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Resolute in the New Year

Dec. 2006 / Jan. 2007 | Bio-IT World asked a variety of scientists and business leaders what advances in 2006 were most notable for their industries, and what technologies or breakthroughs were coming in 2007. Industry leaders in areas from pharmacogenetics to cheminformatics found 2006 to be a year of important steps forward, but looked with even more anticipation to 2007. Some praised regulatory advances, others marked 2006 as a turning point for a technology, and still others recognized maturing trends in industry. Overall, the outlook is, indeed, merry and bright.

Allen D. Roses
Senior Vice President, Pharmacogenetics GlaxoSmithKline
"For me, the most notable in 2006 has been the pilot demonstration that whole genome data can be potentially applied for prediction of rare events [like severe adverse events, or SAEs].

"In 2007, [the technology I'm most anticipating is] the first application to well-phenotyped collections of rare SAEs to test this capability using whole genome analyses for Stevens-Johnson syndrome, drug-induced hepatocellular toxicity, and others. The ability to predict risk for rare SAEs will lead to the use of safer use of medicines."

Robert Powell
Senior Pharmacist, Office of Clinical Pharmacology and Biopharmaceutics, FDA
"The most notable change in 2006 relative to bio-information in clinical and regulatory development has been the willingness of pharmaceutical companies and the FDA to begin sharing pre-competitive disease, drug, placebo information. The FDA Critical Path Initiative has created a space for industry, government and academics to collaborate in both sharing prior knowledge and generating new information on difficult issues that block us developing more effective and safer drugs in a more efficient manner.

"Active work is underway to develop biomarkers in several cancers that may help facilitate drug development and personalize the treatment to individual needs; predict drug toxicities based on genomics and other biomarkers for kidney, liver and relatively rare skin adverse events; develop and implement information standards for clinical trail and genomic information to facilitate rapid access to information as it becomes available; and mine prior clinical trial and epidemiologic studies on disease change, placebo, and drug effects."

Victoria Hale
Founder/CEO, One World Health
"Biotechnologies will increasingly be seen as the solution to vexing global health problems. New models of developing drugs will make it possible to get medicine to populations that have little money to spend in Asia and Africa, and new distribution initiatives and alliances will make it possible to reach isolated people who have great need for medicine. Some of these solutions will be very cost effective and will save millions of lives.

"[In 2007,] tropical diseases will come into the US more with climate change as mosquitoes and other insects head North, and American viewers will also hear more about the health issues of the South as they are addressed by new medicines. Tropical diseases will occasionally be discussed on American television evening news."

David de Graaf
Director Systems Biology, Pfizer
"2006 was the year systems biology started to deliver on its promise. From the general investment in broad consortia like the Liver Toxicity Biomarker Study by BG Medicine to the growth of collaborations with companies like Gene Network Sciences, Entelos, and Genstruct, the industry has gone beyond trial balloons to full fledged collaborations. This is also reflected in the establishment of systems biology function at companies like Novartis, AstraZeneca and, of course, Pfizer. Informally, we are beyond showing utility and have gone to the stage of significant impact.

"2007 is when the Semantic Web will become more than a distant promise and will start to have a significant effect on the management of unstructured information - still by far the major repository of information for the industry and the research community as a whole. This development will be generally enabling and even transformative in areas like systems biology, where currently we spend a lot of time gathering information and parsing through it manually. I'm also excited about moving beyond the open source concept and enabling flexible but IP conscious sharing of information between companies and academia using the framework developed by Science Commons. We are working with partners like Teranode, Linguamatics and Cognia to tackle specific pieces of this space."

Gustavo A. Stolovitzky
Manager, Functional Genomics and Systems Biology, IBM T.J. Watson Research Center
"This year, a milestone was achieved with the publication [in Nature Biotechnology] of the MicroArray Quality Control (MAQC) consortium results to address lingering concerns about the variability of microarray data (see "Microarray Platforms Shine," Bio-IT World, Oct. 2006, p. 18). The results of these studies show that technological noise is reasonably manageable, and support the claim that even though microarrays have a long way to go, the road seems to be paved for the adoption of this technology for the detection of early biomarkers for disease and toxicity.

"I expect that in the coming year(s), the results of the MAQC consortium will make regulatory agencies such as the FDA consider microarray technology as mature, at least for certain types of diagnostic tests. We may start to see the fruits of this work as early as 2007."

Nick Giannasi
Senior Director Life Sciences, Oracle
The most notable event in Life Sciences was the recognition that counterfeit drugs were significant, widespread and growing. Estimates put counterfeits at more than 10% of the global medicines market. They are present in all regions but developing countries bear the brunt of the problem. The Center for Medicines in the Public Interest, in the United States, predicts that counterfeit drug sales will reach $ 75 billion globally in 2010, an increase of more than 90% from 2005.

Some examples:
• January 2006, the United States FDA issued an alert about fraudulent flu remedies, including counterfeit prescription Tamiflu medication
• A recent study in The Lancet concluded that up to 40% of products labeled as containing artusenate for combating malaria contain no active ingredients and have no therapeutic benefits

In 2007, we are looking forward to the breakthrough and more widespread adoption of an electronic pedigree for a more safe and secure supply chain for the industry. We see key technologies such as RFID (radio frequency identification) and software applications to efficiently manage information at every level of the supply chain, as well as transmit and authenticate electronic pedigrees when organizations send and receive pharmaceutical products in the open supply chain.

