Webinar: Interpreting Interim Overall Survival (OS) for Decision Making – Speaker Biographies
Click here to learn more about the Interpreting Interim Overall Survival (OS) for Decision-Making Webinar and explore the agenda.
Panel Discussion:
Briggs Morrison, MD
CEO
Crossbow Therapeutics
Briggs Morrison is a board certified medical oncologist. He spent many years in the pharmaceutical industry; his last position was Chief Medical Officer at AstraZeneca. Over the past 11 years he has focused on Board roles at venture backed companies. He was CEO of Syndax from 2015-2022 and is now CEO of Crossbow Therapeutics.
Andrew Mills
Strategic Principal Statistician
MMS Holdings Ltd
Andrew Mills is a Strategic Principal Statistician within the Strategic Statistical Services group at MMS with over 10 years’ experience in the pharmaceutical industry. Andrew is involved in study design and protocol development in clinical and medical device trials utilizing theoretical methodologies as well simulation-based approaches.
Andrew has been involved in numerous therapeutic areas including Oncology, respiratory diseases, Diabetes, and medical devices. Andrew has experience in designing trials with fixed and numerous adaptive design properties, not shying away from innovation when faced with complexity. Andrew is of the opinion that visualization brings about a greater level of understanding in study design process and that there is no greater visualization tool than simulation.
Kiran Patel
Senior Vice President, Global Head of Solid Tumor Clinical Development and Diagnostics
Johnson & Johnson Innovative Medicine
Dr. Patel is Senior Vice President, Global Head of Solid Tumor Clinical Development and Diagnostics at Johnson & Johnson (JNJ), and a member of JNJ Innovation (JJDC). He joined JNJ in 2015 and is responsible for providing strategic insight of solid tumor clinical development programs across all Disease Area Strongholds (DAS) – prostate, bladder, gastrointestinal (GI), lung, head & neck and immuno-oncology.
Dr. Patel has over 25 years of experience in drug development, spanning drug discovery, as well as early- and late-stage programs, leading to multiple regulatory registration and the approvals of more than 10 life-prolonging new molecular entities (NMEs). He has also authored several publications in reputable oncology journals. Before JNJ, he held various roles, including vice president positions at Incyte and GSK, as well as leadership roles at biotech and start-up companies such as Onyx, Pharmacyclics, and ACT Biotech.
He completed his medical education, training and internship at South Gujarat University – Government Medical College, Surat, Gujarat, India, followed by post-doctoral research fellowship training in hematology and oncology at UCSF in San Francisco, California. He also earned a Master of Business Administration (MBA) from Golden Gate University, California.
Lisa R. Rodriguez, PhD
Statistical Strategic Advisor & Oncology Statistics Policy Head
GSK
Lisa Rodriguez is Statistical Strategic Advisor in Oncology Biostatistics at GlaxoSmithKline, where she provides advice to statisticians and teams across the GSK portfolio to inform regulatory and statistical strategy. Lisa has over 20 years of experience across industry/government in a variety of therapeutic areas. She is also part of several scientific working groups within GSK and the American Statistical Association (ASA) Biopharmaceutical Section, and she serves co-lead for the ASA Safety Working Group. Lisa was previously the Deputy Division Director of the Hematology Biostatistics review division at FDA/CDER, where she was biostatistics signatory for drug approvals, authored FDA guidance, and led development of several FDA & ASA scientific workshops and sessions. She has also co-authored many papers and recently served as co-editor of a special issue published in the journal Statistics in Biopharmaceutical Research, focused on statistical methodologies, benefits, and safety concerns regarding Overall Survival (OS) in oncology drug trials. She earned her Ph.D. from Cornell University and certificate in Strategic Decision and Risk Management from Stanford University.
Shu Wang
Statistical Reviewer, Division of Biometrics IX, CDER
FDA
Shu Wang is a statistical reviewer in Division of Biometrics IX in OB/CDER. Shu joined FDA in October 2022 and has been reviewing malignant hematology products since then. Prior to joining FDA, Shu was a Research Assistant Professor in the University of Florida, collaborating with cancer researchers on various clinical trials, observational studies, and research projects.
Névine Zariffa, M.Math.
Principal and Founder
NMD Group, LLC
Névine is a highly accomplished thought leader in the fields of biostatistics and data science with extensive experience across all phases of drug development. Névine had a 25-year career in senior roles at GlaxoSmithKline and AstraZeneca where she also led the Enterprise Data & Analytics initiative. She has been a key contributor to development strategies for over 200 drug projects across oncology, cardiovascular, metabolic, respiratory, inflammation, and renal diseases. She has been a reviewer for The Lancet and has over 30 peer reviewed publications to her name. She is currently a strategic consultant to several organizations including scientific data consortia such as ctDNA. She advised FDA (Office of the Commissioner) on the application of real-world evidence to COVID19. She serves on the Scientific Advisory Board of ANOVA, ZS Associates, Beaconcure and Intelligencia (Chair). She is a Board member of Ephicacy and served on the Board of CDISC for 6 years. She recently published her first novel, Sisters Pieced Together and her short stories appear in @nevine.storyteller.