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.
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, become Chairman of the Communications Committee 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.
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
Anthony S. Fauci, M.D.
Dr. Fauci was appointed Director of NIAID in 1984. He oversees an extensive portfolio of basic and applied research to prevent, diagnose, and treat established infectious diseases such as HIV/AIDS, respiratory infections, diarrheal diseases, tuberculosis and malaria as well as emerging diseases such as Ebola and Zika. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. The NIAID budget for fiscal year 2017 was approximately $4.9 billion.
Dr. Fauci has advised five Presidents on HIV/AIDS and many other domestic and global health issues. He was one of the principal architects of the President’s Emergency Plan for AIDS Relief (PEPFAR), a program that has saved millions of lives throughout the developing world.
Dr. Fauci also is the long-time chief of the Laboratory of Immunoregulation. He has made many contributions to basic and clinical research on the pathogenesis and treatment of immune-mediated and infectious diseases. He helped pioneer the field of human immunoregulation by making important basic scientific observations that underpin the current understanding of the regulation of the human immune response. In addition, Dr. Fauci is widely recognized for delineating the precise ways that immunosuppressive agents modulate the human immune response. He developed effective therapies for formerly fatal inflammatory and immune-mediated diseases such as polyarteritis nodosa, granulomatosis with polyangiitis (formerly Wegener's granulomatosis), and lymphomatoid granulomatosis. A 1985 Stanford University Arthritis Center Survey of the American Rheumatism Association membership ranked Dr. Fauci’s work on the treatment of polyarteritis nodosa and granulomatosis with polyangiitis among the most important advances in patient management in rheumatology over the previous 20 years.
Dr. Fauci has made seminal contributions to the understanding of how HIV destroys the body's defenses leading to its susceptibility to deadly infections. Further, he has been instrumental in developing treatments that enable people with HIV to live long and active lives. He continues to devote much of his research to the immunopathogenic mechanisms of HIV infection and the scope of the body's immune responses to HIV.
In a 2017 analysis of Google Scholar citations, Dr. Fauci ranked as the 24th most highly cited researcher of all time. According to the Web of Science, he ranked 11th out of more than 1.9 million authors in the field of immunology by total citation count between 1980 and January 2018.
Dr. Fauci has delivered major lectures all over the world and is the recipient of numerous prestigious awards, including the Presidential Medal of Freedom (the highest honor given to a civilian by the President of the United States), the National Medal of Science, the George M. Kober Medal of the Association of American Physicians, the Mary Woodard Lasker Award for Public Service, the Albany Medical Center Prize in Medicine and Biomedical Research, the Robert Koch Gold Medal, the Prince Mahidol Award, and the Canada Gairdner Global Health Award. He also has received 43 honorary doctoral degrees from universities in the United States and abroad.
Dr. Fauci is a member of the National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society, as well as other professional societies including the American College of Physicians, the American Society for Clinical Investigation, the Association of American Physicians, the Infectious Diseases Society of America, the American Association of Immunologists, and the American Academy of Allergy, Asthma & Immunology. He serves on the editorial boards of many scientific journals; as an editor of Harrison's Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,300 scientific publications, including several textbooks.
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".
2018 Founder's Award Recipient
Daniel L. Michaels
Dan never served on the Board. Dan Michels received the Service Recognition award in 2013 and the Volunteer of the Year for 2015 He was a Charter member and only served as Chair of the Nominating Committee. Dan also worked with Andy on the FDA mentoring program.
Andy Bonanno started as an Investigator in LOS-DO in 1974. He joined the FDA Alumni Association as a new member in 2008, shortly before retiring from a 34 year career with FDA’s Office of Regulatory Affairs (ORA). He became active in the association and was elected to the board of directors in 2009, moving onto vice-president in 2011, and later Vice-Chair. He spent about 7 years on the executive committee, helping lead and guide the association forward. In 2018, after the maximum allowable 3 terms on the board of directors, Andy steps down from the board and the position of Vice-Chair, leaving behind 10 years of service and some notable accomplishments:
Established the FDA Alumni Association’s first formal Vision Statement after witnessing a need to clarify the organization’s purpose – “The FDA Alumni Association is the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community." Andy chaired a small group and pushed for consensus among board members and the executive committee in order to develop this simple vision statement that reflects the essence of the FDAAA, and should help chart a clear path into the future.
Established a unique mentoring program with ORA, where retired senior agency officials are re-hired to mentor upcoming agency leaders. The pilot won awards after a very successful debut, and was then established as an official agency program with the help of OPM.
Worked with the agency to incorporate a presentation on the FDA Alumni Association is each pre-retirement course offered to FDA personnel, assuring that pre-retirees are made aware of the alumni organization and its services.
Chaired a working group that explored ways the association could improve finances, and established a procedure for accepting fees for paid job advertisements on the website and in the newsletter.
Co-chaired the governance committee, helping craft needed modifications to the organization’s bylaws.
Worked to establish closer ties with other organizations, such as the Association of Food and Drug Officials.
