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 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.

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…

Crowdfunding is an evolving popular Internet-based process used to raise funding that has been employed by a few start-ups in the biotechnology industry. To solicit crowdfunding, companies profile their case on a specialized web platform (generally called a “crowdfunding portal”) to site members (i.e., the “crowd”) who choose which projects they would like to fund, in exchange for financial and nonfinancial inducements. We examine the evolving commercial and regulatory crowdfunding landscape and also identifies case studies of biotechnology industry use. We have found that a variety of crowdfunding mechanisms have been used and this alternative financing strategy may represent a viable option for biotechnology start-ups during early stage research or early stage clinical trials. A successful crowdfunding campaign may pave the way for the enterprise’s future capital formation phases by attracting angel investors or venture capital because it shows that the business or project is viable. Crowdfunding, like all other forms of capital formation, requires careful planning and execution before, during, and after a campaign. Strategies that appropriately tap into this innovative and disruptive use of technology and social networks may prove to be a unique capital formation niche for biotechnology start-ups; one that has yet to be fully leveraged.

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.”

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
The relevance and importance of business development and licensing in the biopharmaceutical industry.
Go to paperABSTRACT: The importance of the busines…

Much has been written on the controversial price increase of Daraprim. Daraprim treats malaria and another parasitic infection, toxoplasmosis. It was

TechTransferWatch is a search engine and alert service for licenseable technologies from academic labs, foundations, and government. Click the patents

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

The ability to pick biotech talent: Being a better interviewer moves ‘you’ up the ladder

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ABSTRACT: Do you know someone who has this unique skill? That person generally is respected throughout the company for his or her ability to interview well, and to spot those few who have the ‘right stuff.’ Although there is far more to the process of selecting talent than just preliminary interviews, it is indeed interviewing skills that represent the major distinction between managers…

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