continue to march on. Each wave of technology is like a new tide. And while executives can’t stop the tide from rolling in, they can plan for how they will adapt to each new wave and make it work to their advantage. Robert Knecht Cephalon I look at emerging technologies and decide which can be put in place to support and grow the organization. Around the Boardroom Because there are so many solutions, for so many applications, in so many areas, we asked our Forum participants to identify the e-solutions, tools, and products that have been adopted in their companies in the past two years. We also asked them to discuss the biggest challenges to adoption. Lurker. We continually evaluate e-tools and have looked at a number of areas over the past several years. For example, e-prescribing has been assessed and deployed. The biggest challenge to adoption is that ‘e’ is still an evolving space. At both ends, success is a combination of what’s working in the marketplace and what is practical internally. There are technology issues; workflow process issues; and physician, patient, and internal acceptance issues. With any new technology that is deployed, there is an adoption stage that involves two steps forward and one step back. Then there’s a regroup phase followed by a giant leap forward. Knecht. Over the past two years, we’ve adopted three major technologies. One was in the area of document and content management. The second was in the area of business intelligence, covering data normalization analysis and mining. The third was in the area of business process improvements using various modules of SAP. The biggest challenge for all three of these initiatives is globalization and how to ensure our IT efforts to implement global solutions and move the business along. We’re a U.S.-based company, but we have a significant presence in Europe. When we develop global solutions, we have to take into account European requirements. This includes everything from business and regulatory requirements to localization/language, and more. Woodrum. Often the biggest obstacles to adoption are the fear that the solution will not be accepted by regulators and the perceived level of work involved in validating the tool’s use. Waldron. AstraZeneca has an entire program focused on driving drug-development productivity and looking at ways to make drug development more efficient through the use of technology and accompanying standard, global processes. We continue to make investments in the areas of clinical data capture and investigator and patient recruitment. One of the key challenges in the adoption of these solutions is making the tools and processes seamless and interoperable, so that the suite of discrete electronic solutions appear to be integrated with minimal duplication of information, making for a positive end-user experience. Murabito. We have adopted multiple e-solution tools in the last two years, including a salesforce automation tool, several business and research applications, internal portals, and a collaborative workspace for external business partners. The biggest challenge is usability — turning the tools into productivity enhancers. One approach to achieving this is by incorporating e-learning and help-assistance capabilities. Marino. The biggest challenge we face is how to leverage the significant data available to most effectively target our key customers. Over the past few years, we have introduced e-detailing, use of interactive Websites, and extensive data-mining tools to leverage technology to cost-effectively create sales opportunities. For many pharmaceutical and biotechnology companies, the adoption and implementation of technology solutions to address myriad business challenges has resulted in the creation of new c-level roles — the chief technology officer and the chief information officer. We asked this month’s Forum experts to discuss the role this person plays in their organization and how they support the adoption of electronic solutions. Waldron. We have a chief technology officer as well as new enterprise architecture leader, who reports to our chief information officer. This leadership hierarchy recognizes the increasing importance of planning and proactively designing an orchestrated set of solutions that take into consideration technical infrastructure, application functionality, and information integration. Murabito. I am the chief information officer/chief technology officer for Cubist. I drive the support for various initiatives, including e-solutions through several channels. One way I evaluate technologies is to make sure they align with our portfolio of projects. Another mechanism is quite simple, really; I work closely with business partners to ensure there is clear alignment between business priorities and IT initiatives. And the third key approach is through our IT strategy. Key strategic activities for IT in 2006 have included broad adoption and deployment of wireless technologies, server virtualization, and a pilot program for electronic capture of clinical-trial data. Marino. Elina Khurgin is Actelion’s chief technology officer. She is very involved in all aspects of the business process and contributes significantly toward providing effective technology solutions for the marketing and sales challenges that we face. Knecht. While we do not have a chief technology officer by title, I fill that role. And in this role, I am charged with driving innovation throughout the company. I look at emerging technologies and decide which can be put in place to support and grow the organization. Lurker. We have a chief information officer