2017

The inaugural Boston Boston Pharmaceutical Symposium was held in 2017. Below is the information.

Short Course on the Design and Monitoring of Adaptive Clinical Trials

A Practical Introduction with Examples and Software

Date and Time: May 5, 2017, 9 a.m. – 5 p.m.

Location: Takeda Pharmaceuticals, 40 Landsdowne Street, Cambridge

Registration Fees: $150 non-members, $125 Members and $75 students

Please register at: https://adaptivetrials2017.eventbrite.com

Registration Deadline: April 14, 2017

Note: Organizers are also working on setting up a web meeting, with details to follow

When designing a clinical trial, it is important to investigate many different combinations of design parameters - including power, spending functions, timing of interim analyses, and enrollment rates - to discover the most efficient combination for the trial under consideration. This workshop will include hands-on training for East, the industry standard clinical trial design software tool. Attendees will learn how to design, monitor and simulate fixed, group sequential and adaptive trials with one arm, two or multiple arms, for binary, continuous or time-toevent endpoints. We will review other new features, including:

•  extending available simulations through external calls to R functions
• computation of Bayesian power or probability of success (assurance)
• forecasting of enrollments and events 

Pre-requisites: Attendees are expected to have basic knowledge of clinical trials, and a keen interest in adaptive designs.

Software: The attendees are expected to have East 6.4 installed on their computers before the seminar day. The Cytel Support Team and the event organizers will coordinate this effort, providing installation setup and the instructions to install the software well in advance of the seminar day.

Instructor Bios

Cyrus Mehta

Cyrus Mehta is President and co-founder of Cytel Corporation and Adjunct Professor of Biostatistics, Harvard University. Cytel (www.cytel.com) is a leading provider of software, clinical services and strategic consulting on the design, interim monitoring and implementation of adaptive clinical trials, with offices in the United States, Europe and India. Dr. Mehta consults extensively with the biopharmaceutical industry on group sequential and adaptive design, offers workshops on these topics, and serves on data monitoring and steering committees for trials in many therapeutic areas including oncology, cardiology, neurology and metabolic disease. He has led the development of the StatXact, LogXact and East software packages that are widely used by the biopharmaceutical industry, academic research centers and regulatory agencies. He has over 100 publications in leading statistics and medical journals. He is a past co-winner of the George W. Snedecor Award from the American Statistical Association, is a Fellow of the American Statistical Association, and an elected member of the International Statistical Institute. He was named Mosteller Statistician of the Year by the Massachusetts Chapter of the American Statistical Association in 2000, and Outstanding Zoroastrian Entrepreneur by the World Zoroastrian Chamber of Commerce in 2002. He has received the Lifetime Achievement Award from the International Indian Statistical Association (2015) and the Distinguished Alumni Award from the Indian Institute of Technology, Bombay (2016).

Charles Liu

Charles Liu has been a statistician and product manager at Cytel for over 5 years. He has a research background in Psychology, Neuroscience, and Biostatistics. Charles earned a PhD in Psychology from the University of Melbourne, Australia.

Hrishikesh Kulkarni

Hrishikesh Kulkarni has been a statistician at Cytel for over 9 years. He earned his Master’s Degree in Statistics from Department of Statistics, University of Pune, India. Since then, he is involved in products like East and other Cytel products.

Acknowledgement: Thanks to the generosity of Cytel Corporation, all proceeds will benefit the Boston Chapter of the American Statistical Association.

2018

In May of 2017, the Boston Chapter organized a one-day workshop on the "Design and Monitoring of Adaptive Clinical Trials". The workshop was given by Cyrus Mehta and his team at Cytel Inc. and held at Takeda Pharmaceuticals in Cambridge. The workshop gave an overview of recent developments and best practices in clinical trials and included hands-on training for East, the industry standard clinical trial design software tool. The program was of great value to the many participants, as was the opportunity to network with industry colleagues. A decision was made to continue holding similar events on an annual basis in the Boston area. Building on the success of the 2017 event, the Boston Chapter held its second annual pharmaceutical symposium in Cambridge on Friday April 27, 2018. This was a full-day event hosted by Takeda Pharmaceuticals. Below is the event information.

Second Annual Boston Pharmaceutical Symposium on Friday, May 4

The Boston Chapter of ASA will hold its second annual pharmaceutical symposium in Cambridge on Friday, May 4, 2018. This will be a full-day event hosted by Takeda Pharmaceuticals. Details of the program are provided below:

Date and Time: Friday, May 4, 2018, 9 a.m. to 5 p.m.

