FDAAA Awards

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.

2019

Mark Elengold

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."

Norman Baylor

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.

Professional History:

• 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 (mail@fdaaa.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).