Food and Drug Administration Alumni Association - Serving Those Who Have Served

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FDAAA Annual Report Now Available:

The FDAAA Annual Report for 2019, 18th Edition is now available and can be found on the Publications / Reports page of our website.

We thank the Leadership, Committee Chairs, and Committee Members for all of their efforts, and for describing accomplishments and plans in this Annual Report.

Please enjoy reading the report and the pictures.

The report is password protected to prevent editing.

Questions about the report should be directed to Richard A. Baldwin, Chair Communications Committee, at mail@fdaaa.org!

The FDAAA Virtual Annual Meeting:

We look forward to "meeting" many of you during our Virtual Annual Meeting, 6 May 2020 from 3 - 4 PM EDT. If you would like to join the meeting, please send an e-mail to mail@fdaaa.org.

Reminder: Virtual Annual Meeting

We want to remind you of our invitation for you to join the FDAAA VIRTUAL ANNUAL MEETING on Wednesday, May 6, 2020, from 3 PM to 4 PM.

At that meeting, we will announce our new Board of Directors and Officers. We will also share our accomplishments for the year and ask for your input.

If you are interested in participating, please send an e-mail to mail@fdaaa.org, and we will send the instructions to join the virtual meeting.

We hope that you can join us!

Be well and see you on May 6,

The FDAAA Leadership

Updates from FDAAA 4/18/20

• Update for the COVID-19 Crisis

• A Reminder to send us pictures of your blood donations.
  (See the article on Doug Nelson at www.fdaaa.org)

Update for the COVID-19 Crisis

We want to provide additional information regarding the COVID-19 crisis.

We hope this information is helpful to you and that you and your families and loved ones are staying safe.

The COVID-19 pandemic has created challenges in our everyday lives. As we each do our part to help slow the spread of coronavirus disease, we look to the helpers all around us and wonder if we, too, could do more.

Here are some ways you and your family can help.

The following is an active link to FDA's website and this information: How You Can Make a Difference During the Coronavirus Pandemic

Please go to: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html for the complete article, "Use of Cloth Face Coverings to Help Slow the Spread of COVID-19"

Here's Our First Blood Donor!

Doug Nelson sent us some pictures donating blood from the Mesa, Arizona Blood Drive 4/11/20.

Check out Doug's pictures at www.fdaaa.org!

Thanks to Doug for paying it forward!

Who will be next?

We also want to point out FDA's encouragement for people to donate blood. Not only will you feel good about your participation, you will be helping others in the process. Also, if you send us a picture (at mail@fdaaa.org) of yourself donating blood, we will post it on the FDAAA website!

OK -- From Mesa, Arizona Blood Drive 4/11/20.

Doug Nelson complete with mask while donating blood. (pic below, see the others on our website)

I was CSO with MIN-D0 1976-2002 and CFSAN/LACF Team 2002-2006.

The FDAAA wishes to Thank Dr. Fauci for his Outstanding Service to Science (#ThankyouDrFauci)

FDAAA Members:

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.

#ThankyouDrFauci

The FDAAA

AstraZeneca FDA Alumni Lunch Gathering

On February 12, 14 of the 37 FDA alumni who work at AstraZeneca gathered for lunch to connect and share their most meaningful FDA moments.

FDA Fellows Program and FDAAA

FDAAA Lunch with Dr. Amy Abernethy on Monday, March 16–POSTPONED.

The FDA Alumni Association Activities Committee has decided to postpone the speaker luncheon with Dr. Amy Abernethy that was scheduled for Monday, March 16 until a later date. We look forward to hosting Dr. Abernethy in the future and will make details about that rescheduled lunch available as soon as possible. Thank you.

FDAAA Winter Celebration 2019 at Maggiano's Little Italy, Friendship Heights, DC

On December 4, 2019, the FDA Alumni Association hosted its Winter Celebration at Maggiano's Little Italy in Friendship Heights. Nearly 100 current and former FDA staff enjoyed a fun filled evening with their colleagues and friends. FDAAA also recognized Melinda Plaisier, who retired from the agency after 35 years in public service. Many thanks to the numerous sponsors who made this celebration possible. We look forward to a new decade full of many more fun events! Lisa Barclay & Angela Hoague, Co-Chairs FDAAA Activities Committee.

