Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.

Robert Beckman, M.D. is an oncology clinical researcher and biomathematician focused on improving the way cancer therapies are developed and utilized. He has co-invented novel clinical strategies for proof of concept studies, basket trials, and biomarker driven clinical development, as well as novel therapeutic strategies incorporating tumor evolution. In a previous 18 year industry career, he played leadership roles in forming 4 oncology clinical research groups. He has contributed approximately 300 published articles, book chapters, and presentations, emphasizing quantitative approaches to basic and applied oncology, including a recent book on master protocols. He currently leads the DahShu Innovative Design Scientific Working Group.

Fanni Natanegara is a Senior Director and Head for the Japan Statistics team at Eli Lilly and Company responsible for staff development, technical direction as well as strategic planning and execution of statistical deliverables to meet Japan regulatory and post-launch needs. She joined Lilly in 2003 after she obtained her PhD in Statistics from Baylor University. She held various statistical and leadership positions spanning across drug development phases and therapeutic areas. She is actively engaged in external professional organizations including serving as past Chairs of the Bayesian Scientific Working Group and the American Statistical Associations Statistical Partnership among Academe, Industry, and Government committee.

Zoran Antonijevic is Vice President of Statistical Consulting at Abond CRO. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Innovative Designs Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and, with Bob Beckman, “Platform Trials in Drug Development: Umbrella Trials and Basket Trials”.

Michelle Detry, PhD, is the Director of Adaptive Trial Execution and a Senior Statistical Scientist for Berry Consultants. Dr. Detry’s expertise is in the implementation of adaptive clinical trials, including platform trials. As part of her role in implementing Berry Consultant’s trial designs she is a member of numerous statistical analysis committees that conduct the interim analyses. In addition, she has expertise in clinical trial design, reporting for Data Monitoring Committees, and also serves on Data Monitoring Committees.

Kristin Dolinski is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In her role, she leads regulatory policy initiatives focused on the human drug review program, clinical development, and innovative tools and approaches, including digital health and informatics. Kristin works closely with biopharmaceutical companies and stakeholders, including regulators, on the advancement of advocacy strategies, policy positions, and plans. Prior to joining PhRMA, Kristin worked at the Association of Schools and Programs of Public Health where she led the data analytics program and worked on public health preparedness and training initiatives. Kristin received her degree in French and Sociology from Providence College.

AnnCatherine Downing received her Doctor of Pharmacy degree from Butler University in Indianapolis, Indiana. She has over 17 years of pharmaceutical industry experience across all phases of clinical development. She is currently a Sr. Clinical Research Advisor in Eli Lilly and Company's Design Hub responsible for clinical trial design across the neuroscience portfolio.

Dr. Duliege, Senior Executive and Chief Medical Officer for PanCAN is responsible for the organization’s clinical initiatives, including the Precision Promise clinical trial. She has extensive experience in the biopharmaceutical industry; most recently, she was EVP and CMO at Rigel Pharmaceuticals. Previously, she was an epidemiologist with the National Institute of Science and Medical Research in Paris. She received her MD degree from Paris Medical School. She holds a masters in epidemiology from the Harvard School of Public Health. She continues to practice pediatrics as an Adjunct Clinical Assistant Professor at Stanford Children’s Hospital. She also serves on several boards: CIRM, Fe Pharmaceuticals, and two non-profit organizations.

Yi Liu is Vice President of Biometrics at Nektar Therapeutics leading Biostatistics and Statistical Programming functions. Prior to that, she lead the statistical methodological group at Takeda designing and implementing innovative designs in multiple pivotal trials. Her research interests include multiple comparisons, adaptive designs, and issues with efficacy estimands for time-to-event endpoints. She is in the leadership team of the DIA Innovative Designs Scientific Working Group.

Cristiana Mayer is the Head of Biostatistics at Johnson & Johnson Vision, a company dedicated to the eye care, eye health and eye products. She has 20+ years of experience in the pharmaceutical industry. After 18 years in drug development at Janssen R&D LLC working in different therapeutic areas and 5 years in Statistical Modeling & Methodology group, Cristiana is currently leading the biostatistics and data management groups across the Surgical and Vision Care businesses of JNJ Vision. Her current interests are in CID, Bayesian designs and patients’ engagement. Her recent publications are about simulation practices for innovative designs, ethics and innovation in the pandemic and patient engagement in rare diseases.