Recipients of the FDAAA Founder's Awards - See list of recipients
FDAAA Volunteer of the Year Award Recipients
2018 Volunteer of the Year Recipient
In Grateful Recognition for consistent and ongoing contributions to make the FDAAA newletter and website current and updated, communicating the benefits of FDAAA membership and the important ongoing activities conducted by the organization.
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.
2018 Service Recognition Award
In Recognition of placing the finances of the FDAAA on a professional footing by addressing issues in a tactful and collaborative manner which will provide the stability required for FDAAA to move forward and become a stronger and more active organization.
In Recognition of the significant efforts to solidify the legal standing of the FDAAA organization and ensure that the officers and Board of Directors received reliable and solid legal advice on all matters.
In Recognition for ongoing and consistent contributions in all areas, particularly with the recently expanded and active FDAAA Membership Committee.
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).
2018 Certificate of Appreciation Recipient
Lisa Barclay – for showing strong leadership and organizational skills as Chair of the FDAAA Activities Committee, with a number of successful events completed during the 2017 – 2018 FDAAA year.
Wayne Pines – for leading the Communications Committee in a manner that expanded the FDAAA presence in new communications pathways such as LinkedIn, Facebook and other social media and professional networking sites.
Angela Hoague - for acting as the right hand for the Activities Chair and spearheading the planning and organization of a number of FDAAA activities during the 2017 – 2018 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.
Commander (CDR) Tracy MacGill
Commander (CDR) Tracy MacGill, representing the FDA’s U.S. Public Health Service in the Office of the Chief Scientist, Office of the Commissioner
The FDA Alumni Association is nominating Commander (CDR) Tracy MacGill for the FDA Innovator Award. She was the lead for the Development of Medical Countermeasures (MCMs) section under FDA’s Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science to include animal model alternative platforms through a partnership with the Wyss Institute at Harvard University. Harvard University’s Wyss Institute for Biologically Inspired Engineering is a pioneer in the development of micro-physiological systems (MPS or “organs-on-chips) that mimic the structure, function, and interactions between the living tissues within human organs – such as the lung or intestine – on chips the size of a thumb drive. Under one of the first MCM-focused contract, Wyss Institute scientists are developing and refining in silico models of radiation damage in their lung, gut, and bone marrow organs-on-chips and using these models to test candidate MCMs to treat such damage. This will provide a capability to evaluate candidate medical countermeasures for acute radiation syndrome (ARS) within the specific context of a target human organ which will yield valuable mechanistic information for facilitating product develop, that is difficult to study in in animal models of ARS. These models are potentially reducing the number of animal studies needed for product development by supporting the selection of the most promising MCMs to be advanced for consideration.
CDR MacGill has worked closely with the Defense Advanced Project Agency (DARPA), who provided early support, to advance the MPS platform through MCM applications and with the Center for Food Safety and Nutrition (CFSAN) to support establishment of CFSAN’s FDA MPS Core Facility, allowing FDA scientists the opportunity to gain experience with this innovative platform.
Through CMD MacGill’s efforts, this research is advancing more rapidly and with US government commitment and certainty with the expected outcome being a more rapid assessment of medical procedures and medical drugs by confirming there efficacy, effectiveness and impact on various human tissues.
We are confirming that CMD Tracy MacGill meets the criteria for the FDAAA Innovator Award and has received the complete support of the FDAAA Board of Directors.
CITATION: In recognition of the leadership and commitment which allowed the Wyss Institute at Harvard University to advanced medical testing platforms for assessment of new human disease treatments.
Drs. Brandon Gallas and Marios Gavrielides, along with Drs. Darren Treanor (NHS, England) and Stephen Hewitt (NIH)
Drs. Brandon Gallas and Marios Gavrielides, along with Drs. Darren Treanor (NHS, England) and Stephen Hewitt (NIH), established the Whole Slide Imaging (WSI) working group, a collaborative community with wide participation from industry, clinicians, academia and government to address the many challenges associated with the performance assessment of the emerging class of medical devices referred to as whole-slide imaging (WSI) digital pathology systems. The working group chairs recognized the need for collaboration with external experts and organizations to share data and expertise. Together the working group is striving to co- develop new, least burdensome methods for the evaluation of whole-slide scanning systems that would support premarket applications to the FDA, as well as the study of these systems for other purposes (in research settings as well as after they have been in long-time clinical use following FDA’s approval for marketing).
During the last 10 years, significant technological advances have allowed digital scanning systems to rapidly and automatically digitize large numbers of pathology slides at high spatial resolution. This in turn has facilitated the development of many unique applications making use of the digital pathology slide data in support of clinical decisions, especially through the use of machine learning and pattern recognition techniques. However, it wasn’t until this past year that FDA granted marketing approval for the first ever WSI system. The reason for this is that the evaluation of digital pathology systems is especially challenging because of the crucial role the microscope plays in medicine: pathology interpretations provide definitive diagnoses, drive treatment, and serve as the reference standard for evaluating treatments and diagnostics). Thus the risk associated with replacement of the optical microscope with a potentially lower-quality digital system is understood to be high. It must also be appreciated that there is a very wide range and diversity of pathology clinical tasks, as well as an expected large variety in the approaches vendors might take in the engineering design of their digital systems in terms of the image acquisition, processing, and display components.
