Biopharmaceutical Section Executive Committee

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Biopharmaceutical Section Executive Committee

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Description

Biopharmaceutical Section Executive Committee Meeting JSM 2020 August 3, 2020 Past Chair: Richard Zink Chair: Bruce Binkowitz Chair-Elect: Weili He 03-August-2020 ASA Biopharmaceutical Section EC 1 Introductions and Welcome Welcome to the

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Presentation Transcript

Biopharmaceutical Section Executive Committee Meeting JSM 2020 August 3, 2020
Past Chair: Richard Zink
Chair: Bruce Binkowitz
Chair-Elect: Weili He 03-August-2020 ASA Biopharmaceutical Section EC 1

Introductions and Welcome Welcome to the first ever virtual BIOP JSM EC Meeting
Next, the first ever virtual JSM Open Business Meeting, Tuesday August 4, 7:30 p.m. to 8:30 p.m., Eastern Time.
Then, the first ever virtual BIOP Transition EC Meeting September 22, 2020, from 8:30 a.m. to noon, Eastern Time. [Webex invite sent].

Roll call of Elected Officers and Committee Chairs ASA Biopharmaceutical Section EC 2 03-August-2020

Secretary’s Report Janelle Charles
Approval of the Spring 2020 EC Meeting Minutes ASA Biopharmaceutical Section EC 3 03-August-2020

Treasurer’s Report Period Ending 6/30/2020

2019 Year End Balance: $ 391,487.24
2020 YTD (6/30/2020) Balance: $ 396,622.69
2020 YTD Change: $5,135.45 03-August-2020 ASA Biopharmaceutical Section EC 4

Treasurer’s Report ASA Biopharmaceutical Section EC 5 03-August-2020

Chair-Elect’s Report Weili He
2020 ASA Elections for BIOP Officers
Chair-Elect 2021: Alan Hartford
Program Chair-Elect 2021: Freda Cooner
Secretary 2021-2023: Inna Perevozskaya
Council of Sections Representative 2021-2023: Mark Levenson
2021 Regulatory-Industry Statistics Workshop Co-chairs
Bo Huang (Pfizer)
Gene Pennello (FDA)
2021 NCB Conference Chair
Xin Huang (AbbVie) ASA Biopharmaceutical Section EC 6 03-August-2020

Chair-Elect’s Report (Cont’d) 2021 Committee Appointments
At-Large Members (x2) – Martin Ho (FDA CBER), Pallavi Mishra-Kalyani (FDA CDER)
Distance Learning Chair – Lei Nie (FDA)
Editor BIOP Report – Peter Mesenbrink (Novartis)
YouTube committee Chair – Alex Dmitrienko (Mediana Inc.)
Webmaster - Steven Novick (MedImmune)
Fellowship committee chair – Brenda Crowe (Eli Lilly)
Student paper award committee chair – Lanju Zhang (AbbVie)
Contributed Presentation Award Committee chair - Daniel Li (Juno Therapeutics)
Contributed Posters Award Committee chair – Bo Huang (Pfizer)
Scholarship Award Committee chair – Elaine Hoffman
Podcast – Ricard Zink (TARGET)
Membership Committee chair – Kun Chen (Gilead)
Outreach and collaboration committee co-chairs - Amit Bhattacharyya, Wei (Michelle) Zhang (PPC CRO)
Mentoring Committee Chair – Sourav Santra (Sarepta Therapeutics)
Leadership in Practice Chair - Lisa Lupinacci (Merck)
SWG Committee co-chairs – Jerry Wang (AnBio Therapeutics Inc.), Jennifer Gauvin (Novartis)
40th anniversary planning committee co-chairs - Margaret Gamalo-Siebers (Eli Lilly), Jennifer Gauvin (Novartis)
BIOP Survey Monkey manager: Jiajun Liu (Biogen) ASA Biopharmaceutical Section EC 7 03-August-2020

Past Chair’s Report Richard Zink
Open Positions
Chair-elect
Publication Officer
Program Chair-elect
COS Representative
Nominations are due by Nov 1st ASA Biopharmaceutical Section EC 8 03-August-2020

Past Chair’s Report Richard Zink
Manual of Operations Updates
Google DOC (preferred) https://drive.google.com/file/d/1qDErJzS86OXo9hRK6Q_RxR7sjt3lr7KT/view?usp=sharing
PDF is available here: http://higherlogicdownload.s3.amazonaws.com/AMSTAT/fa4dd52c-8429-41d0-abdf-0011047bfa19/UploadedImages/Manual_of_Operations_2019_FINAL.pdf
You can email comments to me richard.c.zink@gmail.com ASA Biopharmaceutical Section EC 9 03-August-2020

Past Chair’s Report Richard Zink ASA Biopharmaceutical Section EC 10 03-August-2020

Funding Committee Richard Zink / Jane Qian / Hiya Banerjee
No Funding Requests
Welcomed participants for virtual meeting-within-a-meeting (MWM). We are now providing annual funding of $2500. ASA Biopharmaceutical Section EC 11 03-August-2020

ASA Biopharmaceutical Section Student Paper Awards Lanju Zhang 03-August-2020 ASA Biopharmaceutical Section EC 12

Best Student Paper Awards Honorable Mention

Robust Blocked Response-Adaptive Randomization Designs

Thevaa Chandereng
Department of Biostatistics, University of Wisconsin-Madison 03-August-2020 ASA Biopharmaceutical Section EC 13

Best Student Paper Awards 3rd Place

One-Step Value Difference Test for The Existence of a Subgroup with Beneficial Treatment Effect Using Random Forests

Dana Johnson
Department of Statistics, North Carolina State University 03-August-2020 ASA Biopharmaceutical Section EC 14

Best Student Paper Awards 2nd Place

Boosting Algorithms for Estimating Optimal Treatment Rules

Duzhe Wang
Department of Statistics, University of Wisconsin-Madison 03-August-2020 ASA Biopharmaceutical Section EC 15

Best Student Paper Awards 1st Place

Inference on Selected Subgroups in Clinical Trials

Xinzhou Guo
Department of Statistics, University of Michigan 03-August-2020 ASA Biopharmaceutical Section EC 16

Nonclinical Biostatistics Working Groups (NCBWG)and 2021 NCB Conference Steven Novick / Xin Huang ASA Biopharmaceutical Section EC 17 03-August-2020

Five workstreams Nonclinical Biostatistics Conference – biennial conference
Chair: Xin Huang
Date: June 21-23, 2021 – to be held @ Rutgers University (in-person, we hope)

Best nonclinical biostatistics paper award – to be presented at 2021 conference
Chair: Jason Zhang

Student Outreach – send professionals to universities to meet with graduate students
Co-chairs: Jyh-Ming Shoung and Wei Zhao 03-August-2020 ASA Biopharmaceutical Section EC 18

4. Nonclinical p-value workstream Chair: Stan Altan
Section leads: Tim Schofield (Biologics/Vaccine CMC)
Kim Vukovinsky (Small molecules CMC)
Steven Novick (Discovery/-omics) 03-August-2020 ASA Biopharmaceutical Section EC 19 Wrap up manuscript in 4Q – submit to SBR

Tackles controversial p-value issue as it pertains specifically to the nonclinical space Website

5. Nonclinical Bayesian workstream Collaboration with DIA Bayesian Scientific Working Group
Co-chairs: Paul Faya (Eli Lilly) and Perceval Sondag (Merck) 03-August-2020 ASA Biopharmaceutical Section EC 20 Website 1. Conducted a survey of nonclinical usage of Bayesian methods:
Manuscript submitted to Pharmaceutical Statistics 2. Organized a topic-contributed section @ 2020 JSM (Aug 1 - 6) 3. Organized a session @ 2020 MBSW 5. Working on manuscripts to showcase use of informative priors in nonclinical settings 4. Proposed Bayesian machine learning short course to NCB Conference 2021

Nonclinical Biostatistics Conference Date: June 21-23, 2021 @ Rutgers University, New Brunswick, NJ
Theme: Nonclinical Statistics in the Age of Data Science
Conference website is live
Monthly planning meeting ongoing (Welcoming contributing ideas):
Four tracks: CMC, Discovery/Biomarkers, safety/Pharmacology, computing/visualization
Two short courses
One keynote speaker
One ASA presidential speaker 03-August-2020 ASA Biopharmaceutical Section EC 21

Mentoring Committee Successfully starting 7th year (2020-2021) of ASA BIOP mentoring program
Learnings from the 2019-2020 program (Based on feedback):
Positive feedback:
Valued advice and encouragement
Guidance to look for multiple opportunities to enhance learning and reaching goals
Inspired to also be a mentor
Nice conversations
Suggestions for improvement:
Better matching by interest (e.g. data science vs other positions) – feedback from a mentor
Need for follow-up - case of a mentee not being contacted by mentor ASA Biopharmaceutical Section EC 22 03-August-2020 Committee Members

Sourav Santra (C)
Wen-Chi Wu
Maggie Wang
Haiyan Xu
Michelle Zhang
Elena Polverejan

Mentoring Committee Awareness of the program:
Announcement in Amstat News May 2020
BIOP section community in June 2020 (Lot more responses)
11 pairs and 4 more mentees waiting for mentors!
Need more mentors!
Please reach out to biopharmmentoring@gmail.com, or ssantra@Sarepta.com
Upcoming plans
Another community message in August 2020 to join
Podcast series in collaboration with Leadership in Practice Committee (LipCom)
Awareness about mentoring, experiences of mentor-mentees pairs
Follow up with the pairs in fall 2020 and spring 2021
Improve the webpage and enhance communication ASA Biopharmaceutical Section EC 23 03-August-2020

