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. Read more »

Biologic-based drugs are increasingly important in the drug pipelines of pharmaceutical companies. Strong growth is projected for biologic-based drugs, and a crucial issue is whether the outsourcing model for biologic-based drugs will follow a similar path as the model for outsourcing small-molecule development and manufacturing or will new paradigms emerge. That question was addressed at one of the sessions at the CPhI Pre-Connect Conference this week in Madrid. Read more »

Guest blog written by Nancy Berg, President and CEO, ISPE.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry. She put the onus on industry and regulators to find ways to work together more effectively, to engage in productive conversations, and to dissolve roadblocks to QbD and the issues that lead to counterfeiting, shortages, and other threats to safe, high-quality medicines. Read more »

What’s the best way to reach first-in-man studies when you have little to no information?   Bioavailability issues, financial constraints, and pressure to meet accelerated deadlines can affect development, so having a firm plan in place is key. PharmTech is hosting a free educational webinar on this topic next week, Oct. 3. Check it out for insight into the signs to look for when finalizing a plan and how to achieve the best outcomes. A detailed case study about a molecule that has successfully navigated through development to commercial success will be presented.

Earlier this week, on Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The event was at the Washington, DC, Newseum and featured as keynote speakers Marc Kennedy Shriver, who wrote a book about his father’s experience with Alzheimer’s, and Meryl Comer, an Emmy award-winning journalist.

The evening was about inspiration and motivation to keep up the fight against AD, whether as caregivers, patient advocates, health professionals, or scientists. Read more »