Archive for the 'Trends' Category

Improving Inhaled-Product Testing

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation. An article in the February 2013 issues of Pharmaceutical Technology and Pharmaceutical Technology Europe, “Improving Inhaled Product Testing: Methods for obtaining better in vitro-in vivo relationships,” discussed testing equipment and techniques. PharmTech recently interviewed the author, Mark Copley, sales director at Copley Scientific, to gain further insight into the importance of this topic. Read more »

Big Pharma Leverages Early-Stage Risk with Innovative Options

In recent years, large pharmaceutical companies have launched a variety of initiatives to restock ailing pipelines and boost business performance including mergers and acquisitions, diversifying business portfolios to non-pharmaceutical products, downsizing, spinoffs, and entering the biopharmaceutical arena.

Whatever the approach, pharmaceutical companies want balanced portfolios with programs at various stages and risk profiles, says Melinda Richter, founder and CEO of San Francisco-based Prescience International in a BioPharm International podcast.

To date, most Big Pharma companies have partnered or acquired assets of biopharmaceutical companies with products in late-stage development, says Richter. However, as the availability of late-stage development opportunities shrink and the landscape becomes more competitive, Big Pharma is turning to more early-stage partnerships with academia and early-stage companies.

It is attractive to for the pharmas to go after early-stage companies because “by nature, they are smaller, they are nimbler, and they are willing to take the risks that the large pharmas just can’t. These small companies have to swing for the fences and they have to win. Pharmas have a lot to protect. They have to be more conservative,“ says Richter.

More scalable innovation opportunities are another part of the story, says Richter.

For example, last year, Merck announced a $90 million, seven-year commitment for the California Institute for Biomedical Research (Calibr), an independent, not-for-profit organization established to accelerate the translation of basic biomedical research to innovative new medicines.

However, for hands-on research, startup companies need laboratory and office space, as well as specialized equipment. Janssen Labs, located on the West Coast Research Center of Janssen Research & Development in La Jolla, Calif., offers short-term leases on wet laboratory and office space.  Tenants also have access to core research facilities and instruments.

The facility, operated by Prescience International, has a “no strings attached” policy. Janssen R&D does not take an equity stake or first right of refusal in the work of tenants, protecting the entrepreneurial rights of startup companies that choose independence.

Janssen Labs and Calibr are two options offered by Big Pharma that will be explored in the session “And Now for Something Completely Different: How Will Pharma Access External Early-Stage Innovation?” at the 2013 BIO International convention on April 23, 2013.


Experts at Symposium Promote Quality by Design for Analytical Methods

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

NICE Responsible for UK’s Value-Based Pricing of Medicines

The UK government has confirmed that from 2014 onwards, the National Institute for Health and Clinical Excellence (NICE), which is the country’s cost-effectiveness watchdog, will play a central role in the new value-based pricing system for assessing the costs and benefits of medicines. Read more »

The Drop in Drug Spending

Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report. The decline is being attributed to patent expirations, causing a greater use of generic drugs and increased competition. According to the report, the higher cost of specialty medications offset the overall decline. Express Scripts’ report anticipates these trends to continue.

Therapy classes saw an increase in utilization; however, unit costs saw a decrease. Cost increases for diabetes medications drove an increase in spending. Other high-use medications, however, such as those to treat depression saw a decrease in spend despite an increase in utilization. Drugs that treat attention disorders saw an upward trend because of increases in both utilization and drug cost.

Has the pharmaceutical industry seen the beginning of an overall decline in sales? Are there enough new drugs in the pipeline to push conventional drug sales forward? How is your company battling the trend?

The Next Horizon: Single-Use Technologies for Finished Drug Product Manufacturing

Patricia Van Arnum PharmTech editor Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials. An educational webcast by Pharmaceutical Technology, “Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies,” on Wednesday Mar. 6th examines this application. Read more »

Informex Perspectives: Still a Small-Molecule World

Patricia Van Arnum PharmTech editor As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

Surveying Trends in Equipment Innovation

Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »

A Call to Integrate Technology Innovation and Healthcare

In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »

Pharma’s Most Productive Innovators

Stephanie Sutton Pharm Tech EuropeConsultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialise new innovations. The company has been published the index for three years and uses publicly available data to reach its conclusions. Read more »

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