Pritibha Singh, a leader at Novartis data42, brings 17 years of global experience spanning Switzerland, Germany, the United Kingdom, Australia, and New Zealand with extensive cross-sector experience (Tech space, Pharmaceutical, Biosimilar, Academia, FMCG, and Banking). Her expertise covers diverse therapeutic areas, including Cardiovascular, Diabetes, Neuroscience, Respiratory, Oncology, Immunology, and Hematology, with a comprehensive background in discovery, development, and late-phase. A blend of expertise in Drug Development (Psychology, Statistics, and Business). Currently pursuing a Doctorate (Dr. sc. ETH Zurich), specializing in sustainable strategies for decentralized clinical trials.

Rui (Sammi) Tang, PhD is currently the VP, Global Head of Biometric Oncology, leading Global biostatistics, statistical Programming and US Medical Writing Departments at Servier Pharmaceuticals US. Her research interests are primarily in adaptive clinical trial design and statistical issues in precision medicine. She authored more than 40 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. She is a co-founder of DahShu, a non-profit organization, founded to promote research and education of 5000 members. She is an active member in ASA and ICSA.

Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.

Amy Burd, Ph.D., is vice president of research strategy for The Leukemia & Lymphoma Society. Dr. Burd first began working with LLS in 2009 as senior director of LLS’s Therapy Acceleration Program. In her current role, Dr. Burd provides strategic planning and oversight for mission special initiatives. She also leads LLS’s Beat AML initiative, a significant multi-institution collaboration to change the paradigm of treatment and improve outcomes for patients with acute myeloid leukemia (AML).

Dr. Pamela Becker is Professor of Clinical Medicine in the Division of Hematology/Oncology at University of California, Irvine (UCI). She is Co-Leader of the Systems, Pathways, Targets Program of the UCI Chao Family Comprehensive Cancer Center. She received her MD from the Harvard Medical School-MIT Health Sciences and Technology Program and her PhD from Harvard Graduate School of Arts and Sciences. She completed residency training in internal medicine at Beth Israel Hospital, Boston, and a postdoctoral fellowship in Hematology at Yale University School of Medicine. Her research has focused on hematopoietic stem cell gene therapy for inherited anemia, drug resistance in hematologic malignancies, and clinical trials in blood cancers.

Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices in Washington, demand optimal care for all young men, and educate the global community.

Nicholas C. Richardson DO, MPH, is a pediatric oncologist in the Division of Hematologic Malignancies 2 within the Office of Oncologic Diseases, at the Food and Drug Administration (FDA). Prior to joining the FDA, he completed his pediatric residency and chief residency at A.I. duPont Hospital for Children/Thomas Jefferson University and fellowship in pediatric hematology and oncology at Vanderbilt University Medical Center. Dr. Richardson’s is currently a clinical team leader for lymphoma drug development and his clinical interest include Hodgkin and non-Hodgkin lymphoma, pediatric drug development in oncology, patient advocate engagement, and innovative trials designs such as master protocols.

Venkat is Head of Biometrics and Data Sciences at BMS. Prior to BMS, Venkat was a partner at ZS, a mngt consulting firm, where he led R&D clinical services. Prior to ZS, Venkat held leadership roles at BMS, Novartis Onc. and GSK. Venkat joined BMS in 2012 leading the early dev. biometrics and in 2016, took responsibility for the specialty pipeline, leading early and late stage biometrics. Prior to BMS, Venkat led the biometrics at Novartis Onc, and was involved with several dev. programs including Tasigna and Affinitor. Venkat has a PhD in Statistics from Temple Univ. and an MBA from Wharton Business School. Venkat is a member of Statistical and Data Science community and has served on the board of Biopharm. Section of American Stat Assoc.

Mercedeh received her Batchelor degree in applied mathematics from Sharif University in Iran in 1988. She obtained her Master degree in Applied Statistics (Genetics) from Simon Fraser University from Canada in 2005. Since then, she has gained experience as a biomarker statistician in different therapeutic areas including oncology and Cardiovascular diseases. She contributed to several presentations, publications and the development of approved biomarker-based panels, in which she holds joint intellectual property. She is an active member of DIA. Her main areas of research are the application of new technologies, advanced analytics, and using Real World Data (RWD) in cardiovascular diseases, rare and pediatric diseases.

