Biotechnology industry news, updates, and press releases
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.
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…
I am putting in a lot of miles on behalf of international regulatory fraternity.
Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Recently I’ve visited with government health officials in China (both PRC and ROC), the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Kuwait, Russia, Brazil, Colombia, South Africa, Indonesia, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation. It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs. But, just as in similar Western agencies (USFDA, EMA, Health Canada, etc.), “doing the right thing” is often a battle of evolving regulatory science, tight resources, competing priorities … and politics.
Venture capitalists (VCs) aim at trade sales as a preferred exit-strategy for biotechnology companies they invest in. Therefore, VCs pay close attention to the wishes of larger (bio)pharmaceutical acquirers. In this paper we explore VCs’ behavior and strategies by analyzing the technology fields and therapeutic areas in which they are invested most and which yield the highest returns by means of trade sales. The data show that VCs are by far most invested in oncology and this is also an area in which relatively high returns are realized. Regarding other areas, VCs could balance their average investment valuations more in correspondence with what acquirers are willing to pay. In addition, VCs have formidable insight in the types of technologies that do well and they seem to employ a strategy focused on both short-term and long-term success. They are investing most in small molecule drugs and protein/peptide therapeutics, which both yield high returns, followed by DNA/RNA technologies which underlie the possibilities of personalized medicine. We conclude that Venture Capitalists act as technological gatekeepers because they are predicting long-term cure and care macro-trends.