Location: Takeda Pharmaceuticals, 35 Landsdowne Street, Cambridge

Registration Fees: $160 non-member, $135 member, $75 student 

RegistrationDeadline: April 13, 2018

Registration link: https://bcasa2018pharma.eventbrite.com

Program Highlights:

Using prediction to conduct adaptive clinical studies

Dr. L.J. Wei is a professor of Biostatistics at Harvard University. Before joining Harvard, he was a professor at University of Wisconsin, University of Michigan, and George Washington University. His main research interest is in the clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. In January 2014, to honor his mentorship, Harvard School of Public Health established a Wei-family scholarship to support students studying biostatistics. His recent research area is concentrated on the personalized medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. Dr. Wei has been closely working with pharmaceutical industry and the regulatory agencies for developing and evaluating new drugs/devices.

Recent Innovation and Development in Joint Models for Longitudinal and Survival Data

Dr. Minghui Chen is currently Professor and Head of the Department of Statistics at the University of Connecticut (UConn). He was elected to Fellow of International Society for Bayesian Analysis in 2016, Fellow of the Institute of Mathematical Statistics in 2007, and Fellow of American Statistical Association in 2005. He has published over 375 statistics and biostatistics methodological and medical research papers in mainstream statistics, biostatistics, and medical journals. He has also published five books including two advanced graduate-level books on Bayesian survival analysis and Monte Carlo methods in Bayesian computation. He served as Program Chair and Publication Officer of SBSS of the American Statistical Association and the ASA Committee on Nomination for 2016-2017 to nominate candidates for ASA President/Vice President. Currently, he serves as an Associate Editor of ASA journals JASA and JCGS and an Editor of Bayesian Analysis and Statistics and Its Interface.

Conjoint Analysis: An Illustrative Primer and Case Study in Rheumatoid Arthritis

Dr. Joseph C. Cappelleri is an executive director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. He earned his M.S. in statistics from the City University of New York, Ph.D. in psychometrics from Cornell University, and M.P.H. in epidemiology from Harvard University. As an adjunct professor, Dr. Cappelleri has served on the faculties of Brown University, University of Connecticut, and Tufts Medical Center. He has co-authored over 800 conference presentations and 400 publications on clinical and methodological topics, including on regression-discontinuity designs, meta-analyses, and health measurement scales. Dr. Cappelleri is lead author of the monograph Patient-Reported Outcomes: Measurement, Implementation and Interpretation. He is a Fellow of the American Statistical Association.

Optimal Seamless Phase 2/3 Oncology Trial Designs and Its Implementation

Dr. Guohui Liu is a director at Takeda pharmaceuticals, which he joined after graduation from University of Maryland, Baltimore county in 2006. Currently he is stat lead for a late stage oncology compound development, including study design, regulatory interaction, global submission and payer analyses. Also, he supervises work on a few early stage compounds.

Dr. Zhaoyang Teng is a senior statistician at Takeda Pharmaceutical, with extensive experience in all phases of oncology drug development. Dr. Teng’s research interests include adaptive design, seamless phase 2/3 study design, biomarker driven study design and multi-regional clinical trials. He has published multiple statistics journal articles, and chapters in statistics books.

Design and analysis of pragmatic trials for patient-centered causal inference

Dr. Eleanor Murray, ScD, is a research fellow in the Department of Epidemiology focusing on causal inference methods after her graduation from the Harvard T.H. Chan School of Public Health in 2016 development under the mentorship of Dr. Miguel Hernan and Dr. James Robins. Her research focuses on methods to improve medical decision making, including the design and analysis of pragmatic randomized trials, and the development of agent-based models for causal inference.

A case study of a Bayesian adaptive dose-finding Phase 2 trial design using Go/No-Go criteria and adaptive randomization

Yeting Du is a Biostatistician in the Strategic Consulting Group at Cytel. He completed his MS in Statistics at McGill University in 2012, and his PhD in Biostatistics at Harvard University in 2017. His expertise includes analysis of longitudinal data and correlated data, feature selection, finite mixture models, and statistical methods for genetic association analysis. He has published theoretical and methodological papers in journals including The American Statistician, Metrika, and The Canadian Journal of Statistics. Since Joining Cytel in July 2017, he has worked with clients to create and simulate complex adaptive designs, conducted data analysis for several confirmatory trials, and performed validation of software packages.

