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
Sunday, September 27, 2009
Wednesday, September 2, 2009
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
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:
- 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
- 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.
- 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.
- 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
Monday, June 8, 2009
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.
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.
Thursday, March 26, 2009
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
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
Wednesday, March 25, 2009
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
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.
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.
Tuesday, February 10, 2009
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:- PK-PD Analysis
- Overview of Toxicology/Thorough QTC
- Adaptive Design - Theory and Methods
- Adaptive Design-Examples
- Longitudinal Analysis and missing data
- Future Directions in planning safety analysis and risk management
- Quantitative Risk /Benefit Assessment
- Global Harmonization -Regulatory
- Global Harmonization -Statistical
- Stat issues in phase I designs
- Design Issues in Clinical Trials
- Interim Analysis Futility Analyisis
- Subgroup Heterogeneity/Adj of covariates
- Survival Analysis
- Stats Modeling , Simulation for decision Making
- Bayesian
- Multiplicities/Multiple Comparison
- Meta Analysis
- Non-Inferiority
- Quality of Clinical Programs- Designs/Methodological/Robustness /Data
- Biomarker/Genomics/Microarray
- Open-source software/global platform
- Oncology I - Issues
- Oncology II. - Designs and Analysis
- Psychiatric Clinical Trials CNS/Insomia
- ICH Guidelines/ISS, ISE Anallysis Plans
- Communication /Stats Consulting
- CMC I
- CMC II
- Food
- Veterinary Medicines I - Design and Analysis
- Veterinary Medicines II - Issues
- Devices I - Medical
- Devices II - Diagnostics
- Vaccines
Sunday, February 1, 2009
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.
FDAIndustry2009@gmail.com
by Feb 27, 2009.
A "Word" template will be mailed to all session organizers.
Monday, January 26, 2009
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
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
Saturday, January 24, 2009
Agenda of Friday January 30th Meeting
Agenda
Organizational Pre-Meeting-
FDA/Industry Statistics Workshop 2009
The Universities at Shady Grove
January 30, 2009
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
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
..............................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/
Address: 9630 Gudelsky Drive Rockville, MD 20850
Phone: 301.738.6059
Website: http://www.shadygrove.umd.edu/
Friday, January 16, 2009
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!
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!
Thursday, January 15, 2009
Jan 15 - Deadline for submission of courses/sessions
Thank you for your interesting suggestions for courses and sessions. We have received over 100 session and 20 course ideas!
The lists of suggested sessions and courses are posted below. If you have made a suggestion but do not see it posted, please drop Tammy/Carmen a note at FDAIndustry2009@gmail.com. In the coming weeks, to prepare for the January 30th organization meeting, we will be consulting with our steering committee to better organize the ideas.
Please come back and check often for updates.
The lists of suggested sessions and courses are posted below. If you have made a suggestion but do not see it posted, please drop Tammy/Carmen a note at FDAIndustry2009@gmail.com. In the coming weeks, to prepare for the January 30th organization meeting, we will be consulting with our steering committee to better organize the ideas.
Please come back and check often for updates.
Also, a quick reminder that all conference correspondences should be directed to our conference e-address: FDAIndustry2009@gmail.com, instead of our work emails. Tammy and I have both been put in e-jail for the volume of emails we've received. This will also ensure that your emails reach us safely.
Submitted Session Proposals (as of Jan 15th)
A. Pre-clinical/Tox
- Individualized medicines? Role of PK-PD analysis
- Overview of Toxicology (Preclinical)
- Using PK-PD modeling to support selection of First-In-Human dose
B. Adaptive Designs
- Adaptive Designs - Implementing a Bayesian Outcome
- Recent Development in Adaptive Design
- Bayesian Adaptive Designs
- Unconditional use of Conditional Power
- Adaptive Group Sequential Designs
- Adaptive Design in practice - Successful implemetationof early/late stage AD
- Case Studies in Adaptive Design
- Adaptive Dose Ranging Studies
- Non-proportional Hazards, Adaptive Design, Group-Sequential Design
C. Analysis of Safety Data
- Safety Analysis and the Role of DSMB
- Analysis Approaches for Pre-marketing Safety Data
- FDA ISS Guidelines And SPERT Initiatives on Safety Analysis
- Benefit/Risk, Motivation of Methods
- Rare events monitoring
- Large Simple Trial for safety evaluation
- Risk-benefits
- Safety, PSAP and Risk Management
- Risk Management Plan: Risk Analysis and Management.
