Archive for the 'R&D' Category

When Will Pharmacogenomics Live up to its Promise?

Stephanie Sutton Pharm Tech EuropeIn about 20 years and with a cost of around $10 billion. That’s the estimate given by researchers at the Beth Israel Deaconess Medical Center in the US who used quantitative modelling to forecast how much time and money would be required before pharmacogenomics could be expected to be used in clinical care. Read more »

A New Year in Pharma

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.

Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

Grad Student Innovation

Angie DrakulichWant to know what the future of pharma science looks like? AAPS knows. They recently awarded several graduate students for their work in research and development, pharma analysis, drug delivery, bio- and nano-technology, and more. PharmTech had the chance to talk with some of the winners and their stories appear in the December issue of PharmTech. You can get a sneak preview of the students’ winning research via a video podcast on and the PharmTech Player.

Video: AAPS 2012 Student Awards

Student Innovation Across the Pharma Sciences

Non-Profit Research Organization’s Mission Includes Hot-Melt Extrusion Studies

markarian online portraitThe Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion. I recently visited with the PPI researchers and toured their facilities. Read more »

In Favour of Needle-Free Injectables

No one likes needles, so imagine the benefits of needle-free delivery systems, especially for chronic conditions where lifetime therapy is required, for example rheumatoid arthritis (RA). Patients already have enough stress to deal with and can definitely do without the added fear and anxiety associated with needles. Other advantages of course include the lack of contamination risks and needle stick injuries, plus disposals are easier when you don’t need a bin for sharps. Read more »

Changing Trends in Laboratory Compliance

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.

Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.

Third Quarter Revenues Wounded by Patent Expiries

As third quarter results were being released last week, we hear of several top drugmakers facing hard knocks from the fall off the patent cliff. Pharmaceutical news have been populated with headlines such as the following: Sanofi drops as major patent expiries take hold, Bristol-Myers results fall short as Plavix sales evaporate, AstraZeneca continues to see revenue decline, and Lilly revenues down as generics erode Zyprexa sales. Read more »

Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

Read more »

Will Pharma Embrace Open Innovation?

Stephanie Sutton Pharm Tech EuropeRecent years of low approvals of new blockbuster products have given rise to the perception that pharmaceutical drug development, in its current format, no longer works. Recent late-stage failures of clinical trials have also served to emphasise the risky nature of drug development. So what’s the alternative?

At the end of last week, GlaxoSmithKline placed its bets on open innovation as a new way forward for developing medicines. Read more »

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