Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.”
In 2009, the FDA announced its Safe Use of Drugs Initiative. The theory being that one way to make drugs safer is to ensure that they are used as directed. The main strategy was education and the agency’s efforts were (and are) aimed at physicians, nurses, pharmacists, and patients.
Earlier this year, the agency announced not just an office, but a Super Office of Pharmaceutical Quality, further underscoring that the FDA operates not under a two-dimensional system of safety and efficacy, but a three-dimensional approach that includes quality … with a capital (indeed a “super”) Q.
Since there is no such thing as a safe substandard product, the agency is putting time, resources, and the use of the bully pulpit to go beyond cGMPs, API and excipient sourcing to develop a risk-based approach that includes data gathered from a variety of sources including manufacturing inspections, adverse event reporting, and substandard pharmaceutical events as evidenced in the agency’s bioequivalence- driven actions with bupropion in 2012, metoprolol in 2014, and methylphenidate in 2015.
So, in many respects, pharmaceutical quality is both a pre and post-licensure endeavor and, like Safe Use, a scientific and educational enterprise that requires close coordination with many stakeholders. And it won’t come easily or inexpensively. As Aristotle said that, “Quality is not an act, it is a habit.”
Flavonoids are one of the major nutrient families recognized to scientists, and comprise over 6,000 already recognized family members. A number of the best – recognized flavonoids include quercetin, kaempferol, catechins, and anthocyanidins. It is well…
As stated in a recent article in the Journal of Clinical Oncology, ASCO established a Value in Cancer Care Task Force, with the goal of “developing a framework for comparing the relative clinical benefit, toxicity, and cost of treatment in the medical oncology setting. “ In developing this framework or tool, the Task Force runs roughshod over basic facts to create a metric that – while established to promote patient centered care – strives mightily to achieve the exact opposite outcome.
The article proposes a “virtual” biotech model for the emerging markets – termed EmergingCo – and develops a comparative financial model to argue that such a virtual biotech can deliver drug candidates from discovery through proof-of-concept (Phase II) more cost effectively than the traditional drug development paradigm. Data from published studies on drug development costs have been compared with a cost structure model for EmergingCo using a framework where all R&D can be accomplished through a virtual network of partnerships within emerging markets. A couple of case studies from China and India are used to lend support to the cost structure model. Such a model, either as a venture backed company or a virtual unit of big pharma, could provide an alternate vehicle for delivering mid-to late stage clinical candidates, similar to Lilly’s Chorus model.
As the global life sciences industry changes, the most successful regions in attracting inward investment will be those that evolve and adapt to provide the most attractive offer. In Scotland, the government is developing an environment to “push” its life sciences sector to complement the strong “pull” that these changes in the global life sciences industry and in investor sentiment have created.
The Scottish Government and the life sciences industry have developed a strategy that aims to anchor in Scotland those businesses that provide vital skills and market access; increase the number of more resilient companies and comprehensive supply chains; and attract new inward investment and talent that will build on Scotland’s existing capabilities.
The Scottish Government is improving on the country’s existing strengths and aims to capitalise on prior investment in Scotland’s research excellence, particularly in areas such as stem cells and regenerative medicine and ”precision medicine”, where there are significant current and emerging commercial opportunities.
Brazil is looking into foreign technology to foster innovation in the country’s industrial health complex. Biological plants are being built and partnerships with multinationals have been established with the goal to in license technology, manufacture and supply the population with biosimilars made in Brazil. This article brings up-to-date information on the biosimilar market in the country, with information on the public-private partnerships and regulatory approvals. With two biosimilars approved in 2015 and the ongoing development regarding the local pharmaceutical companies, there is a good window of opportunity to create new businesses in the soon to be 4th pharmaceutical spender in the world.
Pseudo-controversy continues to rage over whether foods from plants and animals genetically engineered with the newest molecular techniques should have to be labeled as such. The battles, fought in the media, state legislatures, referendum issues, and in federal courts, have been largely fomented and funded by the organic agriculture and food industries. All but one of the proposals to require labeling in the United States have failed, and that exception is being challenged in a federal court . In spite of these failures and the fact that mandatory labeling fails every test –scientific, economic, legal and common-sense–the true believers soldier on.
The regenerative medicine space is one that is set to explode with considerable innovation and profitability for shrewd biotechnologists. I had the opportunity to speak with Michael West, PhD., CEO of BioTime (BTX) and found a man passionate about rege…