FDAAA Announces Officers and Board Members

The Food and Drug Administration Alumni Association (FDAAA), whose members consist of FDA alumni and current employees, has announced its leadership for 2019-2020.

The officers of the Association will be (asterisks mark positions with new incumbents):

• *Chair: Deb Autor
• *President: Allen Sayler
• *Vice President: Anne Marie Finley
• *Treasurer: Brian Mayhew
• Vice Chair: Robert Brackett
• Secretary: Marie Urban
• General Counsel: Jessica O'Connell
• *Nancy Myer, past Chair (Ex-Officio)

The members of the FDAAA Board of Directors will be:

• Deb Autor (Chair)
• Dennis Baker
• Lisa Barclay
• Robert Brackett (Vice Chair)
• Cathy Carnevale
• *Richard Baldwin
• Anne Marie Finley
• Ed Steele
• Fredda Shere-Valenti
• *Lawrence Bachorik
• Marie Urban
• Kathryn Zoon

The leadership will be announced at the "Spring Fling: that FDAAA holds annually with the FDA to celebrate the collaboration between FDA and the Association.

Deb Autor, elected as FDAAA chair, said: "I am delighted to become Chair of the FDAAA, the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community. We strongly believe that once an FDAer, always an FDAer. Today, the Association has an active social calendar, mentors current FDA employees, conducts training sessions, recognizes accomplishments through an active awards program, supports student scholarships for those entering regulatory affairs, has an active international program, and is available to help FDA management and staff as needed. Please join us and help to serve those who have served!"

2019 FDAAA Awards Presented at the 2019 Annual Meeting - May 13, 2019

Service Recognition Award:

• Alan F. Andersen - For "Outstanding Work in Electronic Communications to Spread the Awareness of FDAAA and Its Activities"

  

• 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

Volunteers of the Year:

• Lisa Barclay - 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

Certificates of Appreciation:

• Allen Sayler - 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

• Bryan Coleman - 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"

• Angela Hoague - 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"

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 Board Member's Recognition:

• David L. Chesney

• Nancy Myers

  

  Nancy Myers

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"

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.

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

2019 FDAAA Annual Meeting - May 13, 2019

Frontiers in Flavor Chemistry - Join Us for Free, In Person or Online

An FDA / American Chemical Society (ACS) Collaboration, for any FDAAA members and Associates who are interested.

The inaugural FDA/ACS chemistry colloquium will be on Tuesday, June 4, from 9:00 AM-12:00 PM, at the FDA Wiley Building auditorium in College Park, MD. Presentations on "Frontiers in Flavor Chemistry" will be followed by a panel discussion. The colloquium will focus on taste perception in humans and its impact on nutrient intake and recent advances in food flavors including the discovery of new flavors. Learn more on our website about the experts - Paul Breslin (Rutgers), Devin Peterson (Ohio State), and Guy Servant (Firmenich) - and register for free to join us in person or online!

Richard Baldwin (FDAAA and ACS member)

John "Barr" Weiner, J.D. at April 9, 2019 Luncheon Speaker Series

The FDAAA kicked off its 2019 speaker luncheon series on April 9, 2019 with guest speaker John "Barr" Weiner, J.D., Associate Director for Policy, Office of Combination Products, for a very engaging discussion about recent developments and innovative new issues in the area of combination products.

Members enjoyed the delicious Jewel of India buffet, good company, and a great presentation by Mr. Weiner, who gave a broad overview of the office's current activities and hot topics in combination products and graciously fielded lots of good questions from the audience. We are extremely grateful for Mr. Weiner's time and for his willingness to engage in such a lengthy and fruitful discussion with the group.

Stay tuned for details on the next FDAAA speaker lunch!