Fellows Committee Ilya Lipkovich, 2020 Chair
Members: Brenda Crowe, Paul Gallo, Bill Pikounis, Amy Xia
List of BIOP 2020 Fellows
Committee Update
2021 Chair - Brenda Crowe ASA Biopharmaceutical Section EC 24 03-August-2020

Fellows Committee. BIOP 2020 Fellows ASA Biopharmaceutical Section EC 25 03-August-2020

Fellows Committee. Some statistics ASA Biopharmaceutical Section EC 26 03-August-2020 2020
ASA Total: 57
BIOP: 13
BIOP/ASA total: 22.8% 22.6%

Fellows Committee Activities A collection of reflections provided by members of ASA Fellow committee, nominators and recent nominees
The article prepared by Alex Dmitrienko, Ilya Lipkovich and Paul Gallo
Published in the summer issue of BR and June issue of AmstatNews
A follow-up Webinar on the “best practices” for the ASA Fellow nomination process for Pharma statisticians
Speakers: Ivan Chan, Paul Gallo, Christy Chuang-Stein, Steve Ruberg
Panelists: TBD (BIOP ASA fellows committee + article contributors)
September 17, noon ASA Biopharmaceutical Section EC 27 03-August-2020

Fellows Committee Activities (cont.) A working group/panel of dossier reviewers made of seasoned nominators
A quick at-a-glance review of the dossier
I assume contributors to the BR article will agree to serve
Volunteers are needed!
Recruiting new members to the BIOP Fellow Nomination Committee (new ASA fellows are welcome) 03-August-2020 ASA Biopharmaceutical Section EC 28

Outreach and Collaboration Committee Matilde Sanchez-Kam / Amit Bhattacharyya / Michelle Zhang /Liang Fang ASA Biopharmaceutical Section 29 03-August-2020 ASA-BIOP & PSI Joint Webinar Series
The EFSPI-PSI-BIOP joint webinar 2020 is scheduled on Estimands at 9:00-11:00 am EST on November 5th, 2020. The webinar will include 3-4 presentations followed by panel discussion. Webinar logistics are being sorted out between ASA and PSI.
The plan is to host similar joint webinars on a regular (bi-yearly? Yearly?) basis in the future. A few potential presentation topics are identified and will invite the speakers from FDA, EMA and industry to continue this joint venture.
Michelle Zhang is leading this initiative for BIOP.

Outreach Committee Update (2) ASA (Biopharmaceutical and SSPA Sections)/PHUSE Collaboration Update
The Biopharm Section Chair and SSPA Section Chair are aligned on the scope and deliverable as outlined in the collaboration document (MoU) with PhUSE.
The document was forwarded to ASA Operations for their review and comments. A response with no objections was received from ASA to proceed and this had been communicated with PHUSE. The joint AS/PHUSE activity is noted on the PHUSE website: https://www.phusewiki.org/wiki/index.php?title=R-shiny_Interactive_Forest_Plot_in_Collaboration_with_ASA#Objectives_and_Timelines
An update on the ASA/PHUSE collaboration will also be provided at the PHUSE/FDA CSS 2020 workshop in September
The Work Group working on the joint collaboration meets bi-weekly to work on deliverable (Co-leads: Melvin Munsaka [AbbVie and meeting organizer], Bryant Chen [FDA], and Dhananjay Chhatre [Gilead])
Current activities include finalizing the initial set of requirements (in progress) and identifying programming resources (done) to develop the initial prototype
Alex Dmitrienko, Kyle Wathen and Jeremy Wildfire are BIOP members of the team. 03-August-2020 ASA Biopharmaceutical Section EC 30

Outreach Committee (3) Joint Workshop with BBSW (Bay-area Biopharmaceutical Statistics Workshop) postponed until 2021 due to Covid19 situation
BIOP planned for co-sponsoring the mini workshop in BBSW meeting in Fall 2020 on regulatory aspects in Asia-PAC. De to COvid-19 situation, the conference committee have decided to postpone this jointly held mini-workshop to 2021.
Liang Fang is leading this collaboration with BBSW 03-August-2020 ASA Biopharmaceutical Section EC 31

Outreach Committee (4) Potential Collaboration with Teaching Statistics in Health Sciences (TSHS) section
Carol Bigelow has been in touch with the BIOP leadership.
She is checking if BIOP is interested in the following:
TSHS is keen on developing dataset and/or dataset + accompanying teaching materials for posting on our TSHS Resources Portal (https://www.causeweb.org/tshs/).
TSHS’s suggestion is to develop a dataset or dataset + teaching resource that would be a mentoring resource for BIOP. Need a BIOP volunteer (at least initially) with to work with TSHS if BIOP is interested in this joint collaboration.
Or, any other suggestion from EC? 03-August-2020 ASA Biopharmaceutical Section EC 32

40th Anniversary Committee Membership: Meg Gamalo-Siebers & Jennifer Gauvin (co-chairs); Richard Zink, Lisa Lupinacci, Veronica Bubb