New tools for clinical trial design: East and beyond

Charles Liu, PhD, is a Senior Product Manager at Cytel. Before joining Cytel in 2012, he was a postdoctoral fellow at Boston University. His current research interests include: Enrollment & events prediction, Go/No-Go decision making, and Program & Portfolio optimization.

2019

The BCASA Third Annual Boston Pharmaceutical Symposium took place on May 3, 2019 at Pfizer’s building in Cambridge Massachusetts. Nearly 100 statisticians gathered to discuss statistical methodological research and its applications to biotech and pharmaceutical industry, and to develop connections. The participants had a wide variety of backgrounds, representing industry and academia, senior investigators, students and postdocs, and many were first-time attendees of BCASA events.

Weidong Zhang, the symposium’s host and a member of the symposium’s organizing committee kicked off the event by a short introduction, followed by two welcome addresses from Pfizer leadership team members. Then, 10 invited speakers representing Cytel, Biogen, Novartis, MD Anderson Cancer Center, Harvard University and Pfizer discussed topics on promising zone design, clinical development plans, drug-related safety signals, basket trial design, Bayesian optimal design, adaptive design in East 6.5, translational data science, co-data use in clinical trial, prognostic model construction by statistical learning method, meta-data for Emax model, etc. The audience had ample opportunities to interact during breaks, meet old colleagues and create new contacts.

BCASA thanks the symposium’s organizing committee (Olga Vitek, Northeastern University (chair); Weidong Zhang, Pfizer (host); Wenting Cheng, Biogen; Tim Clough, Novartis; Hrishikesh Kulkarni, Cytel; Andrew Lewandowski, Novartis; Jameson Luks, Cytel; Huyuan Yang, Alnylam Pharmaceuticals) for planning the event, as well as the Pfizer event team for hosting the symposium. We also extend our appreciation to the Bentley University student volunteers for the on-site coordinating work.

BCASA gratefully acknowledges financial support from Cytel.

Below is the event information.

Third Annual Boston Pharmaceutical Symposium

The Boston Chapter of the American Statistical Association (BCASA) invites you all to attend the Third Boston Pharmaceutical Symposium on May 3, 2019 at Pfizer, Building 2, Kendall Sq, Cambridge MA.

As an annual event, the Boston Pharmaceutical Symposium provides a unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in the industry statistical practice. We welcome the participation from industry statisticians, academia researchers, as well as university students and any professionals who are interested in pharmaceutical statistical topics.

Third Boston Pharmaceutical Symposium will be a full-day event, featuring a series of invited talks, a poster session, and networking opportunities.

Date and Time: Friday May 3, 2019, 8:00 am - 4:30 pm. Registration + light refreshments will start at 8:00 am. Welcome address will start at 8:45 am and talks begin at 9:00 am.

Symposium location: Pfizer, Building 2, Kendall Sq, 610 Main Street, Cambridge MA 02139 

Public transportation and parking: The closest T-stop is the Kendall MIT station on the Red line.  Parking is available for a fee of $38 for the day at the garage on-site. Please see Pfizer Event Information for more information on parking garages.

Submit a Poster Abstract

Please consider participating in Third Boston Pharmaceutical Symposium by submitting an abstract to the poster session.

Participants who are interested to have a poster presentation are encouraged to submit an abstract to the poster session. Abstracts need to be submitted by Friday, April 26 to Dr. Olga Vitek via o.vitek@northeastern.edu. Abstracts on topics related to pharmaceutical statistics may include, but are not limited to, adaptive designs, platform trials, umbrella designs, mater protocols, use of machine learning in clinical trials, dose response, wearable devices, analysis of pediatrics studies, etc.

Registration

All participants in the symposium are encouraged to register by Friday, April 26. The registration fee covers a light breakfast, lunch, afternoon snacks, and symposium materials. The registration fee is $165 for industry professionals.  Members of the Boston Chapter (BCASA) receive a discounted registration fee at $135. Thanks to support from Cytel, we are able to reduce the registration fees for participants from academic and nonprofit institutions to encourage broader participation. The fees are $60 for a non-BCASA member and $30 for a BCASA member if a participant is from academic or a nonprofit institution and registers with an academic/nonprofit system email address. To register, please go to https://bcasa2019pharma.eventbrite.com. Please register early! Space permitting, registrations after the April 26 deadline (including on site) may be accepted, but will be subject to a late fee of $30. 

