Biotech IT News

Startups ease access to online data on medical product side effects

Ryan McBride — Tue, 31 Jan 2012 18:08:20 -0500

The FDA has digested huge amounts of data on the hazardous effects of medical products for decades, and some entrepreneurs have set out to turn a profit from the information. Two recently launched startups aim to make FDA records easily searchable for healthcare professionals and individuals, feeding cravings for health information on the web, The Wall Street Journal reported.

AdverseEvents (a name that leaves little doubt what business the company is in) offers free online searches on bad drug reactions for thousands of products, while a separate group called Clarimed provides a similar service for searching adverse events related to medical devices, according to the article. Take notice drug and device makers: It's become increasingly easy for anyone with a web connection to find out about the disastrous results of using certain medical products.

"We think it's important for this information to be framed within context and to be properly evaluated," Kate Connors, a PhRMA spokeswoman, told the WSJ on behalf of the pharma industry group. She added that people should go to the FDA for information about adverse events.

Yet patients could find details on adverse events related to their prescription drugs well before the two startups rolled out their services, even without having to file public records requests with the FDA. For instance, Quintiles' online service now called MediGuard went live in 2007 and lets patients find facts about the safety risks of their meds and hazardous drug interactions. It's well known that the Internet is often one of the first places people turn for health information, and MediGuard has been able to attract 2.5 million registered users.

Given the rush to the web venue for health information, drug companies are keeping a close eye on their online profiles and appear to have plenty of incentives to do so.

- check out the WSJ article

Related Articles:
EU moves toward web portals for adverse events
Supreme Court OKs biotech lawsuits based on adverse events

Google Ventures, VCs backing tech focused on genomics

Ryan McBride — Mon, 30 Jan 2012 09:32:34 -0500

In its examination of the many potential challenges in genomics, Bloomberg made note of how venture capital is playing a role in advancing technologies that aim to tap the full potential of genomic data. Krishna Yeshwant, a partner at Google Ventures, told the news service that Google's ($GOOG) venture unit has placed a "significant" bet on startups in this field. Last year, the group backed Mountain View, CA-based DNAnexus, which provides software for analyzing genomic data, and Cambridge, MA-based Foundation Medicine, which is using DNA sequencing data to develop cancer diagnostics and other products. The article also mentions venture-backed GenomeQuest, a Westborough, MA-based provider of genomics software. Article

Clinical IT outfit upsizes as Big Pharma customers downsize

Ryan McBride — Mon, 30 Jan 2012 09:15:39 -0500

BioClinica ($BIOC) has plans to hire 55 people this year as the provider of clinical trials software and imaging services scales up its operation, which serves companies--such as Pfizer ($PFE)--that are trimming their ranks, The Philadelphia Inquirer reports.

Newtown, PA-based BioClinica has been buying up clinical trials software providers over the past several years, capitalizing on the digitization of clinical data that used to be managed with paper-based systems. And part of its business serves drug developers that outsource the management of images from clinical trials to BioClinica, saving those companies the expense of having to do the work with their own staffs.

"Big Pharma is changing, and small pharma comes and goes," Mark Weinstein, BioClinica's CEO, told the newspaper. "At any point in time, we're working with close to 200 companies. But what changed for everybody is the business model. That is the whole issue of sticking to your core competencies and outsourcing everything else. We're saying we have a low-cost alternative to what you used to do in-house, and we come and go as you need our services. Big Pharma has had monolithic organizations with thousands of people and now is saying, 'I want only hundreds of people, but I need the same services, so where do I go?'"

BioClinica has been among companies such as Oracle ($ORCL) and Medidata Solutions ($MDSO) that have scooped up smaller companies in the clinical trials software business, and all three companies are rivals in the rapidly growing market for clinical trial management system (CTMS) software products. CROs and drug companies are making use of the tools as well as they streamline clinical trials operations. Major drugmakers--including BioClinica's big customer Pfizer--have also axed jobs in R&D and handed the work to outsourcing partners to trim expenses.

- read the Inquirer's article

U.K. genomics database plan faces hurdles

Ryan McBride — Mon, 30 Jan 2012 07:57:49 -0500

Now that the cost of sequencing DNA is quickly plummeting toward $1,000, some scientists in the U.K. are backing a plan to put citizens' genomic data into a national database. Advocates argue that the DNA database would help deliver on the promise of genomics in healthcare, but critics point out the potential high cost of the endeavor and question the utility of the database, The Telegraph reports.

The U.K.'s Human Genomics Strategy Group, which has written a report on the topic, is backing the plan for a national genomics database. Patients would benefit from their doctor having the data to tailor treatments according to their genetic traits, while pharma companies could tap the resource to aid in the development of new drugs. "It's almost impossible to go forward with the whole personalized medicine agenda, unless you have this database," Sir John Bell, chair of the group, said, as quoted by The Telegraph.

Too bad the costs of the IT infrastructure that would be needed to support such a database aren't falling as fast as the cost of whole genome sequencing, which can now be done for around $5,000 per genome. Then there are questions about what value can now be drawn from having the sequencing data on an individual. So many mysteries still lie within a person's genome, so sequencing it doesn't immediately mean that the data can be used in medicine. In cancer treatment, however, genetic data have paid off for patients and drug developers.

There are still serious questions about how far and fast the plan will advance, the U.K. newspaper reports, especially since the British government recently scrapped plans for a £12 billion IT program that involved storing everyone's electronic health records in a national database. A genomics database would involve much more complex data than that commonly found in electronic health records.

- get more in The Telegraph's article

Covance's big IT budget gets thumbs down from analysts

Ryan McBride — Thu, 26 Jan 2012 12:39:54 -0500

Covance ($CVD) wants to reduce annual increases in its information technology budget, but the big CRO told investors Wednesday that it was going to have to make some major investments in the short term to save money in the long term. Yet the dour outlook on earnings for this year weighed on the company's stock price, which sank more than 8% during regular trading Thursday.

This year, Covance plans to pump $90 million into revamping its IT, a 17% increase in spending on such technology according to its annual report. The CRO plans to boost that budget 18% in 2013 as the IT overhaul continues, but the new systems are expected to keep increases to that budget below 10% for several years afterward--lower increases than in the past several years. The major IT initiatives on its plate include consolidating its data centers and infrastructure, adding end-user productivity tools and updating the systems for its central labs.

The IT spending illustrates the growing importance of tech in the research and development of drugs, and Covance is among large CROs that have been plowing money into new IT systems to streamline operations in their labs and clinical trials. And drug developers have been adopting web-based software and cloud apps that promise to help them reduce investments in managing software on their own hard drives.

Nevertheless, Covance and its publicly traded counterparts are, of course, under pressure to deliver strong financial results in the near term, making long-term investments in technology a tough sell in some cases.

Covance's increased investment in IT in part and "further spending growth in 2013 throws cold water on the normal ebullient thesis" that "next year will be better," David Windley, an analyst at Jeffries & Co., wrote to investors, as quoted by Outsourcing-Pharma.

- download Covance's investor presentation here
- read more about the IT spending in Outsourcing-Pharma

Gamers tackle enzyme makeover, beat scientists' efforts

Ryan McBride — Wed, 25 Jan 2012 13:17:06 -0500

Online players of the video game Foldit have notched another first. With a bit of guidance, the players were able to redesign an enzyme and improve its potency, and it's the first time crowdsourcing has been used in this way, Scientific American reported. And the feat is further proof of how the wisdom of many amateurs can potentially trump that of several experts.

Foldit players, who previously gained acclaim for solving a structural problem for an HIV-related enzyme that had stumped scientists for years, have taken their game to a new level with their latest accomplishment. Their efforts resulted in an enzyme that is eighteenfold more effective than the original, Scientific American reported, and the next challenge the gamers plan to tackle is designing an improved protein inhibitor of the 1918 pandemic flu virus.

