FDAAA Service Recognition Award
Dr. Carlos Pena, head of CDRH’s Division of Physical Medicine and Neurological Devices (DNPMD)
Dr. Pena’s leadership, innovative thinking, and focus on patients and collaboration has significantly advanced the Mission of FDA. Under his leadership, DNPMD has transformed the manner in which they conduct their business in order to implement CDRH’s “Vision” of bringing high quality, safe and effective medical devices of public health importance, first to US patients in need of such devices. Dr. Pena has accomplished this first and foremost by focusing on patients. He recognizes that patients are at the heart of FDA’s Mission and it is critically important that FDA staff understand patient perspectives and engage with them to improve their understanding of the patient experience. He has established monthly disease-focused patient engagement seminars for his staff to ensure that they interact with patients, and consider patient perspectives in their work. Dr. Pena has fostered collaboration among regulators, patient organizations, health care providers, industry and other government agencies. He has transformed DNPMD’s approach to the review and oversight of clinical trials, including early feasibility studies, to help make the U.S. a more attractive environment for novel technologies and device development. These actions have started to have a noticeable impact as a number of important, novel neurological devices reaching U.S. patients has increased dramatically during his tenure. A few examples include:
- The first focused ultrasound device to treat essential tremor in medication-refractory patients;
- Clot retrieval devices as an initial therapy for strokes due to blood clots, in order to reduce paralysis, speech difficulties and other stroke-related disabilities;
- First-of-a-kind computerized tests to assess a patient’s cognitive function immediately after a suspected brain injury or concussion;
- A “halo” device that utilizes low-intensity electrical fields to treat patients with an aggressive form of brain cancer, extending the expected life of these patients by years, in some cases.
As a result of the many positive contributions made by Dr. Pena, the FDAAA is nominating him to be receive the FDAAA Innovator Award.
CITATION: In recognition of innovative thinking and management which resulted in increased acceptance of new medical device technology, improving the lives of countless US patients
Transfusion Transmitted Infection Monitoring System (TTIMS) Team led by Steven Anderson and Alan Williams US Food & Drug Administration’s Center for Drug Evaluation and Research (CDER)
Mr. Anderson and Mr. Williams representing a group at FDA’s Center for Drug Evaluation and Research (CDER) that established the revolutionary “Transfusion Transmitted Infection Monitoring System (TTIMS)”. The development of this system was led by CBER, in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), the Center for Disease Control (CDC) and the Office of the Assistant Secretary for Health (OASH) and industry partners. The TTIMS as developed, is the first nation-wide real-time monitoring system of the blood supply to be established in the United States. It has the ability to collect information on more than half of the blood collected voluntarily in the United States and will both facilitate protection of the blood supply against infectious diseases and help FDA understand whether its blood donation policies can be further refined.
As a result of the landmark efforts by Mr. Anderson and Mr. Williams, the FDAAA is nominating both since they led the Team that developed the TTIMS. TTIMS will make significant advancement in public health and significantly reduce the risk of contracting blood-borne disease transmitted through the US blood supply to individuals in need of blood transfusions. Both together meet the criteria for the FDAAA Innovator Award and have received the complete support of the FDAAA Board of Directors.
CITATION: In recognition of the leadership demonstrate to successfully build the TTIMS by integrating the views of various government and industry partners.
FDA’s Center for Tobacco Product’s (CTP’s) Human Capital Team led by Executive Officer Janelle Barth.
The FDA Center for Tobacco Product’s (CTP’s) has over the past year developed new and innovative approaches to create in-house automated solutions to build workforce hiring plans and staffing plans. The use of these innovative human resource approaches also allows the tracking of metrics in real-time by monitoring actual program which motivates CTP supervisors and management to keep the hiring plans moving forward appropriately. As a result, CTP has the fastest hiring metrics at FDA (68 days on average in FY16) while the Agency model is slower (80 days on average), with some parts of FDA even slower ( over 100 days on average in FY 16). In addition, they are leading corporate recruitment efforts for the agency by leveraging public platforms not traditionally used by the US government and establishing partnerships with universities and interest groups to quickly identify qualified candidates. Lastly, they found a way to mine resumes in USAJobs to proactively identify candidates that may be eligible for future CTP vacancies and then sharing those potential opportunities with these qualified individuals.
The CTP Human Capital Team, led and directed by Janelle Barth has through initiative, energy and use of new and innovative human resources tools and partnerships, managed to identify qualified employment candidates, assist CTP managers and supervisors in moving rapidly through the necessary paperwork to qualify and employ qualified individuals for open positions which makes a significant contribution to the work capacity and efficiency of operation of the CTP. This human resources model is an example of an internally developed and successful program that should migrate to other FDA Centers to improve the hiring metrics and directly contribute to the overall ability of these Centers to deliver on their mission(s). The complete Team along with Ms. Janelle Barth meet the criteria for the FDAAA Innovator Award and have received the complete support of the FDAAA Board of Directors.
CITATION: In recognition of the development and implementation of innovative human resource techniques and tools to increase Agency hiring metrics leading to improve CTP operations.
FDA Alumni Advisor Design Group. This was a group award for the following FDA employees who successfully developed a process to re-hire FDA retirees to mentor current employees in leadership skills and career development, having an immediate and positive impact on FDA.
- Patricia Alcock - Director, Division of Human Resource Development, ORA
- Loney Nunemaker - Deputy Director, Division of Human Resource Development, ORA
- Brooke Mullican - Manager, Division of Human Resource Development, ORA
- Denise Collins - Program Lead/Training Officer, Division of Human Resource Development, ORA
- Rosemary Warneke - Consultant, Office of Resource Management, ORA
These employees worked collaboratively to design a process to re-hire twelve former senior FDA employees who had retired with many years of management and leadership experience, and to return them on a part time basis as rehired annuitants. Their areas of strength were identified and they were matched with all level managers from the Office of Regulatory Affairs (ORA) who had identified the same leadership competencies as developmental needs. The resulting advisor/learner relationships were nurtured in a pilot program called the FDA Alumni Advisor Program that began in June 2015 and concluded in March 2016.