Featured Speakers
Plenary Session I-Wednesday, September 23 10:30 a.m. to 11:20 a.m.
Sylva Collins, Office of Biostatistics (FDA/CDER/OTS)
“Impactful Innovation Through Effective Leadership”
Sylva Collins brings more than 30 years of drug development experience and biostatistics leadership to her position at the FDA. Prior to joining, she was vice president of biometrics at ACADIA Pharmaceuticals, leading all aspects of statistical design and analysis of clinical trials, as well as statistical programming and clinical data management. She has emphasized standardization and automation to accelerate clinical development. She pioneered the large-scale deployment of electronic data capture at multiple companies, including Bayer and Novartis. She also implemented standardization of biometrics systems and processes for large pharma organizations to allow near simultaneous regulatory submissions globally.
“Impactful Innovation Through Effective Leadership”
Sylva Collins brings more than 30 years of drug development experience and biostatistics leadership to her position at the FDA. Prior to joining, she was vice president of biometrics at ACADIA Pharmaceuticals, leading all aspects of statistical design and analysis of clinical trials, as well as statistical programming and clinical data management. She has emphasized standardization and automation to accelerate clinical development. She pioneered the large-scale deployment of electronic data capture at multiple companies, including Bayer and Novartis. She also implemented standardization of biometrics systems and processes for large pharma organizations to allow near simultaneous regulatory submissions globally.
Plenary Session II-Thursday, September 24 10:30 a.m. to 11:45 a.m.
Scott Evans, The George Washington University
“Our Most Important Discovery: The Question”
Scott Evans is the author of more than 150 peer-reviewed publications and three books on clinical trials, including Fundamentals for New Clinical Trialists. He is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group, a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of superbugs. He is also a member of the ASA Board of Directors, FDA Advisory Committee, and Clinical Trials Transformation Initiative steering committee. He serves as chair of the Trial of the Year Committee of the Society for Clinical Trials. Additionally, he is the editor of Statistical Communications in Infectious Diseases and co-editor of a special section of Clinical Infectious Diseases.
“Our Most Important Discovery: The Question”
Scott Evans is the author of more than 150 peer-reviewed publications and three books on clinical trials, including Fundamentals for New Clinical Trialists. He is the director of the Statistical and Data Management Center for the Antibacterial Resistance Leadership Group, a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of superbugs. He is also a member of the ASA Board of Directors, FDA Advisory Committee, and Clinical Trials Transformation Initiative steering committee. He serves as chair of the Trial of the Year Committee of the Society for Clinical Trials. Additionally, he is the editor of Statistical Communications in Infectious Diseases and co-editor of a special section of Clinical Infectious Diseases.
Ivan Chan, AbbVie
“Statistical Leadership and Innovations in Practice”
Ivan S.F. Chan has 25 years of experience in the pharmaceutical industry. At AbbVie, he leads the statistics organization supporting discovery, biomarker development, clinical development, and global medical affairs for all therapeutic areas. Prior to joining AbbVie, he was executive director of biostatistics at Merck Research Laboratories.
“Statistical Leadership and Innovations in Practice”
Ivan S.F. Chan has 25 years of experience in the pharmaceutical industry. At AbbVie, he leads the statistics organization supporting discovery, biomarker development, clinical development, and global medical affairs for all therapeutic areas. Prior to joining AbbVie, he was executive director of biostatistics at Merck Research Laboratories.
Plenary Session III-Friday, September 25 10:30 a.m. to 11:30 a.m.
“Global Regulatory Perspectives Panel”
Yuki Ando, Pharmaceuticals and Medical Devices Agency, Japan
Yuki Ando is responsible for the biostatistics review and consultation in the new drug and device review offices at the Pharmaceuticals and Medical Devices Agency (PMDA). Additionally, she works for the Office of Advanced Evaluation with Electronic Data, which is responsible for the use of patient-level electronic study data submitted with new drug applications. She is a member of the Clinical Innovation Network Working Group and Global Clinical Study Working Group, projects spread across multiple offices at PMDA.
Yuki Ando is responsible for the biostatistics review and consultation in the new drug and device review offices at the Pharmaceuticals and Medical Devices Agency (PMDA). Additionally, she works for the Office of Advanced Evaluation with Electronic Data, which is responsible for the use of patient-level electronic study data submitted with new drug applications. She is a member of the Clinical Innovation Network Working Group and Global Clinical Study Working Group, projects spread across multiple offices at PMDA.
Laura Lee Johnson, US Food and Drug Administration
Laura Lee Johnson is a division director in the Office of Biostatistics at the US Food and Drug Administration Center for Drug Evaluation and Research. Her division supports a wide variety of therapeutic areas, many of which rely on less traditional methods to assess evidence. She also works across FDA on patient-focused drug development, rare disease initiatives, and master protocol programs in addition to co-directing the National Institutes of Health Principles and Practice of Clinical Research course.
