Genetic Engineering News –

FDA Commissioner-nominee Califf brings “clinical trial experience, a deep understanding of the scientific standards industry is held to, and a healthy appreciation for innovation,” Catalyst President Nancy Bradish Myers comments in this article. “He has a strong network of high level academics, industry experts, and patients with whom he can consult and bounce ideas off of.”

“Looking forward, FDA is going to need a leader who recognizes that novel cutting-edge technologies are advancing so rapidly that they will likely challenge some of the core tenets of FDA regulation in place today,” she says. “He seems to be a person who truly appreciates that innovation will challenge the status quo, while at the same time he’ll remain the data-driven professional who is grounded in the reality that FDA’s mission is to protect and promote the public health.”

Myers further comments in the article that with Califf, FDA will have leadership that will be constructive and creative in its approach to regulation: “He is going to have to challenge his team to think in new ways when it comes to precision medicine, next gene sequencing technologies, platform technologies, and gene therapy. The agency needs to be prepared for them.”