Activity Planning
Industry Sponsorships
Budget Update ASA Biopharmaceutical Section EC 33 03-August-2020

Activities Sponsorship: Richard Zink
Reach out to 2021 Co-chairs:
Once 2021 webpage is up, add another Sponsorship page for the 40th anniversary;
Contact Amy Ferries - Richard will do this after the fall workshop

Advertisement: Jennifer Gauvin and Lisa Lupinacci
Advertisement within the mixer in this year's RISW (confirmation from Yabing and Thomas received)
Advertisement during the business meeting of Biopharm Section
Dedicated Invited Session at 2021 JSM
Save the date postcards in RISW care packages; postcards also serve as cover slide for sessions at JSM and send to session chairs
Slide show during the mixers showing statisticians who have served in the section 03-August-2020 ASA Biopharmaceutical Section EC 34

Activities Logo and Swags: Margaret Gamalo
Competition for banner and logo
ASA Connect for reminder for the competition and for the 40th Anniversary Events
Selection Committee - 5 member; ASA legal - Steve Porzio
Banner will be used for webpage and sponsorship page
Logo will be used for swags: Mugs, shirts, postcards

Amstat News/Biopharmaceutical Report write-up for the 40th anniversary
Meet every month; need more volunteers for the events 03-August-2020 ASA Biopharmaceutical Section EC 35

Timelines 2020
April 2020
2021 Workshop cochairs will be selected – need to be in communication
2021 BIOP Chair is Weili He. Jonathan Moscovici is JSM Program Chair
August
Communicate with Jonathan about Invited Session for 40th Anniversary
Submit invited session
September
Richard to discuss additional sponsorship levels with Amy Farris (ASA) after
Communicate with Workshop co-chairs about special session for Workshop (perhaps plenary)
Logo/Banner Deadline
2021
February
Discuss additional food orders with Weili and Christina Link (ASA) for JSM
Discuss additional food orders with Workshop cochairs and Kristen Mohebbi (ASA)
March
Article for Amstat News by March 1st to be published in April Issue
May
Discuss with Kristen Mohebbi (ASA) about ordering anniversary swag items for Workshop 03-August-2020 ASA Biopharmaceutical Section EC 36

2020 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop Thomas Birkner (FDA), Yabing Mai (AbbVie) 03-August-2020 ASA Biopharmaceutical Section EC 37

2020 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (Virtual) Date: September 22–25, 2020 Location: Online
Theme: Lead and Impact: Turning Innovation into Practice
Website: https://ww2.amstat.org/meetings/biop/2020/
Co-chairs: Thomas Birkner (FDA), Yabing Mai (AbbVie)
Excellent program with leadership keynote talks, global regulatory panel discussion, late breaking sessions on COVID-19, and many more!
Register Now to receive two FREE Short Courses and a Care Package!
Don’t miss the first ever Virtual Happy Hour (games, competitions, and prizes) in the history of RISW! 03-August-2020 ASA Biopharmaceutical Section EC 38

RISW 2020 Virtual Program Schedule Highlights Start everyday with a plenary session
Start everyday at 10:30am EST for time zone considerations
One extra day for short courses
Two late breaking sessions
Round table and poster on similar dates as past workshops
Virtual happy hour 03-August-2020 ASA Biopharmaceutical Section EC 39

RISW 2020 Virtual Program Schedule Overview 03-August-2020 ASA Biopharmaceutical Section EC 40

RISW 2020: Plenary Sessions and Late Breaking Sessions Keynote Speeches
Impactful Innovation Through Effective Leadership – Sylva Collins (FDA)
Our Most Important Discovery: the Question – Scott Evans (GWU)
Statistical Leadership and Innovation in Practice – Ivan Chan (AbbVie)
Global Regulatory Perspectives Panel
Panelist: Yuki Ando (Japan PMDA), Laura Lee Johnson (FDA), Mark Rothmann (FDA), John Scott (FDA), Andrew Thomson (EMA), Jun Wang (China NMPA)
Moderator: Frank Shen (EffPha)
Late Breaking Sessions
Scientific and Regulatory Considerations for Developing COVID-19 Vaccine During Pandemic – Panel Discussion
Global Impact of COVID-19 on the Design and Analysis of Clinical Trials and the Path Forward – Parallel Session 03-August-2020 ASA Biopharmaceutical Section EC 41

RISW 2020: Other Updates Registration progress
~ 650 registered as of July 31, 2020
Target total: > 800
Free short courses
Two most popular SCs: Causal inference and Complex Innovative Design
Virtual platform
Care package
Sponsorship
Virtual happy hour 03-August-2020 ASA Biopharmaceutical Section EC 42

Best Contributed Paper Award Committee Chair: Freda Cooner (Amgen)
Co-Chair: Lanju Zhang (AbbVie)

JSM 2020 Online Evaluation Form: https://form.jotform.com/202094370163953
17 topic-contributed sessions
14 paper-contributed sessions
No speed sessions 03-August-2020 ASA Biopharmaceutical Section EC 43