who is responsible for all of the technology used at Novartis. One of the intrinsic challenges to technology adoption is that the technology itself morphs so quickly. Another challenge is overcoming the industry’s reluctance to adapt to rapidly evolving solutions. We asked our participants to discuss whether their strategies regarding e-solutions are proactive or reactive. Waldron. It’s so important to take a program-focused approach to e-solutions. Our goal is not to think about point solutions but to always consider addressing business needs in a holistic manner with AstraZeneca’s long-term vision and strategy in mind. Lurker. We definitely have a proactive strategy. I come from the information space, and I am a prudent user of technology. Used correctly and thoughtfully, an e-strategy can be very powerful. Our strategy is proactive, and we are diligent in our approach, which is the difference between the leading edge and the bleeding edge. Knecht. At this point, we are in some ways operating in a reactive manner. We have plans to further streamline our processes and move toward a proactive approach in as many ways as possible. In the past, much of the budget was decentralized. We had departments planning their own IT initiatives. This is the first year that we will have centralized IT budgets, headcounts, resources, and so on, which will allow us to centrally manage the IT portfolio. At that point, we’ll be able to collect requirements as part of the budgeting process, enabling us to become more proactive, especially with regard to prioritizing initiatives and determining how the company will use its IT dollars. Murabito. E-solutions are part of our overall IT strategic plan. Our approach centers on deploying a base infrastructure initially and then constructing appropriate e-solutions. For example, in 2005 we deployed Documentum as our base record and document management infrastructure. In 2006, we are using that technology base to develop specific e-solutions for: quality — standard operating procedures; IT — validation documents; and statistics — clinical data sets. In 2007, we will be addressing records management. We have taken similar approaches with collaboration tools, such as eRoom and Sharepoint, and wireless devices, such as SFA mobility. E in the Clinic There are many solutions available in the marketplace today that are intended to speed clinical development, reduce the cost of trials, and improve safety. Our experts talk about the advantages they are realizing with their chosen “killer apps.” Woodrum. A huge advantage of e-clinical solutions is eliminating the burden of processing paper and the inherent time lag paper introduces into the process. Another advantage is monitoring the progress of a trial in real time. Yet another positive is reducing the time lag between data collection, data verification, and data lock. There is no one killer app yet, but one will evolve as more standards are adopted that move the industry closer to the ability to siphon source data from standard electronic medical records, instruments, and so on. Duffy. We invest in tools that enhance R&D planning, execution, management, and control across the entire product life cycle. We pursue solutions that yield an increase in throughput per dollar invested in drug development, as well as increase the likelihood of success throughout the development chain. Applications that enable seamless and integrated access to trial management, patient/data management, product safety, and regulatory content would be a killer app. The ability to marry planning data to the execution side at the trial-management, the data-management, and the content-management levels would provide a tremendous advantage in driving operational efficiencies and enhance our ability to make timely decisions. This type of information would enhance our ability to make prudent investments, applying the right resources, at the right time, on the right things. Waldron. Among the key advantages of moving to electronic tools are eliminating the costs and burden of managing paper and the faster availability of clinical data, both of which will help us deliver important new medicines to patients faster. I don’t know if there is one killer app per se, as much as killer capabilities, which when used in concert with one another will significantly enhance how clinical research is conducted. One such example is SAFE (Signatures and Authentication For Everyone), an emerging, cross industry standard for authentication. Adoption of this standard by healthcare professionals will enable replacement of today’s costly, proprietary authentication solutions with one universally accepted, cost-effective, and interoperable solution. The SAFE solution could also then serve as the basis for legally binding digital signatures, which will catalyze the elimination of paper. At AstraZeneca we have recently instituted an internal capability using SAFE as the means for digitally signing documents that we will electronically submit to the FDA through its gateway. It is our belief that this will not only benefit us internally but equally help the agency to achieve its efficiency goals. Knecht. There is no one killer app in the clinical arena. Advantages are realized through the careful management and integration of best-in-breed applications to streamline information flow. The killer app is a combination of capabilities brought together by a decision framework that traditionally in the pharmaceutical industry has been two separate entities — demand and delivery. It’s important to forecast the array of resources needed to drive