BLOOMINGTON, Ind. -- Two Washington, D.C.-based professionals with experience at the U.S. Food and Drug Administration, the Centers for Medicare and Medicaid Services and the Congressional Budget Office will lead a roster of experts discussing the Trump administration's impact on health care and the life sciences industry at a conference Nov. 10 in Indianapolis.
The conference -- from 9 a.m. to 3:15 p.m. in Fairbanks Hall of the IU School of Medicine, 340 W. 10th St. -- is the first in a series of three events that are part of the Indiana Life Sciences Collaboration Conference Series, organized by the Indiana University Kelley School of Business and its Center for the Business of Life Sciences.
Speakers and panelists will discuss the effects of Trump administration policies on areas such as new product approvals, off-label usage, and health care coverage and reimbursement.
The keynote speaker will be Howard Sklamberg, a partner at the Washington, D.C.-based firm Akin Gump Strauss Hauer & Feld LLP. Sklamberg was the FDA's deputy commissioner for global regulatory operations and policy from January 2014 to April 2017.
In his previous role, Sklamberg directed the FDA's domestic and international quality and safety efforts, and he oversaw both its Office of Regulatory Affairs and Office of International Programs. This included coordination of standards and agreements with foreign countries, implementation of new food safety and medical product programs, and alignment of agencywide enforcement strategies.
Sklamberg oversaw an office with authority over food, drugs, medical devices, biologics, cosmetics and tobacco; a budget of more than $1 billion; and a staff of 5,000 employees in more than 200 offices, laboratories and import facilities across the United States and overseas. He also interacted with, and testified before, Congress on behalf of the agency.
Earlier at the FDA, Sklamberg served as director of the Office of Compliance, Center for Drug Evaluation and Research. In that role, he led the office that oversees risk-based compliance strategies for drugs, including manufacturing and quality standards, compounding, imports and exports, counterfeit drugs, supply chain issues, recalls and outbreaks, labeling requirements, over-the-counter drugs and clinical trials.
The other keynote speaker will be Sarah Thomas, managing director of Deloitte's Center for Health Solutions, former vice president for public policy and communications at the National Committee for Quality Assurance, and former director of the Public Policy Institute Health Team at AARP.
She worked for 14 years for the federal government, including as deputy director at the Medicare Payment Advisory Commission for five years, and as an analyst in both the Congressional Budget Office and the Centers for Medicare and Medicaid Services.
At Deloitte, she drives the firm's research agenda to inform stakeholders about key trends and issues facing the health care industry, managing a team of 20 researchers, policy analysts and staff.
"Ten months into the Trump presidency, we're beginning to see top administrators at the Food and Drug Administration and the Centers for Medicare and Medicaid Services make their influence felt within their organizations," said George Telthorst, director of the Center for the Business of Life Sciences. "For more than a decade, our conferences have provided a practical forum for key players in health care and life sciences to discuss and debate the issues. We welcome the insights that Howard Sklamberg and Sarah Thomas will offer."
The registration fee is $175 and includes lunch. Students at accredited Indiana institutions of higher education may qualify for a discounted rate. Registration and additional information are available on the conference web page or by contacting Kelli Conder at the Kelley School at 812-856-0915 or firstname.lastname@example.org.
Future events in the 2017-18 Indiana Life Sciences Collaboration Conference Series will include the conference, "Potential Disruptive Innovators in Healthcare," on Feb. 16 at IUPUI; and "Big Data and the Convergence of IT and Biology," on May 18 at Cook Research Inc. in West Lafayette, Indiana. People may register for all three events for $450, or a savings of $75.
Editors: Reporters are welcome. Please contact George Vlahakis, the Kelley School's associate director of communications and media relations, at email@example.com or 812-855-0846, in order to register.