Gottlieb Reshapes FDA to Elevate Centers, Streamline Policymaking

JILL WECHSLER | July 25, 2018

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Most FDA commissioners look to leave their imprint on the agency by making structural changes that update the roles and functions of lead operations. After more than a year at the agency’s helm, Scott Gottlieb now proposes to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff. This change aims to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains “in close contact with the Center leadership,” Gottlieb said in an email to FDA staff announcing the reorg plan.

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The iQ Group Global provides a turnkey solution for life sciences companies, spanning corporate advisory and investment banking, through to research, development, commercialization and sales. The Group facilitates an end to end solution along the drug lifecycle creating the medicines of tomorrow. Our life science and pharmaceutical business unit collaborates with scientists the world over: identifying and owning Intellectual Property, creating and executing drug development plans from discovery to market. In addition, our dedicated investment banking business transforms biotech from an alternative investment option to a requisite mainstream capital market asset. We design and market innovative structured financial products and solutions. These provide entry and exit, investment and divestment, in the 12 or more-year drug development cycle. In this way, The iQ Group Global is bridging capital with science to create the medicines of the future.

OTHER ARTICLES

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PHARMACY MARKET

A pharma outsourcing mission

Article | April 1, 2020

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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Article | April 1, 2020

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Spotlight

The iQ Group Global

The iQ Group Global provides a turnkey solution for life sciences companies, spanning corporate advisory and investment banking, through to research, development, commercialization and sales. The Group facilitates an end to end solution along the drug lifecycle creating the medicines of tomorrow. Our life science and pharmaceutical business unit collaborates with scientists the world over: identifying and owning Intellectual Property, creating and executing drug development plans from discovery to market. In addition, our dedicated investment banking business transforms biotech from an alternative investment option to a requisite mainstream capital market asset. We design and market innovative structured financial products and solutions. These provide entry and exit, investment and divestment, in the 12 or more-year drug development cycle. In this way, The iQ Group Global is bridging capital with science to create the medicines of the future.

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