The 2009 FDA/Industry Workshop is now over.

Thank you all for a great event, with record attendance. We appreciate the help from all volunteers, organizers, speakers, course instructors and of course conference attendees.

See you next year!

Tammy and Carmen

Updates for all conference participants

The workshop is enrolling quickly. We have a few spots left for conference participants as well as some spots left in short courses. If you haven't registered, please do so soon to avoid disappointment. Note that all reserved hotel rooms are now fully booked. Alternative hotels within reasonable distance are now posted on-line. Please visit the official FDA/Industry 2009 website for more information:
http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=main

Tammy and Carmen

**September Update and Instructions for FDA/Industry Statistics Workshop Session Chairs/Organizers**

We hope you are just as excited about the 2009 FDA/Industry workshop to be held on September 23-25 of this month. A few odds and ends as we get ready for this exciting event:

1. Speakers and attending organizers must be registered at the conference, if you have not already done so, please register using this link: http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=registration. At this point, all reserved hotel rooms are fully booked. However, alternative hotels within reasonable distance of the conference are listed here: http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=hotel
   
2. Instructions to upload the presentation will be forthcoming from our ASA colleague in the next couple of days. Please watch out for them. This will allow registered conference participants to access and print out this material ahead of time. We ask that session chair to also keep a copy of all presentations from your session on a USB drive as a backup on the day of the conference.
   
3. Limited spaces are still available in some short courses. Please sign up now if you are interested. The short courses are a great opportunity to keep up with cutting edge statistical methods taught in a way relevant to statisticians in food and health industry and a good value at $100 per course.
   
4. A print program is being finalized and will be provided the day of the conference with program information. Please visit the FDA industry website and review the on-line program for accuracy and send any corrections to Kathleen Wert at the ASA (kathleen@amstat.org) as soon as possible.

We cannot thank you enough for your help and support. The program looks stellar and together we will make the 2009 FDA/Industry workshop the best year yet!

Tammy and Carmen

Workshop Registration Open

FDA/Industry Workshop 2009 now open for registration.

See http://www.amstat.org/meetings/fdaworkshop

for
- Online registration
- Conference Hotel
- List of short courses
- Preliminary program
- New Round Table format

As usual let us know at fdaindustry2009@gmail.com if you have any questions.

Workshop Title/Theme Naming Competition

Sessions have been identified for the 2009 FDA/Industry Statistics Workshop and included in a previous blog post. The three selected plenary sessions are:

1) Future directions in planning safety analysis and risk management
2) Regulatory Issues in Global Harmonization of Clinical Studies
3) World is (almost) Flat: Statistical Considerations as Clinical Development goes Global

Based on this we are ready to open up the Workshop Name/Theme competition!

Previous Session names have included:
2007 - Translating Innovation into Practice through Effective Partnerships
2006 - Statistics in the FDA and Industry: Past, Present, and Future
2005 - Safety and the Critical Path: Keys to Successful Development of Medical Products
2004 - Science, Statistics and Decisions: The Right Questions, The Best Answers
2003 - Statistics: From Theory to Regulatory Acceptance
2002 - The Information Revolution - Who's Mining the Store?
2000 - Statistically Sound Decision Making
1999 - Statistical Issues in the New Millennium
1998 - Current Statistical Issues, Drugs, Biologicals, Medical Devices, Risk Assessment
1997 - Working Together to Expedite the Development of New Pharmaceutical Products
1996 - Analysis and Collection of Adverse Event Data

The competition for naming this year's workshop will occur here, on the FDA/Industry workshop blog.

To be considered for this competition, please leave a "comment" on the blog with your proposed WORKSHOP TITLE/THEME as well as your NAME (and hopefully your contact information or at least your professional affiliation so we can give you credit and your prize at the workshop in September:-).

This competition will be open until April 15th. Please note: in cases of multiplicity issues (i.e., identical suggestions from multiple individuals), the first person who proposes the name/theme/ title within the comment section of this blog post.

Good Luck!

