Orchestra platform could help pharma and biotech clients sing a new tune.
By Kevin Davies
May 12, 2008 | Founded in 1999, PointCross, a Bay Area technology company specializing in unifying business information through its software platform, began with the experience of its founder, Suresh Madhavan, in the defense business. PointCross made its mark in the oil and gas industry, counting BP, Halliburton, and Royal Dutch Shell among its major clients. Indeed, PointCross' flagship software product, Orchestra, is one of just a handful of portfolio solutions that is globally available at Shell.
Now, PointCross is training its sights on another key vertical market, biopharma. Shree Nath, PointCross' director of product technology, cites recent McKinsey studies showing how knowledge-intensive and project-oriented companies differ from transaction-oriented business. People in these businesses engage in "tacit interactions" to find and consider information with security and compliance; while being able to discover, innovate, decide, and execute their core business. But management of tacit interactions requires a breed of information technology that is different from legacy transaction-based architectures.
In December 2006, PointCross acquired PharmQuest, a pre-clinical company closely involved with CDISC standards. One of PharmQuest's products, ToxVision, has been used by the FDA for analysis and review of pre-clinical data in a pilot setting. It is also being deployed as a general purpose pre-clinical analysis toolkit at a major pharma company. According to Seema Handu, head of PointCross' pharmaceuticals business, the FDA "ran a pilot 2-3 years ago to verify the use of CDISC's SEND standard as a data format for submission and review of pre-clinical data. This has since advanced into a full regulatory pilot."
PointCross has implemented PharmQuest's concepts on its Orchestra platform for use in the pharma industry. But this is just one of at least a half-a-dozen critical areas across the vast drug development pipeline where PointCross believes it can provide a strategic edge to its clients.
According to Handu, PointCross is positioning its Integrated Drug Development Suite (IDDS) to target the full lifecycle of inter-related R&D processes including early discovery, lead optimization, pre-clinical and clinical life cycle management, CRO and Agency relationship management, and in-licensing and out-licensing deal maturation processes. (See sidebar, "Suite Spots.")
The goal of the Orchestra platform is to relieve a major headache for large corporations - contextually capturing and self-organizing all the information trapped or lost in emails, meeting notes, papers, data, document management systems, and so on. At the same time, the platform provides toolkits to build and deliver solutions and processes while providing for security, search, and compliance - what Nath calls "the holy trinity for life science companies."
Within big pharma, many disparate processes run across global centers and companies.
Nath says: "People need to search across what they've done, meetings, and the type of work products that scientists routinely create. By managing data in different applications, they have no anchor to organize anything and everything they need to know about topics that concern their business."
PointCross is "not a traditional search engine company," Nath insists, "but we work with commercially available search engines to not only find information, but to make sure people have rights to see [specific information]. If they don't have access, they can hit a button to send a request to the owners of the information, and request permission." Orchestra tracks both relevant information, and the persons or part of the business with which it is associated.
Many large corporations risk losing tremendous knowledge value through email. "Knowledge transacted in emails is available [only] in emails," says Nath, "but you can't throw a search against standard Microsoft Exchange or other email stores, because then people could search emails written by CEO or the legal department! Managing need-to-know is a huge unsolved business issue in the enterprise world, and one that is becoming even more critical each day."
Semantic Data Exchange
Another key issue that PointCross addresses is managing interactions between pharma clients, vendors, and the various applications and data warehouses between the two. For example, Nath notes that contract research organizations (CROs) use a variety of systems and data standards, requiring pharma firms to "spend lots of time collating all that information into a common information base. Many sponsor companies do not even absorb such data into their own internal data warehouses."
To address these needs, PointCross espouses semantic data exchange. Companies can map data arriving from different vendors into a common data model of their choosing or an industry standard published by CDISC or HL7 saving significant time and minimizing human errors during translation. "Several customers end up re-running expensive studies, because they can't find the information, or they can't access it in a usable format. Information is routinely lost to the organization, and potentially may have regulatory implications in the future," says Nath.
PointCross encounters several potential customers using Documentum or OpenText's LiveLink. "We provide a full fledged document management solution, but we don't brand ourselves as a document management solution provider, because managing documents is just a side-show of information management. In fact, their importance is declining in the light of an increased drive towards data-centric regulatory submissions by agencies like the FDA. The 'Media is the Message' of Marshal McLuhan fame has given way to 'The Message is the Data'" says Nath.
PointCross has bundled Orchestra and its accompanying desktop/laptop client, called Solo, into UBIS (Unified Business Information Services). This provides a secure environment for online and offline work, as all data in Solo are encrypted and transmitted securely with the Orchestra server and vice versa. Nath says Solo keeps only the information a user needs, which translates into smaller, secure laptops.
Nath says that business people intuitively get the value proposition of PointCross' product. "They're the ones who relate well to what we do. We're also increasingly starting to work with the CIO's offices... CIOs are now realizing that processes and solutions they once thought were complex can be deployed with our technology in a fifth of the time and cost that it takes for traditional technology implementations."
PointCross sees a variety of intervention points within the drug pipeline where its expertise can assist pharma customers:
Acquisitions and Divestitures (A&D) helps firms to in-license or out-license molecules or products that have gone through different stages of maturity.
Competitive Intelligence (CI) can be applied during the entire lifecycle of product development and also to seek opportunities for business development and partnering.
Lead Optimization (LO) is when firms need to decide on specific candidate molecules that will be taken to the subsequent early drug development stage.
Preclinical-Lifecycle Development Management (PC-LDM) manages the lifecycle for pre-clinical studies, including study execution, analysis, and regulatory submissions. ToxVision is a component of PC-LDM.
Chemical Manufacturing (CMC) workbench helps companies manage the lifecycle of initial drug manufacturing, including substance development, tox lots, and product development.
CRO-Business Operating System (CRO-BOS) is for CROs or Pharmas to facilitate interactions and workflow processes across organizational boundaries.
This article appeared in Bio-IT World Magazine.
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