2024

2024 Boston Pharmaceutical Statistics Symposium

Boston Pharmaceutical Statistics Symposium is the flagship event for the Boston Chapter. The Boston Pharmaceutical Statistics 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 of industry statisticians, academic researchers, university students, and any professionals interested in pharmaceutical statistical topics.

The Boston Chapter first organized the Boston Pharmaceutical Symposium in 2017. Since then, the symposium has become a very successful annual event. Because statistics is a fundamental element of this symposium, the Boston Chapter and the symposium's scientific committee recently changed the name of the symposium from "Boston Pharmaceutical Symposium" to "Boston Pharmaceutical Statistics Symposium".

The 2024 Boston Pharmaceutical Statistics Symposium will be held at Sanofi’s Campus, in Cambridge MA on October 31 and November 1, 2024. On November 1 it is going to be a full-day event, featuring invited talks, a poster session, network opportunities, and much more. On October 31 it is going to be short courses.

 

Registration 

 

Register Here for Symposium Main Event (Day 2)!

 

Register Here for Short Courses (Day 1, In-Person)!

 

Register Here for Short Courses (Day 1, Virtual)!

 

Registration Guide:

• Full-day Main Event (Symposium on November 1^st):  this event is for in-person participation only. Please use the first registration link if you would like to attend the symposium.
• Short Course (In-person): in-person is the primary format that is expected for the short course. If you wish to attend the short course in person, please use the second registration link.
• Short Course (Virtual-participation): the third registration link, labeled “Register Here for Short Courses (Day 1, Virtual)!” should only be used if you are planning to take the short course remotely.
• A valid photo ID is required and must be presented to the Sanofi security on the event day. Please use the first name and last name that is shown on the photo ID for registration purpose. Email address will be used to contact registrants.

  

Thursday, October 31 – Short Course	Fees
morning short course - BCASA Member/Academia/Symposium SC Member	$108
morning short course - Non-BCASA Member	$135
morning short course - Student/Post-Doc	$50
afternoon short course - BCASA Member/Academia/Symposium SC Member	$108
afternoon short course - Non-BCASA Member	$135
afternoon short course - Student/Post-Doc	$50
2 short courses - BCASA Member/Academia/Symposium SC Member	$160
2 short courses - Non-BCASA Member	$200
2 short courses - Student/Post-Doc	$75
2 short courses - Student with Poster submission	$35
Short course virtual attendance	Same fees as in-person short course attendees
Friday, November 1 – Full-day Main Event
Student	$35
BCASA Member/Post-Doc/Symposium SC Member	$85
Non-BCASA Post-Doc, with 1-year membership	$95
Non-BCASA Member, with 1-year membership	$125
Non-BCASA Member	$115

  

 Agenda

Thursday, October 31, 2024

8:55 am - 9:00 am: Welcome: Gautier Paux
9:00 am - 12:00 pm: Short Course
Yixin Fang	Causal inference and AI/ML in deriving RWE from the analysis of RWD
Moderator: Tu Xu
1:00 pm - 4:00 pm: Short Course
Mark Chang	AI/ML for Clinical Trials and Humanized AI for Future Healthcare
Moderator: Jinghui Dong

 