An Vandebosch is EU head of statistical modelling and methodology at Janssen and currently assigned to lead statistics and modeling support for the COVID-19 vaccine. She joined Janssen in 2005 after graduating from Ghent University with a PhD on causal inference. Since then she has taken roles with increasing responsibilities actively contributing statistical expertise to various projects across clinical development and multiple disease areas. She serves as associate editor for statistics in biopharmaceutical research, is Belgian representative in the EFSPI council, European Federation of Statisticians in Pharma Industry and member of the EFSPI-PSI Special Interest Group on Statistical Methods in Vaccines.

Dr. Ying Yuan is Bettyann Asche Murray Distinguished Professor and Deputy Chair in the Department of Biostatistics at University of Texas MD Anderson Cancer Center. Dr. Yuan is an internationally renowned researcher in Bayesian adaptive clinical trial design. He published over 200 papers on top statistical and medical journals, and is the leading author of two books published by Chapman & Hall: “Bayesian Designs for Phase I-II Clinical Trials” and “Model-Assisted Bayesian Designs for Dose Finding and Optimization”. Dr. Yuan was elected as an American Statistical Association (ASA) fellow. He also serves as the Chair of Data Safety Monitoring Board (DSMB) at MD Anderson Cancer Center.

Dr. Carrier is the Executive Director of Clinical Development at Fibrogen Inc, leading oncology program and development of anti-CTGF human monoclonal antibody, pamrevlumab in pancreatic cancer. Dr. Carrier authored over 100 publications and several book chapters and presented her research in multiple scientific meetings.

Kristi has been leading the COVID-19 Neutralizing Antibody program as Chief Operating Officer since early March 2020. Within this role, Kristi is responsible for developing the strategic framework, leading program implementation, and establishing external partnerships to expand Lilly’s capabilities and enhance speed to innovation. Throughout Kristi’s 21+ years at Eli Lilly and Company, she had held various roles leading cross-functional teams within the US, Puerto Rico and Ireland, supporting manufacturing, research and development, and external innovation.

Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development and the assessment of study designs. His main research interests are group sequential trials, adaptive designs and multiple testing, focusing on applications in clinical trials. Martin Posch serves as Associate Editor of Biometrics and Biometrical Journal and is Observer at the EMA Biostatistics Working Party. Furthermore, he is member of the EU Patient-centric clinical trial platform IMI EU-PEARL.

Duncan is a Biostatistician at Bristol Myers Squibb. His interest is in leveraging historical trials for informed decision in clinical trials. He is passionate of new and innovative approaches to make clinical trials more efficient.

Jo Aggarwal is the founder and CEO of Wysa, a global leader in conversational AI for behavioral health. Wysa has helped improve mental health for over 3.5 million people through 485 million conversations in 65 countries across the globe, and is the preferred digital behavioral health partner for organizations like NHS UK, Accenture, Aetna, and Ministry of Health Singapore. Aggarwal was recognized as one of the Top 25 Women Leaders in Consumer HealthTech of 2021 by The Healthcare Technology Report. Previously, Aggarwal was the founding director for Technology & Innovation for a UN-backed foundation and has been the managing director of Pearson Learning Solutions in the U.K. Her work on mobile employability post Arab-spring helped connect o

Jorge DiMartino is Chief Medical Officer and Executive Vice President of Kronos Bio, a biotech focused on drugging transcription in cancer. Jorge trained in pediatrics and pediatric hematology/oncology at Stanford from 1993 to 1998 and was an academic physician scientist until he moved to Industry in 2005. Jorge has held Medical Director positions development at Genentech and Celgene focusing on translational and early clinical drug development in oncology. As Vice President of Translational Development, Jorge co-led the Protein Homeostasis and Epigenetics Thematic Center of Excellence, a vertically integrated research unit spanning drug discovery through clinical Proof of Concept. Jorge joined Kronos Bio in December of 2019.

Lisa LaVange, PhD, is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and former director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President.

Dr. Gianna “Gigi” McMillan is theActing Graduate Director for the Bioethics Institute at Loyola Marymount University in Los Angeles and teaches Research Ethics for their graduate program.. She has extensive experience as a Subject/Patient Advocate on local and national IRBs, was a member of the Sub-part A Subcommittee for the Secretary’s Advisory Committee on Human Research Protection and sits on the FDA’s Pediatric Advisory Committee. Dr. McMillan has served on the board of the American Society for Bioethics and Humanities, and is currently a Board Member for PRIM&R (Public Responsibility in Medicine & Research.) Her primary interests are consent issues in clinical research and the use of narrative as an educational tool in bioethics.

Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and new product/licensing evaluations, and eClinical solutions to optimizing the drug development cycle, from the early start-up stage to global product registration.

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations for the DHCoE to advance health equity. This includes the use of patient-generated data and managing bias in DHTs and improve transparency. Additionally, Annie helped incubate and continues to support to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). Previously, Annie was the Director of the Partnerships team in CDRH.

Dr Kirsty Wydenbach is an Expert Medical Assessor in the Clinical Trials Unit, having joined the MHRA in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and many first-in-man studies (having been an EMA expert for the update of the First-in-Human guideline). Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this aspect for the MHRA in order to implement that aspect of the Life Sciences Industrial Strategy and is taking this further through the new Innovative Licensing and Access Pathway (ILAP) novel methodologies tool.

Jiawen Zhu is a Senior Principal Statistical Scientist in Data Science, Product Development, Roche/Genentech. Jiawen has broad experience across statistical method research, CDx development, early and late oncology molecule development. She has been a key contributor to numerous strategic, scientific and operational topics ranging from clinical development plan, fast-to-market strategies, incorporation of synthetic controls, novel clinical trial designs etc. Jiawen has been focusing on statistical metrologies of Bayesian adaptive designs including phase I dose escalation designs and designs incorporating external control in both single arm and RCT settings. Jiawen holds a Ph.D. in Statistics from SUNY-Stony Brook.

Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics from Yale University in 2008 and BA in Mathematics and Computer Science from the University of Oxford in 2002. He was formerly a tenured Associate Professor at the University of Hong Kong where he led a team to do research in biostatistics and bioinformatics. He remains as an Honorary Associate Professor at the University of Hong Kong and is also an adjunct faculty in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine.

Melanie Quintana is a Director of Consulting and Senior Statistical Scientist at Berry Consultants, LLC. She is an expert in utilizing Bayesian statistics to design innovative clinical trials and answer complex clinical questions across a wide range of therapeutic areas. At Berry Consultants, she collaborates with a wide range of clinical experts to find the best solution for answering complex clinical questions and mentors and oversees a group of consultants to do the same. Her work includes the design of over 100 innovative clinical trials in a wide range of therapeutic areas including adaptive designs, platform trials & statistical innovation in rare disease and unmet medical needs.

I am a retired general cancer surgeon who founded the biospecimen management company Specicare. We believe that extraction of knowledge from the data contained within the biospecimen is key to benefiting the patient of today, in addition to the patient of tomorrow. Drug discovery and development is one of the key usages of biospecimens beyond routine diagnosis and staging. However, too often the biospecimen is not used for patient benefit. Our company's mission is to correct this failing and make all parties better informed about the tremendous worth to the biospecimen in the management of the individual cancer patient.

Sabrina Paganoni, MD, PhD is a physician investigator at the Healey Center for ALS at Mass General, Co-Director of the Neurological Research Institute at the Massachusetts General Hospital and Assistant Professor at Harvard Medical School. Dr Paganoni’s research focuses on clinical trials and therapy development for ALS. She has served as the Principal Investigator of many ALS clinical trials and has been using novel neuroimaging techniques, bio-fluid biomarkers and digital technology as measures of target engagement in these trials. Currently, she is the co-Principal Investigator of the HEALEY ALS Platform Trial. Her research has been funded by the NIH, several ALS Foundations and non-profits, and industry.

Crystal Reinhart is an Acute Myeloid Leukemia survivor and patient advocate. Shortly after completing her PhD program and moving to Illinois, she was diagnosed in 2010 and subsequently received a bone marrow transplant in March of 2012. Since that time, she has become a patient advocate, grant reviewer, survivorship researcher, and is involved with several organizations to help develop better treatments and fight cancer. Dr. Reinhart was a board member for the Illinois chapter of the Leukemia & Lymphoma Society (LLS) and has traveled to Washington D.C. to advocate for better coverage of cancer treatments and funding for research. She has worked with the FDA, Johns Hopkins University, Tufts University, and LLS on multiple research projects.