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

2018

2017

Edward A. Steele

Mr. Edward (Ed) Steele served FDA for thirty (30) years in a number of different capacities (see listing below), all focused on improving the Agency's ability to maintain the "world's safest food supply". After starting his own consulting group specializing in FDA and food safety related issues, Mr. Steele became very active in the FDA Alumni Association, becoming Chairman of the Communications Committee in 2008, significantly improving the awareness of the Association with FDA alumni. In 2013, Edward was elected President of the FDA Alumni Association. Under his leadership, the collaboration and ties between the Agency and the Association have become even stronger, even with the somewhat revolving door of FDA Commissioners, late in the last administration. Of note is that while at FDA, Mr. Steele was awarded the Commendable Service Group Awards, and twice, the Award of Merit. Mr. Edward Steele exemplifies the true intent and visualization of an FDA Distinguished Alumni and is deserving of receiving this award.

William Schultz

Mr. William B. Schultz' career has included key "counsel" positions at FDA and its parent organization, the Department of Health and Human Services (HHS). In addition, he has defended or overseen the defense of FDA regulatory authority and enforcement actions that have provided benchmarks which are being used by FDA's current "counsels". Mr. Schultz has argued FDA's positions before both the US Court of Appeals as well as the US Supreme Court. His is a standout in his profession and has been presented awards by his peers and other organizations.

2016

Kathryn Zoon, Ph.D., NIAID, NIH

Kathryn Zoon, Ph.D. has a long and distinguished career as a government researcher, manager, mentor and leader. Kathy worked at FDA's Center for Biologics Evaluation and Research (CBER) from 1980 to 2002, first as a bench scientist of human interferons, then as the Center Director (1992 - 2002). She is a well-recognized champion for scientific excellence and led the Center at a time of enormous growth and change. Kathy left FDA in 2002 to serve as principal Deputy Director at NIH's National Cancer Institute. In 2006, Kathy joined NIH's National Institute for Allergy and Infectious Diseases to continue her research on the structure and function of human interferons. She also serves on the World Health Organization (WHO) Expert Committee on Biological Standardization. Since leaving FDA, Kathy continues her leadership in public health and the development of new therapies to enhance public health. Kathy's work represents the best in bridging drug and vaccine development with regulatory review, evaluation and marketing approval.

2015

Andrew Bonanno

FDAAA Board Member and Past Vice President Andrew Bonanno was recognized at the 55th Annual FDA Honor Awards Ceremony at FDA headquarters on June 25, 2015. He received the FDA Distinguished Alumni Award for outstanding leadership in establishing the FDAAA/ORA Mentoring Program that enhances communication between ORA managers and alumni fostering management skills and program enhancements. He was presented the award by Acting Commissioner of Food and Drugs, Stephen M. Ostroff, M.D.. Edward A. Steele, FDAAA President, joined Andy on stage for the presentation.

2014

Florence Houn MD, MPH, FACP; Co-Chair
Zili Li, MD, MPH; Co-Chair

Dr. Houn and Dr. Li are co-chairs of the FDA Alumni Association's (FDAAA) International Network (FDAAAIN). Drs. Houn and Li founded the FDAAAIN in 2009 as an activity to fulfill the FDAAA's bylaws mission of "to sponsor humanitarian outreach programs that entail training and technical assistance to health authorities interested in establishing or enhancing national regulatory systems in order to improve the health and social conditions of underserved nations and regions of the world." Dr. Houn and Dr. Li have:

• Established and recruited a planning group (10 members) with monthly meetings to develop strategy and projects
• Developed SOPs for operations: clearance of slides, use of disclaimers on materials, and policies with regard to dissemination of international opportunities to interested FDAAA members
• Developed and implemented a strategy for African and Asian regulatory capacity building based on the conduct of educational activities in regulatory science to promote regulatory capacity building and the FDAAA as an international resource
• Established ties with the Office of International Programs at the FDA,
• Worked to promote FDAAA standing through collaborative activities with DIA, FDA, RAPS. APEC RHSC, WHO, NEPAD, and other organizations,
• Developed educational programs and conducted these in Africa and Asia.

Dr. Florence Houn is Celgene's Vice President, Regulatory Policy and Strategy, having joined in August, 2008. Prior to this, she served 15 years in the US Food and Drug Administration (US FDA), most recently as Deputy Director for the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research (CBER). In recognition of her contributions to public health, Dr. Houn received the US Department of Health and Human Services' Career Achievement Award in January 2009. From 1999 to 2006, Dr. Houn was the Director, Office of Drug Evaluation III in the Center for Drug Evaluation and Research (CDER). She served as a Deputy Director for the Office of Drug Evaluation II in 1998, and from 1993-1998, was the Director for the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health (CDRH). Dr. Houn was on the PDUFA V industry negotiating team with FDA in 2010-2011. Dr. Houn is the co-chair of the FDA Alumni Association's (FDAAA) International Network (FDAAAIN) and has been a member of its Board of Directors since 2012. She served as FDAAA Treasurer from 2009-2012 Dr. Houn received her Bachelor of Arts degree from Harvard University and her medical degree from the Albert Einstein College of Medicine. She completed her Cancer Prevention Fellowship at the National Cancer Institute and obtained her Masters of Public Health from the Johns Hopkins School of Hygiene and Public Health. She attended the Johns Hopkins Breast and Ovarian Surveillance Service as an Instructor in Oncology.

