PharmTech Talk

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).

The greatly feared federal budget sequestration mandate went into effect Mar. 1, 2013, and, initially, the impact was fairly muted.

Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report.

Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials.

In January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles.

The US Orphan Drug Act of 1983 defines a rare disease as one that affects fewer than 200,000.

As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace.