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Whether it’s data mining or electronic drug submissions, biotech has some major information technology (IT) needs. Implementing the appropriate tools and accessing the right infrastructure can be a challenge for many startups, but help is available.
Pacific Coast Information Systems Ltd. (PCIS) (Vancouver, BC) launched its Biotech Roadmap in February. The initiative, which includes a series of articles as well as a poster that covers IT hurdles at four stages of corporate development, is designed to help biotech companies identify their current and future IT needs.
Biotech IT is familiar ground for Paul King, director of Life Sciences at PCIS. King’s background includes serving as director of IT for QLT Inc. (Vancouver, BC), and later for Inex Pharmaceuticals Corp. (Burnaby, BC).
“The challenge that I found at both organizations was that at the senior level of the organization, you normally have very brilliant people, and their main focus is on science,” King says. “Their next concern is public relations and investor relations and finance. And then it would be regulatory and clinical. Way down on the list is information technology.”
Biotechs did not generally devote much planning to IT, King says, but that approach began to change when the U.S. Food and Drug Administration (FDA) introduced 21 CFR Part 11 guidelines for electronic drug submissions in 1997.
“All of a sudden, IT went from being on the very edge of the radar to being a lot closer to the centre,” King says.
New Priorities
The poster that PCIS has designed is intended to help biotech companies identify where they are in the development stage, and ensure that they are prepared for their drug submission when the time comes.
“We started talking about information systems that are needed in biotech companies,” King says. The types of systems required were divided into four stages. “By listing the emerging functions and the characteristics, (we showed) that there’s a correlation between business and scientific objectives, and the information systems that are necessary to move to the next step.”
The poster has received a positive response in the academic and business sectors of the biotech community — and beyond, King says. “We’ve actually had people from recruitment agencies come to us and say, wow, could we get a copy of that? Because it actually helps them understand what the industry is like, and the types of people that biotech companies are going to need to recruit,” he says.
With 21 CFR Part 11 on a lot of people’s minds, IT is a growing concern.
“People have a lot of questions about those regulations, and then how it translates from a regulation to a business practice and process, and then the computer systems that are needed to be put in place to support that,” King says. But he adds that for many biotechs, the IT stumbling block is easily avoidable.
“We’re finding that a lot of it is the awareness,” he says. “The companies that we’ve gone to see in the last few weeks after they’d seen the poster, are starting to see they’re in stage one and stage two. And we’re showing them, well, you need to look ahead to the third and fourth stage, when you’re going to actually do the (FDA) submission.”
HPC Outreach
PCIS is not alone in trying to raise awareness of IT issues and services. The Shared Hierarchical Academic Research Computing Network (SHARCNET) — a high performance computing (HPC) centre based in London, Ont. that involves nine universities and two colleges — recently began a public outreach program to help broaden its contact base in academia and the private sector.
“Part of the effort is to let researchers know more specifically what is available at SHARCNET, how it can help their research by using the computers, and what kind of support services they can rely on as far as our system administration and our high performance computing consultants,” says Carmen Gicante, executive director of SHARCNET.
The outreach program also includes open houses with the private sector to showcase what SHARCNET has to offer.
“Hopefully we’ll be able to create some links with the private sector,” Gicante says. But the exact model of private sector collaboration has yet to be determined.
“That’s part of the outreach,” Gicante explains. “Have a look at what we’ve got, and then we can talk about how you can make use of these resources to help you. Because part of our mandate is to encourage economic benefits for the province in helping companies.”
SHARCNET is offering biotech companies the same services it supplies to its academic clients: “Access to the resources, access to our staff for training, training their students, helping them with their code,” Gicante says. “One of the things I think we’ve done well, because we have 11 institutions with SHARCNET now, we help them make linkages with researchers in their field among the other institutions for more collaborative research. We’ve done a number of those things internally, now can we make those same linkages externally.” Services available through SHARCNET can boost a biotech company’s computational power for research.
“A lot of the biotech companies are simulating proteins, molecular transactions, genomics. This gives them additional resources to conduct that research,” Gicante says. He adds that it is not yet clear which services will prove most applicable in the private sector.
