2025 BSSC Keynote Speakers

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Chief Medical Officer at Alzheon

Topic: Development of New Medicines for Alzheimer's Disease.

Dr. Susan Abushakra is the Chief Medical Officer of Alzheon Inc., a privately held biotechnology company developing oral anti-amyloid agents for Alzheimer’s disease. She is the Principal Investigator of a Phase 3clinical trial supported by a $52-Million grant from the National Institute of Aging to evaluate ALZ-801 inAD subjects with the APOE4/4 genotype. Dr. Abushakra previously held leadership roles in clinical development at Elan, Allergan and Eisai, and in global regulatory affairs at Wyeth, with a major focus on Alzheimer’s and other neurodegenerative diseases. Susan was also a co-founder and CMO of privately held Bonti Inc. (a botulinum-toxin company) until its acquisition by Allergan in 2018. Susan is a board-certified neurologist having completed her residency and neuromuscular fellowship training at Johns Hopkins Medical Institutions.

Director, Division of Biostatistics at City of Hope National Medical Center

Dr. Palmer is a Biostatistician with a background in the biological sciences, training in systems analysis, biostatistics, and epidemiology. She has a 25+ year history of collaboration in biomedical research spanning basic science, translational, and clinical, projects. In her role as the Biostatistics Core Director for the Hematologic Malignancies Research Institute (HMRI) at City of Hope, she provides scientific oversight and statistical support (design, monitoring, analysis, and reporting) for

this Core, the Cellular Immunotherapy Center, and all hematology related programs. Dr. Palmer’s research interests and effort support pre-clinical and clinical studies concerning the major obstacles to disease control/cure of hematologic malignancies and successful hematopoietic stem cell transplantation (HSCT).

Topic: The Changing Landscape of Early-Phase Cell and Immunotherapy Clinical Trials in Oncology

Abstract: The early-phase trial design landscape in oncology continues to evolve in direct

response to advances in our understanding of cancer biology and the development of cell and immunotherapy. Given the underlying complexity and cost associated with conducting such studies, in recent years, Biostatisticians have worked to develop more seamless and efficient approaches to the evaluation of these novel therapeutics. Dr. Palmer will provide a brief overview of the changing trial design landscape and highlight contributions made by Biostatisticians in this space.

Senior Director, Innovation Advanced Technology at Edwards Lifesciences

Allen currently serves as the Senior Director of Innovation for Edwards Lifesciences’ Advanced Technology Incubator. In his role, he brings marketing, engineering, and clinical functions together to discover and build the next wave of groundbreaking products for the future of Edwards, leading a team to build and implement the strategy for needs-driven innovation. The incubator is deeply dedicated to solving complex challenges in order to transform cardiovascular treatment and significantly improve patients’ lives around the world. Prior to Edwards, Allen spent time in product management and R&D roles in various medtech industries ranging from digital health (Verily / Google Life Sciences) to cardiac rhythm management (St. Jude Medical), as well as a stint in management consulting with PwC’s medtech strategy & operations practice. In terms of educational background, he holds an MBA from UC-Berkeley (Haas School of Business) and MS/BS in Biomedical Engineering from Johns Hopkins University.

Director, Center for Applied AI Research at University of California, Irvine

Peter D. Chang is a radiologist physician and full-stack software engineer with over a

decade of experience building FDA-cleared and CE-mark certified tools used in

hospitals around the world. At the University of California Irvine, Dr. Chang is a tenured

Associate Professor and founding Director of the UCI Applied AI Research Center, a

multi-specialty initiative to develop and integrate artificial intelligence technology across

the healthcare system. He is also co-founder of multiple AI startups including most

recently Avicenna.ai, a company focused on deep learning for medical imaging

diagnosis, and collaborates closely with industry partners from Nvidia, Amazon, Canon

Medical, Palantir, and Bayer. Dr. Chang leverages his unique cross-disciplinary clinical,

academic, and industry perspective to provide insights at the intersection of healthcare

and AI technology.