FDAAA presents half-day program to the FDA Commissioner's Fellows

For ten years now, FDAAA has presented a half-day program to the FDA Commissioner's Fellows. The Fellows are people who are just starting their careers at FDA. Some were in the room in person, while others joined by webcast. The FDAAA speakers discuss their diverse FDA careers with an emphasis on lessons learned and advice to the Fellows.

Speakers at the program February 25 at White Oak were, left to right, Wayne Pines, Nancy Myers, Deb Autor, Joe Levitt and Susan Winckler.

The program also included Suzanne Junod, FDA historian, who retired three days later, on February 28. Suzanne has been an enthusiastic FDAAA supporter and has presented at all previous FDA Fellows sessions.

Anyone interested in participating in this session next year to tell about their years at FDA should contact Wayne Pines at wpines@apcoworldwide.com. We are looking to represent a range of Centers and experiences to help the next generation of FDAers!

FDAAA Annual Report - Request for Assistance

Coordinating the development of the FDAAA Annual Report is a responsibility of the FDAAA Communications Committee.

The Annual Report is a compilation of the major accomplishments and activities for the various FDAAA components, including leadership and the various committees.

In addition to narrative aspects of the report, pictures and graphics, as appropriate, are included.

We are seeking to have a member or a supportive friend of the FDAAA, to assist in helping format the report to make it visually appealing and to reinforce the accomplishments of the association.

Interested volunteers can contact:

Richard Baldwin
Chair, Communications Committee
FDA Alumni Association
302-539-7841 (Home - Office)
301-370-0235 (M)
rabaldwin@verizon.net

So Glad You're Back, We Appreciate You FDAers

By: Deb Autor, Bob Brackett, Joe Levitt, Nancy Myers, and Susan Winckler

Bringing handshakes, hugs, notes of appreciation, words of encouragement, and a little light-hearted laughter with 100 Grand candy bars, the FDA Alumni Association worked to support both furloughed and non-furloughed FDAers who attended the FDA government shutdown event for staff on Jan. 25. The mood was clearly a mix of frustration and sadness, due to the situation. However, what was noteworthy was the true underlying camaraderie of FDA staff and their genuine happiness to engage and reconnect with each other after a long month of isolated insecurity. The event, which included several hundred FDA employees and many of the agency's most senior leaders, was a wonderful reminder of the unique culture that is FDA and how colleagues, show caring and concern for each other in a time of need.

The stories of hardship during the furlough were deeply affecting. The silver lining was the common theme that the need for financial security was often due to a situation in which an FDA employee was caring for their families, extended families or someone else in need. There are so many big hearts at our agency.

Kudos need to go to Commissioner Gottlieb and his leadership team on the way they tried to transparently handle this tough situation. Many a tweet was sent to share information and bolster morale, and to ensure FDAers felt appreciated. The information fair was a unique opportunity for senior management to see staff and explain the situation, and for staff to examine their options.

Now with a three-week reprieve as our political leaders explore how to fund the government's remaining annual appropriations, perhaps it is time to also ask how a non-profit, independent alumni organization like ours can improve its support for those who still serve at the FDA. Hopefully, the e-mail to furloughed employees that FDAAA sent was read by those who needed to hear our encouragement. But without a list of personal emails, we were limited to the age-old chain letter process. When we wanted to provide financial support, such as providing the food for the FDA sponsored event, we simply didn't have time to navigate a lengthy ethics review. If you are reading this and have ideas on how we might create a rapid response plan for unforeseen events like the shutdown, we would love to hear them. Please email info@fdaaa.com.

We were honored to be able to interact with FDA staff at a time of uncertainty, and we hope that we can find ways to expand upon those efforts. As Michael Rogers, Assistant Commissioner for Human and Animal Food Operations, said in a note he sent thanking the FDAAA for attending the event, "We have always said that FDA is a family, and it's the mission and the pride that we have for this Agency that creates and keeps that common bond between us. I just wanted to send you a quick note to say that we appreciate the gesture that shows that you were thinking of us during that difficult time." We were especially touched that Michael told us he shared the story of our attendance on a call with the field.

