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The Lead

A Nobel Promise

January 9, 2014 4:40 pm | by Andrew S. Wiecek, Editor | News | Comments

This year’s Nobel Prize in Chemistry was awarded to three researchers—Martin Karplus, Michael Levitt and Arieh Warshel—for their contributions to molecular modeling techniques. The promise of this work lies in the possibility that computational chemistry could one day become a predictive science, ushering in a new age of rational drug design. Read more...

Simplifying UHPLC

January 9, 2014 11:50 am | by Mike May, Contributing Editor | Articles | Comments

In drug research, the science of separation comes into many aspects of discovery and development...

Orphans No Longer

January 9, 2014 9:11 am | by Ted Agres, Contributing Editor | Articles | Comments

With worldwide markets for prescription drugs stagnating, pharmaceutical companies are eyeing...

Pipeline to Scrum

January 8, 2014 11:06 am | by Chris Tachibana, Contributing Editor | Articles | Comments

Once upon a time, drug discovery and development was mostly a game of chance. Then, we began...

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New Opportunities for Stem Cells in Drug Discovery and Development

January 7, 2014 12:53 pm | by Estelle Doudement and Hirdesh Uppal, Genentech Inc. | Articles | Comments

In spite of promising applications, new competencies surrounding stem cell differentiation and proliferation, induction of pluripotent stem cells and creation of efficacy assays are needed to make successful use of stem cells in drug discovery. As part of Genentech’s mission on scientific innovation, our group is attempting novel and pioneering science with stem cells and cellular reprogramming.

Label-Free and iPS Cell Technology Join Forces for Neurological Drug Discovery

January 2, 2014 3:36 pm | by Heidi M. Morgan, M.S.,Frauke Haenel, Maxine Santoro, Tim Henion, Seth Cohen, PerkinElmer Inc. Coby Carlson, Arne Thompson, Rachel Llanas, Cellular Dynamics Inc. | Articles | Comments

The combination of label-free and induced pluripotent stem cell technology provides physiologically relevant, predictive and innovative cell-based assays that will aid the discovery of new drugs for neurodegenerative diseases. Learn more...

Optimizing Oncology Clinical Trials with Personalized Medicine

December 30, 2013 3:37 pm | by Bradley L. Smith, PhD, Philip P. Breitfeld, MD, Quintiles Inc. | Articles | Comments

Patient pre-profiling, determining a patient’s tumor-specific molecular profile, could have great value for physicians and patients as they consider potential clinical trial options. To the extent that a molecular profile is broad, encompassing many potential target alterations, one can easily imagine benefits such as more efficient enrollment, increased participation by physicians and patients and more informed treatment decisions.

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How is the U.S. FDA Preparing for the Era of Personalized Medicine?

December 30, 2013 2:43 pm | by Andrew S. Wiecek, Editor | Articles | Comments

In an October 2013 report, the U.S. Food and Drug Administration (FDA) highlighted the regulatory challenges of personalized therapeutics, as well as the agency’s response. Overall, the report demonstrated the agency’s commitment to establishing regulatory processes, policies and infrastructure to support the review of drugs that target smaller patient populations. One of the biggest challenges comes from...

Predictable Success with Antibody Drug Conjugates and Bispecific Antibody Cancer Therapies

December 30, 2013 11:48 am | by Trevor Hallam, PhD, Sutro Pharmaceuticals | News | Comments

Homogeneity is key to optimal drug design and product safety. The capability to produce homogeneous protein therapeutics is likely to be as impactful for regulators and biologics manufacturers as the realization long ago by small drug manufacturers that single enantiomers, rather than racemates, are the preferred therapeutic.

Acoustic Liquid Handling: Not a One-Trick Pony

December 30, 2013 11:21 am | by Joe Olechno, Labcyte Inc. | Articles | Comments

Liquid handlers are essential in drug discovery but have been prone to limitations inherent in their design. As researchers miniaturize to reduce cost and allow the use of rare reagents and cells, these limitations can become more serious.

Automated, Parallel Dispensing Eliminates Carryover, Increases Microplate Assay Efficiency

December 27, 2013 4:17 pm | by Jason E. Greene, BioTek Instruments Inc. | Articles | Comments

Biochemical and cell-based assay workflows often include several liquid dispensing steps with varying reagents. Although automated liquid dispensers speed these processes in microplate format, fluid carryover from shared pathways may compromise the assay. Additionally, eliminating carryover through inter-reagent flushing increases time and reagent costs, or requires separate, dedicated liquid dispensers.