Doug Engfer
President and CEO, invivodata
"Without a doubt, the FDA release of its draft [Patient-Reported Outcome] (PRO) Guidance in February was the signal event within the ePRO industry. The FDA has helped take the eDiary industry out of pilot mode and into widespread adoption. As a result, we have seen broader adoption of eDiaries in global clinical trials this year and the momentum continues to increase.

"In 2007, we'll see ePRO technology cut through the chatter around adaptive clinical trials and deliver real-world benefits rather than just sound bites and webinars... Real-time, high-integrity patient data [that] can reduce the number of sites and subjects needed to complete a study... yielding more precise science and a [larger] ROI."

William Hayes
Associate Director, Library and Information Services, Biogen Idec
The most notable event for me from 2006 is that the 'Virtual Drug Company' (VDC), where almost every aspect of the company is being outsourced except for financial management, project management and scientific/drug R&D consultants, is starting to have a real economic impact.  Back in 2000 we expected them to become a prevalent and viable business model of the future - it looks like the future is now.

The Semantic Web is the technology I'm most anticipating in 2007.  Our biggest weakness in the industry is the mass of information we must manage and access. Semantic Web technologies appear to be the key to doing that more productively.  The pieces of Semantic Web are almost all there, with several interesting projects that should approach the tipping point in 2007 (e.g. the NeuroCommons projects).

I'm also expecting collaborative Web 2.0 tools to become more mainstream in bioPharma in 2007 to increase internal networking and communication. Wiki's, DabbleDB-like technologies, blogs, RSS feeds, etc are needed to improve internal communication and the de-centralized command and control networks found in most biopharma.

Colin Hill
CEO, Gene Network Sciences
I think the most notable events affecting the drug discovery industry in 2006 were the continuing difficulties that pharma has had in bringing new drugs to market.  This is the beginning of the end of the mega-blockbuster drug paradigm, and as a result there is an increased desire in the industry to understand molecular-level drug mechanism of action and drug applicability to specific patient populations.

Kenneth Getz
Research Fellow & Chairman, Center for the Study of Drug Development, Tufts University
"It is an understatement to say that 2006 was highlight-rich. Two that stand out most for me: First, Pfizer's withdrawal of Torcetrapib captures many of the conditions characterizing the realities of drug development today including the intense volatility of research risk and the pressures on R&D to manage science under capital market and commercialization pressures; second, reports issued by the Government Accountability Office (GAO) and the Institute of Medicine criticizing the FDA's ability to ensure consumer drug safety have set the stage for a new democratic congress to push - not shove - for change within the agency and above.

"There are two innovations that I most anticipate we'll hear much about in 2007: First, biomarker research is resonating loudly among government agencies, foundations, advocacy groups and industry with the promise of accelerating and targeting the delivery of treatments and promoting early detection and disease prevention; and second, the adoption, integration and standardization of electronic health records will continue full throttle as professionals encounter various challenges and improvements to existing health care delivery and clinical research processes."

Andrew Hopkins
Senior Principal Scientist, Pfizer Global R&D, UK
"This was the year 'multi-targeted' drugs or polypharmacology started to challenge to the dominant drug discovery philosophy of designing exquisitely selective ligands. A number of events in 2006 have brought polypharmacology from the sidelines to be a respectable alternative strategy. First, several new kinase inhibitors have now been approved, which each act on multiple targets. Second, groups are now actively working on new informatics tools to predict, identify and help design compounds with polypharmacology.  These new tools are making it easier for drug designers to rationally search for multi-target drugs.

"I'm hoping that 2007 is the year that the life sciences start actively adopting the Semantic Web. The Life Sciences are an ideal place on which to start developing data resources that can actively enable the possibilities of the Semantic Web. Data 'mashups' are an essential step in knowledge discovery. With the vast knowledge-bases now available to the Life Sciences, standards or methods to enable us to rapidly integrate or 'mashup' data would spur innovation. Enabling Data mashups could be the business proposition that finally popularise the adoption of Semantic Web standards."

Raju Kucherlapati
Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School
"The most important event is the recommendation by the FDA Advisory panel to change the label of Warfarin, an anticoagulant drug to include genetic testing prior to prescription."

Jeff Bizzaro
"One of the more significant events of 2006 is the start of the UK Biobank project, which, with profiles of 500,000 Britons, will be the 'world's largest information resource for medical researchers.' The project will, of course, have to balance the privacy of the participants with the need for researchers to access the information, but indications have been that genetic codes won't be patented.

"As for 2007, there are a number of interesting developments to watch on the patent front in the U.S. The U.S. Senate could revisit the PACE-Education Act, which advises the implementation of "comprehensive patent reform that encourages research uses of patented inventions by shielding researchers from infringement liability." And, while the U.S. Supreme Court dismissed the appeal of Laboratory Corp. of America v. Metabolite, in which several justices expressed reservations about the patentability of natural principles, KSR v. Teleflex will be decided in 2007 and address "patent obviousness."  This is being closely watched in the industry."

Vijay Pillai
Director of Life Sciences and Translational Medicine, Oracle
"The most notable realization across the health sciences industry in 2006 is that "information" will drive the transformation toward translation medicine (bedside to bench).  During the next 12 to 18 months there will be widespread adoption of "information platforms" to combine clinical and 'omics datasets for effective patient care which will drive discoveries leading to better drugs."

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