Events

15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference

May 11, 2023 – May 12, 2023

Register now

This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations.

15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference

May 11, 2023 – May 12, 2023

Register now

  1. Overview
  2. Agenda
  3. Speakers
  4. Pricing and Accommodations
  5. Poster Session
  6. Why Attend?

15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference

May 11, 2023 – May 12, 2023

Register now

Overview

We are pleased to invite you this year to Washington, D.C. for the 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference on May 11-12, 2023. The conference will highlight promoting clinical trial innovations and advancing regulatory statistical science for diagnostics, therapeutics and other medical devices. A forum for collaboration between industry, academia and FDA, the conference will address the important mission of educating medical device manufacturers on the recent and future developments of statistical methodology and practice in the evaluation of safe and effective products.

Conference Topics will include:

  • Dialogue with the New FDA/CDRH Biostatistics Division Director
  • External Evidence in the Evaluation of Medical Devices
  • Methods for AI/Machine Learning as a Medical Device  
  • The Analytical Bridging Study or Migration Study and its Study Design, Acceptance Criteria, and Statistical Analysis 
  • Challenges in Validating Device Output  
  • Statistical Issues/Challenges in the Evaluation of Digital Pathology Devices 
  • Latest Standards Revisions and Guidance Documents in Analytical Studies, and the Applicability to the Newest Technology, such as Next-Generation Sequencing Test  
  • Complex Innovative Design in Medical Devices.
  • Challenges with the Pandemic – What Now? 
  • Subgroup Analysis  

Download the full agenda with session descriptions here.

Schedule reflects Eastern Time

Thursday, May 11th
 8:45 am – 9:15 am Registration Check-In and Breakfast  
9:15 am – 9:20 am Welcome and Introduction of Keynote Speaker
Opening remarks from FDA/AdvaMed Conference Steering Committee Co-Chairs: Joanne Lin, Illumina, Inc. and Lu (Laura) Hong, FDA

Gregory Alexander, Division Director, Division of Clinical Evidence and Analysis 2 (Biostatistics), FDA 
9:20 am- 10:00 amKeynote Address
Jennifer Jones-McMeans, Ph.D., Divisional Vice President,
Global Clinical Affairs, Abbott Vascular, Inc.
10:00 am – 10:30 amBreak  
10:30 am – 12:00 pmExternal Evidence in the Evaluation of Medical Devices
Co-organizers:
Tianyu Bai, FDA
Saryet Kucukemiroglu, FDA
Feng Tang, Medtronic  
Xiao Yu, Edwards Lifesciences

Speakers:
Bo Lu, The Ohio State University
Lilly Yue, FDA
Zengri Wang, Medtronic
12:00 pm – 1:30 pmLunch
 1:30 pm – 3:00 pmMethods of AI/Machine Learning for Medical Devices
Co-organizers:
Mourad Atlas, FDA
Feiming Chen, FDA
Charles Gordon, Livanova
Jingye Wang, Illumina, Inc.

Speakers:
Daniel Goldenholz, Beth Israel Deaconess Medical Center
Vinay Pai, FDA
Frank Samuelson, FDA
3:00 pm – 3:30 pmBreak
3:30 pm – 5:00 pmDialogue with the New FDA/CDRH Biostatistics Division
Director, Dr. Gregory Alexander 
Co-organizers:
Cristiana Mayer, Johnson & Johnson Vision
Vicki Petrides, Abbott, Inc. 
Arianna Simonetti, FDA
Jack Zhou, FDA

Speakers:
Gregory Alexander, FDA
Hope Knuckles, Abbott, Inc.
Xiao-Yu Song, Johnson & Johnson Vision
Yun-Ling Xu, FDA
5:00 pm – 5:05 pmDay 1 Adjournment and Announcement of Poster Session Winner
AdvaMed Statistical Working Group Co-Chairs:  
Vicki Petrides, Abbott, Inc. and Roseann White, Edwards Life Sciences 
5:05 pm – 6:00 pmPoster Session and Networking Reception
Friday, May 12
8:00 am – 8:25 amBreakfast
8:25 am – 4:00 pm Concurrent Sessions – Therapeutic Device Track and Diagnostics Track   
11:45 am- 12:45 pmLunch 
Remarks from FDA/AdvaMed Conference Steering Committee Co-Chairs:
Joanne Lin, Illumina, Inc.
Lu (Laura) Hong, FDA
Therapeutic Device Track
8:25 am – 8:30 amWelcome   
AdvaMed Statistical Working Group Co-Chair: 
Roseann White, Edwards Life Sciences 
8:30 am – 10:00 amStatistical Issues in Designing Innovative Adaptive Clinical Trials 
Co-organizers:
Kan Shang, Edwards Lifesciences
Yu-te Wu, FDA

