• Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.
Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later, and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.
By Bruce McDuffee, Vaisala Life Science Division
According to the FDA document Investigations Operations Manual (IOM), the FORM FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment’s top management, in writing, of "significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection." This statement and other background information can be found in section 5.2.3 Reports of Observations of the IOM.
By Hervé Valler, Managing Director, France
For several years, the pharmaceutical industry has been moving away from primarily chemical and synthesized-based drugs and toward biologics. And while research and development is complex for all types of drug therapies, biologics have special challenges since they are made up of living microorganisms and cells. This is especially true where logistics is concerned — whether related to R&D, clinical trials, or ultimately, getting a drug to market.
By Robert McGregor, Global Marketing and High End Product Manager, Brookfield Engineering Laboratories, Inc.
“Yield stress” could be a term that applies to our daily lives. When under pressure, if the stress is too great, you start to “change” in a figurative sense. In the world of science and engineering, fluids and semi-solid materials that are subjected to a strong enough force will start to move. Basically, they “change” from their original shape and move in response to the applied force, remaining in motion as long as the force is great enough.