President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. So how has the pharmaceutical industry responded?
Developing and maintaining the right labor pool is an ongoing challenge for any industry, and it is one that the pharmaceutical industry also is facing. Recent attention in the pharmaceutical industry has focused on the restructuring that has occurred and that is still occurring among the large pharmaceutical companies. And while re-allocating resources, including labor resources, is always a crucial task for companies, it is a challenge made even more difficult amidst shifting industry fundamentals and a demand for higher productivity from scientific talent.
The pharmaceutical industry requires employees with a high-end scientific skill set, and PwC’s 2012 Global CEO Survey indicates that pharmaceutical companies are having a hard time finding the right people. A recent report by PwC’s Health Research Institute (HRI) takes a look at how changes in R&D models have affected the pharmaceutical workforce.
The 2012 European Outsourcing Awards—what some call the “Outsourcing Oscars”—were presented on October 10, 2012 during the CPhI Worldwide/iCSE show and included awards to Vetter for a high-speed filling line and to Catalent for updates to its controlled-release facility. Read more »
Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)
Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.
Sample questions:
• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?
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.
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 »
Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment. Miller is also a member of the PharmTech Editorial Advisory Board. Below are a few highlights from his talk. Read more »
With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight, ensuring the quality and safety of the US’s drug supply is a herculean task. FDA has already taken steps to increase the number of overseas inspections, but it is impractical to assume that one agency is capable of inspecting the world’s manufacturing operations on its own. The Institute of Medicine released a report on Apr. 4, 2012 outlining several practical steps that FDA could take to strengthen supply-chain security. Read more »
Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect? Read more »
Last night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy—and a large component is of that plan is to bring manufacturing back to the US. “Tonight, my message to business leaders is simple: Ask yourselves what you can do to bring jobs back to your country, and your country will do everything we can to help you succeed,” he said. Read more »
From PharmTech.com