Doing More with Less

December 23, 2013 4:25 pm | by Andrew S. Wiecek, Editor | Articles | Comments

To increase the efficiency of their R&D programs, pharmaceutical companies must invest more in external research collaborations, which allow them to leverage the expertise of government agencies and academia—as well as each other—to tackle common problems.

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Figuring Out Physiological Conditions

December 23, 2013 10:22 am | by Mike May, PhD, Contributing Editor | Articles | Comments

Getting the most from fluorescent labeling in drug discovery and development comes from assays that label endogenous genes and provide a specific measurement of their expression levels. “We no longer overexpress fluorescently tagged genes, as has been the norm,” says Christian Nievera, PhD, product manager for zinc finger nucleases (ZFNs) at Sigma-Aldrich (St. Louis, Mo.).

Policy & Projections: More to Share

December 20, 2013 10:40 am | by Ted Agres, Contributing Editor | Articles | Comments

Facing ongoing fiscal challenges, Big Pharma companies are becoming increasingly willing to share precompetitive and noncompetitive data and software in hopes of speeding drug discovery and increasing their chances of clinical success. 

I Can See Clearly Now: in vivo Imaging in Drug Discovery

December 20, 2013 9:46 am | by Neil Canavan, Contributing Editor | Articles | Comments

A mouse may not resemble a black box, but experimentally, what’s going on inside it can often be a mystery. To gain further insight, the mouse is often sacrificed, but this solution provides only a single data point at a fixed time. What’s needed is the ability to acquire data noninvasively over time, and that motivation is the driver behind the development of in vivo imaging techniques in preclinical development.

New Approaches to Virtual Screening

December 18, 2013 3:10 pm | by Ivan Solt, Anna Tomin, Krisztian Niesz, ChemAxon Ltd. | Articles | Comments

Virtual screening (VS) aims to reduce the enormous virtual space of chemical compounds (a practical virtual library might comprise ~1015 molecules) to a more manageable number for further synthesis and screening against biological targets, which could lead to potential drug candidates.  So what are the latest trends in the field?

Better Tools for Screening: Early Biomarkers of Kidney Toxicity

December 17, 2013 4:40 pm | by Dominic Eisinger, PhD, Myriad RBM Inc. | Articles | Comments

The efforts for identifying biomarkers that are suitable for detection and monitoring of kidney injury is an ongoing process. Fortunately, new biomarkers and assays are able to expedite translational development, be integrated with a pharmacokinetic or pharmacodynamic drug development strategy and contribute to more informed decisions regarding range and interval of dosing.

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Next-Generation Sequencing for Non-Bioinformaticians

December 16, 2013 3:17 pm | by Anniek De Witte, Agilent Technologies | Articles | Comments

Targeted sequencing—paired with graphical interfaces for robust open-source bioinformatics algorithms and desktop sequencing instruments—presents the opportunity for low-cost, low-infrastructure expansion of NGS to the larger research community, which currently still depends on Sanger sequencing. How can the analysis of next-generation sequencing data be simplified to support its expanded adoption in clinical research?

Coculture Systems Increase Sensitivity for Predictive Toxicology Studies

December 16, 2013 12:13 pm | by Onyi Irrechukwu, Hepregen Corporation | Articles | Comments

Drug-induced liver injury (DILI) is of primary concern in drug development. Nearly half of all drugs entering clinical trials will fail because of some form of serious toxicity that was missed in preclinical studies, costing the industry billions of dollars. Could a coculture system provide a high-fidelity, in vitro tissue model with a range of liver-specific functions? Learn more...

Demystifying Genetic Biomarker Discovery and Validation

September 5, 2013 9:14 am | by Eugene Chow, Nick Price, and Rachel Scott, Bio-Rad | Articles | Comments

As pharmaceutical and diagnostics companies seek to provide patients with effective and targeted therapies, they’re relying more heavily on genomics based biomarker discovery. Expression profiling studies offer just such a solution for discovering new disease and drug-response biomarkers. The question is where to begin.