Scientists at the University of Washington, where Foldit was created, had tried to use computers to engineer an improved version of an enzyme used to catalyze a reaction in synthetic chemistry. But their redesigned enzyme lacked punch, so they later brought the problem to Foldit's player community, which now has about 240,000 registered users, according to Scientific American. And the collective efforts of Foldit players resulted in a better enzyme design than what the UW scientists produced.

"I worked for two years to make these enzymes better and I couldn't do it," Justin Siegel, a post-doctoral researcher at UW, said, as quoted by Scientific American. "Foldit players were able to make a large jump in structural space and I still don't fully understand how they did it."

UW isn't the only group that is seeking computing capacity and brainpower from crowds. At McGill University, for instance, researchers have developed an online game that lets players correct misaligned DNA sequences, and players have been put to use in studies of hundreds of disease genes.

- here's the Scientific American article
- check out the piece in Ars Technica

Emerging player in DNA analysis joins forces with U. of Missouri

Ryan McBride — Tue, 24 Jan 2012 11:30:14 -0500

Appistry, a recent entrant in the game for providing analytics for genomics data, has picked up a partnership with the University of Missouri. The university is tapping Appistry's system called Ayrris/BIO for analyzing data from DNA sequencing machines as its researchers hunt for meaning in the data in a variety of fields, the company said today.

The genomics field has attracted a bevy of new players from the software world. Appistry, for example, emerged on the genomics scene after launching a life sciences group in September, having previously worked on complex data analysis for customers in defense, financial services and for FedEx, which uses the St. Louis-based company's technology to plan delivery routes, Sultan Meghji, Appistry's vice president of analytics applications, told FierceBiotech IT.

The opportunities in genomics for Appistry and its competitors are huge. Life Technologies ($LIFE) and Illumina ($ILMN) are rapidly bringing the cost of sequencing a whole genome to about $1,000, and the volume of data generated from the experiments is expected to soar as the low cost of sequencing makes it more accessible to more researchers than ever before. Though sequencing has become cheap, analyzing and storing the data add significant expenses for researchers. And Appistry's Meghji says his company's Ayrris tool does the job of analyzing a single genome for about $250.

Oracle ($ORCL) and other software players have been elbowing in on the analytics action as well, aiming to enable biomedical researchers to make practical use of such data.

At the University of Missouri, researchers plan to use Ayrris/BIO to speed their work around sequencing and bioinformatics and the company's storage system to relieve some of its own data management woes, according to Appistry's release.

"Our ability to quickly and efficiently carry out the early and secondary analysis of sequence data to answer important questions about plant, animal and human genomics problems with new state of the art technologies is like the opening of a new bridge on the path to discovery," Gordon Springer, scientific director of the University of Missouri Bioinformatics Consortium, stated. "Where we end up is unknown, but that's what makes it so exciting; to be able to discover new things about ourselves and nature."

- here's the release

Related Articles:
Life Technologies' latest DNA sequencer targets informatics 'bottlenecks'
Big $125M genome center set to start in the Big Apple
Oracle injects genomics capability into analytics platform

Oracle injects genomics capability into analytics platform

Ryan McBride — Mon, 23 Jan 2012 10:36:17 -0500

Oracle ($ORCL) wants to help drug researchers tap and analyze genomic data that are vital to the development of personalized therapies, which have already become key weapons in the war on cancer. The software giant plans to announce today how the company plans to do this with a new "omics" databank that becomes the newest addition to a health data aggregation and analytics platform unveiled in September.

The databank bridges a gap in the original release of the platform, dubbed Oracle Health Sciences Translational Research Center, which initially focused on enabling analysis of electronic medical record (EMR) info but lacked the same capabilities for genomics data, Kris Joshi, the company's VP of healthcare product strategy, told FierceBiotech IT. Now the platform adds the new "Omics Data Bank" to integrate DNA sequencing and gene-expression data, which can come from users' own internal labs and external sources such as large public datasets.

