Last week, I attended the PDA/EMA joint conference in Cascais, Portugal. The topic was on compliance, a prerequisite for availability of medicinal products. The conference kicked off with a plenary session on the impact of the new falsified medicines directive (FMD) on regulators and the pharmaceutical industry. Belen Escribano Romero from the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), a public body that belongs to the Spanish Ministry of Health, provided an overview of the main changes in the new legislation, which included, amongst others, the importation of APIs and excipients from third-world countries, inspection planning, revisions of the GMP guidelines, new GDP guidelines for the distribution of medicinal products by wholesalers and brokers, as well as pending regulations relating to safety features and purchasing medicines via the internet. It is hoped that these additional requirements will increase the quality of medicinal products, reinforce supply-chain security and prevent penetration of counterfeits, and better protect those buying medicines online. Read more »
Archive for the 'Industry conferences' Category
Want 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 PharmTech.com and the PharmTech Player.
Student Innovation Across the Pharma Sciences
Dr. Lei Zhang of CDER’s Office of Translational Sciences gave an update at the AAPS Annual Meeting in Chicago yesterday regarding the agency’s regulatory science initiative, which was rolled out in August 2011. She noted that some of the same challenges facing regulators a few years ago continue to plague FDA drug reviewers, namely:
-products are being developed more quickly using evolving sciences and technologies
-unmet medical needs are growing
-industry is shifting from a treatment focus towards a focus on disease prevention and long-term clinical outcomes
-global drug development is leading to increased responsibilities for all.
The agency is trying to address these challenges not only with increased regulatory collaboration, which we’ve been hearing about for a few years (e.g., EMA, TGA, overseas offices) but also with grant programs to encourage academic research into how drugs and devices are reviewed and evaluated at FDA. Read more »
The CPhI Innovation Awards, this year rebranded as the CPhI Pharma Awards, took place last week at CPhI Worldwide in Madrid, and put into prominence some key scientific advances of exhibitors at CPhI. The awards were designed to encourage entries in diverse areas, including formulation development, drug delivery, chemical manufacturing of APIs and intermediates, and biomanufacturing. 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 »
I’ll be in Chicago next week for the 2012 annual AAPS meeting and hope to see you there. Looking forward to this year’s hot topic conversations on the changing pharma sciences career, drug development at small companies, FDA’s regulatory science initiative, and drug shortages in the United States. These sessions are being led by key industry representatives and offer insight into key challenges facing bio/pharmaceutical developers and manufacturers. Plus, AAPS will be announcing the recipients of its graduate student awards, among other recognitions. If you can’t make it to the show, be sure to follow my tweets @PharmTechAngie. And if you are there, stop by our booth #5011.
The perception of buyers of pharmaceutical ingredients and contract services in how they see market conditions and their own individual business prospects is an important barometer in assessing the market for pharmaceutical outsourcing and ingredients. The results of a survey released this week at CPhI Worldwide in Madrid were largely positive as buyers assessed market and business conditions for the next 12 months. Read more »
As fine-chemical producers, contract manufacturers, and pharmaceutical/biopharmaceutical companies meet this week in Madrid at CPhI Worldwide, what are the key issues on the minds of industry players? Read more »
Innovation is the cornerstone of the pharmaceutical industry. That innovation is not only seen in new drug development but also in approaches to extend the lifecycle of a given product through improved formulations and drug-delivery systems. Recent advances and trends in drug-delivery systems were highlighted at one of the sessions at the Pre-Connect Conference held at CPhI Worldwide in Madrid this week.
The value of innovation was emphasized by Catalent, who provided insight on the increasing role of drug-delivery systems in solving complex drug-development challenges, such as bioavailability problems, and improving patient outcomes. The company shared research showing that compared with conventional formulations, advanced drug-delivery systems can potentially increase the value of existing drugs by 25–50% through patent-life extension, product differentiation, accelerated product development and market entry, better patient outcomes and compliance, and improved returns on R&D investment. Read more »