processes and then ensure delivery of those resources for preclinical, clinical, and regulatory operations. When it comes to execution, how that information is brought to bear helps manage and control the development exercise. For example, anything that can provide insights in terms of pharmacovigilance and the safety of products both in the clinic and postmarket would be extremely helpful. Other applicable tools include solutions that can illuminate patient data or trial data in terms of our ability to enroll patients, collect data, and do source document verification; help to write CSRs sooner; and the ability to have data resident during the trial to start to make some scientific assessment. The list goes on and on in terms of execution. This is all information that can be brought back into our decision framework that will help us to add studies, drop studies, change our clinical-development strategy, and perhaps pursue a different approach to the overall outcome. Woodrum. The real killer app in the e-clinical area will be based on adoption of standards such as SAFE, HL7, DICOM, and CDISC to name just a few. These standards will lead to bigger payoffs in moving away from hybrid approaches to electronic capture and management of source data. As good as a technology is, it still has to be operated by a person or people. Thus, as with anything new, there are challenges to be overcome and bugs to be worked out before efficiencies can be realized. Waldron. One of the biggest challenges facing clinical research is the redundancy of solutions and their lack of integration with existing systems and tools. As an example, if we could determine how the needs of clinical research could be met by emerging electronic medical record systems, we could eliminate a lot of the redundant effort that exists today. Duffy. A fundamental hurdle in applying technology to a given business process relates to organizations having to rethink the way they work, how they behave, and how they are going to measure results. They have to know how to take raw data and formalize this into information sets that drive scientific and financial decisions. We, as an industry, collect a tremendous amount of data. But perhaps only half of the information is of value in terms of driving appropriate outcomes. The challenge is adopting technology in a way that allows us to understand the data so the information can be acted upon. Woodrum. The benefits of streamlining data collection will further compress trial timelines, which equates to shorter development cycles, and, by extension, increases the volume of novel therapies to address unmet medical needs. Waldron. By adopting well-integrated, common, standards-based e-clinical solutions, we have the potential to bring critical therapies to market faster, as well as increase the overall throughput of our drug development organization. Duffy. In the area of enterprise project management (EPM), I’ve seen technology deployed that helps forecast how much work the organizations can take on, how much they can afford, where they should prioritize some of their initiatives, and how they can best manage the process. Demand algorithms and past performance measurements are key inputs into developing a feasible operating plan for study and filing conduct. E-tools that enable customers the ability to continually balance resources against schedule, objectives, and deliverables are invaluable. We asked our Forum experts to gaze into their crystal balls and identify the e-clinical tools they think will make the biggest difference in the next five years. Waldron. Tools that are ubiquitous and provide benefits to all parties engaged in the process will have the biggest impact. I would count SAFE as meeting these criteria, as it would provide one globally accepted vehicle for authentication and digital signatures. Woodrum. Looking ahead, we’d like to have tools that break the paper barrier; tools that support secure authentication of the source of electronic messages and compliant electronic signatures; and tools that are based on data standards that support inter-operability and the exchange of information. E in Marketing and Sales Like their clinical counterparts, marketers from small and large companies are also looking to e-solutions to improve efficiencies, reach greater audiences, and provide compliance messages to their customers. Marino. The reality is that e-marketing is crucial as an effective tool for all companies. As new products become more difficult to launch and each promotional dollar must produce an efficient return, e-marketing emerges as a cost-effective solution for targeting the right customers. The reality of any promotional campaign in today’s cost-conscious pharmaceutical environment is that any media or mechanism that can effectively target the right customers to deliver the right message is one that is highly desirable. Lurker. E-marketing is beneficial and crucial to large and small companies. But it doesn’t just work by itself. It all comes down to the people who are working with the tools and executing. Certainly, large companies can afford to experiment more than small companies can. That said, the leverage is often greater for small companies. An e-marketing campaign could have a much greater proportional effect when used by a small company, because it doesn’t have the large marketing budgets in other areas, such as television and print advertising. Marketers in the life-sciences industry can benefit from more mainstream e-solutions, but they too have challenges that must be overcome. Marino. Direct measure of real effectiveness