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

Accepting Roundtable Luncheon Discussion Proposals

We hope you are planning to attend the FDA/Industry Statistics Workshop September 23-25th, 2009 at the Capitol Hilton in Washington DC.

To ensure the FDA/Industry Statistics Workshop is lively, productive and useful to all attendees, there will be roundtable luncheon discussions on both days of the workshop that have plenary/concurrent sessions (Thursday and Friday September 24-25th).

In a change from other years, it is envisioned the roundtable luncheons will be intimate discussions led by many volunteers. Thus, we are currently seeking interested volunteers.

The deadline for submission of Roundtable Discussion proposals for the 2009 FDA/Industry Statistics Workshop is April 17th. (Please note for those of you who might be like to be paired with a co-discussant an early response deadline of April 5 is needed for participants who wish to be matched with co-leaders from FDA or Industry).

If you have already submitted a proposal to be a roundtable discussion leader, THANK YOU.

If not, we invite you to participate as a roundtable luncheon discussion leader in 2009. This year we are attempting to pair an industry and a FDA statistician as co-leaders at the same table; however both co-leaders can be from industry, or both from FDA, if that is your preference. This year the participants will receive a box lunch and then join a round table group at the mid-day break during both days of the workshop.

Tables of 6-8 persons will be located in zones with similar discussion topics spread out over 7-12 different rooms. Our hope is to have a wide variety of discussion topics led by many different people.

Are you ready to consider this volunteer opportunity?

The Round Table Discussion Table proposal should utilize the following template when sending an e-mail to the roundtable luncheon discussion core committee (Diane Sweeney and Anna Nevius). In this e-mail please include information about the proposal:

EXAMPLE e-mail, expressing interest in volunteering/proposing a Roundtable Luncheon Discussion.


To: FDAIndustry2009Lunch (at) gmail.com (NOTE: use @ symbol when creating e-mail)
CC: Yourself (always a smart idea!)
Subject: Roundtable Discussion Proposal: Your NAME, Proposed TOPIC/TITLE


Indicate Day or Day(s) preferred.
Thursday ( ) and/or Friday ( )

Roundtable Luncheon Discussion Proposal
Title/Topic:
Discussant Leader Name:
e-mail:
phone:
Professional Affiliation:


As you think about volunteering we have the following suggestions for leading an effective discussion--think about 5 questions (and your responses) to jump start or lead the discussion. You do not need to be a well known leader in the field; the idea is to generate exchange of ideas, discussion and to network. In fact we suggest that you allow at least half of the lunch break for networking.

For those of you hesitant to commit to leading a roundtable luncheon discussion solo, we will also endeavor to connect you with other discussion leaders with similar topics in the same zones in the weeks prior to the workshop or even pair you with person with a similar topic (if you respond by April 5th).

Each session included in the conference has contributed two round table discussion leaders, but many more are needed. Thus of course please feel free to distribute this blogpost to other colleagues who may be interested in taking on this rewarding role as a Roundtable Luncheon Discussant Leader.

Sessions selected on Jan 30 Meeting

Update from Jan 30 Organizational meeting:

• 35 sessions were voted in for further considerations.
• Session organizers were identified.
• Each group of session organizers will submit a formal abstact (due Feb 27) to steering committee for final session selection.

If you have a talk you'd like to submit for consideration in any of these sessions, please contact us at fdaindustry2009@gmail.com and we will forward it to the appropriate session organizers

Sessions selected based on a vote:

1. PK-PD Analysis
2. Overview of Toxicology/Thorough QTC
3. Adaptive Design - Theory and Methods
4. Adaptive Design-Examples
5. Longitudinal Analysis and missing data
6. Future Directions in planning safety analysis and risk management
7. Quantitative Risk /Benefit Assessment
8. Global Harmonization -Regulatory
9. Global Harmonization -Statistical
10. Stat issues in phase I designs
11. Design Issues in Clinical Trials
12. Interim Analysis Futility Analyisis
13. Subgroup Heterogeneity/Adj of covariates
14. Survival Analysis
15. Stats Modeling , Simulation for decision Making
16. Bayesian
17. Multiplicities/Multiple Comparison
18. Meta Analysis
19. Non-Inferiority
20. Quality of Clinical Programs- Designs/Methodological/Robustness /Data
21. Biomarker/Genomics/Microarray
22. Open-source software/global platform
23. Oncology I - Issues
24. Oncology II. - Designs and Analysis
25. Psychiatric Clinical Trials CNS/Insomia
26. ICH Guidelines/ISS, ISE Anallysis Plans
27. Communication /Stats Consulting
28. CMC I
29. CMC II
30. Food
31. Veterinary Medicines I - Design and Analysis
32. Veterinary Medicines II - Issues
33. Devices I - Medical
34. Devices II - Diagnostics
35. Vaccines

Abstract Template

Please submit abstract in this format to:
FDAIndustry2009@gmail.com
by Feb 27, 2009.

