News

EU inspectors tap CDISC in GCP guidance

George Miller — Mon, 30 Aug 2010 07:08:18 -0400

Twelve user requirements for source data developed by CDISC form the basis of the European Union's expectations for the handling of electronic data in clinical trials. The principles embodied in the 12 requirements, detailed in the CDISC Standards and Electronic Source Data within Clinical Trials, 20 November 2006, "provide a good basis for the acceptability of source data," according to the EU's reflection paper, and therefore represent good clinical practice.

The EU GCP Inspectors Working Group has sorted the 12 tenets into five topics: system creation and modification; data creation, modification and transfer; source document control; copying; and storage. The document represents the current expectations of GCP inspectors: "Any departure would need to be justified."

Ultimately, "integrity of data must be confirmable," the document says. To protect patient safety, all data must be available to the investigator. Data held by the sponsor should be verifiable by a copy held elsewhere.

- see the paper

Better modeling to reduce animal testing

George Miller — Mon, 30 Aug 2010 07:07:12 -0400

Drug testing via computer modeling, virtual tissue, and human and animal cells are helping the pharma industry move away from the use of animals as primary test subjects.

Researchers recruit tens of millions of animals annually for drug testing, reports The Baltimore Sun. Eighty to 800 are needed per drug.

Robert Kavlock, director at the EPA's National Center for Computational Toxicology, says animals represent the current "gold standard" in drug testing, according to the article. "But there is a collective recognition that we need to do better." And there are solid practical reasons to move away from the use of animals. A chemical that costs $6 million to $10 million to test might yield computer test results for "more like $20,000."

- here's the article

Related Article:
FDA, Tox21 try IT in place of animal tests

Risk approach comes to site monitoring

George Miller — Mon, 30 Aug 2010 07:06:12 -0400

An emerging risk-based approach to site monitoring uses partial source document verification in place of traditional full source document verification (SDV) coverage. In the risk-based approach, monitoring targets the most critical review activities at sites requiring the highest level of attention.

The approach promises a clinical trial database of equal or higher quality than that of full SDV, argues Ashwin Mundra of Medidata Solutions. The effort required in providing full coverage could divert attention away from such monitoring activities as focusing on SDV review of the most critical efficacy and safety data and assessing site protocol compliance.

Among the considerations for researchers interested in using a risk-based approach is focusing more SDV coverage on the most critical data: primary endpoint data and key safety data, including adverse events. Another consideration is to require higher SDV coverage on the first subjects enrolled at each site to establish a data quality standard.

- here's the article

Researchers pit local vs. cloud clusters in compute-intensive race

George Miller — Mon, 30 Aug 2010 07:05:10 -0400

A Stanford team has staged a 13-billion computation drug discovery race, pitting a 198-CPU HP compute cluster against 198 CPUs on a virtual machine in the Amazon cloud. Both platforms ran the same code. The local cluster edged out the virtual cluster by about 12 hours over the six days each system required to complete the analysis, reports genomeweb. But the local cluster also finished more costly over time. Article (subscription required)

Grass-roots effort drives cloud business case

George Miller — Fri, 27 Aug 2010 08:24:23 -0400

At Harvard Medical School, the IT department has become both business partner and service provider to users. The venerable institution has built a cloud computing solution based on user participation, and in so doing built its business case for the cloud.

IT charges a usage-based fee for storage and computing services and a separate fee for a network node. Users can reduce their fees by donating computing resources to the cloud. The model is a good fit with drug discovery and development users, whose computing demand fluctuates widely over time.

The school's cloud is growing by orders of magnitude, says CIO Marcos Athanasoulis, in SearchCIO. Because all users are part of the computing solution, they've become engaged in requirements.

Athanasoulis says he used an iterative development process to address concerns specific to the biomedical area. As a result, people are moving from designing giant projects to trying pieces of them in the cloud.

- here's the article

Decision tree helps IT discern cloud fit

George Miller — Fri, 27 Aug 2010 08:22:53 -0400

Cloud computing, despite its various forms, is not for everyone. To help IT management consider the computing and storage option, The Open Group Cloud Computing Work Group has drafted a cloud buyers' decision tree to help prospective adopters navigate the maze of public vs. private, and software vs. platform vs. infrastructure as a service.

