The FDAAA wishes to Thank Dr. Fauci for his Outstanding Service to Science (#ThankyouDrFauci)
You might have noticed Dr. Fauci has been in the forefront of dealing with the Coronavirus Crisis and COVID-19.
In 2018, The FDA Alumni Association presented our most prestigious Harvey W. Wiley award to Dr. Anthony Fauci, MD.
Dr. Fauci represents the best qualities in our career federal scientists.
Our association is proud to recognize him for all that he does for every citizen in this country.
Dr. Fauci is the Director, National Institute of Allergies and Infectious Diseases, within the National Institute of Health.
The Harvey W. Wiley Award Description: A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of "Father of the Pure Food and Drugs Act" when it was enacted into law in 1906.
You can review his Harvey W. Wiley presentation by clicking on this link Dr. Fauci Wiley Presentation.
2019 Chairman's Special Recognition Award
Deborah M. Autor - For "Dedicated efforts and special recognition in assisting FDAAA Chair Nancy Myers during her term by serving in many leadership roles and strengthening FDAAA"
Nancy Myers, Deb Autor, and Ed Steele
Past Chair of the Board of Directors and President's Recognition
Nancy B. Myers for Outstanding Service as FDAAA Chair of the Board of Directors from 2015 – 2019.
Edward A. Steele for Outstanding Services as the FDAAA President from 2012 - 2019.
Nancy Myers, Deb Autor (Newly Elected Chair, Board of Directors), and Ed Steele
FDA Distinguished Alumni Award
Description: This is an FDA-sponsored award for which FDAAA is asked to nominate candidates. Recipients receive a personal letter signed by the Commissioner, plus an engraved crystal bowl. Items are presented at FDA's annual Honor Awards Ceremony.
Served 13 years in the pharmaceutical industry before starting his career at FDA where he worked in a number of key positions within the Office of the Commissioner, the Center for Drug Evaluation and Research(CDER) and retired after 34 years at FDA as the Deputy Director for the Center for Biologics Evaluation and Research (CBER). While at FDA, he became an expert and frequent speaker on regulatory and compliance activities, GMPs, and FDA application review procedures including electronic submissions. His easy-going management style and personality drove his effectiveness which relied on motivating others to deliver their best in making contributions to FDA and their mission to maintain the safest food supply in the world. Also, his contributions to FDA, directly and indirectly are ongoing as noted below. After retiring from FDA, Mr. Elengold started FDA Strategies LLC to assist the drug and device industry in maintaining FDA compliance. He was also one of the founding members of the FDA Alumni Association. He received many Department of Health and Human Services and FDA awards, including the Secretary’s Distinguished Service Award, the Surgeon General’s Exemplary Service Award, the FDA Distinguished Career Service Award, several FDA Awards of Merit, and a Commissioner's Special Citation. Some testimonials are listed below about the impact that Mr.Elengold had on those he supervised or mentored while at FDA.
"I've never forgotten Mark's kindness and laughter from when I first worked with him inthe very early 1990s. He helped inspire this then-young man to think of working at CBER as not just a job to pay the bills, but as a place to have a nearly 30-year career (so far); quite a big deal for a contractor file clerk barely out of school."
"He was a great person and helped everyone who approached him. In my earlier career, I learned a good deal of FDA regulations through his excellent Review Management training."
"Mark elevated and supported my FDA career and for that I was always grateful. I'll never forget the endless hours we spent preparing for Anthrax hearings and the fact he could make those hours more enjoyable than painful." "I am lucky to have worked with and directly for Mark for many years at FDA/CBER. I appreciate everything about him: the humor, the stories, the sage wisdom, everything. I still have many of the gifts that he gave me from his travels in my office."
"I knew Mark while he was a dedicated public servant at FDA, where he made a significant impact on the public health. He was very supportive of me during my mid-career at FDA, and I often recall his advice and illustrative stories to this day."
Dr. Norman Baylor spent slightly over 20 years at the US Food and Drug Administration. He graduated with a Ph.D in Microbiology from the University of Kentucky and has made a career out of his expertise in global public health and the development of effective regulatory strategies for vaccines and related medical products. During his time at FDA, he was a senior regulatory official in FDA/CBER's Office of Vaccines Research and Review (OVRR) overseeing all facets of the clinical and product regulatory review activity, including quality assurance and oversight of review functions. After leaving FDA, Dr. Baylor joined Biologics.
Consulting after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR). A summarized work history of Dr. Baylor can be found at the end of this narrative. In his prior position at the FDA's Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBER's broad national and international programs and operational activities involving vaccines and related products. He has also served as the FDA's liaison to CDC's Advisory Committee on immunization Practices, and the DHHS National Vaccine Advisory Committee. Dr. Baylor is the President and Chief Executive Officer of Biologics Consulting and continues to serve as an expert advisor to the World Health Organization in addition to providing strategic consulting to Biologics Consulting clients n the areas of vaccines and vaccine-related products. ln both his roles at FDA and at Biologics Consulting, Dr. Baylor has directly and indirectly supported the public health mission of FDA to improve the medical condition and reduce preventable human diseases of not only those individuals living in the United States, but also everyone throughout the world.
- 2011 - Present: President & CEO of Biologics Consulting, Alexandria, Virginia
- 2005 - 2011: Director, Office of Vaccines Research and Review/CBER, Rockville, MD
- 2005 - Deputy Director, Office of Vaccines Research and Review, Rockville, MD
- 1994 - 2005: Associate Director for Regulatory Policy; Rockville, MD
- 1993 - 1994: Deputy Director, Division of Vaccines and Related Products Applications, Rockville, MD
- 1991 - 1992: Regulatory Microbiologist, Rockville, MD
All Recipients - see the full list of FDA Distinguished Alumni Award recipients
Eligibility: Former FDA employees who left the agency at least five (5) years ago and meet the following criteria:
- have a continuing and major impact on FDA as a whole;
- reflect FDA's values; and
- exemplify an outstanding commitment to meeting the agency's mission of protecting the public health.
Selection: Nominations can be made by any Association member. Nominations must be directed to the Awards Committee (firstname.lastname@example.org). The Awards Committee will screen all nominations and forward recommendations to the Board of Directors for final decision. The names of FDAAA nominees will then be forwarded to FDA's Awards Coordinator for presentation to the agency's Executive Council. The FDA Commissioner will make the final selection(s).
The Harvey W. Wiley Lecture
Description: A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of "Father of the Pure Food and Drugs Act" when it was enacted into law in 1906. The Lecture will be presented at the FDAAA Annual Meeting each April.
Richard Pazdur, MD
Director, Oncology Center of Excellence U.S. Food and Drug Administration
All Harvey W. Wiley Lecturers - see list of all Harvey W. Wiley Lecturers
Eligibility: Lecturers shall be prominent figures from the fields of public health, health research, public health education, health care delivery, science journalism, food and drug law, and public policy-making, who can:
- promote broader public enlightenment of, and support for, the mission of FDA;
- provide intellectually stimulating, futurist perspectives on 21st century roles of the FDA in public health;
- initiate a meaningful dialogue on innovative ways the FDAAA and its membership can impact the current and future mission of the FDA and its capacities to protect and promote the public health.
Selection: Suggestions for Lecturers can be made by any Association member and must be directed to the Activities Committee (email@example.com) for initial consideration. Final invitations to Wiley Lecturers will be made by the Chairman of the Board.
FDAAA Founder's Award Recipients
Description: The Founder's Award was approved by the Board in January, 2011. In this, the tenth year of the FDAAA, it was decided that honoring the founders of the organization in the inaugural year of the award was most appropriate! The Founder's Award was established to honor the members of the FDAAA who have served with distinction in a leadership capacity, i.e. Board members or Committee Chairs who:
- Made significant and visible contributions to promoting the growth and/or visibility of the FDAAA;
- Have served more than one term on the Board and in so doing have advanced the organization's goals and mission;
- Exemplifies the true spirit and intention of the motto: "Serving those who have served".
2019 John C. Villforth FDAAA Founder's Award Recipient
John C. Villforth FDAAA Founder’s Award: Presented by Joe Levitt on behalf of FDAAA to Nancy B. Myers - For “Significant and Visible Contributions Exemplifying the True Spirit of the Motto: Serving Those Who Have Served”
Joe Levitt, Nancy Myers, and Ed Steele
FDAAA Founder's Award Renamed in Honor of John C. Villforth:
The FDA Alumni Association (FDAAA) is adding a name to its Founder's Award, which recognizes outstanding leaders of the FDAAA. The award will now be known as the John C. Villforth Founder's Award.
John Villforth's vision, energy and leadership led to the creation of the FDAAA 2002. He navigated the association through its early years and provided the foundation for the present organization.
Villforth is a former director of the Center for Devices and Radiological Health and its predecessor, the Bureau of Radiological Health. A former member of the U.S. Public Health Service Commissioned Corps, he held the rank of Rear Admiral and Assistant Surgeon General and served as the Corps' Chief Engineer. After three decades of federal service, he became Executive Director of The Food Drug and Law Institute and served on several industry boards.
Starting in 2000, Villforth recognized the need for an organization representing FDA alumni. He met with alumni associations from other government agencies, and simultaneously recruited other FDA alumni to join his effort. His goal was to create and maintain an organization that could unite all FDA alumni and provide a framework in which they could continue public service. The original FDAAA board had representatives from every part of the Agency.
Villforth was trained as an engineer, and was a proud graduate of Penn State University. He and his wife have three daughters.
The John C. Villforth Founder's Award recognizes FDAAA leaders who have "made significant and visible contributions to promoting the growth and visibility of the FDAAA." Another award issued by the FDAAA is the Harvey W. Wiley Award, which recognizes leaders who have made lasting contributions to FDA and its mission. Villforth himself was a recipient of the Wiley Award.
Announcement of the renaming of the Founder's Award in honor of John C. Villforth was made at this May 13, 2019 Annual FDAAA meeting.
Recipients of the FDAAA Founder's Awards - See list of recipients
FDAAA Volunteer of the Year Award Recipients
2019 Volunteer of the Year Recipient
For “Outstanding Organizational Skills in Enriching the Experience of FDAAA Members through organization of events and social opportunities for FDAAA members and potential members as well as supporting these events and opportunities through sponsorships”
Nancy Myers, Lisa Barclay, and Ed Steele
Richard A. Baldwin
For “Outstanding Strategic and Visionary Skills to Prepare FDAAA for the Future”
Ed Steele, Richard Baldwin, and Nancy Myers
Recipients of the FDAAA Volunteer of the Year Awards - See list of recipients
Eligibility: Members of good standing of the FDAAA who:
- make extraordinary contributions to the growth, viability and image of the FDAAA or to an affiliated chapter over a sustained period of time; or
- demonstrate highly accomplished leadership in the development and conduct of Association programs; or
- represent the Association in one or more extramural activities in a manner that positively reflects the ideals of the organization and substantially benefits the FDA or public health in general.
Selection: Nominations can originate from any Association member and must be directed to the Awards Committee (firstname.lastname@example.org) for consideration. Final selections(s) will be made by the Board of Directors based on the Committee's recommendation(s). This award can be presented to one or more persons each year at the discretion of the Board of Directors. The award(s) will be presented at the Association's annual meeting in April.
FDAAA Service Recognition Award
Description: Recipients receive a finely-crafted wooden desktop case emblazoned with the FDAAA logo.
2019 Service Recognition Award
F. Alan Andersen
For “Outstanding Work in Electronic Communications to Spread the Awareness of FDAAA and Its Activities”
F. Alan Andersen
Marie A. Urban
For “Providing Outstanding and Ongoing Minutes, Institutional Memory and Advice to the FDAAA Board and Executive Board”
Nancy Myers, Marie Urban, and Ed Steele
Recipients of the FDAAA Service Recognition Award - See the full list of recipients
Eligibility: Persons who serve in leadership positions of the Association (e.g., Officer, member of the Board of Directors, Committee Chair) and whose service has a demonstrably positive effect on the growth, operational success and/or public image of the organization.
Selection: Nominations will be accepted from any FDAAA member and must be directed to the Awards Committee (email@example.com) for consideration. The Awards Committee will make recommendations on all Service Recognition Award nominations to the Executive Committee and, if necessary, to the Board of Directors which will render a final decision. Service Recognition Awards may be presented at any time during the calendar year at the discretion of the Board of Directors, including the Association?s annual meeting in April.
FDAAA Certificate of Appreciation
Description: A standardized, specially designed certificate bearing the FDAAA logo, recipient's name, date, signatures of the Chairman of the Board of Directors and the FDAAA President, and a citation describing the recipient's contribution(s).
2019 Certificate of Appreciation Recipient
For “Continuing to build a strong and sustainable FDAAA Awards Programs that have increased the number of Committee members, provided credible awards to deserving winners, interacted in a positive manner with the FDA Awards Group and participated in a number of FDAAA events throughout the year that contributed to increasing the visibility and recognition of FDAAA among both members and potential members during the 2018 – 2019 FDAAA year”
Nancy Myers, Allen Sayler, and Ed Steele
For “Identifying and establishing a firm operational foundation for the FDAAA by resurrecting the contractual relationship with FDAAA’s financial advisory firm as well as managing and identifying the best ways to preserve and increase the value of FDAAA financial assets and participating in key FDAAA events throughout the year that contributed to increasing the visibility and recognition of FDAAA among both members and potential members during the 2018 – 2019 FDAAA year”
For “Showing strong leadership and organizational skills in organizing and successfully complete key FDAAA events as a member of the FDAAA Activities Committee during the 2018 – 2019 FDAAA year”
Recipients of the FDAAA Certificate of Appreciation - See list of recipients
Eligibility: Any individual who is an FDAAA member or non-member, or entity, who/that:
- makes a remarkable contribution, either on a one-time or continuing basis, to the operation or financial standing of the Association (e.g., pro bono services, large donation);
- provides highly-dependable, productive volunteer service to the FDAAA;
- serves in an appointed or elected position of responsibility in the FDAAA;
- is a guest speaker or participant at an FDAAA-sponsored event;
- performs a charitable act that exemplifies the goal and values of the FDAAA;
- offers a unique idea or recommendation that is adopted and enhances the efficiency, effectiveness and/or integrity of the FDAAA;
Selection Requirements: Nominations can originate from any member of the Association and must be directed to Executive Committee via the FDAAA Secretary (firstname.lastname@example.org) for consideration. Final selection will be made by the Executive Committee. Certificate presentations can occur anytime at the discretion of the Board of Directors.
Theresa Mullin, PhD. Associate Director for Strategic Initiatives, FDA Center for Drug Evaluation and Research
For reforming ICH to significantly increase domestic/international drug manufacturer participation and being a strong advocate for Patient Focused Drug Development in PDUFA 5 and 6.
Recipients of the Innovator's Award - See list of recipients
Eligibility: The awardee currently works at FDA for a minimum of 5 years. The award is based on activity that advances the mission of FDA and the FDAAA, such as:
- Innovations that improve FDA operations and help the Agency prepare for future opportunities or challenges
- Cooperative efforts with FDAAA, industry associations, academia, and international, federal, state and local governments that enhance public health (organizations with supportive programs)
- Other notable activities that enhance the FDA and FDAAA mission.
Retiring Board Members
David L. Chesney
David L. Chesney