Friday, November 1, 2024

8:00 am - 8:35 am	Registration/Light breakfast
8:35 am - 8:50 am	Welcome Address – Gautier Paux and Wenting Cheng
8:50 am - 9:00 am	Remarks from ASA Executive Director, Ron Wasserstein
9:00 am - 9:40 am	Keynote: Statistical Boom: Opportunities for a Statistician in an Era of Quantitative Medicines Development Speaker: Margaret Gamalo Moderator: Disa Yu
9:40 am - 10:30 am	Invited talks session 1: Recent statistical innovation in External data borrowing Moderator/Chair: Xihao Li
	Joseph Ibrahim	Optimal Priors for the Discounting Parameter of the Normalized Power Prior
	Veronica Bunn	Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing
10:30 am - 11:00 am	Coffee Break/Networking
11:00 am - 11:50 am	Invited talks session 2: ML/AI-powered clinical development Moderator/Chair: Jianchang Lin
	J. Kyle Wathen	AI-Generated R Functions Integrated with Proprietary Software for Clinical Trial Simulation
	Zoe Hua	Driving Efficiency of Clinical Drug Supply Chains Management in Adaptive Clinical Trials
11:50 am - 1:00 pm	Lunch
1:00 am - 1:40 pm	Lightning Talks Moderators: Larry Han and Hailu Chen Timer: Jinghui Dong
1:40 pm - 2:20 pm	Poster session/Light snack/Networking Timer: Kush Kapur
2:20 pm - 3:10 pm	Invited talks session 3: Advancing Clinical Trials: Digital Innovation, Advanced Modelling, and Pragmatic Approaches Moderator/Chair: Tu Xu
	Zhaoling Meng	Using Digital Innovation in Clinical Trials: Function of Advanced Modelling and Data Science
	Cynthia Hau	Pragmatic Clinical Trials: Future Directions and Design Considerations
3:10 pm - 4:00 pm	Invited talks session 4: Moderator/Chair: Kristin Baltrusaitis
	James Rogers	Practical Steps Toward Model-informed Drug Development using Causal Diagrams
	Issa Dahabreh	TBD
4:00 pm -4:15 pm	Student poster award: Kush Kapur, Kosalaram Goteti, Jimmy Efird, Ina Jazić
4:15 pm - 4:30 pm	Closing remarks: Zhaoyang Teng

 

Speakers Bios

Short Courses: 

Yixin Fang, PhD

Yixing Fang is a Director of Medical Affairs and Health Technology Assessment Statistics (MA & HTA Statistics for short) and a research fellow of AbbVie Community of Science (ACOS for short) at AbbVie. His research interests include causal inference and machine learning with applications in clinical trials and real-world studies. He co-edited the book titled “Real-world evidence in medical product development” and authored the book titled “Causal inference in pharmaceutical statistics”. He served as co-chair of Phase III of ASA Biopharma Section Real-World Evidence Scientific Working Group and he serves as an associate editor for Statistics in Biopharmaceutical Research.

Mark Chang, PhD 

Mark Chang is the founder of AGInception, devoting to AI research. He is an elected fellow of the American Statistical Association with over 25 years of experience as a statistician in the biopharmaceutical industry and academia. He held various positions from Scientific Fellow to Senior Vice President. As adjunct professor in Boston University he has guided his PhD students on thesis topics of Adaptive Clinical Trial Design and Artificial Intelligence. He has broad research interests, including adaptive clinical trials, AI, principles of scientific methods, paradoxes, issues and methods in modern biostatistics interests in general, and software development. His recent publications include Artificial Intelligence for Drug development, precision medicine, and healthcare (2020) and Foundation, Architecture, and Prototyping of Humanized AI (2023). Dr. Chang served on editorial boards for statistical journals and actively engaged in statistical communities for promoting biostatistics. He is a co-founder of the International Society for Biopharmaceutical Statistics. Dr. Chang earned his Master and PhD degrees from the University of Massachusetts in Amherst, MA. 

 
Keynote Speaker:  

Margaret Gamalo, PhD

Margaret (Meg) Gamalo, PhD, is the Vice President and Statistics Head for Inflammation and Immunology at Pfizer Global Product Development. She brings a wealth of expertise in biostatistics, regulatory science, and clinical development across both adult and pediatric populations in various disease areas. Before joining Pfizer, Meg served as Research Advisor in Global Statistical Sciences at Eli Lilly and Company, and as a Mathematical Statistician at the Food and Drug Administration.

