Nov. 15, 2006 | PHILADELPHIA — More than 100 enthusiastic delegates bridging the full breadth of the drug development pipeline gathered recently for the second annual “Bridging Pharma and IT” conference*. (See “Bridges and Boundaries,” Bio-IT World, November 2005).
This year’s expanded program featured tracks devoted to drug development and clinical trials, in addition to discovery research. But the pervasive theme remained addressing the communication and collaboration chasms bedeviling biopharma organizations — biology and chemistry, discovery and clinical, life sciences and IT, and so on.
The “building a bridge” metaphor received a ringing endorsement from opening keynote speaker Gerhard Noelken, director, research informatics at Pfizer. An internal realignment by therapeutic area at Pfizer necessitated a far-ranging business and informatics collaboration in the design of an integrated data access tool, combining 6-8 software applications, to help bring subject experts together.
Noelken said organizational structure was key, with both business and informatics experts present at each node — seven sites worldwide. Also critical, Noelken said, is, “the need for strong sponsorship at every level — the single most important factor in ensuring implementation.” He noted that Pfizer did not use much off-the-shelf software. “We develop 80 percent in house,” he said.
Overall, Noelken judged the results of the reorganization to be positive: Pfizer is obtaining the same number of hits with fewer compounds screened, reducing the time of compound synthesis, and producing faster, cheaper assays.
In the past year, the workforce at Amylin Pharmaceuticals in San Diego has doubled to about 1400, as the company capitalizes the recent approval of a pair of diabetes drugs. But this “explosive growth,” according to VP Research Michael Hanley, has put a severe strain on IT resources within the company — indeed, draining the talent pool across San Diego. Today, Amylin has more IT staff (136) than discovery scientists.
Amylin’s solution was “inhousing” — hiring Kelaroo to provide IT and informatics support. From Hanley’s perspective, the arrangement provided a fast ramp-up with proven performers, and avoided the “not invented here” problem. Amylin’s senior management also negotiated a creative reimbursement scheme that minimized cash outlay.
Kelaroo was co-founded by Robert Feinstein in 2000, and currently has some 40 clients, mostly in the cheminformatics space. Amylin was an early client, as Kelaroo offered support for Oracle, Accelrys, and MDL applications among others. A key initiative was GoldMiner, a GeneSeq online database miner, which provides data access for both scientists and IP lawyers, with more detail on gene sequences or patents tailored to the interest of the user. Although GoldMiner was owned by Amylin, Feinstein explained, “They struck a deal to allow Kelaroo to market it, helping the industry as a whole.”
Prediction and Feedback
AstraZeneca’s associate director of discovery medicine informatics, Michael Ramaker, said that “discovery medicine” is a priority area for R&D investment. Clinical research helps test the hypotheses from discovery research that “compound X is efficacious in humans,” and development that “compound X is safe in humans.” Ramaker said that the process of feeding back clinical data helps discovery and development improve the ability to predict efficacy and safety, respectively.
One new project involving discovery, development, and clinical involves clinical imaging data. The system allows patient imaging data to be displayed and compared alongside pre-clinical primate data, for example showing receptor occupancy or drug binding. Another example involves meta data — the addition of clinical identifiers to discovery identifiers, affording discovery teams access to clinical project data based on project names they recognize.
Peter Shaw, Merck’s senior director of oncology/clinical research, spoke of the “siloed mentality” of pharma scientists and IT professionals. Biomarker research offers hope of bridging this divide because it transitions the border of pre- and clinical development, but there are challenges because “different data sets are being utilized by different key stakeholders.” For example, are the data to be used for hypothesis generation or for FDA filings?
James McGurk, Merck’s manager of research information systems, agreed that biomarker discovery is an “extremely disruptive technology that imposes novel demands.” But IT problems don’t necessarily require IT solutions, he said. “Anticipating data management problems is more critical than selecting the best software applications,” said McGurk. He also stressed the need for IT representation at the earliest stages of project planning, particularly in areas such as patient privacy, vocabularies, and data cleansing.
Gary Secrest, director of worldwide security for Johnson & Johnson (J&J), delivered a fascinating talk about a new digital encryption technology that is being heavily promoted by the SAFE-Biopharma association. SAFE (Signatures and Authorization For Everyone) is a non-profit group with eight founding biopharma members, including J&J, AstraZeneca, Bristol-Myers Squibb, and Pfizer, representing an industry grappling with suffocating paper-based annual R&D costs estimated at 40 percent ($9 billion in the US).
SAFE’s product is a secure “public key” digital signature. Based on well-established mathematical principles, the technology involves a public and private “signature,” composed of very large (roughly 300-digit) unique numbers, which are related to each other in a unique way. The digital credentials are supplied via a hardware “token” such as a USB flash drive. About two thirds of J&J’s 115,000 staff are already using the system, and Secrest claimed that one J&J subsidiary was already saving $1 million/year. Secrest also indicated that the FDA has begun accepting digitally certified data from three of SAFE’s charter members.
A key part of Wyeth’s efforts to increase productivity (see “Wyeth’s Passage to India,” page 22) center on its new high-throughput screening facility in Collegeville, PA. Victoria Emerick, HTS operations manager, screening sciences, and Sue Tomczyk, associate director, discovery research applications, revealed the give-and-take required to turn fantasy into reality.
According to Emerick, VP screening sciences Jeff Paslay envisioned “a castle with a moat,” with minimal interaction with IS groups or restrictions on software. But as Tomczyk pointed out, vendors needed access to provide technical support, and the data center could hardly be isolated from corporate IT. A joint team from screening sciences (facility and project management), and IS/IT (equipment and the network), produced a satisfactory outcome: a classic manufacturing facility, implementing a virtual network separated by a firewall, allowing vendors to access only their equipment.
Emerick said the early results showed an increase in screening campaigns, higher quality of screened samples, reduced HTS cycle time, and improved efficiency. The facility will be fully operational in January.
David Lowis, senior director of product management at Tripos listed several recurring requests he hears from customers managing data: Wouldn’t it be nice to have data delivered, formatted, and transferred to an analysis tool? New tools and data made available quickly in a known application? A means of capturing the purpose and results of an experimental analysis? Forcing scientists to become data mining and informatics experts is inefficient, while IT and cheminformatics specialists are stuck on maintenance, reducing innovation.
Lowis described Tripos’ Discovery 360 integrated discovery environment, deployed at Bristol-Myers Squibb, which enhances productivity, reduces IT overheads, and affords managers access to data for go/no-go decisions. Lowis claimed that 8-hour projects can be cut to 2 hours, saving project leaders on average 4-6 hours/week.
Don Rule, platform strategy advisor for bioinformatics, Microsoft, wrapped up the meeting with a report on the BioIT Alliance (see Microsoft Forges BioIT Alliance, Bio-IT World April 2006). The alliance was born from recognition of widespread customer frustrations in data integration, knowledge mining, collaboration, and workflows. “Scientists spend too much time programming,” says Rule.
The initial collaboration, involving cancer researcher Peter Kuhn (Scripps Institute) and partner InterKnowlogy, revolves around the Collaborative Molecular Environment, an application that uses the beta version of Microsoft Windows Presentation Foundation and Microsoft Office SharePoint Server 2007 to support data capture, visualization, annotation, and archives, specifically attaching annotations to 3-D protein structure images. Rule said the application would be made available as a shared source for vendors to incorporate in due course. Rule is now turning his sights to biomarkers and translational medicine.
* “Bridging Pharma & IT” — a CHI conference. Philadelphia, 25-27 September, 2006.
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