FDA Commissioner’s Plan for Helping Lower Drug-development Costs

FDA Commissioner, Scott Gottlieb, introduced his plan for helping reduce drug-development costs while speaking at the 2017 RAPS annual conference held on September 11-12 in Washington DC.

Here are highlights of his plan for the FDA to help reduce costs related to drug development and drug approval.

  • Improve the efficiency of the early stage (pre-clinical) of drug development
  • Modernize the agency’s workflow and drug-review process
  • Streamline the process of how the agency collects clinical information
  • Modify traditional clinical trial designs and utilize adaptive and “seamless” approaches, such as combined-phase studies (eg, a large, continuous trial for one developmental drug with potentials for multiple indications)
  • Advance the use of “Master Protocols”
  • Encourage communication between all stakeholders involved in drug development
  • Utilize the power of high-performance computing and harness the potentials of AI

To help lower overall drug prices, Gottlieb noted that the industry and the FDA need to

  • Bring more competition, including generic competition, to the drug market,
  • Improve the efficiency of the drug development process, and
  • Take actions to prevent companies from gaming the system to “extend their drug monopolies.”

Click here to access his full speech.


Trends, Challenges, and Opportunities of Drug Development in China: Highlights from CBA’s 21st Annual Conference

Hundreds of scientists, regulators, and investors from China and the US gathered in Gaithersburg, Maryland, on June 11, 2016 to attend the 21st Annual Conference of the Chinese Biopharmaceutical Association (known as CBA), a Maryland-based non-profit organization striving to serve as “the bridge of US-China biopharmaceuticals.”

From the advances in immune-oncology and precision medicine, to regulatory challenges in global drug development, the one-day conference covered a wide range of topics.

Here are a few highlights pertinent to drug development in China.

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