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.
Archive for the 'R&D' Category
Recent 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 »
At this week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. Pharmaceutical Technology had the chance to talk with a few of the recipients. Read more »
The Nobel Prize for Physiology and Medicine was shared by two researchers: Sir John B. Gurdon of the Gurdon Institute, Cambridge, United Kingdom; and Shinya Yamanaka of Kyoto University, Kyoto, Japan and the Gladstone Institutes, San Francisco, CA, “for the discovery that mature cells can be reprogrammed to become pluripotent.” Read more »
Research into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week. Read more »
Earlier this year, the concept of solar-powered aviation was further propelled from its proverbial runway, testing many limits that had not been previously realized in the realm of energy-efficient transportation. However, as is the case with virtually every achievement since the dawn of civilization, the question remains the same: Where do we go from here?
From May–July 2012, Solar Impulse—with the help of several sponsors, including Bayer MaterialScience, the subsidiary of the pharmaceutical manufacturer Bayer—successfully completed a series of flights (known as Crossing Frontiers) as part of a round-trip journey from Switzerland to Morocco, setting several world records, according to the World Air Sports Federation, in the solar-powered subcategory (including for free distance along a course, and for straight distance with predeclared waypoints). In addition, the mission included the first solar-powered intercontinental flight linking Europe to Africa when Solar Impulse’s HB-SIA plane crossed the Strait of Gibraltar.
An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question. Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.
Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement here.
Ten biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges. The ten founding companies include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi. Read more »
MIT Survey Aims to Correlate Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites. The comprehensive survey on topics related to site characteristics, quality approaches, quality activities, perception of relative consistency of regulators, product-level process details, and product-level compliance performance was deployed over the past 18 months as a secure web-based questionnaire directly to biopharmaceutical manufacturing sites through several different channels. The individuals targeted for inclusion as survey respondents have been manufacturing plant managers or their representatives.
Read the interim results and if you haven’t yet, the survey can be taken on behalf of a biomanufacturing site usin this link.