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 »

Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore, at Twitter@PharmTechAngie or Twitter@PharmTechGroup. Today’s sessions focused on common regulatory citations (the word is that they haven’t changed much in the past 10 years), new ways to handle internal investigations from Big Pharma organizations such as Amgen and Abbott (including a bit of an audience stirup surrounding the management, or lack thereof, of Class I investigations), FDA encouragement of sending novel excipients in for review, best practices for selecting excipients for new drugs (including how to best deal with suppliers), updates on ICH Q11, and a lot of information on knowledge management, risk-based approaches (including QbD), and lifecycle approaches. More information to come tomorrow when the various FDA offices give their reports.

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release. Read more »

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.  The new annual awards, called the Research and Hope Awards, are replacing PhRMA’s Discover’s Award, and this year, will focus on the fight against Alzheimer’s Disease. The Alzheimer’s Foundation of America, the National Alliance for Caregiving, and the National Association for Home Care & Hospice are cohosting the 2012 event. Read more »

This week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships. The event, hosted by PharmTech and CBI, addressed many common challenges facing the outsourcing sector while also offering potential solutions. Below are a few soundbites from the second day’s discussions (see here for the first day summary). Read more »

What will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking? These questions were addressed at a conference this week in Philadelphia, Bio/Pharmaceutical Manufacturing Partnerships, organized by CBI in conjunction with Pharmaceutical Technology. Read more »