Tammy and Carmen

Announcement: Sessions Selected for Inclusion in the 2009 FDA/Industry Statistics Workshop

The following sessions* (presented in no particular order) have been selected for inclusion in the 2009 FDA/Industry Statistics Workshop. Session organizers please see blog post on "Timeline for Session Organizers"

Plenary Sessions (90 minutes):
1. Future Directions in Planning Safety Analysis and Risk Management
2. Regulatory Issues in Global Harmonization of Clinical Studies
3. The World is (almost) Flat: Statistical Considerations as Clinical Development goes Global

Concurrent Sessions (75 minutes):
1. PK/PD Model-based Drug Development
2. Adaptive Design – Theory and Methods
3. Adaptive Design: Applications and Examples
4. Longitudinal Analysis, Missing Data and Assessment of Durability of Treatment Effect
5. Effective Use of Interim/Futility Analysis: A Case Study and Regulatory Considerations
6. Evaluation of Efficacy and Safety in the Presence of Subgroup Heterogeneity
7. Survival Analysis-Issues related to Follow-up in Time to Event Endpoints
8. Bayesian Methods throughout the Lifecycle of Medical Products
9. Multiplicity Adjustment in Clinical Trials with Multiple (Primary and Secondary) Endpoints: Issues and Concerns
10. Meta Analysis with a Focus on Safety
11. Design and Analysis for Non-InferiorityTrials – A Practical Perspective
12. Biomarkers in Drug-diagnositic Co-development
13. Endpoint Issues in Oncology
14. Recent Issues in CNS Drug Development
15. Views on Integrated Summary of Effectiveness and Integrated Summary of Safety: From FDA and Industry Perspective
16. Effective Communication and Collaboration between FDA and Industry Statisticians in the Regulatory environment
17. Quantitative Approaches to Decision Making in Clinical Development
18. Design Issues in Clinical Trials: From Randomization to Assay Sensitivity
19. Food Safety and Validation method
20. Veterinary Medicine I – Design and Analysis
21. Veterinary Medicine II – Issues in Target Animal Safety Studies
22. Medical Devices- Aspects of missing data unique to medical device trials
23. Post-Approval Issues for Diagnostic Devices
24. Statistical Issues in Vaccine Clinical Trials

Special Interest Forum : Avoiding Type III Errors in CMC Statistical Methods

* Program is preliminary and subjected to change

Timeline for session organizers

April 15th —Speakers confirmed. (Note: Session organizers must ensure speakers know that they will be responsible for paying for ALL conference EXPENSES including: registration, hotel, travel)

Session Organizer primary contact to provide a single email to FDAIndustry2009@gmail.com with order of presentation, the timing (length of presentation), speakers’ complete contact information (e-mail, phone and professional affiliation) .

April 17th — Deadline for submission of proposals for Roundtable Luncheon Discussion to FDAIndusty2009Lunch@gmail.com

May 11th — Speakers provide 100-200 word (5-10 Sentence, 1 paragraph) abstract related to their specific topic to session organizers

May 11th — Finalized Abstract due to FDAIndustry2009@gmail.com. (This is the updated version of the abstract submitted on Feb 27). Session Organizer primary contact to provide a single finalized comprehensive session abstract consisting of
· Finalized Title of the session
· Names of all organizers
· Brief session description (~1 paragraph to be included in workshop brochure),
· For each presentation, please include title, abstract (5-10 sentences, 1 paragraph), length of presentation, Speakers’ contact info into the abstract

June 1st — Workshop Registration Opens

Early June — Telecon between Session organizer/chairs and All Session Speakers. Telecon organized by session organizers with all speakers/discussants for introductions and to reduce any presentation overlap.

August 10th — Speakers provide draft presentations to session organizers

August 14th — Deadline for REGISTRATION of speakers, session organizers, short course instructors, roundtable luncheon discussants

August 18th — Speakers provide finalized presentation and Brief Biographical Sketch (for introductions during the workshop) to session organizer/chair

August 20th — Session Organizer primary contact to provide a single email attaching all speakers finalized presentation to FDAIndustry2009@gmail.com

Late Aug/Early Sept — Telecon between Session organizer/chairs and All Speakers in session.
The final teleconference with session speakers, organizing committee/session chairs will provide last minute updates about conference and ensure all tasks are delegated and timing is understood.

Sept 23-25th — Short Course/Workshop from 8 a.m. -5 p.m. Capitol Hilton