The 10-node tree is in the form of a 37-page proposal from the group's Cloud Business Artifacts Project. The bulk of the document is devoted to the line of questioning that prospective cloud users might follow in their decision-making. The questions are followed by a description of decision tree paths and then solution considerations.

The authors note that the tree also works in reverse; it can help cloud service providers identify the business situations for which a cloud type is best suited.

The first branch of the tree involves the question, "is your business situation vertical?" Definitions and an explanation of objectives follow, leading to the second branch: "Are the processes differentiating?" Successive questions take the user through impediment and infrastructure considerations.

- see the paper (free sign-up required)

Roche writes social media rules for employees

George Miller — Fri, 20 Aug 2010 15:01:35 -0400

Drug giant Roche has taken the lead by publishing guidelines for social media. They're written for employees, but posted for all the world to see. The Social Media Principles, which incorporate elements from a company code of conduct, guide employees on both personal and professional social media use. Article | Roche social media site

UK study supports dose-response modeling

George Miller — Fri, 20 Aug 2010 14:53:42 -0400

Researchers studying an overactive bladder treatment have concluded that dose-response models can be used to predict outcomes for doses not studied.

Assessing the dose-response relationship for the antimuscarinic drug fesoterodine wasn't possible using available Phase III trial data because the trials involved only two doses levels. Data on additional doses was required for modeling purposes, so the researchers included stats from earlier-phase trials that studied three doses.

Dose-response data can be obtained directly from clinical trials, the researchers say. They were led by urogynecology professor Linda Cardozo at King's College Hospital in London. However, the study of multiple dosing regimens, which can generate many endpoints, is both costly and problematic. Model-based drug development, by contrast, provides a supplemental means of assessing dosage-increase risk and benefit.

Using the technique, they demonstrated a consistent dose response for fesoterodine in bladder diary endpoints. Their results support the greater efficacy seen with the 8-mg dose found via post hoc analyses of clinical trial data.

- here's a summary

Related Article:
Research group aligns screening tools

Google-like code aids drug development

George Miller — Fri, 20 Aug 2010 14:52:37 -0400

A new generation of companies with more powerful computer technology is applying itself to the business of drug development. And among them is Numerate of San Bruno, CA.

Numerate uses Google-like code to develop drugs, says the San Francisco Business Times. The paper profiles several Bay Area companies that are using algorithms and cloud computing to sort through compounds "faster than ever before to design, create or redirect compounds, then decide whether to test the drugs in humans."

Numerate was recently awarded a patent for methods of using biological assay data to develop predictive models. The models, according to the company, boast accuracy comparable to that of lab testing.

Its approach involves a statistics-based method of discerning what compounds a company might pursue given the discovery and development data it already has. That strategy, says Numerate, contrasts with more traditional assumption-based methods that attempt to "simulate nature."

- see the article (subscription required)
- here's the patent release

Top 10 list rejects cloud for clinical data

George Miller — Fri, 20 Aug 2010 11:34:26 -0400

The debate continues over whether cloud platforms can secure highly sensitive clinical trial data and health records. But eWeek makes no bones about its position in a top 10 list of why it's a bad idea to store such records up there.

The 11-slide presentation encapsulates both well-known and less-well-known arguments for data storage via local services rather than an Internet-based, on-demand system. Among them: the highly sensitive nature of the data makes it a hacker target from the get-go.

Trust is a factor that runs throughout the list: trust in the cloud service provider that it can and will restrict access to the barest minimum, that it truly de-personalizes data, and even that it will still be in existence tomorrow.

A disclosure statement concerning source material explains the anti-cloud bias. But the list remains a useful one.

- here's the slide show

Cloud to host Saffron predictive analytics tool

George Miller — Fri, 20 Aug 2010 10:18:03 -0400

Start-up RedOak Logic is entering the decision-support business for drug development. Its cloud-based, data-analytics platform, currently in beta testing, aims to capture and make use of public, proprietary, structured and unstructured data for decision support.

The solution hails from esoteric territory--it's based on the Saffron Natural Intelligence Platform, an associative-memory technology for predictive analytics. Saffron introduced version 8 last March.

RedOak CEO Dale Fedewa says in an announcement that the company was formed to create a "Saffron-based experience management solution to redefine the way drug manufacturers bring products to market." RedOak customizes the application interface of its platform to each drugmaker client. The software vendor says it anticipates use-based pricing. Product availability is projected in 2011.