“Is it the computational power? Or the linkages that we can create with researchers? Or the other area we’re exploring is we have a number of high performance computing consultants that can help them design better code, better algorithms, help fund their research pro-jects by using computers more efficiently,” he says. “That might vary by company, too. Somebody might want training for the staff, somebody might want access to the computers, somebody wants linkages with researchers and other institutions that are doing research in the biotechnology side.”
SHARCNET provides services in a variety of fields, from physics and chemistry to economics and financial mathematics. “If your research is computational based, or could be, we can help you,” Gicante says.
The fresh funding that was announced last month for SHARCNET — nearly $20 million through the Canada Foundation for Innovation (CFI) (Ottawa, ON) — may benefit the network’s biotech clients.
“One of the needs of bioinformatics, of biotechnology, has been the need for data repositories with large chunks of data, and access to that data,” Gicante says, explaining that bioinformatics is more about data manipulation and data retrieval, rather than raw computing. “As we move forward with our new CFI, we will be installing a significant amount of storage capabilities.”
Access to MaRS
The Medical and Related Sciences Discovery District (MaRS) currently under development in Toronto, Ont. is arranging access to many services for its clients and stakeholders. These services range from mass spectrometry to animal facilities to bio-IT.
“We saw a real opportunity to provide better access to emerging companies or technology companies to excess lab space that existed in the research community,” says John Cook, president and chief operating officer of MaRS.
The organization now has memos of understanding with seven labs across Ontario, including agreements with the High Performance Computing Virtual Laboratory (HPCVL — a Kingston, Ont.-based consortium of four eastern Ontario universities), and with the Ontario Centre for Genomic Computing located at the Hospital for Sick Children (Toronto, ON). MaRS also has a relationship with the Molecular Design and Imaging Technology Centre at the University of Toronto’s Leslie Dan Faculty of Pharmacy (Toronto, ON). This visualization facility allows scientists to interact in real time with 3-D molecular models.
“The idea was to try to create a portal or a marketing opportunity for these labs to get better access to the private market that could purchase their excess capacity,” Cook says of the services MaRS offers. “At the same time, for the early stage companies to be able to preserve their precious capital that’s so hard to raise — keep them from building their own infrastructure when they didn’t need to. And so it seemed like a perfect matchmaking opportunity as a facilitator in the marketplace to help these companies.”
To research the needs of biotech startups, Cook spoke to CEOs of early stage companies about the types of scientific infrastructure they needed.
“One of the ones that would seem most obvious to offer would be computing services,” he says. “I guess the rationale for that is, it’s our belief that computing technologies are absolutely going to be imperative to lower the cost of drug development and improve speed to market.”
But response from the biotech community has been strangely slow. Cook says the early stage companies that MaRS is dealing with have not yet integrated that IT philosophy into their research programs.
“So while MaRS will continue to market the access to high performance computing and virtual modelling of molecules and whatnot to the community, it’s taking time for them to take us up on that,” he says.
Cook predicts this type of service will become an important part of tech transfer and commercialization support.
“I’m just not sure when,” he says, adding that these scientific infrastructure services can be very expensive. “Given how hard it is to raise capital, and that these companies wouldn’t necessarily use the infrastructure to its maximum capacity, I think it makes huge sense if you’re clustering industry, to try to develop efficiencies in that investment in infrastructure.”
Ideally, Cook says demand should drive supply. “At the same time, you have to be a bit forward-thinking,” he adds. “Some entity has to say OK, what will be necessary — because it takes time to develop it.”
So MaRS has established these services in anticipation of the demand.
“We’re set up right now,” Cook says. “We’re looking for stakeholders who are interested in securing access to this infrastructure. That was what the message was from the CEOs: don’t go out and spend a lot of money developing this infrastructure. It exists right now through programs like CFI and OIT (Ontario Innovation Trust, Toronto, ON). There’s been an enormous investment in infrastructure — help us get access to it. So that’s what we’re doing.”