Paolo Fortina says he sympathizes with the challenges facing the regulators of the US Food and Drug Administration who are determining how to establish agency approval for microarray-based devices and the data generated from them.
Fortina, a professor of medicine at the Jefferson Medical College of Thomas Jefferson University in Philadelphia, serves as section chief, genomics and diagnostics, in university’s Center for Translational Medicine.
At the Chips to Hits Conference at Boston’s World Trade Center and Seaport Hotel Oct. 28-31 — at which attendance is expected to equal last year’s 1,200 conference-goers and some 102 vendors are expected to display their wares, according to officials at IBC, the event’s organizers — Fortina will lead a seminar entitled “Innovation in Tools and Methods for Clinical and Biomedical Applications.” Speakers will include those who are creating microarrays to target infectious diseases, and others with new technologies such as quantum dots, carbohydrate microarrays, and peptide microarrays.
As a clinician, and a research user of microarray technology, Fortina stands at the intersection that the industry must cross as microarrays reach maturity in the research area and begin the trek to the clinical market. The metaphorical tollhouse in this journey is the FDA, which is just beginning to envision the types of regulations, protocols, and standards that microarray-based tools must follow in order to produce the type of safe, scientifically valid information that holds so much promise for improving human health.
Fortina said he is sensitive to the task that lies before the FDA.
“In microarrays, you have a technology that works well for gene-expression profiling,” he said. “Take Affymetrix, for instance. They came out with the U95 chip [the five-array Human Genome U95 set launched in April 2000] for doing gene-expression profiling for humans. Then, less than 24 months later, they came out with the U133a chip [Human Genome U133 Set, launched on Jan. 21, 2002], and then recently, with a chip that contains the entire human genome on a single chip [launched on Oct. 2, 2003]. If you are the FDA, and you are trying to give approval for the product, you find the technology has changed in one year. It’s going to be extremely tough for them until we can reach a level in the development of this technology. That’s the problem, it’s an evolving technology, and the knowledge we have of the human genome is not compete, and it’s going to be outdated in six months.”
The regulatory situation makes up a significant part of the context in which the Chips to Hits Conference will take place.
The show includes a two-and-a-half-hour FDA session on Friday moderated by Derk Bergsma of GlaxoSmithKline with presentations by: Joseph Hackett, special programs coordinator with the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, of the Center for Devices and Radiological Health; Emanuel Petricoin, co-director of the FDA-NCI Clinical Proteomics Program, Office of the Director, Center for Biologics Evaluation and Research; and Konstantin Chumakov, chief of the laboratory of methods development, Center for Biologics Evaluation and Research. Hackett will speak to how the agency is handling the regulatory challenges involving this technology; Petricoin will speak of a new protein array technology; and Chumakov will speak of the analysis of viral and bacterial pathogens and respective vaccines. The three presentations will be followed by an open discussion.
As its title says, the show is based on the relationship of chip-based technologies, such as microarrays, to the drug development process.
The pharmaceutical industry will be well represented. Dalia Cohen, vice president and global head of functional genomics at Novartis Institutes, will provide the keynote address, “From Genome to Therapy,”in which she is to discuss “an industrialized multidisciplinary and process-driven approach instituted for drug target identification and validation.”
Other speakers from the pharmaceutical industry include Larry Gelbert and Timothy Ryan of Eli Lilly, Mary Brawner and Priti Hegde of GSK, Ray Salemme of J&J, and Jeffrey Warring of Abbott.
The conference is using a new format with sessions designed to serve end-users, technology developers, and business professionals. In addition to the main conference, the show venue will include conferences entitled “Early Stage Biotechnology Partnering and Deal Making,” and “Systems Biology: The Future of Pharmaceutical Development.”
The overall format of the event includes some 13 hours for networking opportunities, with two cocktail parties, as well as luncheons, and meet-the-posters sessions. The main conference book will be printed in two parts, each about an inch and a half thick, said Derek Kealey, the IBC producer for the event.
Applied Biosystems, which announced in July that it expects to introduce a new product, the Expression Array System, will be one of the vendors presenting in the technology showcases, as well as DNA Software, PerkinElmer, NuGEN, and Amersham Biosciences, among others.
Corning Life Sciences, Mirus, Electric Genetics, and Sigma-Aldrich Israel are expected to launch new products.
Sessions are slated to cover areas such as surface chemistry, intellectual property, protein arrays, emerging technologies, experimental design and data analysis, new solutions for screening tools, microarrays for target or compound discovery and validation, and detection and labeling solutions.
The show will also include presentations from service providers
For Paolo Fortina, there is one theme that is resonating among users.
“I strongly believe,” he said, “that the trend is to try to reduce the complexity of genome, avoiding biochemical steps like PCR, and improving on the sensitivity of the detection system. We need to reduce the genome complexity, and that would expedite the clinical work, and the science.”