Voting Results 2018 JSM:
11 presentations from 5 sessions with 42 votes 03-August-2020 ASA Biopharmaceutical Section EC 44

Award Recipients from JSM 2019 03-August-2020 ASA Biopharmaceutical Section EC 45

Past Award Recipients Recognition– Proposal Hall of fame: Will not be implemented
BIOP Webinars from past year winners: Implemented

Footnote in JSM program book
Roundtable with past winners
One-to-one mentorship for presentation skills
Presentation skills virtual workshop
Short courses or sessions on communication skills in other ASA meetings (e.g., BIOP Regulatory-Industry Workshop) 03-August-2020 ASA Biopharmaceutical Section EC 46

Council of Sections Report Brian Millen, Veronica Powell, Ted Lystig

Charter revision for the 2021 election ASA Biopharmaceutical Section EC 47 03-August-2020

American Statistical Association Council of Sections JSM Business Meeting
July 31, 2020 1:00pm, 3:00pm, 5:00pm
Virtual

Report on the July 2020 ASA Board Meeting to the COSGB COSGB Report to the ASA Board of Directors
The report received a generally positive reception from the Board. Wendy Martinez, 2020 ASA President, applauded the new survey process for obtaining annual section reports. President-elect Rob Santos asked about the possibility of mutually-sponsored sessions at JSM; Katherine responded that we have discussed this in the COSGB and that the current JSM session allocation process discourages collaboration. Session collaborations among two or more sections would need to be incentivized. There was general agreement on this issue by the Board, and Rob will contact JSM staff and the program committee to find out how this incentivizing can happen. The Board again encouraged sections to develop initiatives with other sections, and develop initiatives with chapters. We shared our introductory video created by Natalie and Sarah with the Board, and told them that we expect to have a video explaining to Section treasurers their responsibilities before their Section budgets are due in September. The Board expressed their interest in these videos and were generally pleased with our plans to have these ready for the new section reps. One of the COC board reps mentioned in the chat window that this is something the COC should consider implementing. We informed the Board that the COS-COS Website Committee has a survey to distribute to Section and Chapter reps asking them about their use of the ASA website, the ASA Communities website, and the Leader Hub site. Mark distributed the survey to the Board and invited them to respond if they wish to contribute to the survey.

Report on the July 2020 ASA Board Meeting to the COSGB Steve Porzio’s review of second quarter financials included a discussion of the magnitude of the decline in membership from 2019 to 2020. This drop was about double the size of the decline between 2018 and 2019. The decline could be due in part to Covid-19 and to the loss of an in-person JSM this year. Current membership is in the neighborhood of 16,500. It was at about 18,500 at its peak in 2018.

The Board spent considerable time discussing a new ASA statement on P-values and statistical significance. Members felt there was a need to follow up on the 2019 editorial in the special issue of The American Statistician that focused on methods for determining statistical importance of results. The Board sent recommendations back to the task force but generally approved of the new statement. The final version is expected to be approved at the November meeting.

Report on the July 2020 ASA Board Meeting to the COSGB The Board is developing policy on naming/renaming awards given by the ASA in light of the recent decision to rename the Fisher award by the COPSS committee. We will hear more about this policy in the future.

The Justice, Equity, Diversity, and Inclusion (JEDI) outreach group was approved by the Board. This group, led by Julia Sharp, recently applied to COSGB to become an Interest Group, but we recommended that they apply to the Board to become an Outreach Committee because their goals did not meet the criteria to become a section.

Important Dates Jan 15 - Student paper award winners notified
Feb 4 - JSM 2020 roundtable/luncheon with speaker submitted
Apr 2 - JSM 2020 meetings and events requested
Apr 22 - Outstanding Section Service Awards submitted
Jun 1 - JSM 2020 awards submitted
Aug 10 - Proposed Section dues changes requested
Sep 8 - JSM 2021 invited sessions submitted
Sep 30 - JSM 2021 continuing education proposals submitted
Oct 31 - Section budgets submitted
Nov 15 - Election slates submitted
Dec 10 - JSM 2021 topic contributed sessions submitted
Dec 15 - Student paper competitions close
Dec 31 - Charter revisions submitted
Dec 31 - Annual report/questionnaire submitted https://community.amstat.org/councilofsections/home

Key Upcoming Dates Section 2021 Budgets due 31-Oct, 2020
Electronically at Members-Only site
BY CURRENT SECTION TREASURER
Conference Budgets Separate
FOC will respond with questions in Dec./Jan.
Possibly questions on large expenditures (as needed)

Other Reminders Sections should discuss 2021 budgets NOW
Suggest agenda topic in conjunction with JSM 2020
Spend down large section balances
Transition plans for any Treasurers-Elect
Confirm with ASA HQ to ensure electronic access
Current treasurer to provide transition plan
Communicate with past Treasurer
See Budget Guidance for Section Treasurers

Section Leadership Workshop – Storytelling for
Impact What You’ll Walk Away With:
Why storytelling is important to create impact
How to structure information into a story to better connect with
your audience

Who: Section Leaders

When: Tuesday, Sept 29 from 12-1:30 EST.