Dr. Li is currently deputy director, R&D, at China Office of Bill & Melinda Gates Foundation, responsible for managing and overseeing all local R&D, regulatory and manufacturing efforts in supporting the foundation's global strategic programs and local initiatives across human and animal health, agricultural development, and water sanitation & health. Dr. Li was a medical team leader with US FDA/CDER, overseeing the clinical review of IND and NDA applications of new drug products. Dr. Li also participated in development of FDA's guidance to industry, presented at FDA's advisory committee meeting on behalf of the agency, and was a recipient of many FDA awards, including 2003 FDA Scientific Achievement Award. Dr. Li, a board- certified physician in Preventive Medicine and graduate of Peking Union Medical College, completed his residency training at the Johns Hopkins University. In addition to his medical degree, Dr. Li also holds two master degrees in public health. Dr. Li was on the PDUFA V industry negotiating team with FDA in 2010-2011.

2013

Halyna Breslawec, Ph. D. - For developing efficient, effective scientific review approaches, dramatically expanding the Cosmetic Ingredient Review (CIR) program output, and leading industry support of FDA's cosmetics program goals. Dr. Breslawec served as a regulatory scientist and manager at FDA. She extended her record of scientific review excellence as a manager of the CIR program, significantly expanding the review capacity of the independent CIR safety assessment program. Dr. Breslawec is currently the Chief Scientist and Executive Vice-President at the Personal Care Products Council where she has been an effective advocate for FDA, helping to assure the availability of resources for the FDA cosmetics program and supporting industry outreach to the medical community.

2012

Nancy Bradish Myers - For outstanding contributions advancing FDA's mission, creating a strong coalition to advocate for FDA resources and establishing enduring connections between FDA alumni and staff.

Joseph Fratantoni, M.D. - For distinguished service to FDA, including efforts to foster scientific understanding and appropriate regulation of blood substitutes, platelets and pathogen inactivation technologies.

W. Howard Cyr, Ph.D. - For excellent career work in radiological research studies.

2011

Alan Rulis, Ph.D. - For lifelong commitment to FDA's public health mission through public education about the scientific rigor and objectivity in the toxicological review of new food ingredients.

Mary Beth Jacobs - For distinguished service to FDA, including leading OBRR regulatory efforts, overseeing CDRH research programs, leading organizational improvement activities and serving as a mentor and trainer.

2010

Joe Levitt - For exceptional leadership and advocacy of FDA through education and information thereby promoting greater understanding and support of the agency's mission to protect the public health (recipient nominated by FDAAA)

Bill Hubbard - For unparalleled commitment to and tireless efforts in support of the Food and Drug Administration's mission of promoting and protecting the public health of our nation (recipient nominated by FDAAA)

John Finlayson, Ph.D. - For 51 years of distinguished service to the cause of public health, through research, regulation, and inspired mentoring of the current generation of CBER scientist-regulators.

2009

Robert L. Lake - For distinguished service in improving the safety of the world's food supply and for exemplifying the spirit of service represented by FDA Alumni (recipient nominated by FDAAA)

Daniel L. Michels - For an exceptional life dedicated to protection of the public health and exemplary leadership that has enabled the FDA to fulfill its consumer protection mission (recipient nominated by FDAAA)

2008

Elizabeth D. Krell, Ph.D. - For exceptional scientific leadership of FDA programs, international harmonization, consensus standards, device trade association programs, and alumni relations that contribute to the public health. (recipient nominated by FDAAA)

Arthur Norris - For vision, dedication and commitment to advancing FDA science, education and public health goals.

Linda A. Suydam, D.P.A. - For exceptional management of FDA programs in medical devices, radiological health, and agency-wide, and leadership to fight abuse and insure safe use of over-the-counter medicines. (recipient nominated by FDAAA)

2007

Michael J. Blackwell, D.V.M. – For continuing meaningful support of the FDA mission following his retirement that fully reflects his dedication to the Agency and to protecting the public health.

Robert W. Sauer – For extraordinary service to FDA that continues following retirement and is fully reflective of his strong commitment to government service and protection of public health.

2006

F. Alan Andersen, Ph.D. – For exceptional contributions to FDA and public health as a senior scientist and program manager in radiological health, medical devices, cosmetic safety and alumni relations. (recipient nominated by FDAAA)

W. Fred Hooten – For many years of outstanding leadership, commitment and foresight, resulting in significant changes in the regulation of the medical device industry which had a profound impact on manufacturing standards in the U.S. and the global arena through improvement of FDA programs that focus on the importance of Quality Systems in the protection of public health.