A "Word" template will be mailed to all session organizers.

Sessions to be discussed on Jan 30

With the help of the steering committee, we have reduced the redundancy in the list of sessions suggested. The following 41 candidate sessions will be discussed at the Organizational meeting on Jan 30. Of the 41 sessions listed below, approximately 30 sessions will be selected based on a vote at the meeting.

A Pre-clinical/Tox
1 PK-PD Analysis
2 Toxicology

B Adaptive Designs
3 Adaptive Design - Theory and Methods
4 Adaptive Design - Applications and Examples
5 Adaptive Design - Other Issues (interactions between FDA/Industry)

C Safety
6 Future directions in planning safety analysis and risk management
7 Quantitative risk/benefit assessment
8 DMC and Safety Monitoring
9Thorough QTc study design and analysis

D Global Trials
10 Regulatory Issues in Global Harmonization
11 Statistical Issues in Global Harmonization

E Phase I Trials
12 Statistical and Design Issues in Phase I trial (cross over, blinding)

F Statistical Issues in Clinical Trials
13 Design Issues in Clinical Trials: Placebo/Historical Control/ Randomization
14 Interim Analysis/Futility analysis
15 Subgroup Analysis/Heterogeneity /Adjusting for Covariate
16 Survival Analysis
17 Statistical Modeling/ Simulation for Decision making

G Longitudinal Data Analysis and Missing Data
18 Longitudinal Analysis, Missing Data and Durability

H Bayesian
19 Bayesian Analysis and Designs

I Multiplicities/Multiple Comparison
20 Multiplicities/Multiple Comparison

J Meta Analysis
21 Meta Analysis

K Non-inferiority Trials
22 Non-Inferiority Trials - Designs and Issues

L Quality of Clinical Program
23 Quality of Clinical Programs- Designs/Methodological/Robustness

M Genomics/Biomarkers
24 Biomarker Evaluation
25 Genomics

N Technical/Computations/Graphics
26 Open-source software/global platform

O Therapeutic Area Specific Issues
27 Oncology I - Issues
28 Oncology II. - Designs and Analysis
29 Psychiatric Clinical Trials/ CNS/Insomnia

P Regulatory Issues
30 ICH-E9/ISS/ISE Analysis plans
31 Communication between FDA/Industry statisticians

Q Career Development
32 Statistical Consulting

R Patients Reported Outcome
33 Patients Reported Outcome

S Chemistry, Manufacturing and Control (CMC)
34 CMC I
35 CMC II

T Food Safety
36 Food

U Veterinarian Medicine
37 Veterinary Medicines I - Design and Analysis
38 Veterinary Medicines II - Issues

V Devices
39 Devices I - Medical
40 Devices II - Diagnostics

W Vaccines
41 Vaccines

Agenda of Friday January 30th Meeting

Agenda
Organizational Pre-Meeting-
FDA/Industry Statistics Workshop 2009
The Universities at Shady Grove
January 30, 2009

8:00 a.m. to 4:30 p.m.

8:00 a.m. ...... Continental breakfast available
8:30 ............... Logistics of Shady Grove University
.......................... Introductions
9:15 ................ 2009 FDA/Industry Statistics Workshop Brief Update
9:45 ...................... 15 minute Break
10:00 .............. Workshop logistics
10:15 ............... Brief Discussion Short Course
10:45 ............... Wrap Up Short Course Discussion
11:00 ............... Brief Discussion Session topics
11:45 ............... Description of voting mechanism

12:00 noon ................ LUNCH & VOTE

1:15 p.m. ....... Presentation of Top Selection of Topics/Sessions
1:30 ............... Session logistics
1:45 ............... Review of Workshop themes and theme selection
2:00 ............... Creation of session committee’s (chairs/organizers)
2:30 .......................... 15 Minute Stretch Break
2:45 ................ Summary of Expectations:

..............................Reminder of Roles & Responsibilities
..............................Break out
3:45 ............... Summary of Meeting
................................Reminder of Tasks
................................Timelines
4:00................ Depart

Meeting held at: The Universities at Shady Grove Conference Center
Address: 9630 Gudelsky Drive Rockville, MD 20850
Phone: 301.738.6059
Website: http://www.shadygrove.umd.edu/

Reminder to RSVP to the FDAIndustry Organizational Meeting

If you intend to attend the organizational meeting, please RSVP to FDAIndustry2009@gmail.com

In this e-mail please indicate your meal preference (meat-chicken/vegetarian) as well as your phone number and professional affiliation (particularly if it not obvious).

We look forward to seeing you on Jan 30, 2009.

Additionally updates will be posted during the next 2 weeks, so please keep checking back on this blog!