Tech Talk

The US Food and Drug Administration and industry have been working to incorporate process validation as an integral component of drug development and production, and to avoid divergent policies in the US and Europe.

The issue of patients not receiving essential medicines because they cannot afford them is becoming a serious problem in the EU as the region battles through its economic crisis.

FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality.

The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain.

Evidence of health outcomes is what payers want to see. As a result, biotech companies are now focussing more on demonstrating economic value, for example, by showing survival benefit of a cancer drug or superiority to branded or generic competitors.

AstraZeneca and Exco InTouch have announced a program to develop and launch interactive mobile phone and internet-based health tools that will help patients in the UK and their healthcare providers to track and manage chronic conditions.

As pharmaceutical and biopharmaceutical companies intensify product development in biologics, they are tasked with meeting the challenges of biologic-based drug development and manufacturing.

Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report.

Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate.

Quality by Design (QbD) is changing drug development and manufacturing. The science- and risk-based approach inherent in a QbD paradigm increases process understanding and leads to better drug development and manufacturing.

As I visited the exhibits and attended the conference sessions at INTERPHEX 2013 last week, I noticed a focus on equipment flexibility and ease-of-cleaning and changeover that enables manufacturing efficiency.

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.

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.

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation.

Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative.

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.

FDA has come down on the side of reducing abuse of opioid medications, over encouraging wider availability of low-cost painkiller meds.

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.

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.

“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.

New figures show that last year, doctors in the UK received approximately £40 million from big pharmaceutical companies.

As more companies try to ensure that their validation activities are compliant and cost-effective, it has become increasingly important for quality professionals and validation technicians to manage costs and reduce downtime by accurately evaluating their validation equipment needs

Pharmaceutical Technology interviewed some of the speakers for the upcoming INTERPHEX 2013 conference to get a “sneak peek” of their presentations.

In recent years, large pharmaceutical companies have launched a variety of initiatives to restock ailing pipelines and boost business performance including mergers and acquisitions, diversifying business portfolios to non-pharmaceutical products, downsizing, spinoffs, and entering the biopharmaceutical arena.

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.

INTERPHEX 2013 begins later this month and Pharmaceutical Technology will be previewing the action in the weeks to come.

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013.

The European Commission (EC) has released the draft revision for four chapters of its good manufacturing practice (GMP) guidelines-chapters 3, 5, 6 and 8.

The UK government has confirmed that from 2014 onwards, the National Institute for Health and Clinical Excellence (NICE), which is the country’s cost-effectiveness watchdog, will play a central role in the new value-based pricing system for assessing the costs and benefits of medicines.

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).