Schedule of the Event

Morning session

• 8:45-9:00 am: Welcome address from Pfizer
• 9:00-9:30 am: Optimal promising zone designs (presentation slides) by Sam Hsiao, Senior Biostatistician, Cytel
• 9:30-10:00 am: A practical guide to optimizing clinical development plans (slides available upon request) by Craig Mallinckrodt, Distinguished Biostatistician, Biogen
• 10:00-10:30 am: Break
• 10:30-11:00 am: Drug-related safety signals by Laurence Colin, Director, Novartis
• 11:00-11:30 am: Bayesian basket trial design (slides available upon request) by Chunlei Ke, Senior Director, Biogen
• 11:30 am-12:00 pm: BOP2: Bayesian optimal design for phase II clinical trials with binary, co-primary and other complex endpoints (presentation slides) by Ying Yuan, Professor, Department of Biostatistics, University of Texas, MD Anderson Cancer Center

Lunch and posters 12:00-1:00 pm

Afternoon session 

• 1:00-1:30 pm: Overview of adaptive designs for confirmatory trials in East 6.5 (presentation slides) by Hrishikesh Kulkarni, Principal Statistician, Cytel
• 1:30-2:00 pm: Translational data science (presentation slides) by L.J. Wei, Professor of Biostatistics, Harvard University
• 2:00-2:30 pm: On the use of co-data in clinical trial (presentation slides) by Satrajit Roychoudhury, Senior Director, Pfizer
• 2:30-3:00 pm: Break
• 3:00-3:30 pm: A novel statistical learning method for building prognostic models for heart failure time-to-event outcomes and comparison to other machine learning approaches (presentation slides) by Matthias Kormaksson, Associate Director Statistical Consultant, Novartis
• 3:30-4:00 pm: Meta-data and software for Bayesian Emax dose response models (presentation slides) by Neal Thomas, Executive Director, Pfizer

Scientific Committee

• Olga Vitek, Northeastern University (chair) 
• Weidong Zhang, Pfizer (host)
• Wenting Cheng, Biogen
• Tim Clough, Novartis
• Hrishikesh Kulkarni, Cytel
• Andrew Lewandowski, Novartis
• Jameson Luks, Cytel
• Huyuan Yang, Alnylam Pharmaceuticals

Please contact Dr. Olga Vitek via o.vitek@northeastern.edu for general inquiries.

Acknowledgements: We thank our colleagues at Pfizer for hosting this event. Financial support from Cytel is also gratefully acknowledged.

2020

Forth Annual Boston Pharmaceutical Symposium was fully planned but canceled due to the COVID-19 pandemic. The planned agenda and other plan details are shown below.

Note: After careful consideration of the evolving concerns around COVID-19, the BCASA and Fourth Annual Boston Pharmaceutical Symposium's Scientific Committee have made the decision to postpone (but not cancel) the Fourth Annual Boston Pharmaceutical Symposium to a later date. 

Information regarding the postponed symposium, including the date and the program schedule, will be provided when the situation clarifies, following by registration re-open.

We appreciate those participants who already registered for the symposium. As the symposium is postponed and the new date is not determined yet, we decided to refund the registration fee in full amount to all registrants. The registration fee had already been refunded to the original payment method.

We invite you all to attend the Fourth Annual Boston Pharmaceutical Symposium that will take place on Friday, May 8, 2020, on the campus of Pfizer, Building 2, Kendall Sq., 610 Main Street, Cambridge, MA. The event is organized by the Boston Chapter of the American Statistical Association in collaboration with researchers from several pharmaceutical companies in the Boston area. Financial support from Cytel, Pfizer and Takeda is gratefully acknowledged. The symposium will feature presentations by prominent researchers and industry professionals, and will include refreshments and networking opportunities. As an annual event, the Boston Pharmaceutical Symposium provides a unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in the industry statistical practice. We welcome the participation from industry statisticians, academia researchers, as well as university students and any professionals interested in pharmaceutical statistical topics. Please contact Dr. Olga Vitek via o.vitek@northeastern.edu for general inquiries.

Date: Friday May 8, 2020.

