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Writing in the Washington Post in April 2017, ahead of deliberations around the nomination of Dr. Scott Gottlieb to lead the FDA, I argued that “Trump’s nominee for the FDA could be the leader the agency needs,” adding that his breadth of experiences and his commitment to patients could help unleash the innate creativity of the agency.
This perspective has aged well. By most accounts, Gottlieb has excelled as Commissioner, and has been a tremendous credit to President, earning praise for an Administration that has seen so many appointees subjected to withering and relentless critique; Gottlieb, prioritizing science, transparency, and patients, has emerged as a rare and welcome exception.
Unfortunately, Gottlieb’s abrupt and utterly unexpected resignation threatens to derail so much of the excellent work he’s started, and has left so many to wonder what comes next.
Fortunately, there’s an exceptional candidate who merits consideration by President Trump as Gottlieb’s replacement: Dr. Amy Abernethy, recently installed as Deputy Commissioner of the FDA.
Abernethy, like Gottlieb, would represent a forward-looking choice. An oncologist passionately interested in improving the treatment options for patients, Abernethy has delivered terrible news to scared patients, and understands the urgent need to identify more effective therapies – and more effective ways to leverage the data we are already collecting. Indeed, Abernethy has been on the leading edge of evidence generation, asking how can the medical community make the best use of existing data, and use these data to inform the real-world care of patients. Her entire career seems focused on figuring out how to accelerate innovation for patients.
After exceptionally productive work as an academic physician-scientist at Duke University, where she was an early champion of the concept of the “learning healthcare system,” Abernethy demonstrated the ability to lead change within industry, serving as a top executive at the cancer data company Flatiron, where she was able to effectively integrate cutting-edge technology and a pragmatic sense of patient care. In the same way that Gottlieb’s experience with industry enabled him to serve as a sophisticated and effective leader, Abernethy’s understanding of the complex health data ecosystem will allow her to effectively engage with leading tech players while simultaneously ensuring they are held appropriately accountable to the patients whose data they might manage and seek to analyze.
Abernethy also has experience working with Congress; she was actively involved in the pioneering 21st Century Cures Act, bipartisan legislation that sought to modernize the evidence development process, and pushed for the FDA to embrace opportunities advancing technology enabled.
As Tanisha Carino, Executive Director of the non-profit FasterCures Initiative recently told me, Abernethy “brings a fresh perspective to how the FDA can bring the worlds of clinical research and clinical practice together and place the experience of patients in the center.” Carino added Abernethy might serve as “a critical catalyst in building on the FDA’s momentum in these areas.”
Scott Gottlieb was a brilliant appointment by President Trump; the nomination by Trump of Abernethy would represent a similarly thoughtful choice, one that would compel even the most determined critics of the Administration to look elsewhere for fault, as she would be a credit to the Administration, the Agency, and – mostly importantly – to the patients who would benefit from her vision, compassion, determination, and insight.
March 8, 2019 at 12:04AM
Forbes – Entrepreneurs