Drug Discovery & Development

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The Lead

Important Considerations for the Manufacture of Biological Medicines

February 20, 2013 12:06 pm | by John Petricciani, MD, President; International Alliance for Biological Standardization; Geneva, Switzerland | Articles | Comments

While physicians stay informed about the medications they prescribe to ensure that patients receive the best possible treatment, one question rarely asked is, “How was this medicine manufactured?” Doctors and patients alike tend to take it for granted that drug manufacturers have the right processes and controls in place.

Electronic Clinical Trials and the Expectations of the Regulatory Agencies

February 25, 2013 4:32 pm | by Chris Cramer, Vice President, Clinical Data Management; Boston, Mass. | Articles | Comments

In the days of paper case report forms (CRFs), the accurate recording and review of subject data...

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DDD Update

Daily news and top headlines for drug research professionals

Busting Drug Discovery Bottlenecks

February 7, 2013 4:35 pm | by Megean Schoenberg and Rudy Potenzone, PhD; PerkinElmer, Inc., Waltham, Mass. | Articles | Comments

Drug research scientists often face the challenge of juggling their own research and analytical needs with the needs of the larger institution. Research is variable, yet standardization often implies the need to conform to a process. Given these challenges, science needs a new approach for empowering scientists in drug discovery.

Instrument-driven

June 11, 2012 4:36 pm | by Rita Peters, Editorial Director | Articles | Comments

A recent survey of Drug Discovery & Development readers revealed what types of instruments and systems are behind the wheel of drug research programs.

Ensuring Quality for Container Closure Systems

March 13, 2012 2:45 pm | by Diane M. Paskiet, Associate Director, Scientific Affairs; West Pharmaceutical Services Inc., Lionville, Pa. | Articles | Comments

 GMPs and other guidelines can help suppliers and pharmaceutical manufactures improve product quality, with greater efficiency and reliability. 

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Funding for HIV/AIDS Research: A Challenge for Small Pharma

March 9, 2012 12:02 pm | by Robert McNally, PhD, President and Chief Executive Officer, GeoVax Labs, Atlanta, Ga. | Articles | Comments

In spite of the ongoing urgency to develop HIV/AIDS vaccines, various research groups and small biopharma companies around the globe are encountering challenges in raising the levels of funding that are necessary to sustain effective research and clinical trials.

Hitting Leadoff in Biotech

July 13, 2011 6:40 am | by Emily Walsh, PhD, Principal Consultant; Halloran Consulting Group, Waltham, Mass. | Articles | Comments

Often heard advice for the entrepreneurial set is: “Be a credible threat.” That of course is a tall order. The odds and costs are stark. Historically, only 1 in 10 lead candidates make it through to approval, and this number is likely to be lower in 2010. If this weren’t daunting enough, the failure-inclusive cost of developing that one drug is thought to be a billion dollars.

Principal Investigator System Enables CROs to Improve Bioanalytical Study Management

February 10, 2011 10:26 am | by Richard LeLacheur, Vice President, PharmaNet, Princeton, NJ | Articles | Comments

In order to ensure smooth operation during bioanalytical studies, a novel model, where a principal investigator with direct control over the entire study is the core of the project, has been developed.

Effects of the Emerging Pharmaceutical R & D Model on Informatics

January 14, 2011 4:50 am | by Arjun Bedi, Global Managing Partner, Accenture Health & Life Sciences R&D Practice, Philadelphia, Pa. | Articles | Comments

The need for pharmaceutical R&D organizations to manage expanding volumes of data crucial will require a change in focus and approach.

Immnotherapy Welcomes TLR7

October 7, 2008 9:41 am | by Steve Worland, PhD, President, Chief Executive Officer, and Director, Anadys Pharmaceuticals, San Diego, Calif. | Articles | Comments

Researchers attempting to establish immunotherapies have been challenged when dosing with TLR agonists. With a better understanding of how to optimize the schedule of administering TLR7 agonists in different disease states, they may be able to sculpt the immune response appropriately for different diseases.

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Hot Jobs for a Cool Economy

August 11, 2008 11:05 am | by Peter Ferguson, President, Yoh Scientific and Michael Gamble, Director Strategic Sales, Health & Life Sciences, Yoh Scientific | Articles | Comments

In these tough times, the biotech job market looks promising, if you know how to sell your skills.

The Race to the $1000 Genome: Sprinting Toward the Finish Line

July 9, 2008 11:31 am | by Patrice M. Milos, PhD, Vice President and Chief Scientific Officer, Helicos BioSciences Corporation | Articles | Comments

The question of when it will be possible to sequence a human genome is being replaced by concerns whether the average consumer will choose to have his or her genome sequenced.

A Versatile Strategy

April 17, 2008 7:52 am | by Neil Kurtz, MD, President and Chief Executive Officer, TorreyPines Therapeutics, Inc., La Jolla, Calif. | Articles | Comments

For small biopharmaceutical companies, the mechanism of action approach may build the most attractive pipeline.

Personal Dose: A New Direction and Profit Source?

November 30, 2007 12:51 pm | by Girish Malhotra, PE, President, EPCOT International, Pepper Pike, Ohio | Articles | Comments

With $100 billion in patents expiring by 2011, pharmaceutical companies need new drug discovery and development routes. A "personal dose" model could be an alternative.

The Next Era of Gene Expression Tools

October 11, 2007 12:58 pm | by Bruce Silgmann, PhD, High Throughput Genomics | Articles | Comments

Obstacles to measuring gene expression have hindered the impact of genomics on drug discovery and the life sciences.

Patents on a Budget: The Provisional Application

October 11, 2007 12:51 pm | by Richard Lebovitz, Millen, White, Zelano, and Branigan | Articles | Comments

Patents are the intellectual property currency of the world of commerce.

Bioinformatics Outstrips Info Technology

October 11, 2007 12:38 pm | by Michael Kane, PhD, Purdue University | Articles | Comments

In addition to the growing amount of genomic data, the diversity of data types in the bioinformatics domain are also increasing, and systems biology efforts emerge to integrate genomic data with proteomic, ionomic, metabolomic, biochemical, and pharmacological data to study various fundamental aspects of living systems.

Integrate Integrative Biology?

October 11, 2007 11:38 am | by Ken Rubenstein, PhD, Lion Consulting Group | Articles | Comments

Systems biology underwent a dramatic renaissance in 2000.

Interdisciplinary Training in Bioinformatics, IT

October 11, 2007 8:40 am | by Michael Kane, PhD, Purdue University | Articles | Comments

Information systems are the lifeblood of the new century.

Revitalizing the Peptide

September 20, 2007 11:03 am | by Rodney Lappe, PhD | Articles | Comments

Researchers seeking the "next generation" of therapeutics are taking novel—but undeniably risky approaches.

Biopharma’s Virtual Business Model

September 6, 2007 7:02 am | Articles | Comments

William Porter Jr. At a Glance Title: Senior vice president, business development, Asia-Pacific Company: VDDI Pharmaceuticals, Brentwood, Tenn. Education: BS and MS, Michigan State University Background: Porter has more than 30 years experience in the biopharmaceutical industry, education, project management, and government relations.

RNAi Market Boosted by Price, Ease

September 6, 2007 7:02 am | Articles | Comments

Raju Adhikari, Mbiochem, DPhil At a Glance Title: Pharmaceutical-biotechnology industry analyst. Company: Frost & Sullivan Healthcare Practice, Europe. Education: First Class Masters degree, University of Oxford, UK; Doctorate in immunology, University of Oxford, UK.

Beyond Assay Development 101

September 6, 2007 7:01 am | Articles | Comments

Ralph Garippa, PhD At a Glance Title: Research leader for Cell-based HTS and Robotics Company: Hoffmann-La Roche Inc., Discovery Technologies, Nutley, N.J. Education: PhD, pharmacology, Columbia University, New York; BS, biology, Fairleigh Dickinson University, Rutherford, N.J.

Assembly Line or Custom Design?

September 6, 2007 7:00 am | Articles | Comments

Lisa Minor, PhD At a Glance Title: Principal scientist, vascular biology Company: Johnson & Johnson Pharmaceutical Research and Development, Springhouse, Pa. Education: PhD, biochemistry, Pennsylvania State University, State College, Pa.; BS, zoology/botany, Oregon State University, Corvallis, Ore.

Biomarkers Save Clinical Trial Costs

September 6, 2007 7:00 am | Articles | Comments

Phil Webster At a Glance Title: Pharma-biotech analyst for European Healthcare Practice Company: Frost & Sullivan

Reducing Health Risks of Drugs

September 6, 2007 6:58 am | Articles | Comments

The problem of serious physical risks associated with pharmaceutical drugs is not going away.

Trial Data on the Hot Seat

September 6, 2007 6:58 am | Articles | Comments

The pharmaceutical and biotechnology industries are on the hot seat when it comes to clinical trials...

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