Symposium location: Pfizer, Building 2, Kendall Sq, 610 Main Street, Cambridge, MA 02139

Registration:

The registration fee covers a light breakfast, lunch, afternoon snacks, and symposium materials. The early bird registration fee (before May 1) is $125 for industry professionals. Members of the Boston Chapter (BCASA) receive a discounted registration fee at $95. Thanks to the generous support from Cytel and Takeda, we are able to reduce the registration fees for participants from academic and nonprofit institutions to encourage broader participation. The fees are $60 for a non-BCASA member and $30 for a BCASA member for participants from academic or a nonprofit institutions and retirees. To register, please go to https://bcasa2020pharma.eventbrite.com

Please register early. Space permitting, registrations after the May 1 deadline will be accepted, subject to a late fee of $30.

Submit a Poster Abstract
Participants are encouraged to submit an abstract for poster presentation. Abstracts need to be submitted by Friday, May 1 to Dr. Olga Vitek via o.vitek@northeastern.edu. Abstracts on topics related to pharmaceutical statistics may include, but are not limited to, adaptive designs, platform trials, umbrella designs, mater protocols, use of machine learning in clinical trials, dose response, wearable devices, analysis of pediatrics studies, etc.

Schedule and Confirmed Speakers:

8:45am-9:00am: Welcome address from Pfizer

9-9:30: Keynote, Sandeep Menon, SVP, Pfizer

9:30-10:00: Andrew Bean, Principal Biostatistician, Novartis

10:00-10:30: Break

10:30-11:00: Mike Hale, VP and Chief Statistical Scientist, Takeda

11:00-11:30: Charlie Cao, Senior Director, Biogen

11:30-12:00: Yannis Jemiai, Chief Scientific Officer, Cytel 

12:00-1:30pm Lunch and posters

1:30-2:00: Keynote: Anne Heatherington, SVP, Head of Data Science, Takeda

2:00-2:30: Bo Jin, Executive Director, Boston Biomedical

2:30-3:00: Break

3:00-3:30: Yuan Ji, University of Chicago

3:30-4:00: Meijuan Li, VP of Biostatistics and bioinformatics, Foundation Medicine; formerly deputy director at FDA/CDRH division of Biostatistics

4:00-4:30: Geoffrey Grove, Senior Product Manager, Cytel

 

Scientific Committee:

Alyssa Biller, Cytel

Wenting Cheng, Biogen

Tim Clough, Novartis

Fang Yang, Novartis

Geoffrey Grove, Cytel Inc

Hrishikesh Kulkarni, Alexion

Zhonggai (Kevin) Li, Boston Biomedical

Jianchang Lin, Takeda

Jameson Luks, Cytel

Olga Vitek, Northeastern University

Huyuan Yang, Boston Biomedical

Weidong Zhang, Jounce Therapeutics

Ling Wang, Pfizer

Sponsor:
Support the Fourth Annual Boston Pharmaceutical Symposium! We welcome sponsors to join us at this unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in the industry statistical practice. As a sponsor, you will receive recognition for your support.

Please contact Dr. Olga Vitek via o.vitek@northeastern.edu for general inquiries.

Acknowledgements:
We thank our colleagues at Pfizer for hosting this event. We thank Cytel and Takeda for the financial support for this event.

2021

As an annual event, the Boston Pharmaceutical Symposium provides a unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in statistical practice. We welcome the participation from industry statisticians, academia researchers, as well as university students and any professionals who are interested in pharmaceutical statistical topics.

In lieu of an in-person event, the Fifth Boston Pharmaceutical Symposium included a series of five free webinars hosted on Fridays throughout the summer and fall of 2021. Below is the event information.

Fifth Boston Pharmaceutical Symposium

Virtual Seminar Series by the Boston Chapter of the ASA

The Boston Chapter of the American Statistical Association (BCASA) invites you all to attend the Fifth Boston Pharmaceutical Symposium. In lieu of an in-person event, the Fifth Boston Pharmaceutical Symposium will include a series of five free webinars hosted on Fridays throughout the summer and fall of 2021.

Webinar Schedule

July 23rd, 10am - 11:30am: Use of Real World Data/Real World Evidence in Clinical Development (Presentation on BCASA Youtube channel: July_23_2021_webinar), Qing Li, Senior Manager, Takeda

September 3rd, 9am - 10am: Adaptive Designs for Optimal Dose Determination in I-O and Cell Therapy, Rachel Liu, Associate Director, Takeda

September 17th, 11am - 12pm. Design Considerations in a COVID-19 Platform Trial - Experience from the ACTIV-2 Trial (Presentation on BCASA Youtube channel: Sept_17_2021_webinar), Michael Hughes, Director, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health

October 22nd, 12pm - 1pm: Bayesian Methods for Historical Data Borrowing (Presentation on BCASA Youtube Channel: Oct_22_2021_webinar), Sammi Tang, Global head of Biometrics, Oncology, Servier, and Chenkun Wang, Associate Director of Biostatistics, Vertex

October 29, 10am - 11am: Novel Design and Implementation of Interim and Final Analyses in the Sham-Controlled Double Blind Randomized Phase III Studies in Spinal Muscular Atrophy (Presentation on BCASA Youtube Channel: Oct_29_2021_webinar), Peng Sun, Senior Director, Biostatistics, Biogen

2022

Below is the information for the 2022 Boston Pharmaceutical Symposium. 

