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Cell-Based Assay Tools Helped Drive 52-Percent Jump in R&D Success at Big Pharma; More Business Likely

Genomic technologies, including cell-based assay technologies, have helped to significantly increase the number of drug candidates that enter clinical trials at the world's biggest pharmas, according to a report released last week from the Tufts Center for the Study of Drug Development.

After declining more than 20 percent from the mid-1990s to the early-2000s, the rate at which new drugs entered the clinic increased 52 percent between 1998-2002 and 2003-2005, the report found.

Though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it, TCSDD Director Kenneth Kaitin said discussions he has with officials from big pharma indicate that genomic technologies and methodologies have played "an increasingly important role" in driving the improvement. These tools and methods include mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping.

The report also showed that the overall percentage of drugs that reach the clinic and go on to win US Food and Drug Administration approval — 20 percent — hasn't changed much in 30 years. But most of these candidates began life in the clinic before genomic tools were widely used, and big pharma, emboldened by the way these tools lifted their overall R&D productivity, may decide that investing more in new technologies might lead to better data and improved odds with regulators for the next crop of drug candidates.

"I don't think there is any question [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing," Kaitin told CBA News sister publication BioCommerce Week. "Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools."

TCSDD reports carry enormous weight within the pharmaceutical industry. Its high-profile study on the cost of developing new drugs, which it conducts about every 10 years, most recently found that it costs more than $800 million and takes up to 15 years to bring a drug to market. These results, released in 2001, have become at once a rallying cry for pharmas eager to lower the regulatory cost burden and a defense for skyrocketing prescription costs.

That study has also played into the hands of genomic tool vendors that claim their technologies can lower the cost of drug discovery early in the game, at once saving millions in early-stage R&D funds while stacking the enrollment deck with patients genetically more likely to respond favorably. The new productivity study, therefore, might offer a hint of encouragement to entrenched tool vendors, especially instrument shops that have been buffeted by pharma's cyclical spending patterns.

Kaitin said drug company officials whom he interviews tell him genomic tools are becoming increasingly important to them. R&D heads at big pharma "are all talking about their increasing reliance on these platforms to make better determinations about which products to move forward," he said.

The complete version of this article, which includes tips for building better relationships with big pharma, appears in the current BioCommerce Week, a CBA News sister publication.


Invitrogen to Provide Kinase Screening Services to Locus Pharma

Invitrogen said this week that it has signed a contract to provide Locus Pharmaceuticals with kinase screening services through Invitrogen's SelectScreen platform.

Invitrogen will support Locus' internal kinase discovery programs, principally in the areas of cancer and inflammation, the company said.

Financial details were not disclosed.

Invitrogen said that it has added an additional 123 human protein kinases onto its SelectScreen kinase screening panel. The current collection of 193 assays addresses therapeutically relevant targets, phylogenetic diversity, and key signaling pathways, Invitrogen said.


Dompe and Axxam Partner on GPCR Target Discovery

Axxam said this week that it has signed a research collaboration with Italian pharmaceutical firm Dompe Pharma for the discovery and development of drugs based on GPCR targets.

Dompe Pharma will contribute expertise in medicinal chemistry, while Axxam will contribute know-how in target biology, assay development, and high-throughput screening, Axxam said.

The companies did not disclose disease targets, therapeutic areas, or financial terms.


Upstate to Sell Galapagos' Adenovirus Products; Could Play in siRNA Market

Upstate, a wholly owned subsidiary of Serologicals, will market and sell Galapagos' adenovirus products worldwide, excluding Japan, Galapagos said this week.

In return, Galapagos will receive double-digit royalties on net sales achieved by Upstate.

A hallmark of the adenovirus technology is the stability of the knock-in and knock-down protein levels, and the suitability for high-throughput assays using human primary cells, Upstate said.

These features should allow the adenovirus technology to compete effectively in the global market for siRNA reagents. Galapagos retains rights to continue servicing its existing customers for these products.


BioSeek Expands Drug-Profiling Collaboration with Boston Scientific

BioSeek this week said that it has entered into a non-exclusive agreement with Boston Scientific to profile compounds for potential applications in new products.

The new agreement expands upon an earlier collaboration between the two companies. BioSeek will screen and evaluate a series of compounds selected by Boston Scientific for novel therapeutic uses using its BioMAP System of human cell-based disease models.

Financial terms of the agreement were not disclosed.


Black Dog Will Install Cerionx Pipette Tip Technology on FLIPR Platforms

Cerionx this week said that it has signed an agreement with Black Dog Technical Services of Raleigh, NC, to install Cerionx's TipCharger Systems on FLIPR systems in biopharmaceutical research laboratories.

FLIPR is Molecular Devices' high-throughput platform for intracellular calcium assays. Black Dog Technical Services provides services for FLIPR users, and is not affiliated with Molecular Devices.

Cerionx said that the TipCharger system allows labs to clean and reuse polypropylene pipette tips for "significant process improvement and cost savings."


Genedata, Novartis Expand Lead Discovery Collaboration

Genedata said this week that it has expanded a collaboration with the Novartis Institutes for Biomedical Research in the area of high-throughput screening analysis.

Under the terms of the expanded collaboration, Novartis will use the Genedata Screener software platform at its sites in Cambridge, Mass., and Basel, Switzerland.

The companies began the software collaboration in 2003.

Additional terms were not disclosed.

The Scan

Fertility Fraud Found

Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today.

Ties Between Vigorous Exercise, ALS in Genetically At-Risk People

Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports.

Test Warning

The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK.

Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine

In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.