Ernst & Young recently released its annual biotechnology industry report, Beyond Borders: Matters of Evidence, stating that while the major players are performing well, it is essential that small- to mid-size biotech companies focus on demonstrating the value of products in their pipelines instead of just creating a drug that works. If not, they will lose out in a challenging environment, especially now that there is a global shift towards evidence-based healthcare. Read more »

Steven Eaton, a scientist working for Aptuit, a US pharmaceutical company, has been jailed three months for falsifying preclinical safety data on experimental anticancer drugs due for clinical evaluation. Eaton, 47, who worked at the company’s drug discovery and development site in Riccarton, near Edinburgh, Scotland, is the first person in the UK to be jailed under the country’s scientific safety laws. Read more »

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation. An article in the February 2013 issues of Pharmaceutical Technology and Pharmaceutical Technology Europe, “Improving Inhaled Product Testing: Methods for obtaining better in vitro-in vivo relationships,” discussed testing equipment and techniques. PharmTech recently interviewed the author, Mark Copley, sales director at Copley Scientific, to gain further insight into the importance of this topic. Read more »

Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative. QbD has raised the bar in augmenting process understanding to ensure consistent product quality, and equipment manufacturers, ingredient suppliers, and manufacturers are responding with innovation in their products and services.

Shows such as INTERPHEX 2013 enable attendees to come together to share scientific innovation and discuss the trends and topics affecting the industry. One such topic is the QbD initiative and its impact on the pharmaceutical industry. Pharmaceutical Technology is hosting a panel discussion on implementing QbD during the INTERPHEX sessions, taking place Wednesday, April 24, at 10:15 am. Manufacturing Editor Jennifer Markarian will be moderating a special panel featuring Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co.; Chris Moreton, vice-president pharmaceutical sciences at FinnBrit Consulting; and Jonathon Thompson, technical sales consulting supervisor at Invensys.  The panel will share their insight and practical experience in implementing QbD, including strategies for defining a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verification. The panel will also discuss the benefits and challenges of QbD implementation.

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FDA has come down on the side of reducing abuse of opioid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help halt the epidemic of prescription drug abuse raging across the country. FDA’s decision leaves the market open to Purdue Pharma’s newer version of the drug, which the agency determined has features that make it more difficult to abuse via injection or snorting. Read more »

The Obama administration’s budget plan for fiscal year 2014 apparently assumes that the pharmaceutical industry can support Medicare and other health programs through changes in drug coverage and payments. It also relies on industry fees to keep FDA up and running. Meanwhile, FDA and other public health agencies are contending with the sequestration mandate, which is taking another bite out of government programs and payment policies. Read more »

Pharmaceutical Technology will be moderating a panel discussion, “Lessons Learned: Successes and Challenges in Implementing Quality by Design,” on Wednesday Apr. 24 from 10:15 to 11:15 at INTERPHEX in New York City. You can listen to a podcast about the panel discussion that is posted on PharmTech’s homepage.

Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co., will provide expertise on application of design space and control strategies for API manufacturing. Dr. Chris Moreton, FinnBrit Consulting, will share his expertise in how to incorporate excipients into the design space. Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management will use his experience to discuss challenges in adapting the manufacturing process from a control perspective. Together, the panel will consider the benefits of adapting QbD and the challenges yet to be addressed. I hope to see you there.

“Our vision of success is to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research,” stated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom as it unveiled its 2013–2018 corporate plan on 11 April. The agency announced its aims to be a leading regulator on the world stage in supporting science and research as part of its five-year corporate plan, which was developed using responses from a public consultation launched last December. Read more »

More than 400 eminent scientists and public health experts from around the world have come together to endorse a new initiative to eradicate polio by 2018. The Scientific Declaration on Polio Eradication, published on 11 April, stated that an end to polio is scientifically feasible and achievable. Read more »

New figures show that last year, doctors in the UK received approximately £40 million from big pharmaceutical companies. According to the Association of the British Pharmaceutical Industry (ABPI), a trade body representing pharmaceutical companies, both National Health Service (NHS) and private staff were paid the sum for consultancies and sponsorships and other interactions with drug businesses in 2012. Read more »