Speakers:
Manuela Buzoianu, FDA
Peter Lam, Boston Scientific
Bonnie Zhang, Edwards Lifesciences
10:00 am – 10:15 amBreak  
10:15 am – 11:45 amStatistical Considerations for Utilizing RWD/RWE in Complex Study Designs
Co-organizers:
Feiran Jiao, FDA
Jim Lesko, DePuy Synthes

Speakers:
Paul Coplan, Johnson & Johnson
Amy Crawford, Berry Consultants, LLC
Nelson Lu, FDA
11:45 am – 12:45 pmLunch   
12:45 pm – 2:15 pmChallenges with the Pandemic – What Now?
Co-organizers:
Rhoda Muse, FDA
Roseann White, Edwards Lifesciences  

Speakers:
Joe Marion, Berry Consultants, LLC
Robin Sutherland, Onxeo S.A.
Bram Zuckerman, FDA
2:15 pm – 2:30 pmBreak
2:30 pm – 4:00 pmCovariate Adjustment and Subgroup Analysis 
Co-organizers:
Adrijo Chakraborty, FDA
Elmira Torabzadeh, Illumina, Inc.

Speakers:
Jim Lesko, DePuy Synthes
Michael Rosenblum, Johns Hopkins
Daniel Rubin, CDER/FDA
4:00 pmAdjournment
Diagnostics Track
8:25 am – 8:30amWelcome
AdvaMed Statistical Working Group Co-Chair: 
Vicki Petrides, Abbott, Inc. 
8:30 am – 10:00 am The Analytical Bridging Study or Migration Study and Its Study Design, Acceptance Criteria, and Statistical Analysis
Co-organizers:
Kai Qu, FDA
Bonnie Zhang, Edwards Lifesciences

Speakers:
Shuguang Huang, Stat4ward
Michelle Sonnenberg, Illumina, Inc.
Changhong Song, FDA
Wei Wang, FDA
10:00 am– 10:15 amBreak
10:15 am – 11:45 amChallenges in Validating Device Output
Co-organizers:
Marcus Riley-Green, Abbott, Inc.
Ken Wang, FDA

Speakers:
Chongzhi Di, Fred Hutch
Tim Dunn, Abbott, Inc.
Elaine Tang, FDA
11:45 am – 12:45 pmLunch
12:45 pm – 2:15 pmStatistical Issues/Challenges in the Evaluation of Digital Pathology Devices
Co-organizers:
Mark Holland, Beckman Coulter
Jihye Park, FDA

Speakers:
Weijie Chen, FDA
Robert Magari, Beckman Coulter
Dandan Xu, FDA
2:15 pm – 2:30 pmBreak
2:30 pm – 4:00 pmLatest Standards Revisions and Guidance Documents in Analytical Studies, and the Applicability to the Newest
Technology, such as Next-Generation Sequencing Test

Co-organizers:
Ge Feng, FDA
Linye Song (CBER), FDA
Michelle Sonnenberg, Illumina Inc.

Speakers:
Li Guan, Illumina, Inc.
Mark Holland, Beckman Coulter
Marina Kondratovich, FDA 
Ho-Hsiang Wu, CBER/FDA
4:00 pmAdjournment

View the FDA, industry, and academic speakers that will guide you through the latest and future statistical trends.

Keynote Speaker

Jennifer Jones-McMeans Headshot

Jennifer Jones-McMeans, Ph.D.
Divisional Vice President, Global Clinical Affairs, Abbott Vascular, Inc.

Jennifer Jones-McMeans, PhD, is the Divisional Vice President of Global Clinical Affairs for Abbott’s vascular business based in Santa Clara, California. Since joining Abbott as a clinical research scientist more than 16 years ago, Dr. Jones-McMeans has worked on gaining approval of numerous vascular devices, in the USA and around the world. Through her work, Dr. Jones McMeans has become one of the leading experts in clinical trial design strategy for vascular devices. Jones-McMeans’ journey began while working on her PhD at the University of Maryland, College Park, where her early research focused on evaluating the differences in genes and biomarkers between African Americans and Caucasians who were prehypertensive when they were put on an exercise regimen. As a post-doctoral fellow in the Division of Hypertension at University of Texas Southwestern Medical Center focused on clinical trials evaluating anti-hypertensive therapies, she also worked on the Barbershop Hypertension Program, training barbers to measure the blood pressure of their male customers and connecting those with high blood pressure with trusted contacts in the healthcare community.