The overarching goal of the WSI working group is to develop methods for properly characterizing WSI devices and components with systematic technical measurements and validation studies that will allow the clinical utility of digital pathology to be maximized. The group has been extremely well subscribed, with over 130 current members. More importantly, the group has been highly successful in facilitating collaboration across the digital pathology industry in a pre-competitive environment. The WSI working group has hosted multiple webinars and town halls at pathology conferences where ideas are shared, to the extent that vendors have been willing to discuss planned study designs in a public forum, much like a public grant review or study section, and obtain feedback from the entire community prior to any resource expenditure on their study. The WSI working group has become a widely recognized forum for the exchange of ideas, development of consensus strategies, and benchmarking of methods to assess the image quality of WSI systems. The efforts of Drs. Gallas and Gavrielides, as founders and leaders of the WSI working group have greatly benefited the research and industrial community associated with the design, development, and use of WSI systems. Their efforts benefit the working group members and nonmembers alike, as all the WSI working group discussions and materials are publicly available at this website: https://nciphub.org/groups/wsi_working_group. Most importantly, through the leadership of Drs. Gallas and Gavrielides, patients benefit by the development and dissemination of best practices for the evaluation of WSI systems, which naturally leads to the design and availability of improved devices.
Dr. Jaview Revollo
Scientific breakthroughs have made genome engineering possible. Potential applications of these technologies include the editing of patients’ genetic material (DNA) and could lead to therapies against cancer and AIDS. The safety of genome engineering technologies, however, has yet to be determined, particularly because classic genetic toxicology assays are inadequate to determine the off-target mutations (i.e., unintended mutations) that results from genome engineering. Off-target mutations, even if rare, could have significant adverse health consequences if, for instance, they occur in carcinogenesis-associated genes.
To fill the gap in the FDA’s ability to assess the safety of genome engineering therapeutics, Dr. Javier Revollo developed a method that comprehensively identifies mutations genome-wide. The method works comparing whole genome sequencing datasets from single-cell-derived clones, and is an integral in two projects aimed at assessing the safety of genome engineering therapeutics. The first is an NCTR project titled “Methods to determine off-target effects of CRISPR-mediated genome engineering in mammals” and the second is a Chief Scientist’s Challenge Grant titled “In vitro and in vivo methods for functional evaluation of genomic alterations induced by genome editing.” Dr. Revollo’s newly developed methods have been fundamentally important to researchers trying to assess the safety of genome engineering to develop new therapeutics which do not unintentionally cause harm. We are confirming that Dr. Jaview Revollo meets the criteria for the FDAAA Innovator Award and has received the complete support of the FDAAA Board of Directors.
CITATION: In recognition of the development of a method that detects mutations genome-wide to enable the FDA to assess the safety of genome engineering therapeutics.
ShaAvhrée Buckman Garner, Director of CDER Office of Translational Sciences
The FDA Alumni Association is nominating CDER’s “DASH” Team for the FDA Innovator Award. The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is required to keep detailed records of the drug development review and approval process in order to monitor the agency’s performance and respond to internal and external queries, including congressional requests. The required data existed in a variety of electronic and paper formats, making it difficult and time-consuming to obtain and query accurate data for the required analyses. To begin to address this problem, CDER previously developed a small database for verified clinical development and regulatory information.
However, the current small database had performance, capacity, and security constraints which limit its utility. To better support the growing number of users reliant on these data, CDER established a team to work with the FDA National Center for Toxicological Research (NCTR) to develop an Oracle-supported large capacity database application compatible with FDA’s enterprise infrastructure and information technology standards. This application, called the “Data Analysis and Search Host (DASH)”, will provide a robust and secure platform for monitoring and querying the progress of Marketing Applications, and provide critical information needed to improve the application process and ultimately reduce the time between initial application and final approval. The CDER DASH Team have been addressing the planning as well as the details of converting the small existing database of information into the larger DASH database for access by many FDA and other outside, authorized, scientific bodies. We are confirming that CDER’s “DASH” Team meets the criteria for the FDAAA Innovator Award and has received the complete support of the FDAAA Board of Directors.
CITATION: For its work on the Data Analysis Search Host (DASH), an information-rich scientific database containing Marketing Application information on new molecular entities (NME) and biologics. DASH Team Members:
- CDER Leader and Members: ShaAvhrée Buckman Garner (Director of CDER Office of Translational Sciences), Salvatore Pepe,Ji Feng. Shahrukh Haider, David Guenther, Gregory Jackson, Nisha Bruce
- NCTR Leader and Members: Weida Tong (Director of NCTR Bioinformatics and Biostatistics), Joe Meehan, Jae Hyun Kim, Weizhong Zhao, Steve C. Harris, Suresh Subramani
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
- Andy Bonanno
- Flou Hough