Meg has been a leader in several industry initiatives, including chairing the Pediatric Innovation Task Force at the Biotechnology Innovation Organization. She also contributed to the European Forum for Good Clinical Practice – Children’s Medicine Working Party, which provided guidance on the inclusion of adolescents in adult research. Currently, she co-leads the scientific workgroups on Statistics in Pediatric Drug Development and the Statistical Perspective on AI/ML in Pharmaceutical Development within the Biopharmaceutical Section of the American Statistical Association (ASA). In addition to her leadership roles, Meg is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and has been recognized as a Fellow of the American Statistical Association for her contributions to the field.

 
Morning Session 1: Recent statistical innovation in External data borrowing  

Joseph Ibrahim, PhD

Dr. Joseph Ibrahim is an Alumni Distinguished Professor of Biostatistics and the Director of the Biostatistics Core at UNC's Lineberger Comprehensive Cancer Center. Dr. Ibrahim has spearheaded significant research in clinical trials, cancer research, and genomics, holding key roles such as the biostatistical core leader for the NIH-funded Breast Cancer SPORE project and Principal Investigator of the NCI training grant in cancer genomics. With a Ph.D. in statistics from the University of Minnesota and over 36 years of experience, Dr. Ibrahim's work has focused mainly on Bayesian inference, missing data problems, survival analysis, cancer genomics, and clinical trials. He is an elected fellow of the ASA, IMS, ISBA, RSS, ISI, and a recipient of the 2024 Samuel S. Wilks Memorial Award.

Veronica Bunn, PhD

Veronica Bunn is an Associate Director in Oncology statistics. She is an experienced statistical lead for global submissions and approvals in the Oncology setting. Her research interests include Bayesian borrowing methodologies, subgroup analysis, and incorporation of RWE. She obtained her Ph.D. in Biostatistics from Florida State University.

 
Morning Session 2: ML/AI-powered clinical development

J. Kyle Wathen, PhD

Kyle Wathen is Vice President, Scientific Strategy & Product Innovation at Cytel. With a background in academia, consulting, and industry, he has more than 20 years of experience and is an expert on the development and application of novel Bayesian methodology for adaptive clinical trial designs. Kyle has been involved in many innovative clinical trials in oncology, neuroscience, infectious diseases, cardiovascular, and inflammation as well as many platform trials. He has also released several software packages including OCTOPUS, an R package for simulation of platform trials.”

Zoe Hua, PhD

Zhaowei Hua, PhD is currently a director biostatistician at Servier Bio-Innovation in late stage clinical development for oncology therapies. In her industry career with 12+ years of experience, she plays statistical strategic role in early to development programs in oncology and rare disease. Her research interests include clinical trial design, and application of machine learning and artificial intelligence methods in clinical trials.

 

Afternoon Session 1: Advancing Clinical Trials: Digital Innovation, Advanced Modelling, and Pragmatic Approaches

Zhaoling Meng, PhD

Dr. Zhaoling Meng is Associate Vice President, Global Head of Clinical Modeling and Evidence Integration in Evidence Generation and Decision Science, Sanofi R&D. Zhaoling has 20+ years of experience in Pharma. She built and leads a global team to support and promote modeling & simulation (M&S) and quantitative decision making across drug development stages and various disease areas. Her research interests include development scenario and design decision via competitive landscape modeling, real world data use in informing clinical studies, clinical modeling and simulation to trial optimization, and AI/ML in clinical applications. Prior to Sanofi, Dr. Meng also worked at Bill and Melinda Gates Medical Research Institute, Merck, Pfizer and GSK.

Cynthia Hau, MS

Cynthia Hau is a Statistician for the Veterans Affairs (VA) Cooperative Studies Program at the Boston Coordinating Center. Cynthia and the Point-of-Care (POC) Research Committees are at the forefront of developing a collaborative Learning Health System. Cynthia has 15 years of experience in clinical trial data analysis and had previously worked for the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. Since joining the VA in 2018, Cynthia’s work has focused on applying real-world clinical data to support Comparative Effectiveness Research (CER) and evidence-based care. She is passionate about utilizing modern healthcare infrastructure to expand geographic reach of a clinical trial and coverage of the underserved patient populations.