remains the key hurdle for the future of e-marketing. The beauty of e-marketing is its ability to know exactly which customers received the message, which allows us to assign and even measure some key attributes about its delivery. The Holy Grail of e-marketing is in determining exactly how effective a specific tactic might be such as an e-detail versus a more traditional approach such as face-to-face sales representative detailing or a journal ad insert. As we continue to experiment with these innovative ideas and approaches, eventually we will get much closer to the right answer. Lurker. Adoption is a huge challenge, but it can be overcome. Doctors need to become comfortable with any new technology. When doctors aren’t comfortable with a new technology, our jobs are more difficult. A significant shift is occurring that will alleviate this problem. First, older doctors are retiring. The younger generation is much more technology savvy. Currently, a key target audience has had no incentive to use technology in any sort of ubiquitous way beyond a desktop computer for their office systems. When the government applies mandates toward e-prescribing, this will require physicians to become more familiar with new technology. This will open the floodgates beyond e-prescribing. The adoption curve will be more pronounced, which will benefit all new technology implementations that touch the physician. We asked our participants to identify the tools that are making the biggest impact on their marketing strategies today and what they expect will be tomorrow’s go-to products. Murabito. For Cubist, the predominant tools we use are e-mail and e-detailing. We recently launched a new indication for our drug Cubicin (daptomycin for injection) using both e-mail and e-detailing. The response rate for the e-detailing platform exceeded expectations. We received almost an 8% hit rate against the Website presenting the information. Our initial expectations were only 2.5%. One of the obvious benefits to physicians is that they can access the information in their own time, and based on the amount of follow-up questions received, it is clear that they took great interest in the data presentation. Lurker. Of all the e-solutions used in this industry, Websites are currently making the biggest impact, and they have been for several years. They’ve been around a relatively long time compared with other tools, so it’s not surprising. In many instances, branded and unbranded Websites are the destination for many other forms of e-marketing, such as e-mail campaigns and Web-based advertising. Broadcast and print advertising are even driving traffic to the Web. E-marketing tools are great because it’s easy to track their usage, so we can quantify their effectiveness if we collect and analyze the data correctly. Marino. Websites have now become standard fare for delivering an effective and efficient interface between a variety of customers, for example physicians, patients, and pharmacists, and the pharmaceutical manufacturer. Yet the majority of Websites are fairly crude and have awkward interfaces with the customer. As the virtual, wireless world becomes a reality in the physician offices, so will the innovation of Websites to create a successful, efficient interface with the key customer and the manufacturer. In addition, e-detailing is a natural evolution of this technology, even though it will be like an interactive billboard on the electronic highway. Lurker. Over the next five years, as e-prescribing gains traction, more e-marketing tools will come to the forefront. Websites should continue to mature in terms of how they are used in an integrated marketing strategy and other tools will emerge in support of the overall strategy. Technology moves so fast, it’s almost impossible to predict with any certainty what the e-marketing space will look like five years from now. Marino. We need to ask ourselves: can a pharmaceutical product be launched virtually? Can a manufacturer reasonably expect to be able to sell a product completely through nontraditional means? Because of an increasingly difficult array of obstacles and hurdles in the physician offices, increasingly sales representatives can’t visit and meet with the right target customers. It is only a matter of time before some customers demand that their interaction be completely virtual; just note what has already happened in some major teaching institutions. Experimentation with a wide variety of e-marketing tactics, including e-detailing, will enable the industry to explore what works and what does not. The tools with the biggest impact will be the ones that can demonstrate a quick return on investment and success at generating new prescriptions. PharmaLinx LLC, publisher of the VIEW, welcomes comments about this article. E-mail us at [email protected]. thought leaders n Tim Duffy. Senior Director, Research, Development, Information Technology and Services, Cephalon Inc., Frazer, Pa.; Cephalon is a biopharmaceutical company that specializes in drugs to treat and manage neurological diseases, sleep disorders, cancer, and pain. For more information, visit cephalon.com. n Robert J. Knecht. VP and Chief Information Officer, Cephalon Inc., Frazer, Pa.; Cephalon is a biopharmaceutical company that specializes in drugs to treat and manage neurological diseases, sleep disorders, cancer, and pain. For more information, visit cephalon.com. n Nancy LurkeR. Senior VP and Chief Marketing Officer, Novartis Pharmaceuticals Corp., East Hanover, N.J.; Novartis has core businesses in pharmaceuticals, consumer health, generics, eye care, and