The FDA Alumni Association is proud of "Team FDA," with its caring dedication and professionalism. Now that the furlough is over, it is back to work and hopefully a smooth rest of 2019!

FDAAA Winter Celebration 2018 at Maggiano's Little Italy

On November 28, 2018, the FDA Alumni Association hosted its Winter Celebration at Maggiano's Little Italy in Friendship Heights. The event was widely attended and honored 11 current and former FDA Center Directors. With remarks by Joe Levitt, FDAAA also recognized Dr. Stephen Ostroff, who will be retiring from the agency early next year after a distinguished career in public service. Many thanks to the numerous sponsors who made this celebration possible. We look forward to many more fun events in 2019!

FDAAA Fall Luncheon Featuring Keith Flanagan, J.D.

On October 4, 2018, over 40 FDA Alumni Association members returned to the Jewel of India in Silver Spring for an informative discussion with Keith Flanagan, the Transition Lead for CDER's Policy Office of New Drugs (OND). As current and former FDA employees resisted multiple trips to the delicious buffet, Keith engaged in a substantive discussion about the OND Regulatory Modernization Program and the proposed structure of the OND Policy Office. We are thankful that Keith could take the time to meet with our members and it was wonderful to see so many familiar faces.

China FDA meets with FDAAA

Using DIA China as a Launch Pad: FDAAA Discusses Collaboration Agenda with Chinese National Drug Administration Department of International Cooperation

By: Nancy Myers, Deb Autor, and Jinje Hu

On a windy Tuesday, May 22, an FDA Alumni Association leadership delegation enjoyed a warm meeting with the Chinese equivalent of FDA, previously called CFDA and described at the meeting as the National Drug Administration (NDA) or Chinese National Drug Administration (CNDA). We were all in Beijing for DIA China 2018.

The meeting was intended to advance the friendship between FDAAA and NDA and identify areas of potential collaboration to most effectively advance global public health. The high-level Chinese officials made their interest clear: they see value in engaging FDAAA directly to gain insight into lessons learned and gain forward-leaning insight in several targeted areas. FDAAA expressed its sincere interest in engaging with the Chinese NDA and sharing the experiences in rapidly-developing areas of US FDA regulation as China engages in its transformational regulatory reform efforts.

Chinese NDA Participants included:

• Mr. Yuan Lin, Director General, Department of International Cooperation
• Ms. Jiang Lu, Director of Division of Bilateral Cooperation, Department of International Cooperation
• Mr. Zhang Gaotong, Consultant, Division of Bilateral Cooperation, Department of International Cooperation
• Ms. Liu Yuan, Principal Staff Member, Division of Bilateral Cooperation, Department of International Cooperation

The FDAAA delegation included:

• Deb Autor, FDAAA Board Member and Chair, Nominations Committee
• Jinjie Hu, Chair, FDAAA International Network
• Nancy Bradish Myers, FDAAA Board Chair

Director General Yuan opened the meeting, voicing appreciation for the FDAAA visit and our work. He walked the group through the evolution of his agency over the last few decades from SDA to SFDA to CFDA to the newly established, likely-to-be-called NDA (or possibly CNDA). He shared that the reformed NDA will focus on registration, supervision, and management of drugs, devices, and cosmetics.

Given that it is the prerogative of the National People's Congress to reevaluate the NDA every five years, frequent reforms will likely continue. The biggest difference with this most recent reorganization is that food safety is now shifted to the superior organization, SAMR (State Administration for Market Regulation), which he described as a minister-level agency, the equivalent to the level of our DHHS in the US.

Reform of the agency is now underway; it will occur in two phases, and is intended to strengthen drug regulation and adapt to the rapid development of innovation and the market economy. The ultimate goal for the leadership of China's NDA is to " provide better products for our people and improve efficiency of review and approval and quality of product."

Phase 1 began in August 2015 with the issuing of a directive No. 44, issued by State Council of China; this directive is intended to improve the quality of review and approval and resolve the backlog, in addition to improving the quality of generics, encouraging innovation, and improving transparency of review and approval.

After over two years of reform, NDA can point to what it considers substantial results. The CDE staff totaled less than 200 when Phase 1 began; it is now over 800. The registration application backlog, which was over 22,000 in 2015, is now less than 4,000. Mr. Yung talked about how the speed of review and approval has been increased dramatically. He believes the philosophy of regulators in China has changed and thus has sent a clear signal to industry that the agency is facilitating innovation.

Under Phase 2, which began in August of 2017, the General Office of Central Committee and State Council jointly issued a directive on review and approval and innovation in order to encourage innovation of drugs and devices to better serve public health.

Mr. Yuan pointed out several priorities for reform:

1. The first reform focus is to encourage better new drugs and devices - not just domesticly-made products, but also imported ones.
1. China is putting in place policies to advance innovation within China and to accelerate the approval of innovative new drugs from outside China to meet unmet medical needs.
2. The second priority for China will be to improve the accessibility of medical products. Director General Yuan recognized the value of lower cost drugs and referred to FDA Commissioner Scott Gottlieb recent statements on the need to lower drug prices.
1. Though China has a big focus on supporting innovation, he indicated that the country will need to balance access to high priced, innovative drugs with use of high quality and efficacious generics that are the equivalent of brand name drugs.
2. He discussed the need and steps China is taking to improve the quality of generic drugs as it works to ensure that generic drugs are the same as RLD.

This reform will likely borrow from key learnings from the US FDA, such as: creation of the Orange book, IND review (in particular, the multi-disciplinary subject expert team review model for clinical trial applications), and establishing patent protection and patent linkage systems.

Part of this reform agenda has been to bring the Chinese system more in-line with international standards. For example, China joined a number of important international organizations like the ICH, ICMRA (International Coalition of Medicines Regulatory Authorities}, and IMDRF (International Medical Device Regulators Forum). The participants in the meeting pointed to the fact that China chaired the IMDRF meeting in Shanghai in March this year.

Recently China also applied to be ICH management committee member, hoping to make an active contribution to ICH while learning from ICH and work to harmonize its standards with those of other countries.

We took the opportunity to highlight FDAAA's recent strategic planning efforts and its vision for assisting regulators globally. We shared examples of innovative, supportive collaborations our volunteer have initiated supporting regulators like our FDA Alumni Advisor Program established initially with FDA's Office of Regulatory Affairs. We congratulated NDA on its vision for a modernized medical product review process which is focused on safety, efficacy and innovation. We also recognized NDA for recently being elected to be a Management Committee member of ICH at the recent June 7th, 2018 ICH Annual meeting in Japan.

During the meeting, NDA and FDAAA agreed that there were a few areas of mutual interest and possible meaningful cooperation that should be considered in terms of sharing expertise and experience. These areas are:

• Gene therapy
• Digital medicines
• Treatment of infectious diseases
• Biosimilars
• Generics, and
• Combination Products

Our next step, from the FDAAA perspective, will be to ask the FDAAA International Network to meet and propose to the Board an approach for the NDA and to identify the most impactful synergies where we might collaborate with NDA. Although our resources are finite, this is a great opportunity to help leverage our expertise for the benefit of global health. We will be seeking FDAAA volunteers to staff this initiative and share their expertise.

Director General Yuan and his NDA colleagues indicated that they look forward to our feedback and assigned a specific point person with whom we should work.

We ended the meeting agreeing that NDA and FDAAA share the same goal - to protect and promote the public health. We acknowledged the value of vigorously exploring how we might work together to accomplish this important global objective.

Spring Fling 2018

On June 12, 2018, the FDA Alumni Association hosted its 9th Annual Spring Fling in the Great Room at FDA Headquarters in White Oak, MD. Over 70 current and former FDA staff attended the event and enjoyed delicious BBQ catered by Red Hot & Blue.

This year's Spring Fling was especially meaningful as the FDAAA honored Jim Benson, a founding member for the Board of FDAAA and former Acting Commissioner, Deputy Commissioner and Director of the Center for Devices and Radiological Health (CDRH). Joe Levitt, Former Chair of FDAAA, presented Jim's wife, Cynthia Benson, with a plaque to commemorate the naming of the scholarship fund for students enrolled in the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs graduate program in honor of Jim. CDRH's current Director, Dr. Jeff Shuren, also spoke about Jim's service, noting his dedication to CDRH and to FDA, and his commitment to promoting public health.

Dr. Gottlieb informally addressed the group, highlighting FDA's accomplishments during his first year as Commissioner as well as the Agency's top public health priorities. The Commissioner took questions from the group on a range of topics, including plans for the CDER/OND reorganization, the 2019 budget request, how the Agency can help manage the ongoing opioid epidemic, and how technology has allowed the Agency to communicate more effectively to consumers.

We are thankful to everyone who joined the Spring Fling and look forward to continuing the tradition!

FDAAA Names Temple Scholarship in Memory of Jim Benson

FDAAA has decided to name its scholarship fund for students enrolled in the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs graduate program in honor of Jim Benson, a founding member of the Board of FDAAA and FDA's former Acting/Deputy Commissioner and CDRH Director. Jim recently passed away.

The FDAAA Centennial Scholarship Award was created in 2006 in honor of FDA's centennial. The endowment created the first scholarship in the school's QA/RA program.

At the time, FDAAA said it established the endowment not only to commemorate the 100th anniversary of the Pure Food and Drugs Act but also to encourage academic training in regulatory and quality issues. FDAAA selected Temple after reviewing graduate programs of schools nationwide.

The fund will now be known as the James S. Benson FDAAA/FDA Centennial Scholarship Fund.

In 2006 donations to the fund came from pharmaceutical trade associations, including the PhRMA Foundation, drug firms, and FDAAA members.

Nancy Myers, chair of FDAAA. Urged current members who want to honor Jim Benson to donate to the fund.

"Jim was a highly regarded and admired member of the FDA and FDAAA communities and I can think of no better way to honor him than to name this program in his memory and for current FDAAA members to contribute to his memory, "she said. "The FDAAA Executive Committee believed that adding Jim's name to the Temple award is a fitting recognition of his contributions to the FDA community and to FDAAAA."

Joe Levitt, former chair of FDAAA, said naming of the scholarship fund for Jim was especially appropriate. "Jim was always a champion of education in his many years at the FDA. He began his career in the education division of radiological health. Plus, Jim was a driving force in the creation of the FDAAA/Temple Scholarship Fund by spearheading the fundraising efforts that created the initial endowment of the program."

Jim's wife Cynthia has been invited to attend the June 12 Spring Fling and to accept the honor in Jim's memory. Cynthia is an FDA Alumna, having worked for several decades in CDRH.

Christopher Van Vessem, Assistant Dean For Development and Alumni Relations, Temple University School of Pharmacy, remarked, "I am sorry to hear that Jim passed away. What a fitting gesture to make on Jim's behalf."

Temple University School of Pharmacy is a pioneer in providing advanced academic coursework in quality assurance and regulatory affairs, which refer to the quality practices and regulations governing the pharmaceutical, medical device, biotechnology, healthcare and consumer products, and related industries. The school was the first to create a master’s program in QA in 1968. In the 1990s, the school created the first academic certificate programs in drug development, clinical trial management, and medical device regulation.

Donations designated for the James S. Benson / FDA Centennial Scholarship Fund may be sent to:

Christopher Van Vessem
Director of Development
School of Pharmacy
Temple University
3307 North Broad Street
Philadelphia, PA 19140

FDAAA Announces Officers and Board Members

The Food and Drug Administration Alumni Association (FDAAA), whose members consist of FDA alumni and current employees, has announced its leadership for 2018-2019.

The officers of the Association will be (asterisks mark new positions):

• Chair: Nancy Myers
• President: Ed Steele
• * Vice President: Allen Sayler
• Treasurer: Bryan Coleman
• *Vice Chair: Robert Brackett
• *Secretary: Marie Urban
• General Counsel: Jessica O'Connell

The members of the FDAAA Board will be:

• Deb Autor
• Dennis Baker
• Lisa Barclay
• Robert Brackett
• Cathy Carnevale
• David Chesney
• Anne Marie Finley
• Nancy Myers
• Fredda Shere-Valenti
• Ed Steele
• Marie Urban
• Kathryn Zoon

The leadership was announced at the annual Spring Fling that FDAAA holds annually with the FDA to celebrate the collaboration between FDA and the Association.

Nancy Myers, re-elected as FDAAA chair, said: "The many dedicated leaders of this Association are committed to representing the former and current employees of FDA and to developing joint programs that advance the Agency's mission. We again look forward to an active and productive year."

FDAAA 2018-2019 Annual Report with Activities and Pictures for the past year

2017 Annual Report

FDAAA Spring Luncheon Featuring Jeffrey Shuren, M.D., J.D.

On April 20, 2018, over 40 FDA Alumni Association members spent a sunny Friday afternoon engaged in an informative discussion at the Jewel of India in Silver Spring with Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH). As current and former employees enjoyed unlimited samosas and a wonderful buffet, Dr. Shuren discussed a wide array of topics, from the recently released Medical Device Safety Action Plan, digital health regulation, and his vision for the Center's new organizational structure. We are thankful that Dr. Shuren could take the time to engage in a substantive dialogue with our members.

FDAAA Sponsors FDA Fellows Session

For almost a decade FDAAA has sponsored an FDA history educational session for the FDA Fellows, a group of young professionals working at the agency, many of whom will become permanent employees. This year the panel was, from left, FDAAA members Wayne Pines, Nancy Myers, Andrea Chamblee, Brian Harvey and Coleen Klasmeier. Some of the Fellows actually joined FDAAA after the half day session, which also included a lecture from FDA historian Suzanne Junod and a presentation on FDA's budget by Steven Grossman of the Alliance for a Stronger FDA.

FDAAA's Winter Luncheon Featuring Peter Marks, M.D., Ph.D.

On January 19, 2018, a glimmer of spring was in the air as a crowd of over 40 FDA Alumni Association members gathered in the sunny Terrace Dining Room at Mrs. K's Tollhouse restaurant in Silver Spring for an informative lunch with Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research (CBER). While enjoying a delicious buffet (that finished with amazing cookies), current and former employees from across the Agency enjoyed the informal setting in which Dr. Marks discussed a wide array of topics, from recent FDA approvals of CAR-T cell therapies, innovative new developments in the stem cell arena, and a preview of CBER priorities for 2018. We are grateful that Dr. Marks could take the time to spend with our members. Please stay tuned for future FDAAA events!

West Coast Networking Event

FDAAA held its second annual West Coast Networking Event in early January during the 36th Annual J.P. Morgan Healthcare Conference in San Francisco. More than 30 FDA alumni and guests - triple the attendees from the previous year - gathered at the popular Hotel Zetta to reconnect with old colleagues and make new contacts. We look forward to having an equally successful event next year!

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events

• Here's Our First Blood Donor! (4/13/20)
• AstraZeneca FDA Alumni Lunch Gathering (4/5/20)
• FDAAA Virtual Annual Meeting (3/31/20)
• FDA Fellows Program and FDAAA (3/31/20)
• FDAAA Winter Celebration 2019 at Maggiano's Little Italy, Friendship Heights, DC (3/5/20)
• 2019 FDAAA Awards Presented at the 2019 Annual Meeting - May 13, 2019 (7/22/19)
• 2019 FDAAA Annual Meeting - May 13, 2019 (7/22/19)
• John "Barr" Weiner, J.D. at April 9, 2019 Luncheon Speaker Series (4/29/19)
• Wiley Award and annual FDLI Meeting (4/17/19)
• FDAAA presents half-day program to the FDA Commissioner's Fellows (3/4/19)
• FDAAA Winter Celebration 2018 at Maggiano's Little Italy (12/6/18)
• FDAAA Fall Luncheon Featuring Keith Flanagan, J.D. (10/4/18)
• China FDA meets with FDAAA (6/20/18)
• Spring Fling 2018 (6/20/18)
• FDAAA Names Temple Scholarship in Memory of Jim Benson (6/13/18)
• FDAAA Announces Officers and Board Members (6/12/18)
• FDAAA Spring Luncheon Featuring Jeffrey Shuren, M.D., J.D. (4/24/18)
• Report from President (3/1/18)
• FDAAA Sponsors FDA Fellows Session (2/10/18)
• West Coast Networking Event (2/1/18)
• FDAAA's Winter Luncheon Featuring Peter Marks, M.D., Ph.D. (1/20/18)
• A Winter Celebration (12/14/17)
• Eastern Shore Informal Gathering (7/23/17)
• FDAAA Meets and Greets Current Employees (6/26/17)
• Another Successful Spring Fling (6/22/17)
• Dr. Scott Gottlieb is New FDA Commissioner (5/12/17)
• Dr. Hamburg Receives FDAAA's Wiley Award (5/11/17)
• FDAAA Briefs FDA Fellows Class on FDA History, Perspective (1/24/17)
• FDAAA Luncheon on West Coast, A Huge Success (1/18/17)
• FDA and FDAAA Refresh MOU after 13 years (12/13/16)
• FDAAA's Hail to the Chief Counsels and Their Deputies a Resounding Success (12/12/16)
• Hail to the Chief Counsels (12/09/16)
• FDAAA Midwest Inaugural Luncheon Held in Chicago (12/09/16)
• In Memorium: Ekopimo Ibia, M.D., M.P.H., MRCPCH, FWACP (Peds), FRCP (06/27/16)
• Spring Fling! (05/23/16)
• FDAAA Honors Three Leaders (05/23/16)
• FDAAA Members Are Updated on Combination Products (04/12/16)
• FDA Alumni Advisor Program a Big Success (03/25/16)
• FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices (02/20/16)
• FDAAA Conducts Seminar for FDA Fellows (01/09/16)
• Reception for Chiefs of Staff (12/10/15)
• Luncheon November 6, 2015 (11/06/15)
• FDAAA International Network visits with CFDA Officials and BioBAY Entrepreneurs (08/03/15)
• Dr. Florence Houn Receives DIA China Excellence in Service Award (08/03/15)
• FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China (08/03/15)
• FDAAA International Network hosts an "FDAAA and Friends Night" event in Shanghai (08/03/15)
• FDAAA International Network Featured at 51st Annual DIA Meeting (08/01/15)
• Andrew Bonanno Receives FDA Distinguished Alumni Award (06/29/15)
• Michael Taylor Receives FDAAA Wiley Award (06/28/15)
• FDAAA Launches New Year at Annual Meeting (04/20/15)
• FDAAA Elects New Board Members, Names Officers (04/20/15)
• FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015 (04/10/15)

Announcements

• The FDAAA wishes to Thank Dr. Fauci for his Outstanding Service to Science (#ThankyouDrFauci) (04/09/20)
• FDAAA Announces Officers and Board Members (7/22/19)
• FDAAA Annual Report - Request for Assistance (2/15/19)
• FDAAA Management and Website Enhancements (2/15/19)
• So Glad You're Back, We Appreciate You FDAers (1/28/19)
• NEW FDA Alumni Mentor Program to Begin in the Fall! (8/31/17)
• FDA Celebrates 40th Anniversary of Medical Devices Amendments (06/21/16)
• FDA Seeking "Objective" Reviewers for Grant Funding (04/19/16)
• Vacancy Announcements for Key Alumni Association Positions (12/18/15)
• FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (04/17/15)
• Opportunity: RAPS Seeks Regulatory Experts (03/10/15)
• FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner (02/05/15)

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