2026 BSSC Keynote Speakers

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Chief Medical Officer, Precision for Medicine

Topic:  Innovating clinical trial analysis for a new era of therapeutics: Behind the AdCom, lessons from a former FDA Oncology Director 

Dr. Harpreet Singh serves as Chief Medical Officer of Precision for Medicine, a global leader in biomarker-driven clinical research and development.  Dr. Singh was previously an Oncology Division Director at the U.S. Food and Drug Administration (FDA) and is responsible for medical strategy and oversight at Precision.

She is an experienced leader with a demonstrated track record in building high performing cross functioning teams, developing and maintaining excellent working relationships with colleagues in academia, industry, and international regulatory bodies. Dr. Singh is scientifically driven, patient centered, with high academic integrity and a commitment to regulatory standards.

Motivated by a desire to accelerate breakthrough treatments in oncology and rare disease, Dr. Singh has a multi-dimensional understanding of drug development along with deep experience as a medical oncologist, having trained at the National Cancer Institute and the University of Southern California Keck School of Medicine. Dr. Singh maintains an active public presence as a thought leader for important issues facing the life sciences industry.

CEO and co-founder of Cyntegrity

Topic: The strategic combination of unsupervised and supervised Centralized Statistical Monitoring

Dr. Artem Andrianov is an internationally recognized leader in data-driven quality management for clinical trials. As the CEO and co-founder of Cyntegrity, he has shaped how sponsors and CROs operationalize ICH E6(R3) principles through validated, AI-powered RBQM and QbD frameworks.

With over 25 years of experience across the pharmaceutical and technology sectors, Dr. Andrianov bridges scientific rigor with operational innovation. His expertise spans biostatistics, data quality assurance, spirometry, ECG, oncology, and ePROs, helping organizations transform compliance into competitive advantage.

Holding a Ph.D. in Mathematical Modelling and an Executive MBA from Cass Business School, London, he brings both analytical depth and strategic vision to every presentation. A frequent speaker at global forums, Dr. Andrianov is known for translating complex regulatory and statistical concepts into actionable strategies that make clinical trials safer, faster, and inspection ready.

Executive Chairman and Co-Founder of Equillium, Inc.

Topic:  Biotech Market Dynamics and Macro Drivers 

Dan Bradbury is a Life Sciences Executive with over 40 years of experience creating and

implementing strategies that transform businesses, bring novel medicines to market, and

maximize shareholder value. He is the Managing Member of BioBrit, LLC, a Life Sciences

Consulting and Investment Firm based in La Jolla, CA.

Dan is the Executive Chairman and Co-Founder of Equillium, Inc. (NASDAQ: EQ), a publicly traded

biopharmaceutical company based in La Jolla, CA, focused on developing products to treatsevere

autoimmune and inflammatory disorders with high unmet medical need. He served as Chief

Executive Officer of Equillium until January 2020. He is the former President, Chief Executive

Officer, and Director of Amylin Pharmaceuticals, a biopharmaceutical company based in San

Diego, CA, focused on metabolic diseases. During his 18-year tenure at Amylin, the company

launched three first-in-class medicines, including the first once-a-week therapy to treat diabetes,

and was listed on the Nasdaq 100. He served as Amylin’s Chief Executive Officer from March

2007 until its acquisition by Bristol-Myers Squibb Company in August 2012. Before joining Amylin,

Dan worked in marketing and sales roles for ten years at SmithKline Beecham Pharmaceuticals.

Dan serves on the board of directors of Castle Biosciences, Inc. (NASDAQ: CSTL), Equillium, Inc.

(NASDAQ: EQ), Vivani Medical, Inc. (NASDAQ: VANI) and a number of private companies and

philanthropic organizations.

Dan received a Bachelor of Pharmacy from Nottingham University and a Diploma in Management

Studies from the University of West London in the United Kingdom.

Founder at Stillwave, UCSD Professor of Practice

Topic: From Data Busboys to Strategic Influencers: How Biostatisticians Lead in the Age of AI
 

Chito Hernandez is the founder of Stillwave, an executive coaching company that embodies the philosophy of finding stillness amidst chaos. Building on a successful career as a life science executive, and now as Professor of Practice at UC San Diego, Chito leverages his expertise to guide the next generation of leaders. He empowers them to pause, reflect, and navigate complexities with clarity and purpose. Through tailored coaching, Chito fosters resilience and adaptability, helping leaders align their actions with their core values.