Executive Director, Data Management at Pharmapace, Inc. 

Visionary Clinical Data Sciences Leader with a track record of driving transformative change in data management and analytics. Adept at leading high-performing teams through complex organizational shifts, including mergers and large-scale process overhauls. Expertise in transitioning traditional data management functions into cutting-edge data science organizations by integrating AI/ML, automation, and data visualization to enhance data quality and efficiency. Proven ability to implement Quality by Design (QbD), Risk-Based Monitoring (RBM), and Centralized Statistical Monitoring (CSM) to optimize clinical trial execution and regulatory compliance. A strategic innovator who pioneers metric-driven methodologies to improve productivity across internal teams and outsourced vendors while leveraging emerging technologies to drive higher-quality, efficient, and regulatory-compliant data analytics.

Senior Vice President, Research & Development at Travere Therapeutics

Topic: GLP-1 Agonists – An Overnight Success.

Dr. William Rote has served as senior vice president of research and development for Travere Therapeutics since February 2017. He is responsible for discovery and translational research, regulatory affairs, quality assurance, biometrics, medical writing and technical operations including chemistry, manufacturing and controls (CMC).Prior to joining Travere Therapeutics, Dr. Rote led clinical development at Ardea Biosciences, a wholly owned subsidiary of AstraZeneca. In this role, he was responsible for leading all aspects of clinical trial execution and analysis, including clinical operations, data management, and biostatistics. Prior to his role at Ardea, Dr. Rote held numerous positions of increasing responsibility at Amylin, including vice president and site head for R&D. He earned both his doctorate in pharmacology and bachelor’s in pre-medicine from Pennsylvania State University, and received postdoctoral training at the University of Michigan.

Chief Strategy Officer at Abivax

Topic: Pursuing a Broader Role as A Statistician.

Dr. David Zhang is Chief Strategy Officer at Abivax. Prior to joining Abivax, Dr. Zhang was Senior VicePresident, Head of Biometrics and Data Management at Alumis. As part of the founding management team at Alumis, he served as Chief Information Officer responsible for building up capabilities in Biometrics, IT, Facilities and Investor Relations during the early days of the company. Before joining Alumis, Dr. Zhang was Vice President of biometrics, data science and digital health at MyoKardia where he built the advanced analytics capabilities from the ground up to enable the successful completion of critical phase 3 study design, data readouts and New Drug Application submission of Mavacamten (CAMZYOS) until its acquisition by Bristol Myers Squibb in 2020. Prior to MyoKardia, Dr. Zhang spent 15 years atRoche/Genentech with increasing responsibilities leading and building biostatistics and strategic innovation functions. He began his pharmaceutical industry career at Eli Lilly andAbbott Laboratories after receiving his Ph.D. in biostatistics with a minor in genetics fromUCLA and completing post-doctoral research at Columbia University.In addition to his day job, Dr. Zhang serves on the Advisory Council of BBSW, an organization he was a founding member of and served as its President in 2022.

Executive Director at American Statistical Association

We are honored to welcome Ronald L. Wasserstein, Executive Director of the American Statistical Association (ASA), as a special guest speaker at the 2025 BBSC. With a distinguished career dedicated to advancing the role of statistics in science and society, Ron has been a pivotal figure in promoting ethical statistical practices, innovative methodologies, and meaningful collaboration across diverse fields.

Topic: Moving to a World Beyond p<0.05

Abstract: For nearly a hundred years, the concept of “statistical significance” has been fundamental to statistics and to science. And for nearly that long, it has been controversial and misused as well. In a completely non-technical (and generally humorous) way, ASA Executive Director Ron Wasserstein will explain this controversy, and say why he and others have called for an end to the use of statistical significance as means of determining the worth of scientific results. He will talk about why this change is so hard for the scientific community to make, but why it is good for science and for statistics and will point to alternate approaches