- here's the RedOak release

NIH funds software-based brain plasticity trials

George Miller — Fri, 20 Aug 2010 10:07:15 -0400

The National Institutes of Health is funding development of software to help stroke victims and schizophrenia sufferers. The $3.65 million comes in two grants to a company that specializes in treatments based on principles of brain plasticity, the science of driving brain changes through cognitive exercise.

Brain Plasticity will use the funding for both software development and clinical trials.

The trials concern cognitive exercises and a software-based program for the treatment for hemi-spatial neglect, a consequence of some strokes. The condition can leave sufferers unable to notice or interact with half of their visual world and it can lead to long-term disability, says BPI in an announcement. The effort furthers research into the use of cognitive exercises to improve brain function in normally aging individuals.

The schizophrenia effort involves development of a cognitive remediation program involving software to improve memory and attention. Such improvements may help patients live more independent lives.

- here's the announcement

Lit search used to personalize cancer cures

George Miller — Sun, 15 Aug 2010 10:29:18 -0400

An attempt to crack the melanoma-treatment nut has researchers working on the means for personalized cures through automated literature search. Their goal is to develop a targeted therapy database that matches patient molecular profile with current cancer biology knowledge.

The literature search targets scientific evidence about three types of molecular interactions: those involving the anti-melanoma efficacy of a therapeutic agent; those involving the toxicity of any such agent; and those involving an increase or decrease in efficacy following modulation of functional state. Data in the database are annotated manually and then gathered in a formal representation for computational analysis. Algorithms identify prevalent therapeutic hypotheses and rank treatments based on patient molecular profile.

The database is publicly available. Validation of prediction performance remains before the model can be implemented in the clinic.

- here's the paper

Segregating trial data may ease EMR concerns

George Miller — Sun, 15 Aug 2010 10:27:35 -0400

Storing information obtained during clinical trials within a segment of an individual's electronic record that's marked "research" may help ease patient concerns about sensitive data getting into the wrong hands. The research data segment of an EMR could have greater protection through additional security keys and a requirement for patient permission to access. The security problem needs to be addressed if researchers are to benefit from EMRs; survey data show that three-quarters of the public remains unconvinced that such records can be protected from unauthorized access. Article

iPhone app helps to ID adverse events

George Miller — Fri, 13 Aug 2010 11:28:55 -0400

The National Cancer Institute's Common Terminology Criteria for Adverse Events handbook has been turned into a free app. The book lists adverse events that may occur in clinical trials.

The biomedical informatics group at Children's Hospital of Philadelphia created the tool, which lets iPhone- or iPod-equipped doctors and nurses leave the 200-page reference on the shelf when they go on rounds.

A local press report says that the classifications used in the handbook originated in oncology but have broader application in clinical trials for other conditions. Developers say that in addition to boosting efficiency, the app has potential for standardizing care delivery.

- see the article from Biz Journals

Database breaches remain healthcare vulnerability

George Miller — Fri, 13 Aug 2010 11:16:02 -0400

The healthcare industry boasts three times the number of data breaches as the financial industry so far this year. The most frequent causes include lost and stolen laptop computers, back-up tapes, hard drives and other portable media.

Lincoln Medical and Mental Health Center in New York provides an example. A FedEx package it sent to its billing processor carried CDs with unencrypted data. FedEx lost the shipment--and along with it the personal information of more than 130,000 of Lincoln's patients.

Lax data-handling procedures for storage and access within databases, along with data portability, are big parts of the problem. Another reason is past-prime gear: "Healthcare database technology is still older and a lot of it is proprietary," says a data security consultant in Dark Reading.

- see the Dark Reading article

Data-sharing helps researchers in Alzheimer's fight

George Miller — Fri, 13 Aug 2010 11:15:11 -0400

Jason Karlawish has a message for drug researchers who are protective of discovery and development data: "Get over it."

Karlawish is an Alzheimer's researcher at the University of Pennsylvania. He explains in the New York Times that assembling Alzheimer's discovery and development data requires tremendous effort and promises such limited return that drug companies shy away. The researcher says shortening the onerous Alzheimer's drug development process requires a common data set, available to all, built from commercial and academic contributions.

The Alzheimer's Disease Neuroimaging Initiative is just such collaboration. Both commercial and academic researchers are using its biomarker data, to the tune of 3,200 data-set downloads and almost a million brain scans. The initiative has yielded scientific papers on the early diagnosis of Alzheimer's; dozens of studies are testing treatments.