It's a key step for Oracle in healthcare. Drug companies, a prime customer base for the translational research software, have become increasingly reliant on next-generation sequencing (NGS) data for research of drugs and diagnostics that serve specific patients based on their genetic traits. A great example of this is how Pfizer's ($PFE) recently approved lung cancer drug Xalkori calls for patients to be screened for anaplastic lymphoma kinase (ALK) gene expression before they take the med. With the new omics databank, Oracle wants researchers and investigators to be able to analyze patient disease and genomic data in a matter of seconds, shedding light on, say, whether the patient is a match for a drug study.

"It's really the cornerstone of our data integration and analytics strategy because it gets us close to being able to deliver real-time analytics," Oracle's Joshi said in an interview. "When you have such large volumes of data, one of the traditional models for analyzing that data has been to take high-performance computing ... and use algorithms that churn for weeks and days and actually produce insights. This doesn't completely make those kinds of algorithms redundant, but it provides a unique way of providing almost a real-time response in scanning across these very large datasets. We've highly optimized this so that physicians in 10 seconds can get the answers they want ... without running the big complex algorithms."

Oracle is marketing the platform to drugmakers, contract research organizations (CROs) and academic research centers. Joshi said the platform provides the technical backbone for a pilot electronic clinical research network under way in New York state as part of the Partnerships to Advance Clinical Electronic Research (PACeR). One of the benefits of the network is enabling researchers to conduct searchers of electronic records to find patients for clinical studies, and drugmakers such as Pfizer, Merck ($MRK), Roche ($RHHBY) are backing the effort and willing to pay large sums for such searches.

- here's Oracle's release

Oracle, Parexel among leaders in CTMS market poised to hit $1.3B

Ryan McBride — Mon, 23 Jan 2012 09:06:02 -0500

Drug developers have been aiming to maximize efficiency in notoriously expensive clinical trials, and they have increased investments in clinical trial management system (CTMS) software to streamline clinical operations. Now the market for the software, which has been a hot commodity in recent tech buyouts, is expected to jump from $567.2 million in 2010 to $1.3 billion by 2016, market research firm MarketsandMarkets reports in a new study.

Those numbers are unlikely to shock the top players in the CTMS game, which include Oracle ($ORCL), Parexel International's ($PRXL) Perceptive Informatics unit, Medidata Solutions ($MDSO), eResearch Technology ($ERT) and BioClinica ($BIOC), according to a release on the study. For instance, Oracle boosted its CTMS stake through its buyout of Phase Forward in 2010, and Medidata made a move last year to scoop up Clinical Force to add that group's trials management app to its arsenal of hosted applications.

The new study blueprints where growth is expected in the market for CTMS products, which biopharma groups and CROs use to stay in control of multiple types of data involved in trial operations. With expected annual growth of 14.5% from 2011 to 2016, the market's greatest growth is forecast to come from sales of web-based CTMS products, according to MarketsandMarkets. In general, web-based and cloud-based applications have been attractive to drug developers because of the lower maintenance and IT infrastructure requirements than locally operated software. And the CTMS market appears to be evolving in a similar fashion.

- here's the analyst firm's release

Big Pharma testing waters with mobile tech

Ryan McBride — Mon, 23 Jan 2012 08:08:00 -0500

Developers of mobile technologies have made some inroads with deep-pocketed drugmakers, which have sought the help of new apps and devices to streamline the development, marketing and sales of meds. Tech and biopharma entrepreneurs are betting that Big Pharma has an appetite for more mobile innovations.