Data and time: Friday, OCt 7, 2022. 8:15am - 4:15pm EDT

Location: Pfizer Inc.1 Portland Street Cambridge, MA 02139

Scientific Committee
Kristin Baltrusaitis, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health (chair)
Alyssa Biller, Cytel
Wenting Cheng, Biogen
Geoffrey Grove, Cytel
Hrishi Kulkarni, Alexion
Xihao Li, Harvard T.H. Chan School of Public Health
Jianchang Lin, Takeda
Charles Liu, Gilead
Jameson Luks, Cytel
Gautier Paux, Sanofi
Veena Somayaji, Pfizer (host)
Sammi Tang, Servier
Zhaoyang Teng, Servier
Christie Watters, Novartis
Weidong Zhang, Sana Biotechnology

Interested in being a part of next year's committee? Reach out to kbaltrus@sdac.harvard.edu
We thank our colleagues at Pfizer for hosting this event. support from Cytel and the ASA Biopharmaceutical Section is also gratefully acknowledged.

2023

Below is the information for the 2022 Boston Pharmaceutical Symposium. 

2023 Boston Pharmaceutical Symposium

The Boston Chapter first organized the Boston Pharmaceutical Symposium in 2017. Since then, the symposium has become a very successful annual event. The Boston Pharmaceutical Symposium provides a unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in statistical practice. We welcome the participation from industry statisticians, academia researchers, university students, and any professionals interested in pharmaceutical statistical topics.

The 2023 Boston Pharmaceutical Symposium will be held at Sanofi’s Campus, in Cambridge MA on October 13, 2023. It’s going to be a full-day event, featuring invited talks, a poster session, network opportunities, and much more. 

All participants in the symposium must register by Friday, October 6. The registration fee covers a light breakfast, lunch, afternoon snacks, and symposium materials. 

Please note: Valid photo ID is required at registration and must be presented to the Sanofi security. Requirements to enter Sanofi buildings are subject to change.

Note to poster presenters: all presenters are expected to register for the symposium and are responsible for printing and transport of the poster. For additional information, please contact ASA.Boston.Pharm.Symposium@gmail.com.

Register Here!

Agenda

Keynote Presentation 1: From Traditional Statistics to AI for Clinical Trials and Beyond - A Paradigm Shift Speaker: Mark Chang Moderator: Zhaoyang Teng
Morning Session 1: Innovative Clinical Trial Design and Statistical Leadership in Drug Development  Moderator/Chair: Xihao Li
Gu Mi	A multi-arm two-stage (MATS) design for proof-of-concept and dose optimization in early-phase oncology trials presentation_slides_Gu_Mi
Lisa LaVange	Master Protocols in a Pandemic: A Case Study in Statistical Leadership
Morning Session 2: Unlocking the power of RWD/RWE in decision making and clinical trial design Moderator/Chair: Jianchang Lin
Tianyu Sun	Enriching Real-World Data Based Studies by Conducting Linkage among Multiple Data Sources  presentation_slides_Tianyu_Sun
Wei Wei	Hybrid platform trial incorporating external data
Keynote Presentation 2: Strategic Innovations in Clinical Development: Unpacking the Statistical Team's Significance  Speaker: Sammi Tang Moderator: Wenting Cheng
Afternoon Session: Methods to Design: Innovation in Statistical Approaches, Optimization, and Clinical Trial Design Moderator/Chair: Brooks Clark
Sarah Conner	Marginal versus conditional rate estimation for count and recurrent event data with an estimand framework
George Kong /Ting Wang	Optimization of Graphic Multiple Comparison Procedures in Confirmatory Trials presentation_slides_George_Kong_and_Ting_Wang
Yannis Jemiai	How large-scale simulation is reshaping clinical development strategy: an insider’s guide presentation_slides_Yannis_Jemiai