Storytelling Workshop Agenda Agenda:
Welcomes – Sarah Kalicin, Phil Scinto, Natalie Cheung Rotelli
ASA President comments - Wendy Martinez
Why Storytelling is important to the Statistician’s message
How statisticians can structure information into an
impactful story – Regina Nuzzo
Practice exercise

COSGB in 2020 The ASA needs Sections that are strong and well-functioning. All
sections should be:
Engaging with their membership
Delivering the services and resources that benefit current members
Promoting their activities to attract new members

Building on the work of recent years, the COSGB focused on:
Providing a report to all sections on overall section health in the COS
Providing an Impact Workshop for all COS leaders
Awareness of diversity initiatives in the ASA

Volunteers Needed: 2021 COS Treasurer (1 appointed position)
2020 COSGB Nomination Committee (3 appointed positions)
2021-2023 COSGB Chair-elect (2 nominations needed)
2021-2023 COSGB Vice-Chair (2 nominations needed)
2021-2023 COSGB ASA Board Rep (2 nominations needed)

Evaluation Subcommittee of the ASA Advisory Committee on Continuing Education (1 appointed position)

Founders Award Committee member (1 appointed position)

If you are interested in any above appointed or be considered for a
nomination position, please contact Sarah.Kalicin@intel.com

Annual Section Report/Questionnaire Why?
One of several measures to assess Section health
Sharing of best practices
How?
We incorporated feedback to simplify the process
Sections and IGs fill out required annual survey
COSGB Vice-Chairs compile, analyze, document and present
Timeline Phil Scinto

Phil Scinto
Annual Section Report/Questionnaire Timeline

2019 Annual Section Report: Observations Sections that rated themselves as ‘Excellent/Very Good’
distinguished themselves from other Sections by these traits.
Reach out to members for feedback
Active and operational new member initiatives
Keep in touch with members through Newsletters, Webinars,
Mentoring/Leadership Programs
Higher frequency of Executive Board meetings
Disseminate information to officer candidates and new officers
Active committees to seek out and nominate Fellows
Active student outreach programs

Award for Outstanding Section Service ASA Award for Outstanding Section Service (est. 2018)

This award provides each section with a way to acknowledge
extraordinary contributions made by a particular section member.

The award consists of a certificate, a listing in the JSM awards program, and a COSGB rep who will come present the award at your business meeting or mixer.

Each section establishes procedures for selecting the winner and notifies
the COSGB by late April of the winner.

One-third of sections are eligible to present the award each year. Alyson Wilson

Who can present the award in 2021? Biometrics
Biopharmaceutical
Statistics in Epidemiology
Teaching Statistics in the Health sciences
Health Policy Statistics
Statistics and the Environment
Nonparametric Statistics
Statistical Programmers and Analysts
Statistics in Imaging
Mental Health Statistics
Medical Devices and Diagnostics
Genomics and Genetics Alyson Wilson

Section Charter Review Process Section Charters must be reviewed every 3 years

About one-third of Sections revise charters each year.

COS Rep is sent an email with instructions.
Current charter
Link to our charter template
Sample timeline

2020 Review Cycle Biometrics
Biopharmaceutical
Statistics and the Environment
Statistics in Epidemiology
Statistics in Genomics and Genetics
Health Policy Statistics
Statistics in Imaging
Medical Devices and Diagnostics
Mental Health Statistics
Nonparametric Statistics
Statistical Programmers and Analysts
Teaching Statistics in Health Sciences

What to address in a revision Charter template: areas of interest
Update activities
COS charter has been updated, want to make sure section
charter is consistent
http://ww2.amstat.org/sections/cos.cfm
Ask me any Qs!!!!
Send Phil or Rick the updated version by December 20th;
voted on by members in 2021 elections

Scholarship Award [1 of 3] ASA Biopharmaceutical Section EC 67 The Biopharmaceutical Section Scholarship Award was established in 2018 to recognize notable academic achievement or applied project work related to the area of biopharmaceutical statistics. This annual scholarship award also considers general academic performance, leadership, volunteering, and service.