With drug companies struggling to run clinical trials efficiently and reap the most value out of existing brands, mobile tech players have the opportunity to provide apps that quell the problems. As cited by MobiHealthNews, analysts at research firm Cutting Edge Information recently highlighted opportunities for mobile health apps to aid drug companies in collecting clinical trial data and analyzing the info. The software startup Clinical Ink, of course, offers mobile devices for collecting trials data. Big Pharma companies might also be interested in apps that help clinical investigators attract patients for studies.

On the commercial front, big drugmakers have an incentive to invest in mobile technologies that could help boost sales of products. Biopharma mogul Dr. Patrick Soon-Shiong acquired Boston-area mobile health company Vitality in a deal announced last February. Vitality makes Internet-connected drug bottle caps that tell patients when to take their meds. Novartis ($NVS) is one of the large drugmakers that have worked with Vitality because there's an opportunity to increase adherence to prescriptions and sales of meds through use of the technology, according to Xconomy's article on the deal.

Augme Technologies and other companies have also found clients in Big Pharma for their mobile marketing offerings, MobiHealthNews reports.

Last month, Providence, RI-based Vertical Performance Partners, which makes companies' data accessible on the iPad, raised $1.5 million in venture money and has already attracted major biopharma customers such as AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Biogen Idec ($BIIB) and Vertex Pharmaceuticals ($VRTX), the Boston Business Journal reported.

Vertical Performance Partners' tech has applications in a number of industries, but the company has found an early sweet spot with biopharma customers. Such cases bode well for developers of mobile apps that are looking for viable markets for their products.

- check out the MobiHealthNews piece
- and the Boston Business Journal's article

Special Report: 10 mobile apps in life sciences

FDA brings new workflow software into its labs

Suzanne Elvidge — Mon, 23 Jan 2012 04:00:13 -0500

In the past, the FDA has been criticized for its "antiquated" IT systems--in 2007, the FDA's Subcommittee on Science and Technology described the FDA IT infrastructure as obsolete, unstable, and lacking sufficient controls to ensure continuity of operations or to provide effective disaster recovery services. The organization has been planning an IT overhaul since 2009; another step to bring its technology into the 21^st century comes through a new agreement with Abbott Laboratories ($ABT).

The FDA is licensing the company's STARLIMS technology, a laboratory information management system (LIMS) that is designed to improve the reliability of processes in laboratories, support compliance with regulations and industry standards, and provide reporting, monitoring and analysis capabilities.

STARLIMS will be installed in the FDA's Office of Regulatory Affairs (ORA) laboratories, where government scientists test food and drug chemistries, devices, forensics material and microbiology samples. The laboratories generate huge amounts of information, and using LIMS will help more than 800 users manage the work flow by providing support for sample accountability, data analysis, document control, report generation, and other lab operation functions.

"We're looking forward to working on this important initiative," said Isaac Friedman, head of Abbott's STARLIMS business. "STARLIMS has a successful track record in implementing web-based LIMS for life sciences organizations, public health laboratories and a number of federal agencies."

- read the press release

Consumers to pharma: Let's be Facebook friends (or not)

Ryan McBride — Sun, 22 Jan 2012 13:49:31 -0500

Drugmakers often get a bad rap among consumers for questionable marketing practices and events like the Vioxx scandal. Yet a consumer survey shows that, at least in online circles, pharma isn't as unpopular as one might think. According to Manhattan Research's ePharma Consumer study, four out of 10 people want pharma groups to be active in online health communities, and only two out of 10 people surveyed believed that drugmakers should stay away from such forums. Those numbers could be enough to further embolden many drugmakers' efforts to attract audiences on Facebook, Twitter and YouTube. Release

Medidata chief calls company 'the cloud' for clinical data

Ryan McBride — Wed, 18 Jan 2012 10:55:53 -0500

With IT systems playing a role in the transformation of clinical research, Medidata Solutions ($MDSO) plans to invest big in R&D to stay on the cutting edge of the clinical trials software game. A major component of its strategy is to provide the industry with a platform on which other applications are used to manage trials data efficiently.