It's still an odd concept for scientists: surrendering ownership of data so that others may build on it. But the idea involved the National Institutes of Health as a go-between for the commercial and academic players.

- here's the NY Times article

Related Article:
Big pharmas to share Alzheimer's drug data

Report: India sees rise in trial deaths

George Miller — Tue, 10 Aug 2010 13:13:35 -0400

While informed consent and fastidious data capture are important in clinical trials everywhere, they are now perhaps even more so in India, where the nation's drug controller general is expected to propose penal provisions for clinical research misconduct, following the 462 trial volunteer deaths counted through June.

The action comes as India continues to enjoy big-pharma and big-CRO interest in conducting trials there. Some experts estimate that it is as much as 60 percent cheaper to conduct trials there than in the U.S.

Data from India's Union Health Ministry tell the story. The 462 deaths through June mark a pace that will exceed the 637 deaths of last year, reports Indian Express. And it already exceeds the 288 and 132 deaths for the full years 2008 and 2007, respectively.

The ministry says the deaths may be due to disease-related reasons or unrelated causes, rather than trial participation itself. But a case in which four girls died after vaccination during the trial of a human papilloma virus (HPV) prophylactic fuels the fire. It's still being investigated and officials have halted the trial.

India has granted permission for about 250 trials in the first half of 2010--117 for international companies and 134 for local drugmakers. That's slightly ahead of pace compared with the 453 total trials of 2009, but roughly on par with 2008's 521 trials.

- see the story

Online tool aid patient access to experimental drugs

George Miller — Mon, 09 Aug 2010 08:10:59 -0400

In an effort to help doctors navigate the regulatory maze required to get investigational treatments for patients--as opposed to getting them for research purposes--the American Society of Clinical Oncology and the FDA have developed three educational modules. The course walks physicians through the process of gaining access to the drugs, providing a process overview, help in completing the application, and responsibilities concerning informed consent. The modules are free, and include links to templates for use in the process. Article | Modules

Michigan researchers to gain in IT makeover

George Miller — Mon, 09 Aug 2010 07:52:03 -0400

The University of Michigan Health System has decided on the primary-vendor model for a far-reaching, multi-year IT upgrade. The university, working with Epic Systems, intends to continue using its best-of-breed technology tactic. Epic products will replace or augment the existing clinical, research, quality and business applications developed and purchased by the university over two decades.

In textbook fashion, UMHS and Epic are beginning the process by studying process. Over the next few months, staff will analyze clinical and administrative processes that currently rely on information technology or paper and identify how researchers could leverage improved access to UMHS clinical information. One goal is to allow researchers to identify patients who might meet the criteria for clinical studies.

After the process analyses are complete, UMHS and Epic will "transform the way its physicians, nurses, other care providers and administrators use information technology in every U-M hospital, clinic and office," according to an announcement. The process makeover will encompass outpatient clinics and treatment centers, coding and billing operations, scheduling and registration systems, and emergency department. Epic systems will be used "almost exclusively." Plans call for a second contract to convert systems in the hospitals, pharmacies and central medical record operation. Smaller systems used in highly specialized areas are expected to follow beginning mid-decade.

- here's the U-Michigan announcement

Mayo Clinic to launch center for social media

George Miller — Mon, 09 Aug 2010 07:51:09 -0400

The University of Michigan is not the only health system strutting its IT savvy. The Mayo Clinic is launching a Center for Social Media to speed development of social media tools for its own use and to help other facilities in their efforts to connect patients and doctors online.

The Mayo Clinic already boasts 60,000 followers on Twitter, a medical provider channel on YouTube and several successful blogs, says sister publication FierceHealth IT. Lee Aase, manager of syndications and social media at Mayo, says he sees "immense interest from clinical departments--they want to be able to harness these tools to do their business," in the Wall Street Journal Health Blog.

Among the Center for Social Media services planned are online conferences and other events in which attendees learn from Mayo's experience and from each other. Such resources as manuals, books, policies and guidelines are planned, as is training for healthcare employees through webinars, in-person and on-site workshops and boot camps. An online curriculum also is planned for self-paced learning and review. Mayo will also make available consulting and coaching services to help organizations align social media strategies with business goals, as well as advising on planning and conducting outcomes research.