- Causal Analysis of Safety Data
D. Global Trials
- Global Harmonization
- Multi-Regional Clinical Trials
- Changing Landscapes - Statistical Issues in Global Clinical Development
- Post Marketing Research, Global Perspective
E. Phase I Trials
- Statistical challenges in Ph I Drug Development
- Phase 1 trials: Blinded or Unblinded at the Sponsor Level?
F. Statistical Issues in Clinical Trials
- Cross-Over Design with time-to-event endpoint
- Placebo Response and Mitigation Strategies in Clinical Trials
- Role of statistical modeling in early decision makings of drug development
- Statistical Issues in Identifying Early on-Tx Measures of Efficacy
- Statistical Issues in assessing Durability of Effects
- Forced Randomization in Clinical Trials
- Extracting information from blinded trials
- Futility Analysis
- Interim Analysis
- Subgroup Heterogeneity in Drug Effects
- Post Randomization Adjustment of Covariates
- Non-parametric Resampling techniques in Clinical Trials
- Statistical (Robustness) assessment of clinical development programs
- Analysis of Covariance in RCT
- Experience with Flexible Bayesian Plan in Phase II Biologic
G. Longitudinal Data/Analysis and Missing Data
- Longitudinal Analysis in dealing with missing values
- Missing Data/Multiple Imputation
- Sensitivity analysis for longitudinal studies with withdrawals in practice
- Joint Modeling of Longitudinal and Event Time Data
- Approaches in dealing with missing data
H. Bayesian
- Bayesian Methodologies
- Bayesian Interim Analysis
- Type I Error Rate Related Issues for Bayesian Trial Design in a Regulatory Environment
I. Multiplicities/Multiple Comparison
- Multiplicity in assessing multiple studies
- Multiple Comparisons
- Multiple Endpoints
- False Discovery Rates
J. Meta Analysis
- Analysis of subgroups across studies, in the meta-analytic framework
- Comparative effectiveness via indirect comparisons/historical control
K. Non-inferiority Trials
- Issues in Non-inferiority Trials, margins, population, historical control
L. Quality of Clinical Trials
- Methodological quality of clinical trials
- Assuring Data Quality in Clinical Trials
M. Vaccines
- Vaccines - Multiple Comparisons and Analysis in Vaccines Trials
- Sensitivity analysis for missing data in vaccine trials
N. Genomics/Biomarkers
- Prospective Calculation of Gene Identification power in analysis controlling the false discovery rate
- Analysis of Large Biomarker Data sets
- Defiing Performance Characteristics of Clinical Biomarker Assays
> Variance Function based statistical method for optimal quality assessment for RT-QPCR replicate well performance
> statistical metrics to quantify relative bias due to Rt-qPCR assay - Integrating Evidence for Selecting Diagnostic Biomarkers for Drug Dev
- Enabling biomarker integration in the drug development
- Assessing Clinical Utility of Biomarkers developed by consortia/institutions in Genetics/Genomics
- Prospective calculation of gene identification power in analyzes controlling the false discovery rate
- Weibull Failure Time Mixture Models for evaluating Efficacy in the Presence of Biomarker
- Statistical Issues for Micro-array classifiers.
O. Technical/Computations/Graphics
- Use of Open-source software for regulated clinical Trial research
- Global platform for global clinical trials
- Strategies for Statistical Software Development for Drug and Diagnostics Research
P. Therapeutic Area Specific Issues
- Specific Issues in Oncology Trials
- CNS Issue - Diary Data
- CNS Risk - suicidal ideation
- Cost Effective Go/No Go Decision in Oncology
- Endpoint Issues in Oncology Clinical Trials
- Censoring Issues in Survival Analysis
- Adequacy of patient follow-up and sensitivity analyses in the presence ofmissing data for PFS in oncology trials
- Statistical Issues in Design and Analysis of Psychiatric Clinical Trials
Q. Regulatory Issues
- Changing Political landscape in Drug Development - Discussions of Avandia and other blockbuster drugs that came under dark clouds
- ICH-E9 Update - what works and what doesn't
- Communicating to FDA statisticians unambiguously using CDISC ADaM
- Issues regarding generation of a SAP for ISE/ISS
- Unifying Data in FDA and its use in drug review
R. Career Development
- Effective communication with clinicians
- Statistical Consulting
- Working Session on Improving communications between project statisticians and FDA statistical reviewers
- A statistical Career - beyond power calculation and p-values
S. Patient Reported Outcome
- PROMIS, the NIH Roadmap for a Patient Reported Outcomes Measurement Information System.
- Patient Reported Outcomes
- Determining validity of patient reported outcomes (PROs) as endpoints in clinical research settings
- A review of the impact of the draft PRO Guidance document on the statistical analysis of PRO data.