Chito has led multiple organizations throughout his career. He most recently served as Group Vice President of Data Science at BioMarin, a world leading biotechnology company focused on rare diseases. In addition, Chito is the Founder of FocusQ, an executive consulting firm that he established in the San Francisco Bay Area. Chito held Vice President positions at Elan Pharmaceuticals and Janssen Alzheimer Immunotherapy R&D. He has also made noteworthy contributions to the development of several drugs, eight of which have received regulatory approvals, with seven of them being the first in their class.  Additionally, he serves on boards dedicated to help organizations scale and sustain their impact.

Sr. Director, Global Regulatory Affairs-Body Contouring and Regulatory Innovation at AbbVie

Topic:  TBD

Je Hi An, Ph.D. leads the Global Regulatory Affairs Strategy Team for Body Contouring Devices and Regulatory Innovation at AbbVie. Prior to AbbVie, she worked at the FDA CDRH including the Office of Surgical and Infection Control Devices (OHT4) where she has progressed in responsibilities between 2015-2023 from Lead Reviewer to Assistant Director. Over her career, she has led interdisciplinary teams on regulatory strategy for pre-market documents such as IDEs, Breakthrough, pre-submissions, 513(g), 510(k), de novo, PMAs, and post-market compliance submissions. She obtained her B.E in Biomedical Engineering at the City College of New York and earned her Ph.D. in Biomedical Engineering from Duke University.

Chancellor’s Professor and Chair of Statistics at the University of California, Irvine (UCI)

Topic: Are Futility Bounds Futile?

Daniel Gillen is Chancellor’s Professor and Chair of Statistics at the University of California, Irvine (UCI), and Leader of Data Management and Statistics at the UCI Alzheimer’s Disease Research Center (ADRC). He is a fellow of the American Association for the Advancement of Science (AAAS) and the American Statistical Association (ASA).  His research focuses on the development of statistical methods for the analysis of censored and longitudinal outcomes, as well as methods for the design and analysis of clinical trials. Dr. Gillen has authored or co-authored over 200 peer reviewed publications in statistical and scientific-specific journals as well as the textbook Statistics in Medicine. In addition, he has served as chair or voting member on over 80 independent data monitoring committees (iDMCs) for industry sponsored randomized clinical trials (RCTs) and has served as a standing and ad hoc voting member on numerous FDA advisory committees for over 20 years.

Professor of Biomedical Data Science, Stanford University, Co-Founder Dashu 

Topic:  Transforming Clinical Trials: Harnessing Real-World Data for Optimized Design and Analysis 

Ying Lu, Ph.D., is a Professor of Biomedical Data Science in the Department of Biomedical Data Science, and by courtesy in the  Department of Epidemiology and Population Health, Stanford University School of Medicine. He is a Co-Director of the Stanford Center for Innovative Study Design, the Biostatistics Core of the Stanford Cancer Institute, and Stanford BERD for the SPECTRUM program. His research areas are method development and application in clinical trials in oncology, neurology, cardiology and radiology, statistical evaluation of medical diagnostic tests, meta-analysis, and medical decision making. He published more than 350 research papers in peer-reviewed journals, edited two books and numerous book chapters. Dr. Lu is an elected fellow of the American Association for the Advancement of Science (AAAS) and the American Statistical Association (ASA). 

Prior to his current position, he served as the director of VA Cooperative Studies Program Palo Alto Coordinating Center (2009-2016), Professor of Biostatistics and Radiology at the University of California, San Francisco (1994-2009) and assistant professor at the University of Miami School of Medicine (1990-1994). He served as the 2014 President of the International Chinese Statistical Association (ICSA), the 2020 President of the WNAR, and was a past member of the FDA Peripheral and Central Nervous System (PCNS) Advisory Committee. He is an associate editor of the JCO Precision Oncology and a Co-editor of Cancer Research Section of the New England Journal of Statistics and Data Sciences. Dr. Lu co-founded DahShu (www.dahshu.org), BBSW (www.bbsw.org), and Stat4Onc Annual Symposium (www.stat4onc.org).

Dr. Lu received his BS in Mathematics from Fudan University, MS in Applied Mathematics from Shanghai Jiao Tong University, and Ph.D. in Biostatistics, from the University of California, Berkeley.