2020 Committee:
Brian Millen (Chair)
Elaine Hoffman
Guochen Song

Awardees receive an award certificate and $1k 03-August-2020

Scholarship Award [2 of 3] ASA Biopharmaceutical Section EC 68 Five (5) recipients:
Bryan Blette (UNC, Chapel Hill)
Yan Gao (Univ Illinois, Chicago)
Yunasa Olufadi (Univ Memphis)
Liwen Wu (Univ Pittsburgh)
Xiao Wu (Harvard) 03-August-2020

Scholarship Award [3 of 3] ASA Biopharmaceutical Section EC 69 Looking ahead to 2021 Scholarship Award
Application Deadline: March 15, 2021
2021 Committee
Elaine Hoffman (Chair)
Guochen Song
New member to be appointed (3-yr term) by Section Chair-elect

*Special thanks to past-Chair, Abie Ekangaki, for input on operational aspects* 03-August-2020

Committee to Address Excess BIOP Cash on Hand [1 of 2] ASA Biopharmaceutical Section EC 70 Key Proposal Elements 03-August-2020

Committee to Address Excess BIOP Cash on Hand [2 of 2] ASA Biopharmaceutical Section EC 71 Key Proposal Elements

Initial Membership (terms begin 2021)
Brian Millen (Chair 2021, 22; Past Chair 2023)
Freda Crooner (Chair 2023; Past Chair 2024)
Emily Butler (Chair 2024; Past Chair 2025)
* The committee shall consist of at least 3 and no more than 5 members *
BIOP Chair-elect to appoint new members (2024)

Initial Committee Tenure
5 years ; may be extended by vote of EC, first renewal vote may occur in 2025.

General Expectation
The committee is expected to bring forward spending proposals at least annually. 03-August-2020

Leadership in Practice Committee (LiPCom) Committee Members
Abie Ekangaki - Chair
Lisa Lupinacci - Chair-elect
Rakhi Kilaru - Member
Emily Butler - Member
Veronica Powell - Member ASA Biopharmaceutical Section EC 72 03-August-2020 Updates
Cmttee working together in creating exciting new content for half-day interactive leadership workshop at RISW 2020
LiPCom collaborated with Mentoring sub-cmttee to launch a set of podcast interviews about mentoring
LiPCom exploring further ideas for other types of leadership podcasts
LiPCom website https://community.amstat.org/biop/aboutus/sub-committees/lipcom

Program Chair’s Report Stephine Keeton 03-August-2020 ASA Biopharmaceutical Section EC 73

2020 Program Chair Report Among the 30 Invited session proposals to the section, the invited program includes five Biopharmaceutical Section sponsored sessions and nine co-sponsored sessions
Invited sessions include diverse topics: Patient Reported Outcomes, Real World Data, Personalized/Stratified Medicine, Incorporating Knowledge from Previous Clinical Trials, and Drug Approval/Labeling based Bayesian Approach
A few sessions submitted to BIOP as the primary sponsor were selected as invited sessions in other sections
45 Topic Contributed session proposals; the section sponsored 17 Topic Contributed sessions
Received 168 Contributed abstracts. The most by any section!
13 Contributed Paper sessions
1 Poster session
Six Round table sessions
Continuing education course, ‘Analysis of Clinical Trials: Theory and Applications’ will not be part of JSM 03-August-2020 ASA Biopharmaceutical Section EC 74

2020 Virtual JSM Updates Invited and Topic Contributed sessions will be live at scheduled times
On-demand viewing will be available through August 31st
Contributed Paper and Poster sessions will be available on-demand through August 31st
Continuing Education (CE) Course, ‘Analysis of Clinical Trials: Theory and Applications’ will not be part of JSM this year
Part of ASA's webinar program (presented between September 2020 and May 2021); ASA will advertise CE course
Financial arrangement between ASA and BIOP will not change
ASA and the section will split the net revenue 50/50
FAQ page: https://ww2.amstat.org/meetings/jsm/2020/faq.cfm
Check Out the JSM User Guide 03-August-2020 ASA Biopharmaceutical Section EC 75

Virtual Program Schedule at a Glance ASA Biopharmaceutical Section EC 76 At least 3 Contributed Paper sessions per day
Poster session on Monday
Contributed Papers and all Posters available (on-demand) until August 31 03-August-2020

Scientific Working Groups ASA Biopharmaceutical Section EC 77 Jennifer Gauvin /Jerry Wang
Committee members: Thomas Gwise, Kun Chen, Karen Price

No new proposals in 2020 yet. Expecting one in coming months.
Consideration for possibly resuming or decommissioning Re-randomization WG
There is no written procedure to decommission a SWG 03-August-2020

Scientific Working Groups ASA Biopharmaceutical Section EC 78 Status of Re-randomization WG
No activity for almost three years
Chair did not respond to our committee inquires; WG is either dormant or without a chair
Actions taken, Proposal for next steps
Reached out to key committee members to see whether there is still motivation to move ahead
Dr. Yeh-Fong Chen (FDA) is interested in moving the WG forward and submitted a plan
Does the EC support the plan to resume Re-randomization WG?
If so, assess status of WG at spring meeting 2021. (Note: all SWG Annual Health checks due Feb 1 for review by EC before spring mtg.) 03-August-2020

Contributed Poster Award Committee ASA Biopharmaceutical Section EC 79 Bo Huang (Pfizer) was appointed as the new Poster Award Committee Chair for the next 3 years
New committee members have been appointed (Old committee members retired after 3 years service)
Jingyi Liu (Lilly) will stay one year as past Chair to ensure smooth transition
5 posters were submitted for 2020 (less than previous years) likely due to the virtual meetings
Award winners will be evaluated by the committee members and results will be available Oct/Nov 2020 03-August-2020

Membership Committee Kun Chen (Chair, Gilead Sciences Inc)
Members: Jingjing Guo (GRAIL), Jiajun Liu (Biogen)

From 2020 Spring EC Meeting:
The EC discussed the possibility of having the survey administered earlier than summer in 2021 to capture results prior to the 40th anniversary activities.

