Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Pharmaceutical Technology will present an educational webcast on Thursday Nov. 7th from 1:00 to 2:00 PM EST, “Ensuring Preparedness for Regulatory Inspections,” which will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency for providing access to that information. Read more »
Archive for the 'Trends' Category
It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past. Read more »
CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.
The pharmaceutical industry is shifting away from the blockbuster model towards the development of personalized medicines and niche, individualized therapies and associated companion diagnostics, noted Sam Venugopal, director, healthcare, PricewaterhouseCoopers. These drugs target specific populations and genomic makeups and are known to have greater efficacy. William Botha, Sensei at Interlean, added that there will also be companies moving towards commodity-based, low-margin products. As a result, one can expect to see increased specialization, particularly amongst small and medium companies. Read more »
US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget. While national parks and landmarks, including the Statue of Liberty were closed on October 1 and thousands of government workers were idled, FDA expects to retain approximately 55% of its staff during the current partial government shutdown.
According to a Department of Health and Human Services statement, FDA will continue limited activities related to its user fee-funded programs. The agency will also continue “select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”
The agency reports that it will not support the majority of its food safety, nutrition, and cosmetics activities and may have to cease safety activities such as “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.
Reviews of pending approvals for several drugs, originally scheduled for early October, were uncertain as of Oct. 1.
A provision by House Republicans to delay the implementation of the Affordable Care Act appears to be the major sticking point to an agreement. If elected officials get past this roadblock, the next big debate, over increasing the debt ceiling, is just two weeks away.
Guest blog written by Chris Watson, product manager of Exco InTouch.
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. AstraZeneca’s R&D organisation and Exco InTouch are developing the tool with an initial focus on chronic obstructive pulmonary disease (COPD). Read more »
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 »
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 »
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.
Whatever the approach, pharmaceutical companies want balanced portfolios with programs at various stages and risk profiles, says Melinda Richter, founder and CEO of San Francisco-based Prescience International in a BioPharm International podcast.
To date, most Big Pharma companies have partnered or acquired assets of biopharmaceutical companies with products in late-stage development, says Richter. However, as the availability of late-stage development opportunities shrink and the landscape becomes more competitive, Big Pharma is turning to more early-stage partnerships with academia and early-stage companies.
It is attractive to for the pharmas to go after early-stage companies because “by nature, they are smaller, they are nimbler, and they are willing to take the risks that the large pharmas just can’t. These small companies have to swing for the fences and they have to win. Pharmas have a lot to protect. They have to be more conservative,“ says Richter.
More scalable innovation opportunities are another part of the story, says Richter.
For example, last year, Merck announced a $90 million, seven-year commitment for the California Institute for Biomedical Research (Calibr), an independent, not-for-profit organization established to accelerate the translation of basic biomedical research to innovative new medicines.
However, for hands-on research, startup companies need laboratory and office space, as well as specialized equipment. Janssen Labs, located on the West Coast Research Center of Janssen Research & Development in La Jolla, Calif., offers short-term leases on wet laboratory and office space. Tenants also have access to core research facilities and instruments.
The facility, operated by Prescience International, has a “no strings attached” policy. Janssen R&D does not take an equity stake or first right of refusal in the work of tenants, protecting the entrepreneurial rights of startup companies that choose independence.
Janssen Labs and Calibr are two options offered by Big Pharma that will be explored in the session “And Now for Something Completely Different: How Will Pharma Access External Early-Stage Innovation?” at the 2013 BIO International convention on April 23, 2013.
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 session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »
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. Read more »