2005

Douglas Archer, Ph.D. – For continued outstanding contributions to the Food and Drug Administration’s food safety programs and meeting the Agency’s mission of protecting the public health of the American people.

Anthony C. Celeste – For sustained, high quality managerial and technical leadership within and outside FDA and continued dedication to protecting public health by upholding FDA’s mission and values. (recipient nominated by FDAAA)

Peter Barton Hutt, Esq. – For contributions to food and drug law and policy, and for providing leadership to the FDA bar for many decades. (recipient nominated by FDAAA)

2004

Sherwin Gardner – For enlightened, steady and dedicated leadership of the Food and Drug Administration during critical turning points in the Agency’s history. (recipient nominated by FDAAA)

Richard A. Merrill, Esq. – For furthering the scholarship of food and drug law as an author, teacher and government committee member and enhancing public understanding of FDA’s regulatory process. (recipient nominated by FDAAA)

Wayne L. Pines – For continued outstanding contributions in advancing public health by educating the public and private enterprise on the policies of the Food and Drug Administration. (recipient nominated by FDAAA)

2003

James Benson – For exceptional problem-solving skills, management excellence and a robust passion for valued government service, trademark qualities that have made him a highly effective public health leader within and outside the FDA. (recipient nominated by FDAAA)

J. Richard Crout, M.D. – For enlightened and committed leadership in bringing FDA’s drug review and regulatory programs to a position of world acclaim and respect during a time of unparalleled advancement in medical technologies. (recipient nominated by FDAAA)

2002

Jerome A. Halperin – For continued outstanding contributions to public health in the United States through service in the Commissioned Corps, Food and Drug Administration, United States Pharmacopeia and the Food and Drug Law Institute.

Michael R. Taylor, J.D. – For outstanding leadership, exemplary service, and exceptional dedication as Deputy Commissioner for Policy and in the area of food safety initiatives.

2001

Gerald L. Barkdoll, D.P.A. – For innovative leadership and exemplary service to FDA in establishing the Agency’s strategic management framework, and for outstanding contributions as a planning innovator in the public sector planning community.

Joseph P. Hile – For many years of exemplary senior executive leadership and outstanding contributions, and for being a lifelong trusted friend and colleague of the Food and Drug Administration.

John M. Taylor – For outstanding leadership in directing FDA’s nationwide enforcement and field operations and serving as a consummate public servant dedicated to the mission of consumer protection.

2000

Charles C. Edwards, M.D. – For a career of exceptional dedication and significant contributions to public health through service as Commissioner of FDA, leadership of a major medical research institution, and insightful leadership of the Advisory Committee on the FDA.

Sanford A. Miller, Ph.D. – For outstanding leadership, exceptional vision, and distinguished public service as Director of CFSAN and, subsequently, for continued substantial contributions to understanding food policy issues.

Mark Novitch, M.D. – For outstanding career achievements in public health and in recognition of your commitment to excellence when serving in, and recruiting for, leadership positions within the Office of the Commissioner at the FDA.

John C. Villforth – For superior leadership and a distinguished public health career dedicated to protecting American consumers by ensuring safe and effective medical devices and radiological health products.

1999

D. Bruce Burlington, M.D. – For exceptional vision, innovative leadership, and outstanding service to FDA while managing the regulation of biologics, human drugs, medical devices and radiation-emitting products.

Ronald G. Chesemore – For exceptional vision, competence, and dedication in directing nationwide enforcement and field operations of FDA, and for design and implementation of the Office of Criminal Investigations and the consolidation of FDA field laboratories.

Richard E. Geyer, J.D. – For sustained and distinguished service to FDA while serving as Deputy Director, Office of Surveillance and Compliance, Center for Veterinary Medicine from 1992 to 1999.

Gerald B. Guest, D.V.M. – For exemplary service and outstanding leadership when serving as the Director, Center for Veterinary Medicine, FDA, from 1986 to 1993.

M. Carolyn Hardegree, M.D. – For outstanding contributions to the Agency’s public health mission by oversight of the development, licensing, and use of safe and effective childhood vaccines.

Burton I. Love – For being an innovative leader, role model, and mentor to many other Agency leaders and serving as a consummate public servant dedicated to the mission of the Food and Drug Administration.

Arthur R. Norris – For 29 years of continued outstanding contributions, exceptional service, and managerial wisdom that had a major impact on the Food and Drug Administration and the achievement of its goals.

Carl C. Peck, M.D. – For continued outstanding efforts to improve the science of drug development in this country and abroad, as a friend and colleague of the FDA, as Director of Georgetown University’s Center for Drug Development Science, and as president of the American Society for Clinical Pharmacology and Therapeutics.

John H. Turner – For outstanding leadership, commitment to excellence, and the highest professional standards applied to technical and managerial leadership of the Southeast Region of the Food and Drug Administration.

John E. Vanderveen, Ph.D. – For 37 years of distinctive Federal service of which 23 years were dedicated to work in FDA managing initiatives to promote and protect the public’s health by ensuring that the food supply was safe and food products were labeled honestly and accurately.