Need an EC vote to approve change from Manual of Operations. ASA Biopharmaceutical Section EC 80 03-August-2020

2021 Membership Survey Planning ASA Biopharmaceutical Section EC 81 03-August-2020

Membership Committee ASA Biopharmaceutical Section EC 82 03-August-2020 From Manual of Operations, 3.10.2 Calendar of Activities for reference

Publications / Communications ASA Biopharmaceutical Section EC 83 Yongming Qu 03-August-2020

Publications / CommunicationsWebinars – Wei Zhang, Lei Nie, Xiaofei Wang, Elena Polverejan 03-August-2020 ASA Biopharmaceutical Section EC 84

Publications / Communications ASA Biopharmaceutical Section EC 85 Editors
Xiaofei Wang (2020), Peter Mesenbrink (2021), Herbert Pang (2022)
Two issues planned for 2020
Spring Issue (published in June)
Fall Issue (special issue on Covid-19, to publish in October)
Impact of Covid-19 on ongoing clinical trials; a survey on Covid-19 trials; statistical issues in designing and analyzing Covid-19 studies; and Covid-19 RWE studies
Invited authors: Yongming Qu (Lilly), Peter Mesenbrink (Novartis), Paul Berg (Lilly), Lisa LaVange (UNC), LJ Wei (Harvard), Sheng Feng (Paraxel)
EC meeting updates, etc 03-August-2020

Publications / Communications ASA Biopharmaceutical Section EC 86 P-values in therapeutics and vaccine development during the pandemic
Too big to cover in the special issue of ASA Biopharm Report
Opinions highlighted in Gibson (2020) in SBR have become even more of an issue in the rush to publish results during a pandemic
Opportunity exists to do a deep dive with the Biopharm community
To be discussed further at the September Transitional Meeting 03-August-2020

Publications / Communications ASA Biopharmaceutical Section EC 87 Richard C. Zink
Recent Podcasts
Episode 75: Companion Diagnostics
Episode 76: COVID-19 and Clinical Trials
Episode 77: National Institute of Statistical Sciences
Episode 78: Challenges with Pain Assessments
Upcoming
Nusrat Rabbee on biomarker analysis
2020 Regulatory-Industry Statistics Workshop
Vaccines
External Control Arms
Storytelling
LipCom
Mentoring
Received a question about transcription services 03-August-2020

Publications / Communications ASA Biopharmaceutical Section EC 88 Webmaster Report (Steven Novick)

Despite recent upgrade, web-building tools are terribly outdated (circa late 1990s)

Major updates to web site
NCB 2021 Conference
Statistical Methods in Oncology Working Group 03-August-2020

Publications / Communications ASA Biopharmaceutical Section EC 89 Biopharmaceutical Section’s YouTube channel
Current members
Alex Dmitrienko, Jonathan Moscovici, J. Kyle Wathen
Channel page
https://www.youtube.com/c/ASABiopharmaceuticalSection
Subscribers
365 subscribers (up from less than 200 subscribers in May 2020)
Views
Over 4,000 views 03-August-2020

Publications / Communications ASA Biopharmaceutical Section EC 90 Current playlists
Leadership in the Biopharmaceutical Industry (Abie Ekangaki)
Simulating Adaptive Clinical Trials (J. Kyle Wathen)
Key Multiplicity Issues in Clinical Trials Part I (Alex Dmitrienko)
Future playlists
Clinical Trial Simulations Based on the Clinical Scenario Evaluation Framework (Alex Dmitrienko, Gautier Paux)
Videos on hot topics, including estimands and missing data, go/no-go framework, multiplicity, complex innovative trial designs, R programming and validation
Instructional videos to introduce free software tools supported by BIOP Software Working Group 03-August-2020

Any Other Items / Action Item Review ASA Biopharmaceutical Section EC 91 FYI: Jiajun Liu has been appointed as the BIOP Survey Monkey manager, to oversee the license and maintance of Survey Monkey.
Janelle Charles – Action Item Review 03-August-2020

Adjournment 92 ASA Biopharmaceutical Section EC 03-August-2020

Attachments ASA Biopharmaceutical Section EC 93 03-August-2020 Work Plan for ASA Biopharmaceutical Working Group on Designs with Re-Randomization of 2020-2021 ASA BIOP Outreach Update: EC Meeting – July 2020

Biopharmaceutical Section Executive Committee

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