Laura Lee Johnson is a division director in the Office of Biostatistics at the US Food and Drug Administration Center for Drug Evaluation and Research. Her division supports a wide variety of therapeutic areas, many of which rely on less traditional methods to assess evidence. She also works across FDA on patient-focused drug development, rare disease initiatives, and master protocol programs in addition to co-directing the National Institutes of Health Principles and Practice of Clinical Research course.
Mark Rothmann, US Food and Drug Administration
Mark Rothmann leads three Office of Biostatistics working groups and committees on Bayesian analysis, drug trials snapshots, and pediatric studies. He is also co-chair of the ASA Biopharmaceutical Section Working Group on Pediatric Studies. Previously, he was a reviewer and team leader and involved in the review of oncology, hematology, and metabolism and endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials.
Mark Rothmann leads three Office of Biostatistics working groups and committees on Bayesian analysis, drug trials snapshots, and pediatric studies. He is also co-chair of the ASA Biopharmaceutical Section Working Group on Pediatric Studies. Previously, he was a reviewer and team leader and involved in the review of oncology, hematology, and metabolism and endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials.
John Scott, US Food and Drug Administration
John Scott served as deputy director and a statistical reviewer for blood products and cellular, tissue, and gene therapies at the FDA. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center and did neuroimaging research with the Neurostatistics Laboratory at McClean Hospital. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He has been heavily involved in a number of the FDA’s statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the ICH E9(R1) expert working group on estimands and sensitivity analyses, and the guidance on interacting with the FDA on complex and innovative clinical trial designs.
John Scott served as deputy director and a statistical reviewer for blood products and cellular, tissue, and gene therapies at the FDA. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center and did neuroimaging research with the Neurostatistics Laboratory at McClean Hospital. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He has been heavily involved in a number of the FDA’s statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the ICH E9(R1) expert working group on estimands and sensitivity analyses, and the guidance on interacting with the FDA on complex and innovative clinical trial designs.
Andrew Thomson, EMA Taskforce Dedicated to Data, Analytics, and Methodology
Andrew Thomson supports the methodological aspects of the assessments of marketing authorization applications, as well as scientific advice and methodological aspects of pediatric investigational plans. He has worked extensively on the methodological aspects of the EMA reflection paper on the use of extrapolation of efficacy in pediatric studies and is on ICH E11A, where he leads the statistical workstream.
Andrew Thomson supports the methodological aspects of the assessments of marketing authorization applications, as well as scientific advice and methodological aspects of pediatric investigational plans. He has worked extensively on the methodological aspects of the EMA reflection paper on the use of extrapolation of efficacy in pediatric studies and is on ICH E11A, where he leads the statistical workstream.
Jun Wang, National Medical Products Administration, China
Jun Wang is the deputy director of the Office of Biostatistics and Clinical Pharmacology in the Center for Drug Evaluation of the National Medical Products Administration. He is responsible for the statistical review of new drug applications (NDA), biologics license applications, and Chinese traditional medicines applications, as well as the technical consultations from the sponsors in the investigational new drug and pre-NDA process, mainly on the pivotal trial protocols and statistical analysis plans. He is also in charge of the development of biostatistics regulatory guidances.
Jun Wang is the deputy director of the Office of Biostatistics and Clinical Pharmacology in the Center for Drug Evaluation of the National Medical Products Administration. He is responsible for the statistical review of new drug applications (NDA), biologics license applications, and Chinese traditional medicines applications, as well as the technical consultations from the sponsors in the investigational new drug and pre-NDA process, mainly on the pivotal trial protocols and statistical analysis plans. He is also in charge of the development of biostatistics regulatory guidances.
Chair
Frank Shen, Efficient Pharma Management Corp.
Frank Shen is the president and CEO of Efficient Pharma Management Co. based in Taipei, which helps Asian biopharmaceutical companies develop innovative drugs from preclinical to clinical stages with digital approaches in mind. As an experienced drug developer with expertise in biostatistics and clinical trials, he has served in many leadership roles in major pharmaceutical companies throughout his career, including AbbVie and the Roche Pharma Development Center in Asia.
Frank Shen, Efficient Pharma Management Corp.
Frank Shen is the president and CEO of Efficient Pharma Management Co. based in Taipei, which helps Asian biopharmaceutical companies develop innovative drugs from preclinical to clinical stages with digital approaches in mind. As an experienced drug developer with expertise in biostatistics and clinical trials, he has served in many leadership roles in major pharmaceutical companies throughout his career, including AbbVie and the Roche Pharma Development Center in Asia.