"We don't see any finish line where we'll be done with our platform. The idea is to always think of what people will need in the future and to invest in things that will be useful for those clinical trial processes. If you look at companies in a similar position to us, you'd see something like five percent revenue being put back into R&D," co-founder and President Glen de Vries explained in an interview with Bio-IT World. "We put more than 15 percent revenue back into R&D. We see so much change coming in managing the clinical development process that we want to make sure we stay on top of those future requirements."

Medidata has been one of the pioneers in providing hosted electronic data capture (EDC) and clinical data management system (CDMS) software, and de Vries even told the magazine "we are the cloud for clinical data." In recent years, a bevy of other software developers have joined Medidata's partner network to allow users of Medidata's Rave to seamlessly use those other outfits' applications, positioning Medidata's technology as a platform for the industry. Yet the company has clearly had to reinvest a sizable amount of its revenue to stay on top of its game and compete with rivals such as Oracle/Phase Forward and droves of smaller players.

That said, Medidata has looked to expand its own offerings for the clinical research market, purchasing Clinical Force last year for its clinical trial management system (CTMS) product. And a major emphasis at the company, according to de Vries, is to catch the wave of clinical development outsourcing, helping CROs differentiate themselves with IT systems that help them run trials more efficiently. With drug companies/sponsors outsourcing more trials management work, Medidata has been working to build its CRO customer base.

- get more in the Bio-IT World interview

DecisionView updates clinical trial enrollment software

Ryan McBride — Tue, 17 Jan 2012 09:32:14 -0500

As drug developers struggle to tap patients for clinical trials, software maker DecisionView says it has enhanced its product for subject enrollment planning, tracking and cost forecasting. The company announced last week the latest version of its web-based software StudyOptimizer 4.4.

In many cases, trials don't go as planned because sites aren't able to recruit patients according to schedule. With hiccups like this in mind, DecisionView has tried to make it easy for biopharma groups to analyze "the time and cost trade-offs" of their enrollment strategies. Other features of the updated software include enhancements to cost tracking, cost planning, modeling cost adjustments, support for adaptive trials and investigator scorecards.

Patient recruitment and enrollment is one of the biggest expenses for clinical trials, with drug developers mounting major outreach campaigns to get people into studies according to timelines. DecisionView's products, which are used by 8 of the 10 largest drugmakers, offer web-based technology to automate some of the steps that developers must tackle to manage enrollment.

"In planning clinical trials, patient recruitment and enrollment is a major potential source of delays," said Alan Louie, research director at IDC Health Insights, stated in DecisionView's release. "With as much as 50 percent of trial project plans requiring rescue and rework, the cost of inefficiency can be high."

- here's the release

AB Sciex, Indigo BioSystems join forces on mass spectrometry software

Ryan McBride — Tue, 17 Jan 2012 09:00:54 -0500

With the aim of streamlining the use of mass spectrometry data, AB Sciex and Indigo BioSystems have teamed up to combine their knowledge of the fields of mass spectrometry and advanced data analysis, the companies announced Monday. And the combo of technologies could make analyzing mass spectrometry data easier for clinical researchers and forensics labs.

Indigo BioSystems, a provider of data analysis and quality review software, said it re-engineered the data analysis process and used new algorithms to automate the transition of data from mass spectrometry instruments to processing tools. With the improved workflows for its system, AB Sciex aims to sell the product to clinical researchers, toxicology labs, academics and biopharma companies.

"Automation is an important step to accelerate the adoption of new-generation mass spectrometry for clinical research, forensics and clinical trials," said Joe Anacleto, AB Sciex's vice president of applied markets and clinical research, in a statement. "We are striving to make mass spectrometry as easy to use as possible for researchers analyzing steroids, pain panels, drugs of abuse and an expanding variety of substances."

Through the collaboration with Indigo, AB Sciex has a shot at catering to researchers who might not otherwise use mass spectrometry tech because of complexities associated with traditional systems.

- here's the release