- here's Mayo's release
- see the article
- visit the website for Mayo's center
- read the Wall Street Journal Health Blog interview

Healthcare reform drives investor to IT opportunities

George Miller — Mon, 09 Aug 2010 07:49:46 -0400

Venture capital firm SV Life Sciences has positioned itself in the U.S. health IT sector, which it expects to bloom given incentives aimed at helping doctors automate. Its latest fund, the $523 million Fund V, targets companies that serve U.S. doctors, who now have a $17 billion motivation to adopt information technology, reports Xconomy.

The multimillions in incentives promised by the government are intended primarily to boost adoption of electronic medical records. So the technical terrain may appear familiar to SV, which funded e-clinical solutions provider Phase Forward more than a decade ago when the clinical trial discipline sprouted its automation wings. Phase Forward is now being purchased by Oracle.

SV doesn't restrict itself to solution providers. It helped launch IT staffing company Vitalize Consulting Solutions. The venture funds provider reasons that its own difficulty in finding solid health IT product companies to finance and develop was likely accompanied by a shortage of information technologists trained in healthcare apps.

- see the article

FDA, Tox21 try IT in place of animal tests

George Miller — Fri, 06 Aug 2010 09:45:27 -0400

Information technology is the lead dog pulling drug development away from animal testing. The Tox21 collaboration involves an under-construction database of 3,000 pharma and 7,000 environmental chemicals. Drug developers will use an automated system to screen sets of pharma chemicals in the database against animal and human cell targets, reports Bloomberg.

Tox21 is a collaboration of the National Institutes of Health and the EPA, which joined forces in 2008 to study chemical toxicity and improve risk assessments for environmental chemicals. The FDA joined last month. The Tox21 system promises a means of identifying compounds likely to have toxicity characteristics unacceptable for use in humans. Such identification will allow drugmakers enough insight to truncate costly development efforts prior to animal testing.

Drugmakers are already ponying up failed compounds to populate the database. Pfizer, the only one named as a contributor so far, donated 90 such candidates. Twenty of these had produced liver toxicity in rodents.

The Tox21 initiative helps the regulator with two of its objectives: first, to migrate away from animal testing for the sake of the animals. The second is to find ways to speed the process of bringing new drugs to market. Automated toxicity testing has the potential to lop off months to years of animal-test development time.

- here's the story

Related Article:
FDA joins Tox21 collaboration

Adaptive trial modeling solution aids dose-finding

George Miller — Fri, 06 Aug 2010 09:44:27 -0400

Trial design based on statistical modeling is likely to continue its rise in use given more frequent launches of adaptive trials, which suit dose-finding studies in particular. Trial design software maker Cytel has spotted this opening and launched Compass, a package for such studies based on frequentist or Bayesian methods.

Additional momentum for the use of modeling in clinical trials comes from recently installed NIH director Francis Collins, who advocates mastery of biostatistics for those working in biomedical research. "Not being able to understand a Bayesian analysis will no longer be tolerated," he says.

Compass provides a workflow for dose-identification study build using accepted adaptive methods, the company says. Its simulation engine quantifies design option decision-making. And visualizations of trial characteristics aid both researcher and regulator understanding of trial data.

Compass extends Cytel's solution portfolio: its East solution targets registration studies. And about a year ago, Cytel and the FDA's Center for Devices and Radiological Health joined forces to create Bayesian trial design and analysis software.

- here's the Compass release

Informatics app matches biosamples, projects

George Miller — Mon, 02 Aug 2010 07:32:17 -0400

A computer application called Crimson is accelerating the pace of translational research. The informatics solution helps to get blood and other biological samples to researchers.

Crimson is the brainchild of Lynn Bry, assistant professor of pathology at Harvard Medical School, who is highlighted in Science as an informatics solution developer who has combined computing knowledge with her clinical and research education. The idea for Crimson began during her pathology post-doctoral work, while she was the only holder of biological samples among her peers at a research lab for immunology.

Bry worked in conjunction with Daedalus Software to launch the application in 2007. Crimson matches samples to known research needs while ensuring patient privacy and regulatory compliance. It now receives daily feeds of information on thousands of blood, urine, tissue, cerebrospinal fluid, and bacteria samples from patients in Harvard-affiliated clinical and pathology labs.

