Category: Guest content

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 […]


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