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5 Major Factors in Choosing a Partner Firm to Help Accelerate Your Speed to Market

By David Shenberger, January 24, 2019

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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Does your project team have a common vision and goal?

By Michael Martin, October 16, 2018

Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With each trying to finish their portion of the work and get on to their next project. These “separate” efforts have goals to accomplish, and sometimes they regard each other as the obstacle to accomplishing those goals. The downstream team often feels that the upstream team doesn’t understand the difficulties they are experiencing and that they are just trying to throw the work product over the wall and claim success. The upstream team feels that the downstream team is too demanding and will not accept something less than perfection. Conflict ensues, and the overall program suffers. 

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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry, October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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Optimizing Time to Market

By David Shenberger, June 20, 2017

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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