FDA Speakers

Gregory Alexander, Director, Division of Biostatistics, FDA

Gregory Alexander, Director, Division of Biostatistics, FDA

Manuela Buzoianu, Mathematical Statistician, FDA

Manuela Buzoianu, Mathematical Statistician, FDA

Weijie Chen, Physicist, FDA

Weijie Chen, Physicist, FDA

Marina Kondratovich Headshot

Marina Kondratovich, Associate Director for Clinical Studies, FDA

Nelson Lu, Acting Assistant Director for Biostatistics, FDA

Nelson Lu, Acting Assistant Director for Biostatistics, FDA

Vinay Pai, Digital Health Specialist, FDA

Vinay Pai, Digital Health Specialist, FDA

Daniel Rubin,  CDER/FDA

Daniel Rubin, CDER/FDA

Frank Samuelson Headshot

Frank Samuelson, Physicist, FDA

Changhong Song Headshot

Changhong Song, Lead Mathematical Statistician, FDA

Elaine Tang, Statistical Reviewer,  FDA

Elaine Tang, Statistical Reviewer, FDA

Wei Wang Headshot

Wei Wang, Mathematical Statistician, FDA

Ho-Hsiang Wu, FDA

Ho-Hsiang Wu, FDA

Dandan Xu, FDA

Dandan Xu, FDA

Yun-Ling Xu, Deputy Division Director, Division of Biostatistics, FDA

Yun-Ling Xu, Deputy Division Director, Division of Biostatistics, FDA

Lilly Yue Headshot

Lilly Yue, Deputy Division Director, FDA

Bram Zuckerman, Office Director, Office of Cardiovascular Devices, FDA

Bram Zuckerman, Office Director, Office of Cardiovascular Devices, FDA

Industry Speakers

Paul Coplan Headshot

Paul Coplan, VP and Head, Medical Device Epidemiology & Real World Data Sciences, Johnson & Johnson

Amy Crawford Headshot

Amy Crawford, Statistical Scientist, Berry Consultants, LLC

Tim Dunn Headshot

Tim Dunn, Director, Clinical and Computational Research, Abbot Inc.

Li Guan Headshot

Li Guan, Staff Biostatistician, Illumina, Inc.

Mark Holland Headshot

Mark Holland, Director Biostatistics, Beckman Coulter

Shuguang Huang Headshot

Shuguang Huang, Chief Scientific Officer, Stat4ward

Hope Knuckles, Director, Biostatistics and Data Management, Abbott, Inc.

Hope Knuckles, Director, Biostatistics and Data Management, Abbott, Inc.

Peter Lam Headshot

Peter Lam, Biostatistics Senior Fellow, Boston Scientific

Jim Lesko Headshot

Jim Lesko, Director of Biostatistics and Clinical Data Management, DePuy Synthes

Robert Magari Headshot

Robert Magari, Senior Director of Biostatistics & Data Management, Beckman Coulter

Joe Marion, Senior Statistical Scientist, Berry Consultants, LLC

Joe Marion, Senior Statistical Scientist, Berry Consultants, LLC

Xiao-Yu Song Headshot

Xiao-Yu Song, Worldwide Vice President, Global Head of Research & Development, Johnson & Johnson Vision

Michella Sonnenberg Headshot

Michelle Sonnenberg, Staff Biostatistician, Illumina Inc.

Robin Sutherland Headshot

Robin Sutherland, Former VP, Clinical Operations & HR, Onxeo, S.A.

Zengri Wang Headshot

Zengri Wang, Biostatistics Director, Medtronic

Bonnie Zhang Headshot

Bonnie Zhang, VP of Biometrics, Edwards LifeSciences

Academic Speakers

Chongzhi Di Headshot

Chongzhi Di, Professor of Biostatistics, Fred Hutch

Daniel Goldenholz Headshot

Daniel Goldenholz, Assistant Professor of Neurology, Beth Israel Deaconess Medical Center

Bo Lu Headshot

Bo Lu, Professor of Biostatistics, The Ohio State University

Michael Rosenblum, Professor, Biostatistics, Johns Hopkins

Michael Rosenblum, Professor, Biostatistics, Johns Hopkins

Registration Pricing

AdvaMed Member Companies: $1495.00

AdvaMed Accel Member Companies: $895.00

Non-Members: $1795.00

Government/Academic/Nonprofit: $300.00

Discounts

If three or more register from your company please use this 10% off discount code: GROUP10    

*Please note the group discount must be applied at the time of purchase.

Hotel Information

GRAND HYATT WASHINGTON

1000 H Street NW, Washington, DC 20001

AdvaMed’s housing block is now closed.

Questions? Contact [email protected].