animal health. For more information, visit us.novartis.com. n John Marino. VP, U.S. Marketing, Actelion Pharmaceuticals US Inc., South San Francisco, Calif.; Actelion is an independent biopharmaceutical company discovering, developing, and marketing drugs for high unmet medical needs. For more information, visit actelion.com. n Anthony Murabito. VP, Information Technology, Cubist Pharmaceuticals, Lexington, Mass.; Cubist Pharmaceuticals is a biopharmaceutical company focused on the research, development, and commercialization of anti-infective products that address unmet medical needs in the acute-care environment. For more information, visit cubist.com. n Joe Waldron. Executive Director, U.S. Region, Global Drug Development Information Services, AstraZeneca U.S., Wilmington, Del.; AstraZeneca focuses on six important areas of healthcare: cardiovascular, gastrointestinal, infection, neuroscience, oncology, and respiratory and inflammation, which represent the majority of the worldwide burden of disease. For more information, visit astrazeneca-us.com. n Tam Woodrum. Senior Director, IT Quality Management, Nektar Therapeutics, San Carlos, Calif.; Nektar is a biopharmaceutical company that develops and enables high-value, differentiated therapeutics using drug-delivery technologies, expertise, and manufacturing capabilities. For more information, visit nektar.com. Ms. Woodrum also is Chairperson of SAFE BioPharma Association Clinical Working Group, New York; SAFE is a nonprofit network of recognized trusted healthcare professionals that has developed and manages the SAFE digital identity signature standard and associated operating rules that deliver identity keys for regulatory compliant and legally enforceable digital signatures. For more information, visit safe-biopharma.org. October 2006 VIEW on E-Solutions Nancy Lurker Novartis Pharmaceuticals Of all the e-solutions used in this industry, Websites are currently making the biggest impact, and they have been for several years. We invest in tools that enhance R&D planning, execution, management, and control across the entire product life cycle. Tim Duffy Cephalon PharmaVOICE 2006 View on E-Solutions Survey 1. Challenges For E-Solutions We asked what impact recent regulations and guidances have had on their company’s online strategies. Fewer than a quarter of the respondents say they have been negatively affected. When asked to state which regulations have had the biggest impact, 21 CFR Part 11, HIPAA, and OIG were the most common answers. Impact Response % Regulations have had a positive impact 16% Regulations have had a negative impact 22% Neither positive nor negative 62% Note: Statistics are based on responses from 189 individuals. We asked our survey respondents to select the e-solutions that their companies are currently using to achieve business goals. Tactic Response % E-mail 86% Websites 84% CD-ROM/DVD 65% Electronic Data Collection (EDC) 43% Video 41% e-CME 26% e-Detailing 24% e-CRM 24% Podcasts 22% Other 20% Note: Statistics are based on responses from 181 individuals. We asked our survey respondents to rate the challenges they face using e-solutions on a sliding scale of 1 to 5 with 1 being the least challenging and 5 the most challenging. Tracking ROI was considered the greatest challenge. Tactic 1 2 3 4 5 Getting the creative right (when applicable) 19% 25% 28% 16% 12% Working with multiple technology partners 9% 15% 31% 27% 18% Complying with regulations/policies 14% 18% 33% 23% 11% Integrating offline initiatives 7% 22% 33% 26% 12% Integrating other online initiatives 7% 23% 40% 23% 8% Completing a project on budget 19% 21% 30% 20% 10% Completing a project on time 13% 20% 23% 26% 18% Tracking ROI 11% 11% 14% 33% 31% Note: Statistics are based on responses from 189 individuals. 2. Working with Technology Parters We wanted to know what criteria our participants used to evaluate a technology partner. It’s no surprise the partner has to be able to do the work, but cost and an existing business relationship were also leading selection factors. Criterion Response % Capabilities 94% Cost 78% Reputation 58% Existing/prior relationship 53% Therapeutic expertise 33% Global reach 28% Management 23% Organizational structure 9% Other 10% Note: Statistics are based on responses from 158 individuals. Because of the number of functional areas that depend on e-solutions, we asked our participants how many technology partners they work with. Partners Response % 0 to 5 69% 6 to 10 19% 11 to 15 5% 16 or more 7% Note: Statistics are based on responses from 162 individuals. We also asked our participants what percentage of their e-solutions work is outsourced. Percentage Outsourced Response % 0% to 20% 37.7% 21% to 40% 20.1% 41% to 60% 12.6% 61% to 80% 16.4% 81% to 100% 13.2% Note: Statistics are based on responses from 138 individuals. 