- here's the article

Related Article:
Translational tool helps ID genetic markers

PPD, Microsoft team up for REMS management

George Miller — Mon, 02 Aug 2010 07:31:21 -0400

Adding to Microsoft's growing presence in the clinical trial business, contract researcher PPD says it's working with the software giant on a solution for managing REMS programs. The partners have agreed on a joint implementation based on Microsoft's data aggregation platform--the Amalga Unified Intelligence System--and HealthVault, a personal health application platform.

The concept involves a platform that connects all of the stakeholders involved in Risk Evaluation and Mitigation Strategy programs, which appear to be gaining traction with the FDA as a condition of drug approvals. The programs are driving collaborations not just among stakeholders, but also among units within stakeholder companies.

"Given the nature of REMS programs, multiple departments that traditionally worked together only in a peripheral way or during transitions are now jointly supporting products throughout their lifecycle," says Frank Gallo, executive director for risk management at PPD, in our collection of expert tips for REMS success. "Each department responsible for executing specific components of the program should be involved from the beginning of the process."

The partners are planning a system that will help users manage the operational components of REMS programs. It will incorporate elements to help users connect and manage program components while simultaneously tracking information from such sources as patients, healthcare providers and pharmacies.

There's no word yet on availability.

- see the PPD release

CRO lightens RA publishing load via SharePoint

George Miller — Mon, 02 Aug 2010 07:29:48 -0400

Clinical research service provider Montrium says it has streamlined the management and routing of clinical trial records for submission using a solution born of the partnership of compliance content software provider Adlib Software and Nintex, a Sharepoint solutions provider. The partnership has joined workflow tools from Nintex with Adlib's PDF for SharePoint automated publishing and rendering engine.

Montrium says also that the software has allowed the CRO to lighten the PDF publishing burden on its regulatory group. The solution is called Adlib PDF for SharePoint and Nintex Workflow. It's among the growing number of drug development tools based on SharePoint, which is fast becoming either the biotech IT holy grail or the subject of a hall-of-fame marketing campaign, as we've reported.

The partners say the offering allows users to render documents within larger business workflows and deploy them via Nintex Workflow. One example is the automatic conversion and distribution of documents in a secure PDF format after document approval; another is document conversion to PDF/A as part of an archiving process.

- see the Adlib release

Report: Amazon, Lilly split over cloud liability

George Miller — Mon, 02 Aug 2010 07:28:36 -0400

Eli Lilly may have split with Amazon Web Services in their much heralded cloud computing relationship. The reason: legal indemnification.

SearchCloudComputing.com reported the split last week, though it later posted a comment from Amazon saying that the cloud-pioneering drugmaker "has not dropped its use of AWS." Eli Lilly has not yet replied to a Fierce request for comment made late last week.

Accountability for network outages, security breaches and other forms of risk is cited as the sticking point, and it's becoming an issue as companies in various industries send more of their data to cloud networks. The article says that the drug giant wants AWS to assume greater liability in case of breach or outage.

- here's the article

Omnicomm buoyed by e-clinical licensing deals

George Miller — Mon, 02 Aug 2010 07:23:58 -0400

Licensing contracts have given e-clinical solutions provider OmniComm a big first-half boost. The company reports a 51 percent increase in new tech-transfer licenses over first-half 2009, surpassing $6.9 million. Such licensing accounts for 70 percent of new business while it represents 44 percent for the company's business overall.

Software-as-a-service contracts have shown a "steady increase," according to a statement. The company says also that it has "seen some signs of increased spending in the clinical trial R&D arena."

Omnicomm maintains a roughly even presence in life sciences sectors, including biotech, academic/research, CRO, medical device, and pharma.

- see the Omnicomm earnings release

Related Article:
OmniComm unleashes products, wins

ISI eyes step up to digital signature solution

George Miller — Mon, 02 Aug 2010 07:20:42 -0400

"Remarkably little" case law over the last decade, when electronic signatures began to gain traction, fleshes out legal requirements for their validity, says corporate litigator David Isom of Information Law Group. But the 21 CFR Part 11 provision for them is helping. Several vendors provide e-signature systems, often PDF-based; among them, ISI. VP Ken VanLuvanee says in an interview that while electronic signatures suffice for closed systems, digital signatures--encrypted electronic signatures--are required for use in open systems. ISI currently provides an electronic solution, eCTDXPress, for FDA filings. But VanLuvanee says the company "is having conversations with SafeBiopharma," the life sciences digital signature champion. Article