 
Afternoon Session 2: Advancing Clinical Trials: Digital Innovation, Advanced Modelling, and Pragmatic Approaches

James Rogers, PhD

Jim Rogers is the Vice President of Statistics in the Quantitative Sciences Business Unit at Metrum Research Group. Jim and his Metrum Research Group colleagues have been influential in advancing the participation of statisticians in model-informed drug development (MIDD), a paradigm that emphasizes using the totality of the evidence to inform decision making. Prior to joining Metrum Research Group 15 years ago, Jim worked as a statistician at Pfizer. From a methodological perspective, Jim’s focus in recent years has centered on the role of causal inference and transportability concepts in evidence integration.

Issa Dahabreh, PhD (Will be updated soon)

 

 

Sponsorship Opportunities

The Boston Chapter invites you to the 2024 Boston Pharmaceutical Statistics Symposium. Sponsor categories can be found here

Please contact Wenting Cheng (chengwt@umich.edu, Co-chair of 2024 Boston Pharmaceutical Statistics Symposium, President of Boston Chapter) and Zhaoyang Teng (zhaoyang.teng@servier.com, Co-chair of 2024 Boston Pharmaceutical Statistics Symposium) if you have questions.

Thank you to our 2024 Boston Pharmaceutical Statistics Symposium sponsors which have already been confirmed.

Venue Sponsor:

Platinum Sponsor:

 

 

         

 

 

Silver Sponsor:

     

 

 

2024 Boston Pharmaceutical Statistics Symposium Scientific Committee

    Symposium Co-Chair and President of Boston Chapter of ASA

         Wenting Cheng, Biogen

    Symposium Co-Chair and Chair of Speakers and Short Course Subcommittee

         Zhaoyang Teng, Servier

    Symposium Vice-Chair and Venue Host 

         Gautier Paux, Sanofi

    Symposium Vice-Chair and Chair of Poster and Lightning Talks Subcommittee

         Xihao Li, UNC-Chapel Hill

    Symposium Past-Chair and In-charge of student volunteers, Boston local liaison

         Kristin Baltrusaitis, Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health

    Chair of Communication Subcommittee and Webmaster of Boston Chapter of ASA

         Kush Kapur, argenx, Inc.

    Symposium Scientific Committee Members

         Hailu Chen, Alkermes

         Brooks Clark, Cytel

         Jinghui Dong, Kite, Gilead Science

         Jimmy Efird, VA CSPCC - Boston

         Lei Gao, Moderna

         Kosalaram Goteti, EMD Serono & ISOP (SxP-SIG)

         Larry Han, Northeastern University

         Ina Jazic, Vertex

         Jun Ke, Astrazeneca

         Fotios Kokkotos, Boston University

         Maria Kudela, Pfizer

         Hrishikesh Kulkarni, Alexion

         Qing Li, Morphosys

         Jianchang Lin, Takeda

         Charles Liu, Gilead

         Jameson Luks, MaxisIT

         Jianing Wang, Massachusetts General Hospital

         Ting Wang, Biogen

         Tu Xu, Novo Nordisk

         Disa Yu, Sanofi

         Weidong Zhang, Sana Biotechnology

 

Abstracts for Poster/Lightning Talk (capacity reached)

Participants interested in sharing their work at the symposium are encouraged to submit an abstract to the poster session. A limited number of abstracts will be invited to give a lightning talk before the poster session, and a student poster award competition will be presented. Presentations may be given on any topic related to pharmaceutical statistics. Topics of interest may include but are not limited to, adaptive designs, Bayesian designs, platform trials, basket/umbrella trials, master protocols, use of artificial intelligence/machine learning (AI/ML) in clinical trials, real-world data/evidence (RWD/RWE) studies, dose optimization, quantitative decision-making, wearable devices, analysis of pediatrics studies etc.

SUBMIT HERE! 

All poster presenters are expected to register for the symposium and are responsible for printing and transporting the poster.