This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s […]

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
ApaTech: A biomaterials success story
Go to paperABSTRACT: ApaTech is an excellent example of how innovative technology from a British university can be…

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

Why data exclusivity is the new patent protection

Go to paper

ABSTRACT:   

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

• Management
• Policy
• Finance
• Law
• Regulation
• Bioethics

For more information, see the Journal of Commercial Biotechnology website

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 4^th pharmaceutical spender in the world. 

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 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.

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.”

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.