Category: Guest content

Background: The Clinical and Translational Science Awards Consortium (CTSA program)

Guest content from Christopher Starr: After years of confusion and neglect, translational research is now becoming institutionalized. Citing the barriers between the lab and clinic, along with the difficulties and complexities of conducting clinical research, the NIH set up a major program to advance clinical and translational research. The Clinical and Translational Science Awards consortium, […]


Why the market does not like Flurizan

Guest content from Nicolaj H. Nielsen, managing director of Biostrat. A case-study on the recent licensing-deal between Myriad and Lundbeck: Information asymmetry, calculated bets and royalties in the biotech industry. The share-price of Lundbeck has fallen with approximately 10 %, since the Danish pharmaceutical company announced an inlicensing deal with the US biotech company Myriad […]


Six Pitfalls to Avoid in Supplier Management

Guest content from John Avellanet, managing director and principal of Cerulean Associates: Managing suppliers is fraught with challenges. Rare is the executive who has not made a mistake. In this article, I look at some of the most common mistakes—most of which I’ve made myself—and how to avoid them.


Seeing the Field

Guest content from Sandy Graham, managing partner at Sequoyah Associates: Can you “see the field” of opportunity? Have your clearly defined your plan to achieve your entrepreneurial dreams? Have you mapped out the strategic direction to attain your plan? Have you envisioned your market and know how to position your business to acquire it? Do […]


Generic Biologics: How to Compete

Guest content from John Avellanet, managing director and principal of Cerulean Associates: Follow-on biologics are a foregone conclusion in the US. Too much money is at stake. The more difficult discussion starts with how to prepare your company to compete. Science Succumbs to Dollars The financial pull on reimbursement organizations and the constituent push on […]


FDA Enforcement Trends: 2007-2008

Guest content from John Avellanet, managing director of Cerulean Associates: The US Food and Drug Administration (FDA) intends to increase regulatory enforcement, extending the recent trend of laboratory and clinical site inspections to unapproved drugs and reformulations. How can you avoid compliance trouble? At the Food and Drug Law Institute’s 5th Annual Enforcement and Litigation […]


Expanding the bandwidth of life science investments: Increasing investment viability

Guest content Contributed by Jayme Norrie, Chief Strategic Officer, Incite World From what we have experienced, angel investors are shoring up the gap in new innovations coming forward. However, they seem to be more naive than VC’s in terms of due diligence prior to investing. Scientists from the company march in with charts and scientific […]


Offshoring and U.S. Biotech Labor Shortages

Guest content contributed by Agnes Shanley, Editor in Chief, Pharmaceutical Manufacturing Every day we read about severe shortages of skilled biotech workers in the U.S.. At the same time, the trend to pharma offshoring and outsourcing is becoming more pronounced, and is moving from traditional pharma to biopharma. We recently touched on some of these […]


`Til Death Do Us Part, But First, the Pre-Nup: Why CAPA Needs to Evolve

A guest editorial from Emil Ciurczak, Contributing Editor, PharmaManufacturing.com While reading a trade magazine recently, I was struck with the detailed information on how to design and implement a Corrective and Preventive Action (CAPA) system. ISO 9001:200, Clause 8.5.2 states, “…the organization shall take action to eliminate the cause of nonconformities encountered…” For medical devices, […]


Lessons and analogies from other industries

Guest content from John Avellanet, managing director of Cerulean Associates: As professionals affiliated with the biotechnology industry, we often forget that many of the struggles faced today have been solved before by other fields and industries. As Ambrose Bierce wrote, “There is nothing new under the sun, but there are lots of old things we […]