Expanding the Application of Antibodies

August 30, 2013 8:30 am | by Mike May, Contributing Editor | Articles | Comments

Antibodies play a part in many aspects of today’s drug discovery and development. These molecules enhance drug research and development, clinical diagnostics, and more. Drug discovery starts with identification and validation of targets, and antibodies are the gold standard when it comes to the specific detection of an interesting biomolecule or pathway.

Taking on Cardiac Risk

August 29, 2013 1:30 pm | by Shawne Workman, Scientific Writer, Certara USA Inc. | Articles | Comments

Unanticipated cardiotoxicity is a leading cause of market withdrawal and late-phase attrition. The industry as a whole moved to control cardiac risks in the past decade with new guidelines and development practices, with some success. But a narrow focus on specific risk factors has absorbed substantial development resources, leaving gaps in assurance against the multifactored sources of cardiac risk.

Using Bioisosteric Transformations for Compound Prediction

August 26, 2013 9:21 am | by Dr. James Chisholm, Dr. Matthew Segall, Edmund Champness, Dr. Chris Leeding, Hector Martinez and Iskander Yusof, Optibrium. Cambridge, U.K.; Dr. John Barnard and Dr. Julian Hayward, Digital Chemistry Ltd., Sheffield, U.K. | Articles | Comments

Bioisosteres are functional groups which have similar physical or chemical characteristics and hence similar biological effects. The principle of bioisosterism is widely used in drug discovery, where it is often desirable to maintain similar molecular interactions to retain target potency, while accessing new chemical space.

Beating the First-to-File Clock

August 24, 2013 8:30 am | by Sabine Schefzick, PhD, Product Marketing Manager for Preclinical, ADMET, DMPK; Accelrys, San Diego, CA | Articles | Comments

Inventors and their legal teams accepted sweeping changes in March, when longstanding U.S. laws granting patent rights to “the first-to-invent” were largely replaced by laws granting patent rights to “the first-inventor-to-file.” With ever-increasing patent filings in the United States, the shift brings the country in line with others—especially in Europe—where “first-to-file” has been in place for decades.

Oldies But Goodies

August 22, 2013 8:30 am | by Ted Agres, Contributing Editor | Articles | Comments

Not only is it getting harder and more expensive to bring a drug to market, it now appears that newer drugs are far less effective than those developed 40 or 50 years ago. A new study concludes that drugs tested in placebo-controlled clinical trials in 1971-80 were more than 4.5 times as effective as placebo in treating their primary outcomes, whereas drugs tested in 2001-10 were only 36 percent more effective than placebo.

Accelerating Drug Development for Diabetes

August 20, 2013 9:42 am | by Lubna Hussain, Sr. Product Manager, Lonza | Articles | Comments

Diabetes prevention has become a key focus area for the drug development market. Diabetes currently affects 366 million people worldwide and is expected to affect 552 million by 2030. According to the Schulze Diabetes Institute over $100 billion is spent annually by patients treating their diabetes. North America accounts for the highest share of the diabetes drug market, followed by Europe. 

A New Mix for Microfluidics

August 16, 2013 1:30 pm | by Mike May, Contributing Editor | Articles | Comments

Microfluidics covers most any technology that handles- in an extremely precise and controlled way- very small volumes of fluids. The volumes tend to be controlled in microliter quantities or less. Since microfluidics birth in the1960s and 70s, many microfluidics-based platforms have come on the market.

Better Development of Biosimilars

June 11, 2013 12:03 pm | by Savanna Steele, PharmD, Clinical Scientist; Song Wang, PhD, Associate Statistical Science Director; Brian Healey, PharmD, Associate Director; Dirk Reitsma, MD, Vice President; PPD, Wilmington, N.C. | Articles | Comments

In order to add assurance that the biosimilar candidate is as similar to the originator as possible, multiple tests should be used to assess similar qualities, an approach termed as “orthogonal” in the U.S. Food and Drug Administration draft biosimilar guidelines.

Automating Lead Optimization

June 6, 2013 5:00 pm | by Bobby Chavli, Associate Director, Marketing, BD, and Customer Service; Hamilton Robotics, Reno, Nev.; Mary Napier, Consultant; GeneCom Group, San Francisco, Calif. | Articles | Comments

The drug discovery business is changing rapidly. More pharmaceutical companies are working with smaller biotech firms to create early-stage compounds, and thus need quicker and standardized solutions to early-stage development problems.

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