Author Archive

From Generics to Supergenerics

VLUU L110  / Samsung L110The significant contribution that generic drugs make to health services across Europe cannot be denied. As Nick Haggar, president of the European Generic medicines Association (EGA) pointed out during the 20th EGA Annual Conference, held in Madrid, 25–27 June 2014, the generic drug industry offers value to healthcare by providing increased medicines access to patients (hence, saving lives) while helping governments maximize their healthcare budgets. And these benefits are in addition to the employment and investment opportunities created.

A standard generic drug contains the same active ingredient as the original branded product and is used to treat the same condition at the same dose but at a price that is typically 20% to 90% less than the patented drug. The EGA estimates that generic drugs saves patients and European healthcare systems approximately EUR 35 billion each year. Read more »

CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Ian Haynes of 3C Integrity - Low ResFormer AstraZeneca engineer and serialization specialist, Ian Haynes, looks at the first practical step contract manufacturing organizations need to take to implement a compliance strategy ahead of the impending serialization deadline.

Increasing concerns are being expressed by industry observers and top-tier pharmaceutical manufacturers that contract manufacturing organizations (CMOs) will not be ready to comply with emerging track-and-trace requirements. Read more »

Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success. Part 2 outlines how unified communications (UC) can help overcome some of these challenges.

Any UC deployment is about connecting people with one another (and with data) in a faster, richer, simpler way. Of course, no technology is a silver bullet, and a firm will only realize the full benefits if it is a truly collaborative organization, or making serious efforts to become one.

As well as the right type of culture, companies also need to have appropriate infrastructure in place to support such a solution. For example, getting different modes of communication such as voice, video, and text working together seamlessly requires the right underlying network and hardware. While that could be an in-house system, for smaller and mid-market firms, a hosted, cloud-based offering that allows you to avoid hefty set-up costs is often a more cost-effective and hassle-free option. Read more »

Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanFor an industry that saves millions of lives, pharma is sometimes unfairly perceived by the public as being aloof, unresponsive, or occasionally worse. People outside the sector rarely appreciate the difficulty and cost of bringing new drugs to market, particularly when it comes to rolling them out in emerging global markets such as China, India and Africa.

Although globalization offers the prospect of vastly expanding the market for pharmaceuticals, grasping that opportunity is easier said than done. For a start, firms must ensure they understand and comply with a plethora of ever-changing regulation that varies from country to country. They generally need to liaise with hospitals and other medical and regulatory bodies to conduct country-specific clinical trials, even where a drug has been tested and approved elsewhere. And they may also have to contend with differing cultural attitudes to Western medicine that require them to tailor their marketing efforts accordingly. Read more »

Clusters set to benefit from improved funding climate but IP rights are even more critical

Guest blog written by John Dean, partner and patent attorney at Withers & Rogers LLP.

Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector. However, as big pharma companies increasingly vie for the best spin-out investment opportunities, those with strategic intellectual property plans are likely to find favour. Read more »

A New Strategy to Tackle Antibiotic Resistance

VLUU L110  / Samsung L110We all know that the discovery of penicillin by Alexander Fleming was a turning point in medical history, which led to the development of lifesaving antibiotics. But who would have thought that decades down the road, we would be battling antibiotic resistance on a global scale. Data from the European Centre for Disease Prevention and Control (ECDC), released at the end of last year, showed a marked increase in carbapenem-resistant infections across Europe. Mortality rates have increased as well due to the limited options of antibiotics available to treat these infections. According to the European Commission, the widespread prevalence of antibiotic resistance has been estimated to cause approximately 25,000 deaths annually and more than €1.5 billion in healthcare expenses and productivity losses in Europe alone. A June 2013 report by IMS Health, “Avoidable Costs in US Healthcare,” noted that in 2012, there were 900,000 hospital admissions for drug-resistant conditions. According to IMS Health, the avoidable cost from antibiotic misuse ranges between $27 billion to $42 billion. Read more »

Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »

Pharma Moves Towards Continuous Manufacturing and Low-Cost Products

VLUU L110  / Samsung L110It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past.

“We’ve had improved measurement systems, including light-induced fluorescent spectroscopy (LIFS), near infrared (NIR) and Raman, for years, and have used them to guarantee mixing,” noted Ciurczak, “but now there are automated systems that operate continuously that will allow us to speed up pre-pilot-scale work in design of experiments (DOE), technology transfer and the determination of the design space.” He pointed out that these systems eliminate some of the problems observed with conventional methods when moving from laboratory scale to small manufacturing scale. DOE can now be done in a matter of days with the newer systems instead of weeks or months. Such improved tools lower the costs of manufacturing and enable branded players to get more value out of their products while still under patent. According to Ciurczak, there will be less complains in the future about DOE and quality by design (QbD) costing too much or tying up equipment. Read more »

From Blockbusters to Niche Medicines

VLUU L110  / Samsung L110CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.

The pharmaceutical industry is shifting away from the blockbuster model towards the development of personalized medicines and niche, individualized therapies and associated companion diagnostics, noted Sam Venugopal, director, healthcare, PricewaterhouseCoopers. These drugs target specific populations and genomic makeups and are known to have greater efficacy. William Botha, Sensei at Interlean, added that there will also be companies moving towards commodity-based, low-margin products. As a result, one can expect to see increased specialization, particularly amongst small and medium companies. Read more »

Neutron Studies Reveal New Areas for Improvement in Drug Design of HIV Inhibitors

A team of scientists recently reported on the first study of interactions between the antiretroviral drug, amprenavir, and the HIV-1 protease enzyme. The findings provide the first true picture of how the protease inhibitor blocks viral replication. More importantly, the study reveal how drug design can be improved to enhance performance, combat resistance and reduce dosage of antiretroviral medications to treat HIV. Read more »

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