Poster Session

POSTER SUBMISSIONS DUE WEDNESDAY, APRIL 26 

Submit posters to [email protected]. 

Submitted posters will be on display during the networking reception at the conclusion of Day 1 of 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference.  Posters will be judged by the poster committee of industry and FDA, and the authors of the winning poster will receive a complimentary registration for the 2024 Conference. Posters will be judged on statistical innovation, applicability to medical devices and diagnostics, clarity of presentation, effective use of graphics, appropriate example(s) used, and overall impression. 

Suggested Poster Topics: 

  • Submissions related to workshop session topics 
  • Other topics relevant to therapeutic and diagnostic devices are also welcome and encouraged 
  • Speakers are welcome to submit posters that expand on their session topics 

Requirements: 

  • Authors must be registered attendees of the workshop 
  • Multiple authors are allowed per submission 
  • If more than one author, the presenting author should be clearly indicated 
  • One presenting author per poster 
  • Presenting author may present only one poster, but may be a co-author on other posters 

Details: 

  • Posters due April 26, 2023 at 11:59 p.m. EST. Submit posters via email to [email protected] 
  • Submit an electronic version of the poster as a PDF file 
  • Authors are responsible for bringing the paper (printed) version of the poster to the workshop 
  • 4 ft. x 8 ft. (122 cm x 244 cm) bulletin board will be provided to display posters. Presenters will not be supplied with audiovisual equipment or electricity 
  • Posters will be on display and poster authors will be present in person to discuss their posters during the evening reception of Day 1 of the event  
  • Posters must be given to AdvaMed staff the morning of Day 1 for set up  
  • Authors should remain in the vicinity of the bulletin board for the duration of the session (60 minutes) to answer questions 
  • An award will be given to the presenting author for the winning poster, as judged by the poster committee of industry and FDA 
  • The award for the 2023 competition is waived registration to the 2024 FDA/AdvaMed conference 
  • Posters will be judged on statistical innovation, applicability to medical devices and diagnostics, clarity of presentation, effective use of graphics, appropriate example(s) used, and overall impression

Traditional Poster Tips 

A poster session is a presentation in which materials such as maps, photographs, graphs, charts, and/or tables are posted on a display board along with brief textual summaries of your work. Ideally, a well-constructed poster will be self-explanatory. Successful poster presentations are those that achieve both coverage and clarity. 

Coverage:  In addition to title/author and abstract, most successful posters provide brief statements of introduction, method, subjects, procedure, results, and conclusions. Ask yourself: 

  • Have you provided all the obvious information? 
  • Will a casual observer walk away understanding your major findings after a quick perusal of your material? 
  • Will a more careful reader learn enough to ask informed questions? 
  • What would you need to know if you were viewing this material for the first time? 

Clarity:  People attending a poster session are free to move about from poster to poster and often must view a poster from a distance, making it difficult to read excessive text and small fonts. We recommend you: 

  • Use large fonts and limit text to essential information. Place your major points in the poster and have the nonessential, but interesting, sidelights for informal discussion. 
  • Keep content simple and communicate clearly. 
  • Consider whether the sequence of information is evident. Indicate the ordering of your material with numbers, letters, or arrows when necessary. 
  • “A picture’s worth a thousand words.” Imaginative use of captioned illustrations, photographs, graphs, other types of visually appealing material is an extremely effective mode of communication in a poster presentation. 
  • Make your final conclusions or summary a concise statement of your most important findings. 

People attending a poster session are free to move from poster to poster, and there is not time to read excessive text. Text should be limited to four or five pages of double-spaced, 16–20 point text. This will allow lettering to be read from several feet away. Do not mount materials on heavy board, because these may be difficult to position on the poster board. Be sure to provide clear labels for each section of your presentation. 

Resources for Poster Creation 

For questions, please email Anita Nosratieh.

Why Should You Attend?

Attending the 15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference is a surefire way to learn crucial information to keep you ahead of the rapid industry changes. Watch the video below of a past session from 2022 to see what you can expect to learn during the Conference. Afterwards, use the following justification letter template to help you make the case of why you should attend the Conference.

2022 Session Recordings

Session One: Developments in Analytical Studies (CLSI, Other guidelines)

This session discusses CLSI guidance such as EP12 and summarize current recommended study designs for Sample Community Study/Contrived Sample Functional Characterization Study. 

Justification Letter Template

Do you need your supervisor’s endorsement to participate in the upcoming FDA/AdvaMed Medical Device Statistical Issues Conference? We’ve developed a request template which breaks down the reasons your participation in this event is critical to your future success. Populate the template with relevant information to explain your purpose for attending the conference. Download the template here.

Questions? Contact [email protected] for additional support.

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