3 Investing in E-Solutions We asked our survey respondents to evaluate their e-budgets based on the past 12 months and the next 12 months. Past Next 12 months 12 months Decreased more than 50% 1.4% 2.2% Decreased 1% to 50% 4.9% 4.1% No change from the previous year 33.3% 23% Increased 1% to 50% 45% 51.8% Increased more than 51% 16.3% 13.5% Note: Statistics are based on responses from 141 individuals. We invest in tools that enhance R&D planning, execution, management, and control across the entire product life cycle. Tim Duffy Cephalon AstraZeneca has an entire program focused on driving drug-development productivity, and looking at ways to make drug development more efficient through the use of technology and accompanying standard, global processes. Joe Waldron AstraZeneca A huge advantage of e-clinical solutions is eliminating the burden of processing paper and the inherent time lag paper introduces into the process. Another advantage is monitoring the progress of a trial in real time. Tam Woodrum Nektar Therapeutics The reality of any promotional campaign in today’s cost-conscious pharmaceutical environment is any media or mechanism that can effectively target the right customers to deliver the right message is highly desirable. John Marino Actelion Accelerating E-Solutions with Digital Signatures In an exclusive interview, Mollie Shields-Uehling, President and CEO of SAFE-BioPharma Association, shares her views about the obstacles and opportunities facing advocates of e-solutions within the pharmaceutical arena and the progress the organization is making to improve the safety and reduce risks. E-solutions within the pharmaceutical industry promise to improve efficiencies and reduce costs. The pharmaceutical industry faces a powerful confluence of business-changing pressures. Patients and physicians want new and improved therapies. Wall Street wants higher profits. Politicians want lower prices. The long-held promise of reducing paper and streamlining processes through e-solutions has brought the industry closer to being more efficient and reducing cost, but there is still a ways to go. A group of pharmaceutical companies is committed to reaching these goals through an industrywide approach to breaking down the barriers that make exchanging information costly and burdensome. The group, SAFE-BioPharma Association, was formed by Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, AstraZeneca, Procter & Gamble, and Sanofi-Aventis. The organization is focused on supporting the migration from paper to electronic transactions through an industrywide digital identity and signature standard. PharmaVoice. Some people estimate that 40% of all R&D costs and 33% of all healthcare costs are associated with paper-based process. How can e-solutions reduce costs and improve efficiencies? SHIELDS. A lot of smart people within this industry have been looking at improving the exchange of information across many boundaries. The companies have reasonable control over information exchange within their organizations. The inefficiencies become evident when information needs to be exchanged with outside entities. For example, drug discovery and development is a multicollaborative process that involves constant exchanges of information with outside entities. These entities can be medical institutions, other companies, clinical investigators, and regulatory bodies to name a few. These exchanges are conducted against a complex backdrop of regulatory and legal requirements that historically require long and deep paper trails. PharmaVoice. How can companies make the evolution to a paperless environment? Shields. Paper processes have been unnecessarily expensive, and that must change. Management faces pressure from all quarters to reduce costs. At the same time, to attract investment, they must be more profitable. It is far more efficient for the entire industry to adopt a common approach than for each business to try to solve the problem independently. The banking industry has done it. The airline industry has done it. It is time for the pharmaceutical industry to do it as well. PharmaVoice. Why has it taken the pharmaceutical industry so long to address this problem? Shields. The biopharmaceutical industry is highly regulated and faces unique legal issues. It is a highly conservative industry and one that doesn’t turn on a dime. PharmaVoice. How will the SAFE standard help change that? Shields. The SAFE standard replaces the traditional wet signature with a digital signature. Once digital signatures are used, the ability to transmit documents, records, and other data in business-to-business and business-to-regulator transactions is streamlined. SAFE signatures meet U.S., E.U., and other legal and regulatory requirements. The SAFE digital signature is about as bullet proof as a digital signature can get. For a digital signature to be valid, there needs to be a very high level of identity trust that the person signing a document is who he or she says he is. The signature also needs to be very secure, and it absolutely must be legally enforceable. The signature is made secure using modern cryptography and information technology. It is made legally enforceable in several ways, including a closed user system that binds participants through a legal contract. PharmaVoice. Are there other applications for digital signatures? Shields. There are many. Pfizer is using the SAFE signature in an e-lab notebook application. The company also is using it to sign regulatory applications. AstraZeneca is using SAFE for regulatory submissions. Merck is exploring the SAFE digital signature in a product sampling program. Within J&J, where most employees have been credentialed to use SAFE digital signatures, all digital signatures use the SAFE standard. Procter & Gamble is using SAFE as its enterprise digital signature. And Bristol-Myers Squibb is testing the SAFE standard to authenticate the identity of some of its external partners. For more information, visit safe-biopharma.org. SAFE-BioPharma Association is focused on supporting the migration from paper to electronic transactions through an industrywide digital identity and signature standard. Mollie Shields-Uehling E-solutions are part of our overall IT strategic plan. Our approach centers on deploying a base infrastructure initially and then constructing appropriate e-solutions. Anthony Murabito Cubist