T. QTc Study
- Thorough QTc study design and analysis
- Statistical Issues in Thorough QTc study
U. Chemistry, Manufacturing and Control (CMC)
- ICH-Q8 Design Space: Statistical Strategies and Case Studies
- Issues in Chemistry, Manufacturing, and Control (CMC)
- Increasing Objectivity in Risk-based Approach for Biopharmaceutical Development, Manufacturing, and Control
- The role of multivariate projection methods in Quality by Design
V. Food Safety
- Food Safety-Collection and analysis of safety data of food borne pathogens
W. Veterinarian Medicine
- Important Statistical Concepts in the Planning, Analysis and Monitoring of Veterinary Clinical Trials
- Assay Validation in Veterinary Biologics and Pharmaceuticals
- Monitoring Assay Stability in Veterinary Biologics and Pharmaceuticals
- Measuring the Effect of Intervention in Veterinary Biologics and Pharmaceuticals
- Study Design Issues in Veterinary Biologics and Pharmaceuticals
X. Devices
- Drug Device Co-Development Considerations
- Approaches and Problems with Allergy Device Perfromance Validation
- Regulatory and Statistical Issues for Companion Diagnostics in Drug-Device combination products
Tuesday, January 6, 2009
January 30th Organizational Meeting
The January 30th Organizational Meeting will be held at the Universities at Shady Grove Conference Center from 8 a.m. - 4 p.m.
The Universities at Shady Grove is located off Shady Grove Road in Rockville, MD. There are several hotels located near the Washington Rio which is within 1 mile of this meeting location.
If you are driving, the Shady Grove University (and Washington Rio Hotels) is conveniently located off the major Interstate (I-370). If you are using the train, the meeting location is about a 10 minute taxi-ride from the Metro.
More details will follow including an Agenda.
If you would like to RSVP to attend this meeting please contact Carmen/Tammy at
FDAIndustry2009@gmail.com. *** Please also indicate whether you'd like chicken or vegetarian lunch. ***
The Universities at Shady Grove is located off Shady Grove Road in Rockville, MD. There are several hotels located near the Washington Rio which is within 1 mile of this meeting location.
If you are driving, the Shady Grove University (and Washington Rio Hotels) is conveniently located off the major Interstate (I-370). If you are using the train, the meeting location is about a 10 minute taxi-ride from the Metro.
More details will follow including an Agenda.
If you would like to RSVP to attend this meeting please contact Carmen/Tammy at
FDAIndustry2009@gmail.com. *** Please also indicate whether you'd like chicken or vegetarian lunch. ***
Friday, January 2, 2009
Proposed Short Courses (to date as of Jan. 15)
- Adaptive Designs
- Data Safety Monitoring Committee's
- Working Discussions on Statistical Consulting (interactive small course for <30> pariticpants)
- Statistical Graphics
- Roles and Strategies for Covariate Adjustment in RCTs
- Introduction to Clinical trials (FULL DAY appropriate for statisticians with 5 years experience)
- Examination of Risk/Benefits
- Missing Data Analysis
- Dose Finding
- Longitudinal Analysis
- Survival Analysis
- Safety Analysis
- Bayesian Analysis
- Meta Analysis
- Likelihood Methods in RCT
- Resampling Techniques in Medical Research
- Biomarkers (selecting, identifying, assay issues)
- Assessing and Improving Trial Quality
- Interim Analyses and unblinding
- Non-proportional Hazards, Adaptive Design, Group-Sequential Design
Happy New Year and Brief Update on Workshop details!
Happy New Year!
Carmen and I are excited about the upcoming FDA/Industry Workshop we are co-chairing in Fall 2009.
The conference location/hotel has been arranged: the Capitol Hilton right next to the White House.
The conference date has also now been confirmed: Wed.-Fri. Sept. 23-25th.
We look forward to a productive organizational meeting on January 30, 2009 at the Shady Grove University. If you are interested in participating please contact us at:
FDAIndustry2009@gmail.com
We wish you a Safe and Happy New Year and look forward to seeing you in Sept 2009 or perhaps at the organizational meeting in late January!
Carmen and I are excited about the upcoming FDA/Industry Workshop we are co-chairing in Fall 2009.
The conference location/hotel has been arranged: the Capitol Hilton right next to the White House.
The conference date has also now been confirmed: Wed.-Fri. Sept. 23-25th.
We look forward to a productive organizational meeting on January 30, 2009 at the Shady Grove University. If you are interested in participating please contact us at:
FDAIndustry2009@gmail.com
We wish you a Safe and Happy New Year and look forward to seeing you in Sept 2009 or perhaps at the organizational meeting in late January!
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