15th Annual FDA/AdvaMed Medical Device Statistical Issues Conference

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

Friday, May 12

8:00 am – 8:25 am	Breakfast
8:25 am – 4:00 pm	Concurrent Sessions – Therapeutic Device Track and Diagnostics Track
11:45 am- 12:45 pm	Lunch  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 am	Welcome    AdvaMed Statistical Working Group Co-Chair:  Roseann White, Edwards Life Sciences
8:30 am – 10:00 am	Statistical 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 am	Break
10:15 am – 11:45 am	Statistical 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 pm	Lunch
12:45 pm – 2:15 pm	Challenges 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 pm	Break
2:30 pm – 4:00 pm	Covariate 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 pm	Adjournment
Diagnostics Track

8:25 am – 8:30am	Welcome 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 am	Break
10:15 am – 11:45 am	Challenges 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 pm	Lunch
12:45 pm – 2:15 pm	Statistical 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 pm	Break
2:30 pm – 4:00 pm	Latest 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 pm	Adjournment

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

Keynote Speaker

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 

• Printing services for scientific posters: www.PosterSession.com 

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.