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The Lead

Innovation Reins in Runaway Pharma Spending

July 1, 2014 1:21 pm | by Nancy Dreyfus, Contributing Science Writer | Articles | Comments

To combat the rising costs of bringing a new drug to market, pharmaceutical companies have taken a variety of innovative approaches, according to the U.K. Office of Health Economics, such as deciding earlier in the R&D process to discontinue drugs lacking strong market prospects and better controlling clinical costs. Read more...

Preserving the Future of Drug Discovery

June 9, 2014 9:37 am | by Lori Ball, Chief Operating Officer, BioStorage Technologies | Articles | Comments

Biospecimens - and the genetic and genomic information derived from these...

Last Day for R&D 100 Entries

May 9, 2014 10:12 am | News | Comments

It has arrived...the last day to file your 2014 R&D 100 Awards entry is today, Friday, May 9...

Droplet Digital PCR Advances the Treatment of Cancer

May 6, 2014 9:49 am | by George Karlin-Neumann, Director of Scientific Affairs, Bio-Rad Digital Biology Center, Pleasanton, Calif. | Articles | Comments

One of the more exciting new technologies contributing to current advancements in cancer is...

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Faking Fluorescence

April 9, 2014 11:05 am | by Takeharu Nagai, Ph.D., Osaka University, Japan | Articles | Comments

The world’s brightest luminescent protein, a discovery dubbed the “Nano-lantern,” is lighting up the future of in vivo imaging– without the use of external light. This could benefit more advanced applications, such as high-throughput drug screening and single-cell tracking in live animals and plants.

Next-Gen Gene Synthesis Will Accelerate Biopharmaceutical Design and Development

March 4, 2014 3:56 pm | by Kevin Munnelly, CEO, Gen9 | Articles | Comments

With the biopharmaceutical market valued at $70 billion and counting, scientists need every improvement they can get to design and develop these drugs faster and more accurately. A novel technology that will bring synthetic biology to industrial scale promises to dramatically enhance the development pipeline.

New Therapy Targets Prospective Older Bone Marrow Transplant Patients

February 20, 2014 9:45 am | by Kaushik J. Dave, Ph.D. | Articles | Comments

Bone marrow transplants are the only potential cure for many blood cancers in older patients, but many in this group are ruled ineligible because the procedure is often deemed too harsh for older people. Since more than half of AML patients are over 65 years old, new tactics to prepare these patients for hematopoietic stem cell transplantation are needed.

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The Road More Traveled: Improving Drug Therapies for Not-So-Rare Diseases

January 15, 2014 9:27 am | by Seth Lederman, MD, CEO, Tonix Pharmaceuticals | Articles | Comments

To borrow a line from Robert Frost’s famous poem, for big and small patient populations, two roads are diverging in drug development. Traditional pharmaceutical developers tackle common problems affecting the many; orphan drug and personalized medicine developers target rare problems affecting few people. But which road is more traveled now? Find out...

Addressing Challenges in Production of Cell Therapies

November 7, 2013 10:34 am | by Ronnda L. Bartel, Chief Scientific Officer, Aastrom Biosciences | Articles | Comments

As the challenges in production of cell therapies have grown more complex, new technologies have been developed that can improve performance in key areas including monitoring and coordination of the production process.  How has Aastrom Biosciences maintained a constant focus on our production process at every stage of their development efforts? Ronnda L. Bartel, chief scientific officer of Aastrom Biosciences, explains.

Carbohydrate-Based Drugs: A Unique Tool in Healthcare

October 15, 2013 8:38 am | by David Platt, PhD, CEO, Boston Therapeutics Inc. | Articles | Comments

Carbohydrates play a fundamental role in normal cell functions as well as in major disease pathologies including cancer, cardiovascular disease and inflammatory diseases. So why is complex carbohydrate chemistry a key tool for addressing unmet medical needs in a variety of areas? David Platt, PhD, CEO of  Boston Therapeutics Inc. explains.

The Unrealized Potential of Stem Cell Therapy

October 10, 2013 3:27 pm | by William R. Prather RPh, MD, Sr. VP Corporate Development, Pluristem Therapeutics Inc. | Articles | Comments

Why is the stem cell industry deserving of its love-hate relationship with the public? And are the stem cell products that are closest to approval really stem cells? William R. Prather RPh, MD, senior vice president of corporate development at Pluristem Therapeutics Inc., explains.

Alliqua CEO: Hydrogel-Based Transdermal Drug Delivery, An Innovative Alternative

September 19, 2013 1:24 pm | by James Sapirstein, CEO; Alliqua Therapeutics. | Articles | Comments

The use of hydrogels to enhance transdermal drug delivery may prove useful as an innovative alternative to current drug delivery techniques and could have an widespread impact on medicine, says James Sapirstein, CEO of Alliqua Theraputics.

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Industry Insider: Thin-Film Strip Delivery for Apomorphine

September 11, 2013 9:18 am | by Anthony Giovinazzo, President and CEO; Cynapsus Therapeutics Inc. | Articles | Comments

Cynapsus Therapeutics recently developed a sublingual thin-film strip delivery system for apomorphine, which is similar in concept to Listerine breath strips. The strip dissolves in about 1.5 minutes, delivering the drug into the bloodstream in a similar time interval and concentration as an injectable dose. 

Utilizing Isogenic Cell Lines as in vivo Models

August 12, 2013 9:44 am | by Rajendra Kumari | Articles | Comments

Cancer arises as a result of the acquisition of a series of abnormalities and mutations, typically involving oncogenes and tumor suppressor genes, which ultimately confer a growth advantage upon the cells in which they have occurred. A wide spectrum of types of genetic alteration can contribute to the promotion of cell growth, ranging from single amino acid mutations to deletions and chromosomal translocations.

Enhancing Neurological Drug Delivery

July 11, 2013 1:58 pm | by Kimble L. Jenkins, CEO; MRI Interventions, Inc., Memphis, Tenn. | Articles | Comments

The challenge of delivering drugs to neurological targets has been a major roadblock to many promising therapies for treating diseases and disorders of the brain. The blood brain barrier blocks the vast majority of all small-molecules and virtually all large molecules from reaching therapeutic targets within the brain.

Using Patient-Relevant Models to Fight Acquired Drug Resistance

July 9, 2013 11:56 am | by Rajendra Kumari, Chief Operating Officer; PRECOS Ltd., Belton, U.K. | Articles | Comments

Despite improved efficacy and a reduced side effect profile, second-generation cancer therapies still suffer from the same major limitation associated with traditional chemotherapy drugs—the duration of any observed clinical benefit is invariably short lived, due to the relatively rapid acquisition of drug resistance.

Sharing the Driver’s Seat

July 2, 2013 8:41 am | by E. Neil Lewis PhD, Chief Technology Officer; Malvern Instruments, Malvern, U.K. | Articles | Comments

In the fast-moving world of biopharmaceutical research, where scientists are trying not only to solve today’s analytical problems, but also to guess what’s around the next corner, the traditional models for developing new analytical technologies are no longer viable.

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Sitting Down with Quintiles Outcomes

June 25, 2013 10:07 am | by Peter A. Bennett, Editor | Articles | Comments

As cost-cutting and austerity measures sweep the globe, simply producing a safe treatment is no longer enough. Dr. Gliklich, President of Quintiles Outcomes, discusses how post-approval studies can help pharmaceutical companies improve their drug's chances of success in the age of effectiveness.

Needle-Free Injection: Has its Time Finally Arrived?

June 4, 2013 1:39 pm | by John J. Turanin, Vice President and General Manager; Zogenix Technologies, San Diego, Calif. | Articles | Comments

There have been significant advancements in needle-free injection technology, which aim to increase adoption of self-injectable therapies and adherence. Patients often lack the confidence to self-inject or are put off by the complexity, impacting their ability to incorporate these therapies into their lifestyle.

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 entered into the CRF and diaries was based entirely on trust. The investigator would sign the final page of the CRF to